|
 |
|
|
|
Issue #239: July 23, 1999
FASTFAX is available by fax in the 215 and 610 area codes at no cost, by mail anywhere for 20.00 per year, by calling 215-545-6868, and on the fastfax index page. Information in fastfax is drawn mostly from secondary sources; people living with HIV/AIDS should share information of interest to them with their primary care provider before making treatment choices. For more information on HIV medications and treatments, contact Kiyoshi Kuromiya of the Critical Path AIDS Project, 215-545-2212 or by email to The presence of the name or image of any individual in fastfax should not be construed as an indication of their HIV status or sexual preference unless specifically stated. Questions or comments should be directed to Editor, fastfax, 425 S. Broad St., Phila., PA 19147-1126 or by email to
In This Issue:
State may expand home nursing benefit
Agenerase added to state drug plan
More evidence of PI, cardiovascular risk
HAART less successful in "real world"
AIDS Action: advertising fuels high prices, not research costs
In the midst of the worst AIDS nursing care crisis in three years, the Ridge Administration has joined with a group of advocates to propose a major increase in the availability of home-based nursing services, reducing the need for more expensive skilled nursing and assisted living facilities.
The proposal, which still has several hoops to jump through and will take several years to implement fully, would shift public welfare and Medicaid dollars away from nursing homes to pay for home-care services, adult day care, respite care and assisted living for low- and moderate-income Pennsylvanians.
State officials and advocates believe that the change in funding priorities would dramatically increase the number of disabled working-age adults - including people with AIDS -- and frail elderly who receive care, allowing them to remain at home. If the program is designed to be available to people with AIDS, it could finally be a permanent solution to the inability of the AIDS system to provide skilled nursing services.
Because the program seeks to reduce dependence on nursing facilities, it could also potentially save the state more than $1 billion a year. There are currently 815 licensed nursing homes in Pennsylvania, serving about 76,000 Medicaid recipients.
There are about 8,700 Medicaid-licensed nursing beds in 64 homes in Philadelphia, but only 18 beds have been formally available to people with AIDS. Most nursing homes have resisted admitting more than one or two people with AIDS because their care can sometimes be more complex and expensive, they are younger than other residents and more difficult to manage, or because they have behavioral health problems.
Dept. of Public Welfare Secretary Feather Houstoun has resisted the creation of new nursing facilities in the state as a cost-saving measure, In 1998, only about 750 new beds were created statewide, despite a bed shortage approaching 60,000 statewide.
Ann Torregrossa, director of the Pennsylvania Health Law Project, who chaired the assisted-living work group of the Pennsylvania Intra-Governmental Council on Long Term Care, said she strongly supports the new home-based plan. "We can provide more services for more people, and where they want it. So it is a real win-win situation," she said. "If we could serve 40 percent of those qualifying for nursing-home care in their own home, we would save $1.3 billion a year," Torregrossa said.
An existing Medicaid waiver program which provides home-based nursing care has only been available to the elderly, and disabled people, including people with AIDS, have been excluded.
The proposal comes as Philadelphia's major program providing skilled nursing services to people with AIDS, an 18-bed unit at Girard Medical Center, has announced it has a $2 million deficit and is considering closing in the fall. Betak, a facility which once provided 29 skilled beds and 14 intensive personal care beds in a Mt. Airy facility, closed in early 1996.
While it will probably take at least two years for the program to be fully operational, it could ultimately provide an option for people with AIDS who today are forced to remain at home or in homeless shelters without their long-term care needs being addressed.
Observers believe that the new report shifting the priority to home-based care will likely be adopted by the Pennsylvania legislature because it represents a consensus among so many diverse groups - advocates for the aging and the disabled, the nursing home industry and the Ridge administration, among others. The work group spent 21/2 years developing a consensus and specific recommendations.
"The atmosphere, the environment is kind of prepped for this to happen," said Patricia McNamara, a work group member representing the assisted-living and for-profit nursing-home industry.
"Consumers have wanted this for a long time. It's time for the state to catch up with the marketplace."
Torregrossa expects that legislation with bipartisan support will be introduced this fall.
