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

5160-10-01 Durable medical equipment, prostheses, orthoses, and supplies (DMEPOS): general provisions.

(A) This rule sets forth general coverage and payment policies for durable medical equipment (DME), prostheses, orthotic devices, medical/surgical supplies, and supplier services. Policies set forth in other rules in this chapter of the Administrative Code supersede any provisions in this rule with which they conflict.

(B) Definitions that apply to rules in this chapter of the Administrative Code.

(1) "Certificate of medical necessity (CMN)" is a written statement by a practitioner attesting that a particular item or service is medically necessary for an individual.

(a) Unless a separate prescription is required, a CMN may serve also as a prescription for medicaid payment purposes.

(b) If no other form or format is specified, the CMN form specified in the relevant rule in this chapter of the Administrative Code is the default that must be used.

(c) A rendering or billing provider must obtain a required CMN before a claim can be submitted.

(d) A CMN is not invalidated by a change in an individual's status from one medicaid eligibility category to another (e.g., from fee-for-service medicaid to medicaid managed care).

(e) Renewal of lifetime certification is not required.

(f) An illegible CMN will not be accepted.

(2) "Department" is the Ohio department of medicaid or its designee. The address of the department's web site is http://medicaid.ohio.gov.

(3) "DMEPOS item" is a collective term for a covered durable medical equipment (DME) item, prosthetic device, orthotic device, or medical supply item furnished by an eligible provider to an eligible recipient.

(4) "DMEPOS service" is a covered service, such as labor for repair or replacement, that is furnished by an eligible provider and is related directly to a DMEPOS item.

(5) "Invoice price" is the price printed on the invoice sent by the manufacturer to the provider. The provider must not enter, modify, obscure, or obliterate the invoice price on any supporting document submitted to the department. Documentation of an invoice price is subject to approval by the department.

(6) "List price" is the most current price recommended by the manufacturer for retail sale. A provider that is also a manufacturer may set the list price for a custom product so long as this figure is not greater than the prices of comparable products. The provider must not enter, modify, obscure, or obliterate the list price on any supporting document submitted to the department. Documentation of a list price is subject to approval by the department.

(7) "Need verification" is a process by which the department determines whether to make payment for a DMEPOS item or service that exceeds the established cost threshold or frequency guideline. Because need verification is applied only to items or services for which medical necessity has been established or presumed, no extensive or in-depth clinical assessment is necessary (as it is with prior authorization). One purpose of need verification is to enable the department to consider whether the purchase of a new piece of equipment might be more cost-effective than continued repair.

(8) "Private residence" is a recipient's place of residence other than a hospital or a long-term care facility (LTCF).

(C) Providers.

(1) Prescribers. Eligible medicaid providers of the following types having prescriptive authority under Ohio law may certify the medical necessity of a DMEPOS item:

(a) A physician;

(b) A podiatrist;

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

(d) A physician assistant.

(2) Rendering providers. The following eligible providers may furnish a DMEPOS item or service:

(a) For equipment considered by the state of Ohio board of pharmacy to be subject to licensure or certification in accordance with Chapter 4752. of the Revised Code or the rules promulgated under it, a provider enrolled in medicaid as a DME supplier with specialized state of Ohio board of pharmacy certification or licensure;

(b) For orthotic or prosthetic devices requiring compliance with section 4779.02 of the Revised Code, a provider enrolled in medicaid as a DME supplier with orthotic/prosthetic specification; or

(c) For all other items and services, a provider enrolled as a basic DME supplier.

(3) Billing providers. The following eligible providers may receive medicaid payment for submitting a claim for a DMEPOS item or service:

(a) For equipment considered by the state of Ohio board of pharmacy to be subject to licensure or certification in accordance with Chapter 4752. of the Revised Code or the rules promulgated under it, a provider enrolled in medicaid as a DME supplier with specialized state of Ohio board of pharmacy certification or licensure;

(b) For orthotic or prosthetic devices requiring compliance with section 4779.02 of the Revised Code, a provider enrolled in medicaid as a DME supplier with orthotic/prosthetic specification; or

(c) For all other items and services, a provider enrolled as a basic DME supplier.

(4) Additional provider requirements specific to a particular DMEPOS item or service may be set forth in other rules in this chapter of the Administrative Code.

(D) Coverage.

(1) In most cases, the provision of or payment for a medically necessary DME item or medical supply for a resident of a LTCF is the responsibility of the LTCF. In turn, the LTCF receives medicaid per diem payment on the basis of its cost report. Therefore, claims submitted for such items or supplies furnished to LTCF residents will be denied. Any exceptions are set forth in other rules in this chapter of the Administrative Code.

(2) Separate payment may be made for a prosthesis or orthotic device supplied to a resident of a LTCF.

(3) The provision of a medically necessary DMEPOS item requires a prescription.

(a) Before writing a prescription for certain DMEPOS items, a practitioner must conduct a face-to-face encounter with the medicaid recipient. A list of such DMEPOS items may be found on the website of the centers for medicare and medicaid services (CMS) at http://www.cms.gov.

(b) The date of a prescription cannot precede the date of the related encounter nor can it be more than one hundred eighty days afterward.

(c) The encounter must be documented in the recipient's medical record.

(d) Unless a different length of time is specified, the date of a prescription cannot precede the first date of service by more than sixty days.

(e) The medical practitioner acting as prescriber must be actively involved in managing the recipient's medical care. The department may disallow a prescription written by a practitioner who has no professional relationship with the recipient.

(f) The prescribed DMEPOS item must be directly related to a medical condition of the recipient that the practitioner evaluates, assesses, or actively treats during the encounter.

(g) With proper documentation, a single encounter can serve as the basis for more than one prescription.

(h) No additional face-to-face encounter is necessary for a separate DMEPOS item if an encounter conducted within the preceding twelve months addresses the medical condition for which the DMEPOS item is being prescribed.

(i) Each prescription must specify a quantity (e.g., "TID," "thirty per month"). An unstated quantity is assumed to be one unit.

(4) Certain DMEPOS items require prior authorization (PA). A list of such items is posted on the department's web site.

(a) The following DMEPOS items always require PA:

(i) A custom or a specialized DMEPOS item;

(ii) A "not otherwise specified," "miscellaneous," or "unlisted" item or service; and

(iii) Used DME.

(b) When PA is given, it may specify a quantity, manufacturer, model, part number, or other information identifying a particular item. When such identifying information is present, a provider may supply and subsequently submit claims for the specified items only. No changes or substitutions are allowed without explicit authorization by the department.

(c) The department, on the basis of clinical indications, may grant PA for an item other than one that has been requested.

(d) For items requiring PA, the provider must submit the following documentation:

(i) A certification, signed and dated not more than sixty days before the first date of service, in the form of a fully completed CMN or, if the need for a CMN is not specified, a prescription;

(ii) Pertinent related information, such as a full description of any similar item currently in possession of the recipient or an explanation of a change in the recipient's condition that warrants a change in equipment;

(iii) For a "not otherwise specified," "miscellaneous," or "unlisted" item, a complete description of the item (including, as applicable, the manufacturer, model or style, and size), a list of all bundled components, and an itemization of all charges; and

(iv) Any other information required or requested by the department, as detailed in this chapter of the Administrative Code.

(e) A request for PA of a preparatory prosthesis must include the reason for the amputation, the date of the amputation, and an explanation of the benefit to be derived from having the recipient use a preparatory prosthesis before a definitive prosthesis is designed.

(f) A claim for an item or service that exceeds the specified maximum quantity or frequency but does not otherwise require PA may be subject to need verification before payment will be considered.

(g) A request for PA or need verification may be denied in cases involving malicious damage, neglect, culpable irresponsibility, or wrongful disposition.

(5) For items not requiring PA, the provider must keep on file a certification, signed and dated not more than sixty days before the first date of service, in the form of a fully completed CMN or, if the need for a CMN is not specified, a prescription.

(6) For an item that is shipped directly to a recipient, the shipping date is the dispensing date.

(7) For an item that requires multiple fittings and special construction, the first date of service is the dispensing date.

(8) If a recipient dies after measurements for a prescribed custom item have been taken but before the item has been dispensed, then payment for the item may be made under the following conditions:

(a) The code set description for the item indicates that it is designed or intended for a specific individual;

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

(c) No information available to the provider indicated that the death of the recipient was imminent;

(d) The provider can document the date of measurement; and

(e) On the claim, the provider reports the date of measurement as the date of service.

(9) Any request for a DMEPOS item or service must originate with an individual recipient, the recipient's authorized representative, or a medical practitioner acting as prescriber and must be made with the recipient's full knowledge and consent.

(10) A request that is determined by the department to have resulted from a mass screening or examination will be denied.

(11) When instruction must be given in the safe and appropriate use of a particular DMEPOS item, it is the responsibility of the provider to ensure that the recipient or someone authorized to assist the recipient has received such instruction.

(12) Payment for repair of a DME item, prosthetic device, or orthotic device or for purchase of a related medical supply item or service can be made only if the medical necessity of the DME item, prosthetic device, or orthotic device itself has been established. The medical necessity of an item purchased by the department is established during the purchasing process. For an item not purchased by the department, medical necessity may be documented on an appropriate medicaid certificate of medical necessity, on a prescription that addresses all specified criteria, or on any other form that is acceptable to the department. No additional documentation of medical necessity is necessary for subsequent repairs made to an item. The determination that an item not purchased by the department is medically necessary does not indicate that the item would be authorized for purchase.

(13) Payment may be made for covered repair, maintenance, parts, accessories, or supplies for a DME item that is owned by an individual but has not been purchased by the department. Payment for the initial service or delivery requires PA; payment for subsequent service or deliveries does not require PA.

(14) Unless otherwise specified elsewhere in this chapter of the Administrative Code, for each claim submitted for payment, a provider must keep the following supporting documents on file:

(a) A completed CMN, if required;

(b) If no CMN is required, a legible prescription that specifies a diagnosis;

(c) Any other information, such as practitioner orders or chart notes, used to establish the medical necessity of the DMEPOS item;

(d) Any record indicating a change in an individual's needs or plan of care;

(e) Proof of delivery;

(f) Confirmation that the recipient or the recipient's authorized representative has been instructed in the safe use of the DMEPOS item, if applicable;

(g) A copy of the manufacturer's or dealer's warranty, if applicable; and

(h) A record of any repair or service that has been performed on equipment not paid for by medicaid, if applicable.

(15) The default CMN form for general DME items and supplies is the ODM 01913, "Certificate of Medical Necessity / Request for Need Verification: General Medical Supplies and Equipment" (rev. 7/2018).

(16) Proof is required to show that a DMEPOS item has been delivered to the intended recipient.

(a) Providers, their employees, and anyone else having a financial interest in the delivery of DMEPOS items are prohibited from accepting delivery of an item on behalf of a medicaid recipient.

(b) If a provider delivers directly to a recipient, then proof of delivery must include the signature of the recipient or the recipient's authorized representative. For a DMEPOS item delivered to a resident of a LTCF, the LTCF is responsible for furnishing proof of delivery.

(c) If a provider uses a third-party shipper, then acceptable proof of delivery includes the shipper's tracking slip or a returned postage-paid delivery invoice.

(d) If a signature obtained physically at the time of delivery is not legible, then the provider or shipper must record the name of the person accepting delivery and the relationship of the person to the recipient. If the provider or shipper records such information for a particular person and maintains it in a readily accessible format, then on subsequent deliveries only the signature is required.

(17) No unnecessary extra payment will be made for a DMEPOS item or service. If more than one DMEPOS item or service will meet a recipient's needs equally well, then the maximum payment amount may not exceed the lowest of the respective costs.

(18) No separate payment will be made under this chapter of the Administrative Code for the following items or services:

(a) Items presumed to be nonmedical in nature and for which no medical necessity can therefore be demonstrated, including but not limited to the following examples:

(i) Environmental control devices;

(ii) Items that have no medical benefit but are intended solely for the comfort or convenience of the user;

(iii) Physical fitness equipment;

(iv) Precautionary items (e.g., emergency alert systems);

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

(vi) Communication aids, except as specified elsewhere in this chapter of the Administrative Code;

(vii) Educational aids; and

(viii) Hygiene equipment (e.g., bidets);

(b) Routine over-the-counter treatment supplies (e.g., adhesive bandages, antiseptic solutions, antibiotic ointments) and personal hygiene items (e.g., soap, diapers for children younger than three years of age);

(c) Medical supplies or DME items that are used during a visit with a medical practitioner (i.e., that are incident to a professional service) in the practitioner's office, in a clinic, or in the recipient's private residence;

(d) Items or services that are covered under manufacturer or dealer warranty;

(e) Items or services for which full remuneration is made through other payment mechanisms (e.g., diagnosis-related groups, per diem payments, workers' compensation, commercial insurance);

(f) Costs of delivery (including postage), setup and assembly, pickup, and routine cleaning and maintenance associated with a covered DME item;

(g) Labor, measuring, casting, fitting, travel by the supplier, and shipping or mailing associated with a covered orthotic device or prosthesis;

(h) Maintenance and repair of equipment during a rental period;

(i) Supporting wires, power supplies, cables, or attachment kits;

(j) Related supplies and accessories that are furnished either during a rental period or with the dispensing or delivery of a purchased equipment item and for which no payment amount exists for separate purchase or rental;

(k) A service call in addition to materials and labor;

(l) Repairs, adjustments, or modifications that are made within ninety days after delivery or during the total rental period, unless necessitated by major changes in the recipient's condition;

(m) Instruction of the recipient or the recipient's authorized representative in the safe use of an item; and

(n) Education, training, instruction, counseling, or monitoring conducted in support of an individual's ordered treatment plan.

(19) Payment is not available for DMEPOS items that duplicate or conflict with another item currently in the recipient's possession, regardless of payment or supply source. Providers are responsible for ascertaining whether duplication or conflict exists.

(20) Certain DMEPOS items may be dispensed on a recurring basis. A provider must confirm a recipient's current need before the next delivery. If DMEPOS items are routinely delivered without necessary confirmation of need, then any payment for excess quantities is subject to recovery.

