Frequently Asked Questions regarding the HIV Testing Law
1. When does the testing law go into effect?
The testing law was effective September 1, 2010.
2. What are the Department's expectations around compliance?
The Department has worked collaboratively since the law went into effect to assist providers in complying with its terms. With the adoption of the regulations, we expect that all facilities and providers have implemented the routine offer of testing and other provisions of the law or have made their specific technical assistance needs known to the Department and are making substantial progress toward full compliance. Several evaluation projects are underway to determine the extent that the law has been implemented in a variety of settings. In the event of a patient complaint, the complaint will be reviewed by the Department. Action will be taken with the provider or facility as appropriate. The patient complaint form can be located at http://www.health.ny.gov/forms/doh-4299.pdf.
3. 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 have been 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 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
4. 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 regardless of setting. 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.
5. 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).
6. Instead of making the offer, can we just let patients know that testing is available if they want it or assume they don't need one if they have been tested before?
No. Letting a patient know that testing is available is not an offer of testing. An example of an offer would be “We are routinely offering HIV testing to all of our patients ages 13 and up. Would you like to be tested for HIV?” HIV testing must also be offered when it is clinically indicated.
7. Must an individual have risk factors for HIV to be offered an HIV test?
No. The offer is required except as noted in Question #5.
8. As a patient, what do I do if when I'm seeking care, I am not offered an HIV test?
If you meet the criteria set out by the law and are not offered an HIV test by a health care provider, you should bring it to the attention of that provider and ask for a test or an explanation for why the offer was not made. If you believe your health care provider is not complying with the law, send us your name and contact information, the name of the provider, and whatever details you think would be helpful to hivtestlaw.state.ny.us and the situation will be reviewed.
9. 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 (see Questions 54 for information about circumstances when HIV testing for occupational exposure may be done without consent of the source patient).
- HIV testing may be required of convicted and indicted sex offenders in certain cases.
10. Does the law require insurance companies to pay for the HIV test? What if the patient doesn't have insurance.
HIV testing is covered by Medicaid, Medicare and most private insurance plans, but the law does not necessarily require insurance to pay for an HIV test any time a patient accepts an offer to get one. If a patient accepts the offer of a test but lacks insurance or has insurance that may not pay for the test, clinicians should follow their normal practice for any other test that might be ordered.
11. As a facility or clinician covered by the law, can we refer out for testing if someone accepts or ask the person to come back at another time?
In general, it is expected that covered facilities and clinicians have the capacity to order HIV tests. HIV testing should be handled the same way any other routine test is in the same facility or office.
12. 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 persons, reporting cases, and protecting confidential information pertain to any group that is conducting HIV testing.
13. Does the offer of HIV testing apply to nursing homes, school-based clinics, college health services, retail clinics, urgent care centers, employee health services, STD clinics, 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 regardless of board certification of the practitioner or setting where primary care is provided.
14. 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.
15. Is it appropriate for people to come to an emergency room for the sole purpose of getting an HIV test?
It is not anticipated that emergency rooms should become walk-in HIV test sites. As per the law, the test needs to be offered to all persons who receive care in an emergency room, but this would not include those who are not seeking any care other than an HIV test unless the person has been the subject of a an recent exposure, assault or has another such urgent circumstance. Persons whose sole reason for presenting at the emergency room is routine screening for HIV should be provided appropriate referrals for testing sites if the test cannot be provided for them at the emergency room. State HIV testing law does not change the Emergency Medical Treatment and Active Labor Act which only requires that hospitals provide care to anyone needing emergency treatment.
16. 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 with behaviors that put them at risk for HIV choose not to disclose their risks, providers should consider adopting a low threshold for recommending the test.
17. 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 a) being treated for a life threatening emergency; b) has previously been offered or has been tested for HIV and does not have current risk factors or c) 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.
18. 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.
19. If I provide a poster or brochure which contains the required information on testing and that asks patients to let a staff person know if they would like an HIV test, does that satisfy the offer requirement?
No. The test offer must be more than a provision of information, the advertisement of a recommendation, or an invitation for a patient to ask for testing. Patients should be asked directly in writing or orally if they would like an HIV test.
20. 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.
21. The law says that oral consent can be obtained for a rapid test. How quickly do I need to get the test result back to the patient in order for it to be considered a rapid test?
