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Issue #136: August 3, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include AIDS, AIDS Treatment News, Archives of Family Medicine, New York Times, Reuters.
HealthPartners to delay AIDS centers in Delco; reduces payments in Philadelphia
Blacks lag in access to combo therapy
Low CD4s not always predictive: study
Agouron says early use of combo best
HIV among older women increases
Patient preferences not told to doctors: study
Second STD leads to higher HIV levels
Reduces payments in Philadelphia
HealthPartners to delay AIDS centers in Delco
HealthPartners, one of four managed care companies participating in the state's HealthChoices program for health care for the poor, will not expand its planned "centers of excellence" for AIDS care to Delaware County, as a result of the state welfare department's failure to provide adequate reimbursement for the cost of treating people with AIDS and HIV infection.The company will also be "reducing significantly the payments to doctors and hospitals in Philadelphia," according to Barbara Plager, president of the plan.
The "centers of excellence" program, panned for fourteen sites in Philadelphia, aims to integrate AIDS specialty care and supportive services in a fashion which encourages high quality primary care as well as cost efficiency.
Plager said last week that HealthPartners had received approval from the Department of Public Welfare (DPW) to "temporarily" suspend any new enrollments to the plan from Delaware County residents because of the significant losses that it and its health care network in the county had experienced as a result of low HealthChoices reimbursement rates. This week, she said that the state agreed that the suspension could continue at least through the month of August.
"We are seriously concerned that these actions may threaten access to health care services," Plager said, "but given our current contractual obligations and DPW's intransigence, we have no other choice."
Plager said that HealthPartners will also "be eliminating certain optional benefits from our coverage for recipients," although she did not indicate which benefits would be affected.
HealthPartners is believed in the AIDS community to have the largest number of participants with HIV infection, largely because of its efforts over the past ten year to develop specialized programs for AIDS care, and the fact that the seven teaching hospitals which own the plan care for the bulk of people living with HIV in the region. At least 70% of the 21,000 people living with HIV infection in the region are believed to get their health services through HealthChoices.
fastfax has learned that each of the four managed care plans participating in HealthChoices -- the others are Keystone/Mercy, Oxford/Oak Tree, and Healthcare Management Alternatives -- is eligible for a "supplemental" payment for AIDS care this summer if they can show that they are caring for a larger number of people with AIDS than the state originally predicted. DPW has not acted on the supplemental payments, however.
Sources said that the state has backed away from an earlier position that it would only count those diagnosed with AIDS, as opposed to including those with symptomatic HIV infection, in making the calculation on whether a supplemental payment was appropriate.
HealthPartners is currently in negotiations with DPW on whether it can receive a supplemental payment, and has said that the size of that payment will determine whether it will resume its plan to expand AIDS care in Delaware County or lift the suspension on new enrollments.
That suspension applies to any Delaware County resident eligible for Medical Assistance, regardless of where they seek their medical care.
HealthChoices regulations require each of the participating HMOs to offer their services throughout the entire five-county southeastern Pennsylvania area. Formally pulling out of Delaware County could, under current rules, end HealthPartners participation in HealthChoices, forcing over 100,000 people to seek their health care elsewhere.
Four Delaware County hospitals have already backed out of arrangements with HealthPartners in which they shared financial losses resulting from low HealthChoices reimbursement rates. The hospitals say they have lost over $1 million in the first three months of this year, and HealthPartners claims to have lost almost $8 million.
Plager said that at least half of the losses the plan has suffered under the new HealthChoices reimbursement rates are related to the higher costs of AIDS care. Studies have indicated that the cost of AIDS-related care average between $20,000 and $35,000 per year per patient, not including the costs of protease inhibitors, which only recently became more common in AIDS treatment.
AIDS advocates have long predicted that the high cost of AIDS-related care would undermine the ability of the Medicaid managed care system to provide for people with HIV disease, unless the state set higher reimbursement rates for people with HIV/AIDS and other chronic and disabling conditions. They claim that because of the low reimbursement rates, HMOs will have an incentive to avoid costly AIDS care and seek to avoid enrolling people with AIDS in their plans.
Overall, Medicaid reimbursement rates have been decreased significantly by Pennsylvania Governor Tom Ridge, who claims that the Medicaid program is too costly. Ridge dropped reimbursement rates by 8 percent between 1995 and 1996, and again when HealthChoices began in February. The lower HealthChoices rates have not been made public.
However, the Philadelphia Inquirer has reported that DPW is paying an average of $155 per month per member to the HMOs, down from $211 last year, according to financial reports. Some of the reduction is related to the shift of behavioral health services away from the four HMOs under HealthChoices.
State officials have said that HealthChoices is expected to save the state almost $70 million annually.
"The implementation of HealthChoices in the southeast region [has] brought significant reductions in funding from DPW," Plager wrote in a letter to state senator Allyson Schwartz, which was obtained by fastfax.
