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

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Scope.

(1) This rule sets forth general coverage and payment policies for durable medical equipment (DME), prostheses, orthotic devices, medical supplies, and supplier services dispensed or rendered by an enrolled DMEPOS provider.

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

(3) Policies set forth in other rules in this chapter supersede any provisions in this rule with which they conflict.

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

(1) "Base invoice charge" is the amount charged for an item to a DMEPOS provider by a distributor or manufacturer before the application of any discounts, rebates, or adjustments.

(2) "Certificate of medical necessity (CMN)" is a written statement by a prescribing practitioner that presents clinical information about an item and about the person for whom it was prescribed. This information, which often is not included in the prescription itself, aids in the determination of whether the particular item is the most medically appropriate for an individual (or even medically necessary).

(a) For many DMEPOS items, a specific CMN form is identified in the relevant rule in this chapter of the Administrative Code. Each identified CMN form bears the designation 'ODM' with a five-digit numeral. If no CMN form is identified, form ODM 01913, "Certificate of Medical Necessity / Request for Need Verification: General Medical Supplies and Equipment" (rev. 1/2024), may be used.

(b) 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).

(c) An illegible CMN will not be accepted.

(3) "Coverage" is the principle that medicaid payment is routinely made for a particular medically necessary item or service. The department maintains several payment schedules of covered items and services, which are posted for reference on the department's web site. These schedules are neither all-inclusive nor exclusive. Neither the appearance of an item or service on a payment schedule nor its absence determines, in and of itself, coverage or non-coverage.

(4) "Date of service" is the date on which a DMEPOS service is furnished or a DMEPOS item is dispensed directly to an individual.

(a) For an item that is shipped directly to a medicaid-eligible individual, the date of service is either the shipping date or the delivery date. When the individual is to be discharged from a hospital or long-term care facility, the date of service is the date of discharge.

(b) For an item that needs multiple fittings and special construction, the date of service is the date of the first fitting.

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

(6) "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 a medicaid-eligible individual.

(7) "DMEPOS provider" is a collective term for the following eligible providers:

(a) A basic DME supplier, which furnishes items other than life-sustaining or technologically sophisticated equipment in accordance with Chapter 4752. of the Revised Code;

(b) A specialized DME supplier, which furnishes life-sustaining or technologically sophisticated equipment in accordance with Chapter 4752. of the Revised Code; and

(c) An orthotics and prosthetics (O&P) supplier, which furnishes orthotic and prosthetic devices in accordance with section 4779.02 of the Revised Code.

(8) "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.

(9) "Frequency limit" is the average expected useful life of a DMEPOS item. A frequency limit is not an absolute restriction but a general guideline and therefore may be exceeded with medical justification. For certain DMEPOS items that can be dispensed in multiple units (such as fasteners or items with left/right orientation), a frequency limit applies to each unit that is requested.

(10) "Long-term care facility (LTCF)" is a collective term for a nursing facility (NF), a skilled nursing facility (SNF), and an intermediate care facility for individuals with intellectual disabilities (ICFIID).

(11) "Medical supplies."

(a) For purposes of this chapter of the Administrative Code, this term applies to healthcare-related items delineated by the following criteria:

(i) They have a short useful life. They are expendable, disposable, or non-durable. They are intended either for a single use or for limited repeated use by one individual.

(ii) They are adjunctive in nature. They aid in the treatment or management of an illness, injury, or condition.

(iii) Their therapeutic effect is achieved through application to the body and not through ingestion.

(b) Medical supplies include but are not limited to the following non-exhaustive list of examples:

(i) Incontinence garments;

(ii) Syringes;

(iii) Wound dressings, including gauze;

(iv) Catheters and other urological items;

(v) Ostomy care items; and

(vi) Feeding bags.

(c) The following items are not medical supplies:

(i) Enteral nutrition products; and

(ii) Parenteral nutrition products.

(d) The use of the term 'supply' meaning "quantity" (as in 'the supply of wheelchairs on hand' or 'a three-month supply') does not make the items in question medical supplies.

(e) This definition is useful only in the consideration of items for which no standard medicaid maximum payment amount has been established.

(12) "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 already 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 DME might be more cost-effective than continued repair.

(13) "Prior authorization (PA)" has the same meaning as in rule 5160-1-31 of the Administrative Code.

(14) "Private residence" is a medicaid-eligible individual's place of residence other than a long-term care facility (LTCF).

(15) "Provider cost" is the amount paid for an item by a DMEPOS provider to a distributor or manufacturer after the application of any discounts, rebates, and adjustments that are available to the provider at the time of claim submission. Documentation of provider cost is subject to approval by the department; a figure that has been entered, superimposed, modified, obscured, or obliterated by the provider will not be accepted. Suitable documents for substantiating provider cost include but are not limited to the following examples:

(a) An invoice submitted by the distributor or manufacturer to the provider;

(b) A bona fide quotation (quote) submitted by the distributor or manufacturer to the provider; or

(c) A standard distributor or manufacturer price list that can be independently verified by the department.

(16) "Starting date for dispensing" is the first date on which a DMEPOS item is anticipated to be dispensed on an ongoing basis. The date of signature does not determine the starting date for dispensing.

(C) Coverage.

(1) In general, in accordance with Chapter 5160-3 of the Administrative Code, a LTCF is responsible for ensuring that a resident of the LTCF gets medically necessary DME items and medical supplies, either by providing such items and supplies itself or by paying a DMEPOS provider to dispense them. In turn, the LTCF receives medicaid per diem payment on the basis of its cost report. Therefore, claims submitted to ODM or its designee by a DMEPOS provider 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) A medically necessary DMEPOS item can be dispensed only by prescription. The following provisions apply:

(a) Eligible medicaid providers of the following types having prescriptive authority under Ohio law may prescribe a DMEPOS item:

(i) A physician;

(ii) A podiatrist;

(iii) An advanced practice registered nurse with a relevant specialty; or

(iv) A physician assistant.

(b) Before writing a prescription for certain DMEPOS items, a practitioner conducts a face-to-face encounter with the medicaid-eligible individual and documents it in the individual's medical record. Items for which an encounter is a prerequisite are listed on the web site of the centers for medicare and medicaid services (CMS) at http://www.cms.gov.

(c) A single encounter can serve for twelve months as the basis for a single prescription or for more than one prescription addressing the same medical condition for which a DMEPOS item is being prescribed.

