U P D A T EAIDS COMMUNITY RESEARCH INITIATIVE OF AMERICA

contents

vol. 13 no. 4

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Medicaid andM e d i c a re

Personal Pe r s p e c t i v e :Waiting for ADA P

fall2004

HIV Treatment & CareFrom Approval to Access

The Ryan White C a re Act

ACRIA News

A I D S D r u gAssistance Progra m s

Patient AssistanceP r o g ra m s

Since the beginning of the AIDS epidemic, theresponse in the United States to this devastatingcrisis has been primarily emotional and oftencruel – denial, disgust, neglect, fear, and blame.Only rarely has our country addressed the epi-demic as the true healthcare crisis that it is. Likethe rest of our healthcare system, benefits andmedical services for most people with HIV comefrom a variety of fractured and piecemealsources, often with cumbersome eligibilityrequirements. This issue of ACRIA Updateincludes articles by respected advocates aboutthese sources for services, medical care, andtreatment. The content of these articles was pri-marily driven by questions people with HIV askduring ACRIA’s treatment education workshops.

In the last year, there has been a fair amount ofmedia coverage about the approximately 1,600people on waiting lists for the AIDS Drug

Assistance Programs (ADAPs) in various states.What isn’t widely discussed is that the non-prof-it Institute of Medicine released a report last Mayestimating that nearly 59,000 people with HIV inthe United States currently need antiretroviraltreatment but have no access to it. In part, this isdue to the fact that many people can't even get onan ADAP waiting list since the income require-ments are so low in many states.

The goal of this issue of ACRIA Update isn’tonly to provide information. Access to health-care for most people with HIV is more precari-ous now than ever. We hope that the resourcesincluded in the issue and the actions suggestedby the writers will inspire more people to advo-cate for a comprehensive system of healthcarein the United States that not only serves theneeds of people with HIV but everyone in needof care.

Useful Resourc e s

For every dollar the typical American spends,approximately 25 cents goes to products that areregulated by the U.S. Food and DrugAdministration (FDA). We’re talking abouteverything from food, to drugs, to radiation-emitting products like cell phones, to cosmetics.With respect to drugs used for medical condi-tions, the regulatory role of the FDA reflects thesometimes paradoxical needs of consumers:facilitating rapid access to new therapeutics thatshow promise for patients, while also protectingthem from products that are ineffective, unsafe,and marketed using unproven claims.

When it comes to the approval and regulation ofdrugs used to treat HIV and AIDS, the role ofthe FDA and its various regulations can be

extremely complex. Confusing matters further,the role of the FDA is continually being shiftedand reshaped in accordance with new, some-times conflicting laws designed to protect con-sumers and the pharmaceutical industry. In fact,many FDA regulations in place today – such asexpanded access and accelerated approval ofpromising drugs for life-threatening conditions– arose in response to the HIV/AIDS epidemic.

In order to highlight the most important infor-mation about the Byzantine activities of theFDA as they relate to HIV and AIDS drugs,ACRIA Update asked ACRIA’s treatment edu-cation team and Community Advisory Board tocome up with a list of frequently asked ques-tions about the FDA and its activities.

The Food and Drug AdministrationThe Process of Approval by Tim Horn

(continued on page 3)

Tipranavir Open Label Safety StudyPeople whose virus has become resistant to approved HIV treatments or who are intolerant tothem will take tipranavir with Norvir, along with other anti-HIV drugs, for an open period oftime. Participants should be 13 years of age or older, have a viral load above 10,000 and aCD4 count below 100 to enroll in this program.

UK-427,857 for Drug-Resistant HIV People who have taken anti-HIV drugs from three of the four classes of drugs will take eitherUK-427 (an experimental HIV attachment inhibitor) with an optimized regimen of anti-HIVdrugs, or take a placebo (dummy pill) with the optimized regimen, for 11 months. Participantsmust be 16 or older and have a viral load of at least 5,000.

The Effect of Reyataz on Cholesterol Levels People who have high cholesterol levels and a viral load below 50 while taking Kaletra willeither switch to Reyataz or continue taking Kaletra. The study will last 12 months. Study par-ticipants will be reimbursed $25 for each visit.

Reyataz Compared to KaletraPeople whose viral load has risen to over 1,000 while taking an NNRTI as part of their firstHAART regimen will switch to either Kaletra, or to Reyataz / Norvir. Everyone will also takeViread and either Videx EC or Zerit XR. The study will last for 22 months. Study participantswill be reimbursed $25 for each visit.

One-day study of Reyataz ResistancePeople whose viral load has risen to over 1,000 while taking Reyataz will have blood tests forresistance, CD4 and viral load. Study participants will be reimbursed $25.

Phase I Study of a New GlaxoSmithKline NNRTIPeople who have become resistant to an NNRTI and who have a CD4 count over 200 and aviral load over 2,000 will take one of four doses of W695634G alone, or take placebo pills, for7 days. Those who complete the study will be reimbursed $590.

For the above trials, contact Dr. Douglas Mendez at 212-924-3934 ext. 126 or Dr. YuriyAkulov at ext. 124.

Standard of Care Treatment vs. ZEST Once-Daily Regimen(Closed to Enrollment) This trial is studying whether people on their first HAART regimen whotake their drugs two or more times a day can switch to a once-daily regimen. People in the trialeither remain on their current medications, or switch to Zerit XR, Epivir and Sustiva (ZEST)taken once daily.

U P D AT E ACRIA STUDIES IN PROGRESS

Editor in ChiefJ Daniel Stricker

EditorJames Learned

Medical EditorJerome A. Ernst, MD

Publications ManagerMark Milano

ACRIA Board of DirectorsRoss Bleckner, PresidentDonald Kotler, MD, Vice PresidentVincent Wm. Gagliostro, SecretaryCharles Franchino, DC, TreasurerMarisa CardinaleBob ColacelloDouglas Dieterich, MDTiffany DubinReinaldo HerreraKevin KrierAdam LippesMark J. MontgomeryMartha NelsonMaer Roshan

In MemoriamGary BonasorteKiki MasonDavid SeidnerGeorge N. Stathakis

Medical DirectorJerome A. Ernst, MD

Executive DirectorJ Daniel Stricker

ACRIAis an independent, non-profit, com-munity-based AIDS medical research andtreatment education organization dedicatedto rapidly improving the length and qualityof life for people living with HIV/AIDS.Bulk copies of ACRIAUpdate are availablefree to agencies that provide services to peo-ple living with HIV/AIDS. For more infor-mation, call 212-924-3934 ext. 120.

Copyright © 2004AIDSCommunity Research Initiative ofAmerica. All rights reserved. Non-commercial reproduction is encouraged provided appropriate credit is given.

ACRIA230 West 38th St., 17th FloorNew York, NY10018Phone: (212) 924-3934FAX: (212) 924-3936Internet address: www.acria.org

Editor's Notes• All material in ACRIA Update is presented for educational and informational purpos-es only, and is not intended as medical advice. All decisions regarding one's personaltreatment and therapy choices should be made in consultation with a physician.• A C R I AU p d a t e refers to most drugs by both their commercial and scientific names upontheir first re f e rence in an article. Thereafter in the article, they will be identified with thename by which we feel they are most commonly known, either commercial or scientific.

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Who decides whether the FDAapproves a drug?Once clinical trials have been completed,the approval process begins with a phar-maceutical company filing a New DrugApplication (NDA) with the FDA’sCenter for Drug Evaluation and Research(CDER). The NDA contains volumes ofpaper describing everything that has beenlearned about the drug, including datafrom test tube studies, animal studies, ini-tial dosing studies in HIV-negative andHIV-positive people, along with theresults of all safety and effectivenessstudies that have been completed to-date.

If CDER finds the NDA to be in order –meaning that it contains complete andsufficient information to review – theFDA usually passes the NDA on to anadvisory committee made up of non-FDAexperts. When it comes to antiretroviralagents, it is the Antiviral Drugs AdvisoryCommittee (ADAC) that reviews theNDA. ADAC is made up of researchersand clinicians with significant experiencein the field of HIV research and care. Atleast one community representative – usu-ally a knowledgeable treatment activist/educator working for an AIDS serviceorganization – also serves as a votingmember of ADAC.

In reviewing the NDA, ADAC oftenholds a public meeting with the pharma-ceutical company and members of theFDA to hear oral arguments in support of– and sometimes against – the drug’sapproval. At the close of the meeting, theADAC members take a vote, decidingwhether or not to recommend approval ofthe drug. If ADAC votes to recommendapproval, the FDA usually grants it – inthe form of a letter sent to the pharmaceu-tical company – typically within days orweeks of the ADAC committee meeting.

Why does one drug get approved andnot another?For much of its early history, the FDAwas primarily concerned with one thingwhen deciding whether or not to approvean investigational drug: safety. In 1962,Congress drafted and passed the

Kefauver-Harris Drug Amendments tothe Food, Drug, and Cosmetic Acts inresponse to the horrifying birth defectscaused by thalidomide, a sleeping pillapproved at the time in Europe. The FDAstrengthened its safety requirements andbegan requiring companies to prove thattheir investigational drug was also effec-tive for the disease it was meant to treat.

Almost all of the anti-HIV drugs that havemade their way to the FDA for reviewhave been approved. All except one: ade-fovir dipivoxil. While this drug is nowapproved for the treatment of chronic

hepatitis B (under the brand nameHepsera), it was originally studied as atreatment for HIV. At the dose needed toeffectively suppress HIV (40 mg a day),clinical trials found that it was associatedwith a high rate of kidney problems, with214 patients participating in these studiesrequiring dialysis. The ADAC reviewingthe NDA for adefovir dipivoxil also feltthat there was “insufficient proof of thedrug’s effectiveness.”

Essentially, the heart of all FDA activitiesis a judgment about whether a product’sbenefits to users will outweigh its risks. Inthe case of adefovir, the risks appeared tooutweigh the benefits. Given the high costof developing a new drug, pharmaceuticalcompanies are usually quick to pull the

plug on an investigational candidatebefore an NDA is filed if the drug appearsto be ineffective or too toxic in early clin-ical trials.

A little pressure from community activistscan go a long way as well. There havebeen instances in which the FDA has beenprovided with an NDA containing limitedconvincing data. If it weren’t for commu-nity support for the drug – including pub-lic testimony from patients who benefitedfrom the drug in clinical trials – somemedications used today to treat HIV-relat-ed problems may not have been approved.

