# COMAR Title 10 — Maryland Department of Health

## Subtitle 09 — Medical Care Programs

### Chapter 12 — Disposable Medical Supplies and Durable Medical Equipment

**Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland

**Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1740)

**Administrative History:** Regulation .04A amended effective February 8, 1980 (7:3 Md. R. 264)

**Administrative History:** Regulation .05 amended effective February 8, 1980 (7:3 Md. R. 264) and April 4, 1980 (7:7 Md. R. 708)

**Administrative History:** Chapter revised effective June 26, 1981 (8:13 Md. R. 1139)

**Administrative History:** Regulation .01B amended effective July 11, 1988 (15:13 Md. R. 1553)

**Administrative History:** Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572); May 29, 1989 (16:10 Md. R. 1108)

**Administrative History:** Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)

**Administrative History:** Regulation .04A amended effective July 1, 1987 (14:13 Md. R. 1473); May 29, 1989 (16:10 Md. R. 1108)

**Administrative History:** Regulation .04B amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); May 29, 1989 (16:10 Md. R. 1108)

**Administrative History:** Regulation .04E amended effective July 2, 1984 (11:13 Md. R. 1176); August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .04F G adopted effective June 2, 1986 (13:11 Md. R. 1273)

**Administrative History:** Regulation .04H adopted effective March 23, 1987 (14:6 Md. R. 715)

**Administrative History:** Regulation .05 amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655); May 29, 1989 (16:10 Md. R. 1108)

**Administrative History:** Regulation .05A-3 and A-4 adopted, B amended effective July 1, 1987 (14:13 Md. R. 1473)

**Administrative History:** Regulation .05B and D amended effective June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715)

**Administrative History:** Regulation .06 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273);

**Administrative History:** Regulation .06A amended effective March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); May 30, 1988 (15:11 Md. R. 1331); July 11, 1988 (15:13 Md. R. 1553)

**Administrative History:** Regulation .06D amended effective May 30, 1988 (15:11 Md. R. 1331)

**Administrative History:** Regulation .06D-1 amended effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .07 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); May 29, 1989 (16:10 Md. R. 1108)

**Administrative History:** Regulation .07 amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2392); amended permanently effective February 9, 1987 (14:2 Md. R. 129)

**Administrative History:** Regulation .07B-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .07C-1 repealed effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .07C-1 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)

**Administrative History:** Regulation .07C-2 adopted effective July 1, 1987 (14:13 Md. R. 1473)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)

**Administrative History:** Regulation .07D amended effective October 1, 1983 (10:19 Md. R. 1691); June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); July 1, 1988 (15:13 Md. R. 1554); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984

**Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129)

**Administrative History:** Regulation .07D, F-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625); June 2, 1986 (13:11 Md. R. 1273)

**Administrative History:** Regulation .07F-2 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)

**Administrative History:** Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)

**Administrative History:** Regulation .07Q amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004))

**Administrative History:** Regulation .07Q amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)

**Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)

**Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)

**Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2105)

**Administrative History:** Chapter revised effective March 16, 1992 (19:5 Md. R. 577)

**Administrative History:** Chapter revised effective November 16, 1998 (25:23 Md. R. 1696)

**Administrative History:** Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 30, 2012 (39:8 Md. R. 533); June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568); January 1, 2018 (44:26 Md. R. 1214)

**Administrative History:** Regulation .03G amended effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulation .04 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470); June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .04E amended effective April 30, 2012 (39:8 Md. R. 533)

**Administrative History:** Regulation .05 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); January 1, 2018 (44:26 Md. R. 1214)

**Administrative History:** Regulation .05A amended effective February 9, 2009 (36:3 Md. R. 208)

**Administrative History:** Regulation .05D amended effective April 19, 2010 (37:8 Md. R. 615)

**Administrative History:** Regulation .05K amended effective June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .05L adopted effective June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation05M-Q amended effective June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .06 amended effective January 7, 2002 (28:26 Md. R. 2272); August 1, 2005 (32:15 Md. R. 1320); October 16, 2023 (50:20 Md. R. 887)

