# COMAR Title 10 — Maryland Department of Health

## Subtitle 09 — Medical Care Programs

### Chapter 02 — Physicians' Services

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

**Administrative History:** Effective date: July 1, 1967

**Administrative History:** Amended effective September 1, 1967; October 1, 1967; January 1, 1969; July 1, 1969; December 1, 1969; July 1, 1970; July 1, 1971; January 1, 1976 (2:29 Md. R. 1739)

**Administrative History:** Regulation .22 adopted effective October 13, 1976 (3:21 Md. R. 1206); recodified as Regulation .11 on December 8, 1976 (3:25 Md. R. 1467)

**Administrative History:** Existing regulations repealed and new Regulations .01—.10 adopted effective December 8, 1976 (3:25 Md. R. 1467)

**Administrative History:** Regulation .02C amended effective December 15, 1978 (5:25 Md. R. 1854)

**Administrative History:** Regulation .04D amended effective December 15, 1978 (5:25 Md. R. 1854)

**Administrative History:** Regulation .04K, L adopted effective January 13, 1978 (5:1 Md. R. 18)

**Administrative History:** Regulation .04K amended effective July 1, 1978 (5:12 Md. R. 967)

**Administrative History:** Regulation .04L repealed effective July 1, 1978 (5:12 Md. R. 967)

**Administrative History:** Regulation .05F adopted effective December 15, 1978 (5:25 Md. R. 1854)

**Administrative History:** Regulation .07 amended effective December 15, 1978 (5:25 Md. R. 1854)

**Administrative History:** Regulation .07G amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979)

**Administrative History:** Regulation .07I amended effective April 6, 1979 (6:7 Md. R. 676); repealed effective July 1, 1979 (6:13 Md. R. 1126)

**Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)

**Administrative History:** Regulation .11 repealed effective June 29, 1979 (6:13 Md. R. 1126)

**Administrative History:** Regulations .01—.08 amended effective July 1, 1979 (6:13 Md. R. 1126)

**Administrative History:** Regulation .01 amended effective December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulation .01A-1, A-2, A-3, N-2 adopted effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .01B amended effective October 15, 1990 (17:20 Md. R. 2426); December 29, 1997 (24:26 Md. R. 1757); March 6, 2000 (27:4 Md. R. 453)

**Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)

**Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulations .01B, .03B, .06, and .07Q amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1286) (Emergency provisions are temporary and not printed in COMAR)

**Administrative History:** Regulation .01B amended effective July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .01J-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .01N-1 adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721)

**Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .03 amended effective July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .03A amended effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .03B adopted effective December 29, 1997 (24:26 Md. R. 1757)

**Administrative History:** Regulation .03B amended effective March 6, 2000 (27:4 Md. R. 453); August 28, 2017 (44:17 Md. R. 834)

**Administrative History:** Regulation .03G amended effective October 1, 1985 (12:19 Md. R. 1848); December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572)

**Administrative History:** Regulation .03I—K amended effective December 12, 1988 (15:25 Md. R. 2902)

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

**Administrative History:** Regulation .03K adopted effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .03 amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)

**Administrative History:** Regulation .03O adopted effective October 15, 1990 (17:20 Md. R. 2426)

**Administrative History:** Regulation .04 amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183)

**Administrative History:** Regulation .04 amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221)

**Administrative History:** Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453)

**Administrative History:** Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .04A amended effective August 17, 1981 (8:16 Md. R. 1365); December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulation .04A amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)

**Administrative History:** Regulation .04A amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)

**Administrative History:** Regulation .04A amended effective February 3, 2014 (41:2 Md. R. 91); August 28, 2017 (44:17 Md. R. 834)

**Administrative History:** Regulation .04C amended effective December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulation .04G amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) (adopted as Regulation .04K; recodified as Regulation .04G at 6:13 Md. R. 1126)

**Administrative History:** Regulation .04G amended as an emergency provision effective July 28, 1980 (7:16 Md. R. 1588); adopted permanently effective November 28, 1980 (7:24 Md. R. 2257)

**Administrative History:** Regulation .04G amended effective December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulation .04J adopted effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .05A amended effective August 12, 1985 (12:16 Md. R. 1606); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2902); December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); February 5, 2001 (28:2 Md. R. 99)