"It's going to happen," she said.
More than 80 percent of Pennsylvanians who need long-term care receive it from loved ones, without public help. Under current law, the vast majority of help is for nursing-home care, which comes only when people have spent down their assets to poverty.
The report urges that Pennsylvanians whose monthly income is as high as $1,500 be eligible for these new services. It also recommends paying housing supplements of up to $350 a month to people who earn slightly more than $1,500 a month to help them stay in their homes.
Even with the housing aid, Torregrossa contends the cost of long-term care would still be far less than the $41-50,000 a year it costs taxpayers to keep someone in a nursing home.
The new Pennsylvania report proposes changes that could affect hundreds of thousands who give or receive care.
It recommends a definition for assisted living and licensing for providers, so that consumers can be assured that assisted-living services meet certain standards. Twenty-two states already do this. Pennsylvania has resisted establishing these standards in the fear that it would result in a proliferation of new facilities for people with AIDS and others with long-term disabilities.
The report also changes the state's philosophy of long-term care by putting the consumer in control. Money would not go to care providers but to eligible consumers, who would hire and fire providers as they pleased and choose which services they wanted.
"The dollars will follow the person, not the facility," said Dale Laninga, executive director of the Council on Long-Term Care.
The report also recommends changing state law to allow more "negotiated risk," a fundamental concept in the move to community care. If the care receiver is going to have more autonomy, whether at home or in a residential setting, that person must agree to accept more risk. For instance, if an old, frail woman who insists on staying in her home falls and breaks her hip, it's not necessarily the caretaker's responsibility.
In the national trend over the last decade or so to move care out of nursing homes, Pennsylvania ranks dead last, according to Dick Ladd, the national expert who designed Oregon's long-term-care plan, in which 70 percent of recipients get Medicaid-funded services in the community.
In Pennsylvania, he said, the proportion of Medicaid funds used to pay for home- and community-based options for the frail elderly stood at just half a percent in 1996, and the program has not been offered to people with disabilities who were not senior citizens.
Even though there is a consensus for change among the work group, not all members support all recommendations, particularly the most important single point: how much money to spend on these new options, which could range from having someone come into your home to help with bathing, dressing and cooking to moving into an assisted-living facility.
Some on the task force want anybody who is financially and physically eligible for the new services to be able to receive them. This would create a new entitlement.
Their rationale is that demand for nursing-home beds, already an entitlement for the poor, would diminish as new, more-preferable options became available.
Ladd says that in Washington state, for instance, the number of people getting long-term services has doubled since its system was changed, but expenditures have decreased by $30 million and the number of nursing-home beds has fallen by 3,000.
But DPW secretary Houstoun, who oversees Medicaid expenditures in Pennsylvania, opposes creating a new entitlement. She believes the financial risks to the state are too great. Partly because of the increase in nursing-home beds in Pennsylvania, the amount of public money spent for long-term care has soared from $600 million in 1986 to $2.7 billion in 1997.
Her chief worry is what is known as the "woodwork effect": nursing homes will continue to expand while more people suddenly emerge seeking community care.
"As long as a state cannot contain the growth of nursing homes, it will never have the financial capacity to expand home- and community-based care as much as it would like to," she said.
"The thing that people have a hard time understanding is that...even if you divert a person [to the community], as long as that nursing-home bed exists, it will be filled and probably paid for by Medicaid."
"So the system cost of expanding community- and home-based care," she added, "is not a budget savings." Houstoun had no comment on the fact that her analysis recognizes that such a system would, in fact, result in more care for people who need it, and that that need is currently not being met.
Houstoun has had success halting nursing-home growth. The number of new beds in Pennsylvania last year grew by just 1 percent. She wants to use dollars that would have gone to nursing-home expansion for home- and community-based services. "So we have the objective of gradually shifting the balance," Houstoun said.
But many on the task force, including Torregrossa, believe that significant amounts of money should immediately be spent on home- and community-based alternatives.
They believe Houstoun's fear of a woodwork effect, of an overall increase in welfare expenses, is unfounded. They believe the nursing-home census will fall as people chose more-preferable options.