(d) The prescribing practitioner needs to be actively involved in managing the medicaid-eligible individual's healthcare. The department may disallow a prescription written by a practitioner who has no professional relationship with the individual.

(e) There needs to be a direct relationship between the prescribed DMEPOS item and a medical condition of the medicaid-eligible individual that the practitioner evaluates, assesses, or actively treats during the encounter.

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

(g) Unless a law, regulation, rule, or the prescription itself states otherwise, a prescription is assumed to be valid for one year.

(4) DMEPOS items and services for which payment is subject to PA are so indicated in the applicable DMEPOS payment schedule.

(a) The following DMEPOS items are always subject to PA:

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

(ii) 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.

(5) If a medicaid-eligible individual 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 individual 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.

(6) Any request for a DMEPOS item or service needs to originate with an individual medicaid-eligible individual, the individual's authorized representative, or a medical practitioner acting as the prescriber with the individual's full knowledge and consent. A request that is determined by the department to have resulted from a mass screening or examination will be denied.

(7) When instruction in the safe and appropriate use of a particular DMEPOS item is indicated, it is the responsibility of the provider to ensure that the medicaid-eligible individual or someone authorized to assist the individual has received such instruction.

(8) 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.

(a) The medical necessity of an item purchased by the department is established during the purchasing process.

(b) 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.

(c) No additional documentation of medical necessity is needed for subsequent repairs made to an item.

(d) The determination that an item not purchased by the department is medically necessary does not indicate that the item would be authorized for purchase.

(9) The initial payment 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 is subject to PA. Whether payment for subsequent items or services is subject to PA depends on the item or service.

(10) Proof is needed to show that a DMEPOS item has been delivered to the intended medicaid-eligible individual.

(a) Providers, their employees, and anyone else having a financial interest in the delivery of DMEPOS items are not permitted to accept delivery of an item on behalf of an individual.

(b) If a provider delivers directly to a medicaid-eligible individual, then acceptable proof of delivery includes the signature of the individual or the individual'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 records the name of the person accepting delivery and the relationship of the person to the medicaid-eligible individual. 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 needed.

(11) If more than one DMEPOS item or service will meet a medicaid-eligible individual's needs, then the maximum payment amount cannot exceed the least costly alternative, in accordance with rule 5160-1-01 of the Administrative Code.

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

(a) Items presumed to be non-medical 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 are intended solely for the comfort or convenience of the user and have no medical benefit;

(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 healthcare practitioner (i.e., that are incidental to a professional service) in an appropriate healthcare setting or in the medicaid-eligible individual'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;

(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 DME during a rental period;

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

(j) Related supplies and accessories that are dispensed either during a rental period or with the dispensing or delivery of a purchased DME 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 medicaid-eligible individual's condition;

(m) Instruction of the medicaid-eligible individual or the individual'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.

(13) The use of an item in conjunction with a piece of DME does not in itself make the item an accessory. A smart phone, for example, is not an accessory.

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

(15) Certain DMEPOS items may be dispensed on a recurring basis. A provider is to confirm a medicaid-eligible individual'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.

(16) Most covered DME items are purchased and become the property of the medicaid-eligible individual. Some covered DME items that need 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 is subject to 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 does 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, the cumulative rental amounts paid for a particular "rental/purchase" DME item apply toward purchase.

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

(17) Medical supply items such as gauze pads and 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 cannot exceed one hundred forty-seven per cent of the provider cost for the quantity of the item.

(18) 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.

(19) A provider may furnish a DMEPOS item or service before obtaining a completed CMN but cannot submit a claim until the item or service has been furnished.

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

(21) Only the department can determine coverage. Providers cannot decide on their own that an item or service is not covered or would not be covered with PA. Providers should submit a PA request to obtain an official decision.

(D) Documentation.

(1) When a request is made for PA, the following accompanying documentation is needed:

(a) A completed CMN:

(i) For a DMEPOS item that is dispensed once (such as a wheelchair), the provider submits one completed CMN; or

(ii) For a DMEPOS item that will be needed indefinitely, for a lifetime, or on a recurring or ongoing basis, the provider takes the following steps:

(a) The provider obtains and submits an initial completed CMN;

(b) Each year thereafter the provider obtains and submits an updated prescription no sooner than ninety days before the expiration of the current prescription; and

(c) If the updated prescription indicates a change in the need for a DMEPOS item, the provider obtains a new completed CMN;

(b) Related information, such as a full description of any similar item currently in possession of the medicaid-eligible individual or an explanation of a change in the individual's condition that warrants a change in equipment;

(c) For a preparatory prosthesis, the reason for the amputation, the date of the amputation, and an explanation of the benefit to be derived from having the medicaid-eligible individual use a preparatory prosthesis before a definitive prosthesis is designed;

(d) 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

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

(2) A claim for an item or service that exceeds the specified maximum quantity or frequency but is not otherwise subject to PA is subject to need verification. Documentation of need may be made either on the CMN associated with the item or service or on form ODM 01913.

(3) For each claim, whether or not it is subject to PA or need verification, the provider cannot legitimately receive payment until necessary supporting documents have been obtained and placed in the provider's files. These documents include the prescription and any applicable items from the following non-exhaustive list of examples:

(a) A completed CMN;

(b) Practitioner orders or chart notes;

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

(d) Proof of delivery;

(e) Confirmation that the medicaid-eligible individual or the individual's authorized representative has been instructed in the safe use of the DMEPOS item;

(f) A copy of the manufacturer's or dealer's warranty; and

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

(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 or newly adopted healthcare common procedure coding system (HCPCS) procedure code, the initial maximum payment amount may be established in accordance with rule 5160-1-60 of the Administrative Code. New or newly adopted HCPCS codes are published in a separate table on the department's web site and remain there until the appropriate DMEPOS payment schedules can be updated.

(3) For any covered DMEPOS item or service not represented by a new or newly adopted HCPCS procedure code, the payment amount is the lesser of the submitted charge (which is to 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) The amount listed in the appendix to this rule;

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

(c) For an item for which payment is determined by PA, the relevant amount specified in the following list:

(i) A supply item, one hundred forty-seven per cent of the provider cost;

(ii) A wheelchair, wheelchair item, standing frame, gait trainer, or other DMEPOS item that incorporates complex rehabilitation technology, one hundred twenty per cent of the base invoice charge;

(iii) An enteral nutrition product, one hundred eighty-five per cent of the provider cost; or

(iv) Any other non-supply DMEPOS item or service, an amount determined on a case-by-case basis;

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

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

(f) For a professional service for which separate payment is made (such as an evaluation), the applicable amount listed in appendix DD to rule 5160-1-60 of the Administrative Code.

