Key provisions of the legislation and the proposed regulatory changes include:

• 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 Department website.

• Consent for HIV testing can be part of a general durable consent to medical care, though specific opt out language for HIV testing must be included.

• Consent for rapid HIV testing can be oral and noted in the medical record, except within correctional facilities.

• 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 an appointment for medical care for persons confirmed positive.

• HIV test requisition forms submitted to laboratories will be simplified.

• 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 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.

Statutory Authority:

The authority for this regulation is contained in Public Health Law (PHL) Article 21, Title III, Sections 2130(1); 2135; and 2139: and Article 27-F Sections 2780(4); 2781; 2781-a; 2782(1); 2782(5)(a); and 2786(1) to be consistent with and in conjunction with implementing Chapter 308 of the Laws of 2010, the HIV Testing Law. PHL Section 2786 authorizes the Commissioner of Health to promulgate rules and regulations concerning implementation of Article 27-F for health facilities, health care providers, and other persons to whom this article is applicable. Section 2786 further authorizes the Commissioner to develop standardized model forms for informed consent for HIV testing, for the release of confidential HIV-related information, and materials for pre-test and post-test counseling. The Commissioner is also authorized to promulgate regulations, in consultation with the AIDS Advisory Council, to identify significant risk of contracting or transmitting HIV infection provided, however, that such regulations not be determinative of any significant risk of contracting or transmitting risk determined pursuant to paragraph (a) of subdivision 4 of Section 2782 or Section 2785 of Article 27-F. The commissioner is also authorized by PHL Section 2139 to promulgate rules and regulations as shall be necessary and proper to effectuate HIV reporting.

Legislative Objectives:

In enacting Chapter 308 of the Laws of 2010, the Legislature found that mandating a broad range of health facilities and practitioners to offer HIV diagnostic testing to adolescent and adult patients and streamlining consent, counseling, and information handling practices were important for addressing the ongoing challenge of the HIV epidemic. The legislative objective of the amendments contained in this law is to encourage HIV testing among a broad range of persons as a means of identifying HIV-infected persons as early as possible in the course of their infection and to link them into care. Chapter 308 maintains the informed consent requirement for HIV testing and protection of confidential HIV-related information while removing numerous barriers that are inherent in a broad-based mandated offer of screening. Chapter 308 allows for enhanced use of patient specific and non-patient specific HIV information to improve patient medical care and to assess co-morbidity or completeness of reporting and to direct program needs.

Needs and Benefits:

According to the federal Centers for Disease Control and Prevention (CDC) at the end of 2006, an estimated 1,106,400 persons (range: 1,056,400 - 1,156,400) in the United States were living with HIV. CDC estimates that 56,300 new HIV infections occurred in the United States in 2006. Each year, approximately 16-22 million persons in the United States are tested for HIV, with 2 million of those persons being New Yorkers.

By 2002, an estimated 38%-44% of all adults had been tested nationally for HIV. In 2009, approximately half of all New Yorkers age 18 to 64 reported having ever been tested; however, one-third of persons newly diagnosed with HIV were identified so late in the course of their infection they progressed to AIDS within one year. At the end 2006, approximately 1 in 5 of persons nationally with HIV (21%, or 232,700 persons) did not know they were infected.

In September 2006, CDC released Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. These recommendations, which replaced CDC's 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings, advise routine HIV screening of adults, adolescents, and pregnant women in health care settings in the United States. They also recommend reducing barriers to HIV testing. People who are infected with HIV but not aware of it are not able to take advantage of the therapies that can keep them healthy and extend their lives, nor do they have the knowledge to protect their sex or drug-use partners from becoming infected. Knowing whether one is positive or negative for HIV confers great benefits in health-related decision making.

Cohort studies have demonstrated that many infected persons decrease behaviors that transmit infection to sex or needle-sharing partners once they are aware of their positive HIV status. HIV-infected persons who are unaware of their infection tend to continue their high risk behaviors, therefore increasing the likelihood of transmitting HIV to partners. Medical treatment lowers HIV viral load and reduces risk for transmission to others, and early referral to medical care can prevent HIV transmission in communities and reduce a person's risk for HIV-related illness and death.

Chapter 308 of the Laws of 2010 brings New York State closely into alignment with CDC's 2006 recommendations while reducing barriers to HIV testing. Chapter 308 eases current written consent requirements by providing an option for a durable written general consent that specifically includes HIV testing, or a documented oral consent when the test being ordered is a rapid HIV test. Chapter 308 also makes a corresponding technical change to the law requiring that the Commissioner develop forms to be used for informed consent purposes. Specifically, Chapter 308 designates such forms as "standardized model" forms, and providers no longer need to obtain prior authorization for the use of alternative forms that contain information consistent with the standardized model forms. Similarly, Chapter 308 removes the requirement that physicians confirm to laboratories that informed consent has been obtained before ordering HIV-related testing.

