Chapter 5160-10 Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers

5160-10-01 Eligible providers.

The following provider types are eligible for reimbursement for medical supplies, durable medical equipment (DME), orthoses, and prostheses:

(A) Those providers who have a valid provider agreement, in accordance with eligible provider rules 5101:3-1-17 to 5101:3-1-17.4 of the Administrative Code, as provider type "medical equipment supplier."

(B) The following provider types who have a valid provider agreement, in accordance with eligible provider rules 5101:3-1-17 to 5101:3-1-17.4 of the Administrative Code, may also be approved for the category of service "supplies and medical equipment."

(1) Hospital;

(2) Physician;

(3) Podiatrist;

(4) Advanced practice nurses;

(5) Clinic; and

(6) Pharmacy.

(C) Upon the provision of verification to the Ohio department of job and family services of licensure, registration, or exemption from licensure, providers identified in paragraphs (A) and (B) of this rule are eligible to rent, sell or seek reimbursement for certain equipment considered by the Ohio respiratory care board to be subject to licensure or registration in compliance with Chapter 4752. of the Revised Code or the rules promulgated thereunder.

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 4752.01 , 4752.02 , 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 3/1/84, 5/1/90, 10/15/06

5160-10-02 Coverage and limitations for medical supplier services.

(A) Definitions.

(1) "Medically necessary services."

Those health services which that are necessary for the diagnosis or treatment of disease, illness, or injury and meet accepted standards of medical practice.

(2) "Medical supplies."

Items that are consumable, disposable, or have a limited life expectancy. Examples are: atomizers and nebulizers, catheters, hypodermic syringes and needles.

(3) "Durable medical equipment (DME)."

Equipment that can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury, and is appropriate for use in the home. Examples are: hospital beds, wheelchairs, and ventilators.

(4) "Orthoses."

Devices that assist in correcting or strengthening a distorted body part. Examples are: arm braces, leg braces, hearing aids.

(5) "Prostheses."

Devices that replace all or part of a body organ to prevent or correct physical deformity or malfunction. Examples are: artificial arms, artificial legs.

(6) "Medical equipment."

Durable medical equipment, orthoses, and prostheses.

(7) "Medical supplier services."

Any covered medical supply, durable medical equipment, orthosis, prosthesis, or related service provided by an eligible provider to an eligible recipient.

(8) "Personal residence."

Recipient's place of residence if such residence is not a hospital, nursing facility (NF) or intermediate care facility for the mentally retarded (ICF-MR).

(9) "Professional service."

Service provided by a physician, home health agency, orthotist, prosthetist, certified therapist, or other health care professional, including supplies furnished as incident to the service and that are commonly either furnished as a part of the service without charge or included in the professional charge.

(B) Scope of coverage.

The medical supplier services listed as covered in appendix A to rule 5101:3-10-03 and appendix A to rule 5101:3-10-20 of the Administrative Code have been designated as being within the scope of the medicaid program. Any services not included on the list or designated as noncovered, are outside the scope of the program, or are components of other services. For those within the scope of the program, the department will cover the rental and/or purchase of medical supplier services after third party resources have been exhausted pursuant to rule 5101:3-1-08 of the Administrative Code, and when the item requested:

(1) Is prescribed by a physician (M.D. or D.O.), a doctor of podiatric medicine (D.P.M.), an advanced practice nurse (APN) or an individual who is a certified nurse-midwife, certified nurse practitioner, clinical nurse specialist or a certified nurse anesthetist who is legally authorized under Ohio law to prescribe and/or order the covered medical supplier services;

(2) Is determined by the department or its designee to be medically necessary;

(3) Is provided to an eligible recipient;

(4) Is not a component of a service that is reimbursed by:

(a) A DRG payment;

(b) Per diem rate, such as in NFs; or

(c) Any other payment mechanism that is designed to include coverage of the requested item;

(5) Is not incidental to a professional service;

(6) Is not covered under manufacturer or dealer warranty;

(7) Unless otherwise stated, is not duplicative of any similar equipment or service currently in possession of the recipient;

(8) Is the most cost-effective alternative that will meet the recipient's need as defined in paragraph (F) (8) of rule 5101:3-10-05 of the Administrative Code; and

(9) Is for a recipient who is a resident of a NF or ICF-MR and the item is eligible for direct reimbursement as set forth in appendix A to rule 5101:3-10-03 and appendix A to rule 5101:3-10-20 of the Administrative Code, and will be used exclusively by the recipient for whom it is requested.

(C) Service limitations.

(1) Certain devices and equipment are considered presumptively nonmedical in nature and therefore not within the scope of the medicaid fee-for-service program. Devices and equipment presumptively nonmedical include but are not limited to:

(a) Environmental control devices (e.g., air cleaners, air conditioners);

(b) Comfort and convenience devices (e.g., seat lift chairs, elevators);

(c) Physical fitness equipment (e.g., exercycle);

(d) First aid or precautionary-type equipment (e.g., preset portable oxygen units, emergency alert systems);

(e) Training equipment (e.g., speech teaching machines);

(f) Communication aids, except as covered in rule 5101:3-10-24 of the Administrative Code;

(g) Educational aids; and

(h) Hygiene equipment (e.g., bidets, bed baths).

(2) Routine and minor first aid needs, such as band aids, antiseptics, etc., are not a benefit of the program. Likewise, personal hygiene items such as soap, or diapers for children under the age of three are not a benefit of the program.

(3) Only standard equipment will be authorized and must be dispensed, unless specific medical information indicates a need, and prior approval has been given, for specialized equipment.

(4) Requests for medical supplier services must originate with the recipient's prescriber, family, or caseworker, and must proceed with the recipient's full knowledge and consent.

(a) It is not the intent of the medicaid program that large groups of recipients in institutional or group settings be examined for defects or disabilities to determine the need for medical supplier services, whether examinations are performed in facilities of different types or in a provider's office or store.

(b) When requests for prior authorization of services, submitted either intermittently or en masse, indicate that group examinations have been made, such requests will be referred to the office of research, assessment and accountability.This office, at its discretion, will do an on-site review of mass requests. Those requests determined to be a part of mass screenings will be denied and returned to providers.

(5) Devices and services generally considered by the medical profession, or designated by the federal food and drug administration, as experimental or investigational, are not covered by the program.

(6) Equipment, devices, applications, or services are presumed to be not covered until they have been reviewed by the department for medical applications and appropriateness, safety and effectiveness, and have been designated "covered" or "noncovered"in appendix DD to rule 5101:3-1-60 of the Administrative Code.

Replaces: 5101:3-10- 02.1

Effective: 04/16/2007
R.C. 119.032 review dates: 08/21/2006 and 04/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 10/1/88, 5/1/90, 12/10/93, 12/12/02

5160-10-03 Medical supplies and the medicaid supply list.

(A) This rule sets forth in its appendix (the "medicaid supply list") a table of medical/surgical supplies, durable medical equipment, and supplier services. Columns in the table display the following information:

(1) "Current code": Alphanumeric healthcare common procedure coding system (HCPCS) codes to be used on claims submitted to the department for medical supplier services. Each code is intended to encompass all trade names of the particular product represented. A "not otherwise specified (NOS)" code should be used only when an item is not adequately represented by a specific code.

(2) "Item description": A brief description of the supply or equipment item.

(3) "Unit" indicator: The unit of measure (each one, each pair, box of fifty, etc.).

(4) "Medicaid" indicator: The medicaid coverage for an item.

(a) "Y" indicates that the item is covered by medicaid for all recipients, in accordance with rule 5160-10-02 of the Administrative Code, and the provider may submit claims directly to the department.

(b) "H" indicates that payment may be made only when the item is provided to recipients living in their personal residence.

(c) "H*" indicates that payment will not be made if the item is provided to a recipient living in a nursing facility.

(5) "Prior auth" indicator: Prior authorization requirements.

(a) "Y" indicates that prior authorization by the department is required before payment can be made, in accordance with rule 5160-10-06 of the Administrative Code.

(b) "N" indicates that no prior authorization is required for payment for units up to the maximum number allowable.

(6) "Max units" indicator: The greatest quantity of an item for which payment may be made without prior authorization for the time period specified. This quantity has been established as a guideline rather than a definitive amount. If no maximum quantity is indicated, the quantity authorized will be based on medical necessity as determined by the department. (Note: A provider may receive payment without prior authorization for up to thirty-one units per month of an item with an indicator of "one per day.")

(7) "RNT/P" indicator: Rental/purchase.

(a) "RO" indicates that the item is always rented.

(b) "PP" indicates that the item is always purchased.

(c) "R/P" indicates that the item is subject to the rent-to-purchase provision set forth in rule 5160-10-05 of the Administrative Code.

(B) In order to be eligible for payment for medical supplier services rendered, a provider must either meet the conditions set forth in Chapter 4752. of the Revised Code or be exempt from licensure under Chapter 4752. of the Revised Code.

(C) Medical supplier services must be prescribed by a prescriber actively involved in managing the recipient's medical care through a comprehensive plan of care that addresses the need for medical supplier services, and the medical necessity of the services must be documented in the recipient's medical record. By signing a prescription, the ordering prescriber attests to the medical necessity of the services.

(D) The following documentation must be submitted with all requests for prior authorization:

(1) A fully completed form JFS 01913, "Certificate of Medical Necessity/Prescription; General Medical Supplies: Overage" (rev. 11/2011), that is signed and dated no more than thirty days before the first date of service; and

(2) Any other document required or requested by the department for certain specific medical supplier services, as detailed in Chapter 5160-10 of the Administrative Code.

(E) Requests that exceed the specified maximum for an item but do not otherwise require prior authorization must be submitted to the department for review before payment for the item will be considered.

(F) The submitted charge for gauze pads and for items described as "wound fillers/packing" must not exceed the manufacturer's suggested list price for the item. Providers must maintain a detailed record in the recipient's file of all such items that have been dispensed and for which claims have been submitted to medicaid.

(G) Providers must apply any rebate or discount to the charge submitted on a claim. A "discount" is a reduction in the amount charged to a buyer for a purchase made either directly or through a wholesaler or a group purchasing organization.

Replaces: 5160-10-03

Effective: 12/31/2013
R.C. 119.032 review dates: 12/31/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5164.02 , 5164.70 , 5165.01 , 5165.47
Prior Effective Dates: 03/01/1984, 12/30/1984, 10/01/1988, 12/01/1989, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 05/25/1991, 12/30/1991, 04/01/1992 (Emer), 07/01/1992, 11/16/1992, 12/31/1992 (Emer), 04/01/1993, 07/08/1993, 12/10/1993, 12/30/1993 (Emer), 03/31/1994, 07/01/1994, 02/01/1995, 12/29/1995 (Emer), 03/21/1996, 12/31/1996 (Emer), 03/31/1997, 08/01/1997, 08/01/1998, 12/31/1998 (Emer), 03/31/1999, 01/04/2000 (Emer), 03/20/2000, 12/29/2000 (Emer), 03/30/2001, 12/31/2001 (Emer), 03/29/2002, 03/24/2003, 10/01/2004, 12/30/2004 (Emer), 03/28/2005, 12/30/2005 (Emer), 03/27/2006, 10/15/2006, 12/29/2006 (Emer), 03/29/2007, 07/30/2007, 12/16/2007, 12/31/2007 (Emer), 03/30/2008, 04/01/2009, 07/31/2009 (Emer), 10/29/2009, 12/31/2009 (Emer), 02/01/2010 (Emer), 03/31/2010, 12/30/2010 (Emer), 03/30/2011, 03/29/2012

5160-10-04 Pneumatic Compression Devices and Accessories.

(A) Definitions

(1) Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy), post-radiation fibrosis, and spread of malignant tumors to regional lymph nodes with lymphatic obstruction, among other causes.

(2) Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in veins. Signs of CVI include hyperpigmentation, status dermatitis, chronic edema, and venous ulcers.

(B) Coverage determination

(1) Pneumatic compression devices and accessories are only covered in a private residence for the treatment of lymphedema or the treatment of chronic venous insufficiency with venous stasis ulcers.

(2) Pneumatic compression devices and accessories are covered in a private residence for the treatment of lymphedema if the consumer has undergone a four-week trial of conservative therapy and the prescriber determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The compression garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

(3) Pneumatic compression devices and accessories are covered in a private residence for the treatment of CVI of the lower extremities only if the consumer has one or more venous stasis ulcer(s) which have failed to heal after a six month trial of conservative therapy directed by the treating prescriber. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

(4) For either lymphedema or CVI with venous stasis ulcers, pneumatic compression devices are covered only when prescribed by a prescriber and when they are used with appropriate prescriber oversight, i.e., prescriber evaluation of the consumer's condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.

(5) Any prescription for a pneumatic compression device and accessories must be prescribed by a prescriber actively involved in managing the consumer's medical condition as defined in paragraph (A)(2) of rule 5101:3-10-05 of the Administrative Code and who should be treating the consumer under a comprehensive plan of care which addresses the underlying medical need for any equipment and accessories referenced in this rule.

(C) Non-coverage determination

(1) Pneumatic compression devices and accessories are not separately reimbursable for consumers in long term care facilities (LTCFs) as this equipment and supplies are included in the facility's per diem payment.

(2) Accessories used for pneumatic compression of the chest or trunk will be denied as non-covered.

(D) Authorization

(1) In addition to a fully completed prior authorization form JFS 03142 (rev. 2/2003), a fully completed "Certificate of Medical Necessity/Prescription Pneumatic Compression Devices" form JFS 02929 3/2009 (appendix A to this rule) signed and dated by the treating prescriber must be obtained by the provider no more than thirty days prior to the first date of service in order to request authorization for any pneumatic compression device and/or accessories and must specify:

(a) The consumer's diagnosis and prognosis;

(b) The symptoms and objective findings, including measurements which establish the severity of the condition;

(c) The reason the device is required, including the treatments which have been tried and failed; and (d) The clinical response to an initial treatment with the device via rental which includes the change in pre-treatment measurements, ability to tolerate the treatment session and prescribed parameters, and the ability of the consumer (or caregiver) to apply the device for continued use in the home. The initial rental period of this device cannot be less than thirty days or more than ninety days before request for purchase is made by the provider.

(2) When a pneumatic compression device is covered, a non-segmented device or segmented device without manual control of the pressure in each chamber is generally sufficient to meet the clinical needs of the consumer.

(3) A non-segmented compressor with a segmented appliance/sleeve is considered functionally equivalent to a compressor with a segmented appliance/sleeve.

(E) Dispensing

(1) The following components are considered "inclusive" with any pneumatic compression device payment made by medicaid on behalf of a consumer and cannot be submitted to medicaid for separate payment:

(a) Any supporting wires, cables, or attachment kits;

(b) Education, training, monitoring, or counseling in support of the consumer's ordered treatment plan;

(c) Maintenance, repair, or cleaning charges incurred by the provider during a rental period; and

(d) Delivery, set up, or pick up charges associated with the equipment or supplies.

(2) The provider of a pneumatic compression device must assure that the consumer (or the consumer's caregiver) is properly instructed on how to use the device and is aware of and understands any emergency procedures regarding the use of the device. The provider must maintain written documentation regarding the consumer's instruction on the use of the device in the consumer's medical record.

(3) Upon the dispensing of a pneumatic compression device, the consumer (or the consumer's caregiver) must be supplied by the provider with a twenty-four hour, seven-day-a-week telephone number to be utilized in case of an emergency during the rental period. This telephone number must meet all requirements of the Americans with Disabilities Act of 1990.

(F) Reimbursement

(1) Pneumatic compression devices and accessories are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge, whichever is less.

(2) The department does not purchase previously utilized, refurbished or loaner pneumatic compression devices.

Click to view Appendix

Effective: 01/07/2010
R.C. 119.032 review dates: 01/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021

5160-10-05 Reimbursement for covered services.

(A) Unless otherwise specified, for each claim for reimbursement, providers must keep in their files a legible prescription, including a diagnosis, signed and dated not more than sixty days prior to the first date of service by the consumer's prescriber. For incontinence garments and related supplies, a legible prescriber's prescription, signed and dated not more than thirty days prior to the first date of service must be maintained on file by the provider; prescriptions for incontinence garments and related supplies must include all information required in accordance with rule 5101:3-10-21 of the Administrative Code.

(1) Providers are required to maintain proof of delivery documentation for durable medical equipment (DME), medical supplies and orthotics and prosthetics dispensed to consumers.. Accepted criteria for proof of delivery documentation are as follows:

(a) Providers, their employees, or anyone else having a financial interest in the delivery of DME, medical supplies or orthotic and prosthetic items are prohibited from signing and accepting an item on behalf of a consumer; and

(b) Any person accepting a delivery of DME, medical supplies or orthotic and prosthetic items on behalf of a consumer will note on the delivery slip their relationship to the consumer.. The signature of the person accepting the delivery should be legible. If the signature is not legible, the provider/ shipping service will note the name of the person accepting the delivery on the delivery slip; or

(c) If the provider utilizes a shipping service or mail order, an example of proof of delivery would include the service's tracking slip, and the supplier's own invoice. If possible, the supplier's records will also include the delivery service's package identification number. The tracking slip will reference each individual package, the delivery address, the corresponding package identification number , and the date delivered. The provider shall use the shipping date as the date of service on the claim. Providers may also utilize a return postage-paid delivery invoice from the consumer or consumer's designee as a form of proof of delivery. The descriptive information concerning the DME, medical supplies or orthotic and prosthetic item (i.e., the consumer's name, the quantity, detailed description, brand name, and serial number) as well as the required signatures from either the consumer or the consumer's designee must be included on this invoice as well; and

(d) For residents of a long term care facility , providers will obtain legible copies of the necessary documentation from the nursing facility to document proof of delivery or usage by the consumer (e.g., nurse's notes).

(2) Prescriptions for DME, medical supplies, orthotics or prosthetics listed athttp://jfs.ohio.gov/OHP/bhpp/FSRDisclaimer.stm must have originated as a result of a face-to-face encounter between the prescriber and the consumer. This encounter must occur no more than one hundred and eighty days prior to the prescription being written and cannot occur following the date the prescription is written.

(3) During the face-to-face encounter, the prescriber must have evaluated the consumer, conducted a needs assessment or actively treated the consumer for the medical condition that supports the need for each covered item of DME, medical supply or orthotics or prosthetics. The face-to-face encounter must be documented in the consumer's medical record.

(4) When the face-to-face encounter is conducted by a physician assistant, a clinical nurse specialist or a certified nurse practitioner, it must be documented by a physician signing the pertinent portion of the medical record.

(5) A single face- to-face encounter can support the need for multiple covered items as long as it is clearly documented in the medical record that the consumer was evaluated or treated for a condition that supports the need for each covered item.

(6) Except as provided in this paragraph, prescriptions for DME , medical supplies, orthotics or prosthetics not referenced in paragraph (A)(2) of this rule must originate as a result of a face-to-face encounter between the prescriber and the consumer. A separate examination for each subsequent item prescribed is not necessary if:

(a) The prescriber has reviewed the medical record generated from a face-to-face encounter conducted within the previous twelve months and the DME, medical supply or orthotic or prosthetic item or items prescribed are related to diagnoses established in that face-to-face encounter; or

(b) The prescription is written based on the judgment of a prescriber who has reviewed the consumer's medical record from a face-to-face encounter conducted within the previous twelve months by a different prescriber, and the item or items are related to diagnoses that were established in that face-to-face encounter.

Prescriptions for a long-term supply of disposable items ( e.g., incontinence garments or wound supplies) can be renewed no sooner than ninety days prior to the expiration of the current prescription. DME, orthotic or prosthetic and medical supply prescriptions are valid for a maximum of one year from the originating date of the prescription.

(B) The reimbursement for DME, medical supplies, orthotics or prosthetics includes at a minimumthe following:

(1) The manufacturer's and dealer's warranty; and

(2) Any costs associated with assembling items or parts used for the assembly of items; and

(3) Any adjustments and/or modifications required within ninety days of the dispensing date (for purchases) or during the total rental period (for rentals), except those occasioned by major changes in the consumer's condition; and

(4) Instruction to the consumer in the safe use of the item or items; and

(5) Cost of delivery to the consumer's residence and, when appropriate, to the room in which the item or items will be used.

(6) For further details on specific items, see Chapter 5101:3-10 of the Administrative Code.

(C) Unless prior authorization has been obtained for used DME, all DME must be new at the time of purchase or have been new at the time of rental. Used DME, if clearly designated on the prior authorization request form as used, in good working order, and covered by the same warranty as new , may be provided if approved by the department. Reimbursement for used DME will be the lower of eighty per cent of the medicaid maximum or the billed charge. The modifier code UE must be used when billing for used DME.

(D) Replacement items or parts will only be reimbursed for consumer-owned DME. See rule 5101:3-10-08 of the Administrative Code for details regarding reimbursement for DME repair.

(E) Automatic refills of DME, medical supplies or orthotic or prosthetic items are not eligible for reimbursement. Providers shall not dispense DME, medical supplies or orthotic or prosthetic items in excess of one month's supply for the duration of the prescribed period. No DME, medical supplies or orthotic or prosthetic shall be billed before they have been provided.

(F) Unless otherwise stated, payment for DME (including custom wheelchairs, power wheelchairs and all wheelchair parts and accessories), medical supplies orthotics or prosthetics is reimbursed utilizing the following criteria:

(1) When the item or items appear in appendix DD to rule 5101:3-1-60 of the Administrative Code, the provider shall bill the department the provider's usual and customary charge and will receive the lesser of the usual and customary charge or the medicaid maximum rate that appears in this appendix ; or

(2) When the item or items do not appear in this appendix or appear but without a medicaid maximum rate and the provider has submitted a list price for payment, the provider shall bill the usual and customary charge and will receive the lesser of the usual and customary charge or seventy-two per cent of the list price; or

(3) When the item or items in question do not appear in this appendix or appear but without a medicaid maximum rate and the provider has submitted an invoice price for payment, the provider shall bill the usual and customary charge and will receive the lesser of the usual and customary charge or one hundred forty-seven per cent of the invoice price less any discounts or rebates applicable at the time of billing but exclusive of any discounts or rebates the provider may receive subsequent to the time of billing; or

(4) In circumstances where paragraphs (F)(1), (F)(2) and (F)(3) of this rule occur concurrently, the department will reimburse the amount determined to be the most cost effective.

(5) The "list price" is defined as the most current price recommended by the manufacturer for retail sale. This price cannot be established nor obscured or deleted by the provider on any documentation supplied for consideration of reimbursement. A provider may set list price for custom products where the provider is both the manufacturer and the provider so long as the list price is equal to or less than comparable products. Documentation submitted to support this price is subject to approval by the department.

(6) The "invoice price" is defined as the price delivered to the consumer and reflects the provider's net costs in accordance with rule 5101:3-10-03 of the Administrative Code. This information cannot be obscured or deleted on any documentation supplied for consideration of reimbursement. Documentation submitted to support this price is subject to approval by the department.

(7) Costs of delivery and service calls related to DME,

medical supplies, orthotics or prosthetics are considered an integral part of the provider's cost of doing business. A charge for these services will not be recognized when billed separately.

(8) The consumer must be supplied with the most cost effective DME, medical supply or orthotic or prosthetic that meets their clinical needs.

Cost effective is defined to mean items which meet the consumer's clinical and lifestyle requirements at the lowest available cost.

(9) A supplier of custom items may be reimbursed when the consumer for whom they were intended expires prior to dispensing under the following conditions:

(a) The "Healthcare Common Procedure Coding System" code used to describe the item indicates it is designed or intended for a specific individual; and

(b) The item cannot be modified for use by another individual; and

(c) The provider can document measurements of the consumer were taken for fitting prior to the end of life; and

(d) The provider can document the consumer's health status at the time the item was requested did not indicate the end of life was imminent; and

(e) The provider uses the date the consumer's measurements were taken as the date of service for the item.

(G) Duplicate equipment, supplies, or services, or conflicting equipment prescribed for a consumer are not reimbursable.

(1) "Conflicting equipment" is defined as equipment which serves the same or a similar purpose regardless of payment source. Examples include a wheelchair followed by a power-operated vehicle or more than one wheelchair.

(2) Suppliers are responsible for ascertaining whether there is conflicting equipment. All providers are expected to know whether requested equipment is contraindicated by equipment supplied by a different provider.

(3) If change in a consumer's condition warrants a change in equipment, the existing equipment must be noted when prior authorization is requested for the new equipment.

(H) The department will not reimburse for materials or services covered under the manufacturer's or dealer's warranty. Providers must keep a copy of the warranty in their files. A copy of the warranty must be provided upon request of the department and must be submitted with any prior authorization request for repairs.

Any repair or servicing done on equipment that is consumer owned must be documented, kept in the providers file, and provided to the department upon request.

(I) Purchase or rental of durable medical equipment.

A prescription must accompany each request for the prior authorization of DME. The department reserves the right to determine whether an item will be rented or purchased. Rental of equipment is valid only as long as medical necessity exists.

(1) Rental only.

Certain DME requiring servicing to ensure the health and safety of recipients will be designated as "rental only." Rental only equipment is designated RO in appendix A to rule 5101:3-10-03 of the Administrative Code. The rental payment amount is specified in appendix DD to rule 5101:3-1-60 of the Administrative Code. Unless otherwise specified, no modifier code is used in billing "rental only" items.

(2) Routinely purchased items, lump sum purchase.

Most items on the "Medicaid Supply List" are categorized as "routinely purchased items" and would ordinarily be purchased and become the property of the consumer.

(3) Short- term rental and rent- to- purchase.

(a) The rental of DME may be approved when it is determined to be more cost-effective than purchase. The approved rental period under one prior authorization number shall not exceed six months, unless specified elsewhere in Chapter 5101:3-10 of the Administrative Code. Payment for short- term rental will be made at ten per cent per month of the maximum amount allowable . Providers should use the modifier RR when billing short-term rental.

(b) If a prior authorization request is received for a second rental period, the department will make a determination on whether to purchase the item. Upon a decision to purchase, all prior rental payments will apply toward the purchase price and the provider will receive one final payment for the remainder of the item's maximum allowable amount as specified in appendix DD to rule 5101:3-1-60 of the Administrative Code. The provider will notify the consumer when an item has been purchased on their behalf.

(c) The reimbursement for items purchased within ninety days of the end of a rental period, inclusive of all rental payments and the remaining purchase price, cannot exceed the medicaid maximum amount.

(d) Prior authorization is required prior to reimbursment for those DME items designated as R/P in appendix A to rule 5101:3-10-03 of the Administrative Code.

(J) For items authorized for monthly rental on a monthly basis, payment will be made through the end of the month in which: the consumer becomes ineligible,; the item is no longer medically necessary; or, the maximum amount allowable is reached. For items authorized for rental on a daily basis, the items are billiable only those days when the consumer is eligible and the item is medically necessary.