(21) No prescription for disposable items dispensed on a recurring basis (e.g., incontinence garments, wound dressings) can be renewed earlier than ninety days before the expiration of the current prescription.

(22) Most covered DME items are purchased and become the property of the recipient. Some covered DME items that require ongoing servicing are rented exclusively. Some covered DME items may be rented on a short-term basis, purchased, or rented and then purchased.

(a) The short-term rental of a covered DME item other than a wheelchair requires PA, which may be given if rental is determined to be more cost-effective than purchase.

(b) Unless a different length of time is specified elsewhere in this chapter of the Administrative Code, the initial rental period must not exceed six months.

(c) PA may be given for additional rental periods.

(d) Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.

(e) A monthly rental payment secures the rented item for the entire calendar month.

(f) During a rental period and for ninety days afterward, all rental amounts paid apply toward purchase.

(g) The department reserves the right to determine whether an item will be rented or purchased.

(h) The provider must notify the recipient when an item in effect has been purchased through rental.

(23) Certain medical supply items (e.g., gauze pads, wound fillers/packing) are dispensed in bulk. No payment amount per unit has been established for such items; instead, an overall payment limit per period is specified. The charge submitted by the provider must not exceed the manufacturer's suggested list price for the quantity of the item.

(24) The purchase of torsion cables may be authorized only for the treatment of children with neuromuscular diseases and related conditions. Requests for torsion cables to treat positional deformities will be denied because of anticipated resolution that occurs with maturation.

(25) No provider may submit a claim for a DMEPOS item or service before the item or service has been supplied.

(E) Claim payment.

(1) The payment amount specified in another rule in this chapter of the Administrative Code supersedes any payment amount established by provisions in this rule.

(2) For a covered DMEPOS item or service represented by a new healthcare common procedure coding system (HCPCS) procedure code that takes effect at the beginning of a calendar year, the initial maximum payment amount is established in accordance with rule 5160-1-60 of the Administrative Code.

(3) For any other covered DMEPOS item or service, the payment amount is the lesser of the submitted charge (which must reflect any discounts or rebates available to the provider at the time of claim submission but need not reflect subsequent discounts or rebates) or the first applicable medicaid maximum from the following ordered list:

(a) For a "by report" DMEPOS item or service, an amount determined on a case-by-case basis;

(b) For a supply item for which payment is determined by PA, whichever of the following two figures applies or the lesser of the two if both apply:

(i) Seventy-two per cent of the list price; or

(ii) One hundred forty-seven per cent of the invoice price (minus discounts or rebates);

(c) For a non-supply DMEPOS item or service for which payment is determined by PA, an amount determined on a case-by-case basis;

(d) For a bulk item having an overall payment limit per period, the submitted charge;

(e) For the authorized purchase of a DMEPOS item in used condition, eighty per cent of the payment amount for the item in new condition;

(f) For monthly payment for a "rental/purchase" DME item, ten per cent of the medicaid maximum specified for purchase;

(g) For a professional service for which separate payment is made (e.g., a certain type of evaluation), the applicable amount listed in appendix DD to rule 5160-1-60 of the Administrative Code; or

(h) The amount listed in the appendix to this rule.

Replaces: 5160-10-01, 5160-10-02, 5160-10-03, 5160-10-05, 5160-10-06, 5160-10-20, 5160-4-27

Click to view Appendix

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02 , 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/08/1979, 01/01/1980, 02/01/1980, 03/01/1984, 12/30/84, 05/19/1986, 07/01/1987, 10/01/1987, 04/01/1988, 10/01/1988, 4/13/89 (Emer), 5/15/89, 09/01/1989, 12/1/89, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 5/25/91, 12/30/91, 4/1/92, 7/1/92, 4/1/93, 7/8/93, 12/10/1993, 12/30/93 (Emer), 3/31/94, 7/1/94, 2/1/95, 8/1/95, 12/29/95 (Emer), 3/1/96, 3/21/96, 12/31/96 (Emer), 3/31/97, 8/1/97, 8/1/98, 09/01/1998, 12/31/98 (Emer), 3/31/99, 1/4/00 (Emer), 3/20/00, 12/29/00 (Emer), 3/30/01, 3/29/02, 09/01/2002, 12/12/2002, 3/24/03, 07/01/2004, 10/1/04, 11/1/04 (Emer), 12/30, 04 (Emer), 1/16/05, 3/28/05, 9/1/05, 12/30/05 (Emer), 3/27/06, 07/01/2006, 10/15/2006, 12/29/06 (Emer), 3/29/07, 04/16/2007, 7/30/07, 11/20/2007, 12/16/07, 12/31/07 (Emer), 3/30/08, 12/31, 08 (Emer), 3/31/09, 4/1/09, 7/31/09 (Emer), 10/29/09, 12/31/09 (Emer), 01/01/2010, 2/1/10 (Emer), 3/31/10, 12/30/10 (Emer), 3/30/11, 08/02/2011, 9/1/11, 03/29/2012, 07/01/2013, 12/31/13, 4/1/16

5160-10-02 DMEPOS: repair.

(A) Definitions.

(1) "Major repair" is a repair for which the combined medicaid allowed amounts for materials and labor exceed one hundred twenty dollars for an orthotic or prosthetic device or one hundred dollars for any other item.

(2) "Minor repair" is a repair for which the combined medicaid allowed amounts for materials and labor do not exceed one hundred twenty dollars for an orthotic or prosthetic device or one hundred dollars for any other item. Reporting a major repair on a claim as a series of minor repairs is not permitted.

(B) Coverage.

(1) Provisions governing the repair of wheelchairs are set forth in rule 5160-10-16 of the Administrative Code.

(2) Need verification is required before payment can be made for the following repairs made to a particular item:

(a) The initial repair made to an item that was not purchased by the department;

(b) Major repairs; and

(c) Minor repairs in excess of one per one hundred twenty days.

(3) If no other form or format is specified, a request for need verification must be submitted on form ODM 01904, "Request for Need Verification: Repair of Durable Medical Equipment (Other Than Wheelchairs), Prostheses, or Orthotic Devices" (rev. 7/2018), and must include the following information:

(a) Specification of the item, including manufacturer, model, and serial number (if applicable);

(b) The date on which the item was originally purchased or dispensed or, if the date is not known, the approximate age of the item;

(c) Any warranty period and the type of warranty (manufacturer or dealer);

(d) A full description of the wear, damage, or malfunction;

(e) A full description of the repair;

(f) A description, with dates, of previous repairs (both major and minor);

(g) A complete itemization of parts; and (h) An estimate of labor time needed.

(4) Providers should advise the department when, in their professional opinion, replacement of an item would be more cost-effective than repair.

(5) No separate payment will be made for the following items or services:

(a) Temporary replacement ("loaner") equipment provided while an individual's own equipment is being repaired; and

(b) Repair of an item if within the preceding twelve months the department has paid for the repair of a duplicate or conflicting item currently in the recipient's possession, regardless of payment or supply source.

Replaces: 5160-10-08

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/07/1977, 12/21/1977, 01/01/1980, 03/01/1984, 10/01/1988, 05/15/1989, 05/01/1990, 12/10/1993, 01/01/1995, 09/01/2002, 10/01/2004, 01/13/2006, 04/09/2009, 07/31/2009 (Emer), 10/29/2009, 12/31/13

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

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 03/01/1984, 12/30/1984, 10/01/1988, 12/01/1989, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 05/25/1991, 12/30/1991, 04/01/1992 (Emer), 07/01/1992, 11/16/1992, 12/31/1992 (Emer), 04/01/1993, 07/08/1993, 12/10/1993, 12/30/1993 (Emer), 03/31/1994, 07/01/1994, 02/01/1995, 12/29/1995 (Emer), 03/21/1996, 12/31/1996 (Emer), 03/31/1997, 08/01/1997, 08/01/1998, 12/31/1998 (Emer), 03/31/1999, 01/04/2000 (Emer), 03/20/2000, 12/29/2000 (Emer), 03/30/2001, 12/31/2001 (Emer), 03/29/2002, 03/24/2003, 10/01/2004, 12/30/2004 (Emer), 03/28/2005, 12/30/2005 (Emer), 03/27/2006, 10/15/2006, 12/29/2006 (Emer), 03/29/2007, 07/30/2007, 12/16/2007, 12/31/2007 (Emer), 03/30/2008, 04/01/2009, 07/31/2009 (Emer), 10/29/2009, 12/31/2009 (Emer), 02/01/2010 (Emer), 03/31/2010, 12/30/2010 (Emer), 03/30/2011, 03/29/2012, 12/31/2013, 04/01/2016

5160-10-04 [Rescinded] Pneumatic Compression Devices and Accessories.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03, 5164.02
Prior Effective Dates: 01/01/2015

5160-10-05 [Rescinded] Reimbursement for covered services.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03, 5164.02 , 5164.70
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 10/01/1988, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 09/01/1998, 07/01/2004, 07/01/2006, 01/01/2010, 07/01/2013

5160-10-06 [Rescinded] Prior authorization.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02 , 5162.03
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 10/01/1987, 05/01/1990, 02/17/1991, 09/01/2002, 04/16/2007, 03/29/2012

5160-10-08 DMEPOS: high-frequency chest wall oscillation (HFCWO) devices.

(A) Coverage.

(1) Payment may be made for a high-frequency chest wall oscillation (HFCWO) device on a rental/purchase basis.

(2) The default certificate of medical necessity (CMN) is form ODM 10229, "Certificate of Medical Necessity: High-Frequency Chest Wall Oscillation Devices" (7/2018).

(3) An initial trial period of at least two months is required. Payment may be made for rental during this trial period, excluding any portion that coincides with an inpatient hospital stay, and a CMN must include the following elements:

(a) Evidence of a respiratory condition for which a HFCWO device is an appropriate treatment, including but not limited to the following examples:

(i) A diagnosis of cystic fibrosis that has not been ameliorated by any other treatment;

(ii) A diagnosis of another respiratory condition that produces chronic, excessive, retained bronchopulmonary secretions; or

(iii) A medical history of chronic or recurrent respiratory infections that require antibiotics and multiple hospitalizations and are unresolved by other bronchial hygiene therapy;

(b) If applicable, documentation that other airway-clearance treatments are ineffective or contraindicated;

(c) Specification of the duration and frequency of therapy; and

(d) If applicable, specification of other individuals (e.g., siblings) with whom equipment is to be shared.

(4) If use of the HFCWO device is to be continued in a residential setting after the initial trial period, the CMN must be revised to include the following information:

(a) An attestation to the effectiveness of the device during the trial period and every previous rental period;

(b) If applicable, specification of a change in the duration or frequency of therapy; and

(c) A recommendation either for additional rental or for purchase.

(B) Constraints and limitations.

(1) The need for a HFCWO device is not established if the condition diagnosed is not accompanied by such symptoms of respiratory distress as the accumulation of bronchopulmonary secretions or bronchopulmonary infection. Common diagnoses that by themselves do not establish need include but are not limited to the following examples:

(a) Amyotrophic lateral sclerosis;

(b) Asthma, uncomplicated;

(c) Bronchiectasis, uncomplicated;

(d) Cerebral palsy, any variety;

(e) Chronic obstructive pulmonary disease (COPD);

(f) Chronic respiratory failure, unspecified;

(g) Muscular dystrophy;

(h) Pneumonia, uncomplicated;

(i) Polyneuropathy; and

(j) Quadriplegia.

(2) Payment for a HFCWO device that has been dispensed on the basis of a diagnosis alone is subject to recovery.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02

5160-10-09 DMEPOS: apnea monitors.

(A) Provider requirements. A provider of apnea monitors for use in the home must be capable of performing all of the following services:

(1) Arranging to have certified individuals provide infant cardiopulmonary resuscitation (CPR) training to caregivers;

(2) Providing education and instruction on the mechanical aspects of monitors; and

(3) Providing a technician twenty-four hours a day to service monitoring equipment.

(B) Coverage.

(1) Payment may be made for an apnea monitor on a rental/purchase basis.

(2) The monitoring unit must meet current United States food and drug administration guidelines.

(3) The default certificate of medical necessity (CMN) form is the ODM 02900, "Certificate of Medical Necessity: Apnea Monitors" (rev. 7/2018).

(4) Payment for the initial rental of an apnea monitor is limited to four months. For this initial rental period, the CMN must include the following elements:

(a) At least one clinical indication from the following list:

(i) The occurrence of at least one apparent life-threatening event (ALTE) requiring mouth-to-mouth resuscitation or vigorous stimulation;

(ii) A need for active medical management of apnea of prematurity;

(iii) The occurrence of sudden infant death syndrome (SIDS) in a sibling;

(iv) A need for home oxygen therapy or ventilatory support (either invasive or non-invasive) and associated technology-dependence;

(v) Tracheotomy and associated technology-dependence;

(vi) An abnormal pneumogram at discharge from a medical facility;

(vii) Severe gastroesophageal reflux and associated apnea;

(viii) Severe upper airway abnormality (e.g., achondroplasia, Pierre Robin syndrome); or

(ix) Another, specified disorder necessitating close cardiorespiratory monitoring to facilitate a more timely discharge to home from a medical facility; and

(b) An attestation that appropriate caregivers are capable of being trained to use the monitor properly.

(5) After the first four months, payment may be made either for additional rental or for purchase. The following documentation is required:

(a) A revised copy of the previously completed CMN, on which the prescriber attests to the need for continued home monitoring and supplies the following information pertinent to the child's circumstances:

(i) For a child who is technology-dependent, documentation that the equipment or service on which the child depends is still necessary and is still being used (evidenced, for example, by a copy of a recent clinician follow-up report or home health agency visit report noting equipment and services);

(ii) For a child who is not technology-dependent, documentation of recent, clinically significant apnea or bradycardia (evidenced, for example, by a copy of recent monitor data or a recent pneumogram showing instances of apnea or bradycardia) or documentation of a recent emergency department visit or hospital admission for an ALTE; and

(iii) For a child whose sibling died of SIDS, the birth and death dates of the sibling (for the purpose of indicating whether the child is currently younger than the sibling was at the time of death); and

(b) Either a full report of the information recorded by the apnea monitor during the initial rental period or a summary of the information accompanied by a statement that a full report is available on request.

