# COMAR Title 10 — Maryland Department of Health

## Subtitle 18 — Human Immunodeficiency Virus (HIV) Infection and Acquired Immunodeficiency Syndrome (AIDS)

### Chapter 01 — Maryland AIDS Drug Assistance Program: Temporary Assistance Program

**Authority:** Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland

**Administrative History:** Effective date: March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488)

#### Regulation .01 Purpose.

*COMAR 10.18.01.01*

The purpose of the Maryland AIDS Drug Assistance Program’s Temporary Assistance Program is to provide short term assistance to individuals with Human Immunodeficiency Virus (HIV) who:

A. Need HIV drugs and other products;

B. Have an application for Medical Assistance or Low-Income Subsidy pending; and

C. Are considered likely to have their application approved.

#### Regulation .02 Definitions.

*COMAR 10.18.01.02*

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

B. Terms Defined.

  (1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.

  (2) “Agent” means a case manager, licensed social worker, registered nurse, or any other related professional that assists an individual in submitting an application to the Temporary Assistance Program.

  (3) “Applicant” means an individual on whose behalf an application has been submitted to the Temporary Assistance Program and whose eligibility status for the Temporary Assistance Program has not yet been determined.

  (4) “Department” means the Maryland Department of Health.

  (5) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration, and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04.

  (6) “Enrollment period” means the period of time a recipient may receive Temporary Assistance Program benefits.

  (7) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.

  (8) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS.

  (9) “Low-Income Subsidy (LIS)” means the federal program available under the Medicare Part D prescription drug program and Medicare advantage plans that assists persons who have limited income to pay for the cost of premiums, deductibles, and copayments.

  (10) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.

  (11) “Medical Assistance” has the meaning specified in COMAR 10.09.24.02.

  (12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department per COMAR 10.18.06.04-1.

  (13) “Recipient” means an individual who is enrolled in the Temporary Assistance Program.

  (14) “Resident” means an individual:

    (a) Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and

    (b) For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of residence.

  (15) “Temporary Assistance Program (TAP)” means the program administered by the Department that provides short term MADAP services as specified in Regulation .05 of this chapter for low income eligible individuals.

#### Regulation .03 Eligibility.

*COMAR 10.18.01.03*

To be eligible for benefits, an individual shall meet the following criteria:

A. Be a resident of Maryland;

B. Be infected with HIV; and

C. Have a pending application to Medical Assistance or LIS.

#### Regulation .04 Application and Enrollment.

*COMAR 10.18.01.04*

A. Application.

  (1) The agent of the applicant shall submit a completed TAP application to the Department on the form designated by the Department that includes:

    (a) Responses to all applicable questions; and

    (b) A copy of the completed application or other verifiable documentation for Medical Assistance or LIS enrollment.

  (2) The agent of the applicant or the applicant may voluntarily withdraw the application at any time without prejudice.

  (3) The Department shall:

    (a) Review and process a TAP application by the end of the first business day following receipt;

    (b) Approve a TAP application if the:

      (i) TAP application is complete;

      (ii) Applicant is determined to be eligible; and

      (iii) Department is able to ascertain that the applicant will likely be found eligible for Medical Assistance or LIS;

    (c) Issue a client identification number if the TAP application is approved;

    (d) Disapprove a TAP application if the:

      (i) TAP application is incomplete; or

      (ii) Agent of the applicant fails to provide sufficient information or documentation to determine eligibility; and

    (e) Contact the agent of the applicant with the status of the TAP application.

B. Enrollment.

  (1) A recipient shall be approved for coverage beginning the first day of the month in which the:

    (a) TAP application was received; or

    (b) Recipient will need access to medications through TAP.

  (2) Benefits shall end on the date that a determination of Medical Assistance or LIS coverage occurs.

#### Regulation .05 Covered Services.

*COMAR 10.18.01.05*

A. The recipient shall obtain a prescription for each drug or other product ordered for the recipient.

B. The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.

#### Regulation .06 Recovery of Payments.

*COMAR 10.18.01.06*

If benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.

#### Regulation .07 Fraud.

*COMAR 10.18.01.07*

The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.

#### Regulation .08 Confidentiality.

*COMAR 10.18.01.08*

Except when communicating with the parties listed in §B of this regulation and unless otherwise authorized by law, the agent of an applicant, or the agent of a recipient, the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on an applicant or recipient without written consent of the:

  (1) Applicant;

  (2) Recipient;

  (3) Applicant’s parent or legal guardian; or

  (4) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

  (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

  (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

#### Regulation .09 Availability of Funding and Program Termination.

*COMAR 10.18.01.09*

A. If sufficient monies are not available to fund TAP, the Department shall take the action necessary to eliminate a deficit which may include program termination.

B. If TAP is terminated, the Department shall provide benefits for each current recipient in accordance with Regulation .04B of this chapter.

### Chapter 02 — HIV and CD4+ Investigations and Case Reporting

**Authority:** Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;State Government Article, §10-617; Annotated Code of Maryland

**Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220)

**Administrative History:** Chapter revised effective September 8, 2008 (35:18 Md. R. 1600)

**Administrative History:** Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518

**Administrative History:** Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518)

**Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)

#### Regulation .01 Scope.

*COMAR 10.18.02.01*

A. This chapter establishes the requirements for:

  (1) Physician reporting of a:

    (a) Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and

    (b) Birth of an infant whose mother has tested positive for HIV;

  (2) Institution reporting of a case of HIV or AIDS;

  (3) Laboratory reporting of a test result for:

    (a) HIV detection;

    (b) HIV viral load;

    (c) CD4+ cell count or percentage; or

    (d) HIV genotype sequence; and

  (4) Follow-up of:

    (a) A physician's report of HIV or AIDS;

    (b) A physician's report of an infant whose mother has tested positive for HIV;

    (c) An institution's report of HIV or AIDS; and

    (d) A laboratory’s report of a test result for:

      (i) HIV detection;

      (ii) HIV viral load;

      (iii) CD4+ cell count or percentage; or

      (iv) HIV genotype sequence infection or CD4+ count.

B. Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for:

  (1) HIV detection;

  (2) HIV viral load;

  (3) CD4+ cell count or percentage; or

  (4) HIV genotype sequence.

C. This chapter does not apply if the specimen from a human body is:

  (1) Not tested for:

    (a) HIV detection;

    (b) HIV viral load;

    (c) CD4+ cell count or percentage; or

    (d) HIV genotype sequence;

  (2) Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue;

  (3) Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test;

  (4) Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions:

    (a) All personal identifiers are removed from the specimen before testing;

    (b) The specimen cannot be linked to the individual from whom the specimen was taken;

    (c) The result cannot be linked to the individual from whom the specimen was taken; and

    (d) The research protocol has been approved by an institutional review board;

  (5) Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland;

  (6) Taken from a patient known to reside outside of the United States; or

  (7) Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption.

#### Regulation .02 Exemptions.

*COMAR 10.18.02.02*

A. Qualifications for Exemption. A research project that meets both of the following criteria may be eligible for exemption from the HIV reporting requirements of Regulation .06 of this chapter:

  (1) The research project has been approved by an institutional review board; and

  (2) The research:

    (a) Is intended to determine the safety or effectiveness of a vaccine that would produce immunity against HIV; or

    (b) Is not primarily intended to provide medical treatment to participants.