States that have moved toward community care - including Washington - have done so by using "Medicaid waivers." A state creates a specified number of waiver slots for people to receive care at home rather than in nursing homes. Unlike an entitlement, the waiver allows the state to cap the number of people being served and keep costs manageable - but it also allows the state to deny care to people on the basis of cost control even if they need it.
The state Medical Assistance program has been unable to provide estimates on how much Medicaid spends for those who can't get nursing care and wind up in the hospital, where care is significantly more expensive that in nursing facilities or under the waiver program. Those financial losses are usually suffered by the hospitals themselves rather than the Medicaid program, which now pays its bills under a capitation formula that forces health care providers to suffer the financial losses themselves related to expensive care. It is this dynamic that has been most harmful to care for people with AIDS, who tend to have more consistently expensive medical needs.
In Pennsylvania in 1997-98, 76,312 people received Medicaid-financed nursing-facility care, according to Torregrossa. Just 1,746 - 2.3 percent - received Medicaid-financed home- and community-based services through the waiver program, she said.
By the end of this year, Pennsylvania will have increased the number of waiver slots to 5,500, according to state officials but it is still unclear whether people with AIDS and other disabilities would qualify.
The work group - unable to agree on the entitlement issue - recommends increasing the number of waiver slots to 36,000 by 2010.
Houstoun, with the Department of Public Welfare, does not want to use a target number. "The allocation of slots should be targeted around need," she said.
She predicted that "over the next eight to 10 years, we'll probably be at a 70-30 mix," 70 percent of the money spent on nursing homes, 30 percent on home- and community-based care.
While many specifics will be worked out in the legislature, work group members are confident that the landscape of long-term care will change dramatically.
"It's what people are saying they want," said Laninga. "It's what consumers want." (Adapted from a report in the Philadelphia Inquirer)
State cited deficiencies at Girard home in 1998
Meanwhile, a report from the Pennsylvania Dept. of Health indicates that the Girard Medical Center continuing care unit, which has set aside 18 beds for people with AIDS, was cited for eight serious deficiencies in its operation in 1998. According to a report posted on the federal Health Care Financing Administration website, the home successfully corrected the deficiencies within a few months.
Among most severe citations issued was one which indicated a failure of the home to "develop a complete care plan that meets all of a resident's needs, with timetables and actions than can be measured."
A second deficiency involved making sure "that the nursing home area is free of dangers that cause accidents." In some isolated incidents, staff officials found that the home had failed to "give each resident care and services to get or keep the highest quality of life possible" and to "keep all essential equipment working safely."
The inspection did not result in any action on the home's operating licenses.
A similar inspection several years ago of the Philadelphia Nursing Home, which is operated under a contract with the Philadelphia Health Dept., indicated deficiencies that were so severe that the state planned on lifting the city's license for operating the home. Those complaints revolved around failure to provide appropriate medical care and patient abuse.
The Philadelphia Nursing Home is the only other skilled nursing facility in the city which has set aside beds for people with AIDS, although it is unclear how many PWAs may be resident there at this time.
John Folby, administrator of Pennsylvania's Special Pharmaceutical Benefits Program (SPBP), has announced that Agenerase (amprenavir), the new protease inhibitor recently approved by the federal Food and Drug Administration, will now be covered by the program.
SPBP covers pharmaceutical drugs for the treatment of HIV disease for Pennsylvanians without health insurance, based on certain income requirements.
The addition of the latest protease inhibitor keeps Pennsylvania's plan current with most AIDS-related drug treatments recommended under federal guidelines.
The drug was added to the SPBP formulary on July 1st.
More evidence of PI, cardiovascular risk
erman investigators have found a clear association between treatment with highly active antiretroviral therapy (HAART) containing a protease inhibitor and lipid abnormalities associated with coronary heart disease, along with alterations in the body's ability to metabolize glucose and insulin. Dr. Georg Behrens, of the Hannover Medical School, and associates compared metabolic abnormalities and glucose alterations in 38 HIV-infected patients receiving one or more protease inhibitors with those in 17 HIV-infected patients who had never used protease drugs.
