Chapter 5101:3-10 Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers

5101:3-10-01 Eligible providers.

Two groups of providers 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 rules 5101:3-1-17 to 5101:3-1-17.4 of the Administrative Code, as provider type (76) “medical equipment supplier.”

(B) All other provider types who have a valid provider agreement, in accordance with rules 5101:3-1-17 to 5101:3-1-17.4 of the Administrative Code, and have an approved category of service (32) “supplies and medical equipment.”

(C) Upon the provision of verification to ODJFS 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: 10/15/2006

R.C. 119.032 review dates: 07/27/2006 and 10/01/2011

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

5101:3-10-02 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

(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.

(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);

(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

5101:3-10-02.1 Advanced practice nurses and medical supplier services. [Rescinded]

Rescinded eff 5-1-07

5101:3-10-03 "Medicaid Supply List".

Unless otherwise specified, any provider seeking reimbursement for medical supplier services must meet the provisions contained within Chapter 4752. of the Revised Code or be exempt from licensure under Chapter 4752. of the Revised Code in order to be eligible for reimbursement for services provided.

The “Medicaid Supply List” is a list of medical/surgical supplies, durable medical equipment, and supplier services, found in appendix A to this rule. This list includes the following information as described in paragraphs (A) to (G) of this rule:

(A) Alpha-numeric codes to be used when billing the department for medical supplier services:

(1) Code numbers are designed to accommodate all trade names of products dispensed unless otherwise specified; and

(2) A supply code of “not otherwise specified” (NOS) should only be used when a covered item is not adequately described by a specific code.

(B) Item description.

A brief description of the supply or equipment item.

(D) Two columns indicating coverage status:

(1) “Medicaid” indicator.

The medicaid coverage column has one of three possible indicators for each item. “Y” indicates the item is covered by medicaid for all recipients, in accordance with rule 5101:3-10-02 of the Administrative Code, and may be billed directly to the department. “N” and “NC” indicate that the item is not covered by the medicaid program and should not be billed to the department. “H” indicates that the item is covered by medicaid but may be billed directly to the department by the provider only for consumers who reside in their personal residence.

(2) “Medicare” indicator.

The medicare coverage column has one of three possible indicators for each item. “Y” indicates the item is covered by medicare for all beneficiaries and medicare is the primary payor. “N” indicates the item is not covered by medicare and may be billed to medicaid. “H” indicates that the item is covered by medicare under part B for only those consumers who reside in their home (as consumer’s home is defined by medicare). Providers must always bill medicare first when coverage is available. While medicaid payment will not be denied for certain items with the “Y” or “H” medicare indicator (e.g., diabetic supplies, surgical dressings), payment inadvertently made by medicaid for any item payable by, but not billed to medicare, will be subject to recovery by the department.

(E) “Prior auth” indicator.

A prior authorization (PA) indicator. “Y” indicates prior authorization by the department is required for reimbursement (see rule 5101:3-10-06 of the Administrative Code). “N” indicates prior authorization is not required for reimbursement up to the maximum allowable units.

(F) “Max Units” indicator.

A maximum allowable (MAX) indicator means the maximum quantity of the item that may be reimbursed during the time period specified unless an additional quantity has been prior authorized. If there is no maximum quantity indicated, the quantity authorized will be based on medical necessity as determined by the department.

(G) “RNT/P” indicator.

Rental/purchase indicator. “RO” means item is always rented, “PP” means item is always purchased and “R/P” means item is designated as rent to purchase as described in rule 5101:3-10-05 of the Administrative Code.

(H) Charges for gauze pads and codes for “wound fillers/packing” are not to exceed the manufacturer’s suggested list price for any item. Providers must maintain an itemized list in recipient’s file of all items dispensed and billed to medicaid under these codes.

(I) Providers must fully and accurately report any discount received (including a rebate check) on a good or service when submitting a claim for reimbursement. A “discount” means a reduction in the amount a seller charges a provider who buys either directly or through a wholesaler or a group purchasing organization. “Fully and accurately reporting a discount” means deducting the amount of the discount from billed charges when submitting a claim for payment and if prior authorization is required, indicating on the “Prior Authorization” request form (JFS 03142, rev. 2/2003), or attached documentation, the amount of the discount. This policy is implemented in accordance with federal regulations at 42 C.F.R. 1001.952(h) (April 17, 2002).

APPENDIX

MEDICAID SUPPLY LIST

See Appendix at http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-03_PH_FF_A_APP1_20080320_0816.pdf

Effective: 03/30/2008

R.C. 119.032 review dates: 12/01/2012

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, 12/1/89, 5/1/90, 6/20/90 (Emer), 9/5/90, 2/17/91, 5/25/91, 12/30/91, 4/1/92 (Emer), 7/1/92, 11/16/92, 12/31/92 (Emer), 4/1/93, 7/8/93, 12/10/93, 12/30/93 (Emer), 3/31/94, 7/1/94, 2/1/95, 12/29/95 (Emer), 3/21/96, 12/31/96 (Emer), 3/31/97, 8/1/97, 12/31/98 (Emer), 3/20/00, 12/29/00 (Emer), 3/30/01, 12/31/01 (Emer), 3/29/02, 3/24/03, 10/1/04, 12/30/04 (Emer), 3/28/05, 12/30/05 (Emer), 3/27/06, 10/15/06, 12/29/06 (Emer), 3/29/07, 7/30/07, 12/16/07, 12/31/07 (Emer)

5101:3-10-05 Reimbursement for covered services.

(A) Unless otherwise specified, for each claim for reimbursement, providers must keep in their files a legible written or typed 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 written or typed 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. Medical supply providers are required to keep all records and prescriptions in accordance with rules 5101:3-1-17.2 and 5101:3-1-17.3 of the Administrative Code.

