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Frequently Asked Questions regarding the Amended HIV Testing Law

Overview

When does the testing law go into effect?

The testing law is effective September 1, 2010.

When will the Department begin to enforce the provisions of the HIV testing law?

The Department is aware there are implementation challenges related to the HIV testing law due to the abbreviated time between the enactment and the September 1, 2010 effective date. We will continue to work collaboratively with facilities and providers over the next several months as they come into compliance with the various provisions of the law. Regulations are being developed to assist in the implementation efforts.

What are the key provisions of the law?

HIV testing must be offered to all persons between the ages of 13 and 64 receiving hospital or primary care services with limited exceptions noted in the law. The offering must be made to inpatients, persons seeking services in emergency departments, persons receiving primary care as an outpatient at a clinic or from a physician, physician assistant, nurse practitioner or midwife.
Standardized model forms for obtaining informed consent and providing for disclosure will be developed by the New York State Department of Health and posted on the DOH website. Facilities do not need to use these forms, but may create their own without state review or approval as long as the language is consistent with the standardized model forms.
Consent for HIV testing may be part of a general consent to medical care, though specific opt out language for HIV testing must be included.
Consent for rapid HIV testing can be oral (except in correctional facilities) and noted in the medical record.
Consent can remain in effect for a period of time stipulated by the patient or until revoked by the patient orally or in writing.
Prior to being asked to consent to HIV testing, patients must be provided the seven points of information about HIV required by the Public Health Law.
Health care and other HIV test providers authorizing HIV testing must arrange, with the consent of the patient, an appointment for medical care for those confirmed as positive.
HIV test requisition forms submitted to laboratories will be simplified and no longer require provider certification of informed consent having been obtained.
Deceased, comatose or persons otherwise incapable of providing consent, and who are the source of an occupational exposure, may now be tested for HIV in certain circumstances anonymously without consent.
Confidential HIV information may be released without a written statement prohibiting re-disclosure when routine disclosures are made to treating providers or to health insurers to obtain payment.

Required Offer of HIV Testing

Does the requirement that HIV testing be offered to all persons between the ages of 13 and 64 apply in all medical settings?

The requirement for the offering of testing applies to persons receiving inpatient or emergency department services at hospitals and persons receiving primary care services through hospital outpatient clinics, diagnostic and treatment centers, and persons receiving primary care services from physicians, physician assistants, nurse practitioners and midwives. Exceptions to this requirement are detailed in the response to Question #5. Practitioners who see their patients on a regular basis may consider incorporation of the offer of HIV testing as part of routine physical exams and well child visits to meet the requirement.

What are the exceptions to the mandatory offer of HIV testing in the hospital, diagnostic and treatment center, and primary care settings noted in the law?

The law does not require an offer of testing to be made:

When the individual is being treated for a life threatening emergency.
When the individual has previously been offered or has been the subject of an HIV related test (unless otherwise indicated due to risk factors).
When the individual lacks the capacity to consent (though in these cases the offer may also be made to an appropriate person who is available to provide consent on behalf of the patient).

Must an individual have risk factors for HIV to be offered an HIV test?

No. The offer is required except as noted above.

Is HIV testing mandatory?

The law mandates the offer of HIV testing only, not testing itself. In New York State, HIV testing is voluntary and requires the consent of the person being tested or someone authorized to consent for the individual. Testing is however mandatory in certain limited circumstances as follows:

As of February 1997, all newborns in New York State are tested for HIV antibodies. A newborn's test result also provides information about the mother's HIV status.
Blood, body parts, and organ donations are tested for HIV.
HIV testing can be required in order to participate in some federal programs, such as the Job Corps and the Armed Forces.
Under certain conditions, inmates in federal prisons (but not in state or local correctional facilities) are tested for HIV without their consent.
HIV testing can be required for certain types of insurance, like disability or life insurance. However, insurance companies must tell applicants they will be tested for HIV, must provide them with general information, and must have the applicant sign a consent form. In New York State, people cannot be denied health insurance because they are living with HIV or AIDS.
Testing may be performed without consent in instances of occupational exposure when the source person is not able to themselves consent and other conditions are met.
HIV testing may be required of convicted and indicted sex offenders in certain areas.

Are organizations and individuals that are not required to make an offer of HIV testing still covered by other parts of the law?