How long does it take for a drug tobecome available after the FDAapproves it?Even before the FDA officially reviewsan NDA, the sponsoring pharmaceuticalcompany is usually hard at work produc-ing mass quantities of a drug in anticipa-tion of approval. This is, undoubtedly, arisky business decision – beginning pro-duction of a drug, along with the costlydevelopment of advertising and salesmaterials, before the FDA has given thecompany an official green light.

Fortunately, this decision usually pays offand HIV-positive people in need of thedrug can sometimes look forward to itswidespread availability within just daysof approval. Post-approval access isn’talways this easy, however. Sometimes itcan take several weeks or months for apharmaceutical company to have enoughdrug available for widespread distributionafter its approval.

This is what happened with Crixivan(indinavir), Merck’s protease inhibitor,when it was approved in 1996, resultingin limited distribution through a singlemail-order pharmacy. This was also thecase with Fuzeon (enfuvirtide),Hoffmann-La Roche’s entry inhibitor.Given the complexities and time-consum-ing process associated with the manufac-turing of this drug, the company predictedthat it would only have enough drug sup-ply for 15,000 people worldwide duringthe first several months after approval.

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“If it weren’t for community

support . . .some medications

used today to treat HIV-related

problems may not have been

approved.”

Food and Drug Administration (continued from page 1)

(continued on next page)

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Initially, this created anxiety and panicamong AIDS activists working to secureFuzeon access for everyone who neededit. But in reality, the limited demand forFuzeon – because of its cumbersomeinjectable dosing and its high cost –ended up being more of a problem thanthe limited supply of the drug.

How much safety can a clinical trial foran experimental drug assure? Generally speaking, most experimentalanti-HIV drugs reviewed by the FDAtoday have been tested in at least onestudy that was conducted for at least 48weeks (approximately one year). When adrug is first approved, it is reasonable tosay that we know a lot about its short-term complications: toxicities and sideeffects that may arise during the first yearof treatment.

Many people rightfully argue that this istoo limited of a snapshot given thatsome long-term side effects may occurafter several months or years of contin-ued use. Unfortunately, this has beenthe case with a number of anti-HIVdrugs. For example, long after theywere approved for use, we learned thatnucleoside analogues such as Zerit andVidex – if used for long periods of time– can cause damage to mitochondria,the tiny powerhouses inside cells.Similarly, we learned that long-termprotease inhibitor use is associated withincreases in cholesterol, triglycerides,and glucose levels, along with abnormalbody-shape changes. Because the clini-cal trials needed to approve these drugswere only 24 to 48 weeks in duration,these long-term side effects weren’tdocumented until after the drugs wereapproved.

Some pharmaceutical companies collectlong-term follow-up data from studiesthat continue well after the drug isapproved, allowing for continual updatesof a drug’s package insert to documentboth short- and long-term side effects. Allpackage inserts, including revisions, arereviewed by the FDA before they can bedistributed. Package inserts are the accor-

dion-folded pieces of paper that accompa-ny packaged medications reviewing theireffectiveness, safety, and dosing require-ments.

What is Expanded Access? Compassionate Use? Treatment IND? Parallel Track? These are all programs that helped set thestage for accelerated approval. They arestill used today to help make promisingexperimental treatments available to peo-ple with life-threatening diseases whoaren’t benefiting from approved treat-ments and don’t qualify for clinical trials.Expanded access is the general term forany program that allows doctors and theirpatients to gain access to medications out-side of controlled clinical trials before theFDA officially approves them.

Prior to the activism surroundingHIV/AIDS drug development, expandedaccess usually came in the form of com-passionate use allowances, which wereoften quite cumbersome. First, a doctorhad to get permission from a company touse its experimental agent in a desperate-ly ill patient (lots of paperwork). If per-mission was granted, the doctor then hadto request authorization from the FDA touse the drug in his or her patient (evenmore paperwork). This process some-times took weeks or months.

In response to the activism aroused bythe limited availability of Retrovir(AZT) when it was being developed,the FDA created treatment investiga-tional new drug (treatment IND) r e g-ulations, which went into effect on June22, 1987. These regulations allowedpharmaceutical companies to set upprograms to help doctors and patientsgain access to investigational drugs in amuch more efficient manner, usually inexchange for regular reports trackingthe patients’ progress (and problems)while receiving the treatment. Beforebeing allowed to open a treatment INDprogram, the company had to providethe FDA with data indicating that thedrug was both safe and effective.Within months, however, community

activists protested that treatment INDsweren’t likely to be useful, given thatthe safety and effectiveness datarequirements were too stringent. This,they argued, only shaved six months offthe time that the drug would otherwisebe made available through the usualapproval process.

Soon, regulations were publishedannouncing a new expanded accessapproach: parallel track. As its nameimplies, this program would be providedon a track that ran parallel to the neededsafety and effectiveness clinical trials ofthe drug. Parallel track was designedspecifically with investigational anti-HIV drugs in mind. It made investiga-tional drugs available much earlier inthe development process, after reason-able safety – but not necessarily effec-tiveness – had been determined in clini-cal trials. Parallel track programs usual-ly take the form of a large national study(sometimes called an open-label safetystudy), designed to collect safety datauntil the drug is approved (and some-times thereafter), in which any doctortreating needy HIV-positive patients canparticipate.

While these expanded access programsseemed ideal in terms of rapidly makingnew treatments available to the sickestHIV-positive people, they were alsoproblematic. One problem was fairness.Because of all the initial and follow-uppaperwork involved in expanded accessprograms, many doctors didn’t have thetime or resources to enroll patients.Patients who had private health insurance– and were being seen by private medicaldoctors with flexible schedules and sup-port staff – were most likely to benefitfrom these programs. HIV-positivepatients receiving care through publicclinics, where doctors have enormouscaseloads and little assistance, were oftenleft out of the process. In turn, the focusshifted away from expanded access pro-grams to initiatives to make new drugswidely available by prescription byspeeding up the FDA drug approvalprocess.

(continued on page 14)

Food and Drug Administration (continued from previous page)

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“Of all the forms of inequality, injusticein healthcare is the most shocking andinhumane.” Martin Luther King

Some forty years since these words werespoken, the United States remains theonly Western industrialized country thathasn’t found a way to provide healthcareto all its citizens. Although governmentprograms like Medicaid and Medicarehave done an admirable job of servingvulnerable people, they remain part of afractured system with many gaps.

Tax cuts benefiting the wealthy, warspending, and a sluggish economy areincreasing the national debt whiledecreasing our ability to pay for healthcare. At the same time, the cost of care isrising considerably. In 2002, healthcarecosts increased by 8.3%, the highest since1991. These increases, coupled with lessavailable funding for healthcare, havecaused cutbacks and restrictions in theprograms that people depend on for lifeprolonging care. (See ADAP article onpage 12.)

As of 2003, 45 million Americans wereuninsured, with millions more under-insured. Rates of those without healthinsurance are higher among people ofcolor. In 2002, 14.2 percent of whiteswere uncovered, while 20.2 percent ofAfrican Americans lacked insurance asdid 18 percent of Asian and PacificIslanders and 32.4 percent of Latinos.Most of the uninsured are working, suf-fering from a long-term trend of feweremployers offering health coverage. Eventhose who have employer-based insuranceare hurt by the trend toward fewer optionsand less generous plans, leading to bur-densome out-of-pocket costs.

Why Should We Worry About HealthCare?Strained systems of care are even moreproblematic for people with life-threaten-ing illness. People with HIV not onlyneed access to healthcare, but also need tosee an HIV specialist in order to maintainoverall health and may need other special-

ists for disease complications.Combinations of expensive medicationsare needed to treat HIV disease as itadvances. Without comprehensive,affordable healthcare, including an ade-quate prescription drug benefit, peoplewith HIV will lose health and eventuallyface death.

About a third to a half of people with HIVare estimated to be in medical care, andonly about a third of those have privateinsurance. Between 70 and 83 percenteither depend on public programs or areuninsured. Half depend on Medicaid and

Medicare. It is public programs that aremost clearly showing the increasing strainas they suffer cutbacks and restrictions. Inorder to ensure that we can advocate forthese programs, it’s important to under-stand them.

Medicaid and MedicareMedicaid is the largest public payer of HIVcare, serving about 55% of people livingwith AIDS and 90% of HIV-positive chil-dren. Medicare follows second, spending$2.6 billion in federal funds in 2004, com-pared to Medicaid’s $5.4 billion. Manypeople are understandably confused by thedifference between the programs andunclear about their coverage. Adding to theconfusion, over 50,000 Americans livingwith AIDS qualify for both.

Medicaid and Medicare are entitlementprograms, meaning that those who qualifymust receive covered benefits. However,Medicaid is a joint program run by thefederal government and the states, andeach state has great flexibility in whom itserves and the benefits it provides.Medicare, on the other hand, is a uniformfederal program. For full descriptions ofMedicaid and Medicare, visit the KaiserFamily Foundation website atwww.kff.org.

Medicaid - Eligibility:Medicaid is the safety net healthcare pro-gram that serves three main groups oflow-income Americans: parents and chil-dren, the elderly, and the disabled. Inorder to qualify, people must fall into aspecified category. There are over 25 cat-egories falling into five broad groups:children; pregnant women; adults in fam-ilies with dependent children; people withdisabilities; and the elderly.

Most people with HIV enter Medicaidthrough disability. In general, the state isrequired to use the disability criteriaestablished for the SupplementalSecurity Insurance (SSI) program, butcan choose to use a more restrictive def-inition. To qualify, an individual has tohave a severe “medically determinablephysical or mental impairment” and beunable to engage in any “substantialgainful activity.” These determinationscan take a long time and require a lot ofpaperwork. Even though people withHIV can qualify for presumptive eligibil-ity, meaning they get faster access tobenefits, in most states, they have to doc-ument one or more of a specified listingof opportunistic infections, cancers, orc o n d i t i o n s .

To qualify you must also meet incomeand asset requirements, which are set bythe state and can differ widely state bystate and within state by category of ben-eficiary. Because states set many financialrequirements, in good economic timesthey may choose to invest in health andcover more people. However, when times

Medicaid and Medicare: Ripping Holes in the Safety Net by Anne Donnelly

“Without comprehensive,

affordable health care, including

prescription drugs,people with HIV will lose health and eventually

face death.”

(continued on next page)

are difficult, states can change eligibilityrequirements, leaving some withouthealthcare.