The law and regulations define a rapid test as one which produces results in 60 minutes or less. This does not include the time necessary for results to be confirmed, if necessary, or provided back to the patient. While it would be optimal that results would be provided back during the same visit as the test, this may not always be possible, especially in emergency department settings. As long as the test itself produces results in 60 minutes or less and the facility is making a good faith effort to provide results quickly, with the large majority being within one business day, the testing process would be considered rapid for the purpose of determining whether oral consent can be used. Facilities using oral consent should monitor their success in the expeditious provision of results.
22. 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.
23. 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.
24. Must providers obtain parental consent to test an individual under 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.
25. Who can make the offer of HIV testing and/or obtain patient consent. Is there a DOH certification for this?
The Department has not made any rules as to who can and cannot perform these functions, nor is there a certification process. Similar to any informed consent process, however, it is expected that that the patient will have an opportunity to have questions answered.
26. How do you handle consent for someone with behavioral health issues?
Persons who present at an emergency room with behavioral health issues and who do not have the capacity to consent for an HIV test, do not need to be offered a test. Those who will be receiving inpatient care should be offered the test when they are capable of consenting.
27. 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 been provided with information on HIV testing and I accept testing.
- _____ No, I do not want an HIV test
- Signature:________________________________________(patient or person authorized to consent)
28. We do not have our own forms. Do we have to use the model forms posted on the Department's website?
No. The forms are provided as models. You can use the Department's model forms DOH-2556 (1/11) or either model on DOH-5019 or create your own as long as it is consistent with one of the state forms. You do not need to use any form if you are offering a rapid test, but need to document consent in the medical record.
29. What information needs 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 language may be adjusted to meet the needs of particular populations or settings, but the substance of the information must be preserved.
30. 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 has added to its website information sheets, brochures and posters that can be used to fulfill this requirement. You may choose to use other oral, written or electronic means to deliver the information
31. 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 should consider noting in the medical record 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.
32. 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.
33. 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.
34. 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.
35. 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.
36. 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, including DOH 2556 (1/11) 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.
Provision of Test Results and Post-test Information and Special Rules for HIV-positives
37. 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;
- 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 that available on the Department’s website. 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. Patients who are consented orally and given a rapid test should be provided their results during the same clinic visit or the same day. Also, it is not appropriate to only tell patients that if they are not contacted, they may assume their tests were negative. However, it is acceptable to provide patients with the required information and a phone number or other means of confirming their negative result if they choose to.
38. Can I test people for HIV and have their results sent to another facility to be provided back to the patients?
The facility conducting the test is responsible for provision of results, counseling and provision of information as appropriate. An exception would be the return of positive results to patient seen in an emergency room. Since emergency departments and urgent care clinics are not set up for continuing care, they may establish a policy for persons testing positive to receive results through a Designated AIDS Center, an infectious disease clinic, or another appropriate provider.
39. 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
40. 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 clinician 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. The Department’s website includes contact information for Designated AIDS Centers and other resources available for providers to help them fulfill this requirement.
41. 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.
42. 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).
43. Is it sufficient to provide a person testing HIV positive with the contact information of a Designated AIDS Center or HIV specialist? How quickly does the appointment need to be made?
No. The clinician ordering an HIV test is responsible for arranging for a specific HIV follow-up appointment. Every reasonable effort should be made to link persons who receive positive test results with care, prevention, supportive and partner services. All reasonable efforts should be made to get the newly diagnosed person an appointment as quickly as possible. If you are having difficulty making an appointment for a patient, please contact Lyn Stevens of the AIDS Institute’s Office of the Medical Director at 518-473-8815.
44. How soon after an HIV positive results is provided should the appointment for follow-up medical care take place.
The appointment should take place as soon as possible.
45. 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.
46. As a medical provider, what are my responsibilities for working with the state or local partner services programs?
Partner services are a cornerstone of HIV prevention efforts that provide an opportunity for sexual or needle sharing contacts of an infected person to be expeditiously offered testing, and if positive, be linked into care. Every physician or other person authorized to order diagnostic testing is required to report HIV and AIDS diagnoses to the health department. This report must include identifying information about any contacts known to the physician or provided to the physician by the infected person. As part of post-test counseling the following information must be provided to the patient:
- 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; and
- the protection of names and other information about HIV-infected persons during the contact notification process.
47. Can a facility offer just an HIV rapid test but refer out to a different provider for confirmatory testing for those who have a preliminary positive rapid result?
No. The law defines a rapid test as one that encompasses a confirmatory test. Sites offering rapid testing are responsible for ensuring that confirmatory testing is done for patients with preliminary positive results. In some facilities the confirmatory specimen may be collected by a different unit within that same facility and the result provided by that unit.