(6) Payment for an apnea monitor includes professional time, data recording, transmission or printing, maintenance, and supplies.

(C) Requirements, constraints, and limitations.

(1) The following diagnoses, conditions, or circumstances are not by themselves indications for monitoring:

(a) Seizures or seizure disorders in the absence of ALTEs;

(b) Uncomplicated hydrocephalus;

(c) Mental retardation or other developmental disability;

(d) Terminal illness;

(e) Congenital heart defect, with or without associated arrhythmia;

(f) History of apnea in immediate siblings;

(g) History of monitor use with immediate siblings;

(h) History of apnea or SIDS in family members other than immediate siblings;

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

(j) Need to monitor blood oxygen saturation.

(2) Apnea monitoring in the home does not include pneumograms. A medically necessary pneumogram must be ordered by a qualified licensed prescriber and must be based on the presence of appropriate symptoms or conditions. No payment will be made for a pneumogram that is used as a screening test in the absence of appropriate symptoms or conditions.

Replaces: 5160-10-09

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 03/01/1984, 05/01/1990, 07/01/1997, 10/02/1997, 12/05/2002, 10/15/2006

5160-10-10 DMEPOS: home dialysis equipment and supplies.

(A) Payment may be made to a durable medical equipment (DME) provider for covered home dialysis equipment and related supplies except for items supplied by an end-stage renal disease dialysis clinic under "Method I" (a medicare term for a payment option in which the end-stage renal disease dialysis clinic assumes responsibility for furnishing all equipment, supplies, and support services).

(B) Separate payment may be made for dialysis equipment and supplies furnished to a resident of a long-term care facility (LTCF).

(C) The indicated medicaid maximum monthly payment for covered dialysis equipment and supplies may be made for the following types of dialysis:

(1) Hemodialysis, one thousand two hundred dollars;

(2) Continuous ambulatory peritoneal dialysis (CAPD), one thousand two hundred dollars; or

(3) Continuous cycling peritoneal dialysis (CCPD), one thousand five hundred dollars.

Replaces: 5160-10-10

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 03/01/1984, 09/01/2002, 04/16/2007, 01/01/2008

5160-10-11 DMEPOS: hearing aids.

(A) Definition. "Basic hearing test" is an evaluation of an individual's ability to hear that includes the following components:

(1) Testing of air-conducted stimuli at thresholds of five hundred hertz (Hz), one thousand Hz, two thousand Hz, and four thousand Hz;

(2) Assessment of air-conducted speech awareness or speech reception threshold;

(3) Establishment of most comfortable and most uncomfortable listening levels;

(4) Pure-tone bone conduction audiometry (unless the individual's age or capability precludes such testing); and

(5) For an individual younger than twenty-one years of age, the following components:

(a) Tympanometry;

(b) Acoustic reflex battery; and

(c) Otoacoustic emissions testing.

(B) Coverage.

(1) The default certificate of medical necessity (CMN) form is the ODM 01915, "Certificate of Medical Necessity: Hearing Aids" (rev. 7/2018).

(2) A completed CMN, signed and dated not more than ninety days before the requested dispensing date, must be accompanied by a hearing evaluation report, compiled not more than six months before the requested dispensing date, made up of the following components:

(a) A detailed description of the hearing test, signed by the physician specializing in otology or otolaryngology, audiologist, or licensed hearing aid fitter who administered it;

(b) A copy of the hearing test results; and

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

(3) Separate payment may be made for the hearing test itself. All hearing tests must be administered by authorized individuals working within their scope of practice and must be conducted in an appropriate sound environment in accordance with nationally accepted standards. Hearing tests should be performed on both ears; a detailed explanation must be included in a PA request if bilateral testing cannot be done.

(4) The need for a hearing aid is demonstrated when the results of a basic hearing test performed on one ear indicate the following minimum best pure-tone average hearing loss:

(a) Thirty-one decibels (dB); or

(b) In an individual younger than twenty-one years of age, twenty-six dB.

(5) To assess the performance and acceptability of the hearing aid, the provider must attempt to schedule a follow-up visit with the individual within thirty days after delivery. No claim for payment should be submitted during this period. The provider must keep on file, for at least four years, either a confirmation of the follow-up visit signed by the individual or an explanation of why the visit was not conducted. If as a result of the follow-up visit the hearing aid is deemed unacceptable by either the provider or the individual, then payment is limited to the cost of the earmold insert and batteries. In such an instance, if payment has already been made for the hearing aid, then the provider must arrange for adjustment of the claim.

(6) The following warranty periods apply:

(a) For a covered hearing aid, it is the greater of the manufacturer's warranty period or one year from the date of delivery; and

(b) For an earmold insert, it is ninety days.

(7) A warranty comprehensively covers the following services:

(a) Repair, including labor and parts (except earmold inserts and batteries);

(b) Replacement necessitated by damage or loss; and

(c) Two adjustments per year for changes in hearing sensitivity or growth of the ear canal (after which additional adjustments made during the year will be treated as repairs).

(8) A programmable hearing aid, such as a hearing aid employing contralateral routing of signal (CROS) or binaural contralateral routing of signal (BiCROS), may be indicated if an individual has a documented need for such technology in noisy or otherwise adverse hearing environments.

(9) Separate payment may be made for the taking of an impression for an earmold insert (other than an insert dispensed with a hearing aid). Such payment is limited neither by the place of service nor by the individual's living arrangement.

(10) Regardless of how a hearing aid was purchased, payment may be made for necessary repair only if the following conditions are satisfied:

(a) The medical necessity of the hearing aid has been established;

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

(c) The repair is not associated with routine maintenance or cleaning of the hearing aid.

(C) Requirements, constraints, and limitations.

(1) The provider must keep on file a copy of the manufacturer's original cost estimate, a copy of the manufacturer's final invoice detailing discounts and shipping costs, and (if applicable) an explanation of any differences between the figures.

(2) No payment will be made for the following hearing aids:

(a) A hearing aid designed to be worn inside the ear canal;

(b) A disposable hearing aid; and

(c) A hearing aid that has been previously used by another individual.

(3) No payment (including payment of a deductible amount) will be made for replacement if either of the following conditions is satisfied:

(a) The hearing aid is covered by warranty or insurance; or

(b) Repair or reconditioning would be more cost-effective.

(4) Concurrent requests or claims for two separate hearing aids will be treated as a single request or claim for a binaural hearing aid.

(5) Payment for a hearing aid includes the following items:

(a) A cleaning kit;

(b) An initial earmold insert (applicable to behind-the-ear hearing aids); and

(c) One month's supply of batteries.

(6) Payment for hearing aid dispensing includes the following services:

(a) The taking of initial earmold impressions;

(b) Assistance with selection of the hearing aid;

(c) Up to three hours of counseling;

(d) All vihearing aid (regardless of place of service); andsits (including travel) necessary for the dispensing and fitting of the

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

(D) Claim payment.

(1) Payment for an analog hearing aid is the lesser of two figures:

(a) The medicaid maximum amount listed in the appendix to rule 5160-10-01 of the Administrative Code; or

(b) The provider's acquisition cost, which is the sum of the manufacturer's final invoice price and shipping less any discounts received.

(2) Payment for a digital hearing aid is the lesser of two figures:

(a) A percentage of the medicaid maximum amount listed in the appendix to rule 5160-10-01 of the Administrative Code, determined by the age of the individual:

(i) For an individual younger than twenty-one years of age, one hundred per cent; or

(ii) For an individual twenty-one years of age or older, fifty per cent; or

(b) The provider's usual and customary charge.

(3) Payment for repair of a hearing aid is the submitted charge, which must represent one of the following amounts:

(a) If the provider performed the repair, the provider's usual and customary total charge; or

(b) If the provider subcontracted the repair, one hundred twenty-five per cent of the amount shown on the invoice sent to the provider.

Replaces: 5160-10-11

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 02/01/1993, 12/10/1993, 01/01/1995, 09/01/2005, 12/01/2013

5160-10-12 [Rescinded] Orthopedic shoes and foot orthoses.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03, 5164.02 , 5164.70
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 10/01/1988, 02/17/1991, 12/30/1993 (Emer), 03/31/1994, 01/01/2007

5160-10-13 DMEPOS: oxygen.

(A) Definitions.

(1) "Blood gas study" is the measurement of such characteristics of blood as the partial pressure of oxygen (PO2) or oxygen saturation. The term applies either to pulse oximetry or to an arterial blood gas (ABG) study.

(2) "Group I" and "group II" criteria are sets of clinical indicators used to determine the coverage of oxygen without prior authorization.

(a) Group I criteria.

(i) If the individual is tested while awake and at rest, either of the following measures applies: (a) arterial PO2 of fifty-five millimeters of mercury (mm Hg) or less; or (b) arterial oxygen saturation at or below eighty-eight per cent.

(ii) If the individual is tested while ambulating, either of the following measures applies:

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

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

(iii) If the individual is tested while asleep, any of the following measures applies:

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

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

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

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

(b) Group II criteria.

(i) Either of the following measures applies:

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

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

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

(a) Dependent edema suggestive of congestive heart failure;

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

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

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

(B) Providers.

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

(a) A physician;

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

(c) A physician assistant.

(2) The following eligible medicaid providers may supply oxygen:

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

(b) A pharmacy;

(c) A physician;

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

(e) A physician assistant; or

(f) A service-based ambulatory health care clinic.

(3) The following eligible medicaid providers may receive medicaid payment for submitting a claim for oxygen:

(a) A DME provider;

(b) A pharmacy;

(c) A physician;

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

(e) A physician assistant;

(f) A service-based ambulatory health care clinic; or

(g) A professional medical group.

(C) Certification of medical necessity.

(1) Payment for oxygen can be made only if a prescriber certifies that the oxygen is medically necessary for an individual. A completed certificate of medical necessity (CMN) must be signed and dated by the prescriber before a claim is submitted. The default form is the ODM 01909, "Certificate of Medical Necessity: Oxygen" (rev. 7/2018).

(2) On the CMN, the prescriber must specify an estimated length of need (certification period), which may range from one month to a lifetime.

(a) For an individual meeting group I criteria, each certification period is limited to a maximum of twelve months after the first date of service.

(b) For an individual meeting group II criteria, each certification period is limited to a maximum of three months after the first date of service.

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

(a) An initial CMN must be completed if oxygen has not been supplied under medicaid to an individual for at least two full calendar months.

(b) The individual must be seen and evaluated by a prescriber within a specified period before the date of certification, and a blood gas study is required.

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

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

(4) A renewing CMN is used to extend certification.

(a) If the need for oxygen was established through a sleep study in which a positive airway pressure device was shown to be effective only when supplemental oxygen was administered simultaneously, then the need for oxygen is presumed to last as long as the need for the positive airway pressure device, and no further sleep study is required to confirm a continued need for oxygen.

(b) Otherwise, within ninety days before the end of the existing certification period, the individual must be seen and evaluated by a prescriber, and a blood gas study is required. (The new certification period cannot begin until both the prescriber evaluation and the blood gas study have been completed.).

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

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

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

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

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

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

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

(D) Coverage.

(1) Payment may be made for oxygen supplied in the following forms:

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

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

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

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

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

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

(g) Oxygen concentrator, single delivery port;

(h) Oxygen concentrator, dual delivery port;

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

(j) Transfill unit (private residence only).

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

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

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

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

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

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

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

(6) Oxygen is not medically necessary if it is prescribed for any of the following conditions:

(a) Angina pectoris in the absence of hypoxemia;

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

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

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

(E) Claim payment.

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

(a) Setup and instruction on use;

(b) Equipment and supplies;

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

(d) Transportation or delivery charges;

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

(f) Oxygen consumed (when applicable); and

(g) Equipment monitoring visits.

(2) The maximum payment for oxygen is the amount set forth in the appendix to this rule. When the prescribed oxygen flow is greater than four LPM, the payment amount is increased by fifty per cent.

Replaces: 5160-10-13

Click to view Appendix

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5165.47, 5164.02
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 02/17/1991, 05/25/1991, 04/01/1992 (Emer), 07/01/1992, 03/31/1994, 01/01/1995, 08/01/1995, 08/01/1998, 10/11/2001, 11/01/2007, 07/31/2009 (Emer), 10/29/2009, 08/02/2011, 12/31/2013

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

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

5160-10-14 DMEPOS: compression garments.

(A) Provider requirement. A provider of custom-made or custom-fitted compression garments must either employ or contract with a certified fitter and must keep documentation of this relationship on file.

(B) Coverage.

(1) The default certificate of medical necessity (CMN) form is the ODM 01905, "Certificate of Medical Necessity: Compression Garments" (rev. 7/2018).

(2) Payment may be made only for compression garments generating a pressure of at least eighteen millimeters of mercury (mm Hg).

(3) For a gradient compression garment, the provider must specify at least one clinical indication such as but not limited to the conditions specified in the following list:

(a) Elephantiasis;

(b) Lymphedema;

(c) Milroy's disease;

(d) Orthostatic hypotension;

(e) Post-thrombotic syndrome;

(f) Stasis dermatitis;

(g) Stasis ulcers;

(h) Symptomatic chronic venous insufficiency (characterized by, for example, pain, swelling, ulcers, or severe varicose veins);

(i) Symptomatic venous insufficiency associated with pregnancy; or

(j) Thrombophlebitis.

(4) Payment for an anti-embolism compression garment may be limited to three months, because such garments are generally used for short-term treatment after surgery.

(5) Payment for a post-burn compression garment cannot be made if no burn injury has occurred.

(6) It is understood that because of the nature of certain applications, authorization for payment may be granted after an item has been dispensed.

Replaces: 5160-10-14

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 10/01/1988, 01/15/2007

5160-10-15 DMEPOS: transcutaneous electrical nerve stimulation (TENS) units.