Eligibility is different for immigrants,however. Undocumented immigrants arenot eligible. States can cover legal immi-grants residing in the country beforeAugust 22, 1996 if they meet all the otherrequirements. Most legal immigrants whoentered the U.S. after that date have to waitfive years from their date of entry and livein a state that chooses to cover them. Inaddition, you must be a resident of the stateoffering the Medicaid coverage.

Medicaid benefits:The Medicaid benefits package is broadand flexible. Sometimes that works infavor of the beneficiary, allowing benefitstailored to need. Unfortunately, in difficultbudget times, states can also cut back onessential benefits. States must provide min-imum mandatory benefits, but have broaddiscretion regarding optional benefits.Although federal law prohibits states fromimposing cost sharing (the amount thatsomeone must pay to get service) on somegroups of people who are eligible forMedicaid (beneficiaries), they can requireit for other groups for specific services.Cost sharing must be “nominal” and is notsupposed to create a barrier to care.

Medicaid benefits are divided into twocategories: mandatory and optional. Thereare twelve mandatory service categoriesand a range of optional categories. Forexample, physician visits, lab and x-ray,and hospital in-patient are consideredmandatory services, while prescriptiondrugs, targeted case management, andpersonal care services are consideredoptional services. Notably for people withHIV, prescription drugs fall in the option-al category. However, all states cover pre-scription drugs and some additionaloptional services.

Each state has the discretion to limit thescope of services, although it must complywith some federal rules regarding benefits.For example, the state can’t discriminateby limiting services based on a particular

diagnosis, type of illness, or condition.People who are eligible for Medicaid arealso entitled by federal law to get servicesthat are medically necessary, althoughwhat this means can vary state to state.

Medicaid is a comprehensive safety-nethealthcare program, and it is also com-plex and varies widely from state to state.Understanding your state program gener-ally requires help from either an experi-enced benefits counselor or case manag-er. One way to begin to understand yourstate Medicaid and its services for peoplewith HIV is to visit www.atdn.org andclick on The Access Project. You willfind a synopsis of your state program andcontact numbers. You can also call theProject Inform hotline at 1-800-822-7422for a referral to a benefits counselor inyour area.

Medicare Eligibility:Medicare is a federal health insuranceprogram that covers the elderly and per-manently disabled. Most people over 65are automatically entitled to Part A ofMedicare (Hospital Insurance Program) ifthey or their spouse are eligible for SocialSecurity payments.

Most people with HIV qualify throughdisability. In order to qualify, you musthave worked for a specified period oftime, established disability, and complet-ed a two-year waiting period. Generally,if you receive Social Security payments,you are eligible after the two-year waitingperiod.

There are no income or asset require-ments. Medicare serves anyone who is eli-gible regardless of previous health history.

Medicare Benefits:Medicare provides broad coverage ofbasic benefits but doesn’t provide long-term care and currently has no prescrip-tion drug coverage. As of 2006, the newMedicare prescription drug benefit willprovide some coverage for beneficiaries.Until January 2006, beneficiaries are enti-tled to a prescription drug card that allowsthem a discount on some drugs.

Part A provides inpatient hospital servic-es, skilled nursing facility (SNF) benefits,home health visits following a stay in thehospital or SNF, and hospice care. Part Bis voluntary and covers physician and out-patient hospital services, annual mam-mography and other cancer screenings,and services such as laboratory proce-dures and medical equipment.

Medicare also has a managed care optioncalled Medicare + Choice. Those plans pro-vide both A and B services to beneficiaries.

Unlike Medicaid, Medicare is adminis-tered by the federal government, so itdoesn’t have the wide variance thatMedicaid does. Medicare also offers ahigher reimbursement to providers, mak-ing it easier for beneficiaries to findproviders. However, it also has relativelyhigh cost sharing obligations that can bedifficult for beneficiaries.

In addition, the prescription drug card thatis currently being offered to beneficiariesis confusing and difficult to use. Manypeople haven’t taken the option due tolack of knowledge and, for some, the dis-counts offered don’t represent a signifi-cant savings.

Dual Eligibles:Over 50,000 people living with HIV areeligible for both Medicaid and Medicare(dual eligible). Most dual enrollees arepeople with very low incomes and sub-stantial health needs. Medicare coversbasic health services for this population,but Medicaid is essential because it paysMedicare cost sharing, including the PartB premium, which amounts to over $700annually. It also covers services thatMedicare doesn’t, including long-termcare, vision, dental, and, until 2006, pre-scription drugs. Once the Medicare pre-scription drug benefit is implemented in2006, dual eligibles will lose theirMedicaid prescription drug coverage.

Life-Saving Programs Under AttackThe environment for the provision ofhealthcare has changed dramatically dur-ing the Bush Administration. It has always

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Medicaid and Medicare (continued from page 5)

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THE FOOD AND DRUG ADMINISTRATIONFor more detail about the drug approval process, visitthe pages on the FDA website listed below. They includegraphic flow-charts of various stages of the process:

• www.fda.gov/cder/handbook/ind.htmDescribes the investigational new drug (IND) appli-cation process, which occurs before an experimen-tal drug can begin clinical trials in people.

• www.fda.gov/cder/handbook/develop.htmDescribes drug development from test tube, animal,and human studies through the FDA’s review of aNew Drug Application (NDA).

• www.fda.gov/cder/handbook/nda.htmDescribes the process beginning with the submis-sion of a New Drug Application (NDA) through tothe approval (or not) of an experimental drug formarketing.

The FDA offers a number of free email lists at this site:www.fda.gov/emaillist.html. Click on "FDA HIV/AIDS"to subscribe to the list that emails you information aboutHI V /A IDS-related products and issues, includingapprovals, label changes, safety warnings, and noticesof upcoming public meetings.

MEDICAID and MEDICAREFor detailed descriptions of Medicaid and Medicare, visitthe Kaiser Family Foundation at www.kff.org. For state-specific information, go to www.statehealthfacts.org.You might also want to visit the Centers for Medicareand Medicaid Services:• Medicaid: www.cms.hhs.gov/medicaid• Medicare: www.cms.hhs.gov/medicare• Information about individual State Medicaid programs:

www.cms.hhs.gov/states/default.asp

For help enrolling in your state’s Medicaid program, goto your local AIDS service or other community-basedorganization. A benefits counselor can be extremelyhelpful with this process, since it usually requires quite alot of paperwork. You can also call your Sta t eDepartment of Health to reach the appropriate depart-ment that can help you.

For more information on Medicare benefit advocacy, visitthe HIV Medicine Association website at

www.hivma.org. Go to “Advocacy” at the top of thepage and click on “Medicare.”

The HIV Medicare and Medicaid Working Group ismade up of national and regional HIV/AIDS organiza-tions. To participate, email Project Inform’s TreatmentAction Network at tan@projectinform.org or The AccessProject at theaccessproject@aol.com.

THE RYAN WHITE CARE ACTFor detailed information about the CARE Act, visit:hab.hrsa.gov/history.htm.

This U.S. Department of Health and Human Services sitehas lots of information, including the history, funding, andpopulations served by the CA RE Act over the years.

ADAPFor detailed information about ADAP, visit the NationalADAP Monitoring Project at:www.atdn.org/access/adap/index.html.

For help enrolling in your state’s ADAP, it might be bestto go to your local AIDS service or other community-based organization. There isn’t usually a lot of paper-work, but during a time of stress, having someone helpyou with it can be invaluable. You could also call yourState Department of Health to reach the appropriateperson or people who can help you. The following web-sites have information about each state ADAP:• AIDS Treatment Data Network – The Access

Project www.atdn.orgIncludes comprehensive information about eachstate’s ADAP, including contact information, eligibili-ty criteria, and links.

• AIDS Treatment Activist Coalition (ATAC) – Save ADAP www.atac-usa.org/adap.htmlIncludes PDF files about each state’s ADAP thatare easy to download and information about how toget involved with Save ADAP, a national coalition oftreatment activists, policy advocates, ADAP clients,and service providers to ensure adequate ADAPfunding.

• ACRIA www.acria.orgAs an online addition to this issue of ACRIAUpdate, our website includes a list of the ADAPcontact information for each state.

USEFUL RESOURCES

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I have been HIV-positive for 20 years and, because of a spo-radic work history since my diagnosis, I’ve used the NorthCarolina AIDS Drug Assistance Program (ADAP) on occa-sion. I had to use ADAP again two years ago when I went onlong-term disability. The nausea and diarrhea were constant,and the dosing schedule wouldn’t allow me to work. When Iwent on long-term disability, my insurance ended. I appliedfor Medicaid and, for the first time, encountered an ADAPwaiting list. I was on that waiting list for three months.

When my doctor prescribed the new medications I neededat the time, I wasn’t sure how I was going to obtain them. Ididn’t have any money or income. Mydoctor just gave me the prescriptions.That was it from him. The nurses point-ed me in the direction of the localAIDS service organization (ASO) tohandle the ADAP paperwork and gaveme some information about drug com-pany patient assistance programs. SoI went to the ASO for help and, aftersending my ADAP application to thestate agency that administers the pro-gram, I was left in limbo.

I’d been prescribed – and needed –Kaletra, Ziagen, Zerit, Viread, Ba c t r i m ,Zofran, promethazine, Wellbutrin, andsomething for high blood pressure.With major depression, constant fatigueand nausea, a CD4 count of about 90, and a viral load of75,000, my health was somewhere between fair and not sogood. I was somewhat lucky – the wait didn’t make my HIV anyworse, although it made me even more depressed.

ADAP and Medicaid in North Carolina – and other states –are two different programs, and you’re encouraged to applyfor both at the same time. The criteria are usually similar forboth, but not the same. In a lot of cases, you’re deniedMedicaid and continue to wait for ADAP to come through.

This is when my persistence came in to play. I went back tothe clinic where I was treated and asked what to do until Iwas approved for the meds through ADAP. I figured out thesystem mostly by myself. I went to the pharmacies at theclinics when I didn’t feel like going, stood in line, and askeda lot of questions. Of course, the main question was – Whatam I going to do?

At this stage, I had to rely on the drug company patientassistance program for each medication. I had to fill out atrail of paperwork for each one until ADAP or Medicaidbecame available. I also had to go through a similar process

for medications for depression at another clinic. During thewait for ADAP, before the patient assistance programskicked in, I was in limbo for a month or so. I was approvedfor one medication at a time through the patient assistanceprograms – they kind of staggered in. It’s hard to tell howmany patient assistance programs you’ve applied to unlessyou know which company makes each drug. And whenyou’re sick, you really don’t care. The letters would come, I’dglance at them and then file them or throw them away. All ofthe drug company programs were about the same exceptthat some took longer than others. You don’t really knowwhere the delay comes in – the company, the caseworker at

the clinic, or somewhere in-between.

