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Sunday, August 08, 2010

WORKING IN THREE STATES FOR ROUTINE HIV TESTING

In September 2006, the Centers for Disease Control and Prevention (CDC) recommended routine opt-out HIV testing in health care settings without written consent (see http://www.cdc.gov/mmwr/pdf/rr/rr5514.pdf ).  After all this time, the laws of several states still conflict with these recommendations or make them difficult to apply.  A summary current and pending state-by-state legislation on testing can be found at http://www.nccc.ucsf.edu/consultation_library/state_hiv_testing_laws/)  Beyond AIDS has been working to achieve the CDC standards for simpler HIV testing in New York, Massachusetts, and California.

NEW YORK
Beyond AIDS backed a successful New York State bill (A. 11487, Gottfried), that will eliminate the requirement in that state for written consent, but only for rapid testing where results are available within an hour of specimen collection (see article at http://www.queenscampaigner.com/2010/07/mayersohn-bill-expands-hiv-testing-access-for-new-yorkers/).  That will facilitate the testing process at special HIV testing sites and at laboratories that offer the rapid test, but will not help physicians' offices or clinics that draw blood and send it to outside labs. In the circumstances where written consent is not required, specific oral consent is needed, as opposed to "opt-out" routine testing as recommended by the Centers for Disease Control and Prevention (CDC).  A limited amount of pre-test informing of the patient must be provided.

The bill was passed by both houses and signed by Governor Paterson in July 2010, toward the end of the legislative session.  The new law also mandates the offering of HIV testing in health care settings.  Passage of this bill is the first success in a four-year effort spearheaded by bill co-sponsor Nettie Mayersohn, a state Assembly Member who is also Vice-President of Beyond AIDS. An evaluation process on the success of the bill in increasing testing is part of the bill. Beyond AIDS will be watching for the results, and will be prepared to ask for a follow-up bill to correct the deficiencies we expect will be revealed in the evaluation.

Assembly Members Nettie Mayersohn (left) and Barbara Clark (right), with Ron Hattis and Monica Sweeney in New York

MASSACHUSETTS
Beyond AIDS also worked with former national AIDS policy director Scott Evertz and others, in an attempt to keep a similar bill for HIV testing without the need for written consent, SB 2416, alive in the Massachusetts State Senate. Unfortunately, the bill failed to pass by the end of the legislative session on July 31, 2010. It will be necessary to start over in the new legislative session.

CALIFORNIA
Obtaining a blood specimen for HIV testing
In California, a bill backed by Beyond AIDS (AB 682, Berg), that permits opt-out testing without prior counseling or written consent, became law in 2008. However, this law includes complex informing and documentation requirements, that have limited its utilization and consequently its ability to increase testing.

Beyond AIDS has been invited by the state's Office of AIDS (a part of the state Department of Public Health) to provide some assistance in making it easier for physicians and other healthcare providers to follow the law's requirements. The organization's Beyond AIDS Foundation has proposed a simple checklist to assist providers in following the requirements and in documenting compliance, and is asking that this be posted on the Web site of the Department of Public Health.

A resolution that will be pending before the California Medical Association (CMA) House of Delegates in October 2010, calls for increased availability of patient information sheets that can fulfill the informing requirements of the law. The resolution, which was authored by Beyond AIDS President Ronald Hattis, MD and will be introduced by the California Academy of Preventive Medicine, also calls for CMA to work with the Department of Public Health to assist physicians (e.g., by means of checklists) to comply with the legal requirements of California's testing law.

BACKGROUND
For most of the first 20 years after the HIV antibody test became available in 1985, the official philosophy of most AIDS organizations and public health authorities was that testing should be preceded by counseling to explain the nature of HIV and of the test. Unique written consent requirements were written into laws or regulations in a number of states, due to concerns by activists that people might be pressured into testing, with the potential of discrimination against persons testing positive if the information leaked out.  But by the turn of the century, it was gradually becoming apparent that special consent and pre-test counseling were barriers to more routine testing.

The September CDC recommendations noted the vast scope of HIV testing nationwide. By 2002, at least 38% of all adults in the United States were estimated to have been tested for HIV, and 16–22 million persons aged 18–64 years were being tested annually for HIV.

Nevertheless, at the end of 2003, an estimated 250-300,000 Americans who were HIV positive were unaware of being infected. This amounted to about a quarter of the approximately 1.0–1.2 million persons estimated to be living with HIV in the United States. People who know they have HIV are more likely to avoid high-risk behavior that could pass on the virus, and can receive medical care for the disease to avoid deterioration of the immune system and life-threatening opportunistic infections.

