Assessment Of Public Comments
Thirty-three comments were received by the Department of Health on the revised HIV reporting and partner notification regulations published in the December 15, 1999 State Register. Many comments focused on issues which had been raised in the initial promulgation of the regulations and which have already been considered and addressed in the December 15th Assessment of Public Comment. Significant among these comments were: recommending use of a unique identifier rather than patient name in the reporting process; including a definition of a minor in the regulations; amending the informed consent form to state that there are no penalties for not providing partner names; requiring informed consent for reportable tests other than HIV antibody positive; questioning the Department's authority to require all specified laboratory tests to be reported; questioning the Department's authority to interview index patients; the inclusion of domestic violence issues in pretest counseling; inclusion of the domestic violence protocols in regulation; and questioning the authority to allow disclosure to persons occupationally exposed. A full discussion of these issues was contained in the previous Assessment of Public Comment.
Comments received on the revised Part 63 regulations (12/15/99) and the Department's responses are grouped as follows:
One commenter requested a definition of domestic violence be added. This was not added since a comprehensive definition is beyond the scope of these regulations. The Office for the Prevention of Domestic Violence (OPDV) is the lead agency with appropriate expertise and jurisdiction. The Department has worked closely with OPDV in developing domestic violence protocols to be utilized in the partner notification process and accepts the OPDV's definition of domestic violence for this program.
One commenter suggested the definition of health care provider be amended to refer to a provider of diagnostic medical or "health care" services. Concern was expressed that the Department should avoid broadening the scope of practice of non-physicians. In response the reporting regulations in section 63.4 by their own terms, do not apply to health care providers who do not order diagnostic laboratory tests.
Some commenters inquired about an enforcement protocol for breaches of identifiable program data. The Department is developing procedures for monitoring breaks in protocol by program staff and possible confidentiality breaches. Investigation and resolution will occur utilizing the Department's existing enforcement mechanisms.
One commenter recommended that the regulations contain strong protections against disclosure to law enforcement agencies, immigration officials and to insurance companies. The confidentiality of the information is strictly and explicitly described in the statute, PHL section 2135 and in the regulation section 63.4(c) which limits disclosure to the purposes of epidemiology and partner notification.
One commenter suggested that all disclosures of HIV information be recorded in the medical record. Both PHL section 18, governing access to medical records and PHL Article 27-F governing HIV confidentiality already address the recording of disclosures in the medical record.
Some commenters requested clarification that only correctional personnel directly involved in medical care be provided MV status of inmates, probationers and parolees. Strict confidentiality protections govern access to HIV-related information and do not provide for non-medical correctional staff to obtain names and HIV status of inmates. Further, existing agency regulations for the Department of Correctional Services, Parole and Probation limit the disclosure of HIV-related information in those settings.
A comment was received that the data security policies should be subject to community input. Data security will conform to the technical requirements of the Centers for Disease Control and Prevention (CDC) and will incorporate the best available electronic and other safeguards. General community comment on these technical issues (encryption, firewalls, etc.) is not appropriate. The widespread dissemination of information about the specifics of data security could facilitate active attempts to breach the system.
One person commented that county health departments needed to maintain all program data for an unlimited time to fully implement the law. The Department has weighed the value of short and long term data retention and found that maintaining contact names for no longer than a one-year period after case closure is sufficient to effectively accomplish the intent of the legislation.
One commenter questioned how the reporting source (i.e. physician, laboratory) would maintain confidentiality. PHL Article 27-F limits disclosure of HIV-related information to specified persons and purposes. Strict penalties for violations of confidentiality are set forth in the statute.
The Office for Families and Children Services (OFCS) desired clarification that its present access to HIV information will continue. Appropriate access for foster care and adoption remains unchanged. No revisions have been made to section 63.6(8). The regulations also do not supersede mandated reporting of child abuse under Social Services Law section 413 as no revisions have been made to section 63.6(i).
One comment recommended amending section 63.5(a) to prevent domestic violence information from being shared with insurance companies. Domestic violence (DV) information may be obtained as part of HIV counseling. However, disclosure of HIV information to insurance companies is authorized in PHL 2782 only "to the extent necessary to reimburse." Consequently, if the DV information is part of the HIV record and is not necessary for reimbursement purposes, it must be withheld.