With symptoms of pneumonia (a drycough and loss of appetite), majordepression, and not knowing exactly whata case manager’s role was, obtaining theneeded meds was tedious and disorient-ing. I dealt with a confusing system, goingfrom clinic to pharmacy to ASO to thelocal social service agency feeling likecrap, always on the verge of either throw-ing up or running to the bathroom.

What was most disheartening for me wasthat I was already sick, confused, andu n c e r tain how my diagnosis ofPneumocystis pneumonia (PCP) wasgoing to play out, knowing that particular

opportunistic infection had caused many deaths. I couldn’tget the medicine I needed and worried myself into a frenzy.

Luckily for me, persistence paid off and I learned how to usethe system. But I have friends and associates who haven’tbeen as lucky due to lack of knowledge.

When my closest friend here in Charlotte was recently diag-nosed, I went the same route for him, and the wait was evenl o n g e r. Now I advocate for people who have to use ADA Pand use the insight I gained to help others who aren’t asknowledgeable about the system as I’ve become. The eco-nomics of the state of North Carolina and the Piedmontregion I live in also contribute to the problems. In this area,when someone is diagnosed with HI V, prescribed a regimen,and insurance isn’t there, you have to rely on the drug com-pany programs or donations for medications from some ch a r-i table organizations until you move up the ADAP waiting list.

But what is one to do when you may have to wait for ADAPand the drug company programs and you’re sick at the sametime? Due to a lack of jobs in the rural areas, there aren’tenough charitable contributions to go around for medicines.

Waiting for ADAP By Henry E. Dendy

“This disease is most

devastating to people with little

knowledge of a system that needs

lots of fixing.”

Personal Perspective:

I’ve seen people get sicker while on the ADAP wait-ing list.

My advocacy work today is meant to help lightensome of the worry for people in similar situations andhelp educate the government about the need foraccess to these meds right away. Believe me, thosewaiting lists can mean the difference between lifeand death, especially for people who are diagnosedwith an opportunistic infection at the same time thatthey test HIV-positive.

I learned a lot about advocacy when I participatedwith Save ADAP in February, lobbying Congress formore funding. Save ADAP is a grassroots organiza-tion made up of people from across the UnitedStates who lobby Congress and state legislatures toadequately fund ADAPs throughout the country. Wesend letters to our state and national representativesasking for funds to eliminate these waiting lists, maketelephone calls to their offices, and take trips twice ayear to lobby our representatives’ and senators’offices in person. To join Save ADAP, go to the web-site (atac-usa.org/adap.html).

The most important thing I’ve learned is that this dis-ease is most devastating to people with little knowl-edge of a system that needs lots of fixing. Withoutadequate funding, a good case manager, or some-one to go the distance for the less fortunate, therewill be many unnecessary deaths from HIV/AIDS.

I’m doing okay now, healthwise anyway. My CD4 countis above 300 – higher than it’s been for a good eightyears or more – and my viral load is undetectable. I stilltake my meds (with never-ending side effects) andhaven’t been hospitalized. I now have Medicaid, whichmakes it easier to get the medicines I need.

It hasn’t been HIV that has caused me the mostharm, it’s been the bureaucracy of HIV/AIDS –ADAP, Medicaid, housing, and Social Security (I’mstill waiting after applying two years ago). And thesolution is more funding for these programs.Hopefully some change will come about. This is whatI pray for – CHANGE.

Henry E. Dendy is an HIV/AIDS educator and advo -cate living in Charlotte, North Carolina. He advo -cates with SAVE ADAP, works with the localCommunity Planning Group (CPG), the local con -sortium, and various local, and regional speakersbureaus.

Over a decade and a half ago, America and the world were intro-duced to a courageous young boy with AIDS named Ryan White.He was from Kokomo, Indiana and had been infected with HIV asa result of the blood product transfusions required to treat hishemophilia. The public discrimination that he faced transformed hislife and the lives of others living with HIV and AIDS forever. Ryanmade it possible for many Americans to understand the struggle tobattle HIV and its accompanying stigma. He was truly a championfor that time in our history.

In testimony before thePresident’s Commission onAIDS in 1988, Ryan (picturedat right) stated, “Because ofthe lack of education onAIDS, discrimination, fear,panic, and lies surroundedme. I was labeled a trouble-maker, my mom an unfitmother, and I was not wel-come anywhere. Peoplewould get up and leave sothey would not have to sitanywhere near me. Even atchurch, people would notshake my hand. This broughton the news media, TV crews, interviews, and numerous publicappearances. I became known as the AIDS boy. I received thou-sands of letters of support from all around the world, all because Iwanted to go to school.” He passed away two years later.

In 1990, the bipartisan Ryan White Comprehensive AIDSResources Emergency (CARE) Act was finallly signed into lawafter years of silence and inaction at the federal level on what wasoriginally called Gay Related Infectious Disease (GRID) by theCenters for Disease Control and then renamed Acquired ImmuneDeficiency Syndrome, or AIDS, in 1982.

What the CARE Act DoesAt this point in history, it is clear that the Ryan White CARE Actremains the nation’s most important response to the AIDS epidem-ic. The CARE Act funds treatment for individuals living with HIVwho lack health insurance and financial resources for their care.CARE Act programs serve 533,000 individuals in the United Statesand its territories each year, over half of whom live below the fed-eral poverty level. Outpatient medical care and support services arethe primary focus of the legislation, but training, technical assis-tance, and demonstration projects are also funded (for more detailedinformation on the Ryan White CARE Act go tohttp://hab.hrsa.gov/history.htm). The funding allocated for the

The Ryan White CARE Act: AIDS is Still an Emergency

by Robert Cordero

9

(continued on next page)

10

CARE Act in fiscal year 2004 was slightly over $2 billion.Unfortunately, during the last four years, Congress hasn’tincreased funding, or flat-funded, the program, except for mea-ger and insufficient increases to the AIDS Drug AssistanceProgram (ADAP). As funding has continued to erode, local andState budgets have become strained with increasing caseloadsand high demand for HIV medication, care, and supportive serv-ices. Meanwhile, the patience of AIDS advocates with the gov-ernment’s response to the AIDS epidemic has worn thin.

Advocacy and Media ResponseOn August 30, 2004 thousands of activists chanted, “FightAIDS!” during the Still We Rise march from Union Square toMadison Square Garden in New YorkCity, site of the Republican NationalConvention – demanding that PresidentBush and the Republican Party focus onthe problems of HIV, poverty, healthcare, and education in the United States.Another demonstration in front ofMadison Square Garden grabbed frontpage headlines, with full color pictures ofstarkly naked members of ACT UP, mes-sages stenciled to their bodies calling forthe cancellation of debt from developingcountries so that they might invest ade-quate resources to fight the global AIDSepidemic. In Bedford Stuyvesant,Brooklyn, angry community membersliving with HIV/AIDS protested againstSenator Rick Santorum’s (R-PA) absti-nence-only policies during his visit to acommunity health center to discussAIDS issues. On the final day of theRepublican National Convention, hun-dreds of protesters took over Grand Central Terminal during arush hour civil disobedience to oppose this Administration’s apa-thy toward the domestic AIDS crisis. Nineteen protesters whosurrounded the Grand Central Terminal information booth and afew who hung large banners from above the terminal stairwelldeclaring “America has AIDS” were arrested.

Despite local and national media attention from these and count-less other demonstrations, the media rarely discussed the mes-sage and, instead, focused on the arrests. Political activism andcivil disobedience as well old-fashioned advocacy and lobbyinghave all attempted to keep domestic AIDS issues in the collectivepublic mind as a high priority among many other competing pri-orities like the war on terrorism and homeland security. So, whatwill it take to get through to this President, other legislators, andmany of our fellow Americans that AIDS is still a crisis in thiscountry? How do we invoke the spirit of Ryan White which hadpreviously led to America’s focus on our own AIDS epidemic inthe late 1980s and early 1990s?

The Domestic AIDS CrisisWe often hear from our colleagues in Congress and theAdministration that they don’t hear from the AIDS communitylike they used to. The only AIDS-related messages that getthrough, if any, relate to the global AIDS epidemic in Africa andthe Caribbean. Somehow, the domestic advocacy that created theRyan White CARE Act has diminished, and the voices of peopleimpacted by HIV in the U.S. aren’t being heard. The media nolonger covers national AIDS issues with the same vigor. It’salmost as if AIDS has become the silent epidemic it once was, atthe expense of our most vulnerable communities.

These include the HIV-positive African American woman withAIDS who pays her bills and works tosupport her kids in Biloxi, Mississippi; arecently infected homeless youth scopingout the scene and hanging out withfriends in New York City’s West Village;and the newly arrived immigrant inPortland who works the night shift andbecame infected through sex with anHIV-positive man – even though he does-n’t consider himself to be gay. This sliceof AIDS in America is only an illustrationof the over 40,000 new HIV infectionsthat we see in the U.S. each year, and theRyan White CARE Act touches most oftheir lives at some point in their care.

Protecting AIDS Services in the U.S.The CARE Act is the safety net by whichwe can assure that HIV-positive peoplehave access to adequate medical care andthe critical supportive services that getthem into care and keep them there. As

the board Chair of the CAEAR (Communities AdvocatingEmergency AIDS Relief) Coalition, Patricia Bass, is known tofrequently relate to congressional staffers, “HIV medicationsdon’t come out of a vending machine.” The CARE Act has pro-vided, in most instances, the only service system which enablespeople living with HIV to access medical care because their casemanagement, housing, nutrition, substance use, and mentalhealth needs are being addressed. The entire CARE Act – Title I,Title II, Title III, Title IV, Part F: SPNS (Special Projects ofNational Significance), Dental Reimbursement, and AIDSEducation and Training Centers (AETC)– works in tandem withother HIV/AIDS funding streams to create a sustainable systemof care that will collapse if under-funded.

