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AIDS Trestment News
October 16, 1998

Contents:


For subscription, donation and editorial information and to read our Statement of Purpose, visit AIDS Treatment News' page here at The Body.

Retroviruses Conference Scholarship Deadline Nov. 3


The 6th Conference on Retroviruses and Opportunistic Infections, January 31 to February 4 at the Sheraton Chicago, may be the most important scientific AIDS conference in 1999. Some scholarships have been made available; the deadline for applying for a scholarship is November 3. Information is available at www.retroconference.org (quoted here with minor editing):

Requirements: Applicants must 1) be affiliated with a local AIDS treatment organization, 2) be involved in community outreach activities, and 3) have a commitment to share what was learned at the conference. Preference will be given to individuals representing diverse and under-represented populations who may not have access to community-based newsletters (community-based press are ineligible for this program) and to individuals who have not been Retroviruses Conference scholarship recipients in the past.

Application Process: Applicants should submit 1) a resume (including applicant's history of volunteerism with any AIDS service organizations, community-based organizations, and/or PWA support groups and a list of any AIDS conferences applicant has attended previously), 2) a letter of application indicating whether the applicant is requesting a full or partial scholarship and including a statement outlining how the applicant would share knowledge acquired during the conference, and 3) a letter of support from his/her employer, AIDS treatment organization, or support group.

Selection: Applications will be peer reviewed by the Community Liaison Subcommittee.

Application Deadline: November 3 (Applicants will be notified of the disposition of their application on November 20 via fax.)

For additional forms (registration/housing, press credentials, and scholarship applications) and program updates, contact the Retrovirus Conference 24-hour Fax-on-Demand Service, 800-510-0319.

For questions, contact the Retrovirus Conference Secretariat: Westover Management Group, Inc., 211 N. Union Street., Suite 100, Alexandria, VA 22314, telephone: 703-684-4876, fax: 703-684-4841, email: info@retroconference.org



AmFAR RFPs: Immune Reconstitution, HIV Vaccines

Grants $75,000 to $150,000
Letter Due November 4


On October 2 the American Foundation for AIDS Research announced two special targeted requests for proposals (RFPs): one on immune reconstitution in HIV infection, and one on HIV vaccine development. A letter of intent and eight additional copies, attached to the cover sheet provided, must be received by Wednesday November 4 in New York City. We do not know how many awards will be made.

These grants are only for national or international not-for-profit agencies, and are made to the organizations, not to individuals. Applicants need not be U.S. citizens.

"Requests for over $75,000 will be considered only for projects involving collaboration between two separate research groups. These research groups may be at the same or separate institutions."

For either RFP, the letter of intent consists of the cover page, abstract, description/research plan of three pages or less, relevance description (one page maximum), and biographical sketch (not more than two pages). This "letter" is a pre-application screening process. Full applications will be solicited from groups whose letter of intent is accepted.


Immune Reconstitution Topics

All requests for immune reconstitution grants must be assigned to one and only one of five topics:

"Exploration of the mechanisms to facilitate extrathymic generation of T cells from precursor cells;

"Exploration of innovative approaches to therapy that potentially will both control HIV replication and restore or maintain immune function;

"Role of peripheral lymphoid tissue in selecting antigen- responsive T cells;

"Innovative mechanisms to enhance T lymphocyte diversity and function;

"Innovative mechanisms to expand the number and function of memory and naive T lymphocytes. Research topics could include the role of specific immunotherapies, including vaccination, in concert with anti-HIV drugs."


HIV Vaccine Development Topics

The vaccine RFPs must be in one of the following areas:

"Development of new or novel approaches for an HIV vaccine to enhance the qualitative and quantitative cellular and antibody responses, either systemically or in relevant mucosal areas. Approaches may include, for example, the use of novel adjuvants or cytokines in conjunction with HIV antigens, or the evaluation of new or not well-studied targets for developing protective immunity.

"Studies of the mechanisms of HIV antigen presentation and processing that will result in improved methods for enhancing the cellular and antibody responses to HIV antigens. This may include studies with novel vectors.

"Studies on the structure and characterization of HIV antigens that will enhance understanding of immunogenicity, for example, glycosylation of HIV antigens.

"Small well-characterized hypothesis-testing studies that will lead to an increased understanding of the requirements for protective immunity."


How to Submit

Obtain full information and the cover-sheet form either http://www.amfar.org (see the section on grant information), or by calling 212-806-1696 or faxing a written request to 212-806-1601. Phone or fax requests must mention the specific RFP (either Immune Reconstitution in HIV Infection, or HIV Vaccine Development).

