1. 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. (1) Disposable medical supplies;
   2. (2) Durable medical equipment;
   3. (3) Repairs to purchased durable medical equipment;
   4. (4) All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;
   5. (5) Orthotic devices;
   6. (6) Repair of orthotic devices;
   7. (7) Replacement of orthotic devices;

   8. (8) Prosthetic devices which include:

      1. (a) Artificial eyes;
      2. (b) Breast prostheses, including surgical brassiere;
      3. (c) Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and
      4. (d) Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function;
   9. (9) Repair of prosthetic devices;
   10. (10) Replacement of prosthetic devices;
   11. (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. (12) Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter;
   13. (13) Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and
   14. (14) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home.

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

   1. (1) Home;
   2. (2) School; or
   3. (3) Place of employment.
3. 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.
4. 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.
5. E. Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions.

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

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

      1. (a) A change in the physiological condition of the patient;
      2. (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
      3. (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. (2) For devices more than 3 years old subject to §§B and C of this regulation.

7. G. Documentation Required.

   1. (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:

      1. (a) Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services;
      2. (b) Recertifications of continuous medical need;
      3. (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;
      4. (d) Make, model, and serial number of the item, as applicable; and
      5. (e) Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology.
   2. (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. (3) Documentation shall be retained for 6 years and be made available upon request by the Department.
8. 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.

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

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

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

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

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

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

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

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

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

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)

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

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

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

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)

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

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

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);

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)

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

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

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)

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)

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

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

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

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

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)

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)

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

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)

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

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

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

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

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))

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)

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

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

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

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

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

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)

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)

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

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)

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)

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

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)

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

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

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

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

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

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)

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

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

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

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

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)

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

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)

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

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