Since the passage of the Ryan White CARE Act in 1990, countlessAIDS activists have passed away, yet the soul of their advocacy isnot dead. For example, Keith Cylar, Co-Founder and Co-Presidentof Housing Works in New York City, died in April of this year butlived every day of his life reminding us that we must respond to the

Ryan White Care Act (continued from previous page)

“Thousands of activists chanted

‘Fight AIDS,’demanding thatPresident Bush focus on HIV,

poverty,healthcare, and education in the United States.”

needs of people living with AIDS and HIV, just asRyan White did. “Making sure that we were going tostop this government, changing the way this epi-demic was killing us. Life could not just go on asusual as long as we were suffering, as long as ourfriends, our lovers, and our sisters, our brothers weredying,” said Mr. Cylar in 2003. Keith and so manyof our community heroes played a leading role in thedevelopment of federal legislation to create and fundHIV/AIDS service programs, including the RyanWhite CARE Act. Their legacy of action reminds usthat the struggle to enhance the nation’s response toAIDS is embodied in the importance of the RyanWhite CARE Act as a linchpin of the public healthinfrastructure for people living with HIV/AIDS.

2005 ReauthorizationSince the Ryan White CARE Act was enacted in1990, it has been reauthorized and signed into lawtwice by Congress, in 1996 and in 2000 – alwayspassing by unanimous votes in the House ofRepresentatives and the Senate. Authorization oflegislation expands and creates programs such asthe CARE Act. The CARE Act is due to expire onSeptember 30, 2005. It is timely that this articleappears in ACRIA Update now, with a one yeardeadline looming for the hopefully bipartisan reau-thorization of the CARE Act for an additional fiveyears. Our President may have the unique opportu-nity to demonstrate clear leadership on domesticAIDS by signing the reauthorized CARE Act intolaw in 2005.

In a prelude to his thinking on the Ryan WhiteCARE Act, President Bush surprised many mem-bers of the AIDS community with his commentsregarding the global and domestic AIDS crises at a church inPhiladelphia on June 23, 2004. It’s widely known that thePresident embraces faith-based initiatives and abstinence-onlypolicies, yet it may be less widely understood that he has not pro-posed increased funding for successful and effective domesticprograms like the Ryan White CARE Act. In his speech that day,the President identified areas of focus for the Ryan White CAREAct that grassroots advocates, providers, people living withHIV/AIDS, and government officials need to be aware of as weprepare to formulate potential changes to the CARE Act to makeit more responsive to the emerging needs of the AIDS epidemicin 2005 and beyond. President Bush stated, “When the RyanWhite CARE Act is reauthorized next year, I propose to make itstronger and more effective by focusing resources on life-extend-ing care, such as antiretroviral drugs and doctor visits and labtests. This kind of care was just a dream 20 years ago. It is a real-ity today. And we will work with Congress to make sure that asmany patients as possible are receiving the modern care theydeserve. We need to change the way that money under the RyanWhite CARE Act is provided to care-givers and states and com-munities. Today, funding decisions are made according to a rigid

geographical formula that takes too little account of the mosturgent needs. In other words, you can't set priorities – that's whatthat means.”

Community advocates agree that the CARE Act must be reau-thorized. The Ryan White CARE Act is one of the only pieces ofhealth legislation that mandates a community planning process(for 51 eligible metropolitan areas) and coordination with otherhealthcare systems. In a reauthorized CARE Act, control overlocal decision-making and service needs must not be lost to thefederal bureaucracy, since local communities are in the best posi-tion to assess their own needs, prioritize services, and allocateresources effectively. Furthermore, proposing to focus resources,and the formula which distributes them, is ineffective at best ifannual funding is not increased to meet burgeoning demand.

Defending and Enhancing the CARE ActAIDS is still an emergency, especially among marginalized pop-ulations – low-income people of color, the homeless, drug users,women, gay men, and other populations. Rural communities andurban neighborhoods are disproportionately impacted. Political

11

(continued on page 13)

The Ryan White CARE ActWhat Each Section of the Act Covers

Title I provides assistance to Eligible Metropolitan Areas (EMAs)with the largest numbers of reported AIDS cases to meet theemergency primary care and supportive service needs of peoplewith HIV.

Title II provides funds to States and territories for primary healthcare, including medications through the AIDS Drug AssistanceProgram (ADAP) and to improve the quality, availability, andorganization of healthcare and support services for people withHIV and their families.

Title III supports medical care and early intervention services topeople with HIV through grants to public and non-profit organiza-tions such as Community and Migrant Health Centers.

Title IV supports services and access to research for children,youth, and women with HIV and their families.

Part F:• AIDS Education and Training Centers (AETC), regional cen-

ters that offer trainings for healthcare providers and other peo-ple who provide AIDS-related services;

• Special Projects of National Significance (SPNS), a healthservices demonstration, research, and evaluation program toidentify innovative models of care; and

• Dental Reimbursement Program, which helps cover dentalexpenses incurred by people with HIV that aren’t otherwisecovered.

Finding out you are HIV-positive is a lifealtering experience, as anyone who hasbeen through it can tell you. That futureyou thought was waiting down the roadsuddenly disappears. Priorities take a bigtumble, fear and confusion reign. Livingin the only industrialized country withoutuniversal healthcare, HIV-positiveAmericans must face an additional issuethat few thought critical in the prime oftheir lives: access to healthcare. For peo-ple with no health insurance and who areunable to meet the stringent Medicaid eli-gibility restrictions, the AIDS DrugAssistance Programs, or ADAPs, offer apath to life-saving treatment few canafford on their own. ADAP clients areusually the first to testify to the signifi-cance of this program. It brings a glimmerof the future they once thought lost.

ADAP first came into being in 1987,when AZT was approved by the FDA totreat HIV. At a cost of $10,000 per year,advocates petitioned Congress to help payfor the expensive drug. In 1990, the pro-gram was included in the Ryan WhiteComprehensive AIDS ResourcesEmergency (CARE) Act, becoming thecenterpiece of the nation’s HIV careinfrastructure. It remains one of the moresuccessful responses to the HIV epidemicby the federal government.

Over the years, ADAP slowly expanded tocover treatment and preventive medicine foropportunistic infections and other condi-tions. With the approval of proteaseinhibitors in 1996 and Highly ActiveAntiRetroviral Therapy (HAART), thedemand on ADAP nearly doubled in oneyear as people presented themselves for test-ing and sought treatment. As the number ofAIDS deaths plummeted, people stayed inthe program and the demand grew. Coupled

with the steady increase in new infections,ADAP has seen roughly 600 new enrolleesper month nationwide in recent years.Today, nearly one in five of the HIV-posi-tive Americans in treatment, close to150,000 people, are enrolled in ADAP.

ADAP has matured alongside the evolv-ing HIV epidemic with remarkableresilience and simplicity. Funded primari-ly with federal dollars which are allocatedbased on the number of people living withan AIDS diagnosis, each state-adminis-tered program must use the limited fundsto best meet the needs of the growinguninsured. As the payer of last resort,ADAP’s ability to fulfill its role is contin-gent on the size of the healthcare gap it isfacing. Not surprisingly, states with amore generous Medicaid program and

better healthcare system do better. Thelocal economy also plays a role, deter-mined by the number of jobs that includehealth benefits. Political priorities alsocome into play, demonstrated by eachindividual state’s willingness to allocatestate funds to the program.

Due to all of these reasons, each ADAP’seligibility criteria and the number of drugsthey cover vary greatly from state to state.Annual income eligibility caps rangebetween $12,000 and $50,000, differencesin formularies range between unlimiteddrug coverage to antiretrovirals only, withone state not even providing proteaseinhibitors. While there are ongoing debateson how to resolve these disparities inaccess to HIV care, it is important to notethat ADAP is still an emergency healthcareprogram, even as we cross into the thirddecade of the epidemic. The program’sshortcomings are but a reflection of thestate of healthcare in this country. However

adaptive the program has been in meetingthe needs of the HIV-positive and unin-sured, it is a far cry from a comprehensiveand responsible public health measure.

Unlike the federal Medicaid entitlementprogram where funding follows programgrowth, ADAP funding must be allocatedby the federal government each year. Theprogram is only able to expand coverageto fill the healthcare gap and meet grow-ing demand when adequate funds aremade available, notably in the late 90’s.But as the federal commitment to domes-tic HIV care flagged with the currentadministration, programs across the coun-try suffered. Federal ADAP funding hasfallen short of the projected need in thelast four years, with the current fiscal yearoperating with a $122 million shortfall,about 15% of the program budget.

In this climate of under funding, for thefirst time ADAPs are having a hard timemeeting their core function: providingantiretrovirals. Nearly two years after itsapproval, the entry inhibitor Fuzeon isstill not available in some states, due pri-marily to its exorbitant cost. Clients co-infected with hepatitis C are also havingsimilar problems accessing pegylatedinterferon. Several states have eliminatedcritical prophylaxis and treatment agentsfor opportunistic infections and drugs thatmanage treatment side effects. Other costcutting measures such as prior authoriza-tion and the strict enforcement of medicalcriteria are popping up in many states,creating barriers to care that dispropor-tionately affect those people who areworse off.

The most visible symptoms of the ADAPcrisis are the waiting lists. As ofSeptember, ten states had closed theirprograms to new applicants, relegatingmore than 1,600 people to wait for med-ications just five months into the currentfiscal year. By the end of 2004, half of theprograms in the country will likely closeenrollment and/or implement more pro-gram restrictions.

Was I deceiv’d, or did a sable cloud Turn forth her silver lining on the night?

John Milton, Comus

AIDS Drug Assistance ProgramsA Promising Start, A Shaky Future by Lei Chou

12

While President Bush promised $20 mil-lion dollars in June to remedy the waitlistcrisis, three long months later the admin-istration has yet to come up with a way totranslate this funding into access to treat-ment. For fiscal year 2005, the Presidenthas proposed only $35 million of the pro-jected $217 million increase needed toadequately fund ADAP. As of this writ-ing, the prospect for ADAP is tenuous.

One group that is working to end this cri-sis is the Save ADAP Committee of theAIDS Treatment Activists Coalition. Thecommittee functions via an email listserve and monthly conference calls, gen-erating action alerts to advocate forADAP funding and press releases to callattention to the crisis. Save ADAP mem-bers are composed of ADAP clients,frontline caseworkers, policy advocates,and even ADAP administrators. Thegroup has organized two constituent vis-its to Capital Hill this year, bringing peo-ple from across the country to tell theirlegislators about the importance ofADAP. The stories they tell are aboutcoming back from the brink of deaththanks to a program that was there whenthey needed it. They are about picking upthe pieces and moving on again once theyregained their health and hope and gotanother chance. They are about makingsure that someone else in their shoes willhave the same opportunity when theyneed it.

