HMOs agree to work on HealthChoices improvements
26 arrested at HCFA demonstration
US News threatens WTP over trademark
AIDS Action calls for lower drug prices
AIDS vaccine fails
Representatives of the four managed care companies set to provide health services to over 17,000 people living with HIV disease in February agreed to join a collaborative effort with people living with HIV disease and AIDS services providers this week.
Executives from the four companies -- Healthcare Management Alternatives (HMA), HealthPartners, Keystone/Mercy, and Oxford/Oaktree -- as well as the medical directors of three of the companies, met as a group for the first time with people with HIV/AIDS and their advocates this week at a meeting convened by city health commissioner Estelle Richman.
The meeting culminated a series held by Richman with people with HIV/AIDS, AIDS service providers and others to define ways in which the controversial Medicaid initiative can be made to better meet the medical and access needs of people with HIV/AIDS.
Meanwhile, state officials announced that they have delayed the formal start of the HealthChoices program until February 1st, because of administrative issues at the Department of Public Welfare (DPW) and delays in signing contracts with the individual HMOs. Sources said that the federal Health Care Financing Administration (HCFA) is considering adding special conditions on its approval of the HealthChoices program to pressure DPW to address the concerns of AIDS advocates.
While enrollment for HealthChoices has been underway since October -- a major concern of advocates, since none of the plans has yet distributed information identifying AIDS specialists on their physician panels -- mandatory enrollment has been delayed until February 10th, to give plans time to add additional physicians and providers with more experience in AIDS care.
The coming deadlines apply to Medicaid-eligible individuals who receive Aid to Families with Dependent Children (AFDC) benefits. Other people living with HIV/AIDS eligible for Medicaid, including those receiving disability payments from the Social Security Administration, will not be required to select a plan until next July.
State and federal officials have been severely criticized by AIDS advocates for implementing the HealthChoices program, which is mandatory for all Medicaid-eligible individuals in southeastern Pennsylvania, even though most people with HIV/AIDS have not been informed of which physicians participating in HealthChoices are experienced in AIDS care. Critics have noted that neither DPW nor the managed care companies have revealed how they are defining an "AIDS specialist," even though DPW has assured federal officials that they have guaranteed access to a specialist for all HIV+ clients who request one.
HealthChoices also does not require a quality standard for AIDS care, and has no mechanism for assuring that people with HIV/AIDS in underserved areas of the region -- especially the Philadelphia suburbs -- will be able to find primary care physicians with AIDS care experience.
At the meeting, advocates David Fair, former executive director of We The People and now a consultant to the Philadelphia Health Department, Jane Shull, executive director of Philadelphia FIGHT, and Nan Feyler, executive director of the AIDS Law Project, presented a list of nine major issues which they said the HMOs needed to address before they could effectively assure appropriate care for people with HIV/AIDS. Among them were the definition of an HIV specialist; adoption of a common standard of care across plans; establishing an ongoing advisory process, for all plans together, involving AIDS specialists and consumers; HMO plans for guaranteeing access to protease inhibitors, viral load testing, nutritional interventions, and new treatments on the horizon, recognizing the rapidly changing consensus on what works in HIV care; development of a plan, common across HMOs, to delay forced enrollment for consumers whose current providers are not available through HealthChoices; development of coherent plan for allowing specialists to be Primary Care Physicians in each plan, so that people with HIV/AIDS won't need to have all of their care handled through complicated referral processes; a plan for addressing urgent issues regarding lack of capacity in each of the plans to provide care to suburban county residents with HIV/AIDS; a plan for overcoming practical problems with systems to provide transportation for consumers to providers, especially in suburban counties; and issues related to access and referral through the benefits counseling system, which is supposed to help individual applicants to determine which HMO would best meet their medical and access needs.
HMA operations director Denise Ross, MD, of HMA reported to the group on the recent meeting with DPW, convened held by DPW policy director Peg Dierkers at the request of the Philadelphia Ad Hoc Coalition on HealthChoices. Ross said that at that meeting the HMOs agreed to develop recommendations in a variety of areas of concern to advocates, which had just submitted to DPW and are now awaiting a response:
Ross said that a major issue discussed with Dierkers was that of more clearly identifying who the HIV specialists were in the individual HMO plans. She said that the HMOs have proposed to DPW is that an asterisk be placed next to the names of "special needs" providers, including but not limited to HIV experienced providers, to make it easier for them to be identified. On this issue, Feyler reiterated the recommendation from the Pennsylvania Health Law Project and the Ad Hoc Coalition that a separate "Special Needs Directory" be published which could more directly identify the AIDS care providers. Participants in the meeting reported to fastfax that there appeared to be some reluctance on the HMOs to do that at this stage.