B. Application for Exemption. The principal investigator of a research project shall submit all of the following documents to the Department in order to apply for an exemption:

  (1) A copy of the research protocol approved by the institutional review board of the institution conducting the research; and

  (2) A copy of the notice stating that the protocol has been approved by the institutional review board of the institution conducting the research.

C. Approval.

  (1) The Director of the Infectious Disease Prevention and Health Services Bureau or the Director’s designee shall review the application submitted under §B of this regulation to determine whether the:

    (a) Application is complete; and

    (b) Research protocol meets the criteria specified in §A of this regulation.

  (2) If the application is complete and the research protocol meets the specified criteria, the Director shall grant an exemption from the requirements set forth in Regulation .06 of this chapter for any specimen tested for HIV detection under the research project approved for exemption.

  (3) The Director shall mail written notification to the applicant of an exemption under this regulation within 30 days of receipt of the application, stating whether the exemption:

    (a) Has been approved;

    (b) Has been denied and the reason for the denial; or

    (c) Cannot be processed until further information is provided to the Department.

D. Responsibilities of the Principal Investigator. If a research project is granted an exemption under §C of this regulation, the principal investigator of the research project shall send to each laboratory to which specimens collected under the research protocol will be sent to be tested for HIV detection a copy of the notification from the Director issued pursuant to §C(3)(a) of this regulation to verify that the project has been exempted from the reporting requirements of Regulation .06 of this chapter.

E. Scope of Exemption.

  (1) Except as indicated in §E(2) of this regulation, an exemption approved under §C of this regulation does not relieve the principal investigator, a laboratory director, or another individual from a reporting requirement contained in Health-General Article, §18-201.1, 18-202.1, 18-205, or 18-207, Annotated Code of Maryland, or Regulation .06 of this chapter.

  (2) A principal investigator, laboratory director, or other individual is not required to report HIV detection test results if the test is done as part of the research project and the individual tested:

    (a) Meets the criteria for participation in the research project set forth in the research protocol submitted under §B(1) of this regulation; and

    (b) Has signed an informed consent form agreeing to participate in the research project.

#### Regulation .03 Definitions.

*COMAR 10.18.02.03*

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

B. Terms Defined.

  (1) “Acquired immunodeficiency syndrome (AIDS)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.

  (2) “Anonymous” means that a patient does not use the patient's name as identification and can only be identified through use of a code.

  (3) “Assigned laboratory number” means a number assigned to a laboratory by the Department for use in filing reports of HIV infection or CD4+ count.

  (4) “Case” means an individual who has:

    (a) Been clinically diagnosed as having HIV or AIDS; or

    (b) Laboratory evidence of being infected by HIV.

  (5) “Clinical material” means:

    (a) An organism isolated from a clinical specimen;

    (b) Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or

    (c) If neither §B(5)(a) nor §B(5)(b) of this regulation is available, material from an individual already held by the medical laboratory, in the following order of preference:

      (i) A patient specimen;

      (ii) Nucleic acid; or

      (iii) Other laboratory material.

  (6) “Clinical or infection control practitioner” means a physician, infection control nurse, physician assistant, nurse practitioner, or other clinical staff designated by the administrative head of an institution to report under Health-General Article, §18-202.1, Annotated Code of Maryland.

  (7) “Department” means the Maryland Department of Health.

  (8) “Designated anonymous HIV test site” means an HIV counseling and testing site designated by the Department as a site where a patient may have an anonymous HIV test.

  (9) “Drug” means a drug that has been:

    (a) Licensed by the United States Food and Drug Administration (FDA); or

    (b) Approved by the FDA as an investigational new drug.

  (10) “Exemption” means a research project meeting certain criteria, with the result that no reporting is required under this chapter.

  (11) “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City or the duly designated representative of the health officer.

  (12) “Human immunodeficiency virus (HIV)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.

  (13) “Institution” means an entity that employs an individual licensed to practice osteopathy or medicine by the State.

  (14) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46 to review the use of human subjects in proposed research.

  (15) “Laboratory examination order” means the written document signed by a physician or other authorized individual that specifies one or more laboratory examinations to be performed in regard to a specified patient.

  (16) “Newborn HIV exposure” means a newborn infant whose mother has tested positive for HIV infection.

  (17) “Physician” means an individual licensed to practice osteopathy or medicine by the State or the physician's designee working under the supervision of the physician.

  (18) “Secretary” means the Secretary of Health or the Secretary's designee.

#### Regulation .04 Physician Responsibility.

*COMAR 10.18.02.04*

A. A physician shall:

  (1) Report a case of HIV or AIDS or newborn HIV exposure for a patient under the physician's care to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and

  (2) Include the information requested on the form.

B. A physician may not transmit information to the health officer or the Secretary about a case of HIV or AIDS or newborn HIV exposure by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.

C. A physician authorized to order laboratory examinations shall include all of the following information on the written laboratory examination order for a test covered by this chapter:

  (1) Name, date of birth, race, ethnicity, and gender of the patient;

  (2) Street address, city, state, and zip code of the patient's residence; and

  (3) Name, address, and telephone number of the physician ordering the test.

D. A physician who reports a case of HIV or AIDS or a newborn HIV exposure or orders a laboratory examination for a test covered by this chapter shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland.

E. A physician working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report an HIV or AIDS case if the administrative head of the institution has designated an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners other than the physician to be responsible for reporting on behalf of all clinical and infection control practitioners in the facility, as set forth in Regulation .05 of this chapter.

#### Regulation .05 Responsibilities of Clinical and Infection Control Practitioners in Institutions.

*COMAR 10.18.02.05*

A. A clinical or infection control practitioner working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, shall:

  (1) Report a case of HIV or AIDS under the care of the institution to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and

  (2) Include the information requested on the form.

B. A clinical or infection control practitioner may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.

C. A clinical or infection control practitioner who reports a case of HIV or AIDS shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as defined in Health-General Article, §18-207, Annotated Code of Maryland.

D. The administrative head of an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, may designate an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical and infection control practitioners in the facility.

E. A clinical or infection control practitioner working in an institution required to report as defined in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report HIV or AIDS cases if the administrative head of the institution has designated a different individual clinical or infection control practitioner or specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical practitioners in the facility.

#### Regulation .06 Responsibilities of Laboratory Directors.

*COMAR 10.18.02.06*

A. Except as provided in Regulations .01C and .02 of this chapter, the director of a medical laboratory shall:

  (1) Submit a report to the health officer for the jurisdiction where the laboratory is located, within 48 hours after an examination of a specimen from a human body shows one of the following:

    (a) A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results;

    (b) A quantitative or qualitative HIV viral load test result, including undetectable;

    (c) A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or

    (d) An HIV genotype sequence test result;

  (2) Use the form provided by the Department in making the report required under §A(1) of this regulation;

  (3) Include all of the following information in the report required under §A(1) of this regulation:

    (a) Name and address of laboratory or assigned laboratory number;

    (b) Date the specimen was obtained from the patient;

    (c) Type and result of laboratory test, that is, HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence;

    (d) Name, date of birth, race, ethnicity, and gender of the patient;

    (e) Street address, city, state, and zip code of the patient's residence;

    (f) Name of the physician authorizing the laboratory examination; and

    (g) Address and telephone number of the physician authorizing the laboratory examination; and

  (4) Contact the physician authorizing the laboratory examination to obtain any of the information, as required by §A(3) of this regulation, that is not provided on the laboratory examination order.