(K) Medicare-covered services provided to residents of long-term care facilities who are dually eligible for medicare and medicaid must be billed directly to medicare. Following payment by medicare, medicaid payment will be made directly to the provider.

(L) Reimbursement for a back-up ventilator may be allowed upon provision of the documentation required in rule 5101:3-10-22 of the Administrative Code.

(M) With the exception of nonmolded helmets and splints, all covered orthotic and prosthetic devices listed in appendix A to rule 5101:3-10-20 of the Administrative Code may be submitted for reimbursement when provided to eligible residents of nursing facilities.

(N) RT (right side) and LT (left side) modifiers

Use of either the RT or LT modifiers is required when billing for the codes listed at http://jfs.ohio.gov/OHP/bhpp/FSRDisclaimer.stm. For items having the same billing code and dispensed bilaterally on the same date of service for the same consumer, both the RT and the LT modifier must be used.

Effective: 07/01/2013
R.C. 119.032 review dates: 01/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02 , Sect. 309.30.75 of Am. Sub. H.B. 1 of 128th GA
Rule Amplifies: 5111.01 , 5111.02 , 5111.021 , Section 309.30 75 of Am. Sub. H.B. 1 of 128th GA
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 10/1/88, 5/1/90, 6/20/90 (Emer), 9/5/90, 2/17/91, 9/1/98, 7/1/04, 7/1/06 , 1/1/10

5160-10-06 Prior authorization.

Unless otherwise specified, reimbursement for some medical supplier services is available only upon prior authorization from the Ohio department of job and family services. (See Chapter 5101:3-1 of the Administrative Code for details about prior authorization.)

(A) Requests for prior authorization for medical supplier services must include:

(1)

. A current manufacturer's price list when the item in question does not have a medicaid maximum rate listed in appendix DD to rule 5101:3-1-60 of the Administrative Code.

(2) A description, including approximate age and ownership, of any similar equipment or service currently in possession of the recipient and the reason for the new request.

(3) A prescription issued in accordance with Chapter 5101:3-10 of the Administrative Code. The prescription must contain a diagnosis consistent with the medical necessity of the requested item and indicate the quantity requested.

Medical supplier services must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care which addresses the need for medical supplier services. This prescription must contain the original signature of the ordering prescriber that attests to the medical necessity of these services.

(4) As specified in Chapter 5101:3-10 of the Administrative Code, prior authorization requests for certain medical supplier services require the submission of a fully completed certificate of medical necessity (CMN) that has been signed and dated by an eligible prescriber no more than thirty days before the first date of service. Prior authorization requests for medical supplier services submitted without a fully completed and signed certificate of medical necessity as specified in Chapter 5101:3-10 of the Administrative Code will be denied due to lack of required documentation.

(5) Other documentation as required or requested by the department for certain specific medical supplier services, as detailed in Chapter 5101:3-10 of the Administrative Code.

(6) Any requests for items that exceed the specified maximum allowable indicator referenced in rule 5101:3-10-03 of the Administrative Code and do not otherwise require prior authorization (PA) must be submitted for review by the department before reimbursement for such items will be considered.

(7) The following documentation must be submitted with all PA requests for items referenced in paragraph (A)(6) of this rule:

(a) A fully completed form JFS 01913 "Certificate of Medical Necessity/Prescription General Medical Supplies: Overage" (CMN) (appendix B to rule 5101:3-10-03 of the Administrative Code) that is signed and dated no more than thirty days before the first date of service.

(b) Any other documentation as required or requested by the department for certain specific medical supplier services, as detailed in Chapter 5101:3-10 of the Administrative Code.

(B) Reevaluation and prior authorization requests must be made at appropriate intervals of not more than twelve months, unless otherwise specified in Chapter 5101:3-10 of the Administrative Code.

(C) Providers should not submit the billing claim form with the prior authorization request.

(D) For items that require multiple fittings and special construction, the first service date may be used as the dispensing date for prior authorization. However, the invoice/claim form shall not be submitted for payment until the consumer has received the item/service. Providers are required to maintain proof of delivery documentation for durable medical equipment (DME) items dispensed to consumers in their files. Accepted criteria for proof of delivery documentation are detailed in rule 5101:3-10-05 of the Administrative Code.

(E) The item or service actually supplied to a recipient must be the item/service in the quantity specifically approved by the department on the "Prior Authorization" (PA) form. Unless otherwise specified, no item/service substitutions are allowed without explicit authorization by the department.

(F) Providers using a healthcare common procedure coding system (HCPCS) miscellaneous code on a prior authorization request for a bundled service must itemize all bundled components for which they are requesting reimbursement using the miscellaneous code in question.

(G) When a provider is requesting authorization of a service greater than the department established maximum allowable units for that service, a complete history that includes the date and amount of all services provided and billed previously must be included. A detailed explanation must be provided of the medical necessity for the additional services. Requests for authorization of additional services will not be considered without this information.

(H) Prior authorization requests for replacement medical equipment will be considered based on medical necessity. However, cases suggesting malicious damage, neglect, culpable irresponsibility, or wrongful disposition of the medical equipment in question will be investigated and prior authorization may be denied where the department determines it is unreasonable to make further program payment under the circumstances presented to the department in support of the equipment replacement request. Providers will provide any information regarding requests for the replacement of medical equipment that the department deems necessary in order to evaluate the replacement request.

Effective: 03/29/2012
R.C. 119.032 review dates: 01/13/2012 and 03/01/2017
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 10/1/87, 5/1/90, 2/17/91, 9/1/02, 4/16/07

5160-10-08 Repair of medical equipment.

(A) Durable medical equipment covered under rule 5160-10-03 of the Administrative Code and speech generating devices.

(1) Department coverage for repair of medical equipment has been established for major and minor repairs.

(a) "Major repairs" are those repairs for which the combined charges for materials and labor exceed one hundred dollars. Prior authorization is required for major repairs to durable medical equipment. Prior authorization requests must include complete itemization of parts and labor.

(b) "Minor repairs" are those repairs for which the combined charges for materials and labor are one hundred dollars or less. For a maximum of one repair per recipient per one hundred twenty-day period, prior authorization is not required for minor repairs to durable medical equipment. Prior authorization must be obtained for minor repairs in excess of one per recipient per one hundred twenty-day period and for minor repairs within ninety days after the dispensing date of equipment or prior to the expiration of any applicable warranty. Prior authorization requests must include complete itemization of parts and labor.

(c) Providers must submit the appropriate procedure code(s) including modifiers as required for all equipment repair claims submissions and prior authorization requests. For the reimbursement of repairs requiring materials and labor, the appropriate procedure codes must be submitted together on the same claim for the same date of service.

(i) For the reimbursement of repairs or replacement parts without a specific procedure code, use code E1399 modified with the RB modifier in combination with labor code E1340 as appropriate.

(ii) For the reimbursement of repairs requiring only the time of a technician, without a specific labor code, use labor code K0739.

(iii) For the reimbursement of repairs or replacement of parts of wheelchairs without a specific procedure code, use code K0108 modified with the RB modifier in combination with labor code K0739 as appropriate.

(d) All wheelchair and power operated vehicle (POV) repairs must be billed in accordance with rule 5160-10-16 of the Administrative Code.

(2) Unless otherwise specified, a fully completed "Certificate of Medical Necessity/Prescription Repair of Durable Medical Equipment (DME)," form JFS 01904 (rev. 04/2009), is required if the item requiring repair:

(a) Was not paid for by the department; or

(b) Was originally approved through the department's prior authorization procedure and the repair would substantially change the appearance or function of the item; or

(c) Did not require prior authorization but was paid for by the department and is a major repair.

(3) A written prescription is required if the item requiring repair did not require prior authorization but was paid for by the department and is a minor repair. This documentation must be kept in the consumer's medical record.

(4) "Labor" is the time required by a technician to repair, refurbish, or provide nonroutine service on medical equipment more than ninety days after the dispensing date of that equipment and after the expiration of any applicable warranty.

(5) Requests for prior authorization of repairs (both minor repairs in excess of one per one hundred twenty days and major repairs) must itemize parts and labor separately. Prior-authorized labor will be reimbursed at the lesser of the billed hourly rate or the medicaid maximum rate for labor listed in appendix DD to rule 5160-1-60 of the Administrative Code, prorated for periods of less than one hour.

(6) Requests for prior authorization of major repairs for durable medical equipment must specify who owns the equipment, the date of purchase or the approximate age of the equipment, and the applicable warranty period.

(7) No reimbursement may be made for:

(a) Any repairs covered under manufacturer or dealer warranty; or

(b) Repair of rental equipment covered by the rental payment; or

(c) Costs associated with providing temporary replacement equipment due to repair; or

(d) Costs associated with postage, pick-up, delivery and set-up or installation.

(8) Reimbursement may be provided for major repair of medical equipment not purchased by the department only if that equipment is determined by the department to be medically necessary, evidence of expiration of warranty is submitted with the "Prior Authorization" request, and the department has not provided reimbursement for repair of duplicate or conflicting equipment in the prior twelve months.

(9) The department will not cover new items when simple repairs are all that are necessary. However, providers shall advise the department when, in their professional opinion, replacement of an item would be more cost-effective than repair.

(10) Claims may be submitted to the department for repairs made to durable medical equipment owned by recipients residing in long-term care facilities (LTCFs) except minor wheelchair repairs.

(11) No charge for labor will be reimbursed for repair or replacement of items identified by an asterisk in the appendix to rule 5160-10-20 of the Administrative Code.

(12) Routine maintenance on equipment owned by the recipient is the responsibility of the recipient or the recipient's caretaker. "Routine maintenance" is any action described in the equipment owner's manual as routine and necessary to maintain optimum functioning of the equipment, and which do not require a skilled or trained technician to perform.

(B) Hearing aids.

(1) "Major repair of hearing aids" is a repair for which the combined charges for materials and labor exceed one hundred dollars. No more than one major repair may be reimbursed in any three hundred sixty-five-day period. Prior authorization is required for major repairs to hearing aids. Payment for a major repair of a hearing aid includes a warranty described in rule 5160-10-11 of the Administrative Code to cover all repairs and all related service calls and follow-up during the warranty period. Charges billed to the department shall not exceed:

(a) The provider's usual and customary combined charges when the provider performs the repairs; or

(b) One hundred twenty-five per cent of the provider's cost as indicated on the invoice for repair issued to the provider when the provider does not perform the repairs.

(2) "Minor repair of hearing aids" is a repair for which the combined charges for materials and labor is equal to or less than the medicaid maximum for a hearing aid repair listed in rule 5160-1-60 of the Administrative Code. No more than one minor repair may be reimbursed in any one hundred twenty day period without prior authorization. Charges billed to the department shall not exceed:

(a) The provider's usual and customary combined charges when the provider performs the repairs; or

(b) One hundred twenty-five per cent of the provider's cost as indicated on the invoice for repair issued to the provider when the provider does not perform the repairs.

(3) The cost of postage, pick-up, or delivery of a hearing aid is considered a cost of doing business and may not be billed separately.

(4) Routine maintenance of hearing aids is the responsibility of the recipient or the recipient's caretaker. "Routine maintenance of hearing aids" is any action described in the owner's manual as routine and necessary to maintain optimum functioning of the hearing aid, including cleaning and checking.

(5) Requests for prior authorization of repairs (both minor repairs in excess of one every one hundred twenty days and major repairs) must specify the nature of the repair, the date of purchase or the approximate age of the equipment, and previous dates of both major and minor repair services.

(C) Orthotic and prosthetic devices.

(1) In addition to the requirements of paragraphs (A)(2) to (A)(12) of this rule, coverage and claims submission for the repair or replacement of parts for orthotic devices is specifically defined in rule 5160-10-20 of the Administrative Code.

(2) In addition to the requirements of paragraphs (A)(2) to (A)(12) of this rule, coverage and claims submission for the repair or replacement of parts for prosthetic devices is specifically defined in rule 5160-10-20 of the Administrative Code.

(D) Prior authorization requests for the repair of medical equipment will be considered based on medical necessity. However, cases suggesting malicious damage, neglect, culpable irresponsibility, or wrongful disposition of the medical equipment in question will be investigated and prior authorization may be denied for the repair when the department determines it is unreasonable to make further program payment under the circumstances presented to the department in support of the equipment repair request. Providers will provide any information regarding requests for the repair of medical equipment that the department deems necessary in order to evaluate the repair request.

Effective: 12/31/2013
R.C. 119.032 review dates: 10/15/2013 and 12/31/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5164.02 , 5164.70 , 5165.01 , 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 01/01/1980, 03/01/1984, 10/01/1988, 05/15/1989, 05/01/1990, 12/10/1993, 01/01/1995, 09/01/2002, 10/01/2004, 01/13/2006, 04/09/2009, 07/31/2009 (Emer), 10/29/2009

5160-10-09 Apnea monitors.

(A) Definitions.

(1) "Apnea monitors" are defined as cardiorespiratory monitoring devices capable of providing continuous or periodic two channel monitoring of heart rate and respiratory rate and must meet current food and drug administration guidelines for products in this class. Apnea monitors must have alarming mechanisms to alert caregivers of cardiorespiratory distress or other events that require immediate intervention and must be capable of recording and storing events (sometimes known as memory monitoring) and of providing event recording downloads or printouts of such data.

(2) "Download" is defined as a printout of the two channel (or greater) event recordings from a memory monitor. Normally a download contains waveform printouts, event logs, and compliance and utilization information.

(3) "Sudden infant death syndrome (SIDS)" is defined as the sudden death of any infant or young child under one year of age that remains unexplained after the performance of a complete postmortem investigation, including an autopsy, an examination of the scene of death, and a review of the case history.

(4) "Apparent life threatening event (ALTE)" is defined as an episode that is frightening to the observer and that is characterized by some combination of apnea (central or obstructive), color change (usually cyanotic or pallid but occasionally erythematous), marked changes in muscle tone (usually limpness), choking or gagging. In some cases, the observer fears the infant has died. Terminology such as aborted crib death or near miss SIDS should be abandoned because it implies a possible misleading close association between an ALTE and SIDS.

(B) Apnea monitors are reimbursed on a rent-to-purchase basis in accordance with rule 5101:3-10-05 of the Administrative Code.The medicaid fee includes payment for professional time, event recording(download), and all maintenance and supplies.

(C) The following criteria must be met for coverage of an apnea monitor:

(1) The provider must maintain on file a certificate of medical necessity (CMN) signed by the attending physician documenting at least one or more of the following:

(a) One or more apparent life-threatening events (ALTES) requiring mouth-to-mouth resuscitation or vigorous stimulation;

(b) Symptomatic preterm infant (active medical management of apnea of prematurity);

(c) Sibling of one or more sudden infant death syndrome (SIDS) victims;

(d) Infant requires home oxygen therapy or invasive or non-invasive ventilatory support (technology dependent);

(e) Tracheotomized infant (technology dependent);

(f) Infant with abnormal pneumogram at discharge;

(g) Multiple birth SIDS survivor(s);

(h) Infants with severe gastroesophageal reflux with associated apneas;

(i) Infants with severe upper airway abnormalities (e.g., achondroplasia, Pierre-Robin syndrome, etc.); or

(j) Infants with other disorders, specified on the CMN, that demonstrate a need for close cardiorespiratory monitoring to facilitate a more timely discharge to home.

(2) Requirements for use of home monitoring include but are not limited to the following:

(a) Infant cardiopulmonary resuscitation (CPR) training of caregivers by certified trainers;

(b) Education regarding mechanical aspects of monitors;

(c) In-hospital experience;

(d) Twenty-four hour availability of monitor service staff; and

(e) Attestation by the attending physician that the caregivers are capable of being trained to use the monitor properly.

(3) The following diagnoses or conditions alone are not indications for monitoring:

(a) Seizure disorders (without life threatening events);

(b) Hydrocephalus, uncomplicated;

(c) Mental retardation;

(d) Irreversible terminal conditions;

(e) Congenital heart defects, with or without associated arrhythmias;

(f) Distant family history of apnea or SIDS (other than an immediate sibling);

(g) History of apnea monitor use with other siblings;

(h) History of apnea with other sibling(s);

(i) Parental anxiety or family request for a monitor;and

(j) Monitoring of blood oxygen saturation.

(D) Length of need. Coverage of apnea monitors is generally limited to four months. Apnea monitors should be discontinued as soon as there is no medical indication to support the need for continued home monitoring. If the attending physician recommends continued monitoring beyond the initial rental, evidence to support the medical need must be submitted with the request for subsequent rental or purchase authorization in accordance with paragraphs (D)(1) to (D)(3) of this rule.

(1) Nontechnology dependent infants. Requests for authorization should include:

(a) Evidence that there has been clinically significant apnea or bradycardia within two months before the date of the prior authorization request. Supportive evidence may include a copy of a recent download noting apneas or bradycardias; documentation of a recent pneumogram noting apneas or bradycardias; documentation of a recent emergency room visit or hospital admission for an ALTE;

(b) Download report or download summary information with download report available on request by the department; and

(c) Certificate of medical necessity signed by the attending physician stating the need for continued home monitoring.

(2) Technology dependent child. Requests for authorization should include:

(a) Evidence that the patient is still in need of the high technology products/services. Supportive evidence may include copies of recent clinician follow-up reports noting equipment and services still in use, copies of home nursing agency visits reports noting equipment and services still in use, etc.;

(b) Download report or download summary information with download report available on request by the department; and

(c) Certificate of medical necessity signed by the attending physician stating the need for continued home monitoring.

(3) SIDS sibling. Requests for authorization should include:

(a) Same criteria as noted in paragraph (D)(1)(a) of this rule; or

(b) Patient is not beyond age of the death of the sibling who died of SIDS;

(c) Download report or download summary information with download report available on request by the department; and

(d) Certificate of medical necessity signed by the attending physician documenting the need for continued home monitoring.

(E) Downloads. Recording monitor downloads are covered for recipients receiving home apnea monitor services as part of any payment for service rendered by the department. Downloads are normally used to determine the presence of continued symptoms (apnea/bradycardia) and document such information. They may also be used to document compliance with home monitoring requirements. Download reports provide appropriate, objective medical information that may aid the physician in deciding to discontinue home monitoring or document the need for continued home monitoring.

(F) Pneumograms. For dates of service beginning on or after April 1, 2006, consumers requiring a pneumogram must seek the care of a qualified licensed prescriber in order to have the pneumogram reimbursed by the department. The order for a pneumogram must be based on the presence of appropriate symptoms or conditions as defined by accepted medical standards. Pneumograms used as screening tests without the presence of appropriate symptoms for conditions are not reimbursable by the department.

Effective: 10/15/2006
R.C. 119.032 review dates: 06/15/2006 and 10/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 3/1/84, 5/1/90, 7/1/97, 10/2/97, 12/5/02

5160-10-10 Dialysis equipment.

(A) Unless otherwise indicated, equipment and all related medical supplies necessary for the home dialysis consumer are covered under the Ohio medicaid program when billed by suppliers/providers, except when the consumer elects to receive dialysis under "Method I," as referenced in rule 5101:3-13-01.9 of the Administrative Code.

(B) Dialysis equipment and supplies are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code.

Effective: 01/01/2008
R.C. 119.032 review dates: 04/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 3/1/84, 9/1/02, 4/16/07

5160-10-11 Hearing aids.

(A) Definitions.

(1) "Audiologist."

A person licensed to practice audiology in Ohio under Chapter 4753. of the Revised Code, or who is licensed and practicing in another state and is employed by an eligible Ohio medicaid provider. This individual is authorized to provide hearing screening consistent with the provisions detailed in rule 4753-6-01 of the Administrative Code and audiologic evaluation consistent with the provisions detailed in section 4753.01 of the Revised Code.

(2) "Licensed hearing aid dealer/fitter."

A person licensed in Ohio under Chapter 4747. of the Revised Code, or who is licensed and practicing in another state and is an eligible Ohio medicaid provider. This individual is authorized to provide hearing screening and testing consistent with the provisions detailed in rules 4747-01-02 and 4747-01-19 of the Administrative Code.

(3) "Programmable."

A hearing aid that utilizes analog technology that is controlled by modifying the frequency and output characteristics using a computer. It may contain multiple microphones, multiple memories and multiple channels, and may operate with a remote control.

(4) "Digital."

A digital hearing aid analyzes incoming sound, transforms it by converting the sound into digital bits and manipulates the frequency and output characteristics of the sound before the sound is amplified. Digital hearing aids are programmed with a computer and contain multiple memories, microphones, and channels. The digital processor permits the hearing aid to change its parameters, to reduce background noise, and/or manage feedback without adversely affecting the benefits for the user.

(5) "Conventional."

Conventional hearing aids have a microphone that gathers sound, an amplifier that increases the volume of sound, and a receiver that transmits this amplified sound to the ear. These instruments may have a manual volume control for the user. These devices have screw-set controls mounted onto the hearing aids for the licensed provider to adjust.

(B) Hearing aids of any type must be prior authorized before being eligible for reimbursement by Ohio medicaid. The prior authorization (PA) request must include all of the following documentation:

(1) A fully completed and legible JFS 01915 "Certificate of Medical Necessity/Prescription Hearing Aids" (appendix A to this rule) signed by the prescriber and dated no more than ninety days before dispensing of the hearing aid.

(2) Documentation of a hearing evaluation that supports the consumer's need for a hearing aid and includes all of the following components:

(a) A hearing test that was performed and signed by a physician specializing in otology or otolaryngology, an audiologist, or a hearing aid fitter;

(b) The hearing test report which reflects the specific hearing values resulting from the test; and

(c) A written summation of the hearing test results, performed and signed by a physician specializing in otology or otolaryngology, or an audiologist.

The individual performing either the hearing test, the written summation of the hearing test results, or both, must provide a legible name and provider type with his or her documentation (i.e., physician, audiologist or hearing aid fitter). This information must accompany the provider signature. The hearing evaluation must not have been performed more than six months prior to the date of the PA request; and

(3) Any other documentation that demonstrates medical necessity.

(4) Documentation for the prior authorization of a hearing aid must be submitted to the office with the appropriate healthcare common procedure coding system codes.

(C) Required hearing evaluation.

(1) Hearing tests for consumers twenty-one years or older shall include, at a minimum, all of the following for a basic hearing test:

(a) At least four thresholds for air conducted stimuli of five hundred Hz, one thousand Hz, two thousand Hz, and four thousand Hz;

(b) Air conducted speech awareness, or speech reception threshold;

(c) Most comfortable and uncomfortable listening level; and

(d) Bone-conducted pure-tone evaluation, unless the consumer's cognitive abilities do not permit such testing.

Hearing test results shall be obtained bilaterally unless the recipient's behavior/condition does not permit bilateral evaluation. If bilateral testing cannot be done, supporting documentation regarding this issue must be provided. All tests shall be performed in an appropriate sound environment in accordance with the standards accepted by the American national standards institute.

(2) Hearing test results for consumers aged twenty-one years or older must indicate a best pure-tone average of thirty-one dB HL or greater and, when interpreted in conjunction with the remainder of the hearing test results that constitute a basic hearing test, must demonstrate the need for a hearing aid. If physical or developmental limitations preclude these evaluation results, an explanation and alternative evaluation results must be provided.

(3) Hearing tests for consumers age twenty years or younger shall include, at a minimum, all of the following for a basic hearing test:

(a) At least four thresholds for air conducted stimuli of five hundred Hz, one thousand Hz, two thousand Hz, and four thousand Hz;

(b) Air conducted speech awareness, or speech reception threshold;

(c) Most comfortable and uncomfortable listening level;

(d) Bone-conducted pure-tone evaluation, unless the consumer's cognitive abilities do not permit such testing;

(e) Tympanometry;

(f) Acoustic reflex battery; and

(g) Otoacoustic emissions testing.

Hearing test results shall be obtained bilaterally unless the recipient's behavior/condition does not permit bilateral testing. If bilateral testing cannot be done, supporting documentation regarding this issue must be provided. All tests shall be performed in an appropriate sound environment in accordance with the standards accepted by the American national standards institute.

(4) Hearing test results for consumers aged twenty years or younger must show a best pure-tone average of twenty six dB HL or greater and when interpreted in conjunction with the remainder of the hearing test results, that constitute a basic hearing test, must demonstrate the need for a hearing aid. If physical or developmental limitations preclude these evaluation results, an explanation and alternative evaluation results must be provided.

Hearing test results for consumers are valid only if the testing was conducted by a provider authorized to perform the complete battery of hearing tests that are listed in this rule as part of their respective scope of practice.

(D) The following types of hearing aids are not covered by Ohio medicaid:

(1) All types of "in the canal" and "completely in the canal" hearing aids;

(2) All types of disposable hearing aids;

(3) "Used" or reconditioned hearing aids, which are defined as hearing aids that have been previously utilized by another individual.

(E) Conventional hearing aids.

(1) Hearing evaluation results referenced in this rule must clearly demonstrate the need for a hearing aid.

(2) All conventional hearing aids dispensed must be covered by a one-year warranty to include coverage provisions for all parts (except earmolds and batteries), comprehensive loss, damage, and labor.

(3) Providers must maintain copies of the final manufacturer's invoice, including discounts and shipping costs, in the consumer's record and make them available to the office upon request.

(4) All provisions of this rule apply to conventional hearing aids with the exception of paragraph (F) of this rule.

(5) Payment for a conventional hearing aid is the lesser of the medicaid maximum listed in rule 5101:3-1-60 of the Administrative Code for a conventional aid or the provider's acquisition cost, which consists of the manufacturer's invoice price minus any discounts received by the vendor plus shipping costs.

(6) If the manufacturer's final invoice price does not match the cost estimate submitted as part of the prior authorization request for the conventional hearing aid for any reason, the provider must submit a new prior authorization request reflecting the changed price in order to be eligible for reimbursement.

(7) Providers must maintain copies of the manufacturer's cost estimate and the final manufacturer's invoice including discounts and shipping costs in the patient's record and make them available to the office upon request.

(F) Programmable and digital hearing aids.

(1) Programmable and digital hearing aids are only eligible for reimbursement if the programmable and digital hearing aid is medically necessary as defined in paragraph (B) of this rule.

(2) Hearing evaluation results referenced in this rule must clearly demonstrate the need for a hearing aid.

(3) All programmable and digital hearing aids dispensed must be covered by a one-year warranty to include coverage provisions of all parts (except earmolds and batteries), comprehensive loss, damage, and labor.

(4) Payment for a digital or programmable hearing aid is the lesser of the medicaid maximum listed in rule 5101:3-1-60 of the Administrative Code for a programmable or digital aid or the provider's acquisition cost, which consists of the manufacturer's invoice price minus any discounts received by the vendor plus shipping costs.

(5) Reimbursement for codes V5256, V5257, V5260 and V5261 for consumers twenty-two years of age or older is the lesser of the amount indicated in appendix DD to rule 5101:3-1-60 of the Administrative Code reduced by fifty per cent or the providers usual and customary charge.