"Faced with a devastating financial outlook, HealthPartners must take some drastic measures," Plager said. "We have held off taking these steps in the hope that DPW would provide HealthPartners immediate and substantial relief. DPW, however, has refused our pleas to reassess and reformulate rates based on sound actuarial analysis."
Blacks lag in access to combo therapy
An extensive survey of people living with HIV in New York indicates that whites are much more likely than African American or Latino people to have access to the powerful three-drug combination which has led to decreased death rates and better health for thousands of people with HIV disease.The study, which included 700 people, was begun in 1994 by Columbia University researchers.
The study illustrates that those most in need of access to the life-saving medications -- low-income people of color, who comprise the majority of HIV/AIDS cases in most urban areas -- are not getting the best treatments recommended by federal officials.
In the study, 33% of whites reported using a combination of drugs that include protease inhibitors, while only 12% of blacks and 19% of Latinos were using the combination.
The findings reinforced concerns among many AIDS advocates in minority communities that doctors will not prescribe life-prolonging medications to some patients because they are concerned about their compliance with the often difficult treatment regimens. Others have noted the often deeply-held mistrust of the medical establishment which surveys show is more prevalent among people of color.
The survey was prepared for the New York HIV Planning Council, which performs similar functions to the Philadelphia HIV Commission. Philadelphia AIDS planners have resisted conducting such studies, emphasizing instead broad surveys aimed at evaluating whether consumers are satisfied with existing services.
The federal Health Services and Resources Administration, which awards over $15 million in AIDS care funds to the Philadelphia region annually, has asked city officials to report the success of the local AIDS system in linking people with HIV/AIDS to the new treatments.
"This study clearly shows the kind of discrepancy in access to care that many of us have been concerned about," Ronald Johnson, New York's AIDS policy coordinator, told The New York Times. "It shows what work we need to do to make sure the current advancements and any new advancements are made available to the larger community."
Of the 700 participants in the study, 17% were white, 48% were African American, and 35% were Latino. About two-thirds of the study participants were male, and nearly half of those surveyed reported incomes of less than $10,000 per year.
Researchers said that the study indicated that a patient was more likely to be on the new combination therapy if they received their care from a private doctor, rather than through a hospital or community clinic. People with unstable housing or drug problems were significantly less likely to be on the medications, the study showed.
Men who have sex with men were twice as likely to be using the therapies than heterosexual people and people who contracted HIV through injection drug use, the study indicated.
Over half of the African American participants were taking no drugs at all for their HIV infection, compared to 35% of whites and 38% of Latinos.
1592 program announced
by John S. JamesAIDS Treatment News Issue #276
800/TREAT-1-2
An open-label protocol for 1592 -- a new protease inhibitor -- for adults (the program for children was previously announced), is now being offered by the drug's manufacturer, Glaxo Wellcome.
[Glaxo has been severely criticized by AIDS advocates for limiting access to the drug.]
The number of patients who can enroll will be seriously restricted because of limited drug supply, and limited human experience with the drug. Also, the complete list of sites for the adult program is not yet available -- and many of the sites are not ready at this time, because they still need Institutional Review Board (IRB) approval. A central IRB is in place for those sites that need one.
To be eligible for the 1592 open-label adult program (Protocol CNAA/B3008), persons must be at least 13 years old, have a CD4 count under 100 and viral load at least 30,000 copies "within 60 days of registration and while on currently acceptable combination regimens," have been treated with at least two nucleoside reverse transcriptase inhibitors and one protease inhibitor, or not be receiving treatment due to intolerance to at least two different regimens, one of which contains a protease inhibitor (and be intolerant to at least one nucleoside reverse transcriptase inhibitor and one protease inhibitor). Also they must not qualify for an enrolling study of 1592.
There are other exclusion criteria, the most important of which seem to be pregnant women or women who are breast-feeding, or "patients with hepatic failure evident by grade 3 or 4 hyperbilirubinemia and AST >5 x upper limits of normal." 1592 should be administered "as part of a combination antiretroviral regimen, including other antiretroviral agents which the patient has never received," but otherwise the patient "should take as few concurrent medications as medically feasible." The antiretrovirals used in the combination may include those from other compassionate use programs, if approved by both Glaxo Wellcome and the other company.
Physicians interested in enrolling patients should call 800/501-4672.
Low CD4s not always predictive: study
Findings from a study of HIV-infected patients with low or undetectable CD4 counts, published in the journal AIDS, have revealed that a significant minority at a late stage of disease survived for more than one year and some for more than two years, despite the belief of some doctors that a very low CD4 count is an indication that death is near.Dr. Caroline A. Sabin of the Royal Free Hospital in London and colleagues charted the courses of 169 patients after the patients presented with CD4 counts below 5 x 10 to the 6th power/liter. Dr. Sabin reports in the July 15 issue of AIDS that the median survival time calculated for this cohort was 0.95 years.