B. A laboratory director may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.

C. The laboratory director shall, at the request of the Secretary, make available to the Secretary any remaining clinical material from tested individuals.

D. This regulation does not relieve a physician of the duty to report as set forth in Health-General Article, §§18-201.1 and 18-202.1, Annotated Code of Maryland.

#### Regulation .07 Out-of-State Laboratories.

*COMAR 10.18.02.07*

An out-of-State laboratory that holds a permit to operate issued by Maryland and performs HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence tests shall submit the report required under Regulation .06 of this chapter to the Secretary.

#### Regulation .08 Responsibility of Health Officer.

*COMAR 10.18.02.08*

A. This regulation establishes requirements for follow-up by the health officer of a report of HIV or AIDS or newborn HIV exposure or laboratory report of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence.

B. This regulation does not supplant or otherwise modify the:

  (1) Physician's obligation to report a case of HIV or AIDS or newborn HIV exposure under Health-General Article, §18-201.1, Annotated Code of Maryland, and Regulation .04 of this chapter;

  (2) Clinical or infection control practitioner's obligation to report a case of HIV or AIDS under Health-General Article, §18-202.1, Annotated Code of Maryland, and Regulation .05 of this chapter; and

  (3) Laboratory director’s obligation to report a test result of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence under Health-General Article, §18-205, Annotated Code of Maryland, and Regulation .06 of this chapter.

C. Upon receipt of a report from a physician pursuant to Regulation .04 of this chapter, a clinical or infection control practitioner pursuant to Regulation .05 of this chapter, the health officer shall:

  (1) Determine whether the case of HIV, the case of AIDS, or the newborn HIV exposure has been reported previously;

  (2) Complete the case investigation if the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and

  (3) Submit the HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously.

D. Upon receipt of a test result report from a laboratory director pursuant to Regulation .06 of this chapter, the health officer shall:

  (1) Determine whether the report matches to a case of HIV, a case of AIDS, or a newborn HIV exposure that has been reported previously, and submit the report to the Department if the report matches;

  (2) Complete a case investigation if the report indicates the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously;

  (3) Submit the case report, as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and

  (4) Retain a nonmatching report for up to 4 years, rematching the report, not less than annually, to test result reports and to cases of HIV or cases of AIDS or newborn HIV exposures that had not been reported previously, to identify new matches, and submit the report to the Department if the report matches.

E. A health officer may not transmit to the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.

#### Regulation .09 Record Maintenance and Confidentiality.

*COMAR 10.18.02.09*

A. A person that submitted a report of HIV or AIDS or newborn HIV exposure shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04—.06 of this chapter.

B. Except for a designated anonymous HIV test site, a person that ordered the laboratory examination shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04 and .05 of this chapter, upon receipt of one of the following:

  (1) A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results;

  (2) A qualitative or quantitative HIV viral load test result, including undetectable;

  (3) A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or

  (4) An HIV genotype sequence test result.

C. Confidentiality.

  (1) A report required under this chapter is:

    (a) Confidential;

    (b) Not open to public inspection;

    (c) Not a medical record under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

    (d) Subject to the confidentiality requirements of Health-General Article, Title 4, Subtitle 1, Annotated Code of Maryland.

  (2) The reports and any proceedings, records, or files relating to the reports required under this chapter are not discoverable and are not admissible in evidence in any civil action.

  (3) Section C(1) of this regulation does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties pursuant to State or federal law where the Secretary determines that the agency to whom the information is disclosed will maintain the confidentiality of the disclosure.

### Chapter 03 — AIDS Investigations and Case Reporting

*Repealed*

**Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220)

**Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .04C amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulations .01—.05 repealed effective May 18, 2020 (47:10 Md. R. 518)

### Chapter 04 — Disease Control

*Repealed*

**Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220)

**Administrative History:** Regulations .01 — .03 repealed effective April 24, 2017 (44:8 Md. R. 403)

### Chapter 05 — Maryland AIDS Drug Assistance Program: Eligibility

**Authority:** Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Regulations .01—.15 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180)

**Administrative History:** Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .02 amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .03B, C amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .03C amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .05 amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .05A amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .05E amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)

**Administrative History:** Regulation .06C amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .07 repealed as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); repealed permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .08A amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .08B amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .09C adopted effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .11 amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .15A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488); October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .02D amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .02D, E amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .03 amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04A, D amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .09B amended effective May 20, 2019 (46:10 Md. R. 488)

#### Regulation .01 Definitions.

*COMAR 10.18.05.01*

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

B. Terms Defined.

  (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.

  (2) “Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program and whose eligibility status for the Maryland AIDS Drug Assistance Program has not yet been determined.

  (3) “Department” means the Maryland Department of Health.

  (4) “Disenroll” means to end Maryland AIDS Drug Assistance Program benefits.

  (5) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04.

  (6) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

  (7) “Gross household income” means the income derived from sources provided in Regulation .02E of this chapter.

  (8) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.

  (9) “Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS.

  (10) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.

  (11) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02.

  (12) “Recipient” means an individual who is enrolled in MADAP.

  (13) “Resident” means an individual:

    (a) Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and

    (b) For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of the residence.

  (14) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to Regulation .03B(1)(a) of this chapter.

#### Regulation .02 Eligibility.

*COMAR 10.18.05.02*

A. Except when an individual is enrolled in Medical Assistance but does not have prescription coverage assistance, an individual who is eligible for Medical Assistance is not eligible for MADAP.

B. To be eligible for benefits, an individual shall meet the following criteria:

  (1) Residency;

  (2) Medical; and

  (3) Financial.

C. Residency Criteria. To meet the residency criteria the individual shall be a resident of Maryland.

D. Medical Criteria. To meet the medical criteria the individual shall be infected with HIV as verified by the Department.

E. Financial Criteria.

  (1) To meet the financial criteria the individual shall have a projected gross household income less than or equal to 500 percent of the Federal Poverty Level Guidelines as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2).

  (2) Projected gross household income shall be determined based on what can reasonably be expected to be received during the 12-month period beginning with the month in which the completed application is filed or verification of eligibility is submitted.

  (3) Gross household income includes income derived from:

    (a) Wages and salaries, including tips;

    (b) Net income from self-employment or business;

    (c) Unemployment income;

    (d) Social security payments, including disability payments;

    (e) Alimony;

    (f) Retirement income;

    (g) Pension income;

    (h) Investment income;

    (i) Rental income; and

    (j) Other taxable income, such as prizes, awards, and gambling winnings.

  (4) Gross household income under this chapter does not include income derived from:

    (a) Child support;

    (b) Gifts;

    (c) Supplemental Social Security Income;

    (d) Veterans’ disability payments;

    (e) Workers’ compensation; and

    (f) Proceeds from loans, such as student loans, home equity loans, or bank loans.

#### Regulation .03 Application and Enrollment.

*COMAR 10.18.05.03*

A. Application.

  (1) Applicant.

    (a) An applicant shall submit a completed application to the Department on the form designated by the Department that includes:

      (i) Responses to all required fields and applicable questions; and

      (ii) Supporting documentation related to residency, medical, and financial eligibility criteria.

    (b) An applicant may voluntarily withdraw the application at any time without prejudice.

