Thank you for this opportunity to address the Association on this important topic of HIV policy. Without spending a lot of time dwelling on the past, I will only say that the advances in treatment of HIV in the past 2 years have caused us to look at the HIV epidemic in a different way.

What we really have is an emerging chronic manageable illness. Today, these treatment advances and new technologies for monitoring and testing for HIV are directing the HIV policy agenda for the next century, just like the lack of treatment helped establish our policy in the early 1980s.

Now, I would like to review the top 10 HIV policy issues for the 21st century from a clinician’s perspective. I will try to refrain from editorializing in favor a presenting a balanced up-side/ down-side discussion.

Well, that isn’t quite true either. I am biased. I will continue to push the Treatment Agenda into the 21st century.

Now, here are the top 10, in David Letterman style, starting with #10.

We have come a long way from the days of AZT treatment alone, which prolonged the period of asymptomatic HIV, but did not prolong life. There are now 15 drugs licensed to treat HIV.

• Deaths are down by 50% in the United States and in New York State, and people are spending less time in the hospital.

• For every dollar spent on so-called "cocktail therapy", we save about $3.00 in hospital costs.

• These drugs don’t cure HIV. But for the first time in almost 20 years, we are looking toward the time when HIV can be a chronic, manageable illness for people with HIV, IF...the big ifs...if we work on the next 9 points.

New York State still leads the nation and the world in terms of developing an HIV infrastructure to improve access to care.

• The Department of Health’s AIDS Institute created by the legislature in 1983 has done a remarkable job of making care accessible through its initiatives to develop hospital and ambulatory HIV Centers of Excellence, enhanced reimbursement under Medicaid, standards of care, and quality assurance programs.

• Still there are gaps in care. Not everyone has access to care for many reasons. Fear of disclosure, lack of direction, financial issues, unfamiliarity with the health care delivery system, need for an advocate, misunderstanding of HIV infection and many more reasons.

• This is further complicated by the fact that the hardest hit communities are our maginalized and vulnerable populations, including people of color, women, and gay men.

The drugs work only if people take them. We now talk about adherence to treatment, which includes not only helping patients with access to treatments, but also helping them overcome barriers to treatment once they are able to get the drugs.

New York State and the Federal government are helping address this critical area by funding a variety of programs and initiatives that help patients overcome these barriers. The strategy is important from the clinical standpoint as well because without adherence to treatment, drug resistance can develop, making these treatment advances ineffective.

The funding to support HIV work is still in place. The Ryan White Care Act is the Federal initiative that provides funding for HIV care. The Care Act had an increase in funding for 1999. According to the AIDS Action Council, Title 1: a $40 million increase, Title 2 care services: a $20 million increase, Title 2 ADAP: a $175 Million increase, Title 3: an $18 Million increase, Title 4: a $15 Million increase. The CDC prevention budget was increased by 33 million and the NIH research budget was increased by $185 million.

• According to the New York State Health Department of Health (DOH), this money is used to fund HIV Uninsured Care Programs: Three assistance programs serve uninsured people who are not eligible for Medicaid and who lack adequate private insurance: the AIDS Drug Assistance Program (ADAP), ADAP Plus and HIV Home Care.

• With few exceptions, drugs and treatments are available to patients who are uninsured or do not qualify for Medicaid.

• Unlike some states, there are no lotteries, waiting lists or other exclusionary criteria for enrollment in New York’s ADAP program.

1. In New York Stae, the uninsured programs enrolled 6,019 new participants for a total enrollment of 17,876. A state-wide network of more than 4,200 providers supplied $88 million worth of drugs and medical care.

2. The number of program participants in antiretroviral therapy more than doubled in the past two years, while the number of participants requiring home care services dropped by more than 65 percent.

3. New York State is providing $12 million annually to augment federal ADAP funds and to ensure that HIV-infected New Yorkers have access to the new drugs, such as protease inhibitors

The good news is that the earlier that treatment is given to HIV-positive pregnant women, the lower the risk of transmission of HIV to the baby.