(1) Providers are required to maintain proof of delivery documentation for durable medical equipment (DME) items or equipment dispensed to consumers in their files. 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 items are prohibited from signing and accepting an item on behalf of a consumer; and

(b) Any person accepting a delivery of DME items on behalf of a consumer will note on the delivery slip obtained by the provider his or her relationship to the consumer in question. The signature of the person accepting a delivery of DME items should be legible. If the signature of the person accepting the delivery 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 for the package sent to the consumer. The shipping service’s tracking slip will reference each individual package, the delivery address, the corresponding package identification number given by the shipping service, and the date delivered. If a provider utilizes a shipping service or mail order, 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 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 will be included on this invoice as well; and

(d) For those consumers who are residents of a long term care facility (LTCF), 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) Except as provided in this paragraph, prescriptions for durable medical equipment (DME) and medical supplies must originate as a result of a face to face examination between the prescriber and the consumer. A separate examination for each subsequent DME item prescribed is not necessary if:

(a) The prescriber has reviewed the medical record generated from a face to face examination that was conducted within the previous twelve months by the prescriber, and the DME item or items are related to the diagnoses that were established in that face to face examination; or

(b) The prescription is written based on the judgment of a prescriber who has reviewed the consumer’s medical records from a face to face examination conducted within the previous twelve months by a different prescriber, and the item or items are related to the diagnoses that were established in that face to face examination. All DME and medical supply prescriptions for a long term supply of disposable items (i.e., diabetic test strips, incontinence garments or wound supplies), can be renewed no sooner than ninety days prior to the expiration of the current prescription. DME or medical supply prescriptions are only valid for a maximum of one year.

(3) The DME and medical supply prescriber must be fiscally, administratively, and contractually in compliance with applicable federal Stark II regulation, 42 C.F.R 411.354 and federal Anti-Kickback Safe Harbor regulation, as it applies to referrals sent to entities with which they or members of their immediate family have a financial relationship for designated health services and as it applies to the medicaid program and medicaid consumers.

(B) The reimbursement allowed by the department for medical equipment that is rented or purchased includes at a minimum, the following:

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

(2) 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 patient’sconsumer’s condition; and

(3) Instruction to the consumer in the safe use of the equipment; and

(4) Cost of delivery to the consumer’s residence and, when appropriate, to the room in which the equipment will be used.

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

(C) Unless prior authorization has been obtained for used equipment, all equipment that is purchased must be new at the time of purchase or have been new at the time of rental for the same consumer. Used equipment, if clearly designated on the prior authorization request form as used, in good working order, and covered by the same warranty as new equipment, may be provided if approved by the department. Reimbursement for used equipment 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 the purchase of used durable medical equipment.

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

(E) Automatic refills of medical supply orders are not eligible for reimbursement. Providers of medical supplies shall ascertain the quantity of supplies needed monthly by a consumer and shall not dispense supplies in excess of one month’s supply per month for the duration of the prescribed period. No supplies shall be billed before they have been provided to the consumer.

(F) Unless otherwise stated, payment Payment for durable medical equipment (including custom wheelchairs, power wheelchairs and all wheelchair parts and accessories), medical supplies, orthoses, and prostheses is reimbursed utilizing the following criteria:

(1) When the item or items in question 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 on appendix DD of rule 5101:3-1-60 of the Administrative Code; or

(2) When the item or items in question do not appear in appendix DD to rule 5101:3-1-60 of the Administrative Code, but a list price is presented to the department for reimbursement, 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 seventy five per cent of the list price; or

(3) When the item or items in question do not appear in appendix DD to rule 5101:3-1-60 of the Administrative Code, and there is no list price that is presented to the department for reimbursement, 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 one hundred fifty per cent of the provider’s 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) When paragraph (F)(2) of this rule is otherwise applicable but the department has available the providers invoice price, the department will pay the lesser of the amounts determined under paragraphs (F)(2) and (F)(3) of this rule.

(5) The “list price” is defined as the most current price of an item or items that is recommended by the product’s manufacturer for retail sale. This price cannot be established nor obscured or deleted by the provider on any documentation supplied to the department 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 manufacturer produced products.

(6) The “invoice price” is defined as the price of an item or items delivered by the provider to the consumer that gives details of price, quantity and type of supplies dispensed to the consumer and reflects the provider’s net costs in accordance with paragraph (I) of rule 5101:3-10-03 of the Administrative Code. This information cannot be obscured or deleted on any documentation supplied to the department for consideration of reimbursement.

(7) Costs of delivery and service calls related to DME and medical supply items must be considered an integral part of the supplier’s cost of doing business. A charge for these services will not be recognized when billed separately as a component of any reimbursement rate for services rendered.

(8) It is expected that the consumer will be supplied with the most cost effective durable medical equipment that will meet the consumer’s clinical needs as identified and ordered by the prescriber. Cost effective durable medical equipment is defined by the Ohio department of job and family services (ODJFS) to mean that the provider has taken into account all of the consumer’s clinical and ambulatory needs in order to identify durable medical equipment that will meet the consumer’s clinical and lifestyle requirements utilizing specific equipment and/or medical supplies that are available at the lowest cost to ODJFS.

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

(1) “Conflicting equipment” is defined as equipment which is contraindicated due to the possession by the consumer of equipment, regardless of payment source, which serves the same or a similar purpose. Examples would be a wheelchair followed by a power-operated vehicle (or vice versa), or more than one wheelchair.

(2) Suppliers are responsible for ascertaining in the preliminary discussion with the consumer and/or attending prescriber, whether there is conflicting equipment. All suppliers are expected to know whether currently requested equipment is contraindicated by equipment supplied by a different supplier.

(3) If a consumer’s condition changes and warrants new or different equipment, the existing equipment must be noted and appropriate medical documentation must be furnished 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 equipment specific warranty and the date of purchase in their files. A copy of the equipment specific warranty must be provided on the request of the department and must be submitted with any prior authorization request for repairs. Any repair or servicing done on consumer durable medical equipment that is consumer owned must be documented and kept in the providers file and be accessible to the Ohio medicaid program upon request.

(I) Purchase or rental of durable medical equipment.

A current prescriber’s prescription must accompany each request for prior authorization of purchase or rental of durable medical equipment. 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 and is documented.

(1) Rental only.