Previously, state law required post-test counseling which was the same regardless of the test's results. This legislation requires that counseling be tailored based on whether the HIV test indicates infection. Counseling for positive results will remain consistent with existing law with a requirement added to make an appointment for the infected person to receive follow-up HIV medical care. For negative results, education will emphasize risks associated with participating in high risk behavior and may be accomplished by oral or written reference to information previously provided. Interactive counseling for HIV negatives is no longer necessary.

Chapter 308 also requires physicians to report HIV data obtained through laboratory tests conducted in conjunction with periodic monitoring of HIV infection, which will enable NYS DOH to monitor the spread of HIV/AIDS and to target program initiatives. This provision reflects the availability of data from HIV tests which was not available when Article 21, Title III and Article27-F were originally enacted. Chapter 308 makes similar technical changes to various provisions of law to update references to testing in accordance with newer testing technologies. In addition, Chapter 308 protects individuals who are at risk of acquiring HIV infection due to an occupational exposure by permitting anonymous HIV testing if the source patient is incapable of providing consent.

Finally, Chapter 308 changed confidentiality provisions, first by allowing limited access to confidential HIV information to the executor or administrator of an estate when needed by such persons to fulfill their responsibilities. Second, under the previous law, disclosure of HIV-related information had to be accompanied by a written statement regarding confidentiality and re-disclosure. It is appropriate to exempt from these requirements routine disclosures of information which are made to providers for purposes of treatment and to third party payers for reimbursement purposes.

Costs:

Chapter 308 of the Laws of 2010 created the requirements for the mandated offer of HIV testing for persons between the ages of 13 and 64 and other activities addressed in recommended revisions to Part 63. The proposed regulations add no further costs. The Department took steps in constructing the regulations to incorporate suggestions from regulated parties to minimize the financial burden. It is estimated that the implementation and administration of other requirements of this rule will not impose any costs upon this agency, New York State, or its local governments.

The law and proposed regulations can actually decrease long term costs. By increasing access to HIV testing and requiring a referral to care for HIV infected persons, there is the potential to lower individual and community level exposure to HIV, and also to potentially intervene at an earlier stage of disease (HIV vs. AIDS). Earlier medical intervention may lessen the degree of medical care therefore potentially decreasing costs (HIV treatment vs. AIDS treatment).

The costs associated with Chapter 308 mainly include offering tests to all persons between the ages of 13 and 64 receiving primary care in county operated sites, screening those that accept testing, and linking those found to be positive to HIV medical care. HIV testing can cost between $10 for a rapid screening test and up to $100 for confirmatory for the 1 out of 100 persons on average who have a preliminary positive test and need to have it confirmed with a western blot test. Early identification of HIV reduces medical costs for the identified person who can be treated with medicine rather than in-patient hospital stays and more expensive medical treatment. The infected person can also be educated how not to pass the virus to others. Each new case averted saves $367,134 in projected lifetime medical costs of an HIV infection. Neither the law nor the regulations require additional data reporting.

This rule mitigates costs by streamlining the consent process from a counseling model to one that can be accomplished by the provision of information in written, oral or electronic form. Consent can be obtained orally when a rapid test is being used and written consent can be incorporated into a facilities general medical consent. Similarly, post-test counseling has been eliminated as a requirement except in those instances in which a person is diagnosed with HIV.

Local Government Mandates:

This rule imposes no mandates upon any county, city, town, village, school district, fire district, or other special district other than those required under Chapter 308 of the Laws of 2010 for any entity operating a general hospital or providing primary care. The major mandate of the law is the required offer of HIV testing to all persons between the ages of 13 and 64 who are receiving primary care services. County clinics providing primary care must comply with the requirement to offer HIV testing. Similar to other entities covered under the law, steps were taken in drafting the regulations to minimize the impact by streamlining consent, pre-test, and post-test negative practices. Chapter 308 mandates an appointment for HIV medical care be made with any new positive identified. Posted to the NYSDOH website is contact information for Designated AIDS Centers across the state at which such appointments can be made.

Paperwork:

This rule imposes no new reporting requirements, forms, or other paperwork upon regulated parties.

Duplication:

There are no relevant rules or other legal requirements of the Federal or State governments that duplicate, overlap, or conflict with this rule.