They found that 71% of the protease inhibitor-treated patients had hyperlipidemia compared with only 24% of the protease inhibitor-naive patients. Among the protease inhibitor-treated patients, 44% had isolated hypertriglyceridemia, 7% had type V hyperlipidemia, 37% had type IV hyperlipidemia, 36% had type IIb hyperlipidemia, and 18% had isolated hypercholesterolemia.
"Protease inhibitor treatment was associated with a higher rate of diabetes mellitus, impaired glucose tolerance, hyperinsulinemia, and early hypersecretion of proinsulin," the investigators report in the July 9th issue of AIDS.
The protease inhibitor-treated patents "...had a higher and prolonged output of insulin during the [oral glucose tolerance test] with delayed peak concentrations in the second phase of the test," they write. "In contrast, [protease inhibitor-]naive patients [responded] with rapid insulin release in the first phase of [oral glucose tolerance test] after glucose ingestion."
Based on these findings, Dr. Behrens' group concludes that a significant proportion of patients on protease inhibitor therapy are at increased risk of cardiovascular disease, along with glucose abnormalities. They therefore recommend that HIV-infected patients undergo a comprehensive lipid profile analysis and oral glucose tolerance test before protease inhibitor therapy is initiated and that these patients be closely monitored during treatment. (Reuters/AIDS)
HIV-infected people in the community treated with highly active antiretroviral therapy (HAART) are less likely to achieve undetectable levels of HIV than those treated in clinical trials, results of a study suggest.
Whereas patients in clinical trials tend to be closely monitored under optimal treatment conditions, people in the real world may miss drug doses or appointments, according to researchers from Johns Hopkins University School of Medicine in Baltimore, Maryland.
"Missed clinic visits were the most important risk factor for failure to suppress HIV-1 RNA levels," Dr. Richard D. Moore and colleagues report in the July 20th issue of the Annals of Internal Medicine.
Moore's team and colleagues looked at 273 patients at a large inner-city clinic who began HAART after never having been treated with protease inhibitors in the past.
After 90 days, 42% of the subjects had undetectable HIV-1 RNA levels, which dropped to 37% by 7 to 14 months.
Factors associated with poor response to the drugs included "nonwhite ethnicity, age 40 years or younger, injection drug use, lower baseline CD4+ lymphocyte count, and higher baseline viral load," according to the report.
However, "the strongest risk factor for failure to suppress viral load was missed clinic appointments," the researchers write.
In addition, they found that patients who received the drug -ritonavir were twice as likely to experience an adverse reaction compared with patients who received -indinavir or -nelfinavir. Compared with men, women were also more likely to develop an adverse reaction to the drugs.
The researchers conclude that the "percentage of patients in whom undetectable HIV-1 RNA levels are achieved with HAART is significantly lower in an unselected inner-city population than in patients in controlled trials."
They recommend that further studies examine how the rate of successful HAART can be improved in the real world, along with the possible gender differences in response to antiretroviral drugs. (Reuters/Annals of Internal Medicine)
The national legislative lobbying group AIDS Action has released a report, called "Silence = $", which exposes rising marketing and advertising budgets as the cause of high AIDS drug prices, not research and development costs as the pharmaceutical industry claims.
AIDS Action's analysis of the 15 largest pharmaceutical companies' annual reports found that marketing, advertising and administrative spending is three times more than research and development (R&D) spending. Direct consumer advertising specifically is increasing at a rate three times more than R&D spending.
AIDS Action's report also shows the focus on advertising is occurring as the pharmaceutical industry enjoys unmatched profits, overshadowing all other industries in three leading profit indicators. Even worse, taxpayers are footing the bill for programs and tax credits that pay for R&D as well as the drugs themselves and then get hit with prescription bills that are among the highest in the world. AIDS drugs cost individuals as much as $15,000 per year, about the cost of a GM Saturn.
"Imagine if General Motors could get the American taxpayer to heavily subsidize its research and development, fund government programs that purchase half of its cars and then get many of those same taxpayers to buy a new car each and every year. Good work if you can get it, right? Well, the American pharmaceutical industry's got it," said Daniel Zingale, AIDS Action executive director.