**Administrative History:** Regulation .05A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulation .05A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)

**Administrative History:** Regulation .05A amended effective June 23, 2014 (41:12 Md. R. 667); December 10, 2015 (42:24 Md. R. 1505); July 10, 2023 (50:13 Md. R. 512); June 24, 2024 (51:12 Md. R. 618)

**Administrative History:** Regulation .05D amended effective December 12, 1988 (15:25 Md. R. 2902)

**Administrative History:** Regulations .05G and .06A adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721)

**Administrative History:** Regulation .05H adopted effective October 15, 1990 (17:20 Md. R. 2426)

**Administrative History:** Regulation .05H repealed effective March 6, 2000 (27:4 Md. R. 453)

**Administrative History:** Regulation .05H adopted as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); adopted permanently effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulation .05I adopted effective July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .06A amended effective June 20, 1983 (10:12 Md. R. 1072); February 9, 1987 (14:3 Md. R. 273); December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757)

**Administrative History:** Regulation .06A amended effective October 10, 2016 (43:20 Md. R. 1109)

**Administrative History:** Regulation .06A, D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708)

**Administrative History:** Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834)

**Administrative History:** Regulation .06F adopted effective December 29, 1997 (24:26 Md. R. 1757)

**Administrative History:** Regulation .07 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 .07 amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890)

**Administrative History:** Regulation .07 amended effective March 6, 2000 (27:4 Md. R. 453)

**Administrative History:** Regulation .07 amended as an emergency provision effective December 18, 2003 (31:2 Md. R. 81); amended permanently effective April 26, 2004 (31:8 Md. R. 646)

**Administrative History:** Regulation .07 amended effective June 14, 2021 (48:12 Md. R. 470); July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .07C amended effective December 16, 1996 (23:25 Md. R. 1785)

**Administrative History:** Regulation .07C, E, I amended effective July 4, 2016 (43:13 Md. R. 712)

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

**Administrative History:** Regulation .07D amended effective December 6, 1982 (9:24 Md. R. 2390); May 1, 1983 (10:8 Md. R. 725); November 21, 1983 (10:23 Md. R. 2063)

**Administrative History:** Regulation .07D amended as an emergency provision effective January 27, 1984 (11:4 Md. R. 312); emergency status expired May 26, 1984

**Administrative History:** Regulation .07D amended effective May 27, 1984 (11:10 Md. R. 863)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811)

**Administrative History:** Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542)

**Administrative History:** Regulation .07D amended as an emergency provision effective March 1, 1986 (13:6 Md. R. 668); emergency status expired June 30, 1986

**Administrative History:** Regulation .07D amended effective June 2, 1986 (13:11 Md. R. 1273);

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1986 (13:12 Md. R. 1371); amended permanently effective December 1, 1986 (13:18 Md. R. 2020)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); amended permanently effective October 6, 1986 (13:20 Md. R. 2210)

**Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987

**Administrative History:** Regulation .07D amended effective December 1, 1986 (13:22 Md. R. 2398)

**Administrative History:** Regulation .07D repealed and new Regulation .07D adopted effective February 9, 1987 (14:3 Md. R. 273); amended effective October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903); January 1, 1989 (15:26 Md. R. 2983); July 1, 1989 (16:12 Md. R. 1335)

**Administrative History:** Regulation .07D amended as an emergency provision effective September 8, 1989 (16:20 Md. R. 2178); adopted permanently effective January 1, 1990 (16:25 Md. R. 2710)

**Administrative History:** Regulation .07D amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427)

**Administrative History:** Regulation .07D amended effective December 9, 1991 (18:24 Md. R. 2643)

**Administrative History:** Regulation .07D amended as an emergency provision effective October 26, 1993 (20:23 Md. R. 1799); emergency status extended at 20:24 Md. R. 1863 and 21:11 Md. R. 949; emergency status expired July 4, 1994

**Administrative History:** Regulation .07D amended effective July 4, 1994 (21:13 Md. R. 1156)

**Administrative History:** Regulation .07D amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183); emergency status expired April 30, 1995

**Administrative History:** Regulation .07D amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221)

**Administrative History:** Regulation .07D amended effective December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757)