Some commenters suggested the regulations contain precautions for providers when dealing with domestic violence victims who are minors. Although the Department recognizes that this is a very sensitive area, medical practice precautions are not suitable for regulatory promulgation but must be addressed on a case by case basis. The Department will develop guidance materials regarding HIV partner notification, including domestic violence screening for those cases involving minors. Municipal health commissioner procedures that cover this issue will be subject to Departmental review and approval.
Pre-/Post- Test Counseling
The timeliness of reporting from out-of-state reference laboratories was raised since reporting might occur prior to the patient receiving posttest counseling. The Department is aware that laboratory reporting may occur prior to posttest patient counseling in some cases. Out-of-state laboratories do not present a unique case. Partner notification protocols have been structured such that state/county health staff will first ascertain that counseling has occurred by the provider prior to routinely initiating partner notification activities.
A commenter said that providers do not routinely communicate a patient's diagnosis to a laboratory. Therefore, laboratories could not know whether or not CD4 tests were HIV related In certain situations, e.g. laboratories situated in cancer hospitals, this circumstance occurs and would constitute an exception in section 63.4(a)(4). If CD4<500 test results not related to HIV are reported, these will be deleted from the surveillance registry.
It was also stated that laboratories do not and should not have patient addresses. The New York State direct billing law requires laboratories to bill the patient directly, with certain limited exceptions. This bill was passed in order to avoid excess provider charges. Consequently, laboratories generally should have patient names and addresses.
Some comments requested clarification that newborn HIV test results and the name of the mothers of HIV positive newborns shall not be reported. The state's newborn testing program operates independently from the HIV/AIDS reporting program. A newborn's HIV antibody positive test result will not become part of the Article 2 1, Title III registry, nor will mothers of HIV positive newborns be reported to the registry based solely on their newborn's test result.
A 60-day timeframe for provider reporting was suggested in place of the 21 -day period. The importance of prompt follow-up with respect to partner notification weighs in favor of the shorter period.
One commenter recommended an additional box on provider reporting forms to indicate that no posttest counseling had occurred. Report forms will contain a box which can be marked to indicate whether a person has been informed of his/her HIV status, which would mean that post test counseling had been done.
Another commenter sought clarification as to whether the index case gets reported when partner notification is deferred based on a risk of domestic violence. The statute does not contain an exemption to reporting based on risk of domestic violence.
Partner Notification Issues
Some writers recommended limiting the information which is conveyed to the contact during the partner notification session. These issues are specifically addressed in the regulations, section 63.8(a), which do not allow the name or any other information about the case to be disclosed during partner notification.
Some commenters urged the Department to recognize special populations (e.g., youth, immigrants) in the regulations dealing with partner notification. Special populations present unique circumstances regarding partner notification; interactions must rely on a case-by-case assessment. Guidance and training materials for public health staff and health and human service providers are being prepared in this regard.
One comment suggested that local health departments be certified as capable of implementing the regulations. The Department has visited and surveyed participating health departments, and will require each municipal health commissioner to sign as the party responsible for assuring security and confidentiality of program data according to NYSDOH and CDC standards. Local health departments will submit their procedures regarding partner notification to the state for approval or agree to adhere to State DOH procedures, thereby, assuring adequate policies and procedures. The Department will provide local public health staff with comprehensive training relative to their respective responsibilities in implementing the regulations. Funding has also been provided to assist local health departments in implementing the regulations.
One commenter recommended that contact names be retained for only 30 days. The Commissioner has determined that no more than one year after the date of case closure is a reasonable to allow sufficient time to meet the goals of the partner notification program.
Three comments stated that the regulations failed to define a statewide standard of cases meriting partner notification. However, the PHL section 2133, states that the municipal health commissioner or the department's district health officer, "upon a determination that such reported case or any other known case of HIV infection merits contact tracing in order to protect the public health, shall..." Consequently, although the regulations can and do provide guidelines as to which cases merit partner notification, they cannot preempt the independent judgment of the local health officers.
Some comments requested fuller explanation of the differences between anonymous and confidential HIV antibody testing. The Department's educational materials and the test consent form will clarify the difference. The locations and phone numbers of testing sites was also requested. This information is subject to change. A directory has recently been published by the Department providing a listing of the test sites, hours of operation, languages available and other information.
One commenter suggested, for consistency, that in various phrases in the regulation after the word "physician", " or his/her agent" should be inserted. While the activities of partner notification may be delegated by a provider to a trained member of his/her staff, activities requiring professional judgment remain in the sole province of the physician. Consequently, we have not routinely modified the term "physician" with "or his/her agent".