(4) In accordance with the principle stated in rule 5160-1-60 of the Administrative Code concerning correct coding, a "not otherwise specified," "miscellaneous," or "unlisted" procedure code of the appropriate DMEPOS type may be reported on a claim only if no other code listed on a payment schedule adequately represents the item or service. The department may deny a claim that omits necessary information or that includes a "not otherwise specified," "miscellaneous," or "unlisted" procedure code when an appropriate procedure-specific code is available.

View Appendix

Last updated January 2, 2024 at 8:56 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02, 5165.47
Five Year Review Date: 1/1/2029
Prior Effective Dates: 4/7/1977, 12/21/1977, 12/30/1977, 1/1/1980, 2/1/1980, 3/1/1984, 12/30/1984, 7/1/1987, 10/1/1987, 2/17/1991, 7/1/1992, 4/1/1993, 2/1/1995, 8/1/1995, 12/29/1995 (Emer.), 8/1/1998, 12/31/1998 (Emer.), 3/20/2000, 12/31/2001 (Emer.), 11/1/2004 (Emer.), 12/30/2004 (Emer.), 3/28/2005, 9/1/2005, 3/29/2007, 7/30/2007, 12/31/2007 (Emer.), 12/31/2008 (Emer.), 7/31/2009 (Emer.), 3/31/2010, 3/30/2011, 9/1/2011, 12/30/2011 (Emer.), 3/29/2012, 12/31/2013, 1/1/2019, 7/1/2021

Rule 5160-10-02 | DMEPOS: repair.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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 necessary 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) The default form on which to submit a request for need verification (RNV) is the ODM 01904, "Request for Need Verification: Repair of Durable Medical Equipment (Other Than Wheelchairs), Prostheses, or Orthotic Devices" (rev. 7/2018). An RNV includes 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;

(b) Repair of an item if within the preceding twelve months medicaid payment has been made for the repair of a duplicate or conflicting item currently in the individual's possession; or

(c) Repair of an item that is no longer deemed to be medically necessary.

Last updated January 2, 2024 at 8:56 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 4/7/1977, 12/21/1977, 5/15/1989, 1/1/1995, 9/1/2002, 4/9/2009, 10/29/2009

Rule 5160-10-06 | DMEPOS: wearable cardioverter-defibrillators.

• Effective: September 1, 2021
• Promulgated Under: 119.03

(A) Prescribing provider. Only a physician experienced in the management of patients at risk for sudden cardiac death (SCD), such as a cardiologist, electrophysiologist, or cardiac surgeon, may prescribe a wearable cardioverter-defibrillator (WCD).

(B) Coverage.

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

(2) Payment may be made for a WCD on a rental basis only.

(3) The default certificate of medical necessity (CMN) is form ODM 10275, "Certificate of Medical Necessity: Wearable Cardioverter-Defibrillators" (9/2021).

(4) A completed CMN confirms that the following criteria are met:

(a) The individual is at high risk of SCD, established by the occurrence or presence of medically indicated factors including but not limited to the following examples:

(i) A documented episode of ventricular fibrillation or sustained ventricular tachyarrhythmia lasting at least thirty seconds, either spontaneous or induced during an electrophysiologic (EP) study but not attributable to a transient or reversible cause and not occurring within the first forty-eight hours after an acute myocardial infarction;

(ii) Familial or hereditary conditions with a high risk of life-threatening ventricular tachyarrhythmia, such as long QT syndrome or hypertrophic cardiomyopathy; or

(iii) Recent myocardial infarction, dilated cardiomyopathy, newly diagnosed non-ischemic cardiomyopathy, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI), with a left ventricular ejection fraction (measured during either the acute or post-acute phase) of not greater than thirty-five per cent; and

(b) Treatment of the individual with an implantable cardioverter-defibrillator (ICD) is precluded by any of the following considerations:

(i) A currently implanted ICD needs to be explanted;

(ii) An infection prevents initial implantation of an ICD; or

(iii) Some condition or circumstance, either temporary or permanent, contraindicates ICD implantation surgery.

(c) The individual is able to wear a properly fitted WCD at least ninety per cent of the time (an average total of at least twenty-one and a half hours per day).

(5) A WCD is generally covered for a period of ninety days at a time. Additional ninety-day coverage periods may be authorized if the provider submits documentation, such as a detailed statement signed by the treating physician that the WCD continues to be medically necessity and the individual continues to use it correctly. Authorization may be given for indefinite (lifetime) coverage if the provider submits appropriate documentation, such as a detailed statement signed by the treating physician and a description of the circumstances that preclude future implantation of an ICD.

(6) Rental payment includes necessary replacement of batteries, electrodes, and the cover garment.

Last updated September 1, 2021 at 8:28 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 9/1/2026

Rule 5160-10-07 | DMEPOS: bathing seats.

• Effective: September 1, 2021
• Promulgated Under: 119.03

(A) Definitions and explanations.

(1) "Assistance," for purposes of this rule, is help with bathing-related tasks that individuals cannot accomplish by themselves, such as getting into and out of a bathing chair, moving in and out of the bathing area, or fastening and unfastening securements and positioners. The term does not include actual bathing (soaping, shampooing, scrubbing, rinsing).

(2) "Bathing seat" is a collective term for an item or device that enables an individual to sit securely and comfortably while taking a bath or shower.

(3) The primary healthcare purpose of a bathing seat is to promote cleanliness. Certain bathing seats can also function as commodes, and many commodes can be used as bathing seats. An item that functions equally well as a bathing seat and as a commode is deemed to be a commode for medicaid payment purposes.

(B) Providers.

(1) Prescribing providers. Eligible medicaid providers of the following types, acting within their scope of practice, may prescribe a bathing seat and may certify the medical necessity of a bathing seat when such certification is needed:

(a) A physician;

(b) An advanced practice registered nurse with a relevant specialty;

(c) A physician assistant; or

(d) A podiatrist.

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

(a) A physician, including a physiatrist, orthopedic surgeon, and neurologist;

(b) An advanced practice registered nurse with a relevant specialty;

(c) A physician assistant;

(d) A podiatrist;

(e) A physical therapist; or

(f) An occupational therapist.

(3) Rendering providers. A medicaid provider enrolled as a basic durable medical equipment (DME) supplier may furnish a bathing seat, part, or accessory or may render a related service.