    (c) An applicant may submit a new application at any time.

  (2) The Department shall:

    (a) Approve the application if the:

      (i) Application is complete; and

      (ii) Applicant is determined to be eligible;

    (b) Disapprove the application if the:

      (i) Application is incomplete;

      (ii) Applicant fails to provide sufficient information or documentation to determine eligibility; or

      (iii) Applicant provides the appropriate documentation but is determined ineligible; and

    (c) Provide the applicant with written notice of the final disposition of the application.

B. Enrollment.

  (1) If the Department requests it, a recipient shall:

    (a) Attest to continuing eligibility:

    (b) Submit a completed verification of eligibility form; and

    (c) Provide supporting documentation.

  (2) A recipient’s MADAP benefits shall be suspended, effective at the end of the month following the month the verification of eligibility is due, if the recipient fails to attest to eligibility for MADAP.

  (3) The Department shall:

    (a) Enroll an applicant who has been determined eligible with the stipulation that eligibility must be verified as requested by the Department;

    (b) Establish enrollment in MADAP beginning on the first day of the month in which the:

      (i) Department approves the application; or

      (ii) Recipient will need to access medications through MADAP;

    (c) Redetermine eligibility if the Department receives information that may affect eligibility; and

    (d) Send any relevant verification of eligibility forms to the recipient at least 45 calendar days before the forms are due to be submitted to the Department.

#### Regulation .04 Changes in Eligibility and Disenrollment.

*COMAR 10.18.05.04*

A. A recipient shall notify the Department within 10 business days of a change in:

  (1) Availability of third-party payment for services covered under MADAP;

  (2) Gross household income; or

  (3) Address.

B. If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP, the Department shall:

  (1) Determine the recipient ineligible for MADAP; and

  (2) Disenroll the recipient.

C. The notice of intended action, which notifies the recipient of the disenrollment, shall:

  (1) Be mailed to the recipient at least 15 business days before the effective date of disenrollment;

  (2) Include an explanation of the action;

  (3) Cite the regulation supporting the action; and

  (4) Explain the right of the recipient to request reconsideration or an appeal of the decision.

D. If the recipient is determined to be ineligible before the next verification of eligibility is due to be submitted to the Department because of a change in eligibility, the disenrollment shall be the earlier of:

  (1) The date on which the recipient’s next verification of eligibility is due to be submitted to the Department; or

  (2) The first day of the month that is at least 15 calendar days after the date of the notice of ineligibility for MADAP benefits.

E. If the recipient’s Medical Assistance coverage is pending or active, the recipient shall be disenrolled, as determined by the Department.

#### Regulation .05 Reconsideration and Appeal.

*COMAR 10.18.05.05*

A. An applicant or recipient who has been notified by the Department of ineligibility for or disenrollment from MADAP benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification.

B. If an applicant or recipient submits a timely request for reconsideration, the Department shall:

  (1) Review all additional supporting documentation, within 5 business days of the Department’s receipt of the request for reconsideration; and

  (2) Issue a final decision in writing to the applicant or recipient.

C. If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department.

D. The Office of Administrative Hearings shall:

  (1) Conduct a hearing according to the procedures set forth in COMAR 28.02.01;

  (2) Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and

  (3) Issue a decision in writing to the applicant or recipient.

#### Regulation .06 Recovery of Payments.

*COMAR 10.18.05.06*

If MADAP benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.

#### Regulation .07 Fraud.

*COMAR 10.18.05.07*

The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.

#### Regulation .08 Confidentiality.

*COMAR 10.18.05.08*

Unless otherwise authorized by law, the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on an applicant or recipient without written consent of the:

  (1) Applicant;

  (2) Recipient;

  (3) Applicant’s parent or legal guardian; or

  (4) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

  (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

  (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

#### Regulation .09 Availability of Funding and Program Termination.

*COMAR 10.18.05.09*

A. If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination.

B. If MADAP is terminated the Department shall provide benefits for each current recipient until the earlier of:

  (1) The date on which the next verification of eligibility is due to be submitted to the Department; or

  (2) Six months from the date MADAP is terminated.

### Chapter 06 — Maryland AIDS Drug Assistance Program: Pharmacy Services

**Authority:** Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Regulations .01—.12 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180)

**Administrative History:** Regulation .01B amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .04 repealed and new Regulation .04 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04B amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)

**Administrative History:** Regulation .04C adopted effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .04-1 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04-2 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04-2 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .04-2 amended effective September 15, 2014 (41:18 Md. R. 1010)

**Administrative History:** Regulation .05A amended as an emergency provision effective February 20, 2007 (34:7 Md. R. 694); amended permanently effective June 18, 2007 (34:12 Md. R. 1067)

**Administrative History:** Regulation .05B amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .06A amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)

**Administrative History:** Regulation .06A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .12A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .02 amended effective January 19, 2026 (53:1 Md. R. 20)

**Administrative History:** Regulation .03A amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04-1 amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04-2 repealed effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488), October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .08 amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .09A amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .10 amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488)

#### Regulation .01 Definitions.

*COMAR 10.18.06.01*

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

B. Terms Defined.

  (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.

  (2) “Department” means the Maryland Department of Health.

  (3) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04 of this chapter.

  (4) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

  (5) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.

  (6) “Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS.

  (7) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in Regulation .04 of this chapter for enrolled recipients.

  (8) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02.

  (9) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter.

  (10) “Pharmacist” means an individual registered and licensed to practice pharmacy in the state where the prescription is filled.

  (11) “Pharmacy” means an establishment or institution registered and licensed to dispense U.S. Food and Drug Administration-approved drugs or other products to the public in the state in which the establishment or institution is located.

  (12) “Preauthorization” means an approval required before the dispensing of the prescription.

  (13) “Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product not excluded from the open formulary.

  (14) “Recipient” means an individual who is enrolled in MADAP.

#### Regulation .02 Permit and License Requirements.

*COMAR 10.18.06.02*

A. To qualify for participation in MADAP, a pharmacy shall first obtain a permit from:

  (1) The State Board of Pharmacy, pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or

  (2) The appropriate agency in the state in which the pharmacy is located.

B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.

C. To qualify for participation in MADAP, a health care practitioner shall be:

  (1) Licensed; and

  (2) Legally authorized to practice medicine in accordance with applicable state and federal laws.

#### Regulation .03 Conditions for Participation.

*COMAR 10.18.06.03*

A. To participate in MADAP, a pharmacy shall:

  (1) Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department;

  (2) Accept payment by the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family;

  (3) Maintain records in accordance with standards established by Medical Assistance;

  (4) Maintain prescriptions for a minimum of 5 years and make them available for inspection, upon request, to the Department or its designee;

  (5) Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and

  (6) Bill the recipient’s third-party insurance payer in accordance with the payer’s requirements in order to reduce the cost to be paid by the Department.

B. A pharmacy may not:

  (1) Knowingly employ a person who has been disqualified from Medical Assistance; or

  (2) Place a restriction on a recipient’s right to select a pharmacy of the recipient’s choice.