**Administrative History:** Regulation .06A amended effective February 9, 2009 (36:3 Md. R. 208)

**Administrative History:** Regulation .06A,B amended effective June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .06D amended effective June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .06E amended effective September 29, 2003 (30:19 Md. R. 1331); June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .07 amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 19, 2010 (37:8 Md. R. 615); April 30, 2012 (39:8 Md. R. 534); July 4, 2016 (43:13 Md. R. 712); October 16, 2023 (50:20 Md. R. 887)

**Administrative History:** Regulation .07D amended effective February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)

**Administrative History:** Regulation .07F amended effective February 9, 2009 (36:3 Md. R. 208); February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)

**Administrative History:** Regulation .07F-1 adopted effective June 14, 2021 (48:12 Md. R. 470)

**Administrative History:** Regulation .07Z adopted effective January 1, 2018 (44:26 Md. R. 1214)

#### Regulation .01 Definitions.

*COMAR 10.09.12.01*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients.

  (2) “Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product:

    (a) For a specific recipient according to the description and orders of a physician; and

    (b) In such a way that the equipment can only be used by the specific recipient.

  (3) “Department” means Maryland Department of Health as defined in COMAR 10.09.36.01.

  (4) “Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition.

  (5) “Durable medical equipment” means equipment which satisfies all of the following requirements:

    (a) It can withstand repeated use;

    (b) It is used to serve a medically necessary purpose; and

    (c) It has no practical use in the absence of illness, injury, disability, or health condition.

  (6) “Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution.

  (7) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.

  (8) “Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult.

  (9) “Invoice” means a form designated by the Department for use by providers in submitting bills for payment.

  (10) “Maximum allowable reimbursement” means the payment limitation established by the Department.

  (11) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.

  (12) “Medically necessary” means that the service or benefit is:

    (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

    (b) Consistent with current accepted standards of good medical practice;

    (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

    (d) Not primarily for the convenience of the consumer, family, or provider.

  (13) “Medicare” means Medicare as defined in COMAR 10.09.36.01.

  (14) “Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02.

  (15) “Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body.

  (16) “Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient.

  (17) “Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed.

  (18) “Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient.

  (19) “Prescriber order” means a document on the prescriber's letterhead or prescription form which details the:

    (a) Patient name and Medical Assistance number;

    (b) Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber;

    (c) Estimated quantity of the item;

    (d) Length of time of need;

    (e) Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and

    (f) Prescriber’s signature.

  (20) “Prescription” means a written order for medical supplies or equipment, signed by the prescriber.

  (21) “Program” means program as defined in COMAR 10.09.36.01.

  (22) “Prosthetic device” means:

    (1) An artificial device to replace, in whole or in part, a leg, arm, or eye; or

    (2) An artificial breast, including surgical brassiere.

  (23) “Provider” means provider as defined in COMAR 10.09.36.01.

  (24) “Recipient” means recipient as defined in COMAR 10.09.36.01.

  (25) Wholesale cost.

    (a) “Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid.

    (b) “Wholesale cost” includes, but is not limited to:

      (i) Shipping;

      (ii) Handling; and

      (iii) Insurance costs.

    (c) “Wholesale cost” does not include associated costs such as:

      (i) Evaluation;

      (ii) Assembly by the provider;

      (iii) Fitting and adjustment; and

      (iv) Delivery to the recipient.

#### Regulation .02 License Requirements.

*COMAR 10.09.12.02*

Providers of services shall meet the licensing requirements as set forth in COMAR 10.09.36.02.

#### Regulation .03 Conditions for Participation.

*COMAR 10.09.12.03*

To participate in the Program, the provider:

A. Effective January 1, 2018, shall be in an approved status with Medicare;

B. Effective April 1, 2012 through December 31, 2017, shall, unless exempt from Medicare accreditation requirements:

  (1) Be accredited by a Medicare-approved accreditation organization;

  (2) Provide documentation of:

    (a) Accreditation; or

    (b) Having submitted an application for accreditation; and

  (3) Be accredited or terminated from the Program;

C. Shall meet the conditions for participation as set forth in COMAR 10.09.36.03;

D. Shall be prepared to furnish necessary service and repairs to equipment dispensed by the provider;

E. Shall certify residential service agency status as set forth in COMAR 10.07.05 by submitting either a:

  (1) Copy of the license; or

  (2) Form supplied by the Department which documents exempt status;

F. May not charge the recipient any fee or deposit;

G. Shall collect and report as a collection any and all possible rebates or other third-party reimbursement;

H. Shall mark durable medical equipment with an identification tag as specified and provided by the Program, noting the tag number on all appropriate delivery tickets; and