(4) Billing providers. A medicaid provider enrolled as a basic DME supplier may receive medicaid payment for submitting a claim for a bathing seat, part, accessory, or related service.

(C) Coverage.

(1) Principles.

(a) Before the department will make payment for a bathing seat, its medical necessity is determined and certified. If documentation of medical necessity is needed, the default certificate of medical necessity (CMN) is form ODM 10274, "Certificate of Medical Necessity: Bathing Seats" (9/2021).

(b) If more than one type of bathing seat 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 bathing seat is supplied.

(c) The provision of or payment for the purchase of a medically necessary bathing seat for a resident of a long-term care facility (LTCF) is the responsibility of the LTCF. Therefore, claims submitted to the department for bathing seats furnished to LTCF residents will be denied.

(d) Bathing seats on wheels are not to be used simply as transport chairs from which an individual then transfers to a bathtub, standard shower enclosure, or stationary bathing seat. A request for a bathing seat on wheels is therefore not appropriate if the individual does not have a roll-in shower enclosure.

(e) A back support for use in a bathtub is not a bathing seat.

(2) Classification. For purposes of this rule, bathing seats are classified into three categories (basic, intermediate, complex) and ten total subcategories. The descriptions of the categories and subcategories given here are meant to be generally illustrative and neither all-inclusive nor exclusive.

(a) Basic bathing seats.

(i) Basic bath/shower chair.

(a) Appearance: it looks like a simple chair. It does not have wheels. It may have a back, armrests, or both. It may have any number of legs (including none). It is not wall-mounted.

(b) Construction: it is a standard off-the-shelf product.

(c) Positioning: it does not recline nor have tilt-in-space capability. It does not have securement straps.

(d) Independent use: the individual is able to use it without assistance.

(e) Commode capability: it cannot be used as a commode.

(f) Assessment and documentation: no face-to-face evaluation is needed. No PA is needed. No CMN is needed in addition to the prescription.

(ii) Basic bath/shower bench.

(a) Appearance: it looks like a simple bench. It does not have wheels. It may have a back, armrests, or both. It may have any number of legs (including none). It is not wall-mounted.

(b) Construction: it is a standard off-the-shelf product.

(c) Positioning: it does not recline nor have tilt-in-space capability. It does not have securement straps.

(d) Independent use: the individual is able to use it without assistance.

(e) Commode capability: it cannot be used as a commode.

(f) Assessment and documentation: no face-to-face evaluation is needed. No PA is needed. No CMN is needed in addition to the prescription.

(iii) Basic stationary transfer bath/shower bench.

(a) Appearance: it looks like a simple transfer bench, which straddles the side of the bathtub. It has a stationary seat. It does not have wheels. It may have a back, armrests, or both. It may have any number of legs (including none). It is not wall-mounted.

(b) Construction: it is a standard off-the-shelf product.

(c) Positioning: it does not recline nor have tilt-in-space capability. It does not have securement straps.

(d) Independent use: the individual is able to use it without assistance.

(e) Commode capability: it cannot be used as a commode.

(f) Assessment and documentation: no face-to-face evaluation is needed. No PA is needed. No CMN is needed in addition to the prescription.

(iv) Basic sliding transfer bath/shower bench.

(a) Appearance: it looks like a simple transfer bench, which straddles the side of the bathtub. It has a sliding seat, which may swivel. It does not have wheels. It may have a back, armrests, or both. It may have any number of legs (including none). It is not wall-mounted.

(b) Construction: it is a standard off-the-shelf product.

(c) Positioning: it does not recline nor have tilt-in-space capability. It does not have securement straps.

(d) Independent use: the individual is able to use it (and operate the sliding seat) without assistance.

(e) Commode capability: it cannot be used as a commode.

(f) Assessment and documentation: no face-to-face evaluation is needed. No PA is needed. No CMN is needed in addition to the prescription.

(v) Basic shower chair commode.

(a) Appearance: it looks like a standard wheelchair (two large rear wheels and two eight-inch front casters) or transport chair (four small casters or two small front casters and two slightly larger rear wheels). It generally has a back and may have footrests. It does not have a separate base.

(b) Construction: the frame may be made either of metal such as steel or aluminum or of a polymer such as polyvinyl chloride (PVC).

(c) Positioning: it may recline but does not have tilt-in-space capability. It may have securement straps.

(d) Independent use: the individual is able to use it without assistance.

(e) Commode capability: it is used as a commode.

(f) Assessment and documentation: no face-to-face evaluation is needed. No PA is needed. No CMN is needed in addition to the prescription.

(b) Intermediate shower seats.

(i) Intermediate non-assisted shower chair.

(a) Appearance: it looks like a standard wheelchair (two large rear wheels and two eight-inch front casters) or transport chair (four small casters or two small front casters and two slightly larger rear wheels). It does not have a separate base.

(b) Construction: the frame may be made of steel or aluminum but not PVC.

(c) Positioning: it may recline but does not have tilt-in-space capability. It may have basic securement straps and positioners.

(d) Independent use: the individual is able to use it without assistance.

(e) Commode capability: it should be used as a commode if a commode is needed. (A request for a separate commode will not be granted unless a medical reason contraindicates a bathing seat with a commode function.)

(f) Assessment and documentation: a face-to-face evaluation is needed. PA is needed. A CMN is needed in addition to the prescription.

(ii) Intermediate assisted single-position shower chair.

(a) Appearance: it looks like a transport chair (four small casters or two small front casters and two slightly larger rear wheels). It does not have a separate base.

(b) Construction: the frame may be made of steel or aluminum but not PVC.

(c) Positioning: it does not recline nor have tilt-in-space capability. It may have basic securement straps and positioners.

(d) Independent use: the individual needs assistance in using it.

(e) Commode capability: it should be used as a commode if a commode is needed. (A request for a separate commode will not be granted unless a medical reason contraindicates a bathing seat with a commode function.)

(f) Assessment and documentation: a face-to-face evaluation is needed. PA is needed. A CMN is needed in addition to the prescription.

(iii) Intermediate assisted multi-position shower chair.

(a) Appearance: it looks like an examination or treatment chair on small wheels such as casters. It may have a separate base.

(b) Construction: the frame may be made of steel or aluminum but not PVC.

(c) Positioning: it may recline in multiple positions but does not have tilt-in-space capability. It may have basic securement straps and positioners. It may have a head support.

(d) Independent use: the individual needs assistance in using it.