One commenter stated that the regulations should establish specific protocols for partner notification that is not done in-person. This is an extremely rare and exceptional circumstance that is done usually at the request of the partner. No problems have been encountered with partner notification that is not done in-person since HIV partner notification was authorized by PHL Article 27-F (§2782) in 1989. Therefore, no change was made to these regulations.
One commenter asked that the regulations establish a prohibition on disclosure of information to the parents of minor contacts. The Department and the NYC Department of Health and Mental Hygiene have had a long and successful experience with contact notification involving minors. The importance of the minor's voluntarily communicating his/her HIV status to parents or trusted adults is stressed in all cases. An absolute prohibition is in conflict with PHL section 2782(4)(e). However, the statute provides that disclosure to the person authorized to consent to health care must be "in the best interest of the protected individual." This case-by-case determination involves careful consideration of the unique circumstances of each minor. Consequently, no amendment was made to these regulations.
Regulations specifically governing partner notification occurring in congregate facilities were also recommended. Since congregate facilities are varied in kind and in medical and social support systems available to the resident/inmate, specific regulations covering each type of congregate facility are inappropriate. Guidance for notification in such settings is being developed.
One commenter suggested purging partner names from the information system when no confirmation of partner notification has occurred. The regulations, section 63.80) require destruction of partner names no- later than one year following case closure. Case closure may encompass some situations when notification has not occurred and the case is closed based on other criteria (disappearance of the person, repeated unsuccessful attempts at notification, etc.).
One commenter suggested that persons be afforded administrative review including a fair hearing if they disagreed with a local public health officer that a case merited partner notification. PHL §2133 clearly states that the determination of whether a case merits contact tracing is to be made by the municipal health officer or the local health officer. There is no legally recognized right of a person not to have a known partner notified. This is especially true since partner notification does not involve disclosing the name of the index to the contact. Instituting a fair hearing process is not appropriate under these circumstances.
One commenter raised an issue concerning physician liability for a professional judgment as to whether reasonable arrangements, efforts or referrals had been made to address the safety of persons with a domestic violence risk, as noted in section 63.8 (b). If municipal health commissioners are satisfied that the risk had been addressed, partner notification may proceed. The input of physicians is to be sought, but the municipal health commissioner makes the final decision. In addition PHL section 2136, entitled "Liability", states that "any person who in good faith complies with this title shall be immune from civil and criminal liability for any action taken in compliance with its provisions." Since PHL section 2137 addresses domestic violence recognition, identification and screening, it is likely that a court would find that judgments made about proceeding with partner notification in cases where there is a concern about domestic violence, made in good faith, are covered by the protections of PHL 2136.
A comment was received that the regulations should require that when a parent or guardian is determined to be a contact of a minor, Child Protective Services be notified. Mandated and voluntary reporters of child abuse are already addressed in Social Services Law. It is not necessary to address this in Part 63.
One commenter asked that "confirm" in section 63.8 f (1) be changed to "ascertain" that posttest counseling has occurred before beginning partner notification. In this context, "confirm" means that there is oral or written communication from the provider that posttest counseling has occurred.
One commenter suggested changing section 63.8(c) related to an authorized public health official's "professional" judgment to determine that "reasonable arrangements, efforts or referrals to address the safety of affected persons have been made, if and when the notification is to proceed." It was felt that use of the word "professional" in this situation might be seen to imply a domestic violence expertise, rather than a general public health expertise. The intent was to refer to the judgment of a public health official, based on public health experience and knowledge. Therefore, no change was made.
One commenter suggested that whenever contact notification was noted in various subsections in section 63.8, the regulation be amended to state "without identifying the protected individual." However, definitional section, section 63.1 states: "In all cases of contact tracing authorized in this Part, the name or other identifying information regarding the protected person shall not be disclosed to contacts and the name of contacts shall not be disclosed to other contacts." Contact tracing is defined to include partner notification. Therefore, while agreeing with the writer's position, repeated restatements are unnecessary.
A commenter suggested that for children in the custody of the local district or Office for Children and Family Services (OCFS), the person with capacity to consent to medical care be advised of the child's possible exposure to HIV to enable access to necessary HIV counseling and testing. Although this disclosure may be appropriate in some cases, it may not be appropriate in all cases since a minor who has been determined by a provider to have "the capacity to consent" (PHL section 2781) may consent to the HIV test. Once the results of the HIV test are known, a subsequent decision to inform parties who can legally consent to health care for the child can be made. Therefore, a case by case review of each situation is appropriate.