#### Regulation .04 Covered Services.

*COMAR 10.18.06.04*

A. The recipient shall obtain a prescription for each drug or other product ordered for the recipient.

B. The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for the recipient.

#### Regulation .04-1 Formulary.

*COMAR 10.18.06.04-1*

The Department shall:

A. Maintain a list of drugs and other products excluded from the open formulary; and

B. Make available electronically the list of drugs and other products excluded from the open formulary.

#### Regulation .05 Limitations on Covered Services.

*COMAR 10.18.06.05*

A. A pharmacist may not dispense more than a 100-day supply of a prescribed drug or other product.

B. The Department may not pay for:

  (1) A drug or other product prescribed as part of a recipient’s care in a correctional institution, inpatient hospital, nursing home, or long-term care setting; or

  (2) Drugs or other products excluded from the open formulary, unless the Department grants the recipient preauthorization.

#### Regulation .06 Preauthorization Requirement.

*COMAR 10.18.06.06*

A pharmacist shall obtain preauthorization for each prescription or refill before dispensing a drug or other product marked as restricted.

#### Regulation .07 Payment Procedures.

*COMAR 10.18.06.07*

A. Except as provided in §§B and C of this regulation, the Department shall pay a pharmacy in accordance with the procedures of the Medical Assistance Pharmacy Services Program set forth at COMAR 10.09.03.07.

B. If the Department or the recipient tells the pharmacy that the recipient has or may have third-party insurance coverage to offset some or all of the cost for services provided under MADAP, the pharmacy shall:

  (1) Bill the third-party payer the pharmacy’s usual and customary charge for the services provided; and

  (2) Bill the Department for the difference between the pharmacy’s usual and customary charge and the anticipated third-party receipts.

C. If the recipient has third-party insurance coverage, the Department shall pay the pharmacy the difference between the pharmacy’s usual and customary charge and the anticipated third-party insurance receipts, not to exceed the amount permitted under COMAR 10.09.03.07F and G.

D. The Department shall make payments related to MADAP in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009, and any subsequent modifications to the Act.

#### Regulation .08 Recovery and Reimbursement.

*COMAR 10.18.06.08*

The Department shall follow the same procedures for recovery and reimbursement as the Medical Assistance Program in COMAR 10.09.03.08.

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

*COMAR 10.18.06.09*

A. If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may:

  (1) Suspend the pharmacy from MADAP;

  (2) Withhold payment to the pharmacy; or

  (3) Both.

B. Removal of a pharmacy or a pharmacy’s employee from Medical Assistance shall result in removal from MADAP.

C. The Department:

  (1) May consult with the State Board of Pharmacy regarding the actions of a pharmacy, such as:

    (a) A breach of confidentiality;

    (b) Refusal of service; or

    (c) Discrimination; and

  (2) Shall consider the findings and recommendations of the State Board of Pharmacy when deciding on the imposition of a sanction as stated in §A of this regulation.

D. The Department shall give the pharmacy written notice of the Department’s intention to impose sanctions referred to in §A of this regulation, including:

  (1) The effective date of the proposed action;

  (2) The reason for the proposed action; and

  (3) The pharmacy’s right to appeal the proposed action.

E. A pharmacy voluntarily withdrawing from MADAP or removed or suspended from MADAP according to this regulation shall notify a recipient that the pharmacy is no longer a MADAP pharmacy.

#### Regulation .10 Appeal Procedures.

*COMAR 10.18.06.10*

A pharmacy filing an appeal shall do so in accordance with the Medical Assistance Program as set forth at COMAR 10.09.03.10.

#### Regulation .11 Confidentiality.

*COMAR 10.18.06.11*

Unless otherwise authorized by law, the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on a recipient without written consent of the:

  (1) Recipient; or

  (2) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

  (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

  (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

#### Regulation .12 Availability of Funding and Program Termination.

*COMAR 10.18.06.12*

A. If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination.

B. If MADAP is terminated, the Department shall provide benefits for each current recipient in accordance with COMAR 10.18.05.09B.

### Chapter 07 — Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS)

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

**Administrative History:** Effective date: February 3, 2003 (30:2 Md. R. 76)

**Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .04 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .04D amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04D, E amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .06D amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .10A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .16A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .02 amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .03C amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .06F amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .07B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488)

#### Regulation .01 Definitions.

*COMAR 10.18.07.01*

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

B. Terms Defined.

  (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.

  (2) “Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program—Plus and whose eligibility status for the Maryland AIDS Drug Assistance Program—Plus has not yet determined.

  (3) “Core medical services” means a set of direct health care services as specified by the Ryan White Care Act Part B Program administered by the U.S. Health Resource and Services Administration.

  (4) “Department” means the Maryland Department of Health.

  (5) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

  (6) “Health care provider” means an individual licensed to provide core medical services in the state where services are rendered.

  (7) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS.

  (8) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients.

  (9) “Maryland AIDS Drug Assistance Program—Plus (MADAP-Plus)” means the program administered by the Department to pay insurance premiums, copays, coinsurance, and deductibles for drugs and core medical services.

  (10) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02.

  (11) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.

  (12) “Recipient” means an individual who is enrolled in MADAP-Plus.

  (13) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to COMAR 10.18.05.03B(1)(a).

#### Regulation .02 Eligibility.

*COMAR 10.18.07.02*

A. To be eligible for MADAP-Plus coverage, an individual shall be:

  (1) Enrolled in MADAP; and

  (2) Receiving or eligible to receive health insurance and prescription drug coverage.

B. An individual who is eligible for employer-sponsored health insurance with a prescription drug formulary that includes antiretroviral medications may not receive premium assistance unless the individual is:

  (1) Enrolled in the employer-sponsored health plan; and

  (2) Paying 50 percent or more of the total monthly health insurance premiums.

#### Regulation .03 Application and Enrollment.

*COMAR 10.18.07.03*

A. An applicant shall apply in the manner set forth in COMAR 10.18.05.03A.

B. A recipient and the Department shall meet the enrollment responsibilities set forth in COMAR 10.18.05.03B.

C. The duration of the recipient’s enrollment in MADAP-Plus may not extend beyond the duration of the recipient’s enrollment in MADAP.

#### Regulation .04 Covered Services.

*COMAR 10.18.07.04*

A. The Department shall pay for health and prescription plan premiums with a prescription drug formulary that includes antiretroviral medications.

B. Within the limits established by the Department and in accordance with policy guidance issued by the Health Resources and Services Administration, the Department:

  (1) Shall pay for copays, coinsurance, and deductibles for drugs; and

  (2) May pay for copays, coinsurance, and deductibles associated with core medical services.

#### Regulation .05 Changes in Eligibility and Disenrollment.

*COMAR 10.18.07.05*

A. A recipient shall inform the Department of a change in eligibility as set forth in COMAR 10.18.05.04A.

B. If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP-Plus, the Department shall:

  (1) Determine the recipient ineligible for MADAP-Plus; and

  (2) Disenroll the recipient.

C. If a MADAP-Plus recipient is disenrolled from MADAP, the recipient is automatically disenrolled from MADAP-Plus.

#### Regulation .06 Reconsideration and Appeal.

*COMAR 10.18.07.06*

A. An applicant or recipient who has been notified by the Department of disenrollment or ineligibility for MADAP-Plus benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification.

B. If an applicant or recipient submits a timely request for reconsideration, the Department shall:

  (1) Review all additional supporting documentation, within five business days of the Department’s receipt of the request for reconsideration; and

  (2) Issue a final decision in writing to the applicant or recipient.