• Treatment of the mother at any time during pregnancy and treatment of the baby from birth will decrease the risk of HIV infection to the baby:

• Treatment for the mother starting in the second trimester, at the time of delivery and of baby for 6 weeks has the best results and reduces the risk of transmission from mother from 28% to 8%.

• HIV testing for pregnant women has now become a standard of care in obstetrics, gynecology and primary care settings.

• Techology point: newer, rapid tests for HIV are here. Once these tests are approved for use in New York State, test results will be available quickly, within minutes.

• Still access to care is a barrier; women won’t be tested if they do not have access to care.

This legislation represents New York State’s first effort at mainstreaming HIV and is one example of how science of HIV shapes HIV policy.

New York began mandatory HIV newborn testing in February, 1997. This law is intended to provide a vital safety net for HIV-exposed infants and their mothers, improving their ability to receive needed treatment. Hospitals and birthing centers are required to develop programs for testing and managing test results. All babies born in New York are now routinely tested for HIV, and the baby’s test results are provided to the mother and the physician in charge of the baby’s medical care.

• Within the program’s first twelve months, a total of 257,628 newborns were tested; of these, 1,048 were found to be exposed to HIV.

• More than 75 percent of the infected mothers had been tested prior to delivery. Approximately 100 HIV-exposed infants were identified whose mothers were not tested prenatally, and thus unaware of their HIV status.

• Follow-up efforts have helped ensure that 98 percent of HIV-exposed newborns, and their infected mothers, have been linked to medical care.

• The technology has risen to the occasion here as well and HIV PCR testing, using the same technology as viral load, can tell us whether the baby is infected at birth or not.

The most significant policy change since the beginning of the epidemic is legislation for name based reporting and partner notification.

• Since fewer people with HIV are progressing to AIDS, just counting AIDS doesn’t tell us as much about the epidemic as it once did. Much of the Federal funding to the states under the above-mentioned Ryan White Care Act depends on case load, so a count of HIV infection is important.

• I had the opportunity to serve on the DOH’s Surveillance Committee, which did no reach concensus on the issue of name based reporting vs . unique identifiers. The New York plan is to expand AIDS case reporting to include HIV infection and to do HIV reporting by name as is done for AIDS. The issue of reporting HIV by name vs unique identifiers will be debated for a long time.

• Anonymous testing will continue as will article 27F of the Public Health Law (the "HIV confidentiality law"). Even with these safeguards there is a concern that some people will not get tested.

Another hot potato and the companion to name-based reporting. Both of the pieces of legislation, name-based reporting and partner notification will probably start in Spring, 1999.

• The New York State Health Department has an important job to do first which is to draft Regulations ("the regs") which will describe just how this whole process is to be done.

• As a result of this leglislation, the DOH is undertaking a review of the whole HIV testing and counseling process. The DOH’s AIDS Institute is undertaking a campaign to position HIV testing as something good, reviewing the consent form, and addressing some of the downside of partner notification such as the risk of domestic violence.

• Also holding up implementation is the need for funding, which, to date, has not been included in the Governor’s budget.

The big picture of Medicaid Managed Care. In July 1997, the federal government approved New York’s waiver request allowing mandatory enrollment of 2.2 million Medicaid recipients into managed care. The waiver expands eligibility to include people on Home Relief (Safety Net) and allows for the creation of Special Needs Plans for people with HIV infection and AIDS as well as the seriously mentally ill. The program is being phased in over a multi-year period with 11 counties currently operating mandatory managed care programs. This year about 623,000 Medicaid recipients are enrolled in managed care statewide, served by 34 health plans. A key feature of New York’s Medicaid managed care program is the creation of a $1.25 billion fund ($250 million a year for five years) to assist voluntary and public hospitals to transition to a managed care system. Hospitals that serve a large proportion of Medicaid clients and indigent, uninsured patients will be able to use these funds to restructure their delivery systems, expand primary care services for the poor and retrain hospital workers.

• This is in the form of Special Needs Programs (SNPs) is coming. The SNPs are coming. I don’t know when, but I would guess that implementation of the Health Department’s plan would be some time in the year 2000.