(A) Definitions.

(1) "Accessories" is a collective term that encompasses but is not necessarily limited to the following items:

(a) Adapters;

(b) Clips;

(c) Additional connecting cable for lead wires;

(d) Carrying pouches; and

(e) Covers.

(2) "Supplies" is a collective term that encompasses but is not necessarily limited to the following items:

(a) Electrodes of any type;

(b) Lead wires;

(c) Conductive paste or gel;

(d) Adhesive;

(e) Adhesive remover;

(f) Skin preparation materials;

(g) Batteries; and

(h) Battery charger for rechargeable batteries.

(B) Provider requirement. A provider of transcutaneous electrical nerve stimulation (TENS) units must have a physical location available for face-to-face fitting and instruction purposes.

(C) Coverage.

(1) Payment may be made for a TENS unit on a rental/purchase basis.

(2) The default certificate of medical necessity (CMN) form is the ODM 03402, "Certificate of Medical Necessity: Transcutaneous Electrical Nerve Stimulation (TENS) Units" (rev. 7/2018). The CMN must include one of the following statements of need:

(a) For neurogenic pain, the following information:

(i) An attestation that the individual is experiencing intractable, nerve-related pain that has lasted at least six months;

(ii) An appropriate supporting diagnosis; and

(iii) An attestation that the use of a comparable TENS unit for a trial period of at least thirty days produced substantial relief from pain and, if applicable, enabled a significant reduction in medication (e.g., muscle relaxants, narcotics, analgesics); or

(b) For post-operative pain, the following information:

(i) An attestation that treatment lasting no longer than thirty days is needed for acute pain following surgery; and

(ii) The date of surgery.

(3) Payment may be made for the purchase of a TENS unit if the prescriber attests to the medical necessity of continued treatment.

(4) After a TENS unit has been purchased for an individual, regardless of payment source, separate payment may be made for necessary supplies, which must be dispensed only when they are needed, at a frequency not to exceed once per month. The payment made for supplies is an all-inclusive lump sum and does not depend on the number or nature of items in a particular shipment. No separate payment is allowed for individual supply items.

(5) After a TENS unit has been purchased, no separate payment is allowed for accessories.

(D) Requirements, constraints, and limitations.

(1) A diagnosis of "chronic intractable pain" is not in itself sufficient to warrant coverage.

(2) Rental of a TENS unit to treat intractable, nerve-related pain is limited to four months.

(3) Rental of a TENS unit to treat post-operative pain is limited to a single thirty-day period and may not be extended.

(4) The warranty period for a purchased TENS unit is two years from the date of delivery.

(5) Payment may be made for the rental or purchase of a used TENS unit only if the particular unit was previously used by the individual for whom it is currently prescribed.

(6) Payment for a TENS unit does not indicate or imply coverage of a conductive TENS garment.

(7) Payment is limited to the maximum amount for a two-lead unit unless the provider obtains and maintains documentation in the individual's file establishing the medical necessity of a four-lead unit.

(8) The medical necessity of a TENS unit not purchased by the department must be established before payment is made for supplies or repair.

(E) Claim payment. The lump-sum payment for TENS supplies is twenty-five dollars.

Replaces: 5160-10-15

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/04/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 04/16/2007, 04/01/2009

5160-10-16 DMEPOS: wheelchairs.

(A) Definitions and explanations.

(1) "Basic equipment package" is the following standard set of parts and accessories that come with a wheelchair at the time of purchase:

(a) A sling or solid seat with back, a captain's chair, or a stadium-style seat;

(b) Standard casters or wheels with tires;

(c) Standard armrests;

(d) Standard front rigging (e.g., non-elevating legrests with footrests, a footplate);

(e) Wheel locks or brakes;

(f) With a power mobility device, motors;

(g) With a power mobility device, a non-expandable controller;

(h) With a power mobility device, a battery charger;

(i) With a power wheelchair, a standard proportional joystick; and

(j) With a power-operated vehicle, batteries.

(2) "Complex rehabilitation technology (CRT)" is a categorization of wheelchair equipment items that require individual evaluation, fitting, configuration, adjustment, or programming to meet the specific medical and functional needs of the user, as well as services related to those products. CRT includes, for example, customized seating systems, adaptive positioning devices, and alternative drive systems (directional interfaces other than a standard joystick).

(3) "Custom wheelchair" is a wheelchair that has a customized seating system. A custom wheelchair, therefore, cannot be easily used or adapted for use by another individual.

(4) "Customized seating system" is a wheelchair seat, wheelchair back, or combination of wheelchair seat and back that has been tailored specifically to the particular body shape and positioning needs of an individual user. Customization may be achieved by means of molding, contouring, carving, or other forms of fabrication or by the integration of prefabricated components into the wheelchair frame. Items such as seat cushions and other removable positioning aids do not by themselves constitute a customized seating system.

(5) "DMEPOS Fee Schedule" is a list of payment amounts for durable medical equipment, prostheses, orthoses, and supplies published by the centers for medicare and medicaid services (CMS); it is available at http://www.cms.gov. The January 2015 revision is the basis for the medicaid payment amounts described in paragraph (E) of this rule.

(6) "Individualized seating system" is a wheelchair seat, wheelchair back, or combination of wheelchair seat and back that has been tailored to the body shape and positioning needs of an individual user by means of installing and configuring prefabricated cushions or other removable positioning aids.

(7) "Medical necessity" is defined in rule 5160-1-01 of the Administrative Code.

Wheelchairs and wheelchair parts and accessories must meet additional criteria in order to be considered medically necessary:

(a) Wheelchairs and wheelchair parts and accessories are generally not necessary nor even useful in the absence of illness, injury, impairment, disability, or other condition that limits ambulation. A wheelchair must therefore provide mobility to an individual for whom ambulation is not possible, takes inordinate physical effort, or causes considerable physical discomfort.

(b) A wheelchair must also be suited to the purposes and daily routines of the individual using it.

(c) A manual wheelchair must provide a level of needed functionality that cannot be achieved with an assistive device such as a cane, a crutch or crutches, or a walker.

(d) A power mobility device (PMD) must provide a level of needed functionality that cannot be achieved with a manual wheelchair.

(e) A PMD must be functional in the environment in which it is used. The individual (or someone assisting the individual) must have the ability to take proper care of the PMD, the individual's place of residence must be accessible and have adequate electrical service, transportation of the PMD must be available as necessary, and there must be sufficient protection for the PMD from the elements. The place of residence is considered to be accessible only if the individual will be able to use the PMD without assistance to enter and leave the residence and to move easily about the main living space (which is used for purposes such as food preparation, eating, sleeping, personal hygiene, and relaxation).

(f) A customized seating system must enable an individual to sit (or recline, as appropriate) for long periods of time, provide postural support to permit functional activities, or reduce pressure on the body to a degree that cannot be achieved with items such as a standard wheelchair seat, an individualized seating system (e.g., a prefabricated seat cushion or other removable positioning aid or combination of positioning aids), or a spinal orthotic device.

(8) "Need verification" is a process, similar to prior authorization, by which the department determines whether to make payment for the repair of a wheelchair part or accessory that exceeds the established frequency guideline. One purpose of need verification is to enable the department to consider whether the purchase of a new piece of equipment might be more cost-effective than continued repair.

(9) "Power mobility device (PMD)" is a collective term for a power wheelchair or a power-operated vehicle (POV, commonly referred to as a "scooter"). Each PMD is classified on the basis of performance into one of eight groups developed under the auspices of CMS:

(a) Group one power-operated vehicles;

(b) Group two power-operated vehicles;

(c) Group one power wheelchairs;

(d) Group two power wheelchairs;

(e) Group three power wheelchairs;

(f) Group four power wheelchairs;

(g) Group five power wheelchairs; and

(h) Power mobility devices not otherwise classified.

(10) "Routine maintenance" of a wheelchair is any upkeep that is necessary to maintain optimum functioning of the equipment and that does not require a skilled or trained technician to perform.

(11) "Wheelchair" is a collective term for a manual wheelchair or a power mobility device.

(B) Providers.

(1) Prescribing providers. Eligible medicaid providers of the following types, acting within their scope of practice, may certify the medical necessity of a wheelchair:

(a) A physician;

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

(c) A physician assistant; or

(d) A podiatrist.

(2) Evaluators. The following professionals may evaluate an individual's particular needs:

(a) For wheelchairs incorporating CRT, a physiatrist, orthopedic surgeon, neurologist, physical therapist, or occupational therapist; or

(b) For wheelchairs not incorporating CRT, a physician, physical therapist, or occupational therapist.

(3) Rendering providers. The following eligible providers may furnish a wheelchair, part, or accessory or may render a related service:

(a) For manual wheelchairs without CRT, a provider enrolled as a basic durable medical equipment (DME) supplier; or

(b) For PMDs and CRT, a provider enrolled as a DME supplier with appropriate certification or licensure from the Ohio respiratory care board (ORCB) to engage in business involving wheelchairs.

(4) Billing providers. The following eligible providers may receive medicaid payment for submitting a claim for a wheelchair, part, accessory, or related service:

(a) For manual wheelchairs without CRT, a provider enrolled as a basic DME supplier; or

(b) For PMDs and CRT, a provider enrolled as a DME supplier with appropriate certification or licensure from the ORCB to engage in business involving wheelchairs.

(C) Coverage.

(1) Principles.

(a) A wheelchair must be determined to be medically necessary before the department will make payment. For a wheelchair purchased by the department, this necessity is documented on form ODM 03411, "Certificate of Medical Necessity: Wheelchairs" (rev. 6/2016). The medical necessity of a wheelchair that has not been purchased by the department is documented either on this certificate of medical necessity (CMN) or on an equivalent form.

(b) If more than one type of wheelchair will meet an individual's needs and satisfy the criteria of medical necessity, then the maximum payment amount is the lowest of the respective costs, regardless of which wheelchair is supplied.

(c) The provision of or payment for the purchase, repair, or rental of a medically necessary non-custom wheelchair for a resident of a long-term care facility (LTCF) is the responsibility of the LTCF. This responsibility holds even if the wheelchair incorporates CRT other than a customized seating system. In turn, the LTCF receives medicaid payment in accordance with Chapter 5160-3 of the Administrative Code. Therefore, claims submitted to the department by wheelchair suppliers for the purchase, repair, or rental of non-custom wheelchairs furnished to LTCF residents will be denied.

(2) Purchase.

(a) Custom wheelchairs for individuals living in a LTCF and wheelchairs for individuals not living in a LTCF. Prior authorization (PA) is required, and a face-to-face evaluation of need must be performed by a prescribing provider not earlier than one hundred eighty days before the submission of the PA request.

(b) Requirements, constraints, and limitations.

(i) The purchase of a wheelchair includes the basic equipment package, delivery, setup, instruction and training in use, and adjustments or minor modifications. No separate payment is made for these items. Payment for other parts or accessories, either parts or accessories that are substituted for individual items in the basic equipment package or parts or accessories outside the basic equipment package that are added after a wheelchair is purchased, requires PA.

(ii) Authorization will not be given for the purchase of more than one wheelchair for concurrent use by an individual. An exception to this restriction may be made if it can be satisfactorily demonstrated that having a second wheelchair (e.g., a manual wheelchair in addition to a PMD) significantly improves an individual's mobility and is cost-effective.

(3) Repair, including replacement of existing parts or accessories.

(a) Custom wheelchairs for individuals living in a LTCF and wheelchairs for individuals not living in a LTCF. The repair of a component such as a frame, seating system, motor, drive system, or battery is subject to need verification. No verification is required for the repair of a wear item (e.g., caster bearing, tire, arm pad).

(b) Requirements, constraints, and limitations.

(i) For a wheelchair not purchased by the department, submission of documentation of the medical necessity of the wheelchair itself is required for the initial repair but not for subsequent repairs. The determination that a wheelchair not purchased by the department is medically necessary does not indicate that the wheelchair itself would be authorized for purchase.

(ii) Payment is not permitted for temporary replacement equipment provided while an individual's wheelchair is being repaired (e.g., a "loaner wheelchair").

(iii) No payment is made for routine maintenance.

(4) Rental.

(a) Custom manual wheelchairs. PA is required.

(b) Non-custom manual wheelchairs for individuals not living in a LTCF. No PA is required for the first three months. PA is required for rental periods after the first three months.

(c) PMDs. PA is required.

(d) Requirements, constraints, and limitations.

(i) Payment will not be made for the rental of more than one wheelchair per month for an individual.

(ii) Payment for rental is all-inclusive; no separate payment is made for any other wheelchair-related items.

(iii) During a rental period and for ninety days afterward, all rental amounts paid are applied toward purchase. The total of the rental amounts must not exceed the purchase amount.

(5) Evaluation and management.

(a) An evaluator may receive payment for determining an individual's needs for a wheelchair. Not more than one payment will be made per wheelchair per individual.

(b) Payment includes all services rendered by the evaluator, including evaluation, product selection, confirmation at delivery, and follow-up.

(D) Additional requirements, constraints, and limitations.

(1) After delivery, the supplier must maintain documentary evidence that the following statements are true concerning a wheelchair and any related accessories:

(a) They were delivered to the individual for whom they were prescribed;

(b) They are consistent with the items described in the CMN; and

(c) They correspond exactly to the items listed on the submitted claim.

(2) Claim payments for which there is insufficient documentation are subject to recovery.

(3) A PA request must specify all relevant information (e.g., HCPCS code, manufacturer, model). A PA request for repair must include the serial number of the equipment and a complete itemization of parts and estimated labor needed.

(4) When an authorization specifies a manufacturer, model, part number, or other information identifying a particular item, then a supplier may provide and subsequently submit claims only for the specified item.

(5) Payment will not be authorized for a wheelchair to be used by an individual younger than one year. For a child one year of age or older whose needs are not met by an adult-sized wheelchair, consideration for authorization will be given only to wheelchairs that accommodate growth, unless there is a more appropriate, cost-effective, medically necessary alternative available. Payment may be made for additional parts required to "grow" a wheelchair if the combined cost of the parts and related labor is less than the cost of a new wheelchair.