Certain durable medical equipment requiring servicing to ensure the health and safety of recipients will be designated as “rental only.” Rental only equipment is designated RO in the “Medicaid Supply List”, appendix A of rule 5101:3-10-03 of the Administrative Code. The rental payment is specified in appendix DD of 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) In some instances the department may determine that short term rental would be more appropriate or cost-effective than purchase of an item. In these instances, rental of equipment will be approved. Approved rental 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 of equipment will be made at ten per cent per month of the maximum amount allowable for a specific item. Use the modifier code 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 or items in question, and will note the decision to purchase on the prior authorization form. When a decision is made to purchase the equipment, all prior rental payments will apply toward the purchase price of the item or items in question, and the provider will receive one final payment for the remainder of the items maximum allowable amount as specified in appendix DD to rule 5101:3-1-60 of the Administrative Code. The equipment will then be considered purchased and becomes the property of the consumer. The provider will notify the consumer when an item has been purchased on his or her behalf by ODJFS.

(c) The combined total reimbursement for rental and subsequent (within ninety days of the end of the rental service) purchase of a DME item, cannot exceed the medicaid maximum fee.

(d) All durable medical equipment listed in rule 5101:3-10-03 of the Administrative Code that is designated R/P must have a prior authorization before reimbursement is authorized.

(J) For items authorized for rental on a monthly basis, payment will be made through 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, only those days when the consumer is eligible and the item is medically necessary are billable to the department.

(K) All medicare-covered services provided to residents of long-term care facilities who are medicare and medicaid eligible must be billed by the supplier directly to medicare. When paid by medicare, medicaid payment will be made by the department as a crossover payment directly to the medical supplier.

(L) Reimbursement for back-up equipment for a medically necessary mechanical ventilator may be allowed only when the following documentation required in rule 5101:3-10-22 of the Administrative Code is provided.

(M) With the exception of nonmolded helmets and splints, all covered orthotic and prosthetic devices listed in appendix A of rule 5101:3-10-20 of the Administrative Code, provided to eligible consumers who are residents of nursing facilities, may be billed direct to ODJFS. Nonmolded helmets and splints must be billed to the facility and are reimbursed through the per diem payment in accordance with Chapter 5101:3-3 of the Administrative Code.

Effective: 07/01/2006

R.C. 119.032 review dates: 07/01/2009

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, 10/1/88, 5/1/90, 6/20/90 (Emer), 9/5/90, 2/17/91, 9/1/98, 7/1/04

5101:3-10-06 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 the prior authorization program.)

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

(1) A legible, fully completed prior authorization form (JFS 03142, rev. 2/2003), including pertinent information such as quantity requested, manufacturer, style or model number, size and warranty period; and for purchase requests, whether the equipment is new or used. Purchase requests also must include 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.

(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.

(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.

(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: 04/16/2007

R.C. 119.032 review dates: 01/02/2007 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, 10/1/87, 5/1/90, 2/17/91, 9/1/02

5101:3-10-08 Repair of medical equipment.

(A) Durable medical equipment covered under appendix A of rule 5101:3-10-03 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 defined as 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 defined as 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 “RP” 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 E1340.

(iii) For the reimbursement of repairs or replacement of parts of wheelchairs without a specific procedure code, use code K0108 modified with the “RP” modifier in combination with labor code E1340 as appropriate.

(d) Wheelchair repairs must be billed in accordance with paragraph (J)(10) of rule 5101:3-10-16 of the Administrative Code.

(2) A written prescription 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,

(3) A verbal or 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.

(4) “Labor” is defined as 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 rule 5101:3-1-60 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,

(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) Repair of recipient-owned durable medical equipment which are eligible for direct reimbursement for recipients residing in nursing facilities (NFs) or intermediate care facilities for the mentally retarded (ICFs-MR) may be billed to the department. with the exception of minor wheelchair repairs as specified in paragraph J of rule 5101:3-10-16 of the Administrative Code.

(11) No charge for labor will be reimbursed for repair or replacement of items identified by an asterisk in appendix A of rule 5101:3-10-20 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 defined as those things 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 defined as 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 5101:3-10-11 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 ten 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 defined as 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 5101:3-1-60 of the Administrative Code. No more than one minor repair may be reimbursed in any one hundred and 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 ten 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 defined as those things 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 and 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.

(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 5101:3-10-20 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 5101:3-10-20 of the Administrative Code.

Effective: 01/13/2006

R.C. 119.032 review dates: 10/17/2005 and 01/01/2011

Promulgated Under: 119.03

Statutory Authority: 5111.02, 5111.0112

Rule Amplifies: 5111.01, 5111.02, 5111.0112

Prior Effective Dates: 4/7/77, 12/21/77, 1/1/80, 3/1/84, 10/1/88, 5/15/89, 5/1/90, 12/10/93, 1/1/95, 9/1/02, 10/1/04

5101:3-10-09 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.

(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);

(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;

(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;

(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

(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

(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;

(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

5101:3-10-10 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

5101:3-10-11 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 division (G) of 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 eliminate 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 have a manual volume control for the user. These devices have screw-set controls mounted onto the hearing aids for the hearing health care professional 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, most current version of prior authorization (PA) form (JFS 03142, rev. 02/2003);

(2) A description, including approximate age and ownership, of any similar equipment in possession of the consumer and the reason for the new request if similar equipment ownership is established; and

(3) A current physician’s prescription that verifies the need for a hearing aid by certifying that the provided hearing test results, when interpreted as a set, clearly demonstrate hearing loss and includes a written statement verifying that the performance of a medical examination has indicated that the hearing loss is not due to a temporary, correctable physical condition; e.g., ear infection or impacted wax. The physician’s prescription cannot be dated more than six months prior to the date of the PA request. For the purposes of medicaid reimbursement, the exception allowing the opportunity to waive the medical evaluation for a medical referral or medical evaluation for a consumer eighteen years of age or older specified in paragraph (A)(10) of rule 4747-1-19 of the Administrative Code or paragraph (C)(2) of rule 4753-8-03 of the Administrative Code cannot be applied to medicaid consumers;

(4) 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

(5) Documentation from the physician who is authorizing a digital/programmable hearing aid for a consumer twenty years of age or younger that states the digital/ programmable hearing aid will offer superior performance over a conventional hearing aid for the specific consumer in question. This documentation should also include statements attesting that the particular consumer requires functions that are not found in a conventional hearing aid (i.e., automatic feedback reduction, automatic noise reduction, programmable volume control) and that the digital/programmable hearing aid is necessary for the consumer’s success in educational development; and

(6) Dispensing fee codes as referenced in paragraph (M) of this rule and hearing aid codes must be submitted together on the same prior authorization (PA) request and if approved must be billed together with the same date of service.