Yes. Other sections of the law such as obtaining consent, providing information prior to and after testing, making appointments for HIV-infected person, reporting cases, and protecting confidential information pertain to any group that is conducting HIV testing.

Does the offer of HIV testing apply to nursing homes, school-based clinics, college health services, retail clinics, urgent care centers, employee health services, and family planning sites that provide primary care?

Yes. Even though these facilities are not specifically mentioned in the law, if primary care is being provided by a physician, physician assistant, nurse practitioner, or midwife, they are required to make the offer.

How can I be sure if the state will consider my clinic to be a primary care provider mandated to make the offer of HIV testing?

The important thing is to consider what your facility does rather than what your facility is called. For instance, an urgent care center that offers many or all of the services available at a family physician’s office would be considered a primary care provider. However, there are diagnostic and treatment centers that are restricted to ambulatory surgery, and these would not be covered by the mandated testing offer provision since they do not offer primary care.

How often does the offer of HIV testing need to be repeated?

All persons between 13 and 64 need to be offered an HIV test at least once. In addition, the law requires that offers be made to any person, regardless of age, if there is evidence of risk activity. Testing should be offered annually to persons whose behavior indicates elevated risk such as sexual or drug use activity, or even more often for those with very high risk behaviors such as unprotected anal intercourse. Since many people choose not to disclose their risks, providers should consider adopting a low threshold for recommending the test.

Which providers must offer HIV testing under this law?

Providers who must offer HIV testing include:

Those providing health services in an inpatient or emergency department of general hospital;
Primary care providers, defined to include, without regard to board certification, family medicine, general pediatrics, primary care, internal medicine, primary care obstetrics or primary care gynecology, offering primary care services in a hospital outpatient department or diagnostic and treatment center and
Physicians, physician assistants, nurse practitioners or midwives providing primary care regardless of setting.

Providers are not required to offer HIV testing if the patient is:

being treated for a life threatening condition;
has previously been offered or has been tested for HIV or
lacks capacity to consent to an HIV test. Some dentists currently offer their patients HIV testing and may continue to do so - but are not required to offer the test under the law.

For record keeping purposes, is the offer of an HIV test considered confidential HIV information that needs to be protected?

No. Information about the offer, such as a general medical consent form with the HIV test opt-out language, is not considered confidential HIV information.

Consent

How is this law different from the previous law with regard to informed consent?

Now, informed consent for HIV testing can be incorporated into a general medical consent that is consistent with a model provided by the Department. Consent can remain in force until its stated term expires or until it is revoked by the patient. Even so, the patient needs to be informed orally each time an HIV test will be done. For rapid HIV tests, consent may be obtained orally and must be noted by the ordering clinician in the patient’s medical chart. Laboratories are no longer required to obtain informed consent certification from practitioners ordering HIV tests.

Are there different rules for HIV testing consent in correctional facilities?

Yes. It is not permissible to seek oral informed consent for rapid HIV testing in facilities operated under the Correction Law. Testing in correctional facilities must follow the law for written informed consent regardless of test technology.

Do the consent procedures in the law apply to tests used for monitoring HIV disease progression or treatment such as viral loads, CD4 counts, or HIV resistance?

The law applies specifically to testing that is being performed to diagnose HIV infection.

Must providers obtain parental consent to test an individual between 13-18 years old?

No. In New York State, the capacity to consent to an HIV test (either confidential or anonymous) is determined without regard to age. Providers offering HIV testing must make a determination as to the patient’s capacity to consent. If a practitioner determines a person under18 years old does not have the capacity to consent, the offer of testing for the young person should be made to a parent or other person authorized to provide consent.

What key elements should be added to a medical facility's or provider's general medical consent to comply with the law?

To comply with the law, the general medical consent form must have a clearly marked place next to the signature where the person providing consent is given the opportunity to decline the HIV test. Below is model language. Please note: One, single signature is sufficient for the purpose of consenting to all medical care including HIV testing. The model below includes such a signature line to demonstrate proper placement of the opt out language and check box.

I have received information on HIV testing and I agree to be tested for HIV
Signature:________________________________________(patient or person authorized to consent)
Check below if you do not wish to consent to an HIV test at this time. You may request HIV testing in the future.
_____ I do not want an HIV test

We do not have our own forms ready yet. Do we have to use the model forms posted on the Department's website and attached to the Dear Colleague letter?

