published by We The People Living with AIDS/HIV of the Delaware Valley, Inc.
Feds delay HealthChoices approval
79% of AIDS Ride proceeds go to promoters
FDA formally approves marketing of growth hormone
HIV mutations linked with long-term ritonavir
APM gets federal grant for housing program
Many of the questions relate to guarantees of appropriate care for Medicaid recipients with HIV disease.
The implementation of HealthChoices depends on the granting of a waiver by officials of the Health Care Financing Administration (HCFA), which sets federal requirements for state Medicaid programs. Dennis Gallagher, chief of the Medicaid Operations Branch of HCFA, said that federal officials "need additional information in order to determine if these requirements are met."
In a letter to Houstoun, Gallagher said that the information needed relates to "enrollment, access, quality and cost effectiveness."
Among the areas of concern cited by HCFA in delaying are several which have been previously raised by advocates for people living with HIV/AIDS.
Areas of particular concern to advocates -- and now HCFA -- include guarantees that appropriate standards of medical care will be followed by HealthChoices providers and assuring an adequate number of experienced HIV/AIDS providers in each plan.
HCFA said that the state's HealthChoices program is not clear about how it "will determine the appropriate level of services required by people living with AIDS or HIV infection." Among the questions Houstoun must answer are:
--"How will the State deliver, arrange, or otherwise assure access to those services in each HMO?"
--"Does the State employ standards of care [for HIV/AIDS]?"
--"How will standards be kept updated?"
--"Will community advisory groups, open to consumers and providers, be involved in setting and updating standards?"
--"How will these standards be monitored?"
--"How will Pennsylvania determine that a particular P[rimary] C[are] P[hysician] has adequate experience treating people with HIV/AIDS?
--"How will the State ensure that access to qualified providers or experienced providers will be available for individuals with HIV/AIDS?"
HCFA notes that the state has agreed that, "on a limited basis," it will allow people with HIV/AIDS and others with "complex, debilitating illnesses or conditions" to use a specialist as their Primary Care Physician, a key demand by AIDS advocates. However, HCFA expressed concern that the method for identifying who will have this option is not defined in the state's waiver application.
"Will these individuals be identified through self-identification, by the HMO, or by the State?" HCFA asked. "How will people with HIV/AIDS or other special needs be informed of their option to have a specialist as their PCP provider, or of the option of an open-ended referral to a specialist without compromising their confidentiality?" HCFA also questioned how an individual person with HIV/AIDS will be able to identify PCP's with AIDS experience.
HCFA also asked the state to define whether people with HIV/AIDS will be able to access protease inhibitors and other new treatments under the plan. It further asked the state to clarify how it will prevent HMOs from "rely[ing] on Ryan White funded case management" to provide "Medicaid-covered services to people enrolled in HMOs."
Each of these questions was originally raised by a number of advocates earlier this year when the state's original HealthChoices proposal was submitted for public comment. While the state Dept. of Public Welfare (DPW) incorporated some minor changes in its proposal as a result of the comments by AIDS advocates, the agency -- through Houstoun and her aide on AIDS policy issues, Peg Dierkers -- declined to incorporate most of the advocates' recommendations in their HealthChoices proposal.
HCFA also raised other major concerns about HealthChoices in its response to Pennsylvania's proposal. The federal agency raised concern about whether the state will be able to "ensure that each HMO has an adequate provider network in place to handle the health care of special population groups, both [HCFA's emphasis] prior to the January 1, 1997 implementation of HealthChoices, and periodically after implementation, throughout the 2-year waiver period?"
HCFA is also concerned about how consumers will be able to complain about poor service through HealthChoices. "Precisely what actions will Pennsylvania take," HCFA asked, "to ensure that there is a sound process in place within each HMO, and beyond the HMO to the Department of Public Welfare, for consumer complaints, formal grievances, appeals and hearings, especially in light of the serious deficiencies in the existing State hearings and appeals program?"
Concern that the state will be unable to monitor the HealthChoices program is also a subject of concern to HCFA. "What action is Pennsylvania taking," the agency asked, "to develop the organizational capacity necessary to manage and monitor the HealthChoices program for quality, access, consumer education and outreach, and cost?"
People with HIV/AIDS covered by Medical Assistance and SSI will be required to join new Medicaid health maintenance organizations by July, 1997, according to the state welfare department's plan for implementing HealthChoices.
Families with children, and those not on SSI, will be required to join the plans on January 1, 1997.
The HealthChoices program aims to enroll the 540,000 Medicaid beneficiaries from five Philadelphia-area counties in managed care plans by January 1. The state's Medicaid program costs roughly $1.6 billion annually.