(6) If the manufacturer's final invoice price does not match the programmable or digital hearing aid cost estimate submitted as part of the prior authorization request due to any reason, the provider must submit a new prior authorization request reflecting the changed price in order to be eligible for reimbursement.

(7) Providers must maintain copies of the manufacturer's cost estimate and the final manufacturer's invoice including discounts and shipping costs in the patient's record and make them available to the office upon request.

(8) Payment for a programmable or digital hearing aid includes two adjustments per year for the duration of the warranty for comprehensive loss, damage and repair . If adjustment is necessary due to documented changes in measured hearing sensitivity or the growth of the ear canal, payment for adjustment will be authorized as a repair if this is the third adjustment during a warranty period for comprehensive loss, damage, and repair. In addition, the repair provisions stated in rule 5101:3-10-08 of the Administrative Code must be met.

(G) "CROS" and "BiCROS" hearing aids are not routinely covered by the medicaid program but may be authorized for consumers twenty years of age or younger with special documented needs or with difficulty hearing in adverse or noisy environments.

"CROS" and "BiCROS" hearing aids for consumers twenty years of age or younger require prior authorization.

(H) Hearing aids may be dispensed by a prescriber, a licensed audiologist, or a licensed hearing aid fitter who is enrolled as a durable medical equipment (DME) provider or enrolled as a prescriber or clinic type provider who has also been assigned a DME category of service.

(I) All earmolds must be warranted for ninety days. After the warranty period, necessary earmolds or repairs that are within the maximum allowances specified in rule 5101:3-10-20 of the Administrative Code will not require prior authorization. Prior authorization requests for earmolds in excess of the maximum allowed will be considered for special cases when appropriate documentation of medical necessity is provided. Visits to a hospital, home, nursing facility (NF), or intermediate care facility for the mentally retarded (ICF-MR) for the purpose of taking an earmold impression are covered but subject to limitations specified in rule 5101:3-10-20 of the Administrative Code.

(J) Each recipient of a hearing aid shall be scheduled for a recheck to assess the performance and acceptability of the aid within thirty days of receipt of the aid. A copy of the recheck report, countersigned by the consumer or an explanation of why the recheck was not performed, shall be maintained in the provider's file for a period of four years. No claim for payment should be made prior to a recheck or thirty days from the initial fitting of the aid, whichever comes first.

(K) When a recheck is performed within thirty days and the hearing aid is deemed unacceptable by the hearing aid provider and/or the consumer, the cost of the earmold and batteries will be reimbursed by the office. On the rare occasions that this may happen, the original authorization form must be forwarded to the office in order for the provider to receive a revised authorization reflecting the new cost. If payment has been made on the original authorization, the provider must arrange a cost adjustment which reflects the correct amount for the services rendered.

(L) Payment for all types of hearing aids includes all of the following:

(1) Hearing aid, cleaning kit, earmold insert when required for behind the ear style hearing aids, and a one-month supply of batteries;

(2) Shipping and handling;

(3) All required warranty costs; and

(4) Hearing tests as specified in this rule. Only providers specified in paragraph (B) of this rule may bill the office for hearing tests in conjunction with the fitting and dispensing of any type of hearing aid.

(M) Requests for two hearing aids on the same date of service will be reimbursed using binaural reimbursement codes only.

(N) Payment for any hearing aid dispensing fee includes all of the following:

(1) Earmold impression(s);

(2) Hearing aid selection and fitting(s);

(3) Up to three hours of counseling;

(4) All visits necessary for the dispensing and fitting of the aid (regardless of place of service);

(5) All service calls and follow-up during the warranty period ;and

(6) Charges for travel to dispense the hearing aid.

(O) Providers must document that the consumer and/or the consumer's primary care giver have been instructed in the proper use, wear and care of the hearing aid. Documentation of this instruction must be maintained by the provider.

(P) Conventional (analog) hearing aids can be replaced every four years. Digital hearing aids can be replaced every five years. Requests for replacements any sooner can be made through the prior authorization process. Replacement requests can be denied in instances of malicious damage, neglect, culpable irresponsibility or wrongful disposition. The office will not be responsible for any replacement charges, including deductibles, upon the loss of a hearing aid still covered under warranty.

(Q) A copy of the manufacturer's warranty and any applicable insurance coverage shall be maintained in the provider's file for a period of five years and copies shall be provided to the office on request.

(R) No hearing aid will be authorized for replacement until the office has received proof that replacement is not covered by the manufacturer's warranty or insurance. A request for prior authorization of a replacement hearing aid outside of the warranty period must meet all the requirements of this rule. No hearing aid will be authorized for replacement if repair or reconditioning would be more cost-effective.

(S) A provider may bill the office for necessary repair of a hearing aid only if the following conditions exist:

(1) The aid had been acquired through the office; or

(2) The office has determined that the aid, not acquired through the program, is medically necessary; and

(3) The repair is not covered by warranty or insurance; and

(4) The repair is not associated with routine maintenance or cleaning of the hearing aid; and

(5) All of the requirements for repairs listed in rule 5101:3-10-08 of the Administrative Code are met.

Click to view Appendix

Effective: 12/01/2013
R.C. 119.032 review dates: 08/19/2013 and 12/01/2018
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 5/1/90, 2/1/93, 12/10/93, 1/1/95, 9/1/05

5160-10-12 Orthopedic shoes and foot orthoses.

(A) Definitions.

(1) "Orthopedic shoes" are shoes that are specially constructed to aid in the correction of a deformity of the muscular skeletal structure of the foot; and for the preservation and restoration of the function of the skeletal system of the foot.

(2) "Molded shoes" are orthopedic shoes that are directly molded of leather, plastic, or a similar material, to a patient model.

(3) "Mismated shoes" are one pair of orthopedic shoes in which one shoe is a whole size and/or width larger than the other.

(B) Covered services and limitations.

(1) Prior authorization is required before orthopedic shoes will be considered for payment. Prior authorization requests must contain a precise description of the shoe to be dispensed and must include the manufacturer and/or laboratory, style and size of the item.

(2) Orthopedic shoes are covered only if the shoe is an integral part of a brace with the following exceptions: molded, mismated, and club foot shoes or shoes for children under the age of eight, diagnosed as having a deformity or condition as listed in paragraph (C) of this rule.

(3) Shoe modifications or additions shall be covered if they are medically necessary and are prescribed by a physician (D.P.M., D.O. or M.D.), or an advanced practice nurse (APN) subject to the limitations as specified in appendix A to rule 5101:3-10-20 of the Administrative Code.

(4) Reimbursement for foot orthoses includes all casting and shall only be billed by the individual who performs the actual casting.

(5) For medicaid-eligible recipients age eight and older, a maximum of two pairs of shoes every three hundred sixty-five days shall be considered for payment.

(6) For children under the age of eight, to accommodate growth, a maximum of three pairs of shoes every three hundred sixty-five days shall be considered for payment.

(7) Depth inlay shoes are covered only if the shoe is an integral part of a brace.

(C) Orthopedic shoes, not attached to a brace, for children under the age of eight, will be covered only for the following diagnoses:

(1) Talipes equino varus (club foot).

(2) Metatarsus adductus.

(3) Femoral torsion.

(4) Tibial torsion.

(5) Vertical talus.

(6) Fracture (major bones).

(7) Osteochondroses.

(8) Post-surgical control.

(D) Non-coverage determination.

Orthopedic shoes are denied as non-covered if the shoe is put on over a partial foot prosthesis or other lower extremity prosthesis that is attached to the residual limb.

Effective: 01/01/2007
R.C. 119.032 review dates: 09/27/2006 and 01/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 10/1/88, 2/17/91, 12/30/93 (Emer), 3/31/94

5160-10-13 Oxygen services.

(A) Definitions.

(1) "Blood gas study" is the measurement of such characteristics of blood as the partial pressure of oxygen (PO2) or oxygen saturation. The term applies either to an arterial blood gas (ABG) study, which is performed on blood from an artery, or to pulse oximetry, which is the noninvasive measurement of hemoglobin oxygen saturation (2) "Group I" and "group II" criteria are sets of clinical indicators used to determine the coverage of oxygen services without prior authorization.

(a) Group I criteria.

(i) If the individual is tested while awake and at rest, the following measures apply:

(a) Arterial PO2 of fifty-five mm Hg or less; or

(b)Arterial oxygen saturation at or below eighty-eight per cent.

(ii) If the individual is tested while exercising (ambulating), the following measures apply:

(a) Arterial PO2 of fifty-five mm Hg or less during ambulation without oxygen, with documented improvement during ambulation with oxygen; or

(b)Arterial oxygen saturation at or below eighty-eight per cent during ambulation without oxygen, with documented improvement during ambulation with oxygen.

(iii) If the individual is tested while asleep, the following measures apply:

(a) Arterial PO2 of fifty-five mm Hg or less;

(b) Arterial oxygen saturation at or below eighty-eight per cent;

(c) A decrease in arterial PO2 of more than ten mm Hg, associated with symptoms of or signs reasonably attributable to hypoxemia; or

(d)A decrease in arterial oxygen saturation of more than five per cent, associated with symptoms of or signs reasonably attributable to hypoxemia.

(b) Group II criteria.

(i) Either of the following measures applies:

(a) Arterial PO2 of at least fifty-six mm Hg and not more than fifty-nine mm Hg; or

(b)Arterial oxygen saturation at or above eighty-nine per cent.

(ii) In addition, at least one of the following conditions applies:

(a) Dependent edema suggestive of congestive heart failure;

(b) Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or the presence of P pulmonale on an EKG; or

(c)Erythrocythemia with a hematocrit greater than fifty-six per cent.

(3) "Transfill unit" is a device that transfers oxygen from a source such as an oxygen concentrator or liquid oxygen canister to portable tanks.

(B) Prescribers and suppliers of oxygen services.

(1) The following eligible medicaid providers may prescribe oxygen services:

(a) An independent physician;

(b) An advanced practice nurse with a relevant specialty (e.g., clinical nurse specialist, nurse practitioner); or

(c) A physician assistant.

(2) The following eligible medicaid providers may render oxygen services:

(a) A durable medical equipment (DME) supplier;

(b) A pharmacy;

(c) An independent physician;

(d) An advanced practice nurse with a relevant specialty (e.g., clinical nurse specialist, nurse practitioner);

(e) A physician assistant; or

(f) An ambulatory health care clinic.

(3) The following eligible medicaid providers may receive medicaid payment for submitting a claim for an oxygen service on behalf of a rendering supplier:

(a) A DME supplier;

(b) A pharmacy;

(c) An independent physician;

(d) An advanced practice nurse with a relevant specialty (e.g., clinical nurse specialist, nurse practitioner);

(e) A physician assistant;

(f) An ambulatory health care clinic; or

(g) A professional medical group.

(C) Certificate of medical necessity.

(1) Payment for oxygen services can be made only if an authorized provider certifies on a form, the certificate of medical necessity (CMN), that the services are medically necessary for an individual. For purposes of this rule, the CMN is form JFS 01909, "Certificate of medical necessity/prescription: oxygen services" (rev. 06/2005). A completed CMN must be signed and dated by the prescriber before a claim for a service is submitted. The certification period is limited to a maximum of twelve months after the first date of service for an individual meeting group I criteria and three months after the first date of service for an individual meeting group II criteria. According to the purpose for which a CMN is used, it may be called an initial CMN, a recertifying CMN, or a revised CMN.

(2) An initial CMN is used to document certification for new service.

(a) An initial CMN must be completed in the following circumstances:

(i) The supplier will be rendering oxygen services to an individual for the first time on a fee-for-service basis, even if the individual was using oxygen before gaining medicaid eligibility or oxygen was previously supplied through a medicaid managed care plan;

(ii) Oxygen was previously supplied to the individual on a fee-for-service basis, but a change in the individual's condition has suspended the need for oxygen for at least two full calendar months; or

(iii) Existing equipment must be replaced because it has reached the end of its expected useful life or has been irreparably damaged, lost, or stolen.

(b) If the CMN is needed solely because equipment is being replaced, then neither a prescriber visit nor a new blood gas study is required. (The results and test date of the most recent qualifying blood gas study may be entered on the form.)

(c) If the CMN is needed for purposes other than equipment replacement alone, then the individual must be seen and evaluated by a prescriber within a specified period before the date of certification, and a blood gas study is required.

(i) If the individual started using oxygen while enrolled in a medicaid managed care plan, then the evaluation period is twelve months, and the most recent blood gas study performed while the person was in the managed care plan must be used.

(ii) If the individual is a hospital inpatient or a resident of a long-term care facility (LTCF), then the evaluation period is thirty days, and the earliest blood gas study performed within forty-eight hours before discharge must be used.

(iii) Otherwise, the evaluation period is thirty days, and the most recent blood gas study performed within thirty days before the date of certification must be used.

(3) A recertifying CMN is used to renew certification. Within ninety days before the end of the existing certification period, the individual must be seen and evaluated by a prescriber, and a blood gas study is required. (The new certification period cannot begin until both the prescriber evaluation and the blood gas study have been completed.)

(4) A revised CMN is used to modify an existing certification. No prescriber evaluation is required.

(a) The most recent blood gas study performed within thirty days before the revision date must be used for the following modifications:

(i) The prescribed maximum flow rate has changed. If the new rate is greater than four liters per minute (LPM), then a new blood gas study must be performed while the individual is receiving four LPM.

(ii) The length of need must be extended (if the prescriber has specified a length of need less than lifetime on the most recent CMN).

(iii) Certification has been given for a portable oxygen delivery system to supplement a stationary system for which certification was previously given. If the most recent qualifying study was performed during sleep, then a new blood gas study must be performed while the individual is awake, either at rest or exercising.

(b) No additional blood gas study is required for the following modifications:

(i) There is a new treating practitioner, but the oxygen order is the same.

(ii) There is a new supplier, and the new supplier does not have the most recent CMN.

(D) Coverage.

(1) Payment may be made for the following oxygen services:

(a) Stationary gaseous oxygen system (private residence only);

(b) Portable gaseous oxygen system (private residence only);

(c) Stationary liquid oxygen system (private residence only);

(d) Portable liquid oxygen system (private residence only);

(e) Oxygen contents, gaseous, including supplies (LTCF only);

(f) Oxygen contents, liquid, including supplies (LTCF only);

(g) Oxygen concentrator, single delivery port;

(h) Oxygen concentrator, dual delivery port;

(i) Portable oxygen concentrator (private residence only); and

(j) Transfill unit (private residence only).

(2) A supplier must furnish the least expensive oxygen delivery system that meets an individual's medical and personal needs.

(3) Separate payment for a portable oxygen delivery system may be made in addition to payment for a stationary system only if the following criteria are met:

(a) The individual must have a demonstrable need for a separate portable system, either to maintain mobility in a private residence or to accomplish out-of-home activities;

(b) The individual's stationary oxygen delivery system cannot be used as a portable delivery system; and

(c) The prescribed oxygen flow is four LPM or less. If the prescribed oxygen flow is greater than four LPM, then no separate payment is made for the portable oxygen delivery system.

(4) Separate payment will not be made, however, for both a stationary and a portable oxygen concentrator.

(5) Prior authorization is not required when a supplier has obtained a properly completed CMN and renders oxygen services to an individual who either meets group I or group II criteria or is a resident of a LTCF.

(6) Prior authorization is required when a supplier has obtained a properly completed CMN and renders oxygen services to an individual who meets neither group I nor group II criteria and is not a resident of a LTCF. If approval is given, then the length of the approval period will be based on medical necessity and cannot exceed the timeframe indicated by the prescriber. The request for prior authorization must include a copy of the completed CMN.

(7) An oxygen service will be denied as not medically necessary if it is prescribed for any of the following conditions:

(a) Angina pectoris in the absence of hypoxemia;

(b) Dyspnea without cor pulmonale or evidence of hypoxemia;

(c) Severe peripheral vascular disease that results in clinically evident desaturation in one or more extremity but does not produce systemic hypoxemia; or

(d) A terminal illness that does not affect the respiratory system.

(E) Payment.

(1) All appropriate procedure codes and modifiers must be reported on claims.

(2) Payment for oxygen services is made on a monthly basis and includes the following related items and services:

(a) Setup and instruction on use;

(b) Equipment and supplies;

(c) Maintenance and repair, including the replacement of any part or attachment (such as tubing, cannula, mask, or filter) that is integral to the oxygen system or the operation of the system;

(d) Transportation or delivery charges;

(e) Emergency service, including the provision of backup equipment and supplies;

(f) Oxygen consumed (when applicable); and

(g) Equipment monitoring visits.

(3) The maximum fee for an oxygen service is the amount set forth in the appendix to this rule.

(a) When the prescribed oxygen flow is greater than four LPM, the payment amount is increased by fifty per cent.

(b) When the prescribed oxygen flow is greater than four LPM and portable oxygen is also prescribed, the payment amount is increased by fifty per cent.

Replaces: 5160-10-13, 5160-10- 13.1

Effective: 12/31/2013
R.C. 119.032 review dates: 12/31/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5164.02 , 5164.70 , 5165.01 , 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 05/25/1991, 04/01/1992 (Emer), 07/01/1992, 03/31/1994, 01/01/1995, 08/01/1995, 08/01/1998, 10/11/2001, 11/01/2007, 07/31/2009 (Emer), 10/29/2009, 08/02/2011

5160-10-13.1 [Rescinded] Oxygen: covered services and limitations in an intermediate care facility for the mentally retarded (ICF-MR).

Effective: 12/31/2013
R.C. 119.032 review dates: 10/15/2013
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5164.02 , 5164.70 , 5165.01 , 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 05/25/1991, 04/01/1992 (Emer), 07/01/1992, 03/31/1994, 01/01/1995, 08/01/1995, 08/01/1998, 10/11/2001, 11/01/2007, 07/31/2009 (Emer), 10/29/2009

5160-10-14 Compression garments.

(A) Compression garments.

(1) Compression garments are specialized garments prescribed for ambulatory persons with diagnoses listed under paragraph (A)(2) of this rule. Compression garments must be obtained through prior authorization. Only compression garments equal to or greater than 18mm Hg. will be considered for approval. All prior authorization requests for compression garments must contain the manufacturer and catalogue number.

(2) Coverage of compression garments is limited to the following diagnoses:

(a) Lymphedema.

(b) Elephantiasis.

(c) Milroy's disease.

(d) Orthostatic hypotension.

(e) Pregnancy with associated symptomatic venous insufficiency.

(f) Stasis dermatitis.

(g) Stasis ulcers.

(h) Symptomatic chronic venous insufficiency (for example, pain, swelling, ulcers, severe varicose veins).

(i) Thrombophlebitis.

(j) Post-thrombotic syndrome.

(B) Surgical stockings are specialized stockings covered when ordered by a prescriber to prevent embolisms in the legs of non-ambulatory (e.g., bed-confined) consumers. Surgical stockings are used as a short-term treatment (up to three months) after a surgical event. Surgical stockings must be obtained through prior authorization. If required for treatment during an inpatient hospital stay or outpatient hospital visit, the product will be reimbursed in accordance with Chapter 5101:3-2 of the Administrative Code.

(C) Compression burn garments are covered only when they are used to reduce hypertrophic scarring and joint contractures following a burn injury. Compression burn garments must be obtained through prior authorization.

(D) Providers fitting and dispensing compression garments, surgical stockings, or compression burn garments that are custom-made or custom-fitted must be certified to do so according to industry standards. A provider will not be eligible for reimbursement for custom-made or custom-fitted garments if the provider does not have a certified fitter on staff or under contract. Providers must keep on file documentation subject to review by ODJFS verifying that they have a trained fitter on staff or under contract.

(E) In addition to a fully completed prior authorization form JFS 03142 (rev. 2/2003), a fully completed form JFS 01905 (11/2006), "Certificate of Medical Necessity/Prescription Compression Garments (CMN)" (appendix A to this rule) that is signed and dated no more than thirty days prior to the first date of service must be submitted for prior authorization before reimbursement for compression garments, surgical stockings, or compression burn garments will be considered.

Effective: 01/15/2007
R.C. 119.032 review dates: 09/27/2006 and 01/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 10/1/88

5160-10-15 Transcutaneous electrical nerve stimulators (TENS).

(A) Unless otherwise stated, the dispensing for a TENS unit to a medicaid consumer must include the following documentation to be kept in the provider's records:

(1) A fully completed form JFS 03402 (rev. 10/2008) "Certificate of Medical Necessity/Prescription Transcutaneous Electrical Nerve Stimulator (TENS)" (CMN) (appendix A to this rule) that is signed and dated by an eligible prescriber no more than thirty days prior to the first date of service that documents nerve-related chronic intractable pain of at least six months duration. The CMN must specify a complete diagnosis;"chronic intractable pain" in itself is not a sufficient diagnosis to warrant coverage; and

(2) Attestation by the prescriber that a non-reimbursable trial period of at least thirty days resulted in substantial relief from pain (except for postoperative consumers). When a TENS unit is used specifically for acute post-operative pain, the medical necessity of the TENS unit is limited and reimbursable by the department for thirty days from the day of surgery, and no further reimbursement for this reason is authorized.

(B) Only the following conditions are recognized by the Ohio department of job and family services (ODJFS) as being eligible for consideration for the use of a TENS unit due to medical necessity after other appropriate treatment modalities have been tried and have failed. Use of a TENS unit and related services other than for those listed as covered in this rule are not eligible for reimbursement because the medical effectiveness of such therapy has not been established:

(1) Herpes zoster with other nervous system complications;

(2) Reflex sympathetic dystrophy;

(3) Other nerve root and plexus disorders;

(4) Mononeuritis of upper limb and mononeuritis multiplex;

(5) Mononeuritis of lower limb and unspecified site;

(6) Osteoarthrosis and allied disorders;

(7) Spondylosis of unspecified site;

(8) Intervertebral disc disorders;

(9) Brachial neuritis or radiculitis, not otherwise specified;

(10) Spinal stenosis, other than cervical;

(11) Lumbago;

(12) Sciatica;

(13) Myalgia and myositis, unspecified;

(14) Neuralgia, neuritis, and radiculitis, unspecified; or

(15) Other postsurgical status when used for acute post-operative pain for thirty days from the day of surgery.

(C) The conditions listed in this rule may not be associated with consumers treated with acupuncture, nor may they be associated with any variation of acupuncture techniques.

(D) A rental period of thirty days will be authorized for the initial use of the TENS unit. An additional period of ninety days minimum may be billed to the department if the following criteria are met and documentation is kept in the provider's records:

(1) All criteria listed in paragraph (A) of this rule, and

(2) Documentation of specific reduction in medications, e.g., muscle relaxants, narcotics, analgesics directly resulting from the use of the TENS unit.

(E) TENS units are covered as rental only for a maximum of four months. All rental payments made by ODJFS for the use of a TENS unit by a medicaid consumer are applied to any subsequent purchase of the TENS unit by ODJFS.

(F) Payment for rental includes all necessary accessories and supplies, and includes fitting and instructions/education in the proper use of the TENS unit. The provider must have a physical location available to the consumer for the initial face to face fitting and instruction/education efforts.

(G) The provider of the TENS unit must assure that the consumer utilizing the device is properly instructed in how to use the device in support of his or her ordered treatment plan and is aware of and understands any emergency procedures regarding the use of the TENS unit. The provider must maintain written documentation regarding the consumer's instruction on the use of the TENS unit in the consumer's medical record.

(H) TENS units provided to recipients must have two or four leads with more than one modality and must be covered by a warranty of two years or more when purchased on behalf of a medicaid consumer. Purchases or rentals of used TENS units are not authorized by the department unless the TENS unit was specifically utilized previously by the consumer whom the purchase or rental is being billed for. No sharing of TENS units is allowed by ODJFS. If a TENS unit is ordered for use with four leads, the medical record must document why two leads are insufficient to meet the consumer's needs.

(I) A purchase of a TENS unit may be billed to the department minus any previous rental payments received by the provider only after three months rental and must be documented in the provider's records and accompanied by the prescriber's current signed statement of efficacy of TENS treatment, medical necessity of continued treatment, and documentation of the criterion specified in paragraphs (A) and (D)(2) of this rule.

(J) Supplies for a TENS unit owned by a consumer must be dispensed and billed on a monthly basis in quantities no greater than actually needed by the recipient as no automatic shipments or stockpiling of these supplies are allowed. No supplies shall be billed before they have been provided to the consumer. Reimbursement for supplies shall be made under a single all-inclusive code, subject to a monthly maximum as specified in appendix DD to rule 5101:3-1-60 of the Administrative Code. TENS supplies may not be billed for any month for which rental payment is requested.

APPENDIX

Ohio Department of Job and Family Services

Certificate of Medical Necessity/Prescription

Transcutaneous Electrical Nerve Stimulator (TENS)

See Appendix at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-15_PH_FF_A_APP2_20090320_1057.pdf

Effective: 04/01/2009
R.C. 119.032 review dates: 04/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/1/80, 3/1/84, 5/1/90, 6/20/90 (Emer), 9/5/90, 4/16/2007

5160-10-16 Wheelchairs.

(A) Definitions.

(1) "Standard wheelchair" is a wheelchair, including a hemi (low-seat) wheelchair, that would generally satisfy the needs of a child or adult; is constructed to withstand normal daily use; has the dimensions specified in paragraph (A)(6) of this rule; and is equipped with standard seat and back, with wheel locks, with fixed, swingaway or detachable armrests, and with fixed, swingaway or detachable footrests.

(a) "Standard manual wheelchair" is a wheelchair that meets the specifications in paragraph (A)(1) and paragraph (A)(3) of this rule.

(b) "Standard power wheelchair" is a wheelchair that meets the specifications in paragraph (A)(1) and paragraph (A)(4) of this rule.

(2) "Specially constructed (SC) wheelchair/specially sized (SS) wheelchair" is a wheelchair that does not meet the dimensions of the standard wheelchair as described in paragraph (A)(6) of this rule; is equipped, at a minimum, with standard seat and back, with wheel locks, and with fixed, swingaway or detachable armrests, and with fixed, swingaway or detachable footrests; and is constructed to generally satisfy the needs of populations which require special features (e.g., extra-wide, amputee, reclining, lightweight, high strength lightweight, ultra-lightweight, heavy-duty, and extra heavy-duty wheelchairs).

(a) "Specially constructed wheelchair/specially sized manual wheelchair (SCM/SSM-wheelchair)" is a wheelchair that meets the specifications in paragraph (A)(2) and paragraph (A)(3) of this rule.

(b) "Specially constructed wheelchair/specially sized power wheelchair (SCP/SSP-wheelchair)" is a wheelchair that meets the specifications in paragraphs (A)(2) and (A)(4) of this rule.