(6) Payment will not be authorized for wheelchairs, parts, accessories, or modifications whose primary application is leisure or recreational activities.

(7) Payment will not be authorized for a PMD intended exclusively for outdoor use.

(8) A wheelchair purchased by medicaid is the property of the individual for whom it was prescribed.

(E) Claim payment.

(1) As of the effective date of this rule, the payment amount is established as the lesser of the submitted charge or the applicable medicaid maximum from the following list:

(a) For purchase of a covered new wheelchair, part, or accessory, ninety per cent of the allowed amount listed for Ohio on the "DMEPOS Fee Schedule";

(b) For purchase of a covered group four power wheelchair for which there is no medicare allowed amount, one hundred ten per cent of the medicaid maximum payment amount allowed for purchase of the most closely corresponding covered group three power wheelchair;

(c) For purchase of any other covered wheelchair, new part, or new accessory for which there is no medicare allowed amount, payment by report;

(d) For purchase of a covered wheelchair, part, or accessory that has been previously used but remains in good working order, fifty per cent of the medicaid maximum payment amount allowed for purchase of a comparable new wheelchair, part, or accessory;

(e) For monthly rental of a covered wheelchair to which rental applies, ten per cent of the medicaid maximum payment amount allowed for purchase;

(f) For performance of an evaluation and related services, eighty per cent of the amount established by the medicare physician fee schedule; or

(g) For labor provided for a covered repair or covered maintenance, the result L obtained by the formula L = ([W + B] × P + M) × A × 0.25.

(i) L is the medicaid maximum payment amount for labor, reported in fifteen-minute units.

(ii) W is the hourly median wage for medical equipment repairers in Ohio reported by the United States bureau of labor statistics (available at http://www.bls.gov/oes/). (The initial wage figure used was from May 2014.)

(iii) B is hourly employee-related expenses such as benefits, calculated as thirty-five per cent of wages.

(iv) P is a productivity adjustment factor, defined as the ratio of the number of total work hours per day (specified as eight) to the number of available productive work hours per day (specified as six and a half).

(v) M is an hourly mileage allowance, defined as the ratio of the daily mileage allowance to the number of available productive work hours per day. The daily mileage allowance is the product of the average travel speed (specified as thirty-five miles per hour), the average total travel time (specified as one hour and fifteen minutes), and the federal standard mileage rate for business (available at http://www.irs.gov). (The initial standard mileage rate used was for 2015.)

(vi) A is an administrative cost factor, specified as one hundred ten per cent.

(2) After the effective date of this rule, if the medicare amount for an item or service becomes less than the current medicaid maximum payment amount, then the medicaid maximum payment amounts related to that item or service are reestablished on the basis of the new medicare amount.

(3) After the effective date of this rule, if updates to the median hourly wage or the federal standard mileage rate would cause a variance of at least five per cent in the maximum payment amount for labor, then the maximum payment amount is reestablished on the basis of the updated figures.

(4) The payment provisions of this rule supersede entries in appendix DD to rule 5160-1-60 of the Administrative Code that pertain to wheelchairs, parts, accessories, or related services.

Replaces: 5160-10-16, 5160-10- 16.1

Effective: 1/1/2017
Five Year Review (FYR) Dates: 01/01/2022
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02 , 5165.01, 5165.47
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 12/30/1991, 07/01/1994, 08/01/1995, 08/01/1997, 04/01/1998, 10/01/2004, 10/27/2005, 04/01/2006, 07/31/2009 (Emer), 10/29/2009, 04/25/2011, 12/31/2013

5160-10-16.1 [Rescinded] Wheelchair rentals.

Effective: 1/1/2017
Five Year Review (FYR) Dates: 03/15/2016
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03, 5164.02 , 5164.70
Prior Effective Dates: 10/27/2005, 04/25/2011

5160-10-17 DMEPOS: pneumatic compression devices and accessories.

(A) Payment may be made directly to a provider for a pneumatic compression device or a related accessory only if the equipment and supplies are used to treat either lymphedema in the extremities or chronic venous insufficiency (CVI) with venous stasis ulcers. Accessories used for pneumatic compression of the chest or trunk are not covered. Before prescribing a pneumatic compression device, a practitioner must have found either that there was no significant improvement or that significant symptoms persisted when one of the following treatments was applied:

(1) For lymphedema in the extremities, four weeks of therapy involving the use of an appropriate compression bandage system or compression garment (either prefabricated or custom-fabricated), exercise, and elevation of the limb; or

(2) For CVI, six months of therapy involving the use of an appropriate compression bandage system or compression garment, appropriate wound dressings, exercise, and elevation of the limb.

(B) Payment may be made for the purchase of a pneumatic appliance. Payment may be made on a rental/purchase basis for a pneumatic compressor.

(C) The default form is the ODM 02929, "Certificate of Medical Necessity: Pneumatic Compression Devices and Accessories" (rev. 7/2018). The CMN must include the following information:

(1) A statement that previous treatment produced no significant improvement or that significant symptoms persisted;

(2) The date of the most recent evaluation;

(3) Identification by diagnosis code of the condition or conditions necessitating a pneumatic compression device;

(4) The expected length of time (expressed as the number of months or as 'lifetime') during which the individual will need the pneumatic compression device;

(5) A listing of symptoms observed, measurements taken, and any other data that serve to establish the severity of the condition or conditions;

(6) Specification of the pneumatic compression device and any accessories to be supplied;

(7) Documentation of the individual's clinical response to treatment during evaluation (including changes in measurement results);

(8) A brief summary of the treatment plan, including the pressure to be used, the frequency and duration of use, and a provisional monitoring schedule;

(9) An assessment of the individual's capacity for tolerating the prescribed treatment; and

(10) A statement about the ability of the individual (or someone authorized to assist the individual) to use the device correctly and consistently.

(D) The initial rental of a pneumatic compression device starts a trial period of at least thirty days and not more than ninety days. If the prescriber determines during this trial period that the device satisfactorily meets the individual's needs, then the provider may obtain a revised CMN during the trial period. Unless the expected length of need is so short that additional rental would cost less than purchase, the revised CMN will automatically be considered to support purchase of the device.

Replaces: 5160-10-04

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 01/07/2010

5160-10-18 DMEPOS: hospital beds, bed accessories, and pressure-reducing support surfaces.

(A) Definitions and explanations.

(1) "Group 1," "group 2," and "group 3" are classes of pressure-reducing support surface.

(a) Group 1 surfaces are generally non-powered pads or overlays that are designed to be placed on top of a hospital bed or standard mattress. They achieve their effect through the application of, for example, a gel layer, air pressure, natural lamb's wool, or synthetic sheepskin. Group 1 may also include some powered systems (alternating pressure or low air loss) that are not classified as group 2.

(b) Group 2 surfaces generally encompass powered air flotation beds, powered air mattresses, and non-powered advanced overlays that are designed to be placed on top of a hospital bed frame or standard bed frame.

(c) Group 3 surfaces are generally air-fluidized beds, which simulate the characteristics of fluid by circulating air through a medium such as silicone-coated ceramic beads. They are used for the treatment of stage III or stage IV pressure sores.

(2) "Stage I," "stage II," "stage III," and "stage IV" are classes of tissue breakdown associated with pressure sores.

(a) Stage I is characterized by erythema (redness lasting at least fifteen minutes after pressure is removed), warmth, tenderness, and sometimes blistering. The affected area is usually located over a bony prominence. Further breakdown may be occurring if erythema fails to dissipate when pressure is removed; however, stage I is usually considered a transient circulatory disturbance, and the affected area generally returns to normal within twenty-four hours.

(b) Stage II involves actual tissue damage and appears as a shallow, open ulcer with a red or pink wound bed without slough or as an intact or ruptured serum-filled blister. It is characterized by a distinct break in epidermal integrity (which may extend into the dermis), erythema, disturbance in skin temperature, tenderness, local swelling or edema, and sometimes drainage. (This stage should not be confused with skin tears, tape burns, perineal dermatitis, maceration, or excoriation.) Stage II tissue damage generally heals quickly and easily.

(c) Stage III is characterized by epidermal and dermal destruction that penetrates subcutaneous tissue, infection, cellulitis, eschar, pain, and drainage. Subcutaneous fat may be visible; however, bone, tendon, and muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. There may be undermining and tunneling of surrounding subcutaneous tissue. With proper attention under optimal conditions, a stage III wound can heal in two to four weeks.

(d) Stage IV is characterized by destruction of the epidermis and dermis, penetration of the deep subcutaneous layers, exposure of subcutaneous structures, destruction of muscle or bone, and possible undermining of surrounding subcutaneous tissue. Slough or eschar may be present.

(B) Coverage of hospital beds.

(1) Payment may be made for a hospital bed on a rental/purchase basis.

(2) The default certificate of medical necessity (CMN) form is the ODM 02910, "Certificate of Medical Necessity: Hospital Beds and Bed Accessories" (rev. 7/2018). The CMN must include an attestation that at least one of the following criteria is met:

(a) The individual's condition (e.g., congestive heart failure, chronic obstructive pulmonary disease, problems with aspiration, disease aggravated by excessive body weight) necessitates elevation of the head or upper body to at least thirty degrees, and such elevation cannot be achieved with pillows or wedges in a standard bed;

(b) The individual uses or will use traction equipment that can be attached only to a hospital bed;

(c) The individual needs additional height or support for safe transfer to a chair, wheelchair, or standing position; or

(d) The elevating functions of a hospital bed will facilitate frequent intervention by an assistant or caregiver to alleviate pain or prevent pressure sores.

(3) Documentation of medical necessity must be submitted for any additional feature that is requested (e.g., powered elevation, powered height adjustment, heavy-duty or extra-heavy-duty construction, extra width).

(a) A heavy-duty hospital bed may be indicated for an individual weighing more than three hundred fifty pounds.

(b) An extra-heavy-duty hospital bed may be indicated for an individual weighing more than six hundred pounds.

(C) Coverage of bed accessories.

(1) Payment for the rental or purchase of a bed accessory (e.g., trapeze, side rail, replacement mattress) does not require PA. The provider, however, must keep on file a completed CMN. The default form is the ODM 02910.

(2) If an accessory is to be used with a hospital bed, then the medical necessity of the hospital bed must also have been established.

(D) Coverage of pressure-reducing support surfaces.

(1) The default CMN form is the ODM 02904, "Certificate of Medical Necessity: Pressure-Reducing Support Surfaces" (rev. 7/2018).

(2) For a group 1 surface, the CMN must include an attestation that at least one of the following criteria is met:

(a) The individual cannot make changes in body position without assistance;

(b) The individual cannot independently make changes in body position sufficient to alleviate pressure;

(c) The individual has a pressure sore (of any stage) on the trunk or pelvis; or

(d) The individual's circulation is compromised.

(3) For a group 2 surface, the CMN must include the following information:

(a) If the individual underwent a surgical procedure involving the closure of a wound with a skin graft or skin flap within the thirty days preceding placement of the surface, an attestation to the surgery;

(b) An attestation that at least one of the following criteria is met:

(i) The individual has a stage III or stage IV pressure sore on the trunk;

(ii) The individual has multiple stage II wounds;

(iii) The individual has third-degree burns (irrespective of whether grafting has been performed); or

(iv) Within the sixty days preceding submission of the PA request or placement of the surface, the individual underwent a surgical procedure involving the closure of a wound with a skin graft or skin flap; and

(c) A description of the treatment protocol.

(4) For a group 3 surface, the following information must be included on the CMN directly or by attachment:

(a) An attestation that the individual is being treated for a stage III or stage IV wound;

(b) A detailed description of the wound, prepared by a qualified health practitioner within the twenty-one days preceding placement of the surface, that specifies location, length, width, depth, and overall appearance and characteristics;

(c) A record of the individual's body weight taken intermittently over a period of at least sixty days preceding placement of the surface;

(d) The results of blood tests (which must have been performed within the twenty-one days preceding placement of the surface), including the following levels:

(i) Serum protein;

(ii) Serum albumin or prealbumin;

(iii) Hemoglobin; and

(iv) Hematocrit; and

(e) A current, comprehensive nutritional assessment of the individual, performed by a registered dietitian or licensed dietitian.

(5) The department may determine the length of an initial rental period and any subsequent rental periods.

(E) Requirements, constraints, and limitations.

(1) A bed does not qualify as a hospital bed if it has no elevating function or if its elevating function is not needed.

(2) PA of payment for a group 3 support surface may be denied if its use is contraindicated by factors such as but not limited to the following examples:

(a) Treatment protocols that involve significant quantities of moisture;

(b) Inability of the individual or an assistant to operate the equipment safely;

(c) Inadequate structure to support the weight of the equipment; or

(d) Insufficient electrical supply.

Replaces: 5160-10-18

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 05/01/1990, 02/17/1991, 12/30/1991, 12/29/1995 (Emer), 03/21/1996, 01/01/2000, 10/01/2004, 04/09/2009

5160-10-19 DMEPOS: positive airway pressure devices.

(A) Definition. "Apnea-hypopnea index (AHI)" is the mean number of episodes of apnea or hypopnea per hour recorded over a period of at least two hours without the use of a positive airway pressure device, reported by polysomnogram. The AHI may not be extrapolated or projected.

(B) Coverage.

(1) The default certificate of medical necessity (CMN) form is the ODM 01903, "Certificate of Medical Necessity: Positive Airway Pressure Devices" (rev. 7/2018). The CMN must include the following information:

(a) A diagnosis of obstructive sleep apnea;

(b) The results of a sleep study comprising components for diagnosis and titration, performed either separately as two studies or consecutively as a split study; and

(c) An estimated length of need.

(2) Payment for a positive airway pressure device may be made only if the following criteria are met:

(a) The diagnosis component of the sleep study, performed during at least two hours of recorded sleep without a positive airway pressure device, yields the following results:

(i) An AHI of at least fifteen; or

(ii) An AHI of at least five coupled with documented evidence of any of the following conditions:

(a) Excessive sleepiness during waking hours;

(b) Insomnia;

(c) Mood disorder;

(d) Impaired cognition;

(e) Hypertension;

(f) Ischemic heart disease; or

(g) A history of stroke.