(e) Commode capability: it should be used as a commode if a commode is needed. (A request for a separate commode will not be granted unless a medical reason contraindicates a bathing seat with a commode function.)

(f) Assessment and documentation: a face-to-face evaluation is needed. PA is needed. A CMN is needed in addition to the prescription.

(c) Complex bathing seats.

(i) Complex positioning shower chair.

(a) Appearance: it looks like a complex wheelchair. It has small wheels such as casters. It has no separate base.

(b) Construction: the frame may be made of steel or aluminum but not PVC.

(c) Positioning: it may recline in multiple positions. It generally has basic securement straps and positioners. It may have multiple support devices for the head, torso, arms, and legs.

(d) Independent use: the individual needs assistance in using it.

(e) Commode capability: it should be used as a commode if a commode is needed. (A request for a separate commode will not be granted unless a medical reason contraindicates a bathing seat with a commode function.)

(f) Assessment and documentation: a face-to-face evaluation is needed. PA is needed. A CMN is needed in addition to the prescription.

(ii) Complex transfer bath/shower chair.

(a) Appearance: it consists of a rolling base with a chair seat and small wheels such as casters, a stationary base in the bathing area, and a connecting track or rail that permits the chair seat to slide from the rolling base to the stationary base (and thereby transfer the individual to the inside of the bathtub or shower enclosure).

(b) Construction: the frame may be made of steel or aluminum but not PVC.

(c) Positioning: it may recline in multiple positions and may have tilt-in-space capability. It generally has basic securement straps and positioners. It may have multiple support devices for the head, torso, arms, and legs.

(d) Independent use: the individual may need assistance in using it.

(e) Commode capability: it should be used as a commode if a commode is needed. (A request for a separate commode will not be granted unless a medical reason contraindicates a bathing seat with a commode function.)

(f) Assessment and documentation: a face-to-face evaluation is needed. PA is needed. A CMN is needed in addition to the prescription. This type of bathing seat may be requested only when there is no other appropriate form of transfer in and out of the bathing space. Because the rolling base with chair seat functions as a transport chair, a request for a separate transport chair for travel to and from the bathing area will be denied.

(3) Purchase.

(a) Payment for intermediate and complex bathing seats is subject to prior authorization (PA), which may be given only if a face-to-face evaluation of need has been performed not earlier than one hundred eighty days before the submission of the PA request.

(b) The purchase of a bathing seat includes the bathing seat, delivery, setup, instruction and training in use, adjustments or minor modifications, and other parts or accessories (either substituted or added on). No separate payment is made for these items.

(c) Authorization will not be given for the purchase of more than one bathing seat for concurrent use by an individual.

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

(a) The repair of an individual component is subject to need verification. No verification is needed for the repair of a wear item.

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

(c) Payment is not permitted for temporary replacement equipment (a "loaner bathing seat") provided while an individual's bathing seat is being repaired.

(d) No payment is made for routine maintenance.

(5) Evaluation and management.

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

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

(6) Additional provisions and specifications.

(a) After delivery, the supplier needs to maintain documentary evidence that the following statements are true concerning a bathing seat and any related accessories:

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

(ii) They are consistent with the items described in the CMN, if applicable; and

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

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

(c) A PA request needs to specify all relevant information, such as procedure code, manufacturer, and model. A fully detailed PA request for repair (either of the entire bathing seat or of multiple components) includes the serial number of the equipment and a complete itemization of parts and estimated labor needed.

(d) 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.

(e) Payment will not be authorized for a bathing seat 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 bathing seat, consideration for authorization will be given only to bathing seats that accommodate growth, unless there is a more appropriate, cost-effective, medically necessary alternative available. Payment may be made for additional parts needed to "grow" a bathing seat if the combined cost of the parts and related labor is less than the cost of a new bathing seat.

(f) A bathing seat purchased by medicaid is the property of the individual for whom it was prescribed.

Last updated January 30, 2024 at 10:46 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 9/1/2026

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Coverage.

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

(2) Purchase of a HFCWO device will not be considered without an initial trial period lasting at least two months, excluding any portion that coincides with an inpatient hospital stay. Payment may be made for rental during this trial period.

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

Last updated January 2, 2024 at 8:57 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 7/16/2018

Rule 5160-10-09 | DMEPOS: apnea monitors.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Coverage.

(1) Initial payment may be made for rental of an apnea monitor for a period not to exceed four months, and after the first four months payment may be made either for additional rental or for purchase, only if the following conditions are satisfied:

(a) The monitoring unit meets current United States food and drug administration guidelines.

(b) The provider is capable of performing all of the following services:

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

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

(iii) Providing a technician twenty-four hours a day to service monitoring equipment;

(c) For this initial rental period, the following information is recorded:

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

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

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

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

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

(e) Tracheotomy and associated technology-dependence;

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

(g) Severe gastroesophageal reflux and associated apnea;

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

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

(ii) An attestation that appropriate caregivers are capable of being trained to use the monitor properly; and

(d) For additional rental or purchase, the following information is recorded:

(i) An attestation by the prescriber to the need for continued home monitoring and supplies, including the following information pertinent to the child's circumstances:

(a) 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);

(b) 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

(c) 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

(ii) 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.

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

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

(B) 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) 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 is ordered by a qualified prescriber and is 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.

Last updated January 2, 2024 at 8:57 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 7/1/1997

Rule 5160-10-11 | DMEPOS: hearing aids.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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, is 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, administered by authorized individuals working within their scope of practice and conducted in an appropriate sound environment in accordance with nationally accepted standards. Hearing tests should be performed on both ears; a detailed explanation is needed 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) A claim for payment should be submitted only after the acceptability of the hearing aid has been confirmed, usually during a follow-up visit scheduled within thirty days after delivery. The individual may instead confirm acceptability by waiving the follow-up visit. In either case, the provider maintains relevant documentation. If 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. If payment has already been made for the hearing aid, then the claim is to be adjusted.

(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) Constraints and limitations.

(1) The department may at any time ask a provider to produce 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 disposable hearing aid; and

(b) 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 visits (including travel) necessary for the dispensing and fitting of the hearing aid (regardless of place of service); and

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

(D) Claim payment.

(1) Payment for a hearing aid is the least of three figures:

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

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

(c) The amount the provider customarily charges the general public.

(2) Payment for repair of a hearing aid is the submitted charge, which represents one of the following amounts:

(a) If the provider performed the repair, the total amount the provider customarily charges the general public; 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.