AIDS Action strongly criticized the pharmaceutical industry's prioritization of advertising over R&D, pointing to a study that shows America's physicians want less or no direct consumer advertising by a ratio of about 3 to 1. The report also shows that an 11% reduction in drug prices would lead to better access to life-saving AIDS drugs.
"The crew of the Titanic didn't need to post ads to get people onto the lifeboats. They needed to get more lifeboats to the people," added Zingale. The question of which drugs to take should be influenced by physicians, not the slickest and most expensive ads Madison Avenue can devise."
AIDS Action urged the pharmaceutical industry to voluntarily lower prices, limit the growth of its marketing budgets to the levels of R&D spending growth and allow for the development of generic versions of AIDS drugs in the developing world. AIDS Action also urged the U.S. government to allow for the re-importation of AIDS drugs.
A copy of the AIDS Action report can be found on the Internet at http://www.aidsaction.org/silencewp.html.
The U.S. House of Representatives has passed the controversial Africa Growth and Opportunity Act (AGOA), without provisions which protect the ability of African countries to develop less expensive, generic versions of U.S.-manufactured AIDS drugs.
The fear that AGOA will prevent Africans from benefitting from new AIDS treatments has led to severe criticism of Vice President Al Gore and the Clinton Administration. Gore has been followed on his presidential campaign trail by ACT UP and other AIDS activists in order to bring attention to the issue.
Black caucus members also criticized the bill because it does not grant debt relief to African nations, provisions that remain in the final version.
The bill passed 234-163.
During floor debate, Rep. Jesse Jackson, Jr. (D-IL) said he opposed the bill in part because of "AGOA's ability to undermine the already harsh status quo of food security, access to health and education, control of natural resources and economic sovereignty in Africa." Specifically, he said the bill does not contain AIDS related provisions such as "substantive amendments to prohibit the United States Government from bringing World Trade Organization action against sub Saharan African countries that are seeking to provide low cost drugs where more than 85% of all AIDS related deaths since the early1980s have occurred.
Meanwhile, in an attempt to restore some credibility to his AIDS record, which has generally been supportive of efforts to improve care for people with AIDS, Gore has announced a $100 million budget increase to combat AIDS in sub Saharan Africa.
South Africa's Archbishop Desmond Tutu, Director of the Office of National AIDS Policy Sandra Thurman, and AIDS activists joined the Vice President in making the announcement.
According to Gore's proposal, the budget increase would be split into four main areas:
--$48 million would go to containing the AIDS pandemic through "...a variety of prevention and stigma reduction strategies," such as education programs, blood screening, and interventions to reduce vertical transmission.
--$23 million would be used for to set up community based clinics and home based care workers to provide treatment of opportunistic infections and tuberculosis, counseling and palliative care.
--$10 million would help establish programs to care for children orphaned by AIDS in Africa.
--$19 million would help sub Saharan countries to develop planning, infrastructure and disease surveillance programs.
Officials from the Office of the Vice President say in a written statement that the money for the program would be provided by the Agency for International Development, the Department of Health and Human Services and the Department of Defense.
Gore also announced a series of new initiatives to garner community support for fighting AIDS, including meetings of AIDS donors, a United Nation conference on children orphaned by AIDS and partnerships with private sector leaders and the business communities.
However, even as Gore made the announcement, "administration officials said they would not allow African governments to violate international intellectual property rights" -- the issue that has caused some AIDS activists to dog Gore on the campaign trial.
Wayne Turner of ACT-UP said Gore's announcement was an attempt to deflect criticism. "One hundred million dollars is fine, but it doesn't address the issue of allowing South Africa to produce its own cheap, generic version of AIDS drugs or to shop around and get the cheapest price for drugs on the world market," he said. James Love, "a vocal Gore critic" and head of the Consumer Project on Technology, called the announcement a "big damage control effort" that amounts to $4.50 for each of the 22 million Africans infected with HIV. The Sun reports that Congress will provide a forum for such concerns this week, allowing critics a hearing at a House Government Reform subcommittee meeting. (Associated Press/Reuters/Kaiser Daily HIV/AIDS Report)