(3) "Manual wheelchair" is a wheelchair that is designed and constructed to be manually operated and meets the requirements of either paragraph (A)(1) or (A)(2) of this rule. The term manual wheelchair includes:

(a) Any manual wheelchair that has been (or has been requested to be) converted to a motorized wheelchair with the addition of a power add-on accessory; and

(b) Any manual wheelchair that has been (or has been requested to be) revised with a push-rim activated power assist device.

(4) "Power wheelchair" is a wheelchair that:

(a) Has been originally designed and constructed to be powered by batteries in order to meet the needs of persons physically unable to operate a manual wheelchair;

(b) Meets the requirement of either paragraph (A)(1) or paragraph (A)(2) of this rule; and

(c) Is not a manual wheelchair that has been converted to a motorized wheelchair with the addition of a power add-on accessory or has been converted to a push-rim wheelchair with the addition of a push-rim activated power assist device.

(5) "Push-rim wheelchair" or a "push-rim activated power assisted wheelchair (PAPAW)" is a wheelchair that has a push-rim activated power assist device added to it.

(6) The dimensions for a standard wheelchair are as follows:

(a) The weight is greater than thirty-six pounds;

(b) The seat height is nineteen inches or greater;

(c) The weight capacity is two hundred and fifty pounds or less;

(d) For adult wheelchairs ,

(i) The seat width is fifteen inches to nineteen inches; and

(ii) The seat depth is fifteen inches to nineteen inches;

(e) For pediatric wheelchairs, the seat width or depth must be fourteen inches or less.

(7) "Consumer" is a medicaid-eligible individual.

(8) "Custom seating system" is a wheelchair seating system that is individually constructed from a plaster model , a computer generated model (e.g., CAD-CAM technology), or the detailed measurements of an individual to create either:

(a) A molded, contoured, or carved (foam or other suitable material) seating system that is incorporated into the wheelchair base; or

(b) A seating system made from multiple pre-fabricated components or a combination of custom fabricated materials and pre-fabricated components that have been configured and attached to the wheelchair base or incorporated into a wheelchair seat or back in such a manner that the wheelchair could not be easily re-adapted for use by another individual.

(9) "Adaptive positioning devices" are components that are attached to a wheelchair to facilitate medically necessary, individual-specific posture control, and functioning and are listed as "adaptive positioning devices" under "Wheelchair Part I or Part II" in the appendix to rule 5160-10-03 of the Administrative Code.

(10) "Personal residence" means the consumer's place of residence, if such residence is not a hospital or long-term care facility.

(11) "Long-term care facility (LTCF)" means a nursing facility (NF), which is defined in section 5165.01 of the Revised Code, or an intermediate care facility for individuals with intellectual disabilities (ICF/IID), which is defined in section 5124.01 of the Revised Code.

(12) "Moderate impairment" means an impairment of strength and tone that render a person unable to maintain functional or symmetrical postures; flexible scoliosis; flexible kyphosis; dislocated hip with a leg length discrepancy of less than two inches; or fixed contractures of the hips/knees that cannot be accommodated by standard components (e.g., footrests, legrests).

(13) "Severe impairment" means a severely abnormal (hyper or hypo) tone that prevents a person from obtaining or maintaining symmetrical postures, or abnormally fixed curvature of the spine.

(14) "Custom wheelchair" is any wheelchair with a custom seating system as defined in paragraph (A)(8) of this rule.

(B) Prior authorization.

(1) Except as set forth in paragraph (C) of this rule, prior authorization pursuant to rule 5160-10-06 of the Administrative Code is required for the wheelchair to be covered and reimbursed under medicaid. All requests for authorization for the purchase of a wheelchair must indicate the length of the warranty period and what is covered under the warranty.

(2) Wheelchairs will not be authorized for individuals under the age of one year. Only those wheelchairs that are designed to expand to accommodate the growth of an individual will be considered for authorization for growing children who do not fit into an adult sized wheelchair, unless there is a more cost effective, medically necessary alternative appropriate to meet the individual's need. Additional parts required to grow a wheelchair, that are not included with the purchase of the wheelchair, are eligible for reimbursement by the department, if the cost of the additional parts is less than the cost of a new wheelchair.

(3) Wheelchairs, wheelchair parts and accessories, and wheelchair modifications that are beneficial primarily in allowing the consumer to perform leisure or recreational activities are not considered medically necessary and will not be authorized.

(4) Prior authorization of wheelchairs (inclusive of all parts, options,or accessories) shall be limited to the wheelchair which has been determined by the department to provide mobility to an individual who is either non-ambulatory or who can ambulate for only a brief period of time, and any self-ambulationor assisted ambulation takes considerable physical effort or causes considerable physical pain; and who, without the specifically approved wheelchair, would be confined to a sedentary state (i.e., lying or sitting, bed-confined or chair-confined). Any bed-confined or chair-confined individual would be considered confined to a sedentary state.

(5) Certain wheelchair parts, accessories, or modifications that are distinctly and separately requested from the original wheelchair request require prior authorization. Refer to rule 5160-10-03 of the Administrative Code to determine which codes require prior authorization.

(6) The department may deny prior authorization requests when the required forms have not been fully completed or the required form does not provide sufficient information to establish medical necessity or to determine that the criteria for coverage has been met.

(C) The department will cover the rental of standard manual, hemi manual and lightweight manual (adult or pediatric) wheelchairs for a period of time not to exceed a maximum of three months without prior authorization. The wheelchair bases eligible for rental are denoted by a double asterisk (**) in the appendix to rule 5160-10-03 of the Administrative Code. For the wheelchair rental to be covered:

(1) The wheelchair must be prescribed by a physician; and

(2) The "Letter of Medical Necessity for Manual Wheelchairs without a Custom Seating System" form (JFS 03414, revised 10/2004) must:

(a) Be completed with sufficient information to support that the wheelchair is medically necessary to provide mobility to an individual who, without the specific wheelchair, would be confined to a sedentary state (e.g., lying or sitting, bed-confined or chair confined) for all but very brief periods of ambulation and to confirm that any self-ambulation or assisted ambulation takes considerable physical effort or causes considerable physical pain;

(b) Be signed by the prescribing physician; and

(c) Be maintained on file by the wheelchair provider.

(D) LTCFs: wheelchair coverage and limitations.

(1) Except as provided for under paragraph (D) (2) of this rule, all standard and specially constructed or specially sized manual wheelchairs without custom seating systems and all standard and specially constructed or specially sized power wheelchairs without custom seating systems, which are necessary for the appropriate care of the residents of a LTCF are the responsibility of the facility. Reimbursement of any wheelchairs described in this paragraph is made by the department to the LTCF through the cost-report mechanism. Except as provided for under paragraph (D) (2) of this rule, eligible providers of DME services may not bill or be reimbursed by the medicaid program for wheelchairs dispensed to residents of the LTCF.

(2) Only custom wheelchairs as defined in paragraph (A)(14) of this rule (i.e., those wheelchairs with a custom seating system as defined in paragraph (A)(8) of this rule) and determined by the department to be medically necessary for the resident, in accordance with paragraph (F) of this rule, are eligible for direct payment to the provider. Wheelchairs and wheelchair parts and accessories, prescribed for LTCF residents who do not meet all of the medical necessity criteria listed in paragraph (F) of this rule, are the responsibility of the facility and are reimbursed through the per diem rate calculated under Chapter 5124. or 5165. of the Revised Code.

(a) A standard or specially constructed or specially sized manual wheelchair may be authorized for direct reimbursement to an eligible DME provider for a resident of a LTCF only if the resident meets the coverage requirements for a custom seating system in accordance with paragraphs (D) (2) and (F) of this rule.

(b) A standard or specially constructed or specially sized power wheelchair may be authorized for direct reimbursement to an eligible DME provider for a resident of a LTCF only if the resident meets the coverage requirements for a custom seating system in accordance with paragraphs (D) (2) and (F) of this rule, and also meets the requirements for power wheelchairs in accordance with paragraph (G) of this rule.

(3) Reimbursement of any parts, options and accessories for wheelchairs described in paragraph (D) (1) of this rule is made by the department to the LTCF through the cost-reported mechanism.

(4) Parts, options and accessories for the wheelchairs described in paragraph (D) (2) of this rule and meeting the criteria for coverage as set forth in paragraph (D) (2)(a) or (D) (2)(b) are eligible for direct reimbursement to the DME provider.

(E) Personal residences: Wheelchair coverage and limitations.

For a consumer who resides in a personal residence, the following criteria must be met for the authorization of a wheelchair:

(1) For a standard manual or specially constructed/specially sized manual wheelchair without a custom seating system to be covered:

(a) The consumer must be evaluated by a physician, licensed physical therapist or licensed occupational therapist who is fiscally, administratively and contractually independent from the DME provider and receives no form of compensation (monetary or otherwise) from the billing DME provider.

(i) The evaluation must be performed not earlier than ninety days prior to the submission of the prior authorization request;

(ii) The results of the evaluation must support the information submitted on the required form JFS 03414, ; and

(iii) A copy of the dated and signed written evaluation must be maintained by the billing provider. The results of the evaluation must be written, signed and dated by the individual who evaluated the consumer as required in paragraph (E)(1)(a) of this rule. If the evaluator personally reported the results of the evaluation on the required form JFS 03414 and signed and dated the form, a copy of the form will be considered the written evaluation.

(b) The wheelchair must be prescribed by a physician who personally performed the evaluation or who has reviewed and agreed with the results of the evaluation of the qualifying physician, physical therapist or occupational therapist, in accordance with paragraph (E)(1)(a) of this rule.

(c) Form JFS 03414must:

(i) Be completed and submitted, based on the results of the evaluation required in paragraph (E)(1)(a) of this rule, and with sufficient information to support that the specific wheelchair is medically necessary to provide mobility to an individual who, without the specifically prescribed wheelchair, would be confined to a sedentary state (e.g., lying or sitting, bed-confined or chair-confined) for all but very brief periods of ambulation and to confirm that any self-ambulationor assisted ambulation takes considerable physical effort or causes considerable physical pain; and

(ii) Be signed by the prescribing physician.

(2) For standard power wheelchairs and specially constructed/sized power wheelchairs without a custom seating system to be covered for consumers who reside in (or who will be residing in) a personal residence:

(a) The consumer must meet all the requirements set forth in paragraph (G) of this rule; and

(b) A visit must be performed in the home (i.e., personal residence) and documented in a written report by a person qualified to determine that the consumer or the consumer's caregiver(s) has(have) the ability to properly maintain the power wheelchair; there is electricity available and easily accessible to maintain power to the batteries; transportation of this wheelchair is available, as necessary; the consumer's home (place of residence) is accessible by the power wheelchair; and there is sufficient space and storage area for the wheelchair or power operated vehicle (POV) to assure that it is protected from the elements. The written report may be completed in part E of the "Letter of Medical Necessity for Power Wheelchairs and/or Custom Wheelchairs (i.e., with a Custom Seating System)" form (JFS 03411, revised 10/2004). The home will be considered accessible only if the consumer can enter and leave the home by power wheelchair or POV; and, within the home the consumer can enter and leave without assistance the living room, kitchen/dining area, the consumer's bedroom (or the room with the consumer's bed), and a bathroom.

(i) Except as provided for in paragraph (E)(2)(b)(iii) of this rule, a power wheelchair or POV will not be authorized if all of the conditions set forth in paragraph (E)(2)(b) of this rule are not met.

(ii) A power operated vehicle will not be authorized if the POV is needed only for outside the home or if, because of its size or other features, the vehicle is intended primarily for outside use.

(iii) A power wheelchair or power operated vehicle may still be authorized as long as the written report supports that access to some of the rooms listed in paragraph (E)(2)(b) of this rule are not necessary because special accommodations have been made to meet the consumer's activities of daily living.

(3) For any manual wheelchair with a custom seating system to be covered, the criteria set forth in paragraph (F) of this rule must be met.

(4) For any power wheelchair with a custom seating system to be covered, the criteria set forth in paragraphs (F) and (G) of this rule must be met.

(F) Custom wheelchairs (i.e., wheelchairs with custom seating systems): coverage and limitations.

The following criteria and documentation requirements must be met for authorization of a wheelchair with a custom seating system:

(1) The consumer must be evaluated by a physician who is licensed and board certified as a physiatrist, an orthopedic surgeon, or a neurologist; or by a licensed physical therapist or a licensed occupational therapist. In a LTCF, the evaluator also must be fiscally, administratively and contractually independent from the DME provider, and must not receive any form of compensation (monetary or otherwise) from the billing DME provider.

(a) The evaluation must be performed not earlier than ninety days prior to the submission of the prior authorization request;

(b) The results of the evaluation must support the information submitted on form JFS 03411; and

(c) A copy of the dated and signed written evaluation must be maintained by the billing provider. The evaluation must be written, signed and dated by the individual who evaluated the consumer as required in paragraph (F)(1) of this rule. If the evaluator personally reported the results of the evaluation on the required form JFS 03411and signed and dated the form, a copy of the form would be considered the written evaluation.

(2) The wheelchair must be prescribed by a physician who personally performed the evaluation or who has reviewed and agreed with the results of the evaluation of the qualifying physician, physical therapist or occupational therapist in accordance with paragraph (F)(1) of this rule; and

(3) Form JFS 03411 must:

(a) Be completed and submitted based on the results of the evaluation required in paragraph (F)(1) of this rule and with sufficient information to support that the wheelchair is medically necessary to provide mobility to an individual who is either non-ambulatory, or who can ambulate for only very brief periods of ambulation, and any self-ambulationor assisted ambulation takes considerable physical effort or causes considerable physical pain, and who, without the specifically prescribed wheelchair, would be confined to a sedentary state (e.g., lying or sitting, bed-confined or chair-confined); and with sufficient information to support that the consumer meets the criteria set forth in paragraph (F)(4) of this rule; including information that is consistent with the consumer's reported diagnosis (or diagnoses), medical history, medical records; and current plan of care; and

(b) Be signed by the prescribing physician.

(4) To establish the medical necessity of a custom wheelchair (i.e., a wheelchair with a custom seating system), the following criteria must also be met and documented:

(a) The consumer must have a moderate impairment as defined in paragraph (A)(12) of this rule or a severe impairment as defined in paragraph (A)(13) of this rule;

(b) The consumer must have:

(i) Moderately to severely abnormal tone that prevents him or her from obtaining or maintaining symmetrical postures, or fixed curvature of the spine, for which a custom seating system is necessary; or

(ii) Skeletal or physical deformities or abnormalities that require a custom seating system ;

(c) The addition of a custom seating system to the wheelchair must create a wheelchair that is made to fit the consumer's body or positioning needs so specifically that the wheelchair can only be used by the individual for whom it was designed; and

(d) The consumer's need for prolonged sitting tolerance, postural support to permit functional activities, or pressure reduction cannot be met adequately by a planar type seat, a lap tray,or a spinal orthotic. To meet this condition, the documentation must explain why a specialized seat, a lap tray,or a spinal orthotic is not adequate for the consumer, and include a statement of the number of hours per day that the patient is expected to be in the wheelchair. If a custom seating system is being prescribed for a consumer who also requires a spinal orthotic, document why both the seating system and the orthotic are medically necessary for the consumer.

(5) Equipment prescription.

An equipment prescription (see part C of JFS form 03411) specifying that the wheelchair and a custom seating system that is medically necessary must be completed. The equipment prescription must be prepared by the same professional that performs the assessment, in conjunction with the prescribing physician, and must be signed by all team members involved in the wheelchair prescription process and by the equipment supplier.

(G) Power wheelchairs and power operated vehicles (POVs): coverage and limitations.

For a power wheelchair or a power operated vehicle to be covered, all the requirements specified in this paragraph must be met:

(1) The consumer must be evaluated by a physician, licensed physical therapist or licensed occupational therapist who is fiscally, administratively or contractually independent from the DME provider and receives no form of compensation (monetary or otherwise) from the DME provider billing for the wheelchair.

(a) The evaluation must be performed not earlier than ninety days prior to the submission of the prior authorization request;

(b) The results of the evaluation must support the information submitted on form JFS 03411; and

(c) A copy of the dated and signed written evaluation must be maintained by the billing provider. The results of the evaluation must be written, signed and dated by the individual who evaluated the consumer as required in paragraph (G)(1) of this rule. If the evaluator personally reported the results of the evaluation on the required form JFS 03411 and signed and dated the form, a copy of the form will be considered the written evaluation.

(2) The wheelchair must be prescribed by a physician who personally performed the evaluation or who has reviewed and agreed with the results of the evaluation performed by the qualifying physician, the physical therapist or occupational therapist in accordance with paragraph (G)(1) of this rule.

(3) Form JFS 03411 must:

(a) Be completed and submitted based on the results of the evaluation required in paragraph (G)(1) of this rule, with sufficient information to support that the wheelchair is medically necessary to provide mobility to an individual who, without the specifically prescribed wheelchair, would be bed-confined or chair-confined; with sufficient information to support that the consumer meets the criteria set forth in paragraph (G)(4) of this rule; and with information that is consistent with the consumer's reported diagnosis (or diagnoses), medical history, medical records, or current plan of care;

(b) Include the consumer's diagnosis (or diagnoses) and the estimate of expected hours of use per day; and

(c) Be signed by the prescribing physician.

(4) Except as provided for in paragraph (G)(6) of this rule, the following criteria must be met and documented to establish medical necessity:

(a) The consumer is totally non-ambulatory and has severe weakness of the upper and lower extremities due to an orthopedic, neurological, or muscular condition;

(b) The consumer has no physical ability to operate a manual wheelchair;

(c) The consumer has both the physical and mental ability to safely operate a power wheelchair. Provide documentation addressing head control, upper extremity functioning, joy stick control steering, directionality-steering skill, visual/spatial perception, safety, mobility skills in power wheelchair operation;

(d) The consumer is dependent upon a power wheelchair for functional activities, or there is a significant delay in the acquisition of independence in functional activities that can be positively impacted by a power wheelchair. Document functional status describing how the power wheelchair will allow the consumer to be independent in mobility and allow substantial improvement in achieving independence in one or more of the following functional activities (include a description of how a power wheelchair will increase the consumer's ability to perform these functional activities):

(i) Bathing;

(ii) Grooming;

(iii) Toileting/toilet hygiene;

(iv) Meal preparation;

(v) Housekeeping;

(vi) Laundry;

(vii) Telephone use;

(viii) Medication management;

(ix) Finance management;

(x) Transfers;

(xi) Use and care of equipment; or

(xii) Activities for which the power wheelchair facilitates independent functioning while in school or work.

(5) When applicable, the following additional criteria must also be met:

(a) For consumers residing in a personal residence, a power wheelchair will be covered only if the criteria set forth in paragraphs (E)(2)(b) to (E)(2)(b)(iii) of this rule are met;

(b) For consumers residing in a LTCF, the power wheelchair will be covered only if the criteria set forth in paragraph (F) of this rule are met; and,

(c) Power operated vehicles will be covered only for consumers residing in a personal residence and only if the criteria set forth in paragraphs (E)(2)(b)(i) to (E)(2)(b)(iii) of this rule are met.

(6) The department may determine that coverage of a power wheelchair is necessary under the following circumstances:

(a) The consumer has severe weakness of the upper and lower extremities due to an orthopedic, neurological, or muscular condition but is not totally non-ambulatory; and meets the criteria set forth in paragraphs (G)(4)(b) to (G)(4)(d) of this rule; and meets the criteria set forth in paragraph (G)(5) of this rule, as applicable; and meets the criteria for limited ambulation as set forth in paragraph (B)(4) of this rule; or

(b) The consumer does not meet the criteria set forth in paragraph (G)(4)(b) of this rule, but has limited ability to operate a manual wheelchair; and the consumer meets the criteria set forth in paragraphs (G)(4)(a), (G)(4)(c), and (G)(4)(d) of this rule; and, as applicable, the consumer meets the criteria set forth in paragraph (G)(5) of this rule.

(H) Duplicate equipment.

Medicaid reimbursement is not available for the purchase of more than one wheelchair for current use by a consumer;see paragraph (G) of rule 5160-10-05 of the Administrative Code. A wheelchair will not be authorized if the consumer is in possession of a wheelchair or any other equipment, regardless of payer source, which serves the same or similar purpose.

(I) Provider responsibility.

(1) The cost of any changes or modifications of a specially constructed/specially sized wheelchair, a custom seating system, or adaptive positioning devices purchased by the department, which are found to be necessary within the first ninety days following dispensing, must be borne in full by the provider.

(2) Wheelchair authorizations are specific as to manufacturer/make and model, parts, accessories, adaptive positioning devices, modular components, and custom-molded seating. Providers may only bill the department for the specific wheelchair and manufacturer/make and model, parts, accessories, adaptive positioning devices and custom-molded seating that are authorized and subsequently dispensed to the consumer.

(J) Repair and replacement.

(1) Medicaid reimbursement for repairs is limited to one wheelchair per consumer. Payment for loaner wheelchairs, in addition to reimbursement for repairs, is not covered. Repairs for multiple wheelchairs will not be authorized, regardless of the payer source of the wheelchairs. To be eligible for coverage for repairs, the wheelchair must have been determined by the department to be medically necessary, except as provided for in paragraph (J)(7) of this rule. (See rule 5160-10-08 of the Administrative Code regarding reimbursement for repairs.)

(2) For residents of LTCFs the cost of wheelchair maintenance and minor repairs is reimbursed through the per diem rate calculated under Chapter 5124. or 5165. of the Revised Code and as specified in rules 5160-3-19 and 5123:2-7-11 of the Administrative Code.

(3) For residents of LTCFs direct medicaid reimbursement for repairs is limited to the following "major repairs" as defined in rule 5160-10-08 of the Administrative Code.

(a) Major repair of a wheelchair which would be eligible for direct purchase (i.e., only major repairs for custom wheelchairs) in accordance with this rule and is owned by an eligible consumer; and

(b) Major repairs/replacement of custom seating systems purchased by the department.

(4) Direct reimbursement is limited to a maximum of one wheelchair in five years per consumer. However, if the consumer's condition changes and warrants new or different equipment within the five-year period, the department may authorize new or replacement equipment. Appropriate medical necessity documentation must be submitted when prior authorization is requested for new or different equipment within the five-year period. (See paragraph (B)(2) of this rule regarding growing wheelchairs.)

(5) The replacement of any type of wheelchair, replacement of any custom seating system, or the replacement of adaptive positioning devices will only be prior authorized when medically necessary, regardless of the age of the current equipment, and only when modification or repair of the current equipment is judged by the department not to be cost-effective. A request for authorization for replacement of a consumer-owned wheelchair must meet all the requirements of this rule for the type of chair being requested.

(6) A description, model number, manufacturer serial number, date of purchase, and the condition of a consumer's current equipment must be specified on a request for authorization of additional or replacement equipment. (See paragraph (G) of rule 5160-10-05 of the Administrative Code regarding duplicate and conflicting equipment.)

(7) A current prescription must be submitted with a request for authorization of a repair when the department did not authorize the purchase of the wheelchair. In this case, a current prescription and documentation of medical necessity must be submitted with the initial request for repair. If the wheelchair is determined to be medically necessary and the repair is authorized, subsequent repairs may be authorized without the submission of a current prescription and documentation of medical necessity.

(8) For a consumer who resides in a personal residence, reimbursement may be authorized for the repair of a consumer-owned wheelchair that is not eligible for purchase in accordance with this rule, if it is determined that the wheelchair meets the seating/wheeled mobility needs of the consumer and it would be more cost effective for the department to authorize the repair rather than the replacement of the wheelchair. Authorization for the repair of a wheelchair does not necessarily indicate that the wheelchair would be authorized for purchase. Replacement of any consumer-owned wheelchair will be authorized in accordance with this rule.

(9) When requesting prior authorization (PA) for a major wheelchair repair service requiring the replacement/repair of wheelchair parts or accessories on or after the effective date of this rule, the process set forth in this paragraph will apply.

(a) Providers must itemize in the request for PA all the parts/accessories in need of repair or replacement using the procedure codes listed in part I or part II of the "Wheelchair" section of the appendix to rule 5160-10-03 of the Administrative Code with the modifier RB. If the part does not have a specific procedure code listed , use K0108 modified by the modifier RB and provide a description of the part(s). The RB modifier attached to a wheelchair procedure code indicates that the item described by the code is to be repaired or replaced as part of the major wheelchair repair service.

(b) Providers must itemize in the request for PA the labor services associated with the major wheelchair repair services using the labor code K0739. The PA request should state the estimated labor time.

(c) Under the prior authorization process, the department will continue to issue the repair and labor codes for wheelchair repair services as listed in the appendix to rule 5160-10-03 of the Administrative Code. Both the repair/replacement part(s) component and the labor component of any major wheelchair repair will be bundled into the all-inclusive major wheelchair repair codes. When deemed appropriate, the department may separately authorize any of the codes listed in "Wheelchairs: Part I" of the appendix to rule 5160-10-03 of the Administrative Code, if no additional labor, parts, or accessories are being requested.

(10) Providers must continue to submit claims, and be paid, for both the repair/replacement part(s) and the labor components as an all-inclusive major or minor wheelchair repair service using the wheelchair repair and labor codes specified in the appendix to rule 5160-10-03 of the Administrative Code. The procedure codes/modifiers for claims submitted for major repair services must match the codes issued in the prior authorization approval issued by the department.

(K) Valid wheelchair modifiers.

(1) The following modifiers are valid for wheelchair services:

(a) RR - short term rental; or

(b) RB - major repair or replacement of part(s).

(2) The appropriate modifier, as listed in paragraph (K)(1) of this rule, must be added to the procedure when requesting authorization for payment for wheelchair rentals or major repair services.

(3) Codes and modifiers submitted on the claim must match the codes and modifiers issued in the prior authorization approval letter.

Effective: 12/31/2013
R.C. 119.032 review dates: 10/15/2013 and 12/31/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5164.02 , 5165.01 , 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 12/30/1991, 07/01/1994, 08/01/1995, 08/01/1997, 04/01/1998, 10/01/2004, 04/01/2006, 07/31/2009 (Emer), 10/29/2009

5160-10-16.1 Wheelchair rentals.

(A) Definition

A "Rental Wheelchair" is defined in accordance with paragraph (C) of rule 5101:3-10-16 of the Administrative Code.

(B) Billing

The procedure necessary for billing the Ohio medicaid program for a wheelchair rental is defined in appendix A to rule 5101:3-10-03 of the Administrative Code.

(C) Reimbursement

(1) The reimbursement rate for wheelchair base codes utilizing the following "Healthcare Common Procedure Coding System" (HCPCS) codes in conjunction with the "RR" modifier are as follows:

(a) E1235 reimburses at sixty-five dollars per month.

(b) E1236 reimburses at sixty-five dollars per month.

(c) E1237 reimburses at sixty-five dollars per month.

(d) E1238 reimburses at sixty-five dollars per month.

(e) K0001 reimburses at forty-five dollars per month.

(f) K0002 reimburses at fifty-five dollars per month.

(g) K0003 reimburses at sixty-dollars per month.