(b) The titration component of the sleep study, performed with a positive airway pressure device, yields the following results:

(i) A decrease in the number of airway obstructions per hour; and

(ii) At least one of the following indications of effectiveness:

(a) An absolute increase in oxygen saturation to at least eighty-nine per cent;

(b) A relative increase in oxygen saturation of at least fifteen per cent; or

(c) Other clinical improvement recognized by the department.

(3) Payment for a variable or bilevel positive airway pressure device (i.e., a positive airway pressure device that produces different inspiratory and expiratory pressure levels) may be made only if the following criteria are met:

(a) A positive airway pressure device that produces a single pressure level has been tried and found to be ineffective; and

(b) Evidence gathered during the titration component of the sleep study or during a one-week trial period indicates that a variable or bilevel positive airway pressure device is effective.

(4) A need for oxygen is established if a positive airway pressure device is effective during a sleep study only when supplemental oxygen is administered simultaneously. That need for oxygen is presumed to last as long as the need for the positive airway pressure device, and no further sleep study is required to confirm a continued need for oxygen.

(C) Constraint. The provider of a positive airway pressure device may not perform the qualifying sleep study.

Replaces: Part of 5160-10-22

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 12/30/1991, 07/01/1993, 07/01/1994, 01/01/1995, 08/01/1998, 10/01/2004, 01/01/2008

5160-10-20 [Rescinded] Orthotic devices, prostheses, and related services.

Effective: 7/16/2018
Five Year Review (FYR) Dates: 4/27/2018
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 03/01/1984, 12/30/1984, 10/01/1988, 04/13/1989 (Emer), 05/15/1989, 05/01/1990, 06/20/1990 (Emer), 02/17/1991, 04/01/1992 (Emer), 07/01/1992, 12/10/1993, 12/30/1993 (Emer), 03/31/1994, 08/01/1995, 12/29/1995 (Emer), 03/21/1996, 01/04/2000 (Emer), 03/20/2000, 12/29/2000 (Emer), 03/30/2001, 12/31/2001 (Emer), 03/29/2002, 10/01/2004, 11/01/2004 (Emer), 01/16/2005, 09/01/2005, 12/30/2005 (Emer), 03/27/2006, 10/15/2006, 12/29/2006 (Emer), 03/29/2007, 12/16/2007, 12/31/2007 (Emer), 03/30/2008, 12/31/2008 (Emer), 03/31/2009, 12/30/2010 (Emer), 03/30/2011, 09/01/2011, 12/30/2011 (Emer), 03/29/2012, 04/01/2016

5160-10-21 DMEPOS: incontinence garments and related supplies.

(A) Coverage.

(1) The default certificate of medical necessity (CMN) is the ODM 02912, "Certificate of Medical Necessity: Incontinence Items" (rev. 7/2018). The CMN must include the following elements:

(a) An indication that the individual is at least thirty-six months of age;

(b) The applicable diagnosis of the specific disease, injury, developmental delay, or developmental disability causing the incontinence;

(c) The type of incontinence; and

(d) The type and quantity of incontinence garments or incontinence supplies being prescribed.

(2) Payment cannot be made for items related to stress incontinence to which no specific physiological, psychological, or physiopsychological cause can be attributed.

(3) A certification period cannot exceed twelve months.

(4) A new certification is required for an increase in the quantity of an incontinence item already prescribed or for a change in the type of incontinence item. (No new certification is needed for a decrease in quantity.)

(B) Requirements, constraints, and limitations.

(1) Incontinence items are dispensed in quantities representing one month's supply. A provider must not dispense additional incontinence items to an individual who already has at least a month's supply on hand. Before dispensing additional items, therefore, providers must make contact, either orally or in writing, with each individual (or the individual's authorized representative) to verify the current need. Providers must keep on file a summary of this contact, including in particular the following information:

(a) The quantity of items requested;

(b) The quantity of items currently on hand;

(c) The verification date, which must not be more than fourteen days before the dispensing date;

(d) The full name of the provider's representative who recorded the quantities reported; and

(e) The full name of the person (the individual or the individual's authorizedrepresentative) who reported the quantities.

(2) Payment will not be made for an incontinence item in excess of the quantity prescribed.

Replaces: 5160-10-21

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 05/01/1990, 09/01/1998, 10/01/2004, 04/25/2011

5160-10-22 DMEPOS: ventilators.

(A) Provider requirement. A provider of ventilators for use in the home must make available a licensed respiratory care professional (LRCP) twenty-four hours a day to provide respiratory care, technical support, and clinical ventilator services and to perform emergency servicing of equipment on two-hour notice.

(B) Coverage.

(1) Separate payment may be made for a ventilator furnished to a resident of a long-term care facility (LTCF).

(2) Payment may be made for a ventilator on a rental basis only. The default certificate of medical necessity (CMN) form is the ODM 01902, "Certificate of Medical Necessity: Ventilators" (rev. 7/2018).

(3) For the rental of a primary ventilator, the CMN must include the following information:

(a) Diagnosis;

(b) Specification of the condition or conditions for which ventilatory support is needed;

(c) An estimated length of need;

(d) The continuity of ventilatory support required (e.g., constant, during the day, at night, for sleep only);

(e) The ventilator type, mode, and settings or parameters;

(f) A list of other respiratory equipment in use; and

(g) If applicable, documentation showing that the individual is being weaned.

(4) For the rental of a secondary or back-up ventilator, the CMN must include appropriate attestation to at least one of the following statements:

(a) The individual cannot maintain spontaneous respiration for at least four hours;

(b) Because of regular activities outside the home (e.g., school, outpatient therapy), the individual needs a second ventilator with a suitable power source; or

(c) The average emergency medical team response time to the individual's address is estimated to be more than two hours.

(C) Requirements, constraints, and limitations.

(1) A ventilator with an invasive interface must include backup power capability and alarms indicating disconnection, high pressure, low pressure, and power loss.

(2) Rental of a ventilator includes the following items and services:

(a) Ventilator accessories, including inlet ventilator filters, permanent or reusable ventilator circuits, whisper swivels, exhalation ports, tracheostomy tube elbows, and circuit extensions and adapters;

(b) A humidifier, either heated or unheated;

(c) Humidifier bacteria filters;

(d) Tubing to connect the humidifier to the ventilator;

(e) Evaluation of the individual's residence to ensure compatibility with the equipment and to forestall problems with its use; and

(f) Visits made at an appropriate frequency determined by a LRCP in consultation with the individual's prescribing practitioner, at least one visit during the first week, not less often than once per month for the first six months, and not less often than every sixty days thereafter.

(3) No separate payment is made to a provider for keeping a LRCP on call or for performing emergency servicing of equipment.

Replaces: Part of 5160-10-22

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02 , 5165.47
Prior Effective Dates: 12/30/1991, 07/01/1993, 07/01/1994, 01/01/1995, 08/01/1998, 10/01/2004, 01/01/2008

5160-10-23 DMEPOS: pulse oximeters.

(A) Coverage.

(1) Any pulse oximeter for which payment is made must meet the following criteria:

(a) It is correctly calibrated, preset, and sealed such that its settings cannot be adjusted by the average user; and

(b) It is capable either of converting data (e.g., number of sampling hours, oxygen saturation level, aggregated results) directly to electronic or printed form or of recording and storing data for later conversion.

(2) Payment may be made for a pulse oximeter on a rental/purchase basis. The default certificate of medical necessity (CMN) form is the ODM 03401, "Certificate of Medical Necessity: Pulse Oximeters" (rev. 7/2018). The CMN must include an attestation by a prescriber that a need exists either for diagnostic monitoring or for continuous monitoring:

(a) For diagnostic monitoring undertaken in response to an acute clinical event or the exacerbation of an existing condition, the prescriber includes the following information:

(i) An attestation that at least one of the following two criteria has been met:

(a) The individual was currently being weaned or was about to be weaned from an oxygen supply; or

(b) The individual was oxygen-dependent and was in a clinically unstable condition; and

(ii) Any previously recorded oximeter data accompanied by an assessment of the resulting impact on the management of the individual's care.

(b) For continuous monitoring twenty-four hours per day, the prescriber attests to three statements:

(i) The individual exhibits clinical instability (evidenced by chronically compromised respiration and frequently varying oxygen requirements);

(ii) The individual is at risk for critical fluctuations in oxygen saturation (e.g., hyperoxia, hypoxia), and

(iii) At least one of the following conditions is present:

(a) Frequent bradycardia;

(b) Frequent oxygen desaturation;

(c) Chronic lung disease;

(d) Ventilator-dependency;

(e) Poor growth and development suggesting inadequate oxygenation; or

(f) Another specific risk factor that causes sudden, critical fluctuations in oxygen saturation.

(3) The rental or purchase of a pulse oximeter includes the following items and services:

(a) Service calls;

(b) Supplies and accessories (e.g., cable, printer, printer tape, carrying case); and

(c) Probe wraps or tape.

(4) Separate payment may be made for probes. (B) Requirements, constraints, and limitations.

(1) It is understood that because of the nature of diagnostic monitoring, authorization for payment can generally be granted only after the service has been provided.

(2) No single rental period can be longer than three months.

Replaces: 5160-10-23

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 07/01/1993, 04/16/2007

5160-10-24 DMEPOS: speech-generating devices.

(A) Coverage.

(1) Separate payment may be made for a speech-generating device (SGD) furnished to a resident of a long-term care facility (LTCF).

(2) The default certificate of medical necessity (CMN) form is the ODM 02924, "Certificate of Medical Necessity: Speech-Generating Devices" (rev. 7/2018). The CMN must include the following elements:

(a) A formal, written report of a face-to-face evaluation of the individual's communication abilities performed by a speech-language pathologist (SLP);

(b) Exact specifications for a SGD and the rationale for selection;

(c) Clinical documentation that the individual's cognitive and physical abilities will enable effective use of the specified SGD;

(d) Full disclosure of any SGD equipment currently in the individual's possession and an explanation of why that equipment does not meet the individual's needs;

(e) Documentation of the medical necessity of any accessory or add-on equipment, supplies, or SGD features being requested; and

(f) An explanation of the necessity or functional benefit of any requested upgrade, modification, or replacement.

(3) The formal, written evaluation report must include all of the following components:

(a) A description of the individual's current communication impairment, including the type, severity, and prognosis;

(b) An assessment of the individual's speech skills and capacity for receptive and expressive language;

(c) An explanation, as applicable, of how the individual's cognition, emotions, physical abilities, and behaviors affect the communication of basic needs;

(d) Identification of the persons with whom the individual communicates most frequently and any associated limitations and needs;

(e) Identification of the environments in which the individual communicates most frequently (including vocational and educational settings);

(f) A description of the types of messages the individual generally needs to convey and the range of vocabulary used;

(g) An assessment of the extent to which the individual's daily communication needs could be met by a SGD incorporating less complex technology or by a means of communication other than a SGD;

(h) A description of the functional communication goals expected to be achieved with a SGD;

(i) Recommendations for the following SGD features and functions:

(i) Representational systems (symbols);

(ii) Vocabulary encoding (e.g., icon, level-plus-location, traditional orthography);

(iii) Vocabulary expandability and message generation (e.g., programmed or programmable words or parts of sentences, additional memory);

(iv) Rate-enhancement techniques (e.g., simple symbol selection, symbol sequencing, key linking, dynamic display, abbreviation-expansion, word lists, word prediction, icon prediction, macros);

(v) Access techniques and strategies;

(vi) Keyboard organization (e.g., key size and spacing, overlay size and number, key guard);

(vii) Device output modes (e.g., speech synthesis, printed output, character display, auditory and visual prompting, auditory and visual feedback); and

(viii) Portability;

(j) A description of a comprehensive treatment plan that includes a training schedule for the selected SGD; and

(k) The signature and license number of the SLP and any other member of the evaluation team.

(4) Payment will not be made for a SGD until the individual has used the device for a period of at least four weeks, during which the prescriber determines that the device satisfactorily meets the individual's needs. If the device does not meet the individual's needs, then the provider may choose to submit a request for payment of one month's rental.

(5) The department will consider coverage of SGDs in any of several forms, including but not limited to the following examples:

(a) A standalone unit running dedicated, proprietary software;

(b) Commercially available software and, if necessary, hardware to run it (e.g., a portable or tablet computer);

(c) A software application that may be loaded onto devices already owned by an individual; or

(d) A combination of components that provides functionality for the user.

(6) Separate payment may be made for the following items and services:

(a) A face-to-face evaluation performed by a SLP;

(b) Brackets and mounting hardware; and

(c) An adaptive interface or other accessory if the evaluating SLP provides documentation that the item is necessary for the independent use of a SGD by a particular individual.

(7) Payment for the upgrade, modification, or replacement of a fully functional SGD during its useful life may be made only if the SGD no longer meets the individual's basic communication needs. (In the appendix to rule 5160-10-01 of the Administrative Code, the useful life of a SGD is expressed as a limit or frequency.)

(a) Replacement during the useful life of a SGD will be considered only when it is more cost-effective than modification.

(b) Repair does not extend the useful life of a SGD.

(B) Requirements, constraints, and limitations.

(1) Payment may be made only for the type of SGD prescribed. Substitution (e.g., provision of a tablet instead of a standalone unit running proprietary software) requires the approval of the prescriber.

(2) Payment for a SGD includes the following items and services:

(a) Supplies, equipment (e.g., interface, printer, cables, adapters, connectors), and any standard component or requested accessory that is dispensed with a SGD; and

(b) All professional, technical, and administrative services performed by the provider in relation to a SGD.

(3) No separate payment will be made for the following items:

(a) A second SGD used concurrently by an individual; and

(b) Additional software, applications, accessories, components, peripheral devices, or pieces of hardware that are not related to the main purpose of the SGD.

(C) Claim payment.