No. The forms are provided as models. You can use the Department's model forms or you can continue to use the previous version of DOH-2556 (5/05) and DOH-2556i (6/05). You do not need to use any form if you are offering a rapid test, but need to document consent in the medical record.

What are the seven points of information that need to be provided to persons who will be asked to consent to HIV testing?

Persons being asked to consent to HIV testing must be provided the following explanations:

HIV is the virus that causes AIDS and can be transmitted through: unprotected sex (vaginal, anal, or oral sex) with someone who has HIV; contact with blood as in sharing needles (piercing, tattooing, drug equipment including needles); by HIV-infected pregnant women to their infants during pregnancy or delivery; or while breast feeding.
There are treatments for HIV/AIDS that can help an individual stay healthy.
Individuals with HIV/AIDS can adopt safe practices to protect uninfected persons from acquiring HIV and infected people from acquiring additional strains of HIV.
Testing is voluntary and can be done anonymously at a public testing center.
The law protects the confidentiality of HIV test results and other related information.
The law prohibits discrimination based on an individual’s HIV status and services are available to help with such consequences.
Consent for HIV related testing remains in effect until it is withdrawn verbally or in writing. If the consent was given for a specific period of time, it remains in effect for that time period only. In any case, persons may withdraw their consent at any time.

This information may be provided by the person ordering the test or through his representative (the representative can be a medical or non-medical person) through oral, written or electronic mechanisms with no formal pre-test counseling required. For adults not able to consent for themselves, the Family Health Care Decisions Act stipulates who is able to consent for care in a variety of circumstances.

The general consent is signed upon admission to hospital, how do we fulfill the requirement for providing "information regarding the causes of AIDS, the availability of treatment, safe practices, confidentiality protections, discrimination laws and that the test is voluntary and is available anonymously at public sites"?

The Department's form DOH-2556 Part A fulfills this requirement. You may choose to use other oral, written or electronic means to deliver the information.

What are the requirements for documenting oral consent for rapid HIV testing?

Consent must be noted in the patient’s medical record and should include the date and name of person ordering the test. In non-medical settings, consent should be noted in the program’s testing documentation for each client. The facility may wish to document refusal of the test as a means of documenting counseling without testing if that is to be billed for, or if the provider wants a record of the refusal to help determine if future offers are necessary.

How do patients decline testing and what documentation is required?

Patients may decline testing orally or in writing. Refusal may be documented on a general medical consent form by patients indicating in a clearly marked place near their signature that they do not wish to be tested for HIV. In instances when a general medical consent form is not used, the refusal may be noted in the patient’s medical record including date and name of the person making the note. Chapter 308 does not require documentation of refusals though a model form has been provided by the state for your convenience. Model forms may be found on the Department of Health's website.

What is the process for patients to revoke consent for HIV testing? What is the documentation requirement?

Revoking consent can be done by the patient orally or in writing at any time. It is recommended that oral revocation be noted in the medical record, in close proximity to the original consent, and in the current annotation of the medical record. Medical record documentation should include the date and the name of the person making the note.

What is the expiration period for HIV consent?

There is no specific expiration period unless one is noted on the consent form. However, consent can be withdrawn by the patient at any time.

Do patients who give oral consent to a rapid HIV test have to sign a written consent for western blot confirmation?

No. The oral consent applies to both the screening and confirmation.

In a private medical office offering primary care where there is no general medical consent, what form should be used?

Private medical offices can use any standard model consent forms provided by the Department or create one of their own that contains information consistent with the standard models. They may also use the standard model form for documenting the offer of HIV testing or note the offer in the medical record.

Post-test Counseling

What is the requirement for post-test counseling?