Domestic Violence Issues
The issue of whether all domestic violence information might be protected from disclosure under PHL Article 27-F or under Article 2 1, Title III was raised. The Department can only extend such protection in regulation as provided for in statute. Article 27-F and 2 1, Title III address the confidentiality of HIV related information. Domestic violence information which is integrated into, or which cannot be distinguished from, HIV information, such that a disclosure of the HIV status of a person would necessarily disclose domestic violence information would likely be found by a court to be protected under the HIV law. The regulations cannot require a broad protection of information which solely relates to domestic violence.
Comments were received in relation to the draft domestic violence screening protocol called for in Chapter 163 and related draft documents which accompanied it, which are not in regulation. Chapter 163 directed the Department to develop the protocol in consultation with the State Office for the Prevention of Domestic Violence (OPDV) and statewide and community based organizations. This consultative process is ongoing. The protocol reflects clinical practice and judgment and therefore is inappropriate for regulatory promulgation. Consequently, a detailed description and responses to comments received on the screening protocol are not included in this assessment. However, the Department is reviewing and carefully considering the comments received related to these documents. Staff are continuing to consult with OPDV and others. A final protocol will be made available in advance of implementation of the final regulations.
Consent Form and Related Issues
Some commenters suggested amending the consent form to include a definition of domestic violence and specific domestic violence information. Although these are important issues, providers and patients have long voiced complaints at the length and complexity of the form. The form does discuss domestic violence in relation to partner notification and includes a toll-free telephone number to call for information regarding domestic violence services.
One commenter recommended that the consent form include a "warning" stating that the health department may contact the patient. The consent form already states: "if you do not name any partners to your provider or if a need exists to confirm information about your partners, the health department may contact you to request your cooperation in this process." Another commenter advised that additional releases be obtained from the patients for disclosures in the partner notification process. Since both Article 27-F and Article 21, Title III provide for partner notification to proceed without the consent of the index case and no disclosure of information about the person is made to partners, such consent need not be sought.
A commenter suggested that a patient's right to withdraw consent for HIV testing is contradicted by allowing partner notification to proceed in some cases if posttest counseling is not done and since HIV case reports are maintained under such circumstances. A patient's right to withdraw consent for testing exists until such test is performed. A patient retains the option not to personally be informed of the test result, not to afford him/herself the benefit of posttest counseling, or not to cooperate in partner notification activities. However, in rare cases, both the provider and the Department will have knowledge of the test result and may also have information that contacts as defined in law, exist. In such cases, the law permits notification of the partner, without identifying the protected person.
One commenter noted that the regulations should mention the need for cultural and linguistic appropriateness. These issues are important throughout all aspects of the program and are emphasized in staff training sessions. The Department plans to have the consent form translated into more than fifteen languages and to have culturally and linguistically appropriate public and provider education programs to implement the law.
A commenter recommended the consent form state that a report will be made when a person tests positive through a confidential test and when seeking medical care. The form does state: "your name will be reported to the health department if you have a confirmed positive HIV antibody test result received through a confidential test ... or if you have chosen to attach your name to a positive test result at an anonymous site."
One commenter suggested amending the consent form to indicate that consent for the test could be withdrawn at any time. The first sentence on the form indicates that the test is voluntary. Pretest counseling also will address the voluntary nature of the test. Another issue raised was whether the regulations should be amended to provide instructions as to how a person could withdraw consent and how a physician can alert a lab to a withdrawal of consent was raised. Since arrangements among providers, medical facilities and laboratories differ, these situations need to be addressed on an individualized basis. A formal procedure is not required since a prompt phone call will likely suffice in most situations to stop a sample from being tested.
Two commenters requested that the consent form state that information pertaining to a minor only be given to a parent if the health care provider determines that a minor is incapable of consenting to his/her own care. With very limited exceptions (e.g. consent to HIV testing, family planning situations, sexual transmissible disease care) New York State law does not give a minor the ability to consent to his/her own health care. It is not clear what impact such a statement would have on minors seeking HIV testing, since minors who have been determined by a provider to have the capacity to consent for the HIV test, might not be later determined to have the ability independently to consent for comprehensive HIV care. The issue of consent for health care will have to be dealt with separately after the test result is known. The Department will provide guidance clarifying this matter.
One commenter stated that section 63.3(f), addressing situations when HIV testing is intended to aid in clinical disease monitoring and when pre- and post -test counseling may be tailored to the needs of the patient, erodes patient rights by permitting a provider to determine adequate pre- and posttest counseling. In fact, the Department believes this refinement better informs and protects patients by recognizing individual patient needs in situations where the HIV testing is repetitive and on going.