CDC began looking for ways to encourage the people with undiagnosed infection to be tested. In 2003, CDC introduced an initiative to make HIV testing a routine part of medical care on the same voluntary basis as other diagnostic and screening tests. There was particular emphasis on making testing of pregnant women a universal practice, since the infection of newborns can be prevented by treating the mother and the baby.  Rapid testing was recommended during delivery if the woman had not been tested prenatally.
Self-collecting an oral specimen for rapid testing

CDC by 2003 acknowledged that pre-test counseling might not be appropriate or feasible in all settings, and that some providers perceived requirements for such counseling and for written
informed consent as a barrier to routine counseling. The initiative advocated "streamlined approaches" to counseling and testing, which had substantially increased acceptance of routine prenatal testing. Finally, in the 2006 guidelines, CDC spelled out these approaches more clearly, including elimination of requirements for written consent; making HIV testing an "opt-out" rather than "opt-in" process (i.e., patients should be told of the intent to test and may refuse, rather than requiring them to actively request testing); and doing the counseling post-test, in the course of explaining results.

CURRENT STATE REQUIREMENTS NATIONWIDE
As of 2010, according to the compendium (http://www.nccc.ucsf.edu/consultation_library/state_hiv_testing_laws), Massachusetts, Michigan, Nebraska, and Pennsylvania still required written consent for HIV testing; and as noted above, written consent will still be required in New York under its new law, except when a rapid testing method is employed. Pre-test counseling or specific pre-test informing were required by California (in latest law described above), Georgia, Illinois, Maryland, Michigan, Missouri, Montana, New York (in the latest law described above), Pennsylvania, Rhode Island, and Wisconsin.  Many other states required specific informed consent for HIV testing that may be done orally, but but not on an "opt-out" basis. In addition, many states required post-test counseling, which at least should not serve as a hurdle before testing can be performed, unless it discourages some providers from ordering the test. Beyond AIDS will be looking for opportunities to simplify testing requirements wherever these impede routine testing.

Safe handling of a blood specimen for HIV testing


Thursday, August 05, 2010

BEYOND AIDS LEADERSHIP FOR 2012 AND 2013

In its biennial election on November 19, 2011, Beyond AIDS has selected the following officers to serve during 2012 and 2013:

President: Ronald P. Hattis, MD, MPH (California)
Vice-President: Monica M. Sweeney, MD, MPH (New York)
Secretary: Deanna C. Stover, PhD, FNP (California)
Treasurer: Yvonne W. Pover, RDH (Virginia)
Immediate Past-President: Cary Savitch, MD (California)
Directors: Franklyn N. Judson, MD (Colorado)
                Elizabeth Kidder, MPH (Washington, DC)
                Nettie Mayersohn, Retired Assembly Member (New York)               
                Dennis P. Thompson, MD (California)

Yvonne Pover and Elizabeth Kidder, at meeting in Virginia




The Advisory Council will consist of:
Denise Bleak, MSN, PHN
I. Jean Davis, PA, DC
Frank E. Hayes, Health Educator   
Peter Kerndt, MD, MPH
Evette Oszyk, BA
Gary A. Richwald, MD
                                       

The Public Policy Committee will be chaired by Dr. Hattis.
    
The subsidiary Beyond AIDS Foundation, a 501(c)3 charitable corporation, will be governed by the following Board (appointed by the Board of Beyond AIDS):

President:  Deanna C. Stover, PhD, FNP
Vice-President: Cary Savitch, MD
Secretary: Ronald P. Hattis, MD, MPH
Treasurer: Yvonne W. Pover, RDH
Directors: Franklyn N. Judson, MD
                Elizabeth Kidder, MPH
                Nettie Mayersohn, Retired Assembly Member
                Monica M. Sweeney, MD, MPH
                Dennis P. Thompson, MD

The Foundation's Scientific Committee will be co-chaired by Drs. Franklyn Judson and Monica Sweeney.

Cary Savitch, Monica Sweeney, and Pamela Savitch in New York

MEDICARE FINALLY COVERS HIV SCREENING (WITH NUDGE FROM BEYOND AIDS)

On December 8, 2009, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare would be expanding coverage for preventive services to include HIV screening. Behind this there is a story.

When Medicare was established in 1965, it was purely a program to pay for treatment, not prevention. It took a long time before preventive services began being added, a little at a time, and each one literally required an act of Congress.  For example, mammography coverage began in 1988, Pap testing in 1989. But as of 2009, 28 years into the HIV/AIDS epidemic, HIV testing was still only approved as a diagnostic measure after symptoms had already developed or following an exposure.

In 2008, Congress finally passed a bill that enabled CMS to issue rules covering additional preventive services, without going back to Congress, provided that the services were recommended by the U.S. Preventive Services Task Force. One such preventive service recommended by the Task Force was HIV screening. In spring, 2009, CMS staff were working on plans to post on the Web in September a proposal to make HIV screening the first new preventive service to be covered under this act, and were soliciting public comment. Beyond AIDS was initially unaware of this plan.

