PROPOSAL
Maryland Register
Issue Date: January 6, 2017
Volume 44 • Issue 1 • Pages 31—34
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 18 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
10.18.09 HIV [Counseling and] Testing for Pregnant Women Receiving Prenatal Care
Authority: Health-General Article, §§18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-336, 18-337, 18-338.2, and 20-102, Annotated Code of Maryland
Notice of Proposed Action
[17-018-P]
The Secretary of Health and Mental Hygiene proposes to amend Regulations .01 and .02, repeal existing Regulations .03 — .07, adopt new Regulations .03—.05, and amend and recodify existing Regulation .08 to be Regulation .06 under COMAR 10.18.09 HIV Testing for Pregnant Women Receiving Prenatal Care.
Statement of Purpose
The purpose of this action is to:
(1) Update language in COMAR 10.18.09 to make language in this chapter parallel to COMAR 10.18.08 (HIV Testing Procedures);
(2) Add requirements for HIV testing in the 3rd trimester of pregnancy according to HB 180 (2016);
(3) Add language clarifying that the testing requirements in these regulations apply only to pregnant women receiving regular prenatal care;
(4) Combine consent, counseling, and pre-test requirements in Regulation .03; and
(5) Move information on confidentiality of test results from its own regulation to Regulation .04 Testing Requirements.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. As a result of the changes to streamline pre-test activities related to HIV testing of pregnant women, health care providers may note an indeterminable positive economic impact. As clinical settings implement changes to the testing process, the time they spend with each patient to provide the required information prior to testing will be reduced. This may allow a provider to see more patients, which may increase revenue generated by the additional patients. The insurance industry may face increased costs to cover screening pregnant women for HIV in the 3rd trimester.
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Revenue (R+/R-) |
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II. Types of Economic Impact. |
Expenditure (E+/E-) |
Magnitude |
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A. On issuing agency: |
NONE |
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B. On other State agencies: |
NONE |
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C. On local governments: |
(E+) |
Indeterminable |
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Benefit (+)
Cost (-) |
Magnitude |
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D. On regulated industries or trade groups: |
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(1) Health Care Providers |
(+) |
Indeterminable |
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(2) Insurance |
(-) |
Indeterminable |
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E. On other industries or trade groups: |
NONE |
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F. Direct and indirect effects on public: |
NONE |
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III. Assumptions. (Identified by Impact Letter and Number from Section II.) |
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C. Local governments have, within their local health departments, health care providers who may be impacted by the changes to the HIV testing process for pregnant women. As noted above, providers may see an increase in the number of patients they are able to see. The magnitude of the impact is not measurable as it will be dependent on the number of patients that can be seen, the number of providers who offer testing, and the volume of reimbursable services that are paid for by both public and private insurers. |
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D(1). Health care providers who provide prenatal care will be impacted by the changes to the HIV testing process for pregnant women. As noted above, providers may see an increase in the number of patients they are able to see. The magnitude of the impact is not measurable as it will be dependent on the number of patients that can be seen, the number of providers who offer testing, and the volume of reimbursable services that are paid for by both public and private insurers. |
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D(2). Additionally, insurance companies may be impacted by the changes in the number of HIV tests to be provided to women during pregnancy. The magnitude of the impact is not measurable as it will be dependent on the number of patients that accept third-trimester testing, the cost of paying the provider (as this may vary from provider to provider), and the associated laboratory costs (which may vary from lab to lab and based on the type of test conducted). Additionally, an estimate of the number of women already being screened during the third-trimester cannot be provided because the number of tests with negative results is not available. Therefore, this information cannot be used to estimate the magnitude of the impact from changes in the number of HIV tests. |
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.
.01 Scope.
A. Except as provided in [§§B—E] §§C—F of this regulation, this chapter governs [counseling] pre-test and post-test information, requirements for reporting and control efforts, and requirements for informed consent and counseling when HIV testing is performed on pregnant women.
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.
[B.] C.—[D.] E. (text unchanged)
[E.] F. HIV testing of specimens for research is not governed by this chapter if:
(1)—(2) (text unchanged)
(3) The HIV test result cannot be linked to the individual from whom the specimen was taken; and
(4) (text unchanged)
[F.] G. This chapter pertains to [all] pregnant women receiving prenatal care for whom a diagnostic test for the presence of HIV infection is conducted, including minors.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.
(2) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the United States Department of Health and Human Services.
[(1)] (3) “Counseling” means providing education on:
(a) (text unchanged)
(b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy[, including the use of pharmaceuticals known to reduce the risk of transmission of HIV to the fetus]; and
(c) The topics set forth in [COMAR 10.18.08.06B(3)] Health-General Article, §18-336(b), Annotated Code of Maryland.