ADAP was born out of a public healthemergency. Seventeen years after itsfounding, the emergency is no lessurgent. The program’s existence andwell-being depends on the AIDS commu-nity’s commitment to hold our govern-ment accountable for the healthcare forthose in need. The struggle continues.

To join Save ADAP and find out moreabout the group, please visit www.atac-usa.org/adap. For more information aboutADAP, please visit the ADAPMonitoring Project: www.atdn.org/access/adap/index.html.

Lei Chou is the Director of The AccessProject at the AIDS Treatment DataNetwork and a member of Save ADAP.

13

will is needed to effectively address the epidemic, and that must begin with the CAREAct. Due to woefully inadequate annual AIDS funding from Congress, it can be tempt-ing to focus on fixing all of the problems in our healthcare for people living withHIV/AIDS through legislation like the Ryan White CARE Act. But the CARE Act is nota panacea, and advocates must continue to focus on improving it through the reautho-rization process. This is a unique opportunity to retain what works while improving thelegislation to be more responsive. National AIDS advocacy organizations are currentlydeveloping specific policy positions which may impact on the reauthorized CARE Act,and we should engage in these federal advocacy efforts at all levels.

There are also other proposals like theproposed Early Treatment forHIV/AIDS (ETHA) bill and, morerecently, the Institute of MedicineCommittee’s proposed HIVComprehensive Care Program(HCCP). But at this point, the RyanWhite CARE Act (supplemented by aninadequate Medicaid system for thepoorest Americans) is as close as weget to effectively address and fund thedomestic AIDS crisis. AIDS is still anemergency and the CARE Actresponds to this emergency. Withoutfurther funding, it will be unable to doso.

At minimum, the CARE Act needs tobe protected. No other piece of domes-tic legislation has ever received asmuch scrutiny as the Ryan WhiteCARE Act, with several audits by theGovernment Accounting Office(GAO) and the Health and HumanServices Office of the InspectorGeneral (IG). This doesn’t eveninclude congressional inquiries and other highly subjective CARE Act critiques by gov-ernment reform “think tanks.” Generally, Ryan White providers and governmentgrantees have welcomed any and all efforts to demonstrate program accountability, andthe CARE Act has held up well in these audits and reviews. As we move towards theexpiration of the amended CARE Act of 2000, the community must be diligent in itsefforts to ensure that amendments to the CARE Act of 2005 protect the integrity of thecurrent Act while enhancing the system of care which has taken a decade and a half todevelop. Clearly, the CARE Act will continue to be effective and accountable.

Let Congress and the President know in no uncertain terms – PROTECT THE RYANWHITE CARE ACT BECAUSE AMERICA STILL HAS AIDS. Respond to theAIDS crisis in the nation. Provide much needed increases to the CARE Act and reau-thorize the CARE Act in 2005.

Robert Cordero is the director of federal advocacy at Housing Works, the largest com -munity-based, minority controlled HIV/AIDS agency in the country, and serves as aboard member of CAEAR Coalition, which advocates for Title I and Title III of theCARE Act.

Ryan White Care Act (continued from page 11)

“Bush’s plan...to focus

resources, and the formula that distributes

them, is ineffective at best if annual

funding is not increased to meet

burgeoning demand.”

14

What is accelerated approval? Whichdrugs get it? Why? How does it work? The best way to ensure that all HIV-posi-tive patients had access to promising anti-HIV drugs was to focus on getting themthrough clinical trials and the FDAapproval process as quickly as possible.In short, accelerated approval would ben-efit everyone: HIV-positive people indesperate need of new treatments, doctorswithout the time or resources to partici-pate in expanded access programs, andpharmaceutical companies attracted tothe idea of being able to cash in on theirproduct much earlier in the drug develop-ment process.

Typically, an investigational drug for alife-threatening disease needs to showthat it actually helps people live longerlives with less illness – clinical mark-ers of effectiveness – than people takingeither a placebo (a dummy pill) or a cur-rently available treatment. Studies totest this are usually very large and oftenneed many months or years of follow-updata to yield the necessary results.Fortunately, around the time activistsand doctors were clamoring for therapid release of new therapies,researchers found that certain laboratoryparameters – surrogate markers o feffectiveness – could be used to deter-mine if a new therapy was likely towork without having to conduct time-consuming clinical marker studies. Thefirst surrogate marker was the CD4+cell count, whereby a sustained increasein CD4+ cells was found to be associat-ed with longer survival. Then came viralload, whereby low or undetectable HIVlevels in the blood translated into ahigher likelihood of CD4+ cell recoveryand longer, healthier living. The avail-ability of these surrogate markers hasenabled the FDA to review and approveinvestigational anti-HIV drugs on anaccelerated basis.

When the accelerated approval guidelineswent into effect in April 1992, a pharma-ceutical company was technicallyallowed to file an NDA after the comple-

tion of Phase II studies that showed a pos-itive effect on CD4+ cell counts inpatients failing available options at thattime. However, in exchange for accelerat-ed approval, the company still had to con-duct Phase III clinical trials to demon-strate fewer AIDS-defining illnesses andfewer deaths.

Today, the FDA rarely requires data fromclinical trials employing clinical markerswhen reviewing investigational anti-HIVtherapies given the overwhelming evi-

dence that improvements in CD4+ cellcounts and reductions in viral load areassociated with longer, healthier survival.The agency – and ADAC – usually like tosee at least 48 weeks of CD4+ cell countand viral load data from a sizeable studyinvolving patients who desperately neednew treatment options before they willgrant accelerated approval. Phase IIIstudies must also be well underwaybefore an NDA seeking acceleratedapproval is reviewed. And while the FDAmay no longer require Phase III studies tolook for differences in death rates or thenumber of new AIDS-related illnesses,the accelerated approval guidelines per-mit the FDA to demand additional data

from the company, such as longer-termsafety and effectiveness research (longerPhase III follow-up or the addition ofPhase IV studies, for example).

What about “standard” and “priority”review? Is this the same as acceleratedapproval? No. With accelerated approval, the drugcompany begins working with the FDAearly on in the development process sothat an NDA can be submitted for reviewafter the completion of Phase II or earlyin Phase III. For some drugs, the FDArequires completed data from Phase II orIII studies before the NDA will bereviewed. However, there is still a way toaccelerate the process: request that theFDA grant a priority review.

A standard review is given to drugs thatprovide only minor or no improvementover currently available options. A prior-ity review can be granted to drugs that arelikely to provide a significant advantageover currently available options. A stan-dard review means that the FDA can takeas long as 12 months after the NDA issubmitted to review the data and grantapproval. With a priority review, the FDAcalls on a larger number of staff to reviewthe NDA, reducing the approval time toless than six months.

What’s the deal with FDA regulation ofherbs, vitamins, and complementarytherapies?Herbal products, vitamins, and othercomplementary therapies are classified asdietary supplements in the eyes of theFDA. They are not considered drugs and,therefore, are not regulated by CDER.These products are regulated by theFDA’s Center for Food Safety andApplied Nutrition (CFSAN), using guide-lines stemming from the DietarySupplement Health and Education Act(DSHEA) of 1994.

Generally speaking, dietary supplements– a catch-all term for any vitamin, min-eral, herb, botanical, amino acid, or otherdietary substance (such as enzymes or

“Unfortunately,many

manufacturers make

unsubstantiated marketing claims –

untested supplements

to cure or treat HIV remain popular...”

Food and Drug Administration (continued from page 4)

tissues from organs or glands) – arelargely unregulated. Manufacturers donot need to obtain approval from theFDA or prove that their product is safe oreffective before selling it to the public.The FDA can only intervene in the saleof dietary supplements under two condi-tions: 1) if the drug is found to be toxicor unsafe, relying on reports filed withthe agency by doctors or consumers; and2) if the manufacturer makes claims thatthe product has medicinal value (mean-ing that it can be used to diagnose, cure,mitigate, treat, or prevent a disease).Unfortunately, many manufacturers d omake unsubstantiated marketing claims –untested supplements to cure or treatHIV remain popular – which has con-tributed to the ongoing debate as towhether the FDA should have morepower, not less, in regulating the sale ofthese products.

SummaryThe activities of the FDA since thebeginning of the AIDS epidemic a littlemore than 20 years ago have been noth-ing short of amazing. The regulatory roleof the agency has been tugged in alldirections – by politicians, byresearchers, by the pharmaceuticalindustry, by activists, and by consumers.But through it all, the FDA still has a lotto show for itself: the approval of 26anti-HIV medications, including 19unique agents, three prodrug/extended-release formulations of older drugs, andfour fixed-dose combinations. Not tomention numerous drugs for AIDS-relat-ed conditions. No other disease has everseen this number of FDA approvals insuch a short period of time. This may nothave been possible without the flexibili-ty the FDA has shown. And it definitelywouldn’t have been possible without thededicated individuals – AIDS activists,healthcare providers, and people withHIV – who worked tirelessly, both withand often against the FDA, to make thisa reality.

Tim Horn is Executive Editor of ThePRN Notebook, published by Physicians'Research Network in New York. He isalso the head medical writer forAIDSmeds.com.

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The ever-escalating costs of many prescription medications have created barriers toaccessing necessary treatment for people who are uninsured, underinsured, and/or havea low income. The somewhat negative term often used to refer to folks in this categoryis “medically indigent.” More Americans are falling into this category each year, with15.6 percent of the U.S. population (45 million people) uninsured as of 2003 accordingto the U.S. Census Bureau. It can be argued that the pricing practices of the pharma-ceutical industry have helped to create this situation. But industry has also created aresponse to the problem by creating Patient Assistance Programs (PAPs).

What are Patient Assistance Programs?Patient Assistance Program are drug company plans that provide free medications tolow-income, uninsured, and underinsured people who need them.

What’s the history of these programs?It isn’t clear precisely how or when these programs started, but with the approval ofmore expensive treatments for such serious and chronic illnesses as cancer, viral hepa-titis, and HIV over the past twenty-five years, these programs have grown as well.According to the Pharmaceutical Research and Manufacturers of America (PhRMA),the primary representative and lobbying organization for the pharmaceutical industry,6.3 million Americans were served by PAPs in 2003. No one can really say how muchmoney in “donated” medications was actually spent on these patients. Each drug com-pany puts out its own public relations figures to demonstrate the extent of its philan-thropy through these programs. These figures are often calculated using the inflatedretail cost of the drug, a figure that no one really pays and is certainly far higher thanthe actual cost to the company of manufacturing and distributing the drug.