**Administrative History:** Regulation .07D amended effective February 5, 2001 (28:2 Md. R. 99)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2005 (32:17 Md. R. 1437); amended permanently effective October 24, 2005 (32:21 Md. R. 1707)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 27, 2007 (34:17 Md. R. 1507)

**Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774)

**Administrative History:** Regulation .07D amended effective November 16, 2009 (36:23 Md. R. 1817); November 14, 2011 (38:23 Md. R. 1421); October 28, 2013 (40:21 Md. R. 1775); December 22, 2014 (41:25 Md. R. 1478); February 27, 2017 (44:4 Md. R. 252); August 28, 2017 (44:17 Md. R. 834); August 27, 2018 (45:17 Md. R. 803); December 31, 2018 (45:26 Md. R. 1241); October 7, 2019 (46:20 Md. R. 844); June 24, 2024 (51:12 Md. R. 618); June 9, 2025 (52:11 Md. R. 532)

**Administrative History:** Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625)

**Administrative History:** Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430)

**Administrative History:** Regulation .07J, M, N amended effective December 12, 1988 (15:25 Md. R. 2902)

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

**Administrative History:** Regulation .07O 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 March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)

**Administrative History:** Regulation .07Q amended effective December 29, 1997 (24:26 Md. R. 1757)

**Administrative History:** Regulation .07R adopted effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .07S adopted effective December 16, 1996 (23:25 Md. R. 1785)

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

**Administrative History:** Regulation .08A amended effective December 12, 1988 (15:25 Md. R. 2902); July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .09A, B amended effective March 1, 1982 (9:4 Md. R. 331)

**Administrative History:** Regulation .09E amended effective December 12, 1988 (15:25 Md. R. 2902): July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .09F adopted effective October 1, 1985 (12:19 Md. R. 1848)

**Administrative History:** Regulation .09F amended effective July 10, 2023 (50:13 Md. R. 512)

**Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84)

**Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)

**Administrative History:** Regulation .11 amended effective July 10, 2023 (50:13 Md. R. 512)

#### Regulation .01 Definitions.

*COMAR 10.09.02.01*

A. The following terms have the meanings indicated.

B. Terms Defined.

  (1) “Attending physician” means a physician, other than a house officer, resident, intern, or emergency room physician, directly responsible for the patient's care.

  (2) “Board” means the Board of Physician quality Assurance.

  (3) “Consultant-specialist” means a licensed physician who meets one of the following criteria:

    (a) Has been declared board certified by a member board of the American Board of Medical Specialties and currently retains that status;

    (b) Can demonstrate satisfactory completion of a residency program accredited by the Liaison Committee for Graduate Medical Education, or the appropriate Residency Review Committee of the American Medical Association;

    (c) Has been declared board certified by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association;

    (d) Has been declared board eligible by a specialty board approved by the Advisory Board of Osteopathic Specialists;

    (e) Can demonstrate, if a residency program was completed in a foreign country, that qualifications and training are acceptable for admission into the examination system of the appropriate American Specialty Board.

  (4) “Consultation” means written opinion or advice rendered by a consultant-specialist whose opinion or advice is requested by the patient's attending physician for the further evaluation or management of the patient by the attending physician. If the consultant-specialist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant-specialist is not a consultation. The consultation shall be provided in the specialty in which the consultant-specialist is registered with the Program.

  (5) “Cosmetic surgery” means surgery which can be expected to improve a patient's physical appearance, but does not restore or materially improve a body function.

  (6) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.

  (7) “Direct supervision” means that a physician-employer is physically present in the same area of a facility as a nonphysician providing the service or services. A physician may supervise only two nonphysician practitioners at any given time.

  (8) “Free-standing clinics” means those clinics not associated with a hospital which are under the direction of a physician or dentist.

  (9) “Hospital” means any 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.

  (10) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.

  (11) “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.

  (12) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.

  (13) “Medicare-Certified Facility” means one which is certified for Medicare by the regional office of the Health Care Financing Administration to furnish dialysis services directly to chronic kidney disease patients.

  (14) “Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A.

  (15) “Multispecialty setting” means that type of medical practice which exists in a teaching hospital or in a group practice which is composed of physicians with different specialties.

  (16) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.

  (17) “Patient” means a recipient awaiting or undergoing health care or treatment.

  (18) “Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located.

  (19) “Preauthorization” means an approval required from the Department or its designee before services can be rendered.