Last updated January 2, 2024 at 8:57 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 12/30/1977, 1/1/1980, 7/16/2018

Rule 5160-10-13 | DMEPOS: oxygen.

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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 per cent 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 per cent.

(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; 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) A physician assistant; or

(f) An ambulatory health care clinic.

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

(a) A DME provider;

(b) A pharmacy;

(c) A physician;

(d) An advanced practice registered nurse with a relevant specialty;

(e) A physician assistant;

(f) An 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) needs to 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. 7/2021).

(2) On the CMN, the prescriber specifies 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 needs to be completed if oxygen has not been supplied under medicaid to an individual for at least two full calendar months.

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

(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 is 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 is 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 needed to confirm a continued need for oxygen.

(b) Otherwise, within ninety days before the end of the existing certification period, the individual needs to be seen and evaluated by a prescriber, and a blood gas study is needed. (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 needed.

(a) The most recent blood gas study performed within thirty days before the revision date is 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 needs to 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 needs to be performed while the individual is awake, either at rest or ambulating.

(b) No additional blood gas study is needed 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 has 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 needed 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 needed 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 needs to 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.

View Appendix

Last updated July 1, 2021 at 10:53 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/1/2026
Prior Effective Dates: 4/7/1977, 12/21/1977, 3/1/1984, 5/1/1990, 6/20/1990 (Emer.), 2/17/1991, 1/1/1995, 8/1/1998, 11/1/2007

Rule 5160-10-14 | DMEPOS: compression garments.

• Effective: July 16, 2018
• Promulgated Under: 119.03

(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.

Last updated January 30, 2024 at 10:46 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/16/2023

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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) 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 includes 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) Rental of a TENS unit to treat neurogenic pain is limited to four months.

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

(5) Payment may be made for the purchase of a TENS unit to treat neurogenic pain, either after a rental period or without a rental period, if the prescriber attests to the medical necessity of continued treatment.

(6) Separate payment may be made for repair of or supplies for a TENS unit owned by an individual. If the unit was not purchased through medicaid, such payment may be made only if the medical necessity of the unit has been established beforehand. Supplies are to 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.

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

(C) Constraints and limitations.

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

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

(3) 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.

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

(5) 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.

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

Last updated January 2, 2024 at 8:57 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 3/1/1984, 5/1/1990, 6/20/1990 (Emer.), 9/5/1990, 4/16/2007

Rule 5160-10-16 | DMEPOS: wheelchairs.

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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, such as non-elevating legrests with footrests or 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 for which individual evaluation, fitting, configuration, adjustment, or programming is needed 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 need to 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. Therefore, a wheelchair needs to provide mobility to an individual for whom ambulation is not possible, takes inordinate physical effort, or causes considerable physical discomfort.

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

(c) A manual wheelchair needs to 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) needs to provide a level of needed functionality that cannot be achieved with a manual wheelchair.

(e) A PMD needs to be functional in the environment in which it is used. The individual (or someone assisting the individual) needs to have the ability to take proper care of the PMD, the individual's place of residence needs to be accessible and have adequate electrical service, transportation of the PMD needs to be available as necessary, and there needs to 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 needs to 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 need 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;

(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 specialized DME supplier.

(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 specialized DME supplier.

(C) Coverage.

(1) Principles.

(a) The medical necessity of a wheelchair needs to be determined 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. 7/2021). 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 needed, and a face-to-face evaluation of need has to be performed by a prescribing provider not earlier than one hundred eighty days before the submission of the PA request.

(b) 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, is subject to 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, such as 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 needed for the repair of a wear item, such as a caster bearing, tire, arm pad).

(b) Constraints and limitations.

(i) For a wheelchair not purchased by the department, submission of documentation of the medical necessity of the wheelchair itself is needed 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 (a "loaner wheelchair") provided while an individual's wheelchair is being repaired.

(iii) No payment is made for routine maintenance.

(4) Rental.

(a) Custom manual wheelchairs. PA is needed.

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

(c) PMDs. PA is needed.

(d) 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 cannot 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 constraints and limitations.

(1) After delivery, the supplier needs to 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 needs to specify all relevant information (e.g., HCPCS code, manufacturer, model). A PA request for repair needs to 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 needed 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.

Last updated July 1, 2021 at 10:53 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02, 5165.01, 5165.47
Five Year Review Date: 7/1/2026
Prior Effective Dates: 12/30/1991, 8/1/1995, 4/1/1998

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Payment may be made directly to a provider for a pneumatic compressor or a related appliance or accessory only if the following conditions are satisfied:

(1) The equipment is used to treat either lymphedema in the extremities or chronic venous insufficiency (CVI) with venous stasis ulcers; and

(2) The prescribing practitioner has determined either that there was no significant improvement or that significant symptoms persisted when one of the following treatments was applied:

(a) 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

(b) 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) Pneumatic compression devices to be used to treat conditions of the chest or trunk are not covered.

(C) The provider of the pneumatic compression device is expected to obtain from the prescribing practitioner brief documentation of the need for the device and to keep this documentation on file. Use of form ODM 02929 (rev. 7/2018) for this purpose is permitted but not obligatory. The documentation should include the following information as applicable:

(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) For a covered pneumatic compressor, payment may be made for short-term rental (repeated as necessary for not more than a total of ten months), for rental with subsequent purchase, or for purchase outright, as the prescribing practitioner determines to be appropriate. For a covered pneumatic appliance or accessory, payment is made for purchase.

Last updated January 2, 2024 at 8:58 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 1/7/2010

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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 includes 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 is needed 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) The default form is the ODM 02910.

(2) Payment may be made for an accessory to be used with a hospital bed only if the medical necessity of the hospital bed has 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 includes 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 includes 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 placement of the surface or (if applicable) submission of the request for prior authorization, 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 is 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 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) 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) Prior authorization 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.

Last updated January 2, 2024 at 8:58 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 1/1/2000

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

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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. Extrapolation or projection of the AHI is not permitted.

(B) Coverage.

(1) The default certificate of medical necessity (CMN) form is the ODM 01903, "Certificate of Medical Necessity: Positive Airway Pressure Devices" (rev. 7/2021). The CMN includes the following information:

(a) A diagnosis of obstructive sleep apnea or other condition for which positive airway pressure is an appropriate treatment;

(b) The results of a respiratory study; and

(c) An estimated length of need.

(2) A respiratory study may be performed with a positive airway pressure device that records relevant data automatically.