Who is eligible to participate in PAPs?Each program is somewhat different, so always contact the PAP directly for its specif-ic eligibility criteria. The following are general guidelines for most programs:• You must be a U.S. citizen or legal resident.• You must have a doctor or other healthcare provider who can write prescriptions and

treat you.• You can’t have any health insurance that provides prescription coverage.• You can’t be eligible for Medicaid, Medi-Cal (in California), ADAP (AIDS Drug

Assistance Program), or any other drug assistance program.• You must meet the annual income limits of the specific program.

How do I prepare for application to a PAP?You don’t have to do this alone. It’s hard enough having a serious or chronic illness. It canbe helpful to have a social worker, benefits counselor, healthcare professional, friend, orloved one help you with the application process. Before you call the PAP, have as muchinformation at hand as possible. This will help speed up the process and your peace of mind.Below is a helpful checklist. The more of this information you have prepared, the better.• Know the name of the prescription drug you need.• Know the name of the company that manufactures the drug. This information will

help you locate the specific patient assistance program you need.• Have general information on hand, such as your name, social security number,

address, state of residence, and citizenship/residence status.• Be prepared with contact information for your doctor or other healthcare provider

(the phone and fax number will help a lot).• Have a copy of your Medicaid, Medi-Cal, or other insurance/drug coverage denial letter.

Patient Assistance ProgramsGetting Free Drug from the Drug Makers

by Brian D. Klein, MA, LMSW

(continued on next page)

• If you’re on an ADAP waiting list or your state ADAPdoesn’t cover the drug you need, have a letter or other doc-umentation from the program explaining the situation.

• Be prepared to provide your estimated gross annual householdincome (copies of pay stubs, tax returns, etc.).

•Have proof (such as award letters) of any government income assis-tance: Social Security Disability Insurance (SSDI), SupplementalSecurity Income (SSI), or State Disability Income (SDI).

• Have proof of medical expenses that you have had to payyourself, such as bills or receipts.

Are Patient Assistance Programs the same in every state?In general, the rules are the same acrossthe country. But if a drug is covered byanother program in your state for whichyou are eligible, then the PAP will notcover that drug for you. The PAP rules aregenerally designed and adjusted to be thelast resort for access to the medication.

Can immigrants (legal/illegal/undocu-mented) qualify for PAPs?In practice, drug companies don’t want toact as immigration police and usuallydon’t check into these situations beyondwhat is stated on the form by the applicant.If you have a social security number, cur-rently live in the U.S., and qualify in allother ways, you will usually be approved.

Do I need a healthcare provider beforeI contact a PAP?Yes, you need a doctor or other health-care provider who can legally write prescriptions. The applica-tion form almost always has to be sent or faxed to your health-care provider to complete. Quite often, the PAP requires a health-care provider to apply on your behalf. If your primary provider isa registered nurse (RN), nurse practitioner (NP), or physicianassistant (PA), don’t worry. They almost always work closelywith a physician who can sign the forms if the PAP requires it.

Are there any medical eligibility requirements for PAPs?Depending on the program, you might need to have a specificdiagnosis relevant to the needed medication, verified in writingby your healthcare provider.

What if I have private insurance prescription coverage but itstill leaves me with a big co-payment?If you have health insurance that covers the drug, but leaves youwith a large co-payment, you will not be eligible for the PAP. Byfederal law, patient assistance programs cannot cover co-payments.

What if I have private insurance with prescription coverage,but it only covers my medicine for a limited time?If you have insurance that denies coverage of the drug or only

covers it for a limited amount of time, then a PAP will usuallywork to help you.

Can I qualify for a PAP while I am eligible for Medicaidand/or Medicare?As of this writing in 2004, no one yet has real prescription drug ben-efits through Medicare. Medicare prescription discount cards don’tcount as actual prescription coverage, so you will still be eligible fora PAP if Medicare is your only insurance. On the other hand, if youhave Medicaid (Medi-Cal in California) that includes prescriptiondrug coverage for that drug, you will not be eligible for the PAP.

What if I am on a waiting list for ADAP (AIDS DrugAssistance Program)?If you are on a waiting list for one or moreHIV-related drugs covered by your stateADAP, the PAPs for those drugs will usu-ally provide medication to you until yourADAP benefits begin. Unless all of yourHIV medications happen to be made bythe same company, you’ll have to apply tothe PAP specific for each drug you need.

May I use the PAP from one drug com-pany to get my medication from a dif-ferent company?No. You can only get the medication youneed from the PAP run by the manufac-turer of each specific drug.

What is the general procedure to enrollin a PAP?Most PAPs have a toll free phone number

that you call to make the initial contact. Most of the people whoanswer the phones for these programs are more pleasant, sensi-tive, and better trained than in the past. When you contact them,most drug company PAPs have an application for you to com-plete in writing or over the phone to get general information fromyou including income and medical benefits. As stated earlier, theapplication form almost always has to be sent or faxed to yourprimary healthcare provider to complete.

Do I need to have a certain income level to qualify? Doeswhat I have in the bank and/or assets such as a house or caraffect my eligibility for PAPs?Most PAPs no longer have restrictive asset limitations. Owning ahome or a car, your bank account assets, and the like no longerdisqualify you.

Most PAPs go purely by current income level. The FederalPoverty Guideline annual income level for an individual in thelower 48 states in 2004 is $9,310. Rates vary but, realistically,most PAPs use between 200% and 350% of the poverty level(between $18,600 and $33,500) for current income eligibility.This may vary by region of the country and other circumstances,including the number of people in your household. (For a com-

16

“Most PAPs use between

200% and 350% of the Federal

Poverty Guideline(between $18,600

and $33,500) for income eligibility.”

Patient Assistance Programs (continued from previous page)

plete Federal Poverty Guideline Chart, includ-ing those for Alaska and Hawaii, go to:h t t p : / / a s p e . h h s . g o v / p o v e r t y / 0 4 p o v e r t y . s h t m l . )

Drug companies are reluctant to give out exactincome guidelines, presumably fearing thatpeople may cheat to try to meet them. Whenpushed, some companies will state a specificpercentage of the poverty guidelines. Practicehas actually shown that most of the programsare quite flexible in terms of proof of individ-ual circumstance, even if you’re slightly overtheir limits. But be prepared to justify yourcurrent financial situation, including proof ofmedical expenses. PAPs aren’t going to bailyou out of credit card debt that is non-medical.

What happens if I work while receiving med-ication from a PAP?Most PAPs are primarily concerned with yourinsurance status, and then with your income. Aslong as you have no insurance that covers thedrug a n d your income is within the PAP’s guide-lines – regardless of the source – the fact that youare working shouldn’t affect your eligibility.

How soon after applying will I be eligiblefor benefits from a PAP?Each program is different. For every story ofswift service of only a few days, there is a hor-ror story of waiting several months to receivethe needed medication. On average, it usuallytakes two to four weeks. Submitting all ofyour required information as quickly as possi-ble and following up with your healthcareprovider to make sure that their portions of theapplication have been completed will helpspeed up the process. So advocate courteous -ly for yourself and keep after your provider if necessary. Yourhealthcare team wants you to have your medications, too!

How do I stay enrolled/eligible in a PAP? How do I reapply?Each program has somewhat different requirements that youmust follow. Some require you to reapply each time you need anew prescription, but many require that you only reapply everythree months, six months, or annually with a recheck of yourincome and other eligibility requirements. Be sure that youunderstand the provisions of the specific program.

So tell me how to contact these Patient Assistance Programsalready!Finding out how to contact a PAP has often been the hardest partabout them! These companies are in business to sell drugs, notgive them away, so there is very little printed information avail-able about these programs. There is often little on the actual drugcompanies’ websites either. Because of the amount of paperworkand follow-through required by the healthcare providers, theysometimes don’t keep on top of everything.

Some companies consolidate their various drug products into onePAP. Others have different programs for each drug or each set ofdrugs for a specific disease. Some programs have catchy names(such as Boehringer Ingelheim Cares Foundation, GlaxoSmithKline’s Bridges To Access Program, and Schering-Plough’sCommitment To Care Program), slightly different requirements,and their own application form. It can be very confusing and,frankly, is often geared to make things difficult rather than easy.

Use the Internet resources listed above for the contact informa-tion for most Patient Assistance Programs that provide HIV-related medications. If you apply, don’t get discouraged. Followthe steps suggested above, courteously ask for help, and follow-up with your healthcare provider and the PAP throughout theprocess. Hopefully, you can get the medication you need!

Brian D. Klein MA, LMSW is a former medical social worker anda founder of the Hepatitis C Action & Advocacy Coalition(HAAC). He is an advocate for people living with hepatitis C(HCV) and those co-infected with HIV and HCV.

17

Patient Assistance ProgramsUseful Internet Resources

The Access Project of AIDS Treatment Data Networkwww.atdn.org/access/pa.htmlThis organization, which helps people with HIV access treatment, has a webpage dedicated to up-to-date information on Patient Assistance Programs, par-ticularly for drugs used to treat HIV, hepatitis C, hepatitis B, and opportunisticinfections related to HIV. Scroll down the page and click on the name of thedrug you need, and you will be linked to a page with the corresponding com-pany name, contact information and general eligibility requirements for thatcompany’s Patient Assistance Program.

PhRMA (Pharmaceutical Research and Manufacturers of America)https://www.helpingpatients.org/Intro.phpIf a drug you need isn’t listed on The Access Project, here’s another source totry. Surprising as it may seem, this lobbying organization for the drug industryhas easy-to-use, up-to-date contact information for all of the different PatientAssistance Programs offered by its members. The best way to use the site is toknow the name of the drug you need and the name of the company that manu-factures it.

ACRIA www.acria.orgAs an online addition to this issue of ACRIA Update, our website includes a listof the PAP contact information for the most commonly used medications forHIV, hepatitis C, hepatitis B, and AIDS-related opportunistic infections.

WARNINGThere are a few sites on the Internet that offer to help you apply to any drug com-pany Patient Assistance Program you need. Some of them charge a small feethat may or may not be refunded to you. Some of these sites are run by perfect-ly reputable folks, but others aren’t. It’s probably best to skip them all together.They usually create extra steps for you. They can only use the exact criteria thatthe drug companies provide. You will be far better off applying directly to the PA Pyourself so that you can explain your individual situation as necessa r y.