I. Shall participate in the Program's recycling efforts as set forth in Regulation .07O of this chapter.

#### Regulation .04 Covered Services.

*COMAR 10.09.12.04*

A. The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service:

  (1) Disposable medical supplies;

  (2) Durable medical equipment;

  (3) Repairs to purchased durable medical equipment;

  (4) All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;

  (5) Orthotic devices;

  (6) Repair of orthotic devices;

  (7) Replacement of orthotic devices;

  (8) Prosthetic devices which include:

    (a) Artificial eyes;

    (b) Breast prostheses, including surgical brassiere;

    (c) Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and

    (d) Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function;

  (9) Repair of prosthetic devices;

  (10) Replacement of prosthetic devices;

  (11) Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older;

  (12) Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter;

  (13) Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and

  (14) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home.

B. The items in §A of this regulation are covered when medically necessary for use in the recipient's:

  (1) Home;

  (2) School; or

  (3) Place of employment.

C. The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health.

D. Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community.

E. Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions.

F. Replacements under §A(10) are covered:

  (1) Once annually for devices less than 3 years old if the replacement is for the following reasons:

    (a) A change in the physiological condition of the patient;

    (b) Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or

    (c) Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and

  (2) For devices more than 3 years old subject to §§B and C of this regulation.

G. Documentation Required.

  (1) Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the:

    (a) Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services;

    (b) Recertifications of continuous medical need;

    (c) Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket;

    (d) Make, model, and serial number of the item, as applicable; and

    (e) Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology.

  (2) For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health.

  (3) Documentation shall be retained for 6 years and be made available upon request by the Department.

H. The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements.

#### Regulation .05 Limitations.

*COMAR 10.09.12.05*

The Program does not cover:

A. Incontinency pants and disposable underpads unless the following conditions are met:

  (1) The incontinence supplies are medically necessary for medical conditions associated with prolonged urinary or bowel incontinence;

  (2) For pull-on underwear type garments, the recipient is capable of independently putting on and removing the garment; and

  (3) Disposable incontinence supplies meet, at a minimum, the following absorbent capacity standards:

    (a) For children's diapers and underwear, not less than 800cc;

    (b) For youth diapers and underwear, not less than 1,000cc;

    (c) For small adult diapers and underwear, not less than 1,200cc;

    (d) For medium adult diapers and underwear, not less than 1,750cc;

    (e) For large, extra large, and bariatric adult diapers and underwear, not less than 2,000cc; and

    (f) For disposable underpads, not less than 1,000 cc;

B. Osteogenesis stimulators unless the following criteria are met:

  (1) The use is for noninvasive therapy;

  (2) The bone fracture is at least 6 months old, except when used for pseudarthrosis; and

  (3) The space gap of the fracture measures 1/2 centimeter or less, except when used for pseudarthrosis;

C. Osteogenesis stimulators beyond the first 6 weeks of use unless evaluations at the 6-week and 3-month intervals after initial date of service verify recipient use of at least 50 percent of the time prescribed, on a form designated by the Program;

D. The following durable medical equipment:

  (1) Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, emesis basins, posture support chairs, over-the-bed tables;

  (2) Self-help devices including, but not limited to, grab bars, shower stools, and commode seats;

  (3) Abdominal supports;

  (4) Bed boards;

  (5) Enema bags;

  (6) Environmental controls;

  (7) Exercise equipment and devices, unless home use of such equipment is a necessary component of an active physical therapy program;

  (8) Geriatric chairs;

  (9) Heating pads or lamps;

  (10) Hot water bottles;

  (11) Hydrocollators;

  (12) Ice bags;

  (13) Knee cages;

  (14) Nasal atomizers;

  (15) Restraints;

  (16) Sitz baths;

  (17) Soft collars;

  (18) Whirlpools;

  (19) Whirlpool bath equipment;

E. Disposable medical supplies and durable medical equipment provided in a facility or by a group when reimbursement is covered by another segment of the Program;

F. Items which are investigational or experimental in nature;

G. Nutritional supplements supplied by a DMS/DME provider under this chapter if the provider is also a licensed pharmacy and has a Medicaid Pharmacy provider number;

H. Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products, when administered orally;

I. Purchase of used equipment, except as approved by the Department as per Regulation .07L of this chapter;

J. Equipment if the recipient owns or otherwise has access to useable equipment that serves the same purpose as the requested equipment;

K. Replacement of equipment or a device while the item is still under warranty or before having met the Department’s life expectancy schedule unless prepayment authorization has been obtained.