(2) The department will reimburse submitted claims at the provider's usual and customary charge or at the maximums listed in this paragraph, whichever is less.

(3) The department will authorize only one rental wheelchair per consumer per month.

(4) Wheelchair rental codes are not to be used for temporary replacement equipment due to repair of consumer's primary transportation equipment.

(5) Wheelchair rental codes are not to be billed in conjunction with any other wheelchair codes referenced in appendix A to rule 5101:3-10-03 of the Administrative Code.

Effective: 04/25/2011
R.C. 119.032 review dates: 01/03/2011 and 04/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 10/27/05

5160-10-18 Hospital beds, pressure-reducing support surfaces and accessories.

(A) Hospital beds.

Unless otherwise stated, coverage of hospital beds will be limited to consumers who meet the following criteria.

(1) Variable height hospital bed.

A "variable height" hospital bed is one with manual height, head and leg elevation adjustments. A request for prior authorization must include accompanying documentation signed by the prescriber which specifies the medical condition, severity and frequency of symptoms and the estimated duration of need and documents that:

(a) The consumer's diagnosis/condition (including but not limited to the weight of the patientconsumer) warrants the consistent need for a variable height hospital bed in ways not feasible with an ordinary bed in order to provide elevation in excess of thirty degrees to the consumer due to congestive heart failure, chronic pulmonary disease, or documented problems with aspiration. Pillows or wedges must have been considered and ruled out as elevation of the head or upper body at less than thirty degrees does not require the use of a hospital bed, or

(b) The consumer requires traction equipment which can only be attached to a hospital bed, or

(c) The bed is required to assist the consumer with mobility and/or transfers (e.g., to a chair, wheelchair or standing position), or

(d) The bed is required to facilitate frequent interventions by a care giver in order to alleviate pain and prevent bed sores (e.g., turning the consumer every two hours).

(2) Semi-electric bed.

A "semi-electric" bed is one with manual height adjustment and with electric head and leg elevation adjustments. A semi-electric hospital bed may be approved with supporting documentation when the consumer meets the general requirements in paragraph (A)(1) of this rule and requires frequent changes in body position and has an immediate need for a change in body positon.

(3) Total electric bed.

A "total electric" bed is one with electric height, head and leg elevation adjustments. Total electric beds and other institutional type beds are not covered by the medicaid program.

(4) A heavy duty extra wide hospital bed is covered if the consumer meets the general requirements in paragraph (A)(1) of this rule and the consumer's weight is more than three hundred fifty pounds, but does not exceed six hundred pounds.

(5) An extra heavy duty hospital bed is covered if the consumer meets the general requirements in paragraph (A)(1) of this rule and the consumer's weight exceeds six hundred pounds.

(B) Bed accessories.

(1) Trapeze equipment is covered if the consumer needs this device to sit up because of a respiratory condition, to change body position for other medical reasons, or to get in or out of bed.

(2) Heavy duty trapeze equipment is covered if the consumer meets the criteria in paragraph (B)(1) of this rule and the consumer's weight is more than two hundred fifty pounds.

(3) Side rails are covered when they are required by the consumer's condition and they are an integral part of, or an accessory to, a covered hospital bed.

(4) A replacement innerspring mattress or foam rubber mattress is covered for a consumer-owned hospital bed if a consumer's condition requires it.

(C) Hospital beds, accessories or support surfaces are not separately reimbursed for consumers in LTCFs (long term care facilities) as this equipment is reimbursed to the specific facility through the facility's cost report.

(D) Any prescription for hospital beds, accessories or support surfaces must be prescribed by a prescriber actively involved in managing the consumer's medical condition as defined in paragraph (A) (2) of rule 5101-3-10-05 of the Administrative Code and should be treating the consumer under a comprehensive plan of care which addresses the underlying medical need for any equipment referenced in this rule.

(E) Pressure-reducing support surfaces.

Coverage of pressure-reducing support surfaces is limited to those group 1, group 2, and group 3 codes specified on the medicaid supply list found in appendix A of to rule 5101:3-10-03 of the Administrative Code. A support surface must have a group 1, group 2 or group 3 healthcare common procedure coding system(HCPCS) HCPCS code as defined in rule 5101:3-1-19.3 of the Administrative Code in order to be considered for coverage. Prior authorization is required for all group 2 and group 3 surfaces.

(1) Group 1.

(a) Definition.

"Group 1" pressure reducing support surfaces are typically defined as non-powered pressure reducing mattress overlays. These devices are designed to be placed on top of an ordinary hospital bed or home mattress. Group-1 pressure reducing support surfaces may be, but are not limited to, gel or gel-like overlays, air pressure or dry pressure, synthetic sheepskin, or lambswool sheepskin overlays. Group 1 may also include some powered pressure reducing mattress overlay systems (alternating pressure or low air loss), which are not included in group 2 pressure reducing support surfaces.

(b) Coverage criteria.

A group 1 mattress overlay or mattress is covered if any of the following apply:

(i) Consumer is completely immobile, i.e., cannot make changes in body position without assistance, or

(ii) Consumer has limited mobility, i.e., cannot independently make changes in body position significant enough to alleviate pressure, or

(iii) Consumer has any stage pressure ulcer on the trunk or pelvis, or

(iv) The consumer has compromised circulatory status. Any support surface or bed provided by the department will be one in which the consumer does not "bottom out." Bottoming out is the finding that an outstretched hand, placed palm up between the undersurface of the overlay or mattress and the consumer's bony prominence (coccyx or lateral trochanter), can readily palpate the bony prominence. This bottoming out criterion will be tested by the provider with the consumer in the supine position with their head flat, in the supine position and their head slightly elevated (no more than thirty degrees), and in the side-lying position.

(2) Group 2.

(a) Definition.

"Group 2" pressure reducing support surfaces are typically defined as: a powered air floatation bed (low air loss therapy); a powered pressure-reducing air mattress; a nonpowered advanced pressure reducing overlay for a mattress of standard length and width; a powered air overlay for a mattress of standard length and width; or a nonpowered advanced pressure reducing mattress.

A "low air loss bed" is defined as a hospital bed with a fully integrated power pressure reducing mattress which has all of the following characteristics:

(i) An air pump or blower which provides either sequential inflation and deflation of the air cells or a low interface pressure throughout the mattress;

(ii) Air cells with an inflated cell height through which the air being circulated of five inches or greater;

(iii) Height of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure mattresses), and air pressure provide adequate patient lift, reduce pressure and prevent bottoming out;

(iv) A surface designed to reduce friction and shear; and,

(v) Can be placed directly on a hospital bed frame or ordinary bed frame.

(b) Coverage criteria.

Generally, a group 2 support surface (i.e., an air-floatation bed) for use by an eligible consumer in a private residence may be prior-authorized when the consumer has:

(i) Pressure sore(s) in stage III or stage IV of tissue breakdown, as defined in appendix A of to this rule, located on the trunk, or

(ii) Burns of third degree with or without graft sites, or

(iii) Multiple wounds at stage II, or

(iv) Had a recent surgical procedure (within sixty days prior to the date of the authorization request) of wound closure involving skin grafts and/or skin flaps. (Note: for the first thirty days following a skin graft and/or a skin flap procedure, an original copy of a provider's prescription shall be considered sufficient documentation for medical necessity. Subsequent approvals must meet the requirements of this rule.)

(3) Group 3.

(a) Definition.

"Group 3" pressure reducing support surfaces are typically defined as air-fluidized beds. An "air-fluidized bed" is a device employing the circulation of filtered air through silicone coated ceramic beads creating the characteristics of fluid. It is utilized for the treatment of a patient who has stage III or stage IV pressure sores.

(b) Coverage criteria. A group 3 support surface (i.e., an air-fluidized bed) may be prior authorized when the patient has a stage III wound or a stage IV wound. The department's prior authorization unit will review the request and determine if an alternative support surface, such as a group 2 support surface, may be more appropriate.

(F) Pressure reducing support surfaces and hospital beds - medical necessity documentation requirements.

The following current (within the last thirty days), signed and dated documentation must be submitted to the department with a fully completed prior medical necessity form:

(1) JFS 02904 (4/2009),"Certificate of Medical Necessity/Prescription Decubitus Care Equipment (Pressure Reducing Support Surfaces)" (CMN) appendix B to this rule for all group 2 and group 3 support surfaces except for support surfaces prescribed for the first thirty days after skin graft/skin flap surgery, as per paragraph (E)(2)(b)(iv) of this rule; or

(2) JFS 02190 (4/2009),"Certificate of Medical Necessity/Prescription Hospital beds" (CMN) appendix C to this rule for all hospital beds.

Each additional piece of documentation submitted to the department as an attachment to the CMN must be labeled clearly and legibly with the consumer's name and medicaid identification number.

(3) A current prescriber's prescription or order for the support surface or hospital bed; and.

(4) A current prescriber's prescription or order for treatment of wounds for a support surface; and.

(5) The consumer's current diagnosis for a support surface or hospital bed; and.

(6) The consumer's weight history for at least sixty days prior and up to the request for a support surface; and.

(7) The consumer's current comprehensive nutritional assessment by a licensed/registered dietitian for a support surface; and.

(8) Laboratory reports of blood tests, performed within twenty one days prior to submission of the authorization request for a support surface, showing, at a minimum:

(a) Serum protein,

(b) Serum albumin/prealbumin,

(c) Hemoglobin, and

(d) Hematocrit.

(9) A detailed current wound description of the consumer's with a comprehensive and history describing wound appearance, length, width, depth, and location, prepared by a licensed health practitioner, and describing wound stage as defined in appendix A of to this rule if applicable for a support surface.

(G) When the medical necessity for the pressure-reducing support surface or hospital bed has been established, the consumer's overall health status and any complicating conditions will be considered when authorizing the most appropriate and cost-effective support surface (air-fluidized or low air loss) or hospital bed.

(H) For those support surfaces requiring prior authorization, the initial and any subsequent periods of coverage will be authorized at the discretion of the department.

(I) Hospital beds, accessories or support surfaces are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge, whichever is less.

Appendix A-Pressure Sores-Four Stages of Tissue Breakdown

Tissue breakdown proceeds through four recognizable stages. The four stages as described below should be referenced when submitting documentation for Medicaid reimbursement.

Stage I

Stage I of tissue breakdown is reversible when pressure is removed. The important characteristics of stage I are:

- Erythema (redness that lasts a minimum of fifteen minutes after pressure is removed), that turns white upon finger pressure;

- Warmth;

- Tenderness; and

- Occasional blistering.

Threat of further breakdown is present when erythema fails to dissipate upon removal of pressure. However, stage I is usually considered a transient circulatory disturbance, and the affected area should return to normal within twenty-four hours if pressure is removed. The affected area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue and occurs usually over a bony prominence.

Stage II

Stage II of tissue breakdown is generally reversible, but involves more profound circulation impairment than stage I. Stage II involves actual tissue damage presenting as partial thickness loss of dermis with a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister. Characteristics of stage II include:

- Distinct break in epidermal integrity (may extend into dermis);

- Erythema;

- Disturbance in skin temperature;

- Tenderness; and

- Local swelling or edema.

In addition, stage II ulcers may have drainage. In stage II, there is a distinct break in skin integrity which may appear as excoriation or ulceration. The border of erythema is more sharply defined. The area of erythema does not blanch upon application of fingertip pressure and presents as a shiny or dry shallow ulcer without slough or bruising. This stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation. The skin may be either unusually warmer or cooler to the touch. Additionally, local swelling or edema may be observed. Stage II tissue damage can be reversed with timely intervention; it generally heals quickly and easily.

Stage III

Stage III tissue damage involves more serious destruction with full thickness tissue loss and increased potential for complications. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. Stage III is characterized by the following and varies by anatomical location:

- Epidermal and dermal destruction that penetrates subcutaneous tissue;

- Infection and cellulitis;

- Eschar;

- Pain; and

- Drainage.

Stage III pressure sores are contaminated and may be infected. The presence of eschar (black, gangrenous, necrotic tissue) is not uncommon.

If the subcutaneous layer is involved, whitish, fatty tissue is visible at the base of the wound. When properly attended, progression of a stage III ulcer can be halted and, under optimal conditions, the wound can heal in two to four weeks.

Stage IV

Stage IV wounds involve more extensive damage than is immediately apparent. These ulcers represent serious destruction and opportunities for grave complications with full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling. Stage IV pressure sores are characterized by the following and varies by anatomical location:

- Tissue destruction of the epidermis and dermis and penetration of the deep subcutaneous layers;

- Muscle or bone destruction; and

- Possible undermining of the subcutaneous tissue.

Appendix CERTIFICATE OF MEDICAL NECESSITY/PRESCRIPTION DECUBITUS CARE EQUIPMENT (PRESSURE REDUCING SUPPORT SURFACES)

See Form at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-18_PH_FF_A_APP3_20090330_0810.pdf

Appendix CERTIFICATE OF MEDICAL NECESSITY/PRESCRIPTION HOSPITAL BEDS

See Form at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-18_PH_FF_A_APP4_20090330_0810.pdf

Effective: 04/09/2009
R.C. 119.032 review dates: 01/13/2009 and 04/01/2014
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 5/1/90, 2/17/91, 12/30/91, 12/29/95 (Emer), 3/21/96, 1/1/00, 10/1/04

5160-10-19 Definitions of terms associated with orthotic and prosthetic services.

The following are definitions used in rule 5101:3-10-20 of the Administrative Code.

(A) "Base procedure" - The basic procedure which indicates the simplest form of service being provided.

(B) "Additions to" - The "add-on" codes are added to the base procedure code if additional and more complicated services are provided. Normally the value assigned to the "add-on" codes does not represent the actual value of the component but only the difference in value between the base component found in the base procedure code and the "add-on" component being substituted. Those codes with asterisks can be billed either as "add-on" or as replacement items.

(C) "Molded socket" - In orthotics, this means an impression was taken, modified, and a socket of thermoplastic or other materials was made over the model. This same phrase in prosthetics indicates generally accepted fitting procedures, such as a PTB or quadrilateral socket that have been molded over a modified patient model.

(D) "Molded to consumer model" - A plaster cast is taken of the involved portion of the consumer's body from which a positive cast is then developed. This positive mold represents the patient model from which the ultimate appliance is fabricated.

(E) "Molded to consumer" - Direct molding of plastic or similar material on involved portion of consumer's body. This material is ultimately used in the appliance being fabricated.

(F) "Direct formed" - Direct molding of plastic or similar material on involved portion of

consumer's body. This material is ultimately used in the appliance being fabricated.

(G) "Nonmolded" - No casting or molding techniques used in the fabrication of the appliance in question. It can be a stock item or made from measurements and/or patterns only.

(H) "Premolded" - No casting or molding techniques used in the fabrication of the appliance in question. It can be a stock item or made from measurements and/or patterns only.

(I) "Custom fitted" - No casting or molding techniques are used in the fabrication of the appliance in question. It is normally a stock item that is fitted and adjusted to the patient. All custom-fitted items that require prior authorization must include make and model number.

(J) "Custom fabricated" - The appliance in question has been made for the consumer from measurements and/or patterns only.

(K) "Interface material" - Lining material used in any appliance. It is inserted between the body and the structural support.

(L) "Flexible" - Normally refers to surgical garments or corsets made from material, with reinforcing stays and para-spinal spring steels.

(M) "Thermoplastic or equal" - The device is fabricated from one of the various forms of thermoplastic materials that are commercially available, or in some instances may even refer to a thermosetting plastic resin approach.

(N) "Endoskeletal" - In prosthetics, this implies the modular approach and is all-inclusive of the various manufacturers of endoskeletal components.

(O) "Exoskeletal" - The traditional plastic laminated approach to finishing a prosthesis.

(P) "Immediate fit" - The application of a prosthesis in the operating or recovery room, and the appropriate cast changes.

(Q) "Initial prosthesis" - The application of a plaster direct formed BK or AK prosthesis that was not an immediate fit, and is not intended for extensive use. This is a noncovered service by medicaid.

(R) "Preparatory prosthesis" - A device that will allow for extensive gait training for lower limb amputees, and extensive functional training for upper limb amputees. A patient with a preparatory prosthesis need not be in the hospital, but is still undergoing changes to the amputation that preclude the fitting of the definitive prosthesis. Preparatory prostheses for lower limb amputees with the potential to be ambulatory will be considered for coverage by medicaid only when extensive training is medically necessary prior to the fitting of the definitive prosthesis.

(S) "Medical event" - A physical occurrence or aberration which necessitates medical intervention requiring the one-time use of an orthosis specific to the diagnosis as prescribed by a physician.

(T) "NC" - A noncovered service by medicaid.

Effective: 01/07/2010
R.C. 119.032 review dates: 10/14/2009 and 01/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 10/1/88, 5/1/90, 10/1/04

5160-10-20 Covered orthotic and prosthetic services and associated limitations.

Unless otherwise specified, any provider seeking reimbursement for orthotic and prosthetic services must meet the provisions contained within Chapter 4779. of the Revised Code or be exempt from licensure under section 4779.02 of the Revised Code in order to be eligible for reimbursement for services provided.

(A) Medically necessary orthotic and prosthetic services are covered as listed in appendix A to this rule.

(B) The allowed reimbursement amount for any orthotic or prosthetic device listed in appendix A to this rule includes, but is not limited to, the following:

(1) Labor;

(2) Casting, fitting, or measuring fees;

(3) Charges for travel; and

(4) Charges for shipping and mailing.

(C) It is the provider's responsibility to assure that any orthotic or prosthetic device fits properly for three months from the date of dispensing. Any modifications, adjustments, or replacements within the three months are the responsibility of the provider that supplied the item and no additional charge may be made to the department or the consumer. The provision of these services by another provider will not be separately reimbursed.

(D) "Unlisted procedure" and "not otherwise specified (NOS)" codes require complete description and itemization of charges when being submitted for prior authorization.

(E) Coverage of repair or replacement of parts for orthotic or prosthetic devices.

(1) Orthotic devices.

(a) Prior authorization is not required for the repair or replacement of minor parts for orthotic devices, which includes the amount for labor, when the repair or replacement of the orthotic device is less than or equal to one hundred twenty dollars with the exception listed in paragraph (F) of this rule.

(b) Prior authorization is required for the repair or replacement of major parts for orthotic devices, which includes the amount for labor, when the repair or replacement of the orthotic device is greater than one hundred twenty dollars.

(c) To bill for the repair of orthotic devices or the replacement of minor or major parts for orthotic devices, the provider must bill the appropriate code listed in appendix A to this rule.

(2) Prosthetic devices.

(a) Prior authorization is not required for the repair or replacement of minor parts for prosthetic devices, which includes the amount for labor, when the repair or replacement of the prosthetic device is less than or equal to one hundred twenty dollars.

(b) Prior authorization is required for the repair or replacement of major parts for prosthetic devices, which includes the amount for labor, when the repair or replacement of the prosthetic device is greater than one hundred twenty dollars with the exception listed in paragraph (F) of this rule.

(c) To bill for the repair of prosthetic devices or the replacement of minor or major parts for prosthetic devices, the provider must bill the appropriate code listed in appendix A to this rule.

(3) Prior authorization is required for orthotic and prosthetic device repair or replacement less than or equal to one hundred twenty dollars when the repair or replacement of the orthotic or prosthetic device is in excess of one repair or replacement per consumer per one hundred twenty day period.

(4) Coverage and claims submission for the repair or replacement of parts for orthotic and prosthetic devices are subject to the requirements listed in paragraphs (A)(2) to (A)(12) of rule 5101:3-10-08 of the Administrative Code.

(F) For those codes listed in appendix A to this rule that are preceded by an asterisk, all costs of repair are included in the reimbursement amount.

(G) Preparatory prostheses will be considered for authorization when documentation is provided at the time of submission of the prior authorization. The documentation should include the reason for the amputation, the date of the amputation, and a statement of why the patient will benefit by the application of a preparatory prosthesis prior to the design of the definitive. It is recognized that not every amputee is a candidate for a preparatory prosthesis prior to the fitting of a definitive; however, he or she will be considered where unusual physical changes are anticipated or cardiovascular or other physical conditions require evaluation to determine if a patient will be successful as a user of a definitive prosthetic.

(H) Twister (torsion) cables may be approved for only the treatment of children with neuromuscular diseases, and related diagnoses. Requests for torsion cables to treat positional deformities will not be covered by the Ohio department of job and family services (ODJFS) because of anticipated resolution that occurs with maturation.

Click to view Appendix

Effective: 03/29/2012
R.C. 119.032 review dates: 03/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 3/1/84, 12/30/84, 10/1/88, 4/13/89 (Emer), 5/15/89, 5/1/90, 6/20/90 (Emer), 2/17/91, 4/1/92 (Emer), 7/1/92, 12/10/93, 12/30/93 (Emer), 3/31/94, 8/1/95, 12/29/95 (Emer), 3/21/96, 1/4/00 (Emer), 3/20/00, 12/29/00 (Emer), 3/30/01, 12/31/01 (Emer), 3/29/02 10/1/04, 11/1/04 (Emer), 1/16/05, 9/1/05, 12/30/05 (Emer), 3/27/06, 10/15/06, 12/29/06 (Emer), 3/29/07, 12/16/07, 12/31/07 (Emer), 3/30/08, 12/31/08 (Emer), 3/31/09, 12/30/10 (Emer), 3/30/11, 9/1/11, 12/30/11 (Emer)

5160-10-21 Incontinence garments and related supplies.

(A) Incontinence garments and related supplies, including disposable underpads, are covered by the medicaid program under the following conditions:

(1) The medicaid consumer is thirty-six months of age or more; and

(2) The consumer is not a resident of a nursing facility or an intermediate-care facility for the mentally retarded. Coverage of incontinence garments and related supplies to these consumers is provided as part of the per diem payment already paid to the facility by the department for this consumer's monthly care; and

(3) The type of incontinence is:

(a) Secondary to disease that results in irreversible loss of control of the urinary bladder and/or anal sphincter; or

(b) Secondary to injury of the brain or the spinal cord that results in irreversible loss of control of the urinary bladder and/or anal sphincter; or

(c) Attributed to developmental delay or developmental disability.

(B) Stress incontinence is considered a type of incontinence, but does not meet the definition of disease or injury as specified in paragraph (A)(3) of this rule. Consumers with stress incontinence that is secondary to other disease or injury causing irreversible loss of control of the urinary bladder and/or anal sphincter may be eligible for incontinence garments and related supplies provided that all other requirements of this rule are met.

(C) Unless otherwise specified, a fully completed "Certificate of Medical Necessity/Prescription Incontinence Supplies," JFS 02912 (appendix A to this rule) that is written, signed with an original signature, and dated by the treating prescriber must be obtained at least every twelve months from the date of the prescriber's attestation signature and kept on file by the provider. Existing prescriptions that are in force prior to the effective date of this rule do not require the use of JFS 02912 until the existing prescription is renewed or modified due to medical necessity. The JFS 02912 must be obtained by the provider prior to the first date of service in the applicable twelve-month period and must specify:

(1) The applicable diagnosis of the specific disease or injury causing the incontinence; or

(2) The developmental delay or disability, including applicable diagnoses;

(3) The type of incontinence ; and

(4) The type of incontinence garments or incontinence supplies being prescribed.

(D) A JFS 02912 that only lists incontinence or incontinence supplies and does not specify the disease or injury that has resulted in the incontinence in accordance with paragraph (C) of this rule does not meet the requirements of this rule.

(E) Providers must verify from the consumer or the consumer's designated caregiver on a monthly basis the required type and number of incontinence garments and/or related supplies.

(1) The provider must maintain on file written documentation of the required type and amount of incontinence garments and/or related supplies requested for each month. The documentation must include the date that the provider verified the required type and amount from the consumer or consumer's care giver. The date that the provider verified the required type and amount must be prior to but not more than fourteen days prior to the date that the incontinence supplies are dispensed.

(2) The type and amount required may be verified orally or in writing from the consumer or the consumer's designated caregiver. For each month's worth of incontinence garments and supplies, the date of service entered on the medicaid claim (dispensing date) should not be prior to the date that the provider verified the type and amount of incontinence supplies required for the month.

(3) Documentation of the type and amount of incontinence garments and/or related supplies requested must include the first and last name of the provider's employee that took the request and the first and last name of the consumer, or consumer's care giver, making the request.

(4) Documentation of the type and amount of incontinence garments and/or related supplies required by a consumer on a monthly basis must be obtained and on file prior to dispensing the incontinence garments and/or related supplies. Under no circumstances may the amount of the incontinence garments and/or related supplies exceed the amount prescribed by the consumer's prescriber as originally documented on the JFS 02912. A new JFS 02912 is required when changes in a consumer's medical condition require an increased amount of incontinence garments or related supplies within twelve months of the date of the most recent prior prescriber's attestation signature.

(5) Any prescription for incontinence garments and related supplies must be prescribed by a prescriber actively involved in managing the consumer's medical condition as defined in paragraph (A)(2) of rule 5101:3-10-05 of the Administrative Code. This prescriber should be treating the consumer under a comprehensive plan of care that addresses the underlying medical need for any supplies referenced in this rule.

(6) Any request for incontinence supplies that exceeds the limitation amounts currently referenced in appendix A to rule 5101:3-10-03 of the Administrative Code requires that the provider submit a fully completed JFS 02912 as referenced in paragraph (C) of this rule to the department for prior authorization before payment is authorized for the dispensing of these excess supplies.

(7) Incontinence garments and related supplies are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge, whichever is less.

Click to view Appendix

Effective: 04/25/2011
R.C. 119.032 review dates: 01/03/2011 and 04/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 5/1/90, 9/1/98, 10/1/04

5160-10-22 Volume ventilators, positive and negative pressure ventilators, continuous positive airway pressure (CPAP), alternating positive airway pressure (APAP), and intermittent positive pressure ventilation (IPPV).

(A) Any provider billing for ventilatory support services (including volume ventilators, positive and negative pressure ventilators, CPAP, APAP and IPPV) shall have on staff or under contract a licensed respiratory care professional (LRCP) available on a twenty-four-hour basis, seven days a week to provide respiratory care, technical support and clinical ventilator services.

(B) Mechanical ventilator services are covered for consumers residing in a personal residence, a nursing facility (NF), or an intermediate care facility for the mentally retarded (ICF-MR). The monthly rental fee includes reimbursement for the use of a mechanical ventilator, all service and maintenance, related ventilator supplies and equipment listed in paragraph (B)(6)(a) of this rule, and the LRCP services listed in paragraph (B)(6)(b) of this rule. For a pressure ventilator used as an alternative to a volume ventilator, noninvasive applications are covered when a tracheostomy is not medically necessary.