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

(a) In the absence of positive airway pressure, the respiratory study 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) When positive airway pressure is applied, the respiratory study 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.

(4) A need for oxygen is established if a positive airway pressure device is effective during a respiratory 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 respiratory study is necessary to confirm a continued need for oxygen.

(5) 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 respiratory study or during a one-week trial period indicates that a variable or bilevel positive airway pressure device is effective.

(C) Constraint. The provider of a positive airway pressure device cannot perform the qualifying respiratory study.

Last updated July 1, 2021 at 10:54 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02, 5165.47
Five Year Review Date: 7/1/2026
Prior Effective Dates: 7/1/1993, 7/1/1994, 8/1/1998, 1/1/2008

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

• Effective: July 16, 2018
• Promulgated Under: 119.03

(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 authorized representative) who reported the quantities.

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

Last updated January 30, 2024 at 10:46 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/16/2023
Prior Effective Dates: 10/1/2004

Rule 5160-10-22 | DMEPOS: ventilators.

• Effective: July 1, 2021
• Promulgated Under: 119.03

(A) Condition of provider participation. A provider of in-home use ventilators needs to have 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. 7/2021).

(3) For the rental of a primary ventilator, a CMN includes 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 needed (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 includes 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 such as school or 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.

(5) A multi-function ventilator is an all-in-one device that also has the capability to perform the functions of other respiratory equipment such as an oxygen concentrator, a nebulizer, a suction device, or a cough-assist device. A device that may serve either as a ventilator or as a positive airway pressure device but not as both simultaneously is not a multi-function ventilator.

(a) Payment may be made for a multi-function ventilator only if at least one additional function ("ventilator plus one") is used.

(b) For each additional function, whether included when the unit is first dispensed or activated later, the appropriate CMN applies. A prescription is sufficient when no CMN is specified for a particular function.

(C) Constraints and and limitations.

(1) A ventilator with an invasive interface is covered only if it includes 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) Accessories necessary for the oxygen and ventilator functions of a multi-function ventilator;

(c) A humidifier, either heated or unheated;

(d) Humidifier bacteria filters;

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

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

(g) 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.

Last updated July 1, 2021 at 10:54 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02, 5165.47
Five Year Review Date: 7/1/2026
Prior Effective Dates: 7/1/1993, 8/1/1998

Rule 5160-10-23 | DMEPOS: pulse oximeters.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Coverage.

(1) Payment may be made only for a pulse oximeter that meets 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 includes 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) 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.

Last updated January 2, 2024 at 8:58 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 7/16/2018

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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 includes 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 includes 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.

(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) 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 any of the following items:

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

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

(c) Purchase, rental, lease, subscription, or maintenance associated with a cellular phone, even if the cellular phone has the capability to perform SGD functions; or

(d) Features that may be added on to some models of SGD but have been integrated into the particular SGD under consideration.

(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.

Last updated January 2, 2024 at 8:59 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 9/10/1993, 12/10/1993, 7/16/2018

Rule 5160-10-25 | DMEPOS: lactation pumps.

• Effective: January 1, 2022
• Promulgated Under: 119.03

(A) Definitions and explanations.

(1) "Multiple-user lactation pump" is a lactation pump that is safe for sequential use by multiple individuals. (The term "hospital-grade," which is often applied to such a pump, is not recognized by the United States food and drug administration.) A multiple-user lactation pump comes with a separate set of accessories (e.g., breast shields, tubing) for each individual, which reduces the risk of contamination. It generally features adjustable suction pressure and adjustable pumping speed. It is intended only for temporary, short-term use.

(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 either or both of the following purposes:

(a) Purchase of a single-user manual or electric lactation pump as a medical supply item and purchase of any necessary replacement supplies; or

(b) Rental of a multiple-user lactation pump.

(2) For a single-user manual or electric lactation pump, a prescription is sufficient. No separate certificate of medical necessity (CMN) is needed.

(3) For a multiple-user lactation pump, the default CMN form is the ODM 01901, "Certificate of Medical Necessity: Multiple-User Lactation Pumps" (rev. 1/2022).

(a) On the CMN, the prescriber explains and attests to the medical necessity of the pump.

(b) On the CMN, the prescriber specifies the expected number of ninety-day rental periods. If additional rental periods are needed, the prescriber may either revise the existing CMN or complete a new CMN.

(C) Constraints and limitations.

(1) The warranty period for a covered single-user 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) Payment for the rental of a multiple-user lactation pump includes all accessories, supplies, and cleaning.

(4) ODM is not responsible for failure to return a multiple-user lactation pump in working order.

Last updated January 3, 2022 at 9:50 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2027
Prior Effective Dates: 4/25/2011

Rule 5160-10-26 | DMEPOS: nutrition products.

• Effective: July 16, 2018
• Promulgated Under: 119.03

(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, pured, 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 in a hospital setting.

(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.

Last updated January 30, 2024 at 10:46 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/16/2023
Prior Effective Dates: 1/1/2010

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Coverage.

(1) No particular form or format is specified for the certification of medical necessity.

(2) 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. On the prescription for the device, the first date and last date of use are indicated.

(3) 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) 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.

Last updated January 2, 2024 at 8:59 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 4/1/2006

Rule 5160-10-28 | DMEPOS: osteogenesis stimulators.

• Effective: July 16, 2018
• Promulgated Under: 119.03

(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.

Last updated January 30, 2024 at 10:46 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/16/2023

Rule 5160-10-29 | DMEPOS: insulin pumps.

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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. 7/2021). The CMN includes 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 or insulin-dependent type 2 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 obtains 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) Constraints and limitations.

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

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

(b) 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 can be made for the purchase of an insulin pump that has been previously used by another individual.

Last updated July 1, 2021 at 10:55 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 7/1/2026
Prior Effective Dates: 8/18/2008

Rule 5160-10-30 | DMEPOS: ambulation aids.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(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) No particular form or format is specified for the certification of medical necessity.

(2) 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.

(3) 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.

(f) For a white cane that is to be used as a mobility aid, the provider maintains documentation that the individual cannot obtain an equivalent cane free of charge (e.g., from a source such as the "Free White Cane Program" administered by the national federation of the blind, http://nfb.org).

Last updated January 2, 2024 at 8:59 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 7/16/2018

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Orthopedic shoes.

(1) No particular form or format is specified for the certification of medical necessity.

(2) 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 individual;

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

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

(e) For an individual 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 an individual 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.