Occupational Exposure Issues
A commenter advised that a requirement for baseline testing of the exposed person be required for disclosures to HIV in occupational settings. Such baseline testing is required in section 63.8(m)(6)(ii) and (iii). However, if results of baseline testing are not available and the HIV information about the source of exposure is necessary for immediate treatment decisions or for decisions on continuation of post-exposure prophylactic treatment, then disclosure is permitted. This process is reasonable and compatible with clinical recommendations.
Other commenters suggested that disclosure in cases of possible occupational exposure should be extended to include persons employed by funeral establishments, as well as parties/facilities regulated by the Department of Education, employees/staff of local school district and local boards of education. These additional settings pose little risk of HIV transmission. In funeral establishments, infection control precautions can be planned for and are routinely employed. Further, the funeral director is afforded access to medical
information listed on the death certificate. With respect to parties and facilities regulated by the Department of Education, employees and staff of local school districts and local boards of education are at low risk of exposure. One reason this section is limited to organized, licensed settings is to ensure that there is no abuse of the ability to access HIV information. Permitting disclosures beyond closely regulated situations, such as health care facilities, or when health care staff are involved would be difficult to monitor and, therefore, to limit. Rather than permitting the disclosure of the HIV status of individuals to others in all situations, public and private, employment related and recreational, the Department believes it prudent to limit the ability to disclose to closely controlled, recognized high risk occupations and situations, rather than uncontrolled, low risk ones.
One commenter noted that all hospitals should receive Medicaid payments, similar to that received by the 33 hospitals designated as AIDS Centers, for pre- and posttest counseling and domestic violence screening. Under the HIV Primary Care Medicaid Program, all Article 28 facilities are eligible to receive enhanced Medicaid reimbursement for pre- and posttest counseling if they are willing to sign an agreement with DOH. There are 269 facilities enrolled in this program; 93 are enrolled to provide counseling and testing services only. Applications for this program are accepted on a continuous basis. If more than one posttest counseling session with an infected patient is needed to address partner notification and domestic violence screening, these sessions can be billed under Medicaid with supporting documentation in the record.
Two commenters noted that the Department should ensure that managed care plans and private insurance carriers adequately reimburse for test counseling and domestic violence screening. All capitated rates for Medicaid managed care include HIV counseling and testing since these costs are part of the historic cost base used to calculate the rates. Since posttest counseling of HIV infected persons now includes discussion of partner notification and domestic violence screening as part of the standard of medical care, this should influence how reimbursement rates are set for private carriers. The Department of Health will notify the Department of Insurance of the change related to this new law and recommend that regulated insurance carriers act accordingly.
Anonymous Counseling and Testing
Commenters concerned about availability and accessibility of anonymous HIV counseling and testing recommended an expedited process for approving community based organizations to offer this service and indicated the need for all providers to be able to provide the location and contact information on anonymous testing sites. The Department is similarly seeking to assure that anonymous testing is available and accessible. A directory of HIV counseling and testing services has been published and will be distributed. New York State and City health departments, and most county health departments offer anonymous testing in various community settings and respond to requests for special testing initiatives, including providing anonymous testing on-site at community based organizations. Information on how to access anonymous testing services is on the Department's web site and will be the subject of a media campaign. The Department is closely monitoring the demand for anonymous testing and counseling sites. Ensuring access to sites operated by public health staff will be a priority for the Department and resources will be allocated to meet demands.
A commenter suggested that the reference to the New York City Department of Health and Mental Hygiene approving anonymous testing and counseling sites be retained in section 63.3(c). However, PHL section 2781 authorizes only the State Health Commissioner to approve anonymous sites. The New York City Commissioner of Health and Mental Hygiene acts as an agent of the State Commissioner when approving such sites. In order to ensure the coordination of statewide testing, it is prudent to clarify that the State Health Department is responsible for the accessibility and regulation of anonymous HIV test sites in the state.
Five comments were received which emphasized the need for an evaluation of the HIV Reporting and Partner Notification program, including the possibility of utilizing an independent evaluator. Proposals to evaluate programs, particularly using non-departmental staff, are not routinely placed in regulation. The State Department of Health will conduct a program evaluation, including the impact of the program on rates of HIV testing in the state and the outcome and impact of the partner notification process.
These regulations will have an effective date of June 1, 2000.