Dr. Ross noted that HMA has already convened its own internal group of HIV specialists on their panel to begin to address many of the issues we raised. The other HMO representatives said they had done the same to some degree. Dr. Ross suggested that the various HMO AIDS committees be consolidated, and that the AIDS community identify several other participants, so that a unified plan on the issues around standards and definitions could be developed.
The issue of consumers being able to keep their present doctors until they can find them on the panels or be referred to new, competent PCPs, came up several times but there was no clear or unified response from the HMO representatives, according to participants. Several of the HMO representatives said that they could certify new providers quickly, and invited the group to submit names of physicians not currently included in their physician panels so that the process of adding them could begin. Shull and Feyler agreed to share with the HMOs by the end of the week the consensus list developed by the Ad Hoc Coalition on specialists the AIDS community has confidence in, so that it could be determined how closely they match with the current HMO panels.
Advocates at the meeting said that it appeared that the HMOs would try to expand their panels quickly if appropriate providers who were willing to work with them were identified.
Some of the most popular AIDS specialists in the region have been reluctant to join the Medicaid HMO panels because reimbursement levels are much lower than in private plans.
Participants said that the meeting also discussed the issue of continuing education for HealthChoices providers, given the rapidly changing nature of AIDS care. Shull said that FIGHT and the Pennsylvania AIDS Education and Training Center were "eager" to work with the HMOs to provide such training. Dr. Ross also recommended setting up an "800" number for providers to consult with experts if they had a question regarding diagnosis, therapies, treatment regimens, etc.
Much concern was raised at the meeting on the part of both the HMOs and the advocates on what were called low "capitation" rates -- that is, the amount of money provided by DPW to the plans for each participating patient -- which, in effect, discourage plans and providers from delivering AIDS care because of its likely higher expense than care for other patients. Fair raised the possibility of re-configuring Ryan White and other AIDS dollars in ways which make it easier for the HMOs to address these issues, by providing incentives and enhancements which minimize the impact of low Medicaid rates.
An agreement was reached at the meeting to establish a "medical advisory group," involving each HMO and AIDS physicians and consumers, to focus on standards, definitions, etc.; and a "consumer advisory group," to focus on access and greivance issues. Shull and Feyler agreed to act as contact persons for the medical advisory group, while We The People executive director Joe Cronauer and HIV Commission co-chair Mark Davis agreed to work on developing the consumer group. The HMO representatives charged Drs. Donald Liss and Kenneth Coburn of HealthPartners to help convene the medical advisory group, with Dr. Ross acting as the contact for the consumer group.
No formal follow-up meetings had been scheduled when fastfax went to press.
The HMO representatives agreed to work with Richman on the issue of
capitation rates. Richman said will work with the HMOs to develop a proposal to DPW that can be used by all the HMO's to try to get higher reimbursement fo their AIDS-related care.
Community participants at the meeting, in addition to Fair, Shull and Feyler, included Cronauer, Davis, Linda Smith, chairperson of We The People, Bob Long of Family Service of Montgomery County, Jena Nottingham of the Minority AIDS Project, Ronda Goldfein of the AIDS Law Project, Norma Muurahainen, MD, of Graduate Health Systems, and Ramona Christian, RN, the HIV Coordinator at Temple University. In addition to Richman, the health department was represented by AIDS Activities Coordinating Office director Jesse Milan and CARE Act services director John Cella.
26 arrested at HCFA demonstration
Chanting "HealthChoices is a lie, they don't care if people die," almost 200 people living with HIV disease and their allies staged an angry demonstration at the local offices of the Health Care Financing Administration on December 10th, demanding that the federal government delay an expected decision to give the go-ahead to the start of the new Medicaid managed care program on February 1st.
Twenty-six activists -- including top staff of thirteen AIDS service organizations -- were arrested at the demonstration after they blocked traffic on 36th Street in West Philadelphia near the federal building where the HCFA office is located.
In a statement released after the demonstration, HCFA officials -- who attended a public hearing in Philadelphia last month to hear directly the concerns of people living with HIV/AIDS -- said that they agreed that the HealthChoices plan needed to do a better job of assuring access to HIV specialists and an appropriate HIV standard of care. The Philadelphia Inquirer reported that HCFA spokesman Dennis Gallagher said he expected HCFA to approve the state's plans for HealthChoices, although he said that certain unspecified conditions may be placed on the plan if it has not addressed the concerns of people with HIV/AIDS and other chronic illnesses by the January 1st deadline.