(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;

(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 (ANSI S3.1-1999, R2003).

(2) Evaluation of results for consumers twenty-one years or older must show a best pure-tone average of thirty-one dB HL or greater and in conjunction with the remainder of the hearing evaluation, results that 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;

(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 (ANSI S3.1-1999, R2003).

(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 aged twenty years or younger are valid for prior authorization purposes only if the testing was conducted by a provider authorized to perform the complete battery of hearing tests that are listed in paragraph (C)(3) of 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; and

(4) Digital and programmable hearing aids for adults twenty-one years or older.

(E) Conventional hearing aids.

(1) Adults twenty one years or older are eligible for conventional hearing aids only.

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

(3) 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.

(4) Providers must maintain copies of the manufacturer’s cost estimate and the final manufacturer’s invoice, including discounts and shipping costs, in the consumer’s record and make them available to the Ohio department of job and family services (ODJFS) upon request.

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

(6) 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.

(7) 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.

(8) 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 ODJFS upon request.

(F) Programmable and digital hearing aids.

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

(2) Hearing evaluation results referenced in paragraph (C)(4) of this rule must clearly demonstrate the need for a hearing aid.

(3) All programmable and digital hearing aids dispensed must be covered by a twoyear 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) 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.

(6) 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 ODJFS upon request.

(7) Payment for a programmable or digital hearing aid includes two adjustments per year for the duration of the first-year warranty for comprehensive loss, damage and repair, and two adjustments per year under a second-year 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) Binaural hearing aids, “CROS,” and “BiCROS” aids are not routinely covered by the medicaid program but may be authorized for persons with special documented needs; e.g., child for whom binaural hearing is necessary for development of speech. This documentation must be submitted at the time of the original PA request in order to be considered for coverage.

(H) Hearing aids may be dispensed by a physician, a licensed audiologist, or a licensed hearing aid fitter who is enrolled as a durable medical equipment (DME) provider or enrolled as a physician 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 consumer of a hearing aid shall be scheduled for a recheck to assess the performance and consumer acceptability of the aid within thirty days of receipt of the aid by the consumer. 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 both the hearing aid provider and the consumer, the cost of the earmold, batteries, and one month’s use of the instrument will be borne by the ODJFS. On the rare occasions that this may happen, the original authorization form must be forwarded to ODJFS for cancellation and subsequent issuance of a revised authorization reflecting the new cost. If payment has been made on the original authorization, no adjustment to payment will be authorized.

(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 sections (C)(1) and (C)(3) of this rule. Only providers specified in paragraph (B)(4) of this rule may bill ODJFS for hearing tests in conjunction with the fitting and dispensing of any type of hearing aid.

(M) Effective for dates of service on and after the effective date of this rule, ODJFS will pay a separate fee for dispensing a hearing aid. These fees can be located in 5101:3-1-60 of the Administrative code. ODJFS will reimburse only one dispensing fee code per consumer every four years for a conventional hearing aid or once every five years for a programmable or digital hearing aid.

(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); and

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

(O) In general, reimbursement for a hearing aid will be limited to a maximum of one aid in any four-year period for a conventional hearing aid. Reimbursement for a digital or programmable hearing aid will be limited to a maximum of one hearing aid in any five year period. Requests for more frequent replacement for medically necessary reasons will be considered when appropriate documentation is provided. A request for replacement of a hearing aid for non-medical reasons will be considered. However, cases suggesting malicious damage, neglect, culpable irresponsibility, or wrongful disposition of the hearing aid will be investigated and denied where ODJFS determines it is unreasonable to make program payment under the circumstances. If a hearing aid is lost and is still covered by warranty, ODJFS will not cover any deductible or replacement charges not covered by warranty.

(P) 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 ODJFS on request.

(Q) No hearing aid will be authorized for replacement until ODJFS 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.

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

(1) The aid had been acquired through ODJFS; or

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

(S) ODJFS will pay for only one hearing aid code and only one unit per consumer per date of service in a four-year period as discussed in paragraph (O) of this rule for a conventional hearing aid or only one hearing aid code and only one unit per consumer per date of service in a five-year period for a programmable or digital hearing aid.

Replaces: 5101: 3-10-11

Effective: 09/01/2005

R.C. 119.032 review dates: 09/01/2010

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

5101:3-10-12 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

5101:3-10-13 Oxygen: covered services and limitations in a private residence.

(A) Coverage criteria.

(1) A current prescription is required prior to dispensing oxygen. This prescription must be renewed at least once a year. Any significant changes to the consumer’s treatment plan pertaining to oxygen services require a new prescription be obtained and kept in the consumer’s medical record.

A significant change to the consumer’s treatment plan pertaining to oxygen services is defined as the point where the consumer’s prescribed amount of oxygen requires the use of or change of an oxygen modifier code.

(2) Oxygen services are covered only for consumers with significant hypoxemia in the chronic stable state provided all of the following conditions are met:

(a) The treating prescriber has determined that the consumer has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen services; and

(b) The consumer’s blood gas and/or oxygen saturation levels indicate the need for oxygen services; and

(3) Non-covered diagnoses:

Oxygen services will be denied as not medically necessary if any of the following conditions are present:

(a) Angina pectoris in the absence of hypoxemia; or

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

(c) Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities, but in the absence of systemic hypoxemia; or

(d) Terminal illnesses that do not affect the respiratory system.

(B) Coverage requirements.

(1) Covered blood gas and/or oxygen saturation values. A consumer is considered to have significant hypoxemia if group I or II criteria are met.