Last week, Houstoun announced that six companies had been chosen to provide Medicaid managed care services under HealthChoices. They are Keystone Mercy Health Plan, Healthcare Management Alternatives Inc., Oxford Health Plans, QualMed for Health Inc., Health Partners and PhilCARE Health Systems Inc. State officials said they hope to negotiate the contracts, worth $5.5 billion over the next five years, by October 1.
According to DPW, all individuals and families eligible for Medical Assistance will be required to choose an HMO for their health care from a list of approved companies selected by DPW this summer. People who are currently enrolled in a Medicaid managed care plan will have the option of remaining with their current company, or may select a new plan; those who do not choose will be randomly assigned by computer to an HMO.
Thus far, two-thirds of the Philadelphia-area's Medicaid recipients, or about 358,000 people, have voluntarily enrolled in managed care plans. The new program will force the remaining 182,000 people into HMOs beginning January 1.
The Philadelphia region is the first area in Pennsylvania to begin moving Medicaid beneficiaries into managed care plans. The state Welfare Department intends to expand the program over the next three years to include all of the state's 1.6 million Medicaid beneficiaries
Local organizations which had expected to share about $1 million in proceeds from the Ride were ActionAIDS, Philadelphia Community Health Alternatives, the AIDS Information Network, and the Greater Philadelphia Urban Affairs Coalition (GPUAC).
The Ride effort has previously been criticized for what had been expected to be a 40% overhead cost. Local organizations which had hoped to benefit from the Ride have put on hold plans for holding another event next year, after hearing that almost all of this year's proceeds -- collected under the guise of benefiting people with AIDS -- would instead be spent on promoters, Ride staff and logistical expenses.
Pallotta has demanded a $325,000 fee from the agencies to sponsor a 1997 event.
Still unclear is how much of the Ride proceeds will be needed to repay a 15% loan of $200,000 taken out last year by three Philadelphia AIDS agencies as their "entry fee" into the Ride event, which is a for-profit ventured sponsored by Pallotta and Associates, of San Francisco. It was also unclear whether any of the three original sponsoring organizations would be able to actually dedicate their portion of the proceeds to direct services to people with AIDS, since each of them face increasingly serious financial problems as a result of government funding cutbacks and the drying up of donations for AIDS services generally.
Only the Greater Philadelphia Urban Affairs Coalition -- which supports AIDS service efforts in African American, Latino and Asian communities -- has publicly pledged to distribute all of any benefit it receives from the Ride directly to AIDS service efforts, through a "request for proposals" process for local minority AIDS groups.
"What this [Ride financial report] means is that Philadelphians thought they were contributing one and a half million dollars to help people with AIDS," said one local AIDS activist. "But in fact they were contributing it to people who were using the suffering of people with AIDS to make money for themselves."
The Ride project has also been hurt by unconfirmed rumors that almost a third of the 2,077 Ride participants -- 769 of them from Philadelphia -- were actually bused over the 125-mile route from Philadelphia to the nation's capital because they could not keep up with the unexpectedly difficult course. Ride supporters had marketed the event as relying on the concept of self-sacrifice by healthy bike riders on behalf of suffering PWAs.
According to a report issued by Pallotta and ActionAIDS, the lead agency for the Philadelphia AIDS groups participating in the event, $1.6 million was raised from riders and corporate sponsors, most from the minimum $1400 in pledges each rider was required to guarantee if they wished to participate. Of this amount, almost $1.3 million was spent on expenses related to the Ride, staff salaries and promotional costs.
The Ride project had been severely criticized by AIDS service advocates for diverting the dwindling pool of donations for AIDS services to only selected organizations, as well as for its high overhead and promotion costs. Minority AIDS advocates had condemned the Ride for its exclusion of AIDS service organizations led by people of color from participation. After the intervention of city officials only weeks prior to the event, GPUAC -- which represents over 25 small organizations serving the city's African American, Latino and Asian communities -- agreed to accept 25% of the proceeds for distribution to minority-run AIDS organizations.
James Roberts, executive director of the Minority AIDS Project of Philadelphia, who had led the effort to criticize the Ride prior to the inclusion of GPUAC, told the Philadelphia Gay News several weeks ago that he was disappointed with the small amount of money that would go to GPUAC from the Ride proceeds.
"What can we do with that?" Roberts asked. "Buy everybody a ham sandwich and maybe a Pepsi to go with it? This whole thing was a fiasco from the beginning. Money was bled from Philadelphia that should have gone to people with AIDS."
Roberts said that if minority organizations had been permitted to participate in the Ride planning from the beginning, they would have "questioned Pallotta's administrative fees and asked for a more reasonable budget," according to PGN.