(3) Greater frequency of shoe replacement may be allowed for individuals younger than eight years of age. Payment for shoe replacement beyond an established frequency for individuals younger than twenty-one years of age is subject to prior authorization (PA).

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

(5) 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 an individual 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 includes an attestation that all of the following statements are true:

(a) The individual has diabetes mellitus;

(b) The conditions of coverage are met;

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

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

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

(2) Therapeutic footwear may be prescribed only by a podiatrist, pedorthist, orthotist, prosthetist, or other qualified practitioner who manages the individual's diabetes.

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

(4) Payment may be made for therapeutic footwear (shoes, inserts, or shoe modifications) only if the individual 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 individual 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 individual has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity is to 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 necessary modification. Separate payment may be made for inserts if the provider confirms in writing that the individual has appropriate footwear meeting the industry definition of a depth or custom-molded shoe, into which the insert can be placed.

Last updated January 2, 2024 at 8:59 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 3/1/1984, 12/30/1993 (Emer.), 3/31/1994, 7/16/2018

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

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) No particular form or format is specified for the certification of medical necessity.

(B) Stoma maintenance supplies. 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).

(C) Urination aids.

(1) Indwelling catheters.

(a) Frequency limits imposed on catheter replacement may be exceeded without prior authorization (PA) for reasons including but not limited to the following examples:

(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) Additional documentation of medical necessity is needed for either of the following items:

(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.

(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.

(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 is to 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) rather than a clean intermittent catheter and related supplies if sterile catheterization is medically necessary. Sterile intermittent catheterization is presumed to be medically necessary if the individual experiences any of the following conditions:

(i) Immunosuppression, without regard to cause;

(ii) Both neurogenic bladder dysfunction and pregnancy;

(iii) Documented vesicoureteral reflux; or

(iv) At least two distinct urinary tract infections within the preceding year.

(b) Additional documentation is needed to establish the medical necessity of a coud catheter used instead of a straight catheter. The use of a coud catheter by a female is rarely necessary.

(5) External urinary collection devices.

(a) Payment 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).

(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.

(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.

Last updated January 2, 2024 at 9:00 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 8/17/2009

Rule 5160-10-34 | DMEPOS: wound dressings and related supplies.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) Coverage.

(1) No particular form or format is specified for the certification of medical necessity.

(2) Payment may be made for wound dressings and related supplies as long as medical necessity exists.

(3) 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.

(4) 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 is necessarily based on an evaluation of the wound performed by a qualified healthcare provider. Frequent evaluation is expected if a wound is heavily draining or infected. Each evaluation report, which will be made available to the department on request, includes the wound type; wound location; wound length, width, and depth; the amount of drainage; and any other relevant clinical information.

(2) The provider keeps the prescription for dressings or related supplies on file. The prescription includes the following clinical information, which can be no older than one year:

(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 needed 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) 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 should 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.

View Appendix

Last updated January 2, 2024 at 9:00 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 1/7/2010

Rule 5160-10-35 | DMEPOS: cranial remolding devices.

• Effective: January 1, 2024
• Promulgated Under: 119.03

(A) No particular form or format is specified for the certification of medical necessity.

(B) Payment may be made only for a cranial remolding device that meets the standards established by the United States food and drug administration for a class II medical device.

(C) 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.

Last updated January 2, 2024 at 9:00 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 1/1/2029
Prior Effective Dates: 9/1/2011, 7/16/2018

Rule 5160-10-36 | DMEPOS: continuous glucose monitors.

• Effective: October 15, 2022
• Promulgated Under: 119.03

(A) Definition. "Continuous glucose monitor (CGM)" is a device that can constantly measure glucose levels in interstitial body fluid. The sensor, transmitter, and receiver may be separate parts or may be combined. The receiver may have the capacity to record data.

(B) Coverage.

(1) This rule does not apply to either of the following items:

(a) An insulin infusion pump into which a continuous glucose monitoring sensor is integrated, coverage and payment policies for which are addressed in rule 5160-10-29 of the Administrative Code; or

(b) A disposable tubeless subcutaneous insulin administration device, which is covered as a pharmacy benefit in accordance with Chapter 5160-9 of the Administrative Code.

(2) Payment may be made for the purchase of a CGM and for the periodic purchase of replaceable CGM components.

(3) The default certificate of medical necessity (CMN) form is the ODM 10277, "Certificate of Medical Necessity: Continuous Glucose Monitors" (10/2022). The CMN includes the following information, for which appropriate documentation is kept in the individual's medical record.

(a) A condition for which continuous glucose monitoring is indicated for the individual, such as diabetes mellitus or hypoglycemia;

(b) The intended length of monitoring, either short-term (from three to seven consecutive days, once or twice a year) or long-term; and

(c) A brief explanation of why the use of a CGM is indicated, including contributing conditions and symptoms such as are specified in the following non-exhaustive list:

(i) Unexplained hypoglycemic episodes (generally, excessively low blood glucose levels despite appropriate modifications in insulin therapy);

(ii) HbA1c level consistently outside the target range for the individual;

(iii) Hypoglycemic unawareness (the inability to recognize hypoglycemic events consistently and reliably), evidenced in extreme cases by seizures or loss of consciousness;

(iv) The presence of microvascular complication (e.g., vasculopathy, retinopathy);

(v) A treatment regimen that necessitates either of the following activities:

(a) Frequent adjustments to insulin dosage throughout the day; or

(b) Insulin pump therapy;

(vi) A coexistent condition (e.g., uncontrolled epilepsy) that may make hypoglycemia management difficult;

(vii) Evidence of fasting or postprandial hyperglycemia; or

(viii) Recurrent diabetic ketoacidosis.

(C) Constraints and limitations.

(1) No payment will be made for a CGM if neither the individual nor anyone assisting the individual is able to operate it.

(2) Payment for a CGM includes related software.

(3) Even if a CGM has the capability to use a cellular phone as a receiver, no payment will be made for purchase, rental, lease, subscription, or maintenance associated with a cellular phone.

(4) The warranty period for a CGM receiver is at least one year from the dispensing date.

(5) No payment may be made for the purchase of a CGM that has been previously used by another individual.

(6) Replacement components are dispensed in units representing the quantity an individual is expected to use in one month. Before dispensing additional units, the provider makes contact, either verbally or in writing, with the individual (or the individual's authorized representative) to verify the current need. The provider keeps on file a summary of this contact. If the individual has one unit or less, the provider may dispense up to three units.

Last updated October 17, 2022 at 8:44 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02
Five Year Review Date: 10/15/2027