(a) Group I criteria include any of the following:

(i) An arterial partial pressure (tension) of oxygen (PO2) at or below fifty-five mm Hg, or an arterial oxygen saturation at or below eighty-eight per cent, taken at rest (awake).

(ii) An arterial PO2 at or below fifty-five mm Hg, or an arterial oxygen saturation at or below eighty-eight per cent taken during sleep for a patient who demonstrates an arterial PO2 at or above fifty-six mm Hg or an arterial oxygen saturation at or above eighty-nine per cent, while awake.

(iii) A decrease in arterial PO2 more than ten mm Hg, or a decrease in arterial oxygen saturation more than five per cent, taken during sleep, associated with symptoms or signs reasonably attributable to hypoxemia (e.g., cor pulmonale, “P” Pulmonale on EKG, documented pulmonary hypertension and erythrocytosis). In either of these cases, coverage is provided only for the nocturnal use of oxygen.

(iv) An arterial PO2 at or below fifty-five mm Hg or an arterial oxygen saturation at or below eighty-eight per cent, taken during exercise, for a patient who demonstrates an arterial PO2 at or above fifty-six mm Hg or an arterial oxygen saturation at or above eighty-nine per cent, during the day while at rest. In this case, supplemental oxygen is provided for use during exercise if it is documented that the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.

(b) Group II criteria include any of the following:

(i) An arterial PO2 of fifty-six to fifty-nine mm Hg or an arterial blood oxygen saturation of eighty-nine per cent at rest (awake), during sleep, or during exercise (as described under group I criteria); and

(a) Dependent edema suggesting congestive heart failure; or

(b) Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or “P” pulmonale on EKG (P wave greater than three mm in standard leads II, III, or AVF); or

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

(2) The provider of oxygen services may conduct the pulse oximetry but may not conduct the arterial blood gas measurement. A blood gas measurement must be conducted by a provider qualified to conduct such tests, other than a durable medical equipment (DME) provider. In addition, the qualifying blood gas or oxygen saturation measurement may not be paid for by any DME provider. However, this prohibition does not extend to blood gas or oxygen saturation measurements performed by a hospital certified to do such testing. When both arterial blood gas (ABG) and oxygen saturation (oximetry) tests have recently been performed, greater weight is given to the ABG result when determining medical necessity for oxygen services.

(3) Emergency spare oxygen cylinders are not separately reimbursable.

(1) Prior authorization.

(a) Prior authorization is not required for oxygen services provided to consumers who meet the group I or II criteria as defined in paragraph (B) of this rule.

(b) Prior authorization is required for oxygen services and authorization may be requested for up to twelve months for any consumer that does not meet the group I or II criteria in paragraph (B) of this rule. However, the length of approval will be dependent on diagnosis, length of need, and stability of the patient as determined by the Ohio department of job and family services (ODJFS) based on documentation submitted with the request for services. The prior authorization cannot exceed the time frame documented on the prescriber’s submitted prescription, based on the date that the prescriber signs the prescription.

(2) Documentation requirements.

Requests for reimbursement submitted by the provider for oxygen services must be corroborated by documentation in the consumer’s medical records that medicaid coverage criteria has been met. The consumer’s medical records can include the prescriber’s office records, hospital records, nursing home records, home health agency records, or records from other healthcare professionals. This documentation must be available for review upon request from ODJFS.

(a) The following information must be submitted and maintained by the provider for every prior authorization request for oxygen services:

(i) Form JFS 01909 (rev. 6/2005),”Certificate of Medical Necessity/Prescription for Oxygen Services,” (appendix A to this rule), that is signed and dated by the attending prescriber no more than thirty days prior to the first date of service; and

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

(b) The oxygen provider not seeking prior authorization must have on file, prior to submitting any claim for reimbursement, a fully completed form JFS 01909 (rev. 6/2005), “Certificate of Medical Necessity/Prescription for Oxygen Services,” appendix A to this rule, that is signed and dated no more than thirty days after the first date of service.

(c) A prescription of “Oxygen PRN” that specifies the oxygen flow rate and duration or indications for usage does meet the requirements of this rule.

(d) At the time of recertification (arterial blood gas or pulse oximetry is not required) for individuals on oxygen with CPAP/APAP who only desaturate at night, only a certificate of medical necessity (CMN) for oxygen is required.

(e) The consumer must be evaluated by the treating prescriber and a prescription written within thirty days prior to the date of initial certification. The consumer must be re-evaluated by the treating prescriber and a prescription written within ninety days prior to the date of any recertification.

(f) Documentation for the prior authorization of oxygen services must be submitted with the appropriate healthcare common procedure coding system (HCPCS) codes as defined in rule 5101:3-1-19.3 of the Administrative Code for the actual item or items on the same PA request.

(3) Testing requirements.

(a) The consumer’s qualifying PO2 or arterial blood oxygen saturation level must be established under the following conditions prior to the initial date of service and every year thereafter for recertification in order to establish continued medical necessity:

(i) If the qualifying blood gas study is performed during an inpatient or LTCF (long term care facility) stay, the qualifying blood oxygen saturation or PO2 test must be the one obtained closest to, but no earlier than forty eight hours prior to the hospital or LTCF discharge date, or

(ii) If the qualifying blood gas study is not performed during an inpatient or LTCF stay, the qualifying blood oxygen saturation or PO2 test cannot be dated more than thirty days prior to the initial date of service.

(b) The provider shall submit a copy of a laboratory report of an arterial blood gas (ABG) study that has been ordered and evaluated and countersigned by the attending prescriber at the time of any request for prior authorization.

(c) The provider shall keep on file a copy of a laboratory report of an arterial blood gas (ABG) study that has been ordered evaluated and countersigned by the attending prescriber when prior authorization is not required.

(d) Documentation of current pulse oximetry may be submitted to ODJFS in lieu of an ABG when ordered, evaluated and countersigned by the attending prescriber. If this occurs, a copy of the dated oximetry print-out or a dated form used to document the oximetry results, signed and dated by the prescriber, shall be submitted to ODJFS at the time of the prior authorization request or kept in the providers file when prior authorization is not required.