Ennes Littrell, executive director of ActionAIDS, blamed minority AIDS advocates for the Ride's failure, in an interview with the Philadelphia City Paper. She said she supported doing another Ride next year.
"If we don't do this fundraiser again, people living with HIV absolutely would lose again," Littrell said.
FDA formally approves marketing of growth hormone
For the first time since the AIDS epidemic began, the U.S. Food and Drug Administration (FDA) has applied the accelerated review process to a drug which promotes metabolic changes that address the syndrome of AIDS wasting (cachexia), a leading cause of death among people with AIDS. AIDS wasting causes the body to inappropriately burn lean body mass (LBM), including muscle and organ tissue, instead of fat.
Serostim is indicated for the treatment of AIDS wasting or cachexia. This indication is based on analyses of surrogate endpoints (lean body mass and weight) in studies of up to 12 weeks in duration. Concomitant anti-viral therapy is necessary. The continued use of Serostim treatment should be reevaluated in patients who continue to lose weight in the first two weeks of treatment.
As an anabolic (protein building) and anticatabolic (protein sparing) agent, Serostim therapy results in a significant increase of lean body mass and weight, with a decrease in body fat. During the course of earlier Phase III trials, it was learned that preventing the continued loss, as well as promoting the accrual, of lean body mass, are the keys to improving physical function. The two placebo-controlled trials of Serostim in people with AIDS wasting up to 12 weeks in length found no difference in survival between groups.
In a placebo-controlled clinical trial, participants were asked to respond to a nine item well-being questionnaire that measured subjective assessments of treatment. Positive findings at six and 12 weeks were observed in two of the nine items (changes in appearance and overall benefit of treatment). Results of other measures were inconclusive. Increases in lean body mass and weight and a decrease in body fat were significantly greater in the Serostim group than in the placebo group. While depletion of body weight and lean body mass have been associated with increased morbidity and mortality, the clinical significance of treatment-induced weight gain and LBM accrual have yet to be established.
These Phase III trials also reported that the most common adverse reactions judged to be associated with Serostim therapy were musculoskeletal discomfort (pain, swelling and/or stiffness) and increased tissue turgor (swelling of the hands or feet). These symptoms, characterized as mild to moderate, usually subsided with continued treatment.
"We are very pleased that the FDA has granted Serostim permission to be marketed for the treatment of AIDS wasting, which has been designated as an orphan indication," said Hisham Samra, M.D., president of Serono Laboratories, Inc. "We owe a special thanks to our scientific investigators, the FDA and the HIV/AIDS community, particularly ACT UP Golden Gate, Treatment Action Group (TAG), Project Inform and AIDS Project Los Angeles."
Physicians or people with AIDS wasting who would like additional information on Serostim or full prescribing information should contact the Serostim Access Line at 800-714-2437 (Monday through Friday, 8:30 a.m. to 5:00 p.m., EST).
HIV mutations linked with long-term ritonavir
Multiple mutations of the HIV protease gene that are associated with drug resistance appear to emerge after about one year of ritonavir therapy.
The finding is reported in the August issue of AIDS by Dr. Jean-Claude Schmit at the Rega Institute for Medical Research in Leuven, Belgium. He and his colleagues studied genotypic resistance patterns in 7 HIV-1-infected patients treated with ritonavir for 1 year. The investigators note that the mean CD4 count rose from 130 to 172 cells per microliter, but that drug-resistance mutations in the HIV-1 protease gene appeared in almost all patients after 1 year of treatment.
Moreover, Dr. Schmit's team found that genotypic and phenotypic data also suggest the potential of cross-resistance to other HIV protease inhibitors. This, they conclude, argues against sequential therapy with several protease inhibitors.
APM gets federal grant for housing program
Ten programs that help low-income people with AIDS or HIV find housing will share more than $7.8 million in federal grants, Housing Secretary Henry Cisneros announced last week, including one in Philadelphia.
The competitive grants were possible under the Department of Housing and Urban Development's Housing Opportunities for Persons with AIDS program.
Created in 1992, money from the $171 million program helps community groups and other organizations provide housing and other services to people with HIV/AIDS, as well as their families.
Cisneros said homeless people with AIDS live for an average of six months, although some may live as long as 10 years, given the right care.
"We are dealing with a life and death problem when we talk about homelessness and AIDS," Cisneros told reporters.
One of the national awards went to Asociacion de Puertorriquenos en Marcha, a North Philadelphia group which already operates a personal care boarding home for homeless people with AIDS. The grant amount was $750,000 for a new housing project also supported by other federal and local funds.