C. If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department.

D. The Office of Administrative Hearings shall:

  (1) Conduct a hearing according to the procedures set forth in COMAR 28.02.01;

  (2) Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and

  (3) Issue a decision in writing to the applicant or recipient.

E. The Department shall pay any health insurance plan or prescription drug plan costs due pending a decision by the Office of Administrative Hearings.

F. If the final decision finds in favor of the Department, the Department shall, upon the date of the decision, cease paying the health insurance costs allowed under this chapter and seek recovery in accordance with Regulation .08 of this chapter.

#### Regulation .07 Payment Procedures.

*COMAR 10.18.07.07*

A. A recipient, recipient’s representative, health care provider, insurer, employer, or health plan administrator, as applicable:

  (1) May request payment costs allowed under this chapter on behalf of the recipient according to procedures established by the Department;

  (2) Shall submit a payment request that is:

    (a) An invoice for the recipient’s health or prescription drug plan insurance premium, copays, coinsurance, and deductibles for core medical services issued by an insurer, an employer, a health plan administrator, prescription drug plan administrator, or a health care provider; and

    (b) Submitted timely to allow for payment in accordance with §§A(3) and B(4) of this regulation; and

  (3) Shall make the initial request for the payment of costs within the time frames established by the health or prescription drug insurance policy.

B. The Department:

  (1) Shall process a payment request as required by this chapter;

  (2) Shall inform a recipient or the recipient’s representative if an invoice is not paid;

  (3) Shall make payments in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White CARE Act Amendments of 1996, P. L. 104—146, and any subsequent modifications to the Act; and

  (4) Shall make subsequent payments:

    (a) As permitted under a health or prescription drug plan; or

    (b) Upon agreement between the Department and the:

      (i) Insurer;

      (ii) Employer;

      (iii) Health plan administrator;

      (iv) Prescription drug plan administrator; or

      (v) Health care provider.

#### Regulation .08 Recovery of Payments.

*COMAR 10.18.07.08*

If MADAP-Plus payments have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments.

#### Regulation .09 Fraud.

*COMAR 10.18.07.09*

The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.

#### Regulation .10 Confidentiality.

*COMAR 10.18.07.10*

Unless otherwise authorized by law, the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on an applicant or recipient without the written consent of the:

  (1) Applicant;

  (2) Recipient;

  (3) Applicant’s parent or legal guardian; or

  (4) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

  (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

  (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C; §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

#### Regulation .11 Availability of Funding and Program Termination.

*COMAR 10.18.07.11*

A. If sufficient monies are not available to fund MADAP-Plus, the Department shall take the action necessary to eliminate a deficit which may include MADAP-Plus termination.

B. If MADAP-Plus is terminated, the Department shall provide coverage for each current recipient until the earlier of:

  (1) The date on which the next verification of eligibility is due to be submitted to the Department; or

  (2) Six months from the date MADAP-Plus is terminated.

### Chapter 08 — HIV Testing Procedures

**Authority:** Criminal Procedure Article, §§11-107—11-117; Health-General Article, §§2-104(b) and(i), 2-105(a) and (b),18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-334, 18-336—18-338, 18-338.2, 18-338.3, and 20-102; Annotated Code of Maryland

**Administrative History:** Effective date: February 3, 2003 (30:2 Md. R. 76)

**Administrative History:** Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .02B amended effective September 8, 2008 (35:18 Md. R. 1600); December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .03 amended effective April 13, 2015 (42:7 Md. R. 569)

**Administrative History:** Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569)

**Administrative History:** Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 569)

**Administrative History:** Regulation .06 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .06B amended effective September 8, 2008 (35:18 Md. R. 1600)

**Administrative History:** Regulation .07 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .08 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .10A, C amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .11 adopted effective June 11, 2012 (39:11 Md. R. 687)

**Administrative History:** Regulation .12 adopted effective June 11, 2012 (39:11 Md. R. 687)

**Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Chapter revised effective May 7, 2018 (45:9 Md. R. 462)

#### Regulation .01 Scope.

*COMAR 10.18.08.01*

A. Except as provided in §§C—F of this regulation, this chapter governs:

  (1) Pretest and post-test information;

  (2) Requirements for reporting and control efforts;

  (3) Requirements for informed consent; and

  (4) Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program.

B. In cases exempt from the requirements for consent throughout this chapter, as specified in §§C—F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary.

C. If an HIV test is performed on an individual solely for the purpose of determining the suitability of that individual as a prospective donor of blood, semen, or tissue, the requirements for information and consent are addressed in:

  (1) Health-General Article, §18-334, Annotated Code of Maryland; and

  (2) COMAR 10.50.01.

D. If an HIV test is performed on an individual as a result of a court order issued under the provisions of the Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland:

  (1) The requirements for HIV testing are addressed in COMAR 10.52.10; and

  (2) Informed consent does not apply.

E. HIV testing undertaken under provisions of Health-General Article, §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter.

F. HIV testing of specimens for research is not governed by this chapter if:

  (1) All personal identifiers have been removed from the specimen;

  (2) The specimen cannot be linked to the patient from whom the specimen was taken;

  (3) The test result cannot be linked to the patient from whom the specimen was taken; and

  (4) The research protocol has been approved by an institutional review board.

G. This chapter pertains to all patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care.

#### Regulation .02 Definitions.

*COMAR 10.18.08.02*

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

B. Terms Defined.

  (1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.

  (2) “Anonymous” means that:

    (a) A patient’s name is not used for identification; and

    (b) The patient can be identified only through use of an assigned code.

  (3) “Applicant” means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site.

  (4) “Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter.

  (5) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services.

  (6) “Confidential” means that a patient’s name is used as identification and that the patient’s medical records contain the patient’s name but are protected against disclosure as provided by statute.

  (7) “Counseling” means providing education to pregnant women on:

    (a) The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and

    (b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy.

  (8) “Department” means the Maryland Department of Health.

  (9) “Designated anonymous testing site” means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification.

  (10) “Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider including:

    (a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;

    (b) A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;

    (c) A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;

    (d) The Department of Public Safety and Correctional Services;

    (e) A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter;

    (f) A facility operated by the Department or a local health officer; or

    (g) The office of a health care provider.

  (11) “Health care provider” means a:

    (a) Physician;

    (b) Nurse;

    (c) Licensed direct-entry midwife; or

    (d) Designee of a health care facility.

  (12) “Human immunodeficiency virus (HIV)” means a virus that causes AIDS.

  (13) “Indeterminate HIV test result” means that a test did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria.

  (14) “Informed consent” means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter.

  (15) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research.

  (16) “Negative HIV test result” means the test result failed to document the presence of HIV as defined by the CDC’s laboratory criteria.

  (17) Nonclinical Settings.

    (a) “Nonclinical settings” means locations:

      (i) That are not health care settings;

      (ii) Where medical or treatment services are not provided; and

      (iii) Where selected diagnostic services and selected prevention services may be provided.

    (b) “Nonclinical settings” may include:

      (i) Community based organizations;

      (ii) Outreach settings; or

      (iii) Mobile vans.

  (18) Partner.

    (a) “Partner” means an individual with whom one has:

      (i) Had or will have, oral, anal, or vaginal sexual contact; or

      (ii) Shared hypodermic needles or other similar drug paraphernalia.

    (b) “Partner” includes any individual who:

      (i) Is the marriage partner of an HIV-infected patient; or

      (ii) Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection.