[(2)] (4) (text unchanged)
[(3)] (5) “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 facility operated by the Department or a health officer; [and]
(c) The office of a health care provider;
(d) A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;
(e) The Department of Public Safety and Correctional Services; or
(f) A program approved by the Department to provide human immunodeficiency virus testing services, as described in COMAR 10.18.08.03 and .04.
[(4)] (6) (text unchanged)
[(5)] (7) “Human immunodeficiency virus (HIV)” means [the human immunodeficiency] a virus that causes [acquired immune deficiency syndrome (AIDS)] AIDS.
[(6) “HIV infection” means an infection with HIV.]
(8) “Indeterminate HIV test result” means an HIV test result that did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria.
[(7)] (9) “Informed consent” means the voluntary permission by the individual to be tested for HIV, after the individual receives [counseling] pre-test information as specified in Regulation .03 of this chapter.
(10) “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.
(11) “Negative HIV test result” means an HIV test result that failed to detect the presence of HIV as defined by the CDC’s laboratory criteria.
(12) Partner.
(a) “Partner” means an individual with whom:
(i) One has, or has had, oral, anal, or vaginal sexual contact; or
(ii) One has 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 that patient at any time within the 10-year period before the diagnosis of HIV infection.
(13) “Positive HIV test result” means an HIV test result that documented the presence of HIV as defined by the CDC’s laboratory criteria.
(14) “Post-test information” means notifying an individual about HIV test results and providing an individual with other relevant information after an HIV test has been performed, as required by Regulation .05 of this chapter.
[(8)] (15) “Prenatal care” means obstetric and gynecologic service performed as part of a [prenatal care program, including] medical care program for a pregnant woman and her unborn child, and may include:
(a)—(b) (text unchanged)
(c) Laboratory and diagnostic testing procedures and interpretation; [and] or
(d) (text unchanged)
(16) “Pre-test information” means information provided to an individual before a specimen is tested for the presence of HIV infection, as required by Regulation .03 of this chapter.
(17) “Research” means an investigation carried out according to a protocol approved by an institutional review board;
(18) “Secretary” means the Secretary of the Department of Health and Mental Hygiene;
[(9)] (19) (text unchanged)
(20) “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.
.03 Consent, Counseling, and Pre-test Requirements.
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) Obtain consent from a health care agent designated as per Health-General Article, §5-602, Annotated Code of Maryland, or surrogate consent as per Health-General Article, §5-605 Annotated Code of Maryland.
D. The general informed consent for medical care may specify that an HIV test will be performed.
E. A health care provider may not be required to obtain consent for HIV testing on a separate consent form.
F. Pre-test information and counseling shall be provided to the patient to be tested for HIV before each specimen is tested.
G. A health care provider providing pre-test information and counseling 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; or
(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 recent potential 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 education to the pregnant woman about:
(a) The effect of a positive HIV test result on:
(i) The pregnant woman; and
(ii) The risk of transmission of HIV to the fetus; and
(b) Recognized methods of reducing the risk of transmission of HIV to the fetus, including the use of pharmaceuticals during pregnancy known to reduce the risk of transmission of HIV to the fetus;
(5) Include an opportunity for the pregnant woman being testing to:
(a) Ask and receive answers to questions about HIV and other topics described in this regulation; and
(b) Decline an HIV test; and
(6) Make necessary accommodations with respect to language or disability to ensure that the patient being tested understands the information presented.
.04 Testing Requirements.
A. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care for HIV:
(1) During the first and third trimesters; and
(2) In the third trimester of pregnancy if the woman’s HIV status is unknown.
B. 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.
C. Confidentiality of HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland.
.05 Post-Test Requirements.
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 tested and in the presence of the patient tested 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 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 and in the presence of the patient tested that includes:
(a) That the HIV test result is positive;
(b) The meaning of a positive HIV test result;
(c) How HIV infection may affect a pregnancy, fetus, or newborn;
(d) That there is a potential that the newborn would have HIV infection;
(e) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and
(f) Information regarding the patient’s responsibility to:
(i) Notify all known sexual and needle-sharing partners of possible exposure themselves; or
(ii) Request assistance from the local health department to notify all known sexual and needle-sharing partners of possible exposure; and
(2) The health care provider shall:
(a) Ensure the patient is linked to an appropriate source of HIV medical care and supportive 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.
[.08] .06 Immunity.
A health care provider or a health care facility acting in good faith to provide [the counseling required under Regulation .03 of] HIV testing and information as required under this chapter may not be held liable in any cause of action related to a woman’s decision to consent or not to consent to have an HIV test.
VAN T. MITCHELL
Secretary of Health and Mental Hygiene