Alternatives:

The regulations were developed after considerable input from the community, provider groups, and regulated parties. All day regional meetings were held in Buffalo, Syracuse, Albany and New York City that had over 400 in-person participants, with others connected through telephone conference calls. Input was also elicited from the Healthcare Association of New York State, Greater New York Hospital Association, New York State Academy of Family Physicians, Medical Society of the State of New York, New York City Department of Health and Mental Hygiene, New York State Association of County Health Officials, Community Health Care Association of New York State, New York State AIDS Advisory Council, and the New York State HIV Prevention Planning Group. Alternative approaches were considered with a number of these already being reflected in the Department's publicly available materials for implementation of Chapter 308, as well as in the proposed regulations.

Examples of alternative approaches the Department has included in the proposed regulations include allowing pre-test information to be provided by oral, written, or electronic means. Similarly, negative test results and negative post-test information can be provided by mail, phone, or electronic means as long as the patient's confidentiality is protected. Previously, these would have involved potentially time consuming in-person interactions, which in settings such as emergency rooms are not feasible.

Federal Standards:

The rule does not exceed any minimum standards of the Federal government for the same or similar subject area.

Compliance Schedule:

Chapter 308 of the Laws of 2010 had an effective date of September 1, 2010 for all provisions relating to regulated parties. The Department has continued to assist affected entities in compliance efforts.

Effect of Rule:

Chapter 308 of the Laws of 2010 will impact the existing sixty two local governments. This includes New York City and the fifty-seven counties outside of New York City. Also impacted would be all health care facilities with fewer than 100 employees that use certain licensed professionals to provide primary care such as private medical practices, community health centers, urgent care clinics, employee health services, retail health clinics, and student health services. Chapter 308 requires that all physicians, physician assistants, nurse practitioners, and midwives providing primary care make the offer of HIV testing, and the regulations clarify the mandate is in force regardless of the setting in which primary care is being provided.

Compliance Requirements:

This rule imposes no mandates upon any small business or local government except for those required under Chapter 308 of the Laws of 2010 for any entity operating a general hospital or providing primary care. A major mandate of the law is the required offer of HIV testing to all persons between the ages of 13 and 64 who are receiving primary care services. County clinics providing primary care must comply with the requirement to offer HIV testing. Similar to other entities covered under the law, steps were taken in drafting the regulations to minimize the impact by streamlining consent, pre-test, and post-test negative practices. Chapter 308 mandates an appointment for HIV medical care be made with any new positive identified. Posted to the NYSDOH website is contact information for Designated AIDS Centers across the state at which such appointments can be made.

Professional Services:

The Law does not require any significant changes to existing professional services.

Compliance Costs:

There are no capital costs incurred as a result of this Law. Costs associated with the implementation of this Law may be offset (to some degree) with existing grant and/or State funding. These funding sources include (a) Federal (Ryan White and Centers for Disease Control) and (b) State (Medicaid). Some small businesses may be directly impacted by now, under Chapter 308, having to offer and conduct HIV testing, a service they may not have offered in the past. While the state as a whole may benefit from the early detection of previously undiagnosed cases of HIV in terms of overall treatment cost savings, the individual small business will not directly participate in the benefits.

Economic and Technological Feasibility:

New York State Department of Health provides technical assistance to impacted providers regarding economic and technological feasibility. Providers covered under the law are by definition offering primary care services to patients, and most are providing HIV testing already. For those that must newly add screening services required by Chapter 308, rapid test technology is available that is reasonably priced (approximately $15 per test) and CLIA waived as a point of care device. Additional costs would be incurred in cases of persons testing positive by a rapid screening test (on average 1 in 100). Other point of care specimen collection devices are available for confirming results if the provider does not have phlebotomy capacity.

Minimizing Adverse Impact:

Chapter 308 of the Law of 2010 is intended to ease the compliance requirement of HIV Testing providers through, (a) a streamlined consent process, (b) the delivery of post-test negative test results through a variety of approaches including electronic mail, postal mail or phone.

The regulations were developed after considerable input from the community, provider groups, and regulated parties. All day regional meetings were held in Buffalo, Syracuse, Albany and New York City that had over 400 in-person participants, with others connected through telephone conference calls. Input was also elicited from the Healthcare Association of New York State, Greater New York Hospital Association, New York State Academy of Family Physicians, Medical Society of the State of New York, New York City Department of Health and Mental Hygiene, New York State Association of County Health Officials, Community Health Care Association of New York State, New York State AIDS Advisory Council, and the New York State HIV Prevention Planning Group. Alternative approaches were considered with a number of these already being reflected in the Department's publicly available materials for implementation of Chapter 308, as well as in the proposed regulations.