  (20) “Preoperative day” means an inpatient day in a general hospital before surgery for a patient admitted for a surgical procedure, or a day before surgery for a patient admitted for a nonsurgical service as an inpatient in a general hospital once the need for surgery has been established and the patient's condition is satisfactory for surgery.

  (21) “Prescriber” means a physician, dentist, podiatrist, or other professional authorized to prescribe legend drugs and authorized by the Department to participate in the Program.

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

  (23) “Program” means the Maryland Medical Assistance Program.

  (24) “Provider” means an individual, association, partnership, or incorporated or unincorporated group of physicians duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number.

  (25) “Referral” means a transfer of the patient from one physician to another for diagnosis and treatment of the condition for which the referral was made. The physician to whom the referral is made, whether a generalist or specialist, will be considered as the primary care physician and not as a consultant.

  (26) “United States” means the 50 states, the District of Columbia, and the U.S. territories.

  (27) “Utilization control agent (UCA)” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to professional standards.

#### Regulation .02 License Requirements.

*COMAR 10.09.02.02*

A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.

B. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided.

C. The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.02 or other applicable standards established by the state in which the service is provided.

D. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:

  (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or

  (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.

#### Regulation .03 Conditions for Participation.

*COMAR 10.09.02.03*

A. General requirements for participation in the Program are that a provider shall:

  (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and

  (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.

B. Specific requirements for participation in the Program as a physicians’ services provider require that the provider:

  (1) Shall submit documentation of consultant-specialist status if applying for that status;

  (2) May not place a restriction on a participant’s right to select providers of his or her choice;

  (3) May not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department;

  (4) Shall agree to personally sign all requests for laboratory or other diagnostic services, or to require that copies of personally signed order sheets be supplied to participating providers of these services;

  (5) Shall agree, when requesting laboratory or other diagnostic services, to supply his or her individual practitioner identification (rendering) number to those participating providers;

  (6) Shall agree to identify by the individual physician practitioner's identification number each physician assistant who is authorized by the physician to request laboratory services; and

  (7) Shall comply with the requirements for the delivery of mental health services in accordance with COMAR 10.09.59 and 10.67.08.

#### Regulation .04 Covered Services.

*COMAR 10.09.02.04*

The Program covers the following medically necessary services rendered to participants:

A. Physicians’ services rendered in the physician’s office, the participant’s home, a hospital, a skilled or intermediate care nursing facility, a freestanding clinic, or elsewhere when these services are:

  (1) Performed by the physician or one of the following:

    (a) Another licensed physician either in the physician's employ or one who renders services through a reciprocal agreement as a substitute physician,

    (b) A certified registered physician's assistant, licensed registered nurse, certified psychologist, or a certified social worker, provided that the individual performing the service is in the physician's employ and is under the physician's direct supervision and performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of physicians' services,

    (c) A certified nurse midwife who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.05; and

    (d) A certified nurse practitioner who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.07.

  (2) Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services;

  (3) Adequately described in the participant’s medical record;

B. Consultations;

C. Diagnostic procedures to include:

  (1) Procedures related to the patient's medical needs;

  (2) Laboratory services performed by a physician or personnel under the physician's direct supervision, when the physician is not required to register his office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland;

D. Drugs dispensed by the physician within the limitations of COMAR 10.09.03;

E. Injectable drugs administered by the provider within the limitations of COMAR 10.09.03;

F. Medical equipment and supplies dispensed by the physician within the limitations of COMAR 10.09.12;

G. Abortions performed in accordance with the Health-General Article, Title 20, Subtitles 1 and 2, Annotated Code of Maryland;

H. Sterilizations when performed according to criteria contained in 42 Code of Federal Regulations §§441.250—441.258 and when the appropriate forms, as established by guideline, are properly completed and attached to the claim;

I. Vaccine administrations when the vaccines:

  (1) Meet the following conditions for coverage under the Vaccines for Children Program:

    (a) Covered under the Vaccines for Children program;

    (b) Administered to participants eligible for the Vaccines for Children program; and

    (c) Administered by providers eligible to be reimbursed for vaccine administration under the Vaccines for Children program; or

  (2) Are supplied to providers by the federal government at no charge, including but not limited to the administration of COVID-19 vaccinations.

#### Regulation .05 Limitations.

*COMAR 10.09.02.05*

A. Services which are not covered are:

  (1) Physician services not medically justified;

  (2) Nonemergency dialysis services related to chronic kidney disorders unless they are provided in a Medicare-certified facility;

  (3) Physician inpatient hospital services rendered during any period that is in excess of the length of stay authorized by the Utilization control agent (UCA);

  (4) Physician services denied by Medicare as not medically necessary;

  (5) Services which are investigational or experimental;

  (6) Autopsies;

  (7) Physician services included as part of the cost of an inpatient facility, hospital outpatient department, or free-standing clinics;

  (8) Payment to physicians for specimen collections, except by venipuncture, and capillary or arterial puncture;

  (9) Injectable medications, and visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the patient’s medical records;

  (10) Vaccine administration unless covered under Regulation .04 of this chapter;

  (11) Visits solely to accomplish one or more of the following:

    (a) Prescription, drug or food supplement pick-up, collection of specimens for laboratory procedures,

    (b) Recording of an electrocardiogram,

    (c) Ascertaining the patient's weight;

  (12) Interpretation of laboratory tests or panels;

  (13) Medical Assistance prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control;

  (14) Drugs and supplies dispensed by the physician which are acquired by the physician at no cost;

  (15) Disposable medical supplies;

  (16) Services prohibited by the Board of Physician Quality Assurance;

  (17) Services which are provided outside the United States;

  (18) Services which do not involve direct patient contact;

  (19) Sterilization reversal procedures;

  (20) Prescriptions for drugs written on prescription pads that do not prevent copying, modification, or counterfeiting;

  (21) Physician-administered drugs from manufacturers that do not participate in the Federal Drug Rebate Program; and

  (22) Any covered service that requires a preauthorization, including physician-administered drugs and injectable medications, that is rendered without an approved preauthorization from the Program.

B. Preoperative evaluations for anesthesia are included in the fee for administration of anesthesia and the provider may not bill them as consultations.

C. Referrals from one physician to another for treatment of specific patient problems may not be billed as consultations.

D. The operating surgeon may not bill for the administration of anesthesia or for an assistant surgeon who is not in the operating surgeon's employ.

E. Payment for consultations provided in a multispecialty setting is limited by criteria established by the Department.

F. The Department will not pay a provider for those laboratory or x-ray services performed by another facility. The Department will pay directly the facility performing those services.

G. The Program does not cover services rendered to an inpatient before one preoperative inpatient day, unless preauthorized by the Program.

H. The provider may not bill the Program for services rendered under the supervising physician's provider number by an employed nonphysician extender, such as:

  (1) A physical therapist;

  (2) An occupational therapist;

  (3) A speech language pathologist;

  (4) An audiologist; or

  (5) A nutritionist.

I. Services not rendered in-person shall comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department.

#### Regulation .06 Preauthorization Requirements.

*COMAR 10.09.02.06*

A. The following procedures or services require preauthorization:

  (1) Cosmetic surgery;

  (2) Contact lens evaluation and fitting;

  (3) Lipectomy and panniculectomy;

  (4) Transplantations of vital organs;

  (5) Services rendered to an inpatient before one preoperative day;

  (6) Surgical procedures for the treatment of obesity;

  (7) Surgical procedures for the purpose of gender reassignment; and

  (8) Elective services from a noncontiguous state.

B. Services which have been determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document medical necessity in a particular case. These services are found in the Medicare Carriers Manual, Part 3, Claims Process, Chapter II, Coverage Issues Appendix.

C. Physicians dispensing or prescribing eyeglasses shall comply with the requirements of COMAR 10.09.14.

D. The Department will preauthorize services when the provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.

E. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. Non-Medicare claims require preauthorization according to §§A—D of this regulation.

F. Physicians rendering mental health services shall comply with the preauthorization requirements of COMAR 10.09.70.07.

#### Regulation .07 Payment Procedures.

*COMAR 10.09.02.07*

A. The provider shall submit the request for payment on the form designated by the Department.

B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department.