The original letter of intent and eight copies must be received by 5:00 p.m. Wednesday November 4, at the AmFAR grants department in New York City; fax or email copies will not be accepted.



Oakland, California: Oct. 22 Panel on Alternative Treatments


A panel of experts on Western medicine and alternative treatments will address the question, "HIV and Traditional Chinese Medicine/Acupuncture/Alternative Treatments: Still relevant?" Panelists are Donald Abrams, M.D., Jon Kaiser, M.D., Marcy Shapiro, M.D., and Misha Cohen, L.Ac.; the moderator is Stephan Oxendine, Education Director of AIDS Project of the East Bay. This panel is organized by the Alameda County TEAM, a local consortium of HIV medical providers, with funding through unrestricted educational grants from pharmaceutical companies.

The panel is scheduled for 6:00 p.m. to 8:30 p.m. Thursday, October 22, at the African Methodist Episcopal Church, 476 - 34th Street (between Elm and Telegraph), Oakland, California. For more information, call 510-869-6514.



Advertisement

Help Wanted, AIDS Treatment Writer, New York


Treatment Issues, the AIDS treatment newsletter published by Gay Men's Health Crisis in New York, is seeking a new associate editor to start as soon as possible.

The ideal candidate will have a history of writing medical news articles and being familiar with AIDS treatment activism. A demonstrated ability to translate complicated pharmaceutical and medical data into popular language is essential. Salary is in the high 30s. Send applications, including resume, writing samples, and salary requirements, to CJ Bacino, Human Resources Dept., Gay Men's Health Crisis, 119 W. 24th St., New York, NY 10011 (fax: 212/367-1527).



Nelfinavir (Viracept®) Price Increase 4.6%


Agouron Pharmaceuticals, Inc. raised the price of the protease inhibitor nelfinavir (Viracept) by 4.6%, effective October 1. There is concern that the total cost increase for this drug could be about 15% if nelfinavir is used twice instead of three times a day, since the twice-daily dosage usually requires taking about 11% more pills.

The probable cause of the price increase is large research and development costs for new products (the RemuneTM vaccination strategy studies, and experimental antiretrovirals AG 1549 and AG 1776, and an experimental cancer treatment AG 3340) -- plus the unfavorable financial market, which would make it difficult and expensive to raise investment funding for this research if necessary. At this time the company's only marketed product is nelfinavir.


Drug Price Information on the Web

The Johns Hopkins AIDS Service Web site has basic information on over 160 drugs used in HIV medicine, including prices (average wholesale price, per pill); the prices are from the January 1998 edition of the Medi Span Hospital Formulary Pricing Guide. This information also appears in print in 1998 Medical Management of HIV Infection, by John G. Bartlett, M.D. The Web edition, which will be updated more frequently than the printed book, is at http://www.hopkins-AIDS.edu; select "Publications," then "Medical Management of HIV Infection." The prices are in Chapter 6, "Drugs: Guide to Information"; the prices are included with the drug listings, which are alphabetical by generic name.



11th National HIV/AIDS Update Conference

Abstract Submission Deadline November 1


The 11th National HIV/AIDS Update Conference, "Partnering Science and Practice," will be held March 23-26, 1999 at the Bill Graham Civic Auditorium in San Francisco. Abstracts for workshops and poster presentations are being accepted until November 1. The conference is organized in five tracks -- prevention, public policy, research and clinical management, mental health, affected communities -- and authors can submit proposals for consideration as a 90-minute workshop, 3-hour workshop, or poster presentation. Additional information is available from Cliff Morrison, Program Director, telephone 415-285-8410, fax 415-970-9013, email aidsupdt@aol.com. Abstracts can also be submitted using the World Wide Web at http://www.nauc.org.



Association of Nurses in AIDS Care

November 15-18, San Antonio


The eleventh annual conference of the Association of Nurses in AIDS Care, "Diversity: Walking Together Through the Rivers of Changes/La Diversidad: Caminando Juntos Entre los Rios de Cambios," will take place November 15-18, in San Antonio, Texas. Full registration is $395, and daily registration is $170. Reduced fees are available for members of the Association.

Cultural diversity will be highlighted at this year's conference. Sessions listed in the advance program include: Funding for HIV Care in the Future; Achieving Cultural Competency in HIV/AIDS Nursing; and The Future of HIV Care -- Community-Based and Cost-Containment Care Systems. Additionally, the examination to become an AIDS certified registered nurse (ACRN) will be offered on Sunday, November 15. Advance registration on a space-available basis is required; contact the Professional Testing Corporation at 212-356-0660.