18

been challenging to protect services, par-ticularly for low-income people, but thelast four years have signaled that theadministration would like to place restric-tive limits on healthcare provision. Therehas been an active move to end the enti-tlement status of Medicaid as well as cutfunding to the program. AlthoughMedicare is more protected from theattempts to restrict services because of itsrole of serving more politically powerfulseniors, the much touted prescriptiondrug benefit, which will provide somerelief, also carries great risks for mostpeople living with HIV.

What’s Happening in Medicaid – TheFederal LevelThe federal government matches stateMedicaid spending with the FederalMedical Assistance Percentage (FMAP).FMAP, or the federal percentage, variesstate to state and can be anywhere from50 percent of overall spending for higherincome states to 77 percent for lowerincome states. Matching rates can behigher for some services or programs. It isan open-ended match, meaning that aslong as the state spends to provide servic-es, the federal government matches thatspending. This allows states to incorpo-rate new technologies and drugs andrespond to emerging epidemics anddownturns in the state economy that leadto job and insurance loss.

In the past couple of years, the BushAdministration has tried to cap federalspending through a block grant or a setamount of money that would go to eachstate. The only way the state couldrespond to any program growth would beby spending state money. People withHIV and many others would suffer great-ly under the enactment of block grants,likely losing services and even eligibility.Fortunately, Congress and governorshave been concerned about the idea ofblock grants and the proposals havestalled.

In 2003, in recognition of states’ fiscalcrises, Congress passed a temporaryincrease in the FMAP, which ended in

June 2004. Forty-two states reported thatthe increase helped with their Medicaidincreases, 27 reported that they avoided,postponed, or minimized program cuts,and all reported that the end of theincrease will bring challenges.Legislation has been introduced thatwould renew this temporary funding.

What’s Happening in Medicaid – TheState LevelSince 2001, states have been experiencingvarious degrees of fiscal difficulty. Forthe past three years, growing Medicaidspending has been a target for states try-ing to balance budgets. In spite of thetemporary increase in FMAP, 49 statesstarted 2004 with plans for Medicaid costcontainment and 18 planned mid-yearcuts or cost containment measures. Forpeople living with HIV and others, thesemeasures can mean the loss of life pro-longing comprehensive care. For exam-ple, Mississippi cut eligibility in a movethat could mean that up to 65,000 dis-abled and elderly lose their coverage.

For advocates, fighting cuts at the statelevel has become a critical part of protect-ing Medicaid programs for people whoneed them. We also have to monitorwaivers. States are allowed to submitwaivers to the federal government thatwould remove some beneficiary protec-tions, establish cost sharing obligations,allow changes in benefit packages, andmake other important program changes.Waivers are often enacted with an eye tocutting or containing costs. When cuttingcosts is the primary goal, the outcome islikely to hurt people’s healthcare. Thewaiver process is typically long andbureaucratic, but it is essential to followand provide input.

What’s Happening in MedicareThe most significant gap with Medicarecoverage for people with HIV has alwaysbeen the lack of a prescription drug bene-fit. The Medicare Modernization Act pro-vided a drug benefit for Medicare thatwill be implemented as of January 2006.Unfortunately, the benefit was funded atsignificantly less than what would be

needed for complete coverage. In addi-tion, the pharmaceutical industry lobbiedsuccessfully to include a ban on the feder-al government’s ability to negotiate theprice of drugs provided by the benefit.Therefore, the benefit will have restric-tions that could compromise care.

The Medicare prescription drug benefithas many potential problems. The con-cerns that are most pertinent for peoplewith HIV are included in The MedicarePrescription Drug Benefit – Issues forPeople Living with HIV/AIDS. You canview this document at www.projectin-f o r m . o r g / t a n / 0 4 0 8 m c p o i n t s . h t m l .Advocates are insisting on the creation ofsufficient information for consumers tohelp them understand and utilize theirbenefit, implementation of a sufficientappeals process, and assurance that theformularies (lists of available drugs) areinclusive of necessary medications.

The regulations that will govern the ben-efit were in the public comment perioduntil October 4th. The HIV Medicaid andMedicare Working Group, made up ofnational and regional HIV/AIDS organi-zations, issued comments and providedinformation to help other interested indi-viduals and groups submit comments aswell. To get more information onMedicare benefit advocacy, visit the HIVMedicine Association (www.hivma.org).To join the Work Group, email ProjectInform’s Treatment Action Network(tan@projectinform.org) or The AccessProject (theaccessproject@aol.com).

Medicaid and Medicare are the backboneof HIV care. They are also the onlyattempt in the U.S. to provide healthcarefor low-income and vulnerable popula-tions. We can’t allow the work of the last30 to 40 years to protect the health ofAmericans to be rolled back due to mis-placed political priorities. People withHIV and their advocates have to under-stand and fight for the programs wedepend on.

Anne Donnelly is Public Policy Directorof Project Inform in San Francisco.

Medicaid and Medicare (continued from page 6)

ACRIA’s Over 50Research ReceivesNational Media AttentionTwo major media outlets have recentlyused ACRIA’s research as the centralresource to discuss the aging of thenation’s HIV-positive population. OnJuly 7, 2004, the cable channel CNNfninvited ACRIA’s Associate Director forResearch, Stephen Karpiak, Ph.D., to talkabout this relatively unacknowledgedissue during a 10 minute live broadcast.The New York Times s u b s e q u e n t l ydescribed portions of ACRIA’s seminalresearch on this topic in an August 17,2004 article titled “Facing Middle Ageand AIDS.” Among other things, the frontpage article in the Science Times sectiondescribed our findings on the high levelsof depression in HIV-positive seniors andthe population’s relative lack of supportfrom family and friends as they experi-ence age-related health problems in addi-tion to complications from HIV andAIDS stigma. The BBC also recentlyinterviewed ACRIA researchers aboutour Research on Older Adults withHIV/AIDS (ROAH) initiative, which willbe broadcast in the near future.

ACRIA’s leading role in researching theneeds and circumstances of the older HIV-positive population is an ongoing endeav-or. We are currently recruiting for a majorfollow-up study that seeks to enroll 1,000New York City participants. This newresearch will include the largest samplingof an older HIV-infected population so faraccomplished. We expect its findings tosubstantially advance understanding ofhow the United States HIV population willage in the coming decade, and may signif-icantly impact HIV/AIDS health policy.

Tr i a l S e a r ch Now IncludesInformation On EnrollingStudies NationwideIn August, TrialSearch @ac r i a . o r gachieved a milestone for this nationalonline database of HIV/AIDS clinical tri-als. Information about HIV-related clinicaltrials in all 50 states and Puerto Rico is nowavailable through this interactive database.This could not have been achieved withoutthe help and dedication of a number ofinterns who worked with ACRIA over thesummer. We continue to update the trialinformation on a state-by-state basis, andrecruitment of volunteers is ongoing.

ACRIA NEWS ACRIA NEWS ACRIA

is looking for new COMMUNITY ADVISORY BOARD members.

ACRIA’s Community AdvisoryBoard (CAB) fosters partnershipbetween the education staff andthe local community impacted byHIV/AIDS. Involving communitymembers in the development ofour education programs ensuresthat community values and cultur-al differences are respected inACRIA’s educational work.

Community Advisory Board mem-bers meet every other month,review program materials andhelp us identify education needs.

For more information about theCAB or if you are interested in vol-unteering at ACRIA, please callMark Milano at (212) 924-3934,ext. 123.

Charles Clifton, Executive Director of Test PositiveAware Network in Chicago and Editor of Positively Aware,passed away on August 15, 2004. In addition to many otherresponsibilities, Charles was on the Steering Committee of thenational AIDS Treatment Activists Coalition (ATAC) and hasbeen instrumental in helping to organize the North AmericanAIDS Treatment Action Forum (NATAF) for the last severalyears. Memorial donations can be made to The Charles E.Clifton Memorial Fund by sending a check made payable toTest Positive Aware Network, noting The Charles E. CliftonMemorial Fund on the check. Donations can be sent to:

Test Positive Aware Network (TPAN)5537 N. BroadwayChicago, IL 60640

Keith Cylar, Co-Founder and Co-President of HousingWorks in New York City, died on April 5, 2004. The KeithCylar Activist Fund establishes a continuing legacy to his lifeand work. The Fund will create a permanent endowment tosupport advocacy and activism by people living with AIDS andHIV in America and around the world. The Fund will providepeople living with AIDS and HIV with training and continuedsupport to enable them to be effective advocates who are fullyinvolved in policy and decision making. To contribute, pleasego to www.housingworks.org/activistfund or send a checkmade payable to The Keith Cylar Activist Fund to:

Housing Works, Inc., Attn: Development320 West 13th Street, 4th floor

New York, NY 10014

HONORING OUR HEROESWe’d like to honor two HIV community leaders who died recently, both of whom worked with enormous dedication for equitable

access to care, treatment, and other necessary services for all people living with HIV – Charles Clifton and Keith Cylar.

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CONCLUSION

g e n e r o u sc o n t r i b u t i o n s

The following persons, corporations and organizations mademajor donations between June 16 and September 17, 2004 tosupport ACRIA’s research and education efforts:

AIDSCOMMUNITYRESEARCHINITIATIVE OFAMERICA230 West 38th Street, 17th FloorNew York, N.Y. 10018T 212 924-3934 F 212 924-3936 w w w. a c r i a . o rg

Change Service Requested

Alize

Banana Republic

Bristol-Myers Squibb

Virology

Broadway Cares/

Equity Fights AIDS Inc.

Champagne Taittinger

The Diller-Von Furstenberg

Family Foundation

Gilead Sciences

In Style Magazine

Jewel of Russa Vodka

Calvin Klein

Rainbow Endowment

Roche Molecular Systems, Inc.

Louis & Rachel Rudin

Foundation

Sean Kelly Gallery

Strachan & Vivian

Donnelley Foundation

Until There's A Cure

Foundation

W Hotels

Thoughtful donations were made in memory of thefollowing individuals:

Barry Binkowitz

David A. Eklund

Helen Guberman

Bennie W. Krueger Jr

Vincent Lattuca

David Seidner

Robert L. Stipe

David Tamayo

Joseph John Tamburo

NON-PROFIT ORG.

U.S. POSTAGE PAID

New York, NY

Permit No. 4732

ACRIA Update is sponsored in part byunrestricted educational grants from: