This chapter governs exemptions from the prohibition on self-referral made by the Secretary in conjunction with the Maryland Health Care Commission. This chapter creates the means by which the Secretary and the Maryland Health Care Commission can determine whether: A health care practitioner's beneficial interest is essential to finance and to provide a health care entity; and The health care entity is needed to ensure appropriate access for a community to the services provided by the health care entity. This chapter interprets certain definitions and terms used in the statute for the purpose of enforcement by the licensing boards of the Maryland Department of Health. For the purpose of enforcing Health Occupations Article, §1-301 et seq., Annotated Code of Maryland, the following terms have the meanings indicated. Terms Defined. “Group practice” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. Health Care Service. “Health care service” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. “Health care service” includes but is not limited to: Supplies; Drugs; and Items furnished to a patient by a health care entity.. “Members of the group” means health care practitioners: With an ownership interest in the group practice; or Who are full-time or part-time contractors or employees during the time they furnish services to patients of the group practice that are furnished through the group and are billed in the name of the group. “Patient care services” means the total patient care time spent on any task performed by a group practice member that addresses the medical needs of specific patients, regardless of whether they involve direct patient encounters, and including but not limited to time spent: By a member of the group in consultation with other health care practitioners, whether or not they are members of the group; and Reviewing laboratory tests, as well as the services of other health care practitioners who do not directly treat patients. “Personally supervised” means the responsibility of a health care practitioner to exercise on-site supervision or immediately available direction for employees performing referred in-office ancillary services or tests. “Referring health care practitioner” means a health care practitioner, or group practice, who makes a referral. “Rental or lease of office space” means payments made for the rental or lease of utilities, use of equipment, and secretarial and support staff. In this chapter, the following terms have the meanings indicated. Terms Defined. “Area of concentration” means a limitation of practice by demonstrable training and competence of a health care practitioner. “Department” means the Maryland Department of Health. “Essential” means a health care entity would not be able to exist but for the health care practitioner's beneficial interest in the health care entity. “Health care entity” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. Health Care Practitioner. “Health care practitioner has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. “Health care practitioner” does not include a mortician, an assisted living manager, or a nursing home administrator, unless the mortician, assisted living manager, or nursing home administrator is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services by any board other than the Board of Morticians and Funeral Directors or the Board of Long-Term Care Administrators. “Maryland Health Care Commission (MHCC)” means the Maryland Health Care Commission. “Referral” has the meaning stated in Health Occupation Article, §1-301, Annotated Code of Maryland. “Requestor” means an individual other than the health care practitioner who is an attorney admitted to the Maryland Bar or specially admitted to practice law in the State under Maryland Rules Title 19. “Secretary” means the Secretary of the Maryland Department of Health or their designee. “Specialty” means “area of concentration” as defined in §B(1) of this regulation. The Secretary may exempt a health care practitioner from the prohibition on self-referral pursuant to Health Occupations Article, §1-302(d)(5), Annotated Code of Maryland, in accordance with this chapter. A health care practitioner who has or wishes to have a beneficial interest in a health care entity may request from the Secretary an exemption from the self-referral laws. In order for a health care practitioner to obtain an exemption by the Secretary from the self-referral laws, the health care practitioner shall make a request to the Secretary in the manner specified by the Department that: Identifies the street address, political subdivision, and area of concentration of both the health care practitioner and the entity in which the practitioner has or wishes to have a beneficial interest; Demonstrates to the Secretary's satisfaction that the health care practitioner's beneficial interest is: Essential to finance and to provide the health care entity; and Needed to ensure appropriate access for the community to the services provided at the health care entity; States when the services are proposed to begin; Provides the health care practitioner’s: Name; Licensing board; License number; License expiration date; Business address; and Business telephone number; Includes an attestation in writing that, if the health care practitioner seeks renewal of an exemption from the Secretary and the Secretary no longer deems the beneficial interest to be essential, the practitioner shall: Immediately cease accepting any referrals from sources prohibited under Health Occupations Article, §1-301 et seq., Annotated Code of Maryland; or Divest the practitioner's beneficial interest in the entity within 1 year after the exemption is no longer applicable. Request to MHCC. The Secretary shall request, in writing, the advice of the Executive Director of the MHCC concerning whether the beneficial interest is needed to ensure appropriate access for the community to the services provided at the health care entity. The Secretary shall provide, with the request to the Executive Director of the MHCC, a copy of any materials submitted to the Department in accordance with §B of this regulation and any additional items which may be pertinent to the MHCC’s review. The Secretary shall follow the timetable set forth in Regulation .06 of this chapter. The Executive Director of the MHCC shall advise the Secretary in accordance with the timetable in Regulation .06 of this chapter as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity. If additional information is needed by the Secretary or the Executive Director of MHCC for their determination, the Department may ask the health care practitioner to provide additional information to establish that the practitioner’s beneficial interest is: Essential to finance and to provide the health care entity; and Needed to ensure appropriate access for the community to the services provided at the health care entity. The Secretary shall make the required determinations within 90 calendar days following receipt of a health care practitioner's request for exemption. The Secretary shall request advice from the Executive Director of the MHCC as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 30 calendar days of receipt of the health care practitioner’s request for exemption. The Executive Director of the MHCC shall advise the Secretary as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 60 calendar days after receipt of the Secretary's letter. The term of an exemption shall be in conjunction with a health care practitioner's professional license renewal and shall be renewed at the same time the health care practitioner's professional license is renewed. The exemption expires at the end of its term, unless the exemption is renewed in accordance with this regulation. An exempted health care practitioner, on renewal, shall meet all the requirements of this chapter at the time of renewal. Each health care practitioner who has been exempted by the Secretary from the prohibition on self-referral as an essential health care entity needed for access to health care shall renew the health care practitioner's exemption status in the manner provided by the Department at the time of licensure, certification, or other form of practice renewal authorized under the Health Occupations Article, Annotated Code of Maryland, within the time period specified on the form. At a minimum, the health care practitioner shall provide, at the time of renewal, to the Department: A copy of the initial exemption request; A copy of the Secretary’s approval of the initial exemption; The items specified in Regulation .05B of this chapter; and Any additional pertinent information as requested by the Secretary. Each exempted health care practitioner shall keep the appropriate licensing, certification, or other practice authorizing board apprised of the health care practitioner’s current business address. On request by the Department, the relevant board or boards shall supply the current business addresses of exempted health care practitioners. The Department shall mail a notice of the required renewal to the health care practitioner at the current business address supplied by the appropriate board. If an exempted health care practitioner does not receive notice of renewal, it is the exempted health care practitioner's responsibility to notify the Department so that the Secretary may renew the exemption before the expiration of the current exemption. Failure to Renew Exemption. If an exempted health care practitioner fails to renew the exemption, the practitioner is not considered exempted under the Health Occupations Article, §1-301(d)(5), Annotated Code of Maryland. If an exempted health care practitioner fails to renew the exemption, and fails to carry out the agreed requirements set forth in Regulation .05B(6) of this chapter, the practitioner shall be subject to disciplinary action as set forth in Health Occupations Article, §1-307, Annotated Code of Maryland, for violation of the self-referral laws. Health-General Article, §2-104(b); Health Occupations Article, §1-301 et seq., Annotated Code of Maryland Effective date: June 25, 2001 (28:12 Md. R. 1106) Regulation .02B amended effective March 30, 2026 (53:6 Md. R. 290) Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 290) Regulation .05 amended effective March 30, 2026 (53:6 Md. R. 290) Regulation .06 amended effective March 30, 2026 (53:6 Md. R. 290) Regulation .07 amended effective March 30, 2026 (53:6 Md. R. 290)