For more information contact the Association of Nurses in AIDS Care, 11250 Roger Bacon Drive, Suite 8, Reston, VA 20190. Telephone 703-925-0081, fax 703-435-4390, email AIDSNURSES@aol.com, http://www.anacnet.org/aids.



San Francisco: Hepatitis C Community Forum, Oct. 20


Community Health Resource Center is sponsoring a community forum about hepatitis C on Tuesday, October 20 at California Pacific Medical Center, 2333 Buchanan, Lobby Level-Conference Room. An information display will begin at 6:30 p.m. with the main program scheduled from 7:00 p.m. to 9:00 p.m. In addition to a patient panel, those scheduled to speak include a medical doctor and a naturopathic doctor/licensed acupuncturist.

Pre-registration is requested, phone 415-923-3155.

A non-profit, physician-directed project, Community Health Resource Center provides free and low cost health and wellness services. An ongoing support group for hepatitis C is available, as well as nutritional counseling, disease and medication management, and a health resource library. For more information: phone 415-923-3155, fax 415-441-5128, email chrcpmc@aol.com, or see http://www.citysearch.com/sfo/chrcatcpmc.



Cannabis and Cannabidiol

Interview with Robert Gorter, M.D.

by Fred Gardner


[Notes: (1) Robert Gorter, M.D., is associate clinical professor at the University of California San Francisco Medical Center (Department of Family and Community Medicine), and also the medical director of the European Institute for Oncological and Immunological Research, a nonprofit with headquarters in Berlin and offices in Milan and Amsterdam. (2) Cannabidiol (CBD) is a non-psychoactive ingredient of the hemp plant which is being studied for potential medical uses including treatment of head injury and certain strokes, as an anti-psychotic, and as an anti-inflammatory. (3) The references to "Anthroposophical" refer to Anthroposophy, a movement founded in 1924 by Rudolph Steiner (1861-1925). -- JSJ]


Robert Gorter, M.D., is organizing clinical trials of a cannabis extract, hoping to establish that it leads to weight gain in HIV and cancer patients. In July he attended the annual meeting of the International Cannabinoid Research Society, where he apprised colleagues of his progress and caught up on theirs. We debriefed him in San Francisco in early August.

Fred Gardner: What is your interest in cannabis?

Dr. Gorter: My interest in cannabis goes back to the early 1970s. I studied medicine in Amsterdam in the 1960s and I lived in a commune where almost everybody "blowed" every day -- but I never did. And usually in the middle of the night, people would meet in the kitchen and have fried eggs and snacks; they said that when you smoke, it stimulates your appetite.

When I settled down as an Anthroposophical family practitioner in Amsterdam in 1973, I had many cancer patients in my practice. Many had loss of appetite and severe weight loss. Many older people from Holland had never smoked pot. So we made an oral preparation for them. We grew cannabis in a city park, until it was discovered.

We made an alcohol extract of cannabis, and my patients took half a teaspoon a day twice a day, and they loved it. Almost all reported appetite stimulation after about a week. There was a clear mood elevation -- they felt better. And many patients who were using opiates for pain control said they needed much less opiates with small amounts of cannabis. Most people gained weight, but not all. If patients were close to dying, weight gain was not seen.

Gardner: For how many years were you treating cancer patients in Amsterdam with cannabis?

Dr. Gorter: From 1973 to 1983. At that time cannabis was also available as an injectable from Weleder, an Anthroposophical company that distributes natural medicines. I've used it as an injectable for backaches and muscle cramps and people with insomnia. But for stimulating appetite the injections did not work well; the patients needed a larger dose, delivered orally.

Gardner: And then you came to UCSF in 1983?

Dr. Gorter: In the Nancy Reagan years, I felt insecure about telling patients about medical effects of cannabis. But if people asked me, of course I would tell them what I knew. Then, in 1986, Marinol® (dronabinol) was developed, so right away I could prescribe Marinol for appetite stimulation. I have also tried it with patients with chronic pain. But many people had side effects. My patients who had experience with both cannabis and Marinol almost always preferred cannabis, because Marinol had more side effects, including headaches and a hung-over feeling. In 1989 I set up an efficacy trial of Marinol as an appetite stimulant in AIDS patients.

Gardner: What happened?