(1) The payment amount for a portable/tablet computer with software, for portable/tablet computer software, or for an accessory (e.g., mounting bracket, adaptive interface) is determined through the prior authorization (PA) process.

(2) Payment for a face-to-face evaluation is the lesser of the submitted charge or the amount listed in appendix DD to rule 5160-1-60 of the Administrative Code.

Replaces: 5160-10-24

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 09/10/1993, 12/10/1993, 12/29/1995 (Emer), 03/21/1996, 10/01/2004, 05/01/2012

5160-10-25 DMEPOS: lactation pumps.

(A) Definitions and explanations.

(1) "Multiple-user lactation pump" is a lactation pump that is safe for use by multiple individuals; it comes with a separate set of accessories (e.g., breast shields, tubing) for each individual, which reduces the risk of contamination. Such a pump is sometimes referred to as "hospital-grade," but this term is not recognized by the United States food and drug administration. A multiple-user lactation pump is characterized, but not defined, by the following capabilities:

(a) Adjustable suction pressure from one hundred to two hundred fifty millimeters of mercury (mm Hg);

(b) A mechanism to prevent suction greater than two hundred fifty mm Hg; and

(c) An adjustable pumping speed capable of reaching fifty-two cycles per minute.

(2) The prescriber of a lactation pump may be involved in the care of the individual woman, of the infant, or of both.

(B) Coverage.

(1) Payment may be made for the purchase of a single-user manual or electric lactation pump as a medical supply item or for the rental of a multiple-user lactation pump for a period of ninety days.

(2) The default certificate of medical necessity (CMN) form is the ODM 01901, "Certificate of Medical Necessity: Lactation Pumps" (rev. 7/2018). The CMN must include an attestation to at least one of the following statements of need:

(a) The infant is unable to initiate breastfeeding because of a medical condition (e.g., prematurity, oral defect);

(b) Breastfeeding is not possible because the woman and the infant are separated;

(c) The woman is or will be taking a medication or undergoing a diagnostic test that contraindicates breastfeeding;

(d) The milk supply is inadequate for breastfeeding;

(e) The breasts are engorged; or

(f) Infection of the breast is present.

(3) After the initial rental period, payment may be made for additional rental of a multiple-user lactation pump. The additional rental period is limited to ninety days; overall rental cannot exceed one hundred eighty days. During the initial rental period, the provider must obtain a revised copy of the previously completed CMN, on which the prescriber includes the following information:

(a) A description, including approximate age and ownership, of any similar equipment currently in the individual's possession;

(b) An explanation of why additional rental of the multiple-user lactation pump is warranted; and

(c) The length of the additional rental period.

(C) Requirements, constraints, and limitations.

(1) The warranty period for a covered manual or electric lactation pump is one year from the date of delivery.

(2) When a manual lactation pump is supplied as part of a pump accessory kit, separate payment will not be made for the manual lactation pump, nor will separate payment be made for an additional manual lactation pump.

(3) Separate payment will not be made for more than one set of accessories nor for cleaning of a rental unit. Replacement of a lost or damaged accessory or payment of a reasonable charge for extensive cleaning (if a unit is returned in unusable condition) is the responsibility of the individual.

Replaces: 5160-10-25

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 09/01/2005, 04/25/2011

5160-10-26 DMEPOS: nutrition products.

(A) Coverage.

(1) Enteral and parenteral nutrition.

(a) The default certificate of medical necessity (CMN) form is the ODM 01907, "Certificate of Medical Necessity: Enteral and Parenteral Nutrition" (rev. 7/2018). The CMN must include the following information:

(i) Attestation to one of the following statements:

(a) The individual is able to ingest food but cannot derive sufficient energy and nutrients from ordinary food, even if the food is prepared in a liquefied, puréed, or blended form;

(b) The individual is unable to ingest food safely but can digest it; or

(c) The individual is unable to digest food in the alimentary canal and must obtain nutrition parenterally.

(ii) For an individual who has difficulty in maintaining weight, a current weight history; and

(iii) For an individual who requires a daily intake of more than two thousand calories, an explanation of the need.

(b) A new prescription is required for a change in the type or increase in the quantity of an item.

(c) Substitutions are permitted, so long as the substituted product is correctly formulated to meet the needs of the individual and the prescriber is notified before the supplier dispenses the product.

(d) Payment will not be made for quantities that exceed one month's supply.

(e) Suppliers must not dispense supplies more than one week before the scheduled dispensing date.

(f) Payment includes dispensing and either shipping or delivery.

(2) Provision of donor human milk.

(a) Payment can be made only to a medicaid-enrolled provider that is a member in good standing of the human milk banking association of North America.

(b) The provider must keep on file the following documents:

(i) An explanation by a prescriber of the medical necessity of human milk for the recipient;

(ii) An attestation that the prescriber has given the recipient's parent or guardian information about human milk (e.g., nutrients, growth factors, shelf life, the effects of pasteurization, the possibility of disease transmission) and the donation process (e.g., donor screening, pasteurization, storage, transport), which may be in the form of educational material obtained from the provider; and

(iii) A consent form, signed and dated by the recipient's parent or guardian, indicating that the parent or guardian has been made aware of the benefits and risks of using banked donor human milk.

(c) No separate payment is made to a provider for supplying donor human milk

(d) Payment includes processing and either shipping or delivery; no payment is made for the milk itself.

(B) Constraints and limitations. Separate payment will not be made for the following items as medical supplies:

(1) Ordinary prepared food;

(2) Commercial products that serve as ordinary food (e.g., shakes, smoothies, energy bars, vitamin or mineral supplements, baby food);

(3) Food products to be eaten as part of a diet related to diabetes, obesity, gastric bypass, or bariatric surgery;

(4) Food products for which a provider receives medicaid per diem payment; and

(5) Standard infant formula (not used to treat errors of metabolism) for which payment may be made through a program other than medicaid.

Replaces: 5160-10-26

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 01/01/2006, 08/18/2008, 01/01/2010, 08/02/2011

5160-10-27 DMEPOS: continuous passive motion (CPM) devices.

(A) Coverage.

(1) Payment may be made for the rental of a continuous passive motion (CPM) device to be used in a personal residence, beginning within forty-eight hours after total knee replacement surgery or the surgical revision of a total knee replacement, for a period not to exceed twenty-one days. The prescription for the device must indicate the first date and last date of use.

(2) Separate payment may be made for the purchase of one complete set of accessories (e.g., pads, straps, hook-and-loop closures) if the individual does not already have such accessories as a result of previous use of a CPM device.

(B) Requirements, constraints, and limitations. No payment is made for a CPM device in any of the following circumstances:

(1) The device is used on a joint other than the knee;

(2) The device is used as a substitute for conventional physical therapy; or

(3) Neither the individual nor anyone assisting the individual is able to operate the device or is willing to follow the necessary post-surgery rehabilitation regimen.

Replaces: 5160-10-27

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/01/2006, 04/25/2011

5160-10-28 DMEPOS: osteogenesis stimulators.

(A) Coverage.

(1) Payment may be made for the purchase only of a noninvasive osteogenesis stimulator.

(2) The default certificate of medical necessity (CMN) form is the ODM 07134, "Certificate of Medical Necessity: Osteogenesis Stimulators" (rev. 7/2018). The CMN must include an attestation that appropriate coverage criteria are met.

(3) Payment may be made for a spinal electrical osteogenesis stimulator only if at least one of the following criteria is met:

(a) The individual has undergone multilevel spinal fusion surgery;

(b) The individual has undergone spinal fusion surgery that has failed, and at least nine months have elapsed since the most recent operation; or

(c) The individual has undergone spinal fusion surgery, and previous attempts at spinal fusion at the same site have failed.

(4) Payment may be made for a non-spinal electrical osteogenesis stimulator only if at least one of the following criteria is met:

(a) The fracture is in a long bone and has failed to unite for at least three months, which the provider substantiates with the following documentation:

(i) At least two sets of images including multiple views of the fracture site, the first and last of which were taken at least ninety days apart; and

(ii) A written statement by a qualified interpreting practitioner that there has been no clinically significant evidence of fracture healing during the period when the images were taken.

(b) The individual has congenital pseudarthrosis; or

(c) The individual has undergone joint fusion surgery that has failed, and at least nine months have elapsed since the most recent operation.

(5) Payment may be made for an ultrasonic osteogenesis stimulator only if all of the following criteria are met:

(a) The fracture is in a long bone;

(b) The fracture is not tumor-related; and

(c) The fracture has failed to unite for at least three months, which the provider substantiates with the following documentation:

(i) At least two sets of images including multiple views of the fracture site, the first and last of which were taken at least ninety days apart; and

(ii) A written statement by a qualified interpreting practitioner that there has been no clinically significant evidence of fracture healing during the period when the images were taken.

(6) Payment may be made for either an electrical or an ultrasonic osteogenesis stimulator for an individual who is younger than twenty-one years of age only if all of the following additional criteria are also met:

(a) There is radiological documentation that skeletal maturity has been attained;

(b) The fracture gap is not greater than one half of the diameter of the bone to be treated; and

(c) The fracture does not involve a vertebra.

(B) Requirements, constraints, and limitations.

(1) Contraindications to treatment include but are not limited to the following examples:

(a) Fracture of a short bone, a flat bone, or an epiphysis;

(b) Fracture that results from cancer;

(c) Fracture that needs additional reduction or is comminuted;

(d) Fracture with post-reduction displacement of greater than fifty per cent;

(e) Fracture with internal or external fixation;

(f) Fracture gap greater than one centimeter or greater than one half of the diameter of the bone;

(g) Avascularity, vascular insufficiency, or other vascular problems (e.g., thrombophlebitis);

(h) Severe osteoporosis;

(i) The taking of medication that may interfere with or alter bone metabolism and healing;

(j) Infection or necrosis in the bone;

(k) Paget's disease, renal disease, or diabetes;

(l) Sensory paralysis; or

(m) Synovial pseudarthrosis.

(2) Payment will not knowingly be made for an electrical osteogenesis stimulator used in proximity to vital equipment, such as a pacemaker, that may be adversely affected by changes in electromagnetic fields.

(3) Separate payment will not be made for the concurrent use of more than one osteogenesis stimulator on the same fracture site.

Replaces: 5160-10-28

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 10/15/2006

5160-10-29 DMEPOS: insulin pumps.

(A) Definitions.

(1) "Sensor-augmented insulin pump system" is an insulin infusion pump equipped with a continuous glucose monitoring (CGM) sensor. The pump uses the glucose readings taken by the CGM sensor to modify the amount of insulin infused.

(2) "Insulin pump," for purposes of this rule, is a collective term encompassing a portable external insulin infusion pump and a sensor-augmented insulin pump system.

(B) Coverage.

(1) Payment may be made for a portable external insulin infusion pump on a rental/purchase basis. The initial rental period is limited to three months.

(2) The default certificate of medical necessity (CMN) form is the ODM 07136, "Certificate of Medical Necessity: Insulin Pumps" (rev. 7/2018). The CMN must include an attestation that appropriate documentation is kept in the individual's medical record to demonstrate that the following criteria are met:

(a) The individual has type 1 diabetes mellitus;

(b) The individual has at least one of the following symptoms or conditions:

(i) Glycated hemoglobin level (HbA1c) greater than seven per cent;

(ii) A history of recurring hypoglycemia;

(iii) Wide fluctuations in blood glucose before mealtime;

(iv) A marked early-morning increase in fasting blood sugar (the "dawn phenomenon"), in which the glucose level frequently exceeds two hundred milligrams per deciliter; or

(v) A history of severe glycemic excursions;

(c) The individual has completed a diabetes education program within the preceding twenty-four months;

(d) The individual has been on a maintenance program for at least six months involving at least three injections of insulin per day and frequent self-adjustments of insulin dosage;

(e) The individual has performed glucose self-testing at least four times per day on average during the preceding month; and

(f) The individual is at high risk for preventable complications of diabetes, early signs of which include micro-albuminuria and persistent difficulty in controlling blood sugar levels despite good compliance with an intensive multiple-injection regimen.

(3) After the first three months, payment may be made for the purchase of an insulin pump. During the initial rental period, the provider must obtain a revised copy of the previously completed CMN, on which the prescriber attests that the individual (or someone assisting the individual) is capable of managing the pump and that the desired improvement in metabolic control can be achieved.

(C) Requirements, constraints, and limitations.

(1) The use of an insulin pump is contraindicated by any of the following conditions or circumstances:

(a) The individual has type 2 (non-insulin-dependent) diabetes mellitus, either treated or not treated with insulin;

(b) The individual has end-stage complications such as renal failure; or

(c) Neither the individual nor anyone assisting the individual is able to operate a pump or to perform frequent blood glucose monitoring.

(2) The following insulin-delivery devices are not covered:

(a) A portable external insulin infusion pump that is requested purely as a matter of convenience or individual preference;

(b) Surgically implanted infusion devices or systems;

(c) Jet pressure devices;

(d) Devices associated with chronic intermittent intravenous insulin therapy (CIIIT), or

(e) Devices associated with pulsatile intravenous insulin therapy (PIVIT).

(3) The warranty period for a covered insulin pump is at least one year from the date of purchase authorization.

(4) No payment may be made for the purchase of an insulin pump that has been previously used by another individual.

Replaces: 5160-10-29

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 10/15/2006, 08/18/2008

5160-10-30 DMEPOS: ambulation aids.

(A) Definitions.

(1) "Ambulation aid" is a collective term for a cane, crutch, or walker.

(2) "Ambulatory limitation" is an impediment to walking that has either of two effects:

(a) It prevents an individual from completing activities of daily living within a reasonable time (or at all); or

(b) It places an individual at a demonstrably higher risk of injury, exacerbation of illness, or death when activities of daily living are performed.

(B) Coverage.

(1) Payment may be made for a covered ambulation aid if all of the following criteria are met:

(a) The individual has an ambulatory limitation that is documented in the individual's medical record;

(b) The ambulation aid has been prescribed by a qualified practitioner;

(c) The individual is able to use the ambulation aid safely; and

(d) The ambulation aid reduces the ambulatory limitation enough to permit the individual to complete activities of daily living in a reasonable amount of time and with a reasonable degree of safety.