Older age and a previous diagnosis of AIDS were predictors of shorter than average survival, while young age, no previous history of AIDS and a high CD8 count at baseline predicted a survival rate closer to two years.
Dr. Sabin says that her findings should give some hope to patients and healthcare providers, and allow some time to prepare for death.
Agouron says early use of combo best
Agouron Pharmaceuticals has submitted data to the U.S. Food and Drug Administration showing patients with HIV and AIDS who began therapy with a three-drug cocktail earlier in their infections had a greater and more lasting response than those who waited.Peter Johnson, Agouron's chief executive, said in an interview that the previously unreleased data strengthened the argument for early treatment and could likely influence FDA guidelines for anti-HIV drugs.
Johnson said the FDA had requested data involving hundreds of patients treated with a combination of Agouron's protease inhibitor Viracept in combination with Glaxo Wellcome's reverse transcriptase inhibitors AZT and 3TC.
The clinical data were compiled during a 48-week period beginning in the spring of 1996 at 50 centers in the United States. Other data from the same clinical trials, which are ongoing, were the basis for FDA approval earlier this year of Viracept, which reached the market March 14.
Johnson said the HIV virus was undetectable in 96 percent of patients with early infection, defined as less than 50,000 viruses per cubic millimeter of blood.
And among those who responded to the cocktail, 95 percent continued to have undetectable "viral loads" after 48 weeks, he said.
But among patients with longer infections evidenced by 100,000 or more viruses per cubic millimeter, only 81 percent showed absence of detectible virus after treatment.
Among them, only 80 to 85 percent had undetectable virus after 48 weeks.
"This is an analysis we haven't done before and it confirms the supposition that there's compelling reason to seek treatment early," Johnson said.
"This is an additional piece of information that will substantiate the increasingly prominent thought that it's important to hit the virus hard and hit it early," he said.
Johnson said the FDA had also asked manufacturers of other protease inhibitors -- which include Roche's Invirase, Merck's Crixivan and Abbott's Norvir -- to submit their own comparative data on early-stage and later-stage patients.
HIV among older women increases
Older women are contracting HIV more frequently than ever before, due in part to the fact that their immune system has slowed down with age and that they often do not see themselves as at risk, according to a recent article in The New York Times.In 1986, 102 cases of HIV infection in women over 60 were reported to the Centers for Disease Control and Prevention; by 1996, the number had nearly tripled to 305 cases. The majority of the infections a decade ago were the result of tainted blood transfusions, while 69 percent can now be attributed to heterosexual contact.
However, the statistics fail to reflect the true volume of infected elderly persons, the Times report said. Marcia G. Ory of the National Institute on Aging notes: "Doctors don't expect to see the disease in this group, so they often don't. The women seldom think of having a test for HIV. So many of them are not diagnosed or misdiagnosed and are never properly treated." According to Dr. Marcia Epstein, an infectious disease specialist at North Shore Community Hospital in New York, doctors are now beginning to test women in their 60s for HIV, particularly those who report fever or chronic fatigue.
Patient preferences not told to doctors: study
Among patients with symptomatic HIV disease who have a preference regarding their care, only about one-third actually discuss the options with their physician.Dr. Charles Mouton of the University of Texas Health Science Center at San Antonio and a multicenter team surveyed more than 1,000 HIV+ patients to determine "...the way patients with serious, progressive illnesses communicate their care preferences to their physician."
While 861 patients stated a preference for treatment focused on "extending life" or on "comfort even if it shortened life," only 35.8% had spoken with their physician about it. By race, Dr. Mouton found that black patients "...were half as likely...to have discussed their preferred treatment approach [and] were half as likely to prefer an approach to care that focused only on comfort."
AIDS patients "...who were symptomatic daily, college-educated, and more functionally impaired were more likely to have discussed," their preferences with a physician.
The researchers think that their study highlights the need for further study to understand these differences and find ways to improve treatment preference discussions between patients and physicians.
Second STD leads to higher HIV levels
Researchers at the University of North Carolina School of Medicine in Chapel Hill have found that HIV-positive men who have also contracted another sexually transmitted disease have eight times as much HIV in their semen as do men without two infections.The researchers, who studied 135 HIV-infected men in Malawi, found that after two weeks of treatment, the level of HIV in the men with other STDs was similar to the levels seen in men who did not have other STDs and who had received treatment for skin conditions only. The findings, published in The Lancet, are significant because they suggest that the treatment and detection of other sexually transmitted diseases could help prevent new HIV infections. "The study has important economic and public health implications," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, "because if you can treat a sexually transmitted disease with a few doses of relatively inexpensive antibiotics, you may prevent a number of HIV infections that would cost a lot more to treat." Experts also note that with no vaccine for AIDS, it is necessary to seek more indirect methods to prevent the spread of HIV. Some of these methods include improved STD treatment, condom promotion, needle exchange, and counseling programs.
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