  (19) “Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV.

  (20) “Positive HIV test result” means the test result has documented the presence of HIV as defined by the CDC’s laboratory criteria.

  (21) “Post-test information” means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter.

  (22) “Prenatal care” means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include:

    (a) Screening;

    (b) Physical examination;

    (c) Laboratory and diagnostic testing procedures and interpretation; or

    (d) Counseling.

  (23) “Pretest information” means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .08 of this chapter.

  (24) “Research” means an investigation carried out according to a protocol approved by an institutional review board.

  (25) “Secretary” means the Secretary of Health.

  (26) “Seropositive” means that a positive HIV test result has been obtained from the test of a patient’s specimen.

  (27) “Specimen” means a sample of:

    (a) Blood;

    (b) Other body fluid; or

    (c) Body tissue.

  (28) “Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law.

#### Regulation .03 Requirements for Designated Anonymous Testing Sites.

*COMAR 10.18.08.03*

A. An applicant shall seek approval from an appropriate entity to become a designated anonymous testing site from the:

  (1) Baltimore City Health Department for an applicant offering services in Baltimore City; or

  (2) Department for an applicant offering services outside of Baltimore City.

B. An applicant that seeks approval to become a designated anonymous testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity.

C. The Department or the Baltimore City Health Department shall:

  (1) Review a written request that is submitted for approval; and

  (2) Respond in writing to the written request:

    (a) Indicating approval or disapproval to become a designated anonymous testing site; or

    (b) Soliciting for revision and resubmission of the written request.

#### Regulation .04 Requirements for Designated Confidential Testing Sites.

*COMAR 10.18.08.04*

A. An applicant shall seek approval from an appropriate entity to become a designated confidential testing site from the:

  (1) Baltimore City Health Department for an applicant offering services in Baltimore City; or

  (2) Department for an applicant offering services outside of Baltimore City.

B. An applicant that seeks approval to become a designated confidential testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity.

C. The Department or the Baltimore City Health Department shall:

  (1) Review a written request that is submitted for approval; and

  (2) Respond in writing to the written request:

    (a) Indicating approval or disapproval to become a designated confidential testing site; or

    (b) Soliciting for revision and resubmission of the written request.

#### Regulation .05 Denial and Reconsideration.

*COMAR 10.18.08.05*

A. An applicant under Regulation .03 or .04 of this chapter that has a written request denied by the appropriate entity may request reconsideration of the decision:

  (1) By submitting the request in writing to the appropriate entity; and

  (2) Within 30 calendar days of the date on the notice of denial.

B. If an applicant requests a reconsideration according to §A of this regulation, the appropriate entity shall:

  (1) Review the request for reconsideration and any supplemental documentation submitted by the applicant within 45 calendar days of the date on the letter requesting reconsideration; and

  (2) Issue a decision in writing to the applicant.

#### Regulation .06 Consent and Pretest Requirements for HIV Testing by Health Care Providers.

*COMAR 10.18.08.06*

A. General medical consent is sufficient to perform HIV testing.

B. Consent for HIV testing is only required to be obtained one time during a patient’s visit.

C. A health care provider who obtains consent for HIV testing shall:

  (1) Obtain consent as a part of a patient’s general consent for medical care in the same manner as for other screening and diagnostic tests;

  (2) Document all declinations of an HIV test in the medical record of the patient; and

  (3) When needed, obtain:

    (a) Consent from a health care agent designated per Health-General Article, §5-602, Annotated Code of Maryland; or

    (b) Surrogate consent per Health-General Article, §5-605 Annotated Code of Maryland.

D. The general informed consent form for medical care may specify that an HIV test will be performed.

E. Except as provided under Regulation .08 of this chapter, a health care provider may not be required to obtain consent for HIV testing on a separate consent form.

F. Pretest information, including counseling for pregnant women, shall be provided to the patient to be tested for HIV before each specimen is tested.

G. A health care provider providing pretest information, including counseling for pregnant women, shall:

  (1) Provide HIV-specific information:

    (a) Verbally;

    (b) In writing;

    (c) Through video; or

    (d) Through any combination of §G(1)(a)—(c) of this regulation;

  (2) Provide HIV information in a manner that protects the confidentiality of the patient being tested;

  (3) Using layman’s terms, provide, at minimum, the following information to the patient being tested:

    (a) That the patient is being tested for HIV;

    (b) That the patient has the right to:

      (i) Ask questions; and

      (ii) Decline the test without penalty;

    (c) An explanation of HIV infection;

    (d) That a negative HIV test result means that:

      (i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and

      (ii) If the patient has had any potential recent exposures, the patient should be retested within an appropriate time frame based on the type of testing used; and

    (e) That a positive HIV test result means the patient:

      (i) Is infected with HIV; and

      (ii) Will be linked with medical treatment and other supportive services;

  (4) Provide counseling as defined in Regulation .02 of this chapter to pregnant women;

  (5) Include an opportunity for the patient to:

    (a) Ask questions and receive answers about HIV and other topics described in this regulation; and

    (b) Decline an HIV test; and

  (6) Make necessary accommodation with respect to language or disability to ensure that the patient being tested understands the information presented.

#### Regulation .07 Testing Requirements for Pregnant Women Receiving Prenatal Care.

*COMAR 10.18.08.07*

A. As part of a health care provider’s patient acceptance procedures or protocol, a health care provider shall give a pregnant woman information on being tested for the presence of HIV as part of the woman’s prenatal care program.

B. In addition to §§C—E of this regulation, a health care provider testing a pregnant woman shall follow all requirements for pretest and post-test information as set forth in Regulations .06 and .08—.10 of this chapter as appropriate.

C. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care:

  (1) During the first trimester of pregnancy or the first prenatal visit; and

  (2) In the third trimester of pregnancy.

D. A health care provider who provides labor and delivery services to a pregnant woman shall offer:

  (1) A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and

  (2) Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive.

E. Confidentiality.

  (1) HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland.

  (2) Except as otherwise provided in §E(3) of this regulation, the record of an HIV test performed under this section is confidential and not discoverable or admissible in evidence in any criminal, civil, or administrative action.

  (3) Provided that the identity or any other information that could readily be associated with the identity of the pregnant woman is not disclosed, the results of an HIV test performed under this section may be introduced into evidence in a criminal, civil, or administrative action, including the adjudication of a workers’ compensation claim.

#### Regulation .08 Consent and Pretest Requirements for HIV Testing in Nonclinical Settings.

*COMAR 10.18.08.08*

A. For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall:

  (1) Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent;

  (2) Read and explain the HIV informed consent form, through an interpreter if necessary, to anyone who cannot read or understand the form’s contents; and

  (3) Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen.