(1) Ventilator definitions

(a) "Invasive mechanical ventilator." An invasive application requires the ventilator be interfaced directly with the consumer via an artificial airway (e.g., tracheostomy tube). Invasive mechanical ventilators (volume and/or pressure) are life support devices designed specifically for invasive mechanical ventilation applications and must accommodate direct current (DC) backup power supply and include disconnect, high pressure, low pressure and power loss alarms.

(b) "Non-invasive mechanical ventilator." Non-invasive mechanical ventilators (volume, or positive or negative pressure) may be used as an alternative to invasive mechanical ventilator services for consumers with appropriate medical necessity and when the consumer's attending prescriber has deemed a tracheostomy not medically necessary.

(2) Mechanical ventilator coverage criteria

(a) To be considered for coverage, consumers must require periodic or continuous mechanical ventilation (volume, or positive or negative pressure). A consumer must demonstrate appropriate medical necessity supporting the need for mechanical ventilatory support as treatment for respiratory insufficiency and/or respiratory failure resulting from one or more of the following conditions:

(i) Chronic respiratory failure

(ii) Spinal cord injury

(iii) Neuromuscular diseases

(iv) Chronic pulmonary disorders

(v) Other neurological disorders and thoracic restrictive diseases

(3) Medical necessity for pressure support ventilator with volume control is the same as above and also includes the following supportive information:

(a) Statement from the prescriber that the consumer has tried unsuccessfully to be managed with a volume ventilator, and

(b) Statement from the prescriber that the advanced technology offered by this pressure ventilator is required for the safe and appropriate management of the consumer.

(4) Invasive mechanical ventilator services, with backup rate feature, do not require prior authorization for the first three months of use by any particular consumer. Other ventilator services may be prior authorized for up to six months at the time of initial prior authorization. Consumers with chronic nonreversible respiratory insufficiency and/or failure may receive lifetime authorization for rental, or purchase at the discretion of the department. All requests for prior authorization of ventilator services must include a fully completed "Certificate of Medical Necessity/Prescription Mechanical Ventilators" form JFS 01902, rev. 06/2007 (appendix to this rule) within thirty days prior to the first date of service being requested. The certification of medical necessity, must include:

(a) Medical history (not required if request is for continuation of services),

(b) Diagnosis and degree of impairment,

(c) Degree of ventilatory support required (e.g., continuous, nocturnal only),

(d) Ventilator settings/parameters including mode and type of ventilator ordered at time of prior authorization request,

(e) List of other respiratory equipment in use,

(f) Documentation that recipient is being weaned (if applicable),

(g) Documentation of initial LRCP services described in (B)(6)(b) of this rule, when performed before prior authorization request, and

(h) Documentation (e.g., copy of a recent checksheet) that a LRCP routinely checks or changes ventilator settings in compliance with prescriber ordered parameters or protocol (not applicable to initial prior authorization request).

(5) Any change in the type of equipment provided, other than invasive mechanical ventilators with backup rate feature used with invasive interface, will require a new prior authorization request with supporting documentation as described in paragraph (B)(4) of this rule.

(6) The monthly rental payment for ventilator services includes reimbursement for the following equipment and supplies and respiratory services:

(a) Equipment and supplies

(i) Mechanical ventilator and accessories, including inlet ventilator filters,

(ii) Humidifier bacteria filters,

(iii) Humidifier tubing (ventilator to humidifier),

(iv) Heated humidifiers,

(v) Permanent or reusable consumer circuits (disposable consumer circuits are billable only to NFs and ICFs-MR), and

(vi) Related accessory and supply items including tracheostomy flex tubes, and peep valves.

(b) Licensed respiratory care professional (LRCP) services

(i) Home evaluation (prior to discharge), and home equipment set-up.

(ii) In-home training of the caregiver(s) (e.g. ventilator operation, tracheostomy care, cleaning/sterilization techniques).

(iii) LRCP visits to include multiple visits in the first week of service and subsequent visits no less frequent than once per month for the first six months, then not less than every sixty days thereafter, at a frequency determined by the LRCP, in consultation with the consumer's prescriber, to be appropriate to the consumer's condition.

(iv) Routine maintenance as specified by manufacturer or company protocol and in compliance with industry standards.

(v) Twenty-four-hour on call respiratory therapist services with two-hour response for emergency visits to include equipment servicing, repair or replacement.

(7) Reimbursement for a secondary or back-up mechanical ventilator for a medically necessary mechanical ventilator may be allowed when the consumer meets the following criteria and only when appropriate documentation is provided:

(a) Statement from the prescriber that the consumer cannot maintain spontaneous ventilation for four or more hours, or

(b) Statement from the prescriber that the consumer requires mechanical ventilation during regular mobility (e.g. attends school or outpatient therapy) as prescribed in their plan of care and needs a second ventilator attached to their wheelchair or mobility device, or

(c) Statement from the supervisor of the emergency team(s) responsible for serving the sconsumer's address that the emergency medical team estimated response time is more than two hours.

(8) When ventilators are provided to medicaid eligible residents of a NF or ICF-MR, reimbursement shall not be provided for more than one back-up ventilator per eight primary ventilators present in the same facility.

(C) Service and maintenance on consumer-owned ventilators requires prior authorization and may be billed once per month. The prior authorization request and documentation of medical necessity must include a prescriber prescription for mechanical ventilatory support, consumer diagnosis and degree of impairment. Payment will be authorized only when the department determines that the ventilator is medically necessary.

(D) Sleep therapy

(1) Definitions

(a) "Apnea" is the cessation of airflow for at least ten seconds documented on a polysomnogram.

(b) "Hypopnea" is an abnormal respiratory event lasting at least ten seconds associated with at least a thirty per cent reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a four per cent decrease in oxygen saturation.

(c) The "apnea-hypopnea index" (AHI) is the average number of episodes of apneas and hypopneas per hour and must be based on a minimum of two hours of recording time without the use of a positive airway pressure device, reported by polysomnogram. The AHI may not be extrapolated or projected.

(2) With prior authorization, payment can be made for a continuous positive airway pressure (CPAP) home system. The CPAP system was designed for consumers with obstructive sleep apnea. Rental for a six-month period or purchase may be authorized only when a trial period has proven to be beneficial. Documentation will be necessary to substantiate ongoing rental or purchase.

(a) A request for prior authorization must contain all of the following information:

(i) A statement of medical necessity from the consumer's attending prescriber indicating:

(a) Diagnosis of obstructive sleep apnea (OSA).

(b) Surgery is a likely alternative.

(ii) Sleep study reports from both a diagnostic and a titration sleep study (these may be performed as two separate studies or consecutively as a split study) conforming to the following:

(a) The sleep studies must be performed in an attended, facility-based sleep study laboratory which is eligible for reimbursement by the department for the study, and not in the home or in a mobile facility. A DME supplier may not perform the study.

(b) During at least two hours of recorded sleep for the diagnostic study,

(i) The AHI is equal to or greater than fifteen events per hour, or

(ii) The AHI is from five to fourteen events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia or hypertension, ischemic heart disease, or history of stroke.

(c) The titration study of at least three hours duration shows efficacy of the CPAP system by decreasing the number of airway obstructions per hour and

(i) Shows a percentage increase in oxygen saturation of at least fifteen per cent (e.g., eighty per cent to ninety-two per cent), or

(ii) Shows an increase in oxygen saturation to eighty-nine per cent or greater, or

(iii) At the discretion of the department, shows other clinical improvement.

(d) If oxygen is needed in addition to CPAP, documentation of effectiveness must be shown by the sleep study.

(iii) A statement from the attending prescriber documenting any correctable causes of the consumer's sleep apnea which are present, (e.g., alcohol, bedtime sedatives/hypnotics, weight) and whether or not they are being treated or have been abolished. It must be specified if none exist.

(iv) A statement from the attending prescriber, indicating whether the consumer is symptomatic or asymptomatic and what impairment(s) secondary to sleep apnea is (are) present. If the consumer is symptomatic, improvement must be documented and significant to be considered for coverage.

(v) A statement from the attending prescriber certifying that the consumer is using the device regularly as prescribed.

(b) If any of the information in paragraph (D)(2)(a) of this rule is missing or provided by the supplier instead of the attending prescriber, prior authorization will be denied. A new request for authorization may be resubmitted with the required information.

(3) When determined medically appropriate based on a facility-based sleep study, a bi-level/alternating positive airway pressure (APAP) system may be prior authorized for obstructive sleep apnea when a fully completed "Certificate of Medical Necessity/Prescription IPPV or APAP in lieu of a Volume Ventilator" form JFS 01903, rev. 6/2007 (appendix to this rule) is provided that demonstrates:

(a) CPAP has been tried and is ineffective.

(b) APAP was titrated during the sleep study, or a one-week trial period using a respiratory support system bi-level/APAP was effective; and

(c) The attending prescriber certifies in writing the effectiveness of the system and that the consumer is using the device regularly as prescribed.

(E) If there is discontinuation of the use of any respiratory assist device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

Appendix

Ohio Department of Job and Family Services

Certificate of Medical Necessity/Prescription

Mechanical Ventilators

See Form at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-22_PH_FF_A_APP1_20071221_0937.pdf

Effective: 01/01/2008
R.C. 119.032 review dates: 10/16/2007 and 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 12/30/91, 7/1/93, 7/1/94, 1/1/95, 8/1/98, 10/1/04

5160-10-23 Pulse oximeters.

(A) A pulse oximeter is a covered medical equipment item eligible for reimbursement when used in a personal residence as an alternative to hospitalization to manage the care of oxygen dependent pediatric recipients. Home pulse oximetry is covered when used to monitor oxygen saturation in order to determine appropriate supplemental oxygen levels. Home pulse oximetry is not covered for the purpose of qualifying or requalifying a patient for home oxygen.

(1) All oximeters approved for coverage must have printing capabilities that document an adequate number of sampling hours, per cent of oxygen saturation and an aggregate of the results.

(2) The oximeter must be preset, self-sealed and not adjustable by the consumer or anyone in the home.

(3) All oximeter printouts must be reliable, legible and maintained in the consumer's medical record.

(4) The consumer and/or the consumer's caregiver must be trained in the proper use of the pulse oximeter, the proper recording of measurements, and in whatever action is necessary to reverse a low oxygen saturation level. Documentation of this training must be kept in the provider's files.

(B) The following methods of home pulse oximetry services are covered:

(1) "Diagnostic monitoring," which is defined as monitoring for periods of up to twenty-four hours in length. Coverage is limited to a maximum of four monitoring periods per month. Prior authorization is required for diagnostic monitoring.

(2) "Continuous monitoring," which is defined as twenty-four-hour monitoring, seven days a week. Prior authorization is required for rental or purchase of an oximeter for use in continuous monitoring and may be requested for three months at a time when equipment is rented.

(C) All prior authorization requests must include a fully completed JFS 03401 (rev. 6/2006) "Certificate of Medical Necessity/Prescription Pulse Oximeter"(CMN) (appendix A to this rule) that is signed by an eligible prescriber and dated no more than thirty days prior to the first date of service. Additionally, the following criteria and documentation requirements must be met to establish medical necessity:

(1) Diagnostic monitoring.

(a) Diagnostic monitoring may be approved for payment to assess oxygen saturation:

(i) When a consumer is weaning from oxygen and/or prior to weaning; or

(ii) On a periodic basis for oxygen dependent, clinically unstable consumers.

(b) Prior authorization requests must include legible oximeter printouts of any prior oximeter monitoring and documentation of the resulting impact on the management of the consumer's care.

(c) Diagnostic monitoring may be considered for authorization when provided to a consumer in response to a significant clinical event or exacerbation of clinical status that results in a critical change in oxygen saturation or that requires diagnostic monitoring in order to assess oxygen saturation. Since oximeter monitoring under these circumstances must be provided immediately after the clinical event in order to assure timely assessment of oxygen requirements, authorization for payment will only be considered after the service has been provided.

(2) Continuous monitoring.

Continuous oximeter monitoring in the home may be appropriate in the management of pediatric consumers with prolonged oxygen dependency who are at risk of a critical fluctuation in oxygen saturation. Requests for prior authorization of continuous home oximeter monitoring will include documentation by the managing prescriber that the consumer is clinically unstable with chronically compromised respiration and frequently varying oxygen requirements, at risk for critical fluctuations in oxygen saturation, and experiencing one or more of the following:

(a) Frequent bradycardia;

(b) Frequent oxygen desaturation;

(c) Chronic lung disease;

(d) Ventilator dependent;

(e) Poor growth and development and suspect for inadequate oxygenation; or

(f) Other risk factors that may result in sudden, critical fluctuations in oxygen saturation (hyperoxia, hypoxia).

(D) Rental payments will be made for oximeters used for diagnostic and continuous monitoring. Oximeters will be considered for purchase when continuous monitoring is authorized for periods in excess of ten months; subsequent monthly rental payments, less the cost of the probes, will be applied to the purchase price. The monthly rental payment amount includes reimbursement for:

(1) Set up and instructions;

(2) Maintenance and repair;

(3) Emergency service visits or other interim visits;

(4) Supplies and accessories (cable, printer/printer tape, carrying case, etc.); and

(5) Permanent, reusable, or disposable probes (transducers) and probe wraps or tape.

(E) Oximeter probes may be purchased when prior authorized for use in conjunction with continuous monitoring when a monitor is purchased by the Ohio department of job and family services (ODJFS) and when a monitor is owned by the consumer, if continuous monitoring has been determined to be medically necessary in accordance with this rule. Oximeter probes must be billed using the code codes established for that purpose and listed in appendix A to rule 5101:3-10-03 of the Administrative Code.

Appendix Certificate of Medical Necessity/Prescription Pulse Oximeter

See Form at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-23_PH_FF_A_APP1_20070330_1019.pdf

Effective: 04/16/2007
R.C. 119.032 review dates: 11/16/2006 and 04/01/2012
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 7/1/93

5160-10-24 Speech generating devices (SGD).

Unless otherwise specified, the licensing of persons authorized to conduct a formal evaluation of a consumer's communication and related cognitive and physical abilities for the purpose of dispensing an SGD to a medicaid consumer is administered according to Chapter 4753. of the Revised Code. Any provider seeking reimbursement for this service must meet the provisions contained within Chapter 4753. of the Revised Code in order to be eligible for reimbursement for services provided.

(A) Definitions

(1) Speech generating device (SGD): Any electronic aid or device approved for use as an SGD that provides external assistance for communication and is an integral part of a speech-language pathology treatment plan for a consumer with a communication disability who is unable to satisfy his or her basic communication needs.

Basic communication needs are defined as a consumer's ability to communicate needs and wants, transfer information, achieve social closeness, and demonstrate social etiquette.

(2) Speech: The ability to vocalize by coordinating the muscles controlling the vocal apparatus (lips, tongue, jaw and vocal folds). It is the mechanical aspect of oral communication.

(3) Language: Refers to symbolic communication and permits the ability to converse, comprehend, repeat, read, and write. Language ability depends on central processing for either comprehension or formulation for expressing the sounds and symbols of prepositional communication. Difficulty in articulation or vocalization implies a speech disorder, whereas the inability to find words, comprehend, read, or write is indicative of a language disorder.

(4) Speech language pathologist (SLP): The SLP is a licensed health professional, educated at the graduate level in the study of human communication, its development and its disorders. The SLP must comply with all applicable federal and state licensing laws.

(5) Date of service (DOS): The effective DOS for this rule is defined as the date that the consumer is evaluated by the provider for the use of an SGD device.

(B) Coverage determination

(1) Before the delivery of the SGD, the consumer must have a documented face-to-face evaluation of his or her communication abilities by an SLP. The SLP performing the consumer evaluation may not be an employee or have a financial relationship with the supplier of the SGD. The formal, written evaluation must include all of the following elements:

(a) Current communication impairment, including the type, severity, language skills, and anticipated course of the impairment;

(b) An assessment of whether the consumer's daily communication needs could be met using other natural or aided modes of communication;

(c) Clinical documentation supporting the assessment that the consumer possesses the linguistic capability to formulate a message independently;

(d) Clinical documentation supporting the assessment that the consumer possesses cognitive and physical abilities to effectively use the selected device and any accessories to communicate;

(e) A description of the functional communication goals expected to be achieved and treatment options;

(f) Rationale for selection of a specific device and any accessories;

(g) Demonstration that the consumer possesses a comprehensive treatment plan that includes a training schedule for the selected device;

(h) For any subsequent upgrade to a previously issued SGD, information regarding the functional benefit to the consumer of the upgrade compared to the initially provided SGD to include a full device description of the most current SGD being requested;

(i) A full disclosure of any SGD equipment that the consumer already possesses to include a statement as to why the current equipment does not currently meet the consumer's needs which is supported by clinical documentation from the consumer's medical record;

(j) Documentation supporting the medical necessity of any accessory or add-on equipment, supplies or SGD features being requested;

(k) The evaluation must be signed and dated by all parties of the consumer's evaluation team to include professional licensure numbers;

(l) The consumer's medical condition is one resulting in a severe expressive speech impairment that is supported by documentation in the consumer's medical record;

(m) The consumer's speaking needs cannot be met using natural communication methods;

(n) Other forms of speech impairment treatment have been considered and ruled out; and

(o) The consumer's speech impairment and communication ability will benefit clinically from the device ordered.

(2) A copy of the SLP's written evaluation and recommendation must be forwarded to the consumer's treating prescriber before the device is ordered and kept in the consumer's medical records.

(3) Mounting brackets used in association with the installation of the SGD to a consumer's wheelchair can be billed to the department for separate reimbursement using the appropriate billing codes for these devices.

(C) Eye control SGD accessory

(1) Eye control technology for use with an SGD commonly employs infrared illumination of the pupil or cornea with digital camera tracking integrated into the SGD.

(2) Eye control technology for an SGD must only be considered as a last choice after all other methods of operating the SGD device have been evaluated and determined by the evaluating SLP not to meet the consumers needs. The SLP must document on the prior authorization form and in the consumer's medical record that alternative SGD control devices other than eye control were evaluated before requesting eye control technology for a specific SGD device.

(3) The consumer must have a specific documented medical necessity that supports the request for an eye control SGD accessory including but not limited to the following:

(a) Consumer has a documented history of a brainstem stroke;

(b) Consumer has Guillain Barre syndrome;

(c) Consumer is in the final stages of amyotrophic lateral sclerosis (ALS);

(d) Consumer has a documented occurrence of a severe traumatic brain injury that resulted in the complete loss of head movement.

(4) Approval for an eye control SGD accessory for a consumer is based on medical necessity as determined by the department.

(5) In order for a request for an eye control SGD accessory to be considered the provider must document that the consumer is able to use an eye control SGD accessory independently and successfully in the environments and situations in which the consumer is using the SGD device.

(6) Any SGD eye control accessory associated with the consumer's use of an SGD device will not be reimbursed by the department for an amount greater than five thousand six hundred dollars .

(7) The consumer must be provided with the most cost-effective SGD available to meet the medical needs of the consumer.

(D) Non-coverage determination

(1) Claims for more than one SGD at a time per qualifying consumer will be denied as not medically necessary.

(2) Environmental control devices are not separately reimbursable.

(3) Any non-medical software, accessory, application or hardware to include internet capabilities used in conjunction or compatible with the SGD are not separately reimbursable without the department's prior authorization.

(4) Personal computers and related hardware are not reimbursable unless the system has been adapted for use primarily as an SGD. The documentation supporting this adaptation must be maintained in the provider's records and on the prior authorization form.

(5) There will be no separate billing of any interfaces, printers, printer paper, cables, adapters, interconnects, or any other standard component necessary for the accessory to interface with any SGD in conjunction with the initial dispensing of this equipment to the consumer that is non-medical in nature without the department's prior authorization.

(6) Consumer training expenses related to the operation of the SGD are not separately reimbursable.

(E) Authorization

(1) The following documentation must be submitted for prior authorization (PA) before reimbursement for an initial SGD will be considered:

(a) A fully completed and legible JFS 02924 "Certificate of Medical Necessity/Prescription Speech Generating Device (SGD) Initial Certification" (appendix A to this rule) that is signed by the applicable licensed providers and dated no more than ninety days before submission for prior authorization; and

(b) Any other documentation required or requested by the department.

(2) Documentation for the prior authorization of an SGD must be submitted with the appropriate reimbursement codes.

(F) Trial use period

When recommended by the prescribing SLP, a trial use period must be conducted before the department will consider authorizing the purchase of an SGD. Monthly rental payments, limited to the lower of the provider's usual and customary monthly rental charge, are not to exceed ten per cent of the authorized purchase price of the prescribed SGD, and will be paid during the trial use period. Payments authorized during the trial use period are limited to four monthly payments. Long-term rental may be considered for authorization up to a maximum of ten months. If long-term rental is required, documentation must support why a long-term rental is necessary as an alternative to a trial period and/or purchase. Rental payments require prior authorization in accordance with paragraph (E) of this rule. Authorization for rental of SGDs for a trial use period or long-term rental will be limited to one device per month per consumer.

(G) Requesting purchase of an SGD at the end of a trial use period or subsequent to any rental period.

The following documentation must be submitted for review by PA before reimbursement for an SGD following a trial use period or subsequent to any rental period:

(1) A fully completed and legible JFS 02925 "Certificate of Medical Necessity/Prescription Speech Generating Device (SGD) Recertification" (appendix B to this rule).

(2) Documentation for the prior authorization of an SGD must be submitted with the appropriate reimbursement codes.

(3) Documentation that details any previous rental payments received by the SGD provider made on behalf of the consumer by the department in relation to providing the consumer with an SGD device.

(4) Any other documentation required or requested by the department.

(H) Repair, upgrade and replacement

(1) Repair

Medicaid reimbursement for repairs is available for no more than one SGD per recipient as detailed in rule 5101:3-10-08 of the Administrative Code. Repair costs for an SGD not originally covered by the department are to be considered on a case-by-case basis and are approved with a prior authorization. Repairs to consumer-owned SGD equipment that meet or exceed one thousand dollars in a twelve-month period will be deemed to extend the useful life of the consumer-owned SGD by one year from the date of the last repair request. No follow-up requests for a new SGD device in association or in conjunction with a repair request will be considered for a consumer during this extension period.

The repair of an SGD (including battery pack replacement) requires prior authorization. The following documentation, including the appropriate reimbursement codes, must be submitted when requesting prior authorization:

(a) A fully completed and legible JFS 02926 "Certificate of Medical Necessity/Prescription Speech Generating Device (SGD)" (appendix C to this rule); and

(b) Any other documentation required or requested by the department.

Requests for minor repairs as defined in rule 5101:3-10-08 of the Administrative Code do not require prior authorization. However, the SGD provider must maintain the documentation detailed in this rule in the consumer's medical record in order to document the need for the repair.

(2) Replacement or modification of a consumer-owned SGD that was originally covered by the department will be authorized only if it is determined by the department that the current SGD does not meet the recipient's basic communication needs in accordance with this rule, regardless of the age of the current equipment, and the current SGD cannot be repaired or modified to meet basic communication needs due to situations such as a change in a consumer's cognitive, communication or physical status. If the current SGD can be modified or repaired, replacement will only be considered when modification or repair of the current equipment is judged by the department to be more costly than replacement. A request for prior authorization for replacement or modification of a recipient-owned SGD must meet all the requirements specified in paragraphs (H)(1)(a) and (H)(1)(b) of this rule. In addition, a description, model number, and the condition of a recipient's current equipment must be specified on the documentation submitted for prior authorization of additional or replacement equipment. (See rule 5101:3-10-05 of the Administrative Code regarding duplicate and conflicting equipment.)

(I) Reimbursement

(1) SGDs are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code, or the provider's usual and customary charge, whichever is less.

(2) Under no circumstances will the department pay more than the amount of the cumulative sum of ten rental payments for any SGD made to a provider by the department on behalf of a medicaid consumer. Ownership of any SGD that has had ten rental payments made to the SGD provider by the department on behalf of a consumer immediately transfers to the consumer upon receipt of the tenth rental payment to the SGD provider by the department. The SGD provider is responsible to notify the consumer that the ownership of the SGD was transferred upon completion of the rental or trial agreement as explained in this rule.

(3) Any compensation paid to an SGD provider on a consumer's behalf in association with the dispensing, repair, replacement or modification of an SGD is inclusive of all professional, technical or administrative services required to supply the SGD to the consumer. These costs cannot be billed to the department separately.

Replaces: 5101:3-10-24

Click to view Appendix

Click to view Appendix

Click to view Appendix

Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 9/10/93, 12/10/93, 12/29/95 (Emer), 3/21/96, 10/1/04

5160-10-25 Lactation pumps.

(A) Lactation pumps are covered by the medicaid program under the following conditions:

(1) The requested lactation pump is subject to the coverage and limitations for medical supplies as defined in rule 5101:3-10-02 of the Administrative Code.

(2) The requested lactation pump is prescribed by an eligible prescriber involved in the consumer's or infant's care.

(3) The lactation pump is deemed medically necessary by the ordering prescriber when one or more of the following conditions exist:

(a) The infant is unable to initiate breast feeding due to a medical condition such as prematurity, oral defect, etc.; or

(b) Temporary weaning (i.e., direct breast feeding is not possible) due to:

(i) Mother/infant separation; or

(ii) Mother is required to take a medication or undergo a diagnostic test that is contraindicated with breast feeding; or

(c) Inadequate milk supply; or

(d) Engorgement; or

(e) Breast infection.

(4) In addition to the aforementioned criteria, the lactation pump must have been authorized by a prescriber who is actively involved in managing the consumer's or infant's medical care through a comprehensive plan of care that addresses the medical need for a lactation pump.

(B) Prior authorization is not needed for the purchase of a lactation pump .Providers must keep on file a fully completed JFS 01901, "Certificate of Medical Necessity/Prescription Lactation Pumps" (CMN) (appendix A to this rule) that is signed and dated no more than thirty days prior to the first date of service. This documentation must be available for review at the request of ODJFS.

(C) Hospital grade (HG) rental lactation pumps do not require an initial prior authorization . The rental period is ninety consecutive days. The rental period may be extended beyond the initial ninety days with prior authorization. Total rental period for a lactation pump will not exceed one hundred eighty consecutive days to include the initial rental period.

(D) Reimbursement for the purchase of either an electric or a manual lactation pump will include a one- year manufacturer's warranty that covers product malfunction, repair or replacement .

(E) Prior authorization (PA) requests for extension of the initial HG lactation pump rental period must be compliant with rule 5101: 3-10-06 of the Administrative Code. The PA request must include the following documentation:

(1) A fully completed JFS 01901, "Certificate of Medical Necessity/Prescription Lactation Pumps" (CMN) (appendix A to this rule) that is signed and dated no more than thirty days prior to the first date of service.

(2) A description, including approximate age and ownership, of any similar equipment currently in possession of the recipient and the reason for the new request if similar equipment ownership is established.

(3) Any other documentation as required or requested by ODJFS for certain specific medical supplier services, as detailed in Chapter 5101:3-10 of the Administrative Code.