(e) All tests for oxygen saturation shall be performed while the consumer is in a chronic stable state and not during a period of acute illness or an exacerbation of the consumer’s underlying disease.

(D) Portable/ ambulatory oxygen systems.

A portable/ambulatory oxygen system is covered with a prescription if medically necessary as an adjunct to a stationary system which has been established as medically necessary previously. The following criteria must be met in order to qualify for this coverage:

(1) The patient must be mobile within the home;

(2) It is documented in the providers file that the need for the portable oxygen system is required for the consumer to accomplish out of the home activities (ex. work, school, etc);

(3) In a personal residence, only rented home care oxygen systems are covered. Purchased oxygen systems will be denied as noncovered. Oxygen contents are included in the allowance for rented systems;

(4) Accessories including, but not limited to, cannulas, masks and tubing are included in the allowance for rented systems;

(5) If oxygen usage is greater than four liters per minute continuous, the portable oxygen system is included in the reimbursement fee for the stationary unit and should be billed with the “QF” modifier.; and

(6) Consumers supplied with oxygen systems that can be utilized as both a stationary and portable/ ambulatory delivery system are not eligible for consideration of an additional portable/ambulatory system. Consumers may not be supplied with both a stationary and a portable oxygen concentrator. Unless specified otherwise by the prescriber, delivery systems will be able to be utilized as both a portable and stationary system. It is expected that the consumer will be supplied with the most cost effective oxygen delivery system that will meet the consumer’s clinical needs as identified by the ordering prescriber.

A cost effective system is defined by ODJFS to mean that the provider has taken into account all of the consumer’s clinical and ambulatory needs in order to identify an oxygen delivery system that will meet the consumer’s clinical and lifestyle requirements utilizing a specific delivery system that is available at the lowest cost to ODJFS.

(E) Modifier requirements.

To receive a payment adjustment, one of the following modifiers must be used with the oxygen system codes specified in paragraph (F) of this rule when appropriate. Unless otherwise specified, oxygen concentrators are not subject to these modifiers.

(1) No modifier is used when:

(a) The prescribed amount of oxygen is greater than one liter per minute and no more than four liters per minute; or

(b) Supplying portable oxygen contents or a portable system rental; or

(c) The prescribed amount of oxygen is greater than four liters per minute non-continuous. The provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(2) Modifier code QE shall be used and the medicaid maximum payment amount reduced by fifty per cent of the amount set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code when the prescribed amount of oxygen is one liter per minute or less. If the QE modifier is used, the provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(3) Modifier code QG shall be used and the medicaid maximum payment amount increased by fifty per cent of the amount set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code when:

(a) The prescribed amount of oxygen is greater than four liters per minute continuous and portable oxygen is not prescribed; and

(b) If the QG modifier is used, the provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(4) Modifier code QF shall be used and the medicaid maximum payment amount increased by fifty per cent of the amount set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code when the following occurs:

(a) The prescribed amount of oxygen is greater than four liters per minute continuous and portable oxygen is also prescribed; and

(b) If the QF modifier is used, the provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(5) Modifier code U1 shall be used when oxygen services are provided via the use of a stationary oxygen concentrator to a consumer in a private residence. A reimbursement request using this modifier code will be reimbursed at the rate of one hundred and eight per cent of the maximum allowable price currently listed in appendix DD to rule 5101:3-1-60 of the Administrative Code per month for this service.

(F) Payment for oxygen claims.

(1) The following codes are the only codes authorized to be utilized in a private residence when seeking reimbursement for oxygen services rendered:

(a) E0424-Stationary compressed gaseous oxygen system;

(b) E0431-Portable gaseous oxygen system;

(d) E0439-Stationary liquid oxygen system;

(e) E1392-Portable oxygen concentrator;

(f) K0738-Trans fill oxygen system;

(g) E1390U1-Oxygen concentrator, single port; and

(h) E1391U1-Oxygen concentrator, dual port.

(2) Trans fill oxygen system or portable concentrator codes cannot be billed to ODJFS in combination with any other oxygen code approved for use by the department for oxygen services provided in a private residence. Trans fill oxygen systems and portable concentrators must operate as independent integrated oxygen systems.

(3) Code E1391 is used in situations in which two consumers are both using the same concentrator. In this situation, this code will only be billed for one of the consumers using the equipment. Both consumers must be using medicaid benefits in order for this code to be valid for reimbursement.

(4) Oxygen claims are paid on a per month basis. All claims must show billed charges for one month’s service. Billed charges for gaseous and liquid oxygen as well as services provided by the use of an oxygen concentrator shall be no more than the provider’s usual and customary charge for these services in the same setting. For consumers receiving gaseous or liquid oxygen, documentation of the amount of oxygen actually used each month (as determined from the documented refill amount and delivery information) must be maintained in the provider’s file. For consumers receiving oxygen that is supplied by an oxygen concentrator, providers must keep the consumer’s most current prescription on file to verify that continued oxygen services are warranted due to medical necessity.

(5) Payment will be limited to the lower of the usual and customary charge of the supplier for services provided when compared to similar services provided in the same setting to consumers with payer sources other than medicaid, or the medicaid maximum payment as set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code.

(6) When oxygen services are delivered from an oxygen concentrator, the oxygen concentrator will be serviced and maintained in accordance with the manufacturer’s specifications, unless ordered otherwise by the prescriber. Service and maintenance records will be documented in the consumer’s medical record or provider’s file.

(7) Documentation of the amount of oxygen used does not meet the requirements of this rule when such documentation is created, or collected from sources other than the provider, after the service has been billed.

(8) All billing for oxygen services will stop immediately when a consumer fails to meet any of the criteria contained within this rule pertaining to the qualifications necessary for the administration of oxygen services.

(9) Payment for oxygen services provided to a consumer in a personal residence is inclusive of the following components:

(a) Set up and instructions;

(b) Equipment (including concentrator) and supplies;

(c) Maintenance and repairs to include any supplies or attachments that are integral to the operation of the oxygen system being supplied;

(d) Transportation and/or delivery charges;

(e) Emergency services (to include the supply of backup oxygen supplies) or subsequent/interim visits;

(f) Oxygen consumed (when applicable); and

(g) Equipment monitoring visits.