A person who tests HIV positive must be provided directly by the person ordering the test (or through a representative) the test result, an appointment for follow-up HIV medical care (with the patient’s consent) and counseling that addresses:

coping emotionally with the test results;
discrimination issues relating to employment, housing, public accommodations, health care and social services;
authorizing the release and revoking the release of confidential HIV-related information;
preventing high risk sexual or needle-sharing behavior;
the availability of medical treatment;
HIV reporting requirements for the purposes of monitoring of the HIV/AIDS epidemic;
the advisability of contacts being notified to prevent transmission, and to allow early access of exposed persons to HIV testing, health care, and prevention services, and a description of notification options and assistance available to the protected individual;
the risk of domestic violence in conformance with a domestic violence screening protocol developed by the commissioner pursuant to law;
the fact that known contacts, including a known spouse, will be reported and that protected persons will also be requested to cooperate in contact notification efforts of known contacts and may name additional contacts they wish to have notified with the assistance of the provider or authorized public health officials;
protection of names and other information about HIV-infected persons during the contact notification process;
information on the availability of medical services, the right to have an appointment made for HIV follow-up medical care, the use of HIV chemotherapeutics for prophylaxis and treatment, and the availability of peer group support.
the risk of perinatal transmission

A person who tests HIV negative must be provided with the result and information concerning risks of participation in sexual and needle-sharing activities that can result in infection. This information may be in the form of written materials such as the Department's Part A form DOH-2556i. The negative test result and required information do not need to be provided in person. Other mechanisms such as email, mail, and phone may be used as long as you have taken steps to ensure the patient's confidentiality. It is not appropriate to tell the patient that if he is not contacted, he may assume his test was negative.

What kind of assistance will the New York State and City Health Departments offer in instances where a newly diagnosed person fails to return for test results and post-test counseling?

In instances where the newly identified HIV-infected patient has not returned for post-test counseling, the HIV Partner Services (PS)/Contact Notification Assistance Program (CNAP) Specialist can assist the medical provider in locating the person to advise them to return to the medical provider for post-test counseling. When positive results are verbally confirmed by the testing provider and the provider requests such assistance, the HIV PS/CNAP Specialist can perform post test counseling on behalf of the provider.

If there are partners known to the medical provider, including spouses, and if after repeated follow-up efforts the index patient cannot be located or chooses not to return for post-test counseling and/or domestic violence screening, the authorized public health official, in consultation with the reporting medical provider, determines whether notification of known partners should proceed. This decision will primarily be based on the likelihood of the index patient returning for post-test counseling, potential for risk domestic violence, and the risk to the potentially exposed spouse and/or other sexual and needle sharing partners known to the medical provider. For partner services assistance in New York City you can call 212-693-1419. In other parts of the state call 800-541-2437.

Follow-up Appointments for HIV-infected persons

The law requires that persons ordering HIV testing provide or arrange for an appointment for follow-up HIV care for those who test positive and who agree to have such an appointment made. Does that appointment need to be with an infectious disease physician and what are the documentation requirements?

The law does not specify the clinician specialty but does specify that the appointment must be for follow-up HIV care. The patient’s medical record should reflect the name of the provider/facility with whom the appointment was made.

Do I need to document that the HIV-infected patient attended the follow-up medical appointment I was required to make for him?

No, the law does not require that you confirm that the appointment was kept.

Does the requirement to provide or arrange for an appointment for follow-up HIV care apply only to those facilities and practitioners noted in law as having to offer testing?

No. These are separate parts of the statute. The requirement for providing or arranging for a medical appointment for those diagnosed as HIV-infected applies to anyone providing HIV testing with some exceptions (such as a blinded research protocol or for procuring body parts for transplantation).

Is it sufficient to provide a person testing HIV positive with the contact information of a Designated AIDS Center or HIV specialist?

No. The clinician ordering an HIV test is responsible for arranging for a follow-up appointment. Every reasonable effort should be made to link persons who receive positive test results with care, prevention, supportive and partner services.

In emergency room settings where the person may be tested late at night, may we arrange the appointment on the next business day.

Yes. It is to have the appointment made the next business day when offices are open.

Reimbursement

Does this law impact access to Medicaid, Medicare or other insurance reimbursement HIV counseling and testing?

No. Reimbursement mechanisms were not impacted directly by the law. However, changes do occur. For instance, the NYSDOH released the following guidance in late October 2010:

It is anticipated that the HIV Primary Care Medicaid Program's HIV Testing Visits will be subsumed into the Department's Ambulatory Patient Groups (APGs) Methodology effective January 1, 2011. At that time, HIV Primary Care Medicaid Program (HPCMP) participants should no longer use the currently carved out rate codes - < unless the provider is a Federally Qualified Health Center and has opted out of APG's.