(2) Additional coverage criteria are specific to particular ambulation aids:

(a) For a heavy-duty walker, the individual weighs at least three hundred pounds.

(b) For a heavy-duty walker with multiple braking system and variable wheel resistance (a four-wheeled walker having at least two wheels with hand-operated brakes that can be independently adjusted and lock the wheels when either or both hand levers are released), the individual both weighs at least three hundred pounds and is unable to use a standard heavy-duty walker because the use of one hand is restricted.

(c) For an enclosed-frame walker, the prescriber describes and attests in writing to the medical necessity, and the provider keeps a copy of this document in the individual's file.

(d) For a trunk-support walker, the prescriber describes and attests in writing to the medical necessity, and the provider keeps a copy of this document in the individual's file.

(e) For walker leg extensions, the individual stands at least six feet tall.

Replaces: 5160-10-30

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 08/17/2009

5160-10-31 DMEPOS: footwear and foot orthoses.

(A) Orthopedic shoes.

(1) Payment may be made for an orthopedic shoe only if at least one of the following conditions is met:

(a) The shoe is an integral part of an orthotic device (brace);

(b) The shoe has been molded specifically for the recipient;

(c) The shoe is one of a mismated pair;

(d) The shoe is used to treat talipes equino varus (club foot);

(e) For a recipient younger than eight years of age, the shoe is used independently of an orthotic device for one of the following purposes:

(i) Treatment of metatarsus adductus, femoral torsion, tibial torsion, vertical talus, fracture of a major bone, or osteochondrosis; or

(ii) Post-surgical control;

(f) For a recipient eight years of age or older, the shoe is used for treatment of moderate or severe peripheral neuropathy or peripheral arterial disease; or

(g) A modification or addition to the shoe is medically necessary and has been prescribed by a physician, an advanced practice registered nurse, or a physician assistant.

(2) Greater frequency of shoe replacement may be allowed for recipients younger than eight years of age. Payment for shoe replacement beyond an established frequency for recipients younger than twenty-one years of age requires prior authorization (PA).

(3) No payment is made for an orthopedic shoe that is to be worn over a prosthesis.

(4) Payment for a foot orthosis includes the acquisition (by casting or other means) of the model on which the orthosis is constructed.

(B) Specialized non-orthopedic shoes. Payment may be made for a specially constructed non-orthopedic shoe for a recipient younger than twenty-one years of age only if both of the following conditions are met:

(1) The shoe is to be worn over an orthotic device; and

(2) Commercially available shoes that fit over the orthotic device would be unacceptably long or otherwise ill-suited to ambulation.

(C) Therapeutic footwear for individuals with diabetes.

(1) The default certificate of medical necessity (CMN) form is the ODM 01912, "Certificate of Medical Necessity: Therapeutic Footwear for Individuals with Diabetes" (rev. 7/2018). The CMN must include an attestation that all of the following statements are true:

(a) The recipient has diabetes mellitus;

(b) The conditions of coverage are met;

(c) The prescriber is treating the recipient for diabetes under a comprehensive plan of care;

(d) Therapeutic footwear is medically necessary for the recipient because of diabetes; and

(e) All relevant information is documented in the recipient's medical record.

(2) Therapeutic footwear must be prescribed by a podiatrist or other qualified practitioner who manages the recipient's diabetes.

(3) Therapeutic footwear must be fitted and dispensed by a podiatrist, pedorthist, orthotist, or prosthetist.

(4) Payment may be made for therapeutic footwear (shoes, inserts, or shoe modifications) only if the recipient has diabetes mellitus and at least one of the following conditions is met:

(a) Either an entire foot or part of either foot has been amputated; or

(b) In either foot, the recipient has a history of ulceration, pre-ulcerative calluses, peripheral neuropathy with evidence of callus formation, foot deformity, or poor circulation.

(5) Payment may be made for a custom-molded shoe only if the recipient has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity must be well documented in the provider's records. If there is insufficient evidence of need for a custom-molded shoe, then payment will be limited to the cost of the least expensive medically appropriate alternative.

(6) No payment is made for the following items:

(a) Inserts that are compression-molded to the foot over time by the heat and pressure of being worn inside a shoe;

(b) Inserts used in noncovered shoes; and

(c) Deluxe features.

(7) Payment for a therapeutic shoe includes fitting, necessary inserts, and any required modification. Separate payment may be made for inserts if the provider confirms in writing that the recipient has appropriate footwear meeting the industry definition of a depth or custom-molded shoe, into which the insert can be placed.

Replaces: 5160-10-12, 5160-10-31

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/07/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 10/01/1988, 02/17/1991, 12/30/1993 (Emer), 03/31/1994, 10/15/2006, 01/01/2007, 08/02/2011

5160-10-32 DMEPOS: ostomy supplies and urological supplies.

(A) Stoma maintenance supplies.

(1) Stoma maintenance supplies may be dispensed on a monthly basis.

(2) If more than one type of supply serve the same function, then payment may be made only for the dispensing of one type at a time (e.g., skin barrier applied as a liquid, in a spray, or with a wipe or swab; drainage management with a stoma cap, a stoma plug, or gauze pads).

(B) Urination aids.

(1) Indwelling catheters.

(a) Frequency limits imposed on catheter replacement may be exceeded without prior authorization (PA) for any of the following reasons:

(i) Accidental removal of a catheter;

(ii) Malfunction of a catheter;

(iii) Obstruction of a catheter by encrustation, mucus plug, or blood clot; or

(iv) A history of recurrent obstruction or infection, as a precaution against which the prescriber has specified more frequent changing of the catheter.

(b) Additi following items:onal documentation of medical necessity is needed for either of the

(i) A specialty indwelling catheter or all-silicone catheter used in lieu of a standard coated Foley catheter; or

(ii) A three-way indwelling catheter used either alone or with other components.

(c) Payment will not be made for more than one insertion tray per episode of indwelling catheter insertion.

(2) Supplies for intermittent irrigation of indwelling catheters.

(a) Payment may be made for either an irrigation tray or an irrigation syringe used on an as-needed basis to clear an obstruction from an indwelling catheter by irrigation.

(b) Payment may be made for sterile water or saline solution for irrigation. No additional payment is made if the irrigation solution contains acetic acid or hydrogen peroxide. No payment is made for an irrigation solution containing antibiotics or chemotherapeutic agents.

(c) No payment is made for supplies used for the irrigation of an indwelling catheter at predetermined intervals (routine irrigation).

(3) Supplies for continuous irrigation of indwelling catheters.

(a) Payment may be made for an irrigation tubing set, as well as for a three-way Foley catheter, if there is a history of catheter obstruction and catheter patency cannot be maintained by intermittent irrigation and necessary changing of the catheter. Payment will not be made for more than one irrigation tubing set per day.

(b) Payment may be made for sterile water or saline solution for irrigation. No additional payment is made if the irrigation solution contains acetic acid or hydrogen peroxide. No payment is made for an irrigation solution containing antibiotics or chemotherapeutic agents.

(c) No payment is made for supplies if continuous irrigation is used as a preventive measure.

(d) Additional documentation is needed to establish the medical necessity of continuous irrigation used instead of intermittent irrigation. This documentation must indicate the rate of administration and the duration of need.

(e) Additional documentation is needed to establish the medical necessity of continuous irrigation lasting more than two weeks.

(4) Intermittent catheters and related supplies.

(a) Payment may be made for a sterile intermittent catheter and related supplies (or a catheter kit) only if at least one of the following additional criteria is met:

(i) The individual is immunosuppressed;

(ii) The individual has neurogenic bladder dysfunction because of a spinal cord injury or defect and is currently pregnant;

(iii) The individual currently performs intermittent catheterization but has documented vesicoureteral reflux; or

(iv) The individual currently performs sterile intermittent catheterization and had at least two distinct urinary tract infections in the year before starting sterile intermittent catheterization.

(b) Payment will not be made for more than one kit containing an intermittent catheter with insertion supplies per episode of intermittent catheterization.

(c) Additional documentation is needed to establish the medical necessity of a coudé catheter used instead of a straight catheter. The use of a coudé catheter by a female is rarely necessary.

(5) External urinary collection devices.

(a) Payent may be made for a medically necessary external urinary collection device (e.g., a condom-style catheter for a male, a meatal cup or a pouch for a female) as an alternative to an indwelling catheter for an individual who has permanent urinary incontinence.

(b) Payment will not be made for the concurrent dispensing of both an external urinary collection device and an indwelling catheter.

(c) Additional documentation is needed to establish the medical necessity of a specialty external urinary collection device (e.g., an inflatable condom-style catheter, a pouch with a faceplate).

(d) Payment will not be made for more than one meatal cup per week or one pouch per day.

(6) Urinary drainage systems.

(a) Payment may be made for the routine changing of a urinary drainage system.

(b) Payment will not be made for the concurrent dispensing of a vinyl and a latex bag.

(c) Payment will not be made for leg bags for individuals who do not leave their bed.

(d) Payment will not be made for more than one type of leg bag or leg bag strap within a twelve-month period.

(7) Miscellaneous supplies.

(a) Payment may be made for cleaner for a urinary collection device or drainage system only if the individual is using the collection device or drainage system.

(b) Payment may be made for a medically necessary adhesive anchoring device used to secure an indwelling urethral catheter, a suprapubic catheter, or a nephrostomy tube.

(c) Payment may be made for a medically necessary leg strap used to secure an indwelling urethral catheter.

Replaces: 5160-10-32

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 08/17/2009, 08/02/2011

5160-10-33 DMEPOS: commodes.

(A) Payment may be made for a commode if both of the following criteria are met:

(1) A medical condition, documented in the individual's medical record, prevents the individual from accessing the toilet facilities of the individual's place of residence; and

(2) The commode has been prescribed by a qualified practitioner.

(B) Additional coverage criteria are specific to particular commodes, and the satisfaction of these criteria must be ocumented in the individual's medical record:

(1) For an extra-wide or heavy-duty commode, either the individual weighs at least three hundred pounds or, if the individual weighs less than three hundred pounds, the medical necessity of the commode is established in detail.

(2) For a commode with detachable arms, the individual has a documented functional need (such as extra open space for transferring to and from the commode).

(C) Payment will not be made for the concurrent dispensing of both a commode and a bedpan.

Replaces: 5160-10-33

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 08/17/2009

5160-10-34 DMEPOS: wound dressings and related supplies.

(A) Coverage.

(1) Payment may be made for wound dressings and related supplies as long as medical necessity exists.

(2) Payment may be made for dressings placed over a percutaneous catheter or tube as long as the catheter or tube remains in place and after removal until the insertion point heals.

(3) Clinical indications, contraindications, and application guidelines for certain types of wound dressing are summarized in the appendix to this rule.

(B) Documentation.

(1) A prescription for a wound dressing or related supply must necessarily be based on an evaluation of the wound performed by a qualified health care provider. Frequent evaluation is expected if a wound is heavily draining or infected. The evaluation report must include wound type; wound location; wound length, width, and depth; the amount of drainage; and any other relevant clinical information. Any such report must be made available to the department on request.

(2) The provider must keep the prescription for dressings or related supplies on file. The prescription must include the following clinical information, which must not be more than one year old:

(a) The type and number of wounds;

(b) The type, size, and quantity of each dressing;

(c) The purpose of each dressing (e.g., primary or secondary covering for a surgical or debrided wound, wound cleansing);

(d) The quantity to be applied at one time (if more than one unit);

(e) The frequency of dressing change; and

(f) The expected duration of need.

(3) A prescription is valid for not longer than three months. A new prescription is required for the addition of a dressing or for an increase in the quantity of a dressing already prescribed. (No new prescription is needed for a decrease in quantity.)

(C) Requirements, constraints, and limitations.

(1) Providers should not dispense dressings that will be used together but have conflicting characteristics (e.g., a hydrating dressing with an absorptive dressing, a primary dressing that must be changed daily with a secondary dressing that needs to be changed less frequently).

(2) The use of more than one type of wound filler or more than one type of wound cover on a single wound is rarely medically necessary. (An additional, dry wound cover is not incompatible, however, with an alginate or other fiber-gelling dressing or saline-, water-, or hydrogel-impregnated gauze.)

(3) Providers must gauge the quantity of dressings actually being used by an individual and adjust the dispensing of dressings accordingly. Not more than one month's supply of dressings may be dispensed at one time.

(4) No payment is made for gauze impregnated with water or normal saline, because there is no medical necessity for it. Standard gauze may instead be moistened with bulk saline or sterile water.

Replaces: 5160-10-34

Click to view Appendix

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 01/07/2010

5160-10-35 DMEPOS: cranial remolding devices.

(A) Any cranial remolding device for which payment is requested must meet the standards established by the United States food and drug administration for a class II medical device.

(B) Payment may be made for the purchase of a cranial remolding device to treat any of the following conditions if the associated criteria are met.

(1) Positional (non-synostotic) plagiocephaly:

(a) The individual is at least three months old but not older than eighteen months;

(b) Any of the following asymmetries is present:

(i) A right/left discrepancy in the skull base of at least six millimeters, measured subnasally to the tragus;

(ii) A right/left discrepancy in the cranial vault of at least ten millimeters, measured from the frontozygomaticus point to the euryon; or

(iii) A right/left discrepancy in the orbitotragial distances of at least four millimeters; and

(c) The asymmetry has not substantially improved after two months of conservative cranial repositioning therapy or physical therapy.

(2) Positional (non-synostotic) braciocephaly: The cephalic index (the ratio of the maximum width of the head to its maximum length) is greater than ninety-one per cent.

(3) Positional (non-synostotic) scaphocephaly: The cephalic index is less than seventy-five per cent.

(4) Synostotic deformity:

(a) The individual is not older than eighteen months;

(b) Premature closing of the cranial structures has been documented; and

(c) Surgery with post-operative remolding is medically indicated.

Replaces: 5160-10-35

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 09/01/2011