Appendix

Ohio Department of Job and Family Services

Certificate of Medical Necessity/Prescription

OXYGEN SERVICES

See Appendix at http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-13_PH_FF_N_APP1_20070911_0938.pdf

Replaces: Part of 5101:3-10-13

Effective: 11/01/2007

R.C. 119.032 review dates: 11/01/2012

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, 2/17/91, 5/25/91, 4/1/92 (Emer), 7/1/92, 3/31/94, 1/1/95, 8/1/95, 8/1/98, 10/11/01

5101:3-10-13.1 Oxygen: covered services and limitations in a long term care facility (LTCF).

(A) Coverage criteria.

(1) A current prescription is required prior to dispensing oxygen. This prescription must be renewed once a year and kept in the consumer’s medical record in order to justify a consumer’s continued need for oxygen services. Any significant changes to the consumer’s treatment plan pertaining to oxygen services require a new prescription be obtained and kept in the consumer’s medical record.

(2) Oxygen services are covered only for consumers with significant hypoxemia in the chronic stable state provided all of the following conditions are met:

(a) The treating prescriber has determined that the consumer has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen services; and

(b) The consumer’s blood gas and/or oxygen saturation levels indicate the need for oxygen services; and

(3) Non-covered diagnoses: oxygen services will be denied as not medically necessary if any of the following conditions are present:

(a) Angina pectoris in the absence of hypoxemia; or

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

(c) Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities, but in the absence of systemic hypoxemia; or

(d) Terminal illnesses that do not affect the respiratory system.

(4) A prescription of “Oxygen PRN” that specifies the oxygen flow rate and duration or indications for usage does meet the requirements of this rule.

(B) Coverage requirements.

(1) Covered blood gas and/or oxygen saturation values. A consumer is considered to have significant hypoxemia if group I or II criteria are met.

(a) Group I criteria include any of the following:

(i) An arterial partial pressure (tension) of oxygen (PO2) at or below fifty-five mm Hg, or an arterial oxygen saturation at or below eighty-eight per cent, taken at rest (awake).

(ii) An arterial PO2 at or below fifty-five mm Hg, or an arterial oxygen saturation at or below eighty-eight per cent, taken during sleep, for a patient who demonstrates an arterial PO2 at or above fifty-six mm Hg or an arterial oxygen saturation at or above eighty-nine per cent, while awake.

(iii) A decrease in arterial PO2 more than ten mm Hg, or a decrease in arterial oxygen saturation more than five per cent, taken during sleep, associated with symptoms or signs reasonably attributable to hypoxemia (e.g., cor pulmonale, “P” pulmonale on electrocardiogram (EKG), documented pulmonary hypertension and erythrocytosis). In either of these cases, coverage is provided only for the nocturnal use of oxygen.

(iv) An arterial PO2 at or below fifty-five mm Hg, or an arterial oxygen saturation at or below eighty-eight per cent, taken during exercise, for a patient who demonstrates an arterial PO2 at or above fifty-six mm Hg or an arterial oxygen saturation at or above eighty-nine per cent, during the day while at rest. In this case, supplemental oxygen is provided for use during exercise if it is documented that the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.

(b) Group II criteria include any of the following:

(i) An arterial PO2 of fifty-six to fifty-nine mm Hg or an arterial blood oxygen saturation of eighty-nine per cent, taken at rest (awake), during sleep, or during exercise (as described under group I criteria); and

(a) Dependent edema suggesting congestive heart failure; or

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

(2) The provider of oxygen services may conduct the pulse oximetery but may not conduct the arterial blood gas measurement. A blood gas measurement must be conducted by a provider qualified to conduct such tests, other than a durable medical equipment (DME) provider. In addition, the qualifying blood gas or oxygen saturation measurement may not be paid for by any DME provider. However, this prohibition does not extend to blood gas or oxygen saturation measurements performed by a hospital certified to do such testing. When both arterial blood gas (ABG) and oxygen saturation (oximetry) tests have recently been performed, greater weight is given to the ABG result when determining medical necessity for oxygen services.

(1) Prior authorization.

Prior authorization is not required for reimbursement of oxygen services provided to residents in LTCFs once the medical necessity of services is established and documented in the provider’s file.

(2) Documentation requirements.

(a) Requests for reimbursement submitted by the provider for oxygen services must be corroborated by documentation in the consumer’s medical record that demonstrates medicaid coverage criteria have been met. The consumer’s medical records could include the prescriber’s office records, hospital records, home health agency records, or records from other healthcare professionals. This documentation must be available for review upon request by the Ohio department of job and family services (ODJFS).

(b) The oxygen provider must have on file, prior to submitting any claim for reimbursement, a fully completed form JFS 01909 (rev. 6/2005), “Certificate of Medical Necessity/Prescription for Oxygen Services,” (appendix A to this rule), that is signed and dated by the attending prescriber no more than thirty days after the first date of service.

(c) The consumer must be evaluated by the attending prescriber and a prescription written within thirty days prior to the date of initial certification. The consumer must be re-evaluated by the attending prescriber and a prescription written within ninety days prior to the date of any recertification.

(3) Testing requirements.

(a) The consumer’s qualifying PO2 or arterial blood oxygen saturation level must be established no earlier than forty-eight hours prior to the initial date of service or the renewal of service and every year thereafter for recertification in order to establish continued medical necessity.

(b) The provider shall keep on file a copy of a laboratory report of an arterial blood gas (ABG) study that has been ordered evaluated and countersigned by the attending prescriber.

(c) Documentation of pulse oximeter results may be kept on file in lieu of an ABG when ordered, evaluated and countersigned by the attending prescriber. If this occurs, a copy of the dated oximetry print-out or dated form used to document the oximetry results, signed and dated by the prescriber, shall be kept in the provider’s file.

(d) All tests for oxygen saturation shall be performed while the consumer is in a chronic stable state and not during a period of acute illness or an exacerbation of the consumer’s underlying disease.

(D) Modifier requirements.