(F) In order for an HG lactation pump to be eligible for program reimbursement, the following criteria must also be met:

(1) The pump must utilize suction and rhythm equivalent to the equipment commonly found in hospital settings. This means it must have an adjustable suction pressure between one hundred and two hundred fifty mm Hg and a mechanism to prevent suction beyond two hundred fifty mm Hg.

(2) The pump must have an adjustable pumping speed capable of reaching fifty- two cycles per minute.

(3) The pump must be cleaned and serviced as needed between rentals.

(G) Rental payments for lactation pumps are considered "bundled," which includes but is not limited to the following components:

(1) Set up and instructions as to pump and attachment kit usage and cleaning.

(2) Maintenance and repair during rental period.

(3) Any required attachment kit, which must be new and will become the property of the consumer upon issuance.

(4) Applicable cleaning/return service charges, unless the unit is returned excessively dirty, which is defined as the unit requires extensive cleaning before it can be utilized by another consumer, in which case the durable medical equipment (DME) vendor may seek reasonable cleaning charges from the consumer.

(H) "" Bundled accessories are the responsibility of the DME provider to dispense during the consumer's initial rental period. No replacements for lost or damaged supplies and or accessories are billable to Ohio medicaid during the rental period. Any lost or damaged supplies and/or accessories are the responsibility of the consumer to replace.

(I) Any manual lactation pump that was supplied to a consumer as part of a pump attachment kit cannot be billed to the Ohio medicaid program as a separate item by a DME vendor.

(J) Any consumer that acquires a manual lactation pump as part of a vendor supplied pump attachment kit cannot purchase an additional manual lactation pump at Ohio medicaid program expense.

(K) All DME providers that submit claims to Ohio medicaid for reimbursement of a rental lactation pump must keep in the consumer's medical record documentation to demonstrate that the lactation pump was actively being utilized by the consumer during the time frame for which compensation is sought. The type of documentation that meets this requirement is left to the discretion of the DME provider. This documentation must be available for review at the request of ODJFS.

(L) Inpatient lactation services or those provided to a resident of a long term care facility (LTCF) or an intermediate-care facility for the mentally retarded and/or DME equipment are not covered under this rule and cannot be billed separately. These services are considered a component of the diagnostic related group (DRG ) or facility per diem payment.

(M) Lactation pumps are reimbursed at the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Click to view Appendix

Effective: 04/25/2011
R.C. 119.032 review dates: 01/03/2011 and 04/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 9/1/05

5160-10-26 Enteral nutritional products.

(A) Definition

"Enteral nutrition" is defined as oral or tube-delivered caloric sustenance products for those medicaid consumers demonstrating a disability or life-threatening disease with significant nutritional problems that cannot be managed by ordinary or blenderized foods.

(B) Coverage determination

(1) For an enteral nutritional product to be considered for coverage, one of the following criteria must be met:

(a) The consumer is unable to swallow food due to a damaged or diseased (non-functioning) oral pathway and must be tube-fed, as determined and documented by a licensed prescriber.

(b) The consumer has the ability to swallow, but is unable to meet caloric and nutritional requirements from ordinary foods, including pureed or blenderized foods, to maintain life-sustaining functions, as determined and documented by a licensed prescriber.

(2) Consumers with infants and children age five or younger whose children require enteral nutrition products, breast-feeding consumers with an infant one year of age or younger, or post-partum mothers with a child six months of age or younger, must apply to their county women, infant and children (WIC) program for an eligibility evaluation before coverage by the Ohio department of job and family services (ODJFS) will be considered.

(C) Non-covered products

(1) Enteral nutrition products that are designed to provide meal replacements, or snack alternatives to be eaten within the context of a consumer's individualized meal plan, are not covered. These products include, but are not limited to:

(a) Shakes;

(b) Meal bars;

(c) Snack bars;

(d) Supplement thickeners;

(e) Cereals;

(f) Puddings;

(g) Vitamins/ minerals; and

(h) Blenderized or pureed foods prepared in a personal residence or long term care facility (LTCF).

(2) Enteral nutrition products that are designed as meal replacements, or to be eaten within the context of a consumer's prescribed reduced calorie diet for consumers with diabetes, obesity issues, pre- or post-gastric bypass, or bariatric surgery, are not covered.

(3) Enteral nutrition products that are administered in an outpatient provider setting (i.e., a dialysis outpatient clinic or a facility receiving per diem payments from the department) are not separately reimbursable.

(4) Adult and pediatric electrolyte replacement is covered under the pharmacy benefit program as described in Chapter 5101:3-9 of the Administrative Code.

(5) Any facility receiving per diem reimbursement from the Ohio medicaid program for a consumer's care cannot submit claims to ODJFS for separate reimbursement for enteral nutritional products.

(D) Prior authorization

(1) The following documentation must be submitted for prior authorization (PA) before reimbursement for enteral nutrition products will be considered:

(a) A fully completed form JFS 01907 , "Certificate of Medical Necessity for Enteral Nutrition Services/ Prescription" (CMN) (appendix to this rule) that is signed and dated no more than thirty days prior to the first date of service.

(2) Prior authorization requests for medicaid consumers who cannot maintain weight must include a current weight history. Providers requesting for a consumer a daily caloric intake of greater than two thousand calories must have "section 9" of form JFS 01907 completed prior to requesting a prior authorization.

(3) Initial prior authorization requests for enteral nutrition products may be approved for a maximum of twelve months. Subsequent PAs for the same consumer for the same disease state may be approved for a maximum of twelve months.

(4) Consumers having a change in their treatment plan that requires the use of an enteral product that is different than a previously authorized enteral product will require a new certificate of medical necessity before a new enteral product will be authorized.

(E) Dispensing

(1) Enteral nutrition products shall be dispensed in no greater quantity than one month's supply.

(2) Providers may dispense enteral nutrition products' generic equivalents (e.g., vendor branded or private label equivalent) if available, as long as the substituted product is correctly formulated to meet the needs of the consumer and the consumer's prescriber is notified in advance of dispensing.

(3) Medicaid providers may not provide a re-supply of enteral nutrition products sooner than one week before a consumer's next scheduled supply dispense date.

(4) No dispensing, mailing, or delivery fees are separately reimbursable by the Ohio medicaid program.

(5) The consumer will be supplied with the ordered enteral product that is in the most cost effective formulation that the consumer can tolerate.

(F) Reimbursement

(1) Unless otherwise specified, enteral nutrition products are reimbursed by the Ohio medicaid program consistent with paragraph (F) of rule 5101:3-10-05 of the Administrative Code.

(2) For enteral nutrition products that do not have a predesignated medicaid maximum allowable on the Ohio medicaid fee schedule as listed in appendix DD to rule 5101:3-1-60 of the Administrative Code, the Ohio medicaid program will reimburse the supplier's average wholesale price (AWP) minus twenty-three per cent.

(3) No more than one month's supply of enteral nutrition products is allowed for one month's prospective billing.

(4) For enteral nutrition that is administered orally, the modifier BO must be utilized in conjunction with the appropriate "Healthcare Common Procedure Coding System" (HCPCS) code . This modifier will be authorized for use by the PA department during the initial PA review and documented on the provider's PA letter.

Click to view Appendix

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02 , Section 309.30.75 of Am. Sub. H.B. 1, 128th G.A
Rule Amplifies: 5111.01 , 5111.02 , 5111.021 , Section 309.30.75 of Am. Sub. H.B. 1, 128th G.A
Prior Effective Dates: 1/1/06, 8/18/08, 1/1/10

5160-10-27 Continuous passive motion (CPM) devices.

(A) Definition

The continuous passive motion (CPM) device is a treatment modality in which knee joint motion is provided by a machine without causing active contraction of muscle groups. The CPM device allows passive movements to be performed to a knee joint for hours at a time. The knee joint area is secured in the CPM machine, and the machine is programmed to passively flex and extend the knee joint through a pre-selected range of motion and rate of repetition. Movement is slow and controlled, and the patient does not actively exert muscle force to move the knee joint.

(B) Coverage determination

The CPM device, when initiated during the immediate post-operative period (beginning within forty-eight hours after surgery), will be considered for coverage if the CPM device is to be utilized following total knee replacement or revision of a total knee replacement and is being sought for use in the consumer's personal residence.

(C) Non-coverage determination

(1) CPM therapy is not covered for joints other than the knee.

(2) A CPM device is not separately reimbursable for consumers who are hospitalized or in a long term care facility (LTCF) .

(3) CPM is not covered as a substitute to conventional provider delivered physical therapy.

(4) CPM therapy is not appropriate for consumers unable to independently turn the device on and off, or who are not willing to participate in a course of rehabilitation in relation to the medical event prompting the request for CPM therapy.

(D) Authorization

(1) The use of a CPM device does not require a prior authorization when utilized for a single knee surgery. However, the provider of the CPM device is required to maintain on file a legible written prescription issued by a licensed prescriber that is signed and dated no more than thirty days prior to the first date of service that defines the specific "from" and "to" dates that reflect the actual days the CPM device is to be utilized.

(2) The maximum days allowable for the utilization of a CPM device is twenty-one per medical event, per knee.

(3) If the consumer has the surgery mentioned in paragraph (B) of this rule on both knees concurrently, the following documentation must be submitted for prior authorization (PA) before reimbursement for services rendered with two machines will be authorized in accordance with the provisions set forth in rule 5101:3-1-31 of the Administrative Code:

(a) A legible written prescription issued by a licensed prescriber that is signed and dated no more than thirty days prior to the first date of service that defines the specific "from" and "to" dates that reflect the actual days the CPM device is to be utilized.

(b) Any other documentation as required or requested by ODJFS for certain specific medical supplier services, as detailed in Chapter 5101:3-10 of the Administrative Code.

(4) CPM devices must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the medical need for the CPM device.

(E) Dispensing

(1) CPMs are expected to be dispensed with one complete set of supporting soft goods per CPM unit dispensed unless the consumer currently owns the supporting soft goods resulting from a previous medical event.

Soft goods are defined as including at a minimum, thigh and calf pads, foot bootie pad, thigh straps and hook and loop contact closures constructed of quilted sheepskin or moisture wicking materials.

(2) The following components are considered "bundled" with any CPM payment made by ODJFS on behalf of a consumer and cannot be submitted to ODJFS for separate payment:

(a) Any supporting wires, cables, or attachment kits;

(b) Consumer education, training, monitoring, or counseling ;

(c) Maintenance, repair, or cleaning charges; or

(d) Delivery, set up, or pick up charges.

(3) The provider of a CPM device must assure that the consumer or the consumer's caregiver is properly instructed on how to use the device and understands any emergency procedures regarding the use of the device. The provider must maintain written documentation in the consumer's medical record regarding the consumer's or the consumer's caregiver's instruction on the use of the CPM device .

(4) The prescriber of a CPM device must assure and document in the medical record that the continued use of the CPM device is resulting in the clinical improvement of the consumer . The use of the CPM device must be discontinued immediately and an alternative therapy method considered if the consumer demonstrates no progressive clinical improvement during the CPM rental period.

(5) The provider of a CPM device must supply the consumer or the consumer's caregiver with a twenty-four hour, seven-day-a-week telephone number to be utilized in case of an emergency . This telephone number must meet all federal Americans with Disabilities Act (ADA) of 1990 requirements.

(F) Reimbursement

CPM devices and associated soft goods are reimbursed according to the ODJFS fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code, or the providers usual and customary charge, whichever is less.

Effective: 04/25/2011
R.C. 119.032 review dates: 01/03/2011 and 04/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/1/06

5160-10-28 Non-invasive bone (osteogenesis) stimulators.

(A) Definition

(1) An electrical bone (osteogenesis) spinal or nonspinal stimulator is a device that provides electrical stimulation to augment bone repair. A non-invasive electrical bone stimulator is characterized by an external power source that is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.

(2) An ultrasonic bone (osteogenesis) stimulator is a non-invasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.

(B) Coverage determination

(1) A nonspinal electrical bone stimulator is covered only if any of the following criteria are met:

(a) Nonunion of a long bone fracture, defined by radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the bone stimulator and documented by a minimum of two sets of radiographs obtained prior to starting treatment with the bone stimulator, separated by a minimum of ninety days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs;

(b) Failed fusion of a joint other than the spine where a minimum of nine months has elapsed since the last surgery; or

(c) Congenital pseudarthrosis.

(2) A nonspinal electrical bone stimulator will be denied as not medically necessary if none of the criteria listed in paragraph (B)(1) of this rule are met.

(3) A spinal electrical bone stimulator is covered only if any of the following criteria are met:

(a) Failed spinal fusion where a minimum of nine months has elapsed since the last surgery;

(b) The consumer has undergone a multilevel spinal fusion surgery; or

(c) The consumer has undergone spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

(4) A spinal electrical bone stimulator will be denied as not medically necessary if none of the criteria listed in paragraph (B)(3) of this rule are meet.

(5) An ultrasonic bone stimulator is covered only if all of the following criteria are met:

(a) Nonunion of a long bone fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the bone stimulator, separated by a minimum of ninety days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs;

(b) Fracture is not of the skull or vertebrae; and

(c) Fracture is not tumor-related.

(6) An ultrasonic bone stimulator will be denied as not medically necessary if all of the criteria listed in paragraph (B)(5) of this rule are not met.

(7) In order to qualify for the use of any bone stimulator, a consumer that is twenty years of age or younger must meet all of the following criteria in addition to the medical criteria for the applicable bone stimulator prescribed listed in paragraphs (B)(1), (B)(3) and (B)(5) of this rule:

(a) There is radiological documentation that skeletal maturity has been attained;

(b) The fracture gap is not more than one-half of the diameter of the bone to be treated; and

(c) The fracture does not involve a vertebrae.

(C) Non-coverage determination

(1) Bone (osteogenesis) stimulators are considered noncovered if any of the following contraindications exist:

(a) Fracture of short or flat bones or epiphyses;

(b) Fracture as a result of cancer;

(c) Fractures that need additional reduction or are comminuted;

(d) Fractures with post-reduction displacement of greater than fifty per cent;

(e) Fractures with internal or external fixation;

(f) Fracture gaps greater than one centimeter;

(g) Avascularity, vascular insufficiency or other vascular problems (e.g.,thrombophlebitis) or severe osteoporosis;

(h) When stimulator is to be used in conjunction with medications that may interfere with or alter bone metabolism and healing;

(i) When osteomyelitis, active infections or necrotic bone is present;

(j) Paget's disease, renal disease or diabetes;

(k) Sensory paralysis; or

(l) Synovial pseudoarthritis.

(2) Consumers with demand type pacemakers in proximity to the proposed treatment site are not eligible for electric bone stimulators.

(D) Prior authorization

A fully completed form JFS 07134 (rev. 2/2006), "Certificate of Medical Need/Prescription Non-Invasive Bone Growth (Osteogenesis) Stimulator" (CMN) (appendix A to this rule) that is signed and dated no more than thirty days prior to the first date of service must be submitted for prior authorization (PA) before reimbursement for a bone stimulator will be considered.

(E) Dispensing

(1) The following components are considered "inclusive" with any bone stimulator device payment made by the department on behalf of a consumer and cannot be submitted to the department for separate reimbursement:

(a) Any supporting wires, power supply, cables, attachment kits or disposable items such as electrodes, or in the case of the ultrasound stimulator, coupling gel;

(b) Stimulator education, training, monitoring, or counseling in support of the consumer's ordered treatment;

(c) Maintenance, repair, or cleaning services; or

(d) Delivery or set-up services.

(2) The provider of the bone stimulator must assure that the consumer utilizing the device is properly instructed on how to use the device in support of the ordered treatment and is aware of and understands any emergency procedures regarding the use of the bone stimulator device. The provider must maintain written documentation regarding the consumer's instruction on the use of the bone stimulator in the consumer's medical record.

(3) A bone stimulator may not be used concurrently with any other bone stimulator device on the same fracture site.

(4) Upon dispensing of a bone stimulator device, the consumer must be supplied by the provider with a twenty-four hour, seven day a week telephone number to be utilized in case an emergency situation arises concerning the device. This telephone number must meet all federal Americans with Disabilities Act (ADA) of 1990 requirements.

(F) Reimbursement

Bone stimulator devices are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge, whichever is less.

Appendix A

Certificate of Medical Necessity/Prescription Osteogenesis Bone Stimulators

See Appendix A at

http://emanuals.odjfs.state.oh.us/emanuals/DataImages.srv/emanuals/pdf/pdf_forms/31028APX.PDF

Effective: 10/15/2006
R.C. 119.032 review dates: 10/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021

5160-10-29 External insulin infusion pump.

(A) Definition

A standard portable external insulin infusion pump is a small battery-operated pump about the size of a personal pager, is filled with insulin, and is connected to thin tubing ending in a needle. The needle is inserted into the skin around the abdomen, and supplies a regulated dose of insulin to the user for a day or more at a time. The pump may be carried in a pocket or in a case worn attached to a belt fastened around a consumer's waist.

(B) Coverage determination

(1) Ohio medicaid covers standard portable external insulin infusion pumps for patients with type 1 diabetes mellitus documented by a C-peptide level less than 0.5 and when all of the following medical necessity criteria are met:

(a) The consumer has completed a diabetes education program within the last twenty four months of being prescribed an insulin infusion pump;

(b) The consumer has been on a program of multiple daily injections of insulin (i.e., at least three injections per day), with frequent self-adjustments of insulin dose, for at least six months before initiation of the insulin infusion pump;

(c) The consumer had documented frequency that is kept in the consumer's medical record of glucose self-testing an average of at least four times per day during the two months before initiation of the insulin infusion pump;

(d) The consumer is at high risk for preventable complications of diabetes. Early signs of diabetic complications include micro-albuminuria and/or documented in the consumer's medical record persistent difficulty in achieving optimal control of blood sugar levels despite good compliance with an intensive multiple injection regimen.

(2) In addition to the aforementioned criteria, the consumer needs to meet at least one of the following criteria in order to be eligible for a standard portable external insulin infusion pump:

(a) Glycated hemoglobin level (HbA1c) greater than seven per cent;

(b) History of recurring hypoglycemia;

(c) Wide fluctuations in blood glucose before mealtime;

(d) Dawn phenomenon with fasting blood sugars frequently exceeding two hundred mg/dL; or

(e) History of severe glycemic excursions.

(C) Non-coverage determination

(1) Standard portable external insulin infusion pumps are not covered if any of the following contraindications exist:

(a) Consumer has non-insulin dependent (NIDDM or IR-NIDDM, Type II) diabetes, even if insulin is taken;

(b) Consumer has end-stage complications such as renal failure;

(c) Consumer is unable, because of behavioral, psychological problems or functional ability, to technically operate the pump and perform frequent blood glucose monitoring; or

(d) Consumer is being prescribed pump therapy to be used for convenience purposes.

(2) The department will not cover jet pressure or surgically implanted infusion devices or systems, chronic intermittent intravenous insulin therapy (CIIIT), or pulsatile IV insulin therapy (PIVIT).

(D) Prior authorization

(1) The following documentation must be submitted for prior authorization (PA) before reimbursement for a standard portable external insulin infusion pump will be considered:

A fully completed form JFS 07136 (rev. 3/2008) "Certificate of Medical Necessity/Prescription External Infusion Pump" (CMN) (appendix to this rule) that is signed and dated no more than thirty days before the first date of service.

(2) Prior authorization for a standard portable external insulin infusion pump must include a three-month trial rental period conducted in which the consumer has undergone a successful trial period with a pump that demonstrates that the consumer is capable of managing the pump and that the desired improvement in metabolic control can be achieved. If a prescriber certification is submitted to the department at the conclusion of a successful trial rental period, the device will be considered for purchase by the department in accordance with paragraph (I) of rule 5101:3-10-05 of the Administrative Code.

(E) Dispensing

(1) The following components are considered "inclusive" with any portable external infusion insulin pump rental or purchase payment made by the department on behalf of a consumer and cannot be submitted to the department for separate reimbursement:

(a) Any supporting wires, power supply, cables, attachment kits, or disposable items associated with the operation of the pump;

(b) Pump education, training, monitoring, or counseling in support of the consumer's ordered treatment;

(c) Maintenance, repair, or cleaning charges in association with the three-month trial rental period; or

(d) Delivery, set-up, or pick-up charges.

(2) The provider of the portable external infusion insulin pump must assure that the consumer utilizing the device is properly instructed on how to use the device in support of his or her ordered treatment and is aware of and understands any emergency procedures regarding the use of the pump. The provider must maintain written documentation regarding the consumer's instruction on the use of the pump in the provider's records.

(3) The prescriber of the portable external infusion insulin pump must assure and document in the consumer's medical record that the continued use of the device is resulting in the clinical improvement of the consumer utilizing the device. The use of the device must be discontinued immediately and an alternative treatment method considered if the consumer demonstrates no progressive clinical improvement during the rental period of the device.

(4) When the department determines that the purchase of a portable external infusion insulin pump is appropriate, the consumer must be provided with a product warranty that covers any required maintenance or repairs for a duration of at least one year and commences on the date the infusion pump was authorized for purchase.

(F) Reimbursement

(1) Portable external infusion insulin pumps are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the providers' usual and customary charges, whichever is less.

(2) Previously utilized or loaner portable external infusion insulin pumps are not eligible for purchase by the department.

Ohio Department of Job and Family Services

Certificate of Medical Necessity/Prescription

External Insulin Infusion Pump

See Form at

http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-29_PH_FF_A_APP2_20080804_0938.pdf

Effective: 08/18/2008
R.C. 119.032 review dates: 10/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 10/15/2006

5160-10-30 Canes, crutches and walkers.

(A) Definitions

(1) Mobility-related activities of daily living (MRADL): MRADL's are considered to be activities relating to toileting, feeding, dressing, grooming, and bathing performed in customary locations in the home.

(2) Mobility limitation: The consumer is considered to possess a mobility limitation if one of the following criteria is met:

(a) The consumer is prevented from accomplishing MRADL's entirely; or

(b) The consumer is placed at a reasonably determined heightened risk of morbity or mortality secondary to the attempts to perform MRADL's; or

(c) The consumer is prevented from completing MRADL's within a reasonable time frame.

(B) Canes and crutches

(1) Coverage determination

(a) Canes and crutches are covered if all of the following criteria are met:

(b) The consumer has a mobility limitation, documented in the consumer's medical record, that significantly impairs his or her ability to participate in one or more MRADL's in the home; and

(c) The consumer is able to safely use the cane or crutch; and

(d) The functional mobility deficit can be sufficiently resolved by use of a cane or crutch.

(2) In addition to the aforementioned criteria, the cane or crutch must have been authorized by a prescriber who is actively involved in managing the consumer's mobility difficulties and should be treating the consumer under a comprehensive plan of care that addresses the consumer's mobility difficulties.

(C) Walkers

(1) Coverage determination

(a) Walkers are covered if all of the following criteria are met:

(i) The consumer has a mobility limitation, documented in the consumer's medical record, that significantly impairs his or her ability to participate in one or more MRADL's in the home; and

(ii) The consumer is able to safely use the walker; and

(iii) The functional mobility deficit can be sufficiently resolved by use of a walker.

(b) In addition to the aforementioned criteria, the walker must have been authorized by a prescriber who is actively involved in managing the consumer's mobility difficulties and should be treating the consumer under a comprehensive plan of care that addresses the consumer's mobility difficulties.

(2) Heavy duty walkers

(a) A heavy duty walker is covered only for consumers who meet the criteria in paragraph (C) of this rule for a standard walker and who weigh more than three hundred pounds.

(b) A heavy duty, multiple braking system, variable wheel resistance walker is covered for consumers who meet the criteria in paragraph (C) of this rule for a standard walker, who weigh more than three hundred pounds and who are unable to use a standard walker due to a documented severe neurologic disorder or other condition causing the restricted use of one hand. Obesity, by itself, is not a sufficient reason for this type of walker.

(3) Enclosed frame walker

In order to justify reimbursement for an enclosed frame walker, providers must document in the consumer's medical record why this type of walker is medically necessary in place of a standard walker. This documentation must contain the original signature of the ordering prescriber that attests to this medical necessity.

(4) Trunk support walker

In order to justify reimbursement for a walker with trunk support, providers must document in the consumer's medical record why this type of walker is medically necessary in place of a standard walker. This documentation must contain the original signature of the ordering prescriber that attests to this medical necessity.

(5) Walker leg extensions

Walker leg extensions are covered only for consumers six feet tall or more when standing.

(D) Canes, crutches and walker limitations

(1) It is the provider's responsibility to assure that the consumer receives the appropriate mobility assistive device consistent with his or her present medical condition and diagnosis and to verify that the consumer has not previously acquired a duplicate mobility assistive device that exceeds the limitations set forth in appendix A to rule 5101:3-10-03 of the Administrative Code from a different provider.

(2) Canes, crutches and walkers for consumers residing in long term care facilities are reimbursed through the facility's cost report.

(E) Reimbursement

Canes, crutches and walkers are reimbursed the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Effective: 08/17/2009
R.C. 119.032 review dates: 08/01/2014
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021

5160-10-31 Therapeutic footwear for consumers with diabetes.

Unless otherwise specified, the licensing of persons authorized to fit or dispense therapeutic footwear for consumers with diabetes is administered and enforced by Chapter 4779. of the Revised Code. Any provider seeking reimbursement for therapeutic footwear must meet the provisions contained within this rule when applicable in order to be eligible for reimbursement for services provided.

(A) Coverage determination

For a consumer to be eligible for therapeutic footwear the following criteria must be met:

(1) The consumer has diabetes mellitus ("International Classification of Diseases, Ninth Revision" (ICD-9) diagnosis codes 250.00 - 250.93 ); and

(2) The consumer has one or more of the following conditions:

(a) Previous amputation of the other foot, or part of either foot;

(b) History of previous foot ulceration of either foot;

(c) History of pre-ulcerative calluses on either foot;

(d) Peripheral neuropathy with evidence of callus formation of either foot;

(e) Foot deformity of either foot; or

(f) Poor circulation in either foot; and

(3) The certifying prescriber who is managing the consumer's systemic diabetes condition has certified that the indications in paragraphs (A)(1) and (A)(2) of this rule are met and that he or she is treating the consumer under a comprehensive plan of care for his or her diabetes and that the consumer needs therapeutic footwear.

(B) Non-coverage determination

(1) Items represented by code A5510 refer to inserts that are compression molded to the consumer's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category and will be denied as noncovered.

(2) Inserts used in noncovered shoes are noncovered.

(3) Deluxe features of diabetic shoes (A5508) are noncovered.

(4) Shoes, inserts and/or modifications that are provided to patients who do not meet the coverage criteria are noncovered.

(C) Authorization

(1) The following documentation must be submitted for prior authorization (PA) before reimbursement for therapeutic footwear will be considered in accordance with the provisions set forth in rule 5101:3-10-31 of the Administrative Code :

(a) Documentation to establish medical necessity of the requested item or service; and

(b) Any other documentation as required or requested by ODJFS for certain specific medical supplier services, as detailed in Chapter 5101:3-10 of the Administrative Code.