• However, mandatory enrollment is happening now.

• Medicaid recipients with HIV are exempt from enrollment until SNPs come. Fortunately, if the patient with HIV self identifies to the Department of Social Services staff will not enroll the patient because of the exemption. The problem occurs when patients do not identify themselves as having HIV and are enrolled in managed care.

• Therefore, provider’s need to develop a strategy regarding patient disenrollment.

In the old days, we used to think that if we gave everyone the same lecture and passed out condoms at the end of the talk, HIV would be over and we had done a good day’s work. Well, we did do a good day’s work, but we now know that not every person is on the same page in terms of HIV prevention. The concept of "meeting people where they are" and moving forward from that point in terms of HIV prevention information is a better way to spread the prevention message.

Still there are new infections and we ask ourselves why. The answers again are different for each person. The bottom line is that prevention efforts need to continue as a part of our activities. The generation of people who heard my first prevention messages in the early 1980s have either gotten the message, become infected despite the message, or have died.

It is unlikely that they are too old to have sex. We know this because so-called "senior adults" defined as people over the age of 50 constitute yet another emerging risk group for HIV.

These "seniors" need to be added to gay men, injection drugs users, other sexually active people, and let us not forget the current generation of young people who are just forming their sexual agenda and have a drug culture around them, unlike those of us who are now called "senior adults."

We have heard about occupational exposures to HIV and our standard of care has been to use a 3 drug cocktail in exposed individuals to reduce the risk to the health care worker.

Buried in the previously mentioned Ryan White Care Act is a provision that allows release of information of the patient’s HIV status, if known, to emergency reponse workers who indicated that they have been exposed to blood in the course of their work with that patient.

Also, tucked away in the partner notification legislation is a new definition of exposed individual whose language makes HIV test results, if known, available to exposed heath care workers, so that PEP can be started without unecessary delay.

For non-occupational exposure, the DOH AIDS Institute has issued guidelines for PEP in cases of sexual assault and other non-occupational exposures.

Still there are barriers to access to drugs for PEP because of reimbursement for the approximately $1000.00 cost of 4 weeks of 3-drug cocktail therapy. Not all workers’ compensation carriers and third party carriers reimburse for the cost of these drugs. The DOH is encouraging carriers to adopt a more uniform reimbursement strategy for occupational and non-occupational PEP.

Finally, I will briefly mention the complexity of AIDS vaccine development and associated policy issues. Trials of vaccines for prevention are interesting because these placebo-controlled trials recruit people who are HIV negative but at risk of acquiring HIV sexually. In the current VaxGen trials, both placebo and vaccine groups are given counseling and information about how to reduce the risk of HIV and remain HIV negative. The conundrum, of course, is trying to measure effectiveness of vaccine vs. placebo, while trying to modify behavior to prevent infection. This trial, more than any other HIV trial, brings ethicists and clinicians to the table to try to find the answers together. Not just for the US, but for the rest of the world as well.

At the end of the century, HIV/ AIDS public policy is being driven more and more by the advances in medical care that have made HIV a chronic, manageable illness, instead of a death sentence for many people. This evolving treatment and policy needs to build on existing policy, not replace it. An example is that New York State’s policy on Surveillance (name based-reporting and partner notification) needs to be built on a strong confidentiality law, in this case, Article 27-F.

All of these policies are controversial, either because they are expensive like the Ryan White Care Act or push the envelope toward mainstreaming HIV, such as partner notification and name-based reporting. The question to ask when evaluating AIDS policy in the next century is whether our public policy will marginalize people with HIV further. Will these policies discourage people from being tested and getting into care? Or will our public policy actually help us to better manage the HIV epidemic?

Certainly, the Ryan White Care Act has been good policy. Access to drugs, medical care and case management services has resulted in fewer deaths from AIDS because people aren’t getting AIDS if they are able to get into medical care and have access to drugs and services.

Since we are at a crossroads here in terms making HIV a chronic, manageable illness instead of a fatal disease, it is important for our public policy to facilitate this using a rational public health model that avoids draconian measures to deal with a medical problem.

Thank you.