HIV counseling that occurs in conjunction with a medical visit is a billable service when a physician or other qualified health care professional spends time with the patient to discuss at some length topics including but not limited to HIV disease, the importance of testing, and risk factor reduction. Billing for such counseling services is through one of the CPT codes for "Preventive Medicine, Individual Counseling" (CPT codes 99401 - 99404) appropriate for the time spent with the patient and for which adequate documentation is made in the patient's chart. HIV counseling services are distinct from evaluation and management (E&M) services that may be reported and billed separately when performed. In addition, the HIV test itself can be billed, as can the blood draw if a non-rapid test is performed, in a manner appropriate to the provider setting (e.g., hospital outpatient clinic or freestanding diagnostic and treatment center). All billing and payments are subject to and paid in accordance with Medicaid regulation.

The website below is regularly updated with important, useful and keenly relevant information. We strongly encourage you to review the site:

http://www.health.ny.gov/health_care/medicaid/rates/apg/

Persons with private insurance should refer to their policy or contact their carrier.

Must HIV testing offered under the law be provided free of charge if Medicaid or private insurance is not in place?

No. The HIV Testing Law has not changed the way HIV testing is paid for. Reimbursement rules for Medicaid and private insurers are subject to change. Patients who would like information about free or anonymous testing sites may call 1-800-541-AIDS (2437).

If a person does not want any out of pocket expenses or to have his insurance company know he was tested for HIV, can I refer him to a state, local or community provider that conducts free HIV testing?

Yes. If a patient would otherwise refuse an HIV test, it is appropriate to make this kind of referral. Patients who would like information about free or anonymous testing sites may call 1-800-541-AIDS (2437).

Disclosure of HIV-related Information

What changes does the law make with regard to disclosure of HIV-related information?

The law adds two exceptions to the current list of exceptions to the requirement that disclosures of HIV-related information be accompanied by a re-disclosure statement. The additional exceptions are disclosure to:

A health care provider or health facility when knowledge of the HIV related information is necessary to provide appropriate care or treatment to the protected individual, a child of the individual, a contact of the protected individual, or a person authorized to consent for health care for such a contact.
Third party reimbursers or their agents to the extent necessary to reimburse health care providers for health services; provided that, where necessary, an otherwise appropriate authorization for such disclosure has been secured by the provider.

What does the law say about access to confidential HIV information of deceased persons?

The new law clarifies that executors and administrators of an estate shall have access to confidential HIV information as needed to fulfill their responsibilities.

Occupational Exposure

In what cases can a provider test a source patient of an occupational exposure without that patient's consent?

Situations may occur where a source patient in an instance of occupational exposure is unable to provide consent for HIV testing. The Family Health Care Decisions Act stipulates who is able to consent for care in a variety of circumstances like this. In cases of occupational exposures which create a significant risk of contracting or transmitting HIV infection, an anonymous test may be ordered without consent of the source patient if all of the following conditions are met:

the source person is deceased, comatose or is determined by his or her attending professional to lack mental capacity to consent, and
the source person is not expected to recover in time for the exposed person to receive appropriate medical treatment, and
there is no person available or reasonably likely to become available who has legal authority to consent in time for the exposed person to receive appropriate medical treatment, and
the exposed person will benefit medically by knowing the source person's HIV test results.

Since treatment decisions for the exposed person need to be made expeditiously, with therapy ideally beginning within two hours post exposure, the decision to perform an anonymous test on the source patient may be made immediately if there is no surrogate present to provide consent.

How should HIV testing be done in occupational exposure cases that meet all of the criteria above?

The law requires that the provider order an anonymous test of the source person with results being provided only to the attending professional of the exposed person solely for assisting the exposed person in making appropriate decisions regarding post-exposure medical treatment. The results of the test cannot be disclosed to the source person or placed in that person’s medical record.

In cases of occupational exposure, how is authorization to conduct anonymous testing obtained?

A clinician may only order an anonymous test in the specific instance of an occupational exposure involving a source patient who is deceased, comatose or otherwise unable to consent, and there is no surrogate available prior to the time when post-exposure prophylaxis should optimally begin. The medical benefit of knowing the source person’s test result must be documented in the exposed person’s medical record.