To receive a payment adjustment, one of the following modifiers must be used with the oxygen system codes specified in paragraph (E) of this rule when appropriate. Oxygen concentrators are not subject to these modifiers.

(1) No modifier is used when:

(a) The prescribed amount of oxygen is greater than one liter per minute and no more than four liters per minute; or

(b) Supplying portable oxygen contents or a portable system rental; or

(3) Modifier code QG shall be used and the medicaid maximum payment amount increased by fifty per cent of the amount set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code when:

(a) The prescribed amount of oxygen is greater than four liters per minute continuous and portable oxygen is not prescribed; and

(b) If the QG modifier is used, the provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(4) Modifier code QF shall be used and the medicaid maximum payment amount increased by fifty per cent of the amount set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code when:

(a) The prescribed amount of oxygen is greater than four liters per minute continuous and portable oxygen is also prescribed; and

(b) If the QF modifier is used, the provider must document all applicable gaseous and liquid refill amounts and delivery information in the consumer’s medical record.

(E) Payment for oxygen claims.

(1) The following codes are the only codes authorized to be utilized in a LTCF when seeking reimbursement for oxygen services rendered:

(a) E0441-Oxygen contents, stationary system, gaseous;

(b) E0442-Oxygen contents, stationary system, liquid;

(d) E1391-Oxygen concentrator, dual port.

(2) Code E1391 is used in situations in which two medicaid consumers are both using the same concentrator. In this situation, this code will only be billed for one of the consumers using the equipment. Both consumers must be using medicaid benefits in order for this code to be valid for reimbursement.

(3) Oxygen claims are paid on a per month basis. All claims must show billed charges for one month’s service. Billed charges for gaseous or liquid oxygen as well as services provided by the use of an oxygen concentrator shall be no more than the provider’s usual and customary charge for these services provided in the same setting. For consumers receiving gaseous or liquid oxygen, documentation of the amount of oxygen actually used each month (as determined from the documented refill amount and delivery information) must be maintained in the provider’s file. For consumers receiving oxygen that is supplied by an oxygen concentrator, providers must keep the consumer’s most current prescription on file to verify that continued oxygen services are warranted due to medical necessity.

(4) Documentation of the amount of oxygen used does not meet the requirements of this rule when such documentation is created or collected from sources other than the provider after the service has been billed.

(5) All equipment and supplies associated with oxygen administration to residents of an LTCF is reimbursable through the facility’s cost report as set forth in Chapter 5101:3-3 of the Administrative Code. Therefore, the cost of reservoirs, stands/carts, regulators, humidifiers, cannulas, masks, and tubing must be billed to the facility.

(6) In a LTCF, rented oxygen systems, including portable units, are contained in the cost report of the facility in question and are not separately reimbursable. Purchased oxygen systems will be denied as noncovered.

(7) Payment for oxygen services provided to a consumer is inclusive of the following components:

(a) Set up and instructions;

(b) Transportation and/or delivery charges;

(d) Maintenance and repairs to include any supplies or attachments that are integral to the operation of the oxygen system being supplied;

(e) Oxygen consumed (when applicable); and

(f) Equipment monitoring visits.

(8) When oxygen services are delivered from an oxygen concentrator, the oxygen concentrator will be serviced and maintained in accordance with the manufacturer’s specifications, unless ordered otherwise by the prescriber. Service and maintenance records will be documented in the consumer’s medical record or provider’s file.

(9) All billing for oxygen services will stop immediately when a consumer fails to meet any of the criteria contained within this rule pertaining to the qualifications necessary for the administration of oxygen services.

(10) Except as otherwise provided, ODJFS reimburses medical suppliers at the lesser of billed charges or the medicaid maximum payment as set forth in appendix DD to rule 5101:3-1-60 of the Administrative Code. Providers must bill their usual and customary charge for services provided when compared to similar services provided in the same setting to consumers with payer sources other than medicaid.

Appendix

Ohio Department of Job and Family Services

Certificate of Medical Necessity/Prescription

OXYGEN SERVICES

See Appendix at http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-13_PH_FF_N_APP1_20070911_0938.pdf

Replaces: Part of 5101:3-10-13

Effective: 11/01/2007

R.C. 119.032 review dates: 11/01/2012

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, 2/17/91, 5/25/91, 4/1/92 (Emer), 7/1/92, 3/31/94, 1/1/95, 8/1/95, 8/1/98, 10/11/01

5101:3-10-14 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.

(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

5101:3-10-15 Transcutaneous electrical nerve stimulators (TENS).

(A) Requests for the initial prior authorization of a TENS unit must include the following documentation:

(1) A fully completed form JFS 03402 (rev. 6/2006) “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 nonreimbursable trial period of at least fourteen days resulted in substantial relief from pain (except for postoperative consumers).

(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. 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) Temporomandibular joint disorders;

(7) Osteoarthrosis and allied disorders;

(8) Spondylosis of unspecified site;

(9) Intervertebral disc disorders;

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

(11) Spinal stenosis, other than cervical;

(12) Lumbago;

(13) Sciatica;

(14) Disorders of sacrum;

(15) Myalgia and myositis, unspecified;

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

(17) Other postsurgical status.

(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 only may be authorized for the initial prior authorization request. An additional period of ninety days minimum may be approved if the following criteria are met:

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

(2) Documentation of specific reduction in medications; e.g., muscle relaxants, narcotics, analgesics.

(E) TENS units are covered as rental only for a maximum of four months. All rental payments are applied to any subsequent purchase requests.

(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. 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 request for prior authorization of a purchase of a TENS unit may be submitted only after three months rental and must be 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 paragraph (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. 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 of 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 Certificate of Medical Necessity/Presecription Transcutaneous Electric Nerve Stimulator (TENS)

See Form at http://www.registerofohio.state.oh.us/pdfs/5101/3/10/5101$3-10-15_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: 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

5101:3-10-16 Wheelchairs.

(A) Definitions

(1) “Standard wheelchair” is a wheelchair that would generally satisfy the needs of a pediatric or adult individual, including hemi (low seat wheelchairs); 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