Dr. Gorter: After a delay it was conducted in Texas. In 1991 Marinol received approval of an additional indication for appetite stimulation in HIV infection.

In 1992 I took a sabbatical and went to Europe to conduct a clinical trial of Iscador in HIV patients. To make a long story short, I was offered an opportunity to establish the European Institute for Oncological and Immunological Research in Berlin, and since then I have been flying back and forth.

Gardner: What became of your cannabis-vs.-Marinol study?

Dr. Gorter: We decided to start a clinical trial in Europe to study Marinol against placebo and then compare cannabis against placebo and then cannabis against Marinol for its efficacy, toxicity and so on. It took me about two years of lobbying, but then the German government and the Dutch government agreed that it was time to have these studies done. Both governments have given me an official okay to conduct such a trial in about 800 AIDS and cancer patients. Our institute has developed an oral preparation of cannabis which we have named Cannador -- from "cannabis" plus "dor/doron" for gift.

Gardner: You will not be testing smoked cannabis?

Dr. Gorter: For the elderly, in a hospital setting or a hospice, smoking raises all kinds of problems. And smoking cannabis is so strongly associated with recreational drug use, that it is not palatable to people in the government. A clean, standardized extract works better. Ours will be a whole-plant extract made from male and female plants, and standardized for its THC and other cannabinoid contents by thin-layer chromatography. We will process it in a fatty medium for packaging in a soft-gel capsule. [Note: THC, or tetrahydrocannabinol, is the main psychoactive ingredient in marijuana.]

Gardner: Do the male and female plants have significantly different components?

Dr. Gorter: Yes. Cannabis contains at least 600 different components; among them 64 different cannabinoids have been identified, and everybody agrees that there are more. And there are 10 times as many other substances. They differ from year to year depending on the soil, the weather, the degree of sexual separation, and other factors. The highest concentration of THC is in the glands of the female plant.

Gardner: Donald Abrams, M.D., told SYNAPSE you were planning a study in the U.S. involving cannabis and appetite in HIV patients.

Dr. Gorter: As soon as the German government approved our protocol I sent it to the FDA, and in September of last year they accepted us under the Investigational New Drug program. But one of their pharmacists said "You can never standardize plant extracts." We said, "Maybe not for all the components, but for the main components, we can." They wanted more proof of that, which we have delivered, and they have accepted.

It was decided that we could go straight to a phase III trial, because so much is known already about safety.

But in February of this year we had a conference call from the same FDA committee but with a different chair; she said, "You have to do a phase I trial." We ended agreeing to do a combined phase I/II trial. I am now raising money for that trial and hopefully it will be conducted in the spring of next year. In the late fall we will start with the phase III trial at 18 universities in Germany, the Netherlands, Austria and Switzerland. There will be 360 cancer patients and 360 AIDS patients who have lost at least 5% of their body weight in the last six months, and who are candidates for appetite stimulation, and have been free of cannabis for at least four weeks (so we can test the efficacy of our preparation). So soon we will have both studies running parallel -- a phase III trial in Europe and a phase I/II in the US. [Phase I tests toxicity in humans; phase II tries to determine an optimum dose. Phase III is an efficacy trial against placebo or other medications -- the key step in obtaining a license to market the drug. Phase IV trials, conducted after market approval, involve thousands of patients followed over time to assess long-term toxicity.]

Gardner: From what source are you obtaining your cannabis?

Dr. Gorter: The cannabis used in the U.S. will come from NIDA [the National Institute on Drug Abuse, which has authorized Professor Mahmoud ElSohly, a commercial grower employed by the University of Mississippi, to cultivate marijuana on their farmland for sale to the federal government.] The cannabis to be used in Europe will be purchased by the Dutch government, also from NIDA.

Gardner: NIDA's marijuana is reportedly weak and stale.

Dr. Gorter: I trust ElSohly to provide a suitable product. In any case, the concentrations we get in the extraction process are what matters, and we can control that.

We will soon start in Amsterdam and in England trials of Cannador on multiple sclerosis patients.

Gardner: There were references at the International Cannabinoid Research Society meeting to the immunosuppressant activity of THC.

Dr. Gorter: Only in high doses in animal studies that do not correspond to the pattern of human use. After a while you see a drop of blood pressure and immune dysfunction. Animals are generally given 125 milligrams of THC per kilogram body weight. That would be for humans 7 or 8 thousand milligrams per day. The average amount in a joint is about 10-15 milligrams; so 8 thousand milligrams is beyond every form of human use.