It was my understanding that only state and local health departments could provide anonymous HIV testing. Has that changed?

Yes. The law now allows for anonymous testing to be ordered by health care providers in very specific situations involving occupational exposures as noted in Question 40. In almost all other instances, anonymous testing is conducted by staff of state and local health departments. Persons wishing an anonymous test can be referred to one of these by having them call 1-800-541-AIDS (2437).

Is there a specific type of HIV test that is to be used for anonymous testing involving occupational exposure from a patient unable to give consent?

No. However, NYSDOH strongly recommends use of a rapid HIV test. Rapid test results are usually available within 30 minutes of testing. In those organizations subject to OSHA regulations, rapid testing is the mandated technology for source patient testing in cases, including occupational exposures. NYSDOH guidelines recommend that post exposure prophylaxis should be initiated as soon as possible, ideally within two hours post exposure.

Is testing of the source patient under the Family Health Care Decisions Act (FHCDA) anonymous, as it is in the HIV Testing Law? If not, which law takes precedence?

The FHCDA gives providers the ability to locate someone who has the legal authority to consent to HIV testing before going forward with an anonymous test, as per the amended HIV Testing Law. Testing under FHCDA is just as if the patient or a health care agent under a health care proxy consented to the test – it is not anonymous. It is not a question of which law takes precedence, because the laws are not in conflict. Rather, it is more about the steps to be taken, which are as follows:

Approach source patient. Determine 'no capacity to consent', go to next step:
Approach surrogate. Surrogate available. Obtain consent. No surrogate available, go to next step:
Test source patient anonymously as per the amended HIV Testing Law.<

If the source patient declines testing in a case of occupational exposure, may we test him anonymously?

No. If the source patient declines testing, no HIV test may be conducted.

Is it allowable to include consent for occupational exposure testing and related disclosure on a facility's general consent form?

Yes. A facility can include language around occupational exposure testing and disclosure in their consent form. If a patient consents and later becomes the source of an occupational exposure, it would be the responsibility of the facility to inform the patient or his surrogate before the testing was conducted or as soon after as practical that testing took place and to note the test and the result in the patient’s medical record.

If a source patient is tested anonymously for an occupational exposure, can we inform him when he has regained consciousness that he was tested?

Yes. The law does not preclude the source from being informed that a test was conducted; however, you cannot inform him of the result or place it in his medical record. A confidential test could be ordered with his consent at that point so he would have the benefit of knowing the result of his HIV test.

Laboratory Questions

Our laboratory's test requisition form includes a place for physician certification that informed consent was obtained. Can the laboratory continue to use this form after the new law goes into effect?

Yes, the laboratory may continue using existing stock of requisition forms for HIV testing. At the time the laboratory revises its form, the lines for certifying consent should be removed. Forms may retain statements to the effect that informed consent is required. Reasonable effort should be made to notify ordering providers that their certification of consent on requisitions is no longer required effective September 1.

NYS has required specific statements regarding disclosure of HIV-related information on the laboratory report. Are these statements still required?

A general statement regarding re-disclosure of HIV-related information that complies with 10 NYCRR Section 63.5 will continue to be required on reports of test results.

Does this new law change any of the existing requirements for reporting preliminary positive HIV testing results?

No. A preliminary positive may be reported at the request of the ordering provider.

Will laboratories continue to be involved in the consent process?

Laboratories that offer HIV testing at health fairs or community screening events using rapid HIV tests are required to document the test subject’s consent. However, under the new law when a rapid test is used, consent may be oral and documented by testing personnel.

Does the change to the law's definition of HIV-related test affect a laboratory's obligation to report to the Department all confirmed positive HIV tests?

No. Reporting requirements are stipulated in Department regulations at 10 NYCRR Section 63.4. They types of tests that are reportable will remain unchanged.

Can HIV lab results be posted on an electronic medical record?

Yes. Facilities may post such information but are responsible for the protection of confidential information.

If I am not currently providing rapid HIV testing, where can I find information about how to apply to be able to offer HIV rapid tests?

Information on registering as a Limited Service Laboratory for the performance of HIV rapid tests in clinics and other settings can be found on the DOH website. Physicians or physician practices performing HIV testing must apply for a CLIA Certificate of Waiver. Instructions and applications are also available online.

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