Examples of alternative approaches the Department has included in the proposed regulations include allowing pre-test information to be provided by oral, written, or electronic means. Similarly, negative test results and post-test information can be provided by mail, phone, or electronic means as long as the patient's confidentiality is protected. Previously, these would have involved potentially time consuming in-person interactions, which in setting such as emergency rooms are not feasible.

Small Business and Local Government Participation:

Small businesses and local governments had the opportunity to participate in the rule making process through (a) a series of New York statewide stakeholder meetings, (b) participation in regional meeting updates with New York State Association of County Health Officials (c) individual local government technical assistance provided by electronic mail, phone and in person as requested, and (d) discussions with the Academy of Family Physicians, the Greater New York Hospital Association, and the Healthcare Association of New York State. Groups have generally acknowledged that the Department has taken substantial steps to accommodate the legitimate concerns of providers by streamlining processes and not creating new requirements for data collection or reporting.

Types and Estimated Numbers of Rural Areas:

Chapter 308 of the Laws of 2010 is a statewide mandate including rural and urban counties. This would include any general hospital or provider of primary care. The proposed regulations do not expand the type of facilities to which the law applies, but do clarify that the mandated offer of HIV must be made by any physician, physician assistant, nurse practitioner or midwife providing primary care regardless of setting.

Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:

This rule imposes no mandates upon entities in rural areas except those required under the law for any entity operating a general hospital or providing primary care. The major mandates of the law are the required offer of HIV testing to all persons between the ages of 13 and 64 who are receiving primary care services. Steps were taken in drafting the regulations to minimize the impact by streamlining consent, pre-test, and post-test negative practices. Chapter 308 mandates an appointment for HIV medical care be made with any new positive identified. Posted to the NYSDOH website is contact information for Designated AIDS Centers across the state at which such appointments can be made.

Costs:

There are no capital costs associated with Chapter 308 of the Laws of 2010. Costs associated with the implementation of this Law may be offset (to some degree) with existing grant and/or State funding. These funding sources include (a) Federal (Ryan White and Centers for Disease Control) and (b) State (Medicaid). HIV testing and counseling are covered benefits in Medicaid managed care, Family Health Plus and Medicaid fee-for-service. Some entities in rural areas may be directly impacted by now, under Chapter 308, having to offer and conduct HIV testing, a service they may not have offered in the past. While the state as a whole may benefit from the early detection of previously undiagnosed cases of HIV in terms of overall treatment cost savings, the individual small business will not directly participate in the benefits.

Minimizing Adverse Impact:

There are no capital costs associated with Chapter 308 of the Laws of 2010. Costs associated with the implementation of this Law may be offset (to some degree) with existing grant and/or State funding. These funding sources include (a) Federal (Ryan White and Centers for Disease Control) and (b) State (Medicaid). HIV testing and counseling are covered benefits in Medicaid managed care, Family Health Plus and Medicaid fee-for-service.

The regulations were developed after considerable input from the community, provider groups, and regulated parties. All day regional meetings were held in Buffalo, Syracuse, Albany and New York City that had over 400 in-person participants, with others connected through telephone conference calls. Input was also elicited from the Healthcare Association of New York State, Greater New York Hospital Association, New York State Academy of Family Physicians, Medical Society of the State of New York, New York City Department of Health and Mental Hygiene, New York State Association of County Health Officials, Community Health Care Association of New York State, New York State AIDS Advisory Council, New York State HIV Prevention Planning Group. Alternative approaches were considered with a number of these already being reflected in the Department's publicly available materials for implementation of Chapter 308, as well as in the proposed regulations.

Examples of alternative approaches the Department has included in the proposed regulations include allowing pre-test information to be provided by oral, written, or electronic means. Similarly, negative test results and post-test information can be provided by mail, phone, or electronic means as long as the patient's confidentiality is protected. Previously, these would have involved potentially time consuming in-person interactions, which in setting such as emergency rooms are not feasible.

Rural Area Participation:

Rural area participation was available through (a) New York State Department of Health statewide stakeholder meetings, (b) an ongoing mechanism for email inquiries and (c) individual technical assistance available through electronic mail, phone or in person as requested.

Nature of Impact:

There is no anticipated loss of jobs due to the implementation of Chapter 308 of the Laws of 2010.

Categories and Numbers Affected:

The requirement for the offering of HIV 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.

Regions of Adverse Impact:

An adverse impact is not anticipated in any region of the state due to the implementation of Chapter 308 of the Laws of 2010.

Minimizing Adverse Impact:

Not applicable.

Self-Employment Opportunities:

Not applicable.