Cannabidiol

Dr. Gorter: In Berlin we will develop another form of Cannador with a much higher content of CBD (cannabidiol), and do a pilot project on patients with epilepsy. CBD counters, to some extent, the psychoactive effects of THC.

Gardner: How do you adjust to get a plant heavy on CBD and light on THC?

Dr. Gorter: You grow plants with high content of CBD. No problem.

Gardner: Does ElSohly have that kind of sophistication?

Dr. Gorter: We will collaborate and share our expertise.


For More Information

For more information, you can search the AIDSLINE and MEDLINE databases free through the World Wide Web, at http://igm.nlm.nih.gov. You can contact Dr. Robert Gorter at the European Institute for Oncological and Immunological Research, email robertgorter@compuserve.com, fax +49-30-315- 744-44.



California ADAP Alert

by John S. James


Starting September 1, hundreds of California residents on ADAP (the AIDS Drug Assistance Program) are having prescriptions rejected on the grounds that their eligibility for the program has expired. In fact, most of them are still eligible for the services, but they need to re-apply for ADAP, since Federal regulations require that eligibility be re-established each year. Also, through an emergency procedure they can usually get their current prescriptions filled quickly, allowing them 30 days to complete the process of re-entering ADAP.

Unfortunately, few California ADAP recipients have been warned in advance that their eligibility is about to expire. Usually they first learn about this when their pharmacist tells them that their prescription was not approved -- and often no one they are working with knows what is going on, or what needs to be done to assure continued drug supply.

If your prescription is rejected on the grounds that you are no longer eligible for California ADAP -- even if you have an ADAP card which gives a later expiration date -- you should:

  1. Make sure that your pharmacist has submitted an emergency authorization form (the PMDC prior authorization form) so that your drug supply is not interrupted. Under a new system which was started in October 1998, the pharmacist will receive instructions with the rejection notice. You must sign the form, acknowledging that you have been informed that you must re-apply to ADAP within 30 days. Without your signature, ADAP will not pay the pharmacist for the prescription.

  2. Within 30 days you need to apply again to ADAP so that your eligibility will be re-established for another year; this cannot be done at the pharmacy, but must be through an ADAP enrollment center in your area. Your doctor may need to provide some medical information, so start early, as there could be delays due to the need for coordination among four different offices -- pharmacist, doctor, enrollment center, and PMDC (Professional Management Development Corporation, located in San Leandro, which is the California ADAP contractor).

  3. For answers to questions about these procedures, you, your pharmacist, or others can call PMDC toll-free, 888-311-7632 (888-311-PMDC), Monday through Friday 9 a.m. to 7 p.m., Saturday 9 a.m. to 5 p.m., or Sunday 11 a.m. to 4 p.m. Callers can use the voicemail to reach an eligibility worker during these hours.

If necessary, PMDC can refer you to an ADAP enrollment center in your area.

You can also call the same number 24 hours a day to verify your own eligibility electronically, using your ADAP identification number (which is usually the same as your Social Security number). Use the voicemail to select the electronic verification system.

According to the PMDC Pharmacy Provider Manual, a pharmacy which gets a "not eligible" message should call PMDC before turning the patient away. But there is no way to know how often this is done.

The rest of this article has background on why the problem has surfaced now, and on the process of applying or re-applying for ADAP.


Background: California ADAP

The Federal ADAP program is run separately by each state, which makes its own rules (subject to Federal regulations). To be eligible to receive prescription drugs under this program, you must have HIV, be a resident of the state, and have income within limits which are set by that state. The drugs which can be covered by ADAP vary tremendously by state. This article applies only to California.


Why Now?

California's current blizzard of prescription rejections started on September 1, and became much worse on October 1. There are likely to be many additional rejection notices in November (although a new procedure may handle them more smoothly). By next year this problem will largely correct itself automatically. Why did it happen now?

About a year ago California fundamentally changed the administration of its ADAP program. Before, each county (or other ADAP jurisdiction -- for example, the city of Berkeley has its own program, separate from Alameda County in which it is located) was responsible for administering its program. California's ADAP data was kept in about 60 different file formats scattered throughout the state, which usually made it impossible to provide usage statistics quickly enough to project the need accurately when funding decisions were made. And patients had to use the same pharmacy every time.

For these and other reasons, California centralized its ADAP program last year. Now a central office (PMDC) maintains the eligibility records for everyone in the program, and tells pharmacists when they can fill prescriptions and be paid for them. Enrollment of patients is still handled at the local ADAP jurisdictions (not by PMDC), but PMDC provides one