C. Except as provided in §F of this regulation, the Provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid:

  (1) The provider:

    (a) May charge the Program; and

    (b) Shall be reimbursed in accordance with §D of this regulation; and

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

D. The Maryland Medical Assistance Program's procedures for payment are contained in the following documents, the provisions of which are incorporated by reference:

  (1) The Professional Services Provider Manual and Fee Schedule (Effective January 2024); and

  (2) The Medical Laboratories Fee Schedule pursuant to COMAR 10.09.09.07D.

E. Except as provided in §F of this regulation, the Department will pay for covered services at the lesser of:

  (1) Physician's customary charge or acquisition cost unless the service is free to individuals not covered by Medicaid; or

  (2) The Department's fees in accordance with §D of this regulation.

F. The Program shall reimburse providers up to the acquisition cost for diagnostic and therapeutic radiopharmaceuticals, contraceptive products and devices, and injectable medications when the provider submits documentation indicating that the acquisition cost of the product, device, or drug is greater than the reimbursement allowed in §E of this regulation.

G. The Program reserves the right to negotiate and establish a different fee for a physician or a group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital's cost, provided this fee does not exceed limitations set forth in §E of this regulation.

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

  (1) Deductible insurance will be paid in full;

  (2) Beginning with August 1, 2010 dates of service, and subject to the limitations of the State budget, coinsurance, shall be paid:

    (a) In full for the following:

      (i) Mental health services;

      (ii) CPT codes that are priced by report;

      (iii) Claims for anesthesia services;

      (iv) Claims from a federally qualified health center; and

      (v) HCPCS codes beginning with A through W; and

    (b) For all other claims, at the lesser of:

      (i) 100 percent of the coinsurance amount; or

      (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and

  (3) Services not covered by Medicare are payable according to §E of this regulation.

I. Payments on Medicare claims are authorized if the:

  (1) Provider accepts Medicare assignments;

  (2) Medicare makes direct payment to the provider;

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

  (4) Services are covered by the Program;

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

J. The provider may not bill the Department or the participant for:

  (1) Completion of forms and reports;

  (2) Broken or missed appointments;

  (3) Professional services rendered by mail; or

  (4) Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant.

K. The Program will make no direct payment to participants.

L. The Program will reimburse the provider for dispensed drugs at rates established in COMAR 10.09.03. The provider shall bill the Program in accordance with COMAR 10.09.03 using the Pharmacy Invoice.

M. The Program will reimburse the provider for dispensed medical supplies at actual cost or at rates established by COMAR 10.09.12, whichever is less.

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

O. Providers shall bill the Program in the following manner:

  (1) A physician whose laboratory is not required to be registered pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under these regulations;

  (2) A physician whose laboratory is registered as a medical laboratory pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under COMAR 10.09.09.

P. Reimbursement.

  (1) The Program shall reimburse providers for all laboratory and other diagnostic services performed by a physician, or by authorized personnel under that physician's supervision, for that physician's patients.

  (2) Reimbursement shall be according to all applicable provisions of COMAR 10.10.06 and fees established according to §D of this regulation.

  (3) Maximum reimbursement may not exceed the Medicare laboratory fee established by the Maryland Medicare carrier recognized by the Program.

  (4) The Program shall reimburse providers for mental health services performed by a physician according to the fees established under COMAR 10.21.25 and the requirements of this chapter.

#### Regulation .08 Recovery and Reimbursement.

*COMAR 10.09.02.08*

A. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less.

B. The provider shall reimburse the Department for any overpayment.

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

*COMAR 10.09.02.09*

A. If the Department determines that a provider, physician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:

  (1) Suspension from the Program;

  (2) Withholding of payment by the Program;

  (3) Removal from the Program;

  (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.

B. If the Secretary of Health and Human Services suspends or removes a physician from participation in Medicare, the Department will take similar action.

C. The Department may consult with the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The Department will give the findings and recommendations of this group consideration.

D. The Department will give the provider reasonable notice of its intention to impose sanctions. In the written notice the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal.

E. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards.

F. If the Department determines that a provider participating in the Program as a case manager has violated any provision of the agreement executed under the terms of Regulation .03B of this chapter, the Program may suspend or disqualify the provider from participating as a case manager without otherwise restricting the provider’s participation as a physician.

#### Regulation .10 Appeal Procedures.

*COMAR 10.09.02.10*

Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.

#### Regulation .11 Interpretive Regulation.

*COMAR 10.09.02.11*

Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.