L. Replacement of a prosthetic device or component if necessary due to misuse.

M. Rental of any equipment not in good working condition for the entire length of rental;

N. Rental of equipment for any period longer than 90 days without renewed documentation of continued medical need from the prescriber for each 90-day period;

O. Modifications to motor vehicles;

P. Disposable medical supplies and durable medical equipment ordered by an individual who is not enrolled as a provider in the Program on the date of service; and

Q. Disposable medical supplies and durable medical equipment ordered by an entity, facility, or other provider that is not an individual.

#### Regulation .06 Prepayment Authorization Requirements.

*COMAR 10.09.12.06*

A. Prepayment authorization is required for:

  (1) Disposable medical supplies with a charge exceeding $500, except as specified in §B(1) and (4) of this regulation and durable medical equipment on the approved list of items as individual consideration (I/C);

  (2) All incontinency pants for recipients 3 through 15 years old in excess of 240 in any 30-day period, and disposable underpads for recipients 3 through 15 years old in excess of 135 in any 30-day period;

  (3) All incontinency pants for recipients 16 years old or older in excess of 180 in any 30-day period, and disposable underpads for recipients 16 years old or older in excess of 100 in any 30-day period;

  (4) All disposable incontinency pants and all disposable underpads for recipients younger than 3 years old;

  (5) Disposable medical supplies and durable medical equipment not on the approved list of items;

  (6) Any rental of durable medical equipment after 3 months of rental;

  (7) All repairs to purchased durable medical equipment exceeding $500;

  (8) Durable medical equipment with a purchase price of $1,000 or more except as specified in §B(1) and (4) of this regulation;

  (9) Prosthetics and orthotics with a charge exceeding $1,000 except as specified in §B(1) and (4) of this regulation; and

  (10) Medical equipment, supplies not listed on the approved list of items.

B. Prepayment authorization is not required for:

  (1) Any disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;

  (2) Prosthetic devices under $1,000;

  (3) Orthotic equipment under $1,000; and

  (4) Enteral and parenteral supplies not exceeding one unit per day.

C. For the rental of durable medical equipment, the following prepayment authorization requirements apply:

  (1) For durable medical equipment below $1,000:

    (a) Months 1 through 3, the rental does not require a prepayment authorization;

    (b) Months 4 through 10, the rental does require a prepayment authorization; and

    (c) Month 10 is the final rental month, after which the item is considered purchased.

  (2) For durable medical equipment above $1,000, and items requiring individual consideration:

    (a) Months 1 through 10, the rental does require prepayment authorization; and

    (b) Month 10 is the final rental month, after which the item is considered purchased.

D. The prescriber shall submit requests for prepayment authorization, when required, using the format and procedures designated by the Department.

E. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile shall be followed by a request for prepayment authorization, which shall be submitted immediately to the Department. Providers shall call the Program before making a request via facsimile.

F. Except as provided in §H of this regulation, providers shall submit prepayment authorization requests to the Program not later than 30 days following the first date of service.

G. Prepayment authorization is issued when:

  (1) Program procedures are met;

  (2) The prescriber submits to the Department adequate documentation demonstrating that the service to be authorized is medically necessary; and

  (3) A request for supplies or equipment on the list of approved items, or on the list but without a specified maximum Program price, is accompanied by the manufacturer's suggested retail price or an invoice or other documentation of the wholesale cost, whichever is applicable under Regulation .07 of this chapter.

H. Prepayment authorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—G of this regulation.

I. The Department is not responsible for any reimbursement to a provider for any service provided which requires prepayment authorization unless the authorization has been granted by the Program.

#### Regulation .07 Payment Procedures.

*COMAR 10.09.12.07*

A. Payment procedures shall be as set forth in COMAR 10.09.36.04.

B. The provider’s billed charges to the Program may not exceed the provider’s customary charge. If the item is free to individuals not covered by Medicaid:

  (1) The provider:

    (a) May charge the Program; and

    (b) Shall be reimbursed in accordance with the provisions of this regulation; and

  (2) The provider’s reimbursement is not limited to the provider’s customary charge.