Among those arrested at the demonstration were the executive directors of We The People, Critical Path AIDS Project, ActionAIDS, the Philadelphia AIDS Consortium, the AIDS Law Project, From All Walks of Life, SafeGuards, MANNA, the Gay and Lesbian Latino AIDS Education Initiative, AIDS Services in Asian Communities. Others arrested included members of We The People and ACT UP, including HIV Commission co-chair Mark Davis.
US News threatens WTP over trademark
Jo Anne Davis, a legal representative of the national newsmagazine U.S. News and World Report, has threatened legal action against We The People for its use of the term "News You Can Use" as the title of a monthly medical update column in its monthly newsletter, Alive & Kicking!
"I am writing to inform you that "News You Can Use" is a federally registered trademark owned by U.S. News & World Report pursuant to registration No. 600,005, registered on November 28, 1954," Davis wrote to newsletter editor David Fair in an e-mail on December 12th. "We have extensively used and promoted our trademark in print as well as all other mediums including on-line."
Davis' letter apparently was in reaction to the World Wide Web edition of Alive & Kicking!, which has been published on the Internet since November, 1995. "News You Can Use" has been the title of the monthly A&K! column since the publication began in November of 1991. The column reviews medical information of interest to people living with HIV/AIDS as well as other national and regional news updates drawn from medical journals, newspapers, and on-line resources.
"The use of the phrase "News You Can Use" by We The People is an infringement of our trademark," Davis said. "Please call me to ensure that you are taking appropriate measures immediately to preclude any further use of the trademark."
Fair said that We The People was unaware of the trademark on the term held by U.S. News and would change the title of the column beginning with the January, 1997 issue.
"Let's hope they don't tell us we can't use information about AIDS they publish in U.S. News," Fair said, noting that the publication is among almost a hundred which is reviewed by We The People for information of interest to A&K! readers. "If they tell us we can't use the information they publish, maybe we should call the column 'News You Can't Use,'" he said.
Fair noted that We The People is a non-profit corporation, and that Alive & Kicking! relies almost solely on public funds for its publication and distribution. No staff costs are associated with the newsletter either, Fair said, with all grant funds being used solely for printing and postage costs.
We The People executive director Joe Cronauer confirmed that no income has ever been earned by A&K! in its history.
Critical Path AIDS Project director Kiyoshi Kuromiya noted that his organizational newsletter had a similar problem several years ago with the publication AIDS Clinical Care and its publisher, the Massachusetts Medical Society, which also publishes the New England Journal of Medicine.
Last year, Kuromiya said, the publisher "warned Critical Path through their lawyers that we were violating their copyright by scanning and putting on the web their newsletter. They had found their newsletter quite easily by using any easily available search engine. They explained in their letter that they themselves were going to put it on the web so that everyone (PWAs with limited funds) could read the useful information that they publish. Of course, they never did."
"In the meantime, we simply posted their letter in our publications archive in place of AIDS Clinical Care. So, anybody who searches the Internet for AIDS Clinical Care will find their letter refusing to let us continue to post their newsletter," Kuromiya said.
Those interested in relaying their personal comments to U.S. News on their claim of trademark infringement can contact Ms. Davis at 202-955-2558, or by email at Jdavis@usnews.com.
AIDS Action calls for lower drug prices
The AIDS Action Council, recognizing that "new and promising drugs and support for the programs that provide that access must remain at the center of our agenda," has initiated a national campaign to oppose "the astronomical prices of the new regimens makes that work more difficult."
The Ad-Hoc Coalition for Drug Pricing been seeking signers to a letter which demands that major pharmaceutical companies address issues of cost of their drugs. The letter is to be delivered to a large number of companies producing AIDS therapies, including Glaxo Wellcome, Hoffman-Laroche, Abbott Laboratories, Merck & Company, Agouron Pharmaceuticals, Pfizer, Amgen, Inc., Genentech, Serono Laboratories, Bio-Technology Group, Boeringer Ingelheim/Roxane, Gilead Sciences, Astra, Smithkline Beecham, Pharmacia & Upjohn, Parke-Davis, Miles Inc. Pharmaceuticals, Bristol-Myers Squibb, Syntex Laboratories Inc., Janssen Pharmaceuticals, Ortho-Biotech, Schering Plough, Sandfi Winthrop, Fujisawa, Sequus, and Vestar.
The letter demands that the companies "take the following steps to help end the crisis in access to life-saving prescription HIV/AIDS drugs:
1. Glaxo-Wellcome must immediately rescind their 2.9% price increase for the drugs AZT, 3TC and Zovirax. AZT, 3TC, and Zovirax are, by most estimations, already the most profitable drugs in the history of the AIDS epidemic. A recent article in The Economist estimated that AZT alone has made $2.3 billion since approval.
2. All manufacturers of drugs for HIV and AIDS, particularly those making protease inhibitors and expensive drugs to treat opportunistic infections, must immediately reevaluate the prices of their respective drugs taking into consideration the impossible burden that prescription drug prices are placing on people living with HIV/AIDS and the assistance programs that serve them - primarily Medicaid and the AIDS Drug Assistance Program (ADAP).
3. In keeping with the concerns expressed in #2, we demand that all manufacturers of drugs provided through AIDS Drug Assistance Programs offer to those programs at the Public Health Service/Medicaid price. While large programs in high incidence states have had great success in negotiating for these lower prices, other states with fewer patients are known to pay average wholesale price which can have a dramatic impact on the number of patients the programs are capable of serving.
4. The pharmaceutical industry must provide children and pregnant women with real access to new HIV combination therapies. HIV/AIDS drugs recently approved by the FDA for adults have not been approved for children or pregnant women. Since the Omnibus Reconciliation Bill of 1996 (HR 3610) calls for a report on initiatives by the industry to expedite clinical trials for pregnant women and children with HIV/AIDS by December 31, 1996, we demand that the industry implement such initiatives and extend the use of their products to all people infected with HIV.
"The sad reality is that our fractured health care system is unable to bear the current cost of drugs," the coalition letter said. "Limitations on access are everywhere, in both public and private insurance programs. These include impossibly low prescription drug caps, restricted formularies, unreasonably high prescription co-payments and burdensome prior authorization procedures. This cost squeeze is escalating, at a time when people with HIV and AIDS need access to more, and more costly, prescription drugs than ever - if they want to stay alive. It truly is an emergency. Hundreds of thousands of lives are at stake, and as a result, caring about questions of access must become standard business practice."
Meanwhile, ACT UP/Philadelphia is distibuting a consensus letter aimed at encouraging Hoffman-LaRoche to "follow through on their extremely overdue promise" to inform those who received free viral load tests last summer of the results of the tests."
The letter also asks that the coupons which Roche has promised for two additional tests -- offered after earlier complaints at the delay in distributing the results of the summer testing -- be
distributed immediately, rather than according to the company's current plan to distribute them piecemeal between now and March, 1997.
Some of those who took the original tests "followed Roche's guidelines of initiating new therapies right after they got tested and, with Roche's present intentions, may not know whether their treatments are working for up to 10 months!" said Glenn Brown, an ACT UP member.
The ACT UP letter also demands that Roche reduce their prices and sponsor education programs for people relying on the viral load testing program. "They need to make a special effort in educating women living with HIV/AIDS and people responsible for the care of HIV+ kids, people who were blatantly not a big focus in last summer's access program," Brown said.
A copy of the consensus letter can be accessed by e-mailing Brown at glenzie@critpath.org, or by calling ACT UP at 215-731-1844.
by Jody A. Charnow
Medical Tribune News Service
A vaccine designed to halt the progress of the viral infection that leads to AIDS does not work, according to a report published in the international medical journal The Lancet.
The vaccine contains a component of the outer covering of HIV.
Scientists led by Dr. Joseph J. Eron Jr., of the University of North Carolina in Chapel Hill, theorized that by injecting people with that component -- a protein called gp120 -- they could enhance the body's production of antibodies against HIV.
Eron and colleagues tested the vaccine in 573 patients infected with HIV who did not have symptoms of the infection. They injected 288 subjects with the vaccine and 285 subjects with a placebo over a 15-month period.
The researchers had intended to conduct the study for 36 months, but a committee monitoring the trial's progress stopped the study at 15 months because data showed that the vaccine had little impact on the number of CD4 cells in patients' blood.
CD4 cells are important infection-fighting white blood cells and are the primary target of HIV. In most people, the number of CD4 cells in blood decreases during the course of HIV infection, leading people with HIV to become increasingly susceptible to infections and other ailments. CD4 cell counts are widely used as a way to measure the progress of HIV infection.
Also during the study, the Eron team found that vaccine recipients did not differ from placebo recipients in the amount of HIV in the blood, which indicates how rapidly somebody's HIV infection will progress.
In a commentary in the same issue of The Lancet, Dr. Barton F. Haynes of the Duke Center for AIDS Research in Durham, N.C., wrote that "carefully performed work" such as the study by Eron and colleagues showing that a drug or strategy does not work "is as important as a positive study, in that it shows that the field can now move on to other strategies."
Previous efforts to develop vaccines to prevent HIV infection also have failed.
A dozen other HIV vaccines are under development in the United States, according to the Pharmaceutical Research and Manufacturers of America, an industry trade group.