Hattis on temporary USPHS duty on a NOAA research vessel, passing an iceberg over the mid-Atlantic ridge, June 2009

However, in August 2009, Beyond AIDS President Ron Hattis, who had recently become eligible for Medicare, happened to need an HIV test as part of a physical exam for renewing his reserve status in the U.S. Public Health Service.

Hattis was shocked to get a bill for $77.00 from the laboratory, and called CMS to find out why Medicare did not cover HIV screening.  He learned that Medicare had never covered HIV screening, but that this was a timely issue being considered due to the 2008 legislation.  Hattis quickly engaged Beyond AIDS to provide testimony during the brief comment period, and to solicit the support of additional organizations.

Beyond AIDS initially feared that the Medicare proposal would leave off persons 65 and older, who are the vast majority of Medicare beneficiaries, and would not provide for more than one test a year under any circumstances. That was because the Task Force recommendation on HIV screening had been silent on the issues of age and repeat testing; and CDC's testing recommendations of September 2006 had recommended testing only for ages 13-64 and "at least" once a year for high risk individuals. When the proposal was posted in September, it fortunately did not include an age restriction, but did have a limitation of one test per year. Beyond AIDS posted testimony during the brief public comment period, and succeeded in soliciting similar testimony from the California Medical Association and the California Academy of Preventive Medicine, urging adoption of the proposal. All three organizations urged coverage of up to three tests per year, noting a number of indications for testing more than once in a year (such as pregnant women, persons with recent or ongoing exposure, and those whose Western Blot confirmatory tests are indeterminate).

Testimony was overwhelmingly positive for expanding Medicare to cover HIV testing, but Beyond AIDS and its allies were almost alone in suggesting flexibility in the one test a year limitation. In the final rule issued December 8 after consideration of all the testimony, HIV screening for all beneficiaries was covered, and additional tests for pregnant women were authorized, a partial victory for Beyond AIDS.

Hopefully, CMS will proceed with similar proposals for additional prevention services recommended by the Task Force. The Obama administration has since announced, on July 14, 2010, its intent to require other types of health insurance operating under the new health care reform plan to cover all preventive services recommended by the Task Force, at no cost to patients.

Sunday, August 01, 2010

BEYOND AIDS MEETINGS WITH WASHINGTON OFFICIALS

On July 20, 2009, one day after a productive Annual Meeting of Beyond AIDS in Alexandria, Virginia hosted by Yvonne Pover (Treasurer), representatives of the organization met with top government officials in charge of HIV/AIDS policy.  A Beyond AIDS delegation consisting of N.Y. Assemblywoman Nettie Mayersohn (Vice-President), Michael Simanowitz, and Harry Dunsker from New York, and Ron Hattis (President) and Denise Bleak (Secretary) from California, provided input to two key Obama Administration leaders for the development of a National HIV/AIDS Strategy.  A document entitled "Making a Difference in the Control of HIV Transmission: Policy Recommendations for the Administration and Congress," was presented to both administration and congressional offices. It emphasized early identification of HIV infections through routine testing; linkage of  HIV reporting to prevention services; adequate inclusion of HIV screening, prevention, and treatment in healthcare reform legislation; special programs for HIV prevention for African American and other minority populations; and an equitable distribution formula for Ryan White CARE Act funding among the states and municipal area.

From left to right: Dunsker, Mayersohn, Bates, Bleak, Hattis at Humphrey Building, Washington, DC


The delegation first renewed contact with Christopher Bates, HIV/AIDS Policy Director for Health and Human Services, who was continued in that role by Obama and had previously met several times with Beyond AIDS officials during the Bush Administration.  Mr. Bates indicated that over the years his views had converged toward those of Beyond AIDS on a number of key issues. such as reporting and partner services. He reviewed some initiatives being taken by the Administration and accepted the list of recommendations to consider in the future. The visit was cordial.

Left to right: Mayersohn, Crowley, Bleak, Dunsker, and Simonawitz, at White House

Later that day, they met at the White House Executive Office Building with Jeffrey Crowley, Director of National AIDS Policy. Mr. Crowley had been assigned primary responsibility for drafting the President's National HIV/AIDS Strategy. The delegation emphasized that control of HIV at the source, i.e., the infected person, should be a key element in national strategy, and suggested that some funding for entitlements for AIDS patients might be better directed toward new prevention services working with HIV positives. Mr. Crowley defended the entitlements and did not agree with all of the positions suggested by Beyond AIDS, but listened courteously.

Later in the afternoon, Congress members from New York and California were visited by delegation members. These visits were part of the ongoing efforts of Beyond AIDS to influence the direction of HIV/AIDS prevention policy at the national level.