C. The provider shall give the Program the full advantage of any and all manufacturer's warranty offered on the item.

D. Effective July 1, 2022, the Department shall pay providers 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare rate established January 1 of each year for prosthetic devices. For prosthetic devices for which Medicare has not established a rate, the Department shall pay providers the manufacturer’s suggested retail price of the item, less 26.5 percent. The payment shall include all fitting, dispensing, and follow-up care.

E. Charges for osteogenesis stimulators shall include all follow-up care, batteries, repairs, and replacement parts within the limitations of Regulation .05E and F, at the following times:

  (1) Initial date of service;

  (2) After 6-week evaluation;

  (3) After 3-month evaluation.

F. With the exception of items free to individuals not covered by Medicaid, the Department shall reimburse providers for the purchase of covered services at the lesser of the provider’s customary charge or:

  (1) For the purchase of items for which Medicare has established a rate:

    (a) Disposable medical supplies and durable medical equipment other than enteral nutritional products and enteral and parenteral therapy supplies at 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate established January 1 of each year;

    (b) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(1) of this regulation;

    (c) Enteral and parenteral therapy supplies as established in §F-1(2) of this regulation; and

    (d) For medical equipment for which Medicare has established a rental rate, the purchase price shall be 10 times the lowest rural, non-rural, or competitive bidding area (CBA) Medicare monthly rental rate.

  (2) For the purchase of items for which Medicare has not established a rate:

    (a) Disposable medical supplies not otherwise specified in this section are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or the provider’s wholesale cost plus 37.2 percent;

    (b) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(3) of this regulation;

    (c) Enteral and parenteral therapy supplies as established in §F-1(4) of this regulation;

    (d) Incontinence supplies at the provider's wholesale cost plus 25 percent;

    (e) Customized equipment at the provider's choice of the manufacturer's suggested retail price minus 30 percent or provider's wholesale cost plus 40 percent; and

    (f) Durable medical equipment, not otherwise specified in this section, are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or provider’s wholesale cost plus 27.4 percent.

F-1. Enteral Nutritional Product and Enteral and Parenteral Supply Reimbursement Rates Effective February 1, 2021.

  (1) Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:

  (2) Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:

  (3) Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:

  (4) Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:

G. The Department shall reimburse providers for the monthly rental of covered services as follows:

  (1) For items for which Medicare has established a purchase rate, 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate divided over 10 months;

  (2) For items for which Medicare has not established a purchase rate, items will be rented at the provider’s choice of:

    (a) The manufacturer’s suggested retail price minus 41.2 percent, divided over 10 months; or

    (b) The provider’s wholesale cost plus 27.4 percent, divided over 10 months; and

  (3) After 10 months of monthly rental, the item will be considered purchased.

H. The Department reserves the right to prorate the monthly rental amount for daily rentals.

I. The Department shall pay for repairs to purchased durable medical equipment according to the following:

  (1) The provider's choice of wholesale cost plus 37.2 percent or the manufacturer's suggested retail price minus 31.4 percent to the provider for all materials;

  (2) Labor costs shall be billed in quarter hour increments using the appropriate procedure code and shall be reimbursed the lesser of:

    (a) The supplier’s customary charge unless the service is free to individual not covered by Medicaid; or

    (b) The reimbursement rate specified in the Medicaid Durable Medical Equipment Program's approved list of items.

J. The determination to purchase or rent medical equipment shall be based on the prescriber's best faith estimate of length of time the equipment will be needed by the recipient. When the equipment is ordered for:

  (1) 10 or more months, the provider shall charge the Program for a purchase, unless:

    (a) The items cannot be purchased, in which case the items shall continue to be rented for the duration of their need at the amount determined on the fee schedule or elsewhere in this chapter; or

    (b) There is justification to request a rental rather than a purchase of the item, and a request for prepayment authorization is submitted to and approved by the Program before the submission of the invoice for the item; and

  (2) Less than 10 months, the provider shall charge the Program for rental of the item for the duration of the medical necessity except that:

    (a) If the equipment is still medically necessary after 10 months of rental and the equipment is purchasable,  the tenth rental payment is the final rental payment, and the equipment is considered purchased by the Program; or

    (b) If there is justification to request a purchase rather than a rental of the item, a request for prepayment authorization shall be submitted to the Program and approved by the Program before the submission of the invoice.