B. A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent.

C. Pretest information shall be provided to the patient being tested before each specimen is tested.

D. An individual providing pretest information shall:

  (1) Provide HIV-specific information:

    (a) Verbally;

    (b) In writing;

    (c) Through video; or

    (d) Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the patient;

  (2) Provide HIV information in a manner that protects the confidentiality of the patient;

  (3) Using layman’s terms, provide, at a minimum, the following information to the patient:

    (a) That the patient is being tested for HIV;

    (b) That the patient has the right to:

      (i) Ask questions; and

      (ii) Decline the test without penalty;

    (c) The primary modes of HIV transmission including:

      (i) Sexual contact without the use of condoms, other barriers, or other biomedical interventions;

      (ii) Injection drug use; and

      (iii) Mother-to-child transmission;

    (d) Counseling as defined in Regulation .02 of this chapter to pregnant women;

    (e) That a negative test result means that:

      (i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and

      (ii) If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used;

    (f) That a positive test result means the patient:

      (i) Is infected with HIV;

      (ii) Will be linked with medical treatment and other supportive services; and

      (iii) May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and

    (g) Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name;

  (4) Include an opportunity for the patient to:

    (a) Ask questions and receive answers about HIV infection and other topics described in this regulation; and

    (b) Decline HIV testing; and

  (5) Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented.

#### Regulation .09 Post-Test Requirements for HIV Testing by Health Care Providers.

*COMAR 10.18.08.09*

A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:

  (1) That the HIV test result is negative; and

  (2) The meaning of a negative result.

B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient in person that includes:

  (1) That the HIV test result is indeterminate;

  (2) The meaning of an indeterminate HIV test result; and

  (3) A recommendation that the patient:

    (a) Return in a medically appropriate time frame for another HIV test; and

    (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested.

C. If a patient’s HIV test result is positive:

  (1) The individual providing testing shall provide post-test information to the patient in person that includes:

    (a) That the HIV test result is positive;

    (b) The meaning of a positive HIV test result;

    (c) If the patient is pregnant:

      (i) How HIV infection may affect a pregnancy, fetus, or newborn;

      (ii) That there is a potential that the newborn will have HIV infection; and

      (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and

    (d) Information regarding the patient’s responsibility to:

      (i) Notify all known sexual and needle-sharing partners of possible exposure; or

      (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;

  (2) The health care provider shall:

    (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services; and

    (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals;

  (3) For contact control, the health care provider shall:

    (a) Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by:

      (i) Requesting the health officer to conduct a contact investigation of any case of HIV; or

      (ii) Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; and

    (b) Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result;

  (4) A health officer shall:

    (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and

    (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction; and

  (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.

#### Regulation .10 Post-Test Requirements for HIV Testing in Nonclinical Settings.

*COMAR 10.18.08.10*

A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:

  (1) That the HIV test result is negative;

  (2) The meaning of a negative result; and

  (3) A recommendation about whether a repeat test is advisable based on potential recent exposures and the type of test technology used.

B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient tested in person that includes:

  (1) That the HIV test result is indeterminate;

  (2) The meaning of an indeterminate HIV test result;

  (3) Information regarding transmission of HIV and means of preventing transmission of HIV; and

  (4) A recommendation that the patient:

    (a) Return in a medically appropriate time frame for another HIV test; and

    (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested.

C. If a patient’s HIV test result is positive:

  (1) The individual providing testing shall provide post-test information to the patient tested in person that includes:

    (a) That the HIV test result is positive;

    (b) The meaning of a positive HIV test result;

    (c) Information regarding transmission of HIV and means of preventing transmission of HIV;

    (d) If the patient is pregnant;

      (i) How HIV infection may affect a pregnancy, fetus, or newborn;

      (ii) That there is a potential that the newborn would have HIV infection; and

      (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus;

    (e) That the patient should have a medical evaluation by a physician or physician’s designee who knows that the patient is HIV positive;

    (f) That the patient should receive ongoing health care appropriate for an HIV seropositive individual; and

    (g) Information regarding the patient’s responsibility to:

      (i) Notify all known sexual and needle-sharing partners of possible exposure; or

      (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;

  (2) The individual performing the HIV test shall:

    (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services including evaluation and treatment for:

      (i) Tuberculosis;

      (ii) Hepatitis;

      (iii) Pregnancy; and

      (iv) Sexually transmitted infections; and

    (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals;

  (3) For contact control, the individual providing the testing shall:

    (a) Request the health officer from the patient’s home jurisdiction conduct a contact investigation of any case of HIV; and

    (b) Report immediately to the health officer from the patient’s home jurisdiction any known individual identified as having had potentially infectious contact with a patient with a positive HIV test result;

  (4) A health officer shall:

    (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and

    (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s jurisdiction for referral to the health officer of the proper jurisdiction; and

  (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.

#### Regulation .11 Immunity for Health Care Providers Working with Pregnant Women.

*COMAR 10.18.08.11*

A health care provider may not be subject to disciplinary action by the professional licensing board that licenses the health care provider for following the requirements for prenatal HIV testing established by the Department.

#### Regulation .12 Health Care Providers, First Responders, and Public Safety Workers — HIV Exposure.

*COMAR 10.18.08.12*

A. Definition.

  (1) In this regulation, the following term has the meaning indicated.

  (2) “Infection preventionist or employee health provider” means the designated infectious disease/communicable disease officer of a hospital.

B. A health care provider, first responder, or public safety worker involved in an exposure as defined in Health-General Article, §18-338.3, Annotated Code of Maryland, shall comply with the provisions of Health-General Article, §18-338.3, Annotated Code of Maryland.

C. A hospital’s designated infection preventionist or employee health provider or its designee shall follow the requirements in Health-General Article, §18-338.3, Annotated Code of Maryland, if an exposure, as defined in Health-General Article, §18-338.3, Annotated Code of Maryland:

  (1) Occurs:

    (a) In a hospital, between a patient and a health care provider; or

    (b) Before admission of the patient to a hospital, between a patient and a:

      (i) First responder; or

      (ii) Public safety worker; and

  (2) Is such that, in accordance with the CDC’s recommendations, warrants recommending or offering chemoprophylaxis treatment for the health care provider, first responder, or public safety worker.

#### Regulation .13 Information on Exposures.

*COMAR 10.18.08.13*

A. A hospital where an exposure occurred shall:

  (1) Maintain a confidential record or incident report for an HIV test conducted under Regulation .12 of this chapter;

  (2) Adopt procedures for the confidential HIV testing of blood samples or other body fluids used or collected for purposes of Regulation .12 of this chapter;

  (3) Maintain a record of:

    (a) An exposure as defined by Health-General Article, §18-338.3(a), Annotated Code of Maryland; and

    (b) A refusal to consent by a patient as described in the Health-General Article, §18-338.3(b)(2)(ii), Annotated Code of Maryland; and

  (4) Provide records as specified in §A(3)of this regulation or information from the records to the Department when and as requested by the Secretary.

B. Nothing in Regulation .12 of this chapter or this regulation shall be construed to exempt any individual or entity required to report infectious diseases from reporting the infectious diseases as required in Health-General Article, Title 18, Annotated Code of Maryland.

### Chapter 09 — HIV Testing for Pregnant Women Receiving Prenatal Care

*Repealed*

**Administrative History:** Effective date: August 28, 2006 (33:17 Md. R. 1437)

**Administrative History:** Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .02B amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .03 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .04 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .05 amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Regulation .07B amended effective December 14, 2009 (36:25 Md. R. 1954)

**Administrative History:** Chapter revised effective March 27, 2017 (44:6 Md. R. 326)

**Administrative History:** Chapter repealed effective May 7, 2018 (45:9 Md. R. 462)

### Chapter 10 — Urgent Maryland AIDS Drug Assistance Program

*Repealed*

**Administrative History:** Effective date: March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulations .01—.09 repealed effective June 13, 2022 (49:12 Md. R. 640)