(2) Documentation for the prior authorization of therapeutic footwear must be submitted with the appropriate healthcare common procedure coding system (HCPCS) codes .

(D) Dispensing

(1) The particular type of footwear that is necessary must be prescribed by a podiatrist or other qualified prescriber knowledgeable in the fitting of therapeutic footwear. The footwear must be fitted and dispensed by a podiatrist, pedorthist, orthotist, or prosthetist meeting the qualifications specified in Chapter 4779. of the Revised Code. Documentation that the provider is authorized to fit and dispense therapeutic footwear pursuant to Chapter 4779. of the Revised Code must be kept in the provider's records.

(2) The certifying prescriber (i.e., the prescriber who manages the systemic diabetic condition) may not furnish the footwear unless he or she practices in a defined rural area or a defined health professional shortage area.

(3) Separate inserts may be covered and dispensed independently of diabetic shoes if the provider of the shoes verifies in writing that the consumer has appropriate footwear into which the insert can be placed. This footwear must meet the industry definition for a depth or custom-molded shoe.

(4) A custom molded shoe (A5501) is covered when the consumer has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity must be well documented in the provider's records and such records may be requested by the Ohio department of job and family services (ODJFS) for review. If there is insufficient justification for a custom molded shoe but the general coverage criteria are met, reimbursement for services will be based on the allowance for the least costly medically appropriate alternative (A5500).

(E) Reimbursement

(1) There is no separate reimbursement for the fitting of shoes, inserts or modifications or for the certification of need or prescription of the footwear.

(2) Therapeutic footwear is reimbursed according to the ODJFS fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code, or the provider's usual and customary charge, whichever is less.

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 10/15/2006

5160-10-32 Ostomy and urological supplies.

(A) Ostomy supplies

(1) Coverage determination

(a) The quantity of ostomy supplies needed by a consumer is determined primarily by the type of ostomy, its location and construction, and the condition of the skin surface surrounding the stoma. The department recognizes that there will be variation according to individual consumer need and that this need may vary over time.

(b) The provider must maintain documentation in the consumer's medical record that clearly supports the medical necessity for ostomy supplies.

(c) Ostomy supplies must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the need for ostomy supplies on a continual basis. This prescription must contain the original signature of the ordering prescriber that attests to this medical necessity and clearly designates the quantity and type of ostomy supplies being prescribed.

(d) Any change to a consumer's care plan regarding the quantity or type of ostomy supplies requires a new prescription be obtained by the provider that details the changes to the care plan. The provider must keep any new orders regarding the consumer's ostomy care plan in the consumer's medical record to be available for review by the department upon request.

(2) Coverage limitations

(a) Provision of ostomy supplies is limited to a one-month supply per calendar month. Consumers are eligible for re-supply on a calendar month basis starting with the initial dispensing date. The provider is responsible for determining the appropriate amount of ostomy supplies on any given month based on consumer need. The stockpiling of ostomy supplies by a consumer is not allowed.

(b) Providers are responsible for determining whether additional ostomy supplies have been acquired by the consumer from a different provider during any given month. Ostomy supplies dispensed over and above the stated maximum allowables as listed in appendix A to rule 5101:3-10-03 of the Administrative Code will not be reimbursed without prior authorization.

(c) Ostomy supplies for consumers residing in long term care facilities are reimbursed through the facility's cost report.

(d) When a liquid barrier is necessary, either liquid or spray or individual wipes or swabs is appropriate. Only a single type is reimbursable by the department at a given time.

(e) Consumers with continent stomas may use either a stoma cap, stoma plug, or gauze pads to prevent/manage drainage. Only a single type is reimbursable by the department at any given time.

(f) Consumers with urinary ostomies may use either a bag or bottle for drainage at night. Only a single type is reimbursable by the department at any given time.

(B) Urological supplies

(1) Coverage determination

(a) The provider must document in the consumer's medical record the medical necessity for urological supplies.

(b) Urological supplies must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the need for urological supplies on a continual basis. This prescription must contain the original signature of the ordering prescriber that attests to this medical necessity and clearly designates the quantity and type of urological supplies being prescribed.

(c) Any change to a consumer's care plan regarding the quantity and type of urological supplies requires that a new prescription be obtained by the provider that details the changes to the care plan. The provider must maintain any new orders regarding the consumer's urological care plan in the consumer's medical record to be available for review by the department upon request.

(d) Indwelling catheters

(i) No more than one catheter per month is covered for routine catheter maintenance. Non-routine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications:

(a) Catheter is accidentally removed (e.g., pulled out by consumer); or

(b) Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter); or

(c) Catheter is obstructed by encrustation, mucous plug or blood clot; or

(d) History of recurrent obstruction or urinary tract infection for which it has been established by the prescriber that an acute event is prevented by a scheduled change frequency of more than once per month.

(ii) When a specialty indwelling catheter or an all-silicone catheter is used, documentation must be maintained in the consumer's medical record that attests to the medical necessity for that catheter rather than a straight foley type catheter with coating.

(iii) A three-way indwelling catheter either alone or with other components will be covered based on medical necessity documentation in the consumer's medical record.

(e) Catheter insertion tray

(i) One insertion tray will be covered per episode of indwelling catheter insertion. More than one tray per episode will not be reimbursed by the department.

(ii) One intermittent catheter with insertion supplies will be covered per catheterization episode based on supporting documentation of medical necessity in the consumer's medical record.

(f) Urinary drainage collection system

(i) Coverage is authorized for the routine changes of the urinary collection system based on supporting documentation of medical necessity in the consumer's medical record.

(ii) Leg bags are covered for consumers who are ambulatory or are chair or wheelchair bound. The use of leg bags for bedridden consumers is not authorized.

(iii) If there is a catheter change and an additional drainage bag change within a month, the combined utilization for these supplies should be considered by the provider when determining if prior authorization is necessary due to the consumer's medical need to exceed the monthly maximum allowable that is designated for these supplies in appendix A to rule 5101:3-10-03 of the Administrative Code.

(iv) Payment will not be made for concurrent use of a vinyl and a latex bag.

(g) Intermittent irrigation of indwelling catheters

(i) Supplies for the intermittent irrigation of an indwelling catheter are covered by the department when they are used on an as-needed (non-routine) basis in the presence of acute obstruction of the catheter. Documentation supporting medical necessity must be maintained in the medical record and available for review by the department. Routine intermittent irrigations of a catheter are not reimbursable by the department. Routine irrigations are defined as those performed at predetermined intervals.

(ii) Covered supplies for non-routine irrigation of a catheter include either an irrigation tray or an irrigation syringe, and sterile water/saline. Syringes, trays, sterile saline or water are not reimbursable by the department when used for routine irrigation. Irrigation solutions containing antibiotics and chemotherapeutic agents and solutions such as acetic acid or hydrogen peroxide used for the treatment or prevention of urinary obstruction are not reimbursable by the department.

(h) Continuous irrigation of indwelling catheters

(i) Supplies for continuous irrigation of a catheter are covered if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation in conjunction with medically necessary catheter changes. Supplies used as a result of continuous irrigation being utilized as a primary preventive measure are not reimbursable by the department. Documentation that verifies the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation must be maintained in the consumer's medical record. This documentation must indicate the rate of solution administration and the consumer's duration of need.

(ii) Covered supplies for medically necessary continuous bladder irrigation include a three-way foley catheter, irrigation tubing set, and sterile water/saline. The department does not reimburse for more than one irrigation tubing set per day for continuous catheter irrigation.

(iii) Irrigation solutions containing antibiotics and chemotherapeutic agents are not reimbursable by the department. Reimbursement claims for irrigating solutions such as acetic acid or hydrogen peroxide should be billed using the appropriate healthcare common procedure coding system (HCPCS) code for sterile water/saline .

(iv) Continuous irrigation is considered by the department to be a temporary measure. Continuous irrigation for more than two weeks duration requires supporting medical necessity documentation in the consumer's medical record.

(i) Intermittent catheterization

(i) Intermittent catheterization is covered by the department when the basic coverage criteria in paragraph (B)(1)(i)(ii) of this rule are met and the consumer or consumer's caregiver can perform the procedure. Documentation supporting the capability of the consumer or consumer's caregiver to perform this procedure must be included in the consumer's medical record.

(ii) For each episode of covered catheterization, the department will reimburse for one catheter or one sterile catheter kit if the following additional coverage criteria are met:

(a) The consumer is immunosuppressed; or

(b) The consumer has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or

(c) The consumer is a spinal-cord injured female with neurogenic bladder who is pregnant (covered for duration of pregnancy only); or

(d) The consumer has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization, two or more times within the twelve months prior to the initiation of using sterile intermittent catheter kits.

(iii) A consumer is considered to have a urinary tract infection if he or she has a documented urine culture with greater than ten thousand colony forming units of a urinary pathogen and concurrent presence of one or more of the following signs, symptoms or laboratory findings:

(a) Fever (oral temperature greater than thirty-eight degrees Celsius or 100.4 degrees Fahrenheit); or

(b) Systemic leukocystosis; or

(c) Change in urinary urgency, frequency, or incontinence; or

(d) Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation); or

(e) Physical signs of prostatitis, epididymitis, orchitis; or

(f) Increased muscle spasms; or

(g) Pyuria (greater than five white blood cells (WBCs) per high powered field).

(iv) If the medical necessity of sterile catheterization is not documented in the consumer's medical record, sterile supplies associated with this procedure are not reimbursable by the department.

(v) Use of a coude (curved) tip catheter in females is considered to be rarely necessary. When a coude tip catheter is used (for either males or females), there must be documentation of medical necessity in the consumer's medical record for the use of this type of catheter rather than a straight tip catheter.

(j) External catheters or urinary collection devices

(i) Male external catheters (condom-type) or female external urinary collection devices are covered for consumers who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

(ii) Male external catheters or female external urinary collection devices will not be reimbursable if the consumer is currently also using an indwelling catheter.

(iii) Specialty type male external catheters such as those that inflate or that include a faceplate or extended wear catheter systems are covered only when documentation in the consumer's medical record establishes the medical necessity for such a catheter.

(iv) For female external urinary collection devices, more than one metal cup per week or one pouch per day is not reimbursable.

(k) Miscellaneous supplies

(i) Appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (e.g., A5102 or A5112). Reimbursement is not approved for this cleaner unless the consumer is also using one of the specified corresponding appliances.

(ii) Adhesive catheter anchoring devices and catheter leg straps for indwelling urethral catheters are covered. A catheter/tube anchoring device is covered and separately reimbursable only when it is used to anchor a covered suprapubic tube or nephrostomy tube.

(2) Coverage limitations

(a) Provision of urological supplies is limited to a one-month supply per calendar month. Consumers are eligible for re-supply on a calendar month basis starting with the initial dispensing date. The provider is responsible for determining the appropriate amount of urological supplies on any given month based on consumer need. The stockpiling of urological supplies by a consumer is not allowed.

(b) Providers are responsible for determining whether additional urological supplies have been acquired by the consumer from a different provider during any given month. Urological supplies dispensed over and above the stated maximum allowables as listed in appendix A to rule 5101:3-10-03 of the Administrative Code will be not be reimbursed without prior authorization.

(c) Urological supplies for consumers in long term care facilities are reimbursed through the facility's cost report.

(C) Reimbursement

Ostomy and urological supplies are reimbursed at the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 08/17/09

5160-10-33 Commodes.

(A) Coverage determination

(1) The provider must document medical necessity in the consumer's medical record that clearly supports the need for a commode.

(2) Commodes must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the need for a commode. This prescription must contain the original signature of the ordering prescriber that attests to the medical necessity of the commode.

(3) A commode is covered when the consumer is physically incapable of utilizing regular toilet facilities and is physically able to use a commode, otherwise a bedpan is indicated. This limitation must be documented in the consumer's medical record and available for review upon request by the department. One or more of the following situations must be present in order for a commode to be justified for reimbursement:

(a) The consumer is confined to a single room due to a documented medical condition; or

(b) The consumer is confined to one level of the home due to a documented medical condition and there is no toilet on that level; or

(c) The consumer is confined to the home due to a documented medical condition and there are not toilet facilities in the home.

(4) An extra wide/heavy duty commode chair is covered for consumers who weigh three hundred pounds or more. If a consumer weighs less than three hundred pounds, the consumer's medical record must document the medical necessity of this type of commode chair.

(5) A commode chair with detachable arms is covered only if this feature is necessary to facilitate transferring the consumer or if the consumer has a body configuration that requires extra width. The consumer's medical record must document the medical necessity of this type of commode chair.

(B) Coverage limitations

(1) Providers are responsible, prior to dispensing a commode, to determine whether the consumer previously acquired this item from another provider.

(2) Commodes for consumers residing in long term care facilities are reimbursed through the facility's cost report.

(3) Providers cannot bill for the concurrent supply of both a commode and a bedpan.

(C) Reimbursement

Commodes are reimbursed at the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Effective: 08/17/2009
R.C. 119.032 review dates: 08/01/2014
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021

5160-10-34 Surgical Dressings and Related Supplies.

(A) Definitions

Unless otherwise specified, the staging of pressure ulcers used in this rule is as follows:

(1) Suspected deep tissue injury: Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.

(2) Stage I: Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area.

(3) Stage II: Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.

(4) Stage III: Full thickness loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling.

(5) Stage IV: Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often includes undermining and tunneling.

(6) Unstageable: Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.

(B) Coverage determination

(1) Surgical dressings are covered for as long as medical necessity exists. Dressings over a percutaneous catheter or tube (e.g., intravascular, epidural, nephrostomy, etc.) are covered as long as the catheter or tube remains in place and after removal until the wound heals.

(2) Any prescription for surgical dressings and related supplies must be prescribed by a prescriber actively involved in managing the consumer's medical condition as indicated in paragraph (A)(2) of rule 5101:3-10-05 of the Administrative Code. The prescriber should be treating the consumer under a comprehensive plan of care which addresses the underlying medical need for any supplies referenced in this rule.

(3) When a wound cover with an adhesive border is being used, no other dressing is needed on top of it and additional tape is usually not required. Reasons for use of additional tape must be documented by the provider. An adhesive border is usually more binding than that obtained with separate taping and is therefore indicated for use with wounds requiring less frequent dressing changes.

(4) Use of more than one type of wound filler or more than one type of wound cover in a single wound is rarely medically necessary. The reasons for use of more than one type of wound filler or wound cover must be well documented by the provider. An exception is an alginate or other fiber gelling dressing or a saline, water, or hydrogel impregnated gauze dressing which might need an additional wound cover.

(5) It may not be appropriate to use some combinations of a hydrating dressing on the same wound at the same time as an absorptive dressing (e.g., hydrogel and alginate).

(6) When used as a secondary dressing, composite dressings, foam and hydrocolloid wound covers, and transparent film are meant to be changed at frequencies less than daily and appropriate clinical judgment must be used to avoid their use with primary dressings which require more frequent dressing changes. When claims are submitted for these dressing for changes greater than once every other day, the quantity in excess of that amount will not be reimbursable by the department for a period not to exceed thirty days during the initial treatment. While a highly exudative wound might require such a combination initially, with continued proper management the wound usually progresses to a point where the appropriate selection of these products results in the less frequent dressing changes which they are designed to allow. An example of an inappropriate combination is the use of a specialty absorptive dressing on top of non-impregnated gauze being used as a primary dressing.

(7) Dressing size must be based on and appropriate to the size of the wound. For wound covers, the pad size is usually about two inches greater than the dimensions of the wound.

(8) The quantity and type of dressings dispensed at any one time must take into account the current status of the wound(s), the likelihood of change, and the recent use of dressings.

(9) Dressing needs may change frequently (e.g.,weekly) in the early phases of wound treatment and/or with heavily draining wounds. Providers are expected to have a mechanism for determining the quantity of dressings that the consumer is actually using and to adjust their provision of dressings accordingly. No more than one month's supply of dressings may be provided at one time. The stockpiling of surgical dressings and related supplies by a consumer is not allowed.

(10) Providers are responsible for determining whether additional surgical dressings and related supplies have been acquired by the consumer from a different provider during any given month. Surgical dressings and related supplies dispensed over and above the stated maximum allowables as listed in appendix A to rule 5101:3-10-03 of the Administrative Code will be not be reimbursed without prior authorization.

(11) Surgical dressings must be tailored to the specific needs of an individual consumer. When surgical dressings are provided in kits, only those components of the kit that meet the definition of a surgical dressing and are specifically ordered by a prescriber and are medically necessary are covered. Components included in a kit such as scissors and/or tape may not be billed separately to the department.

(C) Alginate or other fiber gelling dressing

Alginate or other fiber gelling dressing covers are covered for moderately to highly exudative full thickness wounds (e.g., stage III or IV ulcers), and alginate or other fiber gelling dressing fillers for moderately to highly exudative full thickness wound cavities (e.g., state III or IV ulcers). They are not medically necessary on dry wounds or wounds covered with eschar. Usual dressing change is up to once per day. One wound cover sheet of the approximate size of the wound or up to two units of wound filler (one unit equals six inches of alginate or other fiber gelling dressing rope) is usually used at each dressing change. It is usually inappropriate to use alginates or other fiber gelling dressings in combination with hydrogels.

(D) Composite dressing

Usual composite dressing change is up to three times per week, one wound cover per dressing change.

(E) Contact layer dressing

Contact layer dressings are used to line the entire wound and are not intended to be changed with each dressing change. Usual dressing change is up to once per week.

(F) Foam dressing

Foam dressings are covered when used on full thickness wounds (e.g., stage III or IV ulcers) with moderate to heavy exudate. Usual dressing changes for a foam wound cover used as a primary dressing is up to three times per week. When a foam wound cover is used as a secondary dressing for wounds with a very heavy exudate, dressing change may be up to three time per week. Usual dressing change for foam wound fillers is up to once per day.

(G) Gauze, non-impregnated dressing

Usual non-impregnated gauze dressing change is up to three times per day for a dressing without a border and once per day for a dressing with a border. It is usually not necessary to stack more than two gauze pads on top of each other in any one area.

(H) Gauze dressing, impregnated, with other than water, normal saline, hydrogel, or zinc paste

Usual dressing change for this type of dressing is up to once per day.

(I) Hydrocolloid dressing

Hydrocolloid dressings are covered for use on wounds with light to moderate exudate. Usual dressing change for hydrocolloid wound covers or hydrocolloid wound fillers is up to three times per week.

(J) Hydrogel dressing

Hydrogel dressings are covered when used on full thickness wounds with minimal or no exudate (e.g., stage III or IV ulcers). Hydrogel dressings are not usually medically necessary for stage II ulcers. Documentation must substantiate the medical necessity for use of hydrogel dressing for stage II ulcers (e.g., location of ulcer in sacrococcygeal area). Usual dressing change for hydrogel wound covers without adhesive border or hydrogel wound fillers is up to once per day. Usual dressing change for hydrogel wound covers with adhesive border is up to three times per week.

The quantity of hydrogel filler used for each wound must not exceed the amount needed to line the surface of the wound. Additional amounts used to fill a cavity are not medically necessary. Provider documentation must substantiate the medical necessity for this product billed in excess of three units (fluid ounces) per wound in thirty days.

Use of more than one type of hydrogel dressing (filler, cover, or impregnated gauze) on the same wound at the same time is not medically necessary.

(K) Specialty absorptive dressing

Specialty absorptive dressings are covered when used for moderately or highly exudative wounds (e.g., stage III or IV ulcers). Usual specialty absorptive dressing change is up to once per day for a dressing without an adhesive border and up to every other day for a dressing with a border.

(L) Transparent film dressing

Transparent film dressings are covered when used on open partial thickness wounds with minimal exudate or closed wounds. Usual dressing changes is up to three times per week.

(M) Wound filler, not elsewhere classified

Usual dressing change is up to once per day. (N) Wound pouch Usual dressing change is up to three time per week.

(O) Tape

Tape is covered when needed to secure a wound cover, elastic roll gauze or non-elastic roll gauze. Tape is usually not required when a wound cover with an adhesive border is used. The medical necessity for tape in these situations must be documented by the provider. Tape change is determined by the frequency of change of the wound cover. Quantities of tape must reasonably reflect the size of the wound cover being secured. Usual use for wound covers measuring sixteen square inches or less is up to two units per dressing change; for wounds covers measuring sixteen to forty-eight square inches, up to three units per dressing change; for wound covers measuring greater that forty-eight square inches, up to four units per dressing change.

(P) Light compression bandage, moderate/high compression bandage, self-adherent bandage, conforming bandage, padding bandage

Most compression bandages are reusable. Usual frequency of replacement would be no more than one per week unless they are a part of a multi-layer compression bandage system.

Conforming bandage dressing change is determined by the frequency of change of the selected underlying dressing.

(Q) Non-coverage determination

(1) Surgical dressings are not separately reimbursable for consumers in long term care facilities (LTCFs) as these supplies are included the facility's cost report.

(2) Gauze, impregnated, water or normal saline

There is no medical necessity for these dressings compared to non-impregnated gauze moistened with bulk saline or sterile water. These dressings are not separately reimbursed by the department.

(3) Providers can not bill the department for any surgical dressing or a related supply item past the date of medical necessity.

(R) Authorization

(1) A fully completed and legible prescription signed by an eligible prescriber must be kept on file by the provider and made available for review upon request by the department and sent to the department for review as a part of a prior authorization request for surgical dressings or supplies.

(2) The prescription must specify the type of dressing being prescribed, the size of the dressing being prescribed, the number/amount to be used at one time (if more than one), the frequency of dressing change, and the expected duration of need for the surgical dressings and related supplies.

(3) A new prescription is needed if any new dressing is added or if the quantity used of an existing dressing is increased. A new prescription is not needed if the quantity of dressings used is decreased. However, a new prescription is required at least every three months for each dressing being used even if the quantity used has remained the same or decreased.

(4) The prescription for the dressing must identify the number of wounds being treated and the reasons for the dressing (e.g., a primary or secondary dressing to cover a surgical or debrided wound, or for wound cleansing). Dressing use or the use of a related supply item must be documented in the provider's records and include the date and source of this information (e.g., prescriber or home care nurse).

(5) The prescription must contain clinical information not more than one year old supporting the necessity of the type and quantity of surgical dressings provided and must be maintained in the consumer's medical records. An evaluation of the consumer's wound (s) must be performed at least on a monthly basis by a qualified health care provider unless there is documentation in the consumer's medical record which justifies why an evaluation could not be done within this timeframe and what other monitoring methods were used to evaluate the continuing need for dressings. Evaluation is expected on a more frequent basis (e.g., weekly) if a consumer has a heavily draining or infected wound. The wound evaluation must include the type of each wound (e.g., surgical wound, pressure ulcer, burn, etc.), its location, size (length and width in centimeters) and depth, the amount of drainage, and any other relevant clinical information. This information must be available for review upon department request.

(S) Reimbursement

Surgical dressings and related supplies are reimbursed at the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Effective: 01/07/2010
R.C. 119.032 review dates: 01/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021

5160-10-35 Cranial orthotic remolding devices.

Any provider seeking reimbursement for this service must meet the provisions contained within Chapter 4779. of the Revised Code in order to be eligible for reimbursement for services provided.

(A) Definitions

(1) A cranial orthotic remolding device is an orthotic helmet that can progressively mold the shape of the cranium. Treatment is typically initiated around five to six months of age and continues for an average of four to six months.

(2) Cephalic index is the ratio of the maximum width of the head multiplied by one hundred divided by its maximum length (i.e., in the horizontal plane, or front to back).

(B) Coverage determination

(1) A cranial orthotic remolding device is covered for treatment of positional (non-synostotic) plagiocephaly only if all of the following criteria are met:

(a) Consumer is at least three months of age but not greater than eighteen months of age; and

(b) Marked asymmetry has not been substantially improved following conservative therapy of at least two months duration with cranial repositioning therapy and/or physical therapy; and

(c) Asymmetry of the cranial base as documented by any of the following:

(i) Skull base asymmetry: At least six millimeter (mm) right/left discrepancy measured subnasally to the tragus, defined as the cartilaginous projection of the auricle at the front of the ear; or

(ii) Cranial vault asymmetry: At least a ten mm right/left discrepancy measured from the frontozygomaticus point (identified by palpation of the suture line above the upper outer corner of theorbit) to the euryon, defined as the most lateral point on the head located in the parietal region; or

(iii) Asymmetry of the orbitotragial distances, as documented by at least a four mm right/left asymmetry.

(2) A cranial orthotic remolding device is covered for treatment of positional (non-synostotic) braciocephaly if the cephallic index is greater than ninety-one per cent.

(3) A cranial orthotic remolding device is covered for the treatment of positional (non-synostotic) scaphocephaly if the cephallic index is less than seventy-five per cent.

(4) A cranial orthotic remolding device is covered for treatment of synostotic deformity if all of the following criteria are met:

(a) Consumer is between the ages of birth and eighteen months; and

(b) Premature closing of the cranial structures is documented by treating prescriber and surgery with post-operative treatment including remolding orthotic helmeting is medically indicated and documented in the consumers medical record.

(5) All documentation supporting the above medical criteria must be kept in the provider's file and be available for review at the request of the Ohio department of job and family services (ODJFS).

(6) Cranial orthotic remolding devices must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care which addresses the need for a cranial orthotic remolding device. This prescription must contain the original signature of the ordering prescriber that attests to medical necessity of this device.

(C) Non-coverage determination

A cranial orthotic remolding device is non covered for consumers who cannot document an appropriate medical need based on the provisions of this rule.

(D) Prior authorization

No prior authorization is necessary for the dispensing of a cranial orthotic remolding device.

(E) Dispensing

(1) The following components are considered "inclusive" with any payment made by the department for a cranial orthotic remolding device on behalf of a consumer, cannot be submitted to the department for separate reimbursement and must be dispensed and/or maintained by the billing provider:

(a) Labor;

(b) Orthotic remolding device;

(c) Casting, fitting, or measuring fees;

(d) Charges for travel; and

(e) Charges for shipping and mailing.

(2) Providers must document that the consumer's primary care giver is instructed as to the proper use and wear of the cranial orthotic remolding device and documentation of this instruction must be kept in the provider's file.

(3) Any dispensed cranial orthotic remolding device must be of a type and fabricated at a facility approved for consumer use as an approved class II medical device by the food and drug administration (FDA).

(4) Any provider dispensing and fitting a cranial remolding orthotic device must have the appropriate documentation on file that demonstrates the appropriate training necessary to fit the device properly.

(5) Consumers are eligible for only one cranial orthotic remolding device per lifetime.

(F) Reimbursement

Cranial orthotic remolding devices are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the providers usual and customary charge, whichever is less.

Effective: 09/01/2011
R.C. 119.032 review dates: 09/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021