K. Medical equipment that is determined by the Department to require frequent and substantial servicing in order to avoid risk to the recipient's health shall be reimbursed at the rental rate in accordance with §G of this regulation until either the equipment is no longer medically necessary or the recipient is no longer eligible for Medical Assistance fee-for-service benefits.

L. Every 90 days during the rental term the provider shall obtain recertification from the prescriber and keep in the provider's records a recertification of continuous medical need that the equipment is still medically necessary.

M. The Department shall review purchase prices and rental charges for items for which Medicare has not established a rate at least every 3 years.

N. If services are provided under a contract pursuant to Regulation .04F of this chapter, the Department shall reimburse the contracted vendor or vendors at rates and under conditions in accordance with the contract or contracts.

O. Once an item has been purchased in full, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered by the Department or its designee. The Department may arrange for the provision of recycled equipment under an exclusive contract with a vendor or vendors that have been awarded in accordance with State regulations and policies governing contracts and procurement. The Department also may determine the geographical scope and the types of equipment, or both, to be included under the contract. The vendor or vendors shall be reimbursed at a rate and under terms established in the contract.

P. For equipment that is not covered under a contract awarded under §O of this regulation, the provider that originally furnished the equipment to the recipient shall recover the equipment after it is no longer required by the recipient. After recovery of the equipment, the provider shall determine the viability of recycling the item and, upon its reissue, bill the Program 75 percent of the Program's original payment.

Q. To the extent that the Department chooses to use an exclusive contract to provide recycled equipment under §O of this regulation, the Department shall reimburse providers for evaluation of a recipient for equipment that is subsequently provided through the Department's recycling program at 11.5 percent of the reimbursement rate established under §§AH of this regulation.

R. The Department will authorize payment on Medicare claims if:

  (1) The provider accepts Medicare assignments;

  (2) Medicare makes direct payment to the provider;

  (3) Medicare has determined that services were medically justified;

  (4) The services are covered by the Program;

  (5) Initial billing is made directly to Medicare according to Medicare guidelines.

S. Supplemental payments on Medicare claims are made subject to the following provisions:

  (1) Deductible insurance will be paid in full;

  (2) Coinsurance will be paid in full;

  (3) Services not covered by Medicare, but by the Program, will be paid in accordance with the limitations of §I of this regulation.

T. The provider may not bill the Department for:

  (1) Completion of forms and reports;

  (2) Broken or missed appointments;

  (3) Professional services rendered by mail or telephone; or

  (4) Fitting, dispensing, or follow-up care except as set forth in §D of this regulation.

U. The methodology in §§F and G of this regulation shall be used to establish a list of approved items with the corresponding procedure code, maximum allowable reimbursement amount, useful life expectancy, and maximum number allowed. This list shall be made available to the providers for ease of administration of the Program. When the approved list of items contains a price for a procedure code, the Department shall reimburse providers the lesser of the price listed in the approved list or the provider’s customary charge unless the service is free to individuals not covered by Medicaid.

V. The provider shall ensure that the equipment is in good working condition both throughout the rental of the equipment and at the end of the rental term.

W. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.

X. Durable medical equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing medical equipment and supplies.

Y. Refills.

  (1) For durable medical equipment or disposable supplies, or both that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order.

  (2) The provider shall maintain documentation of contact and confirmation of any changes and modifications of the order for audit purposes.

  (3) The provider shall contact the recipient or designee regarding refills no earlier than 7 business days before the anticipated delivery date or anticipated shipping date.

  (4) For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product.

Z. The disposable medical supplies or durable medical equipment provider shall identify the individual who ordered the disposable medical supplies and durable medical equipment by recording the individual practitioners National Provider Identifier (NPI) number on the claim.

#### Regulation .08 Recovery and Reimbursement.

*COMAR 10.09.12.08*

Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.

#### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions.

*COMAR 10.09.12.09*

Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.

#### Regulation .10 Appeal Procedures.

*COMAR 10.09.12.10*

Appeal procedures shall be as set forth in COMAR 10.09.36.09.

#### Regulation .11 Interpretive Regulation.

*COMAR 10.09.12.11*

State Regulations shall be interpreted as set forth in COMAR 10.09.36.10.