48. 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, some programmatic changes in reimbursement have occurred since the law's implementation. NYSDOH released the following guidance in late June 2011:
The HIV Primary Care Medicaid Program's HIV Testing Visits were subsumed into the Department's Ambulatory Patient Groups (APGs) Methodology effective July 1, 2011. Since that time, only the Federally Qualified Health Centers that are enrolled in the HIV Primary Care Medicaid Program (HPCMP) and that have opted out of APG's continue to access the HPCMP's HIV Testing codes.
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:
Persons with private insurance should refer to their policy or contact their carrier.
49. 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).
50. 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
51. 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.
52. 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.
53. May a medical provider discuss a patient's confidential HIV information with another medical provider for the purposes of continuity of care without getting a specific release from the patient? How about community based organizations?
Yes. Such medical provider to medical provider disclosure is standard practice and can be covered by a general consent to use and disclose health information for the purpose of treatment. Non-medical providers should get a specific signed release from their clients before divulging or discussing confidential HIV information with anyone.
54. 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 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 immediately 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.
* See next question for patients that are deceased.
54a. How does this standard address HIV testing for a deceased source patient when the next of kin or other person representing the estate is available?
In a situation in which a source patient of an occupational exposure is deceased, anonymous testing should be done. When a patient expires, health care proxy and other surrogacy status ends with death.
55. 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. The source patient or person providing consent for that patient may be told that the exposure occurred and an HIV test was performed. It would be appropriate to urge the source patient to accept confidential testing so he may have access to information about his own HIV status.
56. 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.
56a. Is form DOH-4054 (Informed Consent to Perform HIV Testing and Authorization for Release of HIV-related Information for Purposes of Providing Post-exposure Care to a Health Care Worker EWxposed to a Patient's Blood for Body Fluids) still required?
Due to the fact that source patient authorization is not needed for sharing HIV test results with the exposed person’s provider, form DOH-4054, Informed Consent to Perform HIV Testing and Authorization For Release of HIV related Information for Purposes of Providing Post-exposure Care to a Health Care Worker Exposed to a Patient’s Blood for Body Fluids, is discontinued.
57. 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. Laboratories are no longer required to have a patient name in order to run an HIV test in these circumstances. In almost all other instances, anonymous testing is only 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).
58. 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.
59. 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.
60. 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.
61. 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.
62. 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.
63. Can we add a statement to our general medical consent that would allow for source patient testing in the event of an occupational exposure?
Yes. Here is an example of such language: "If a healthcare worker involved in my care and treatment becomes exposed to certain bodily fluids resulting in the possibility of transmission of a blood borne disease, my blood will be tested for HIV, Hepatitis B and Hepatitis C to determine risk of exposure."
64. 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 has not been required since September 1, 2010.
65. NYS has required specific statements regarding disclosure of HIV-related information on the laboratory report. Are these statements still required?
A statement regarding re-disclosure of HIV-related information under10 NYCRR Section 63.5 is no longer required on reports of test results because the lab report is necessary to provide appropriate care or treatment.
66. Does this 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.
67. 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.
68. 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. Laboratory communicable disease reporting requirements are stipulated in Department regulations at 10 NYCRR Section 63.4. The 2010 HIV testing law has not introduced any changes to the types of test results that are reportable to the Department.
69. 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.
70. 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.
71. Will NYSDOH require any data be reported from health care facilities or private practitioners with regard to activities mandated under this law?
No. There are no new reporting requirements included in the Law. Medical providers must continue to complete and submit the NYS Medical Provider HIV/AIDS and Partner/Contact Report Form (PRF) within 14 days to report new diagnoses of HIV or AIDS and/or persons needing partner services. As has been the case, New York City physicians are required to send their reports to the NYCDOHMH. Forms or additional information on this routine reporting requirement can be obtained by calling the NYSDOH at 518-474-4284.
72. How can clinicians determine the tests "approved for the diagnosis of HIV"?
Approved tests technologies include those consistent with state and national guidelines for HIV diagnosis. A list of FDA-approved diagnostic tests is maintained by the FDA is available on their website.
73. Can HIV-infected minors consent for their own treatment?
In general, as per NYS Public Health Law Section 2504, parental or guardian consent is required for a physician to treat a minor for HIV/AIDS, including in school-based clinics. Family planning clinics can provide only family planning related care to minors with the minor’s consent. Minors who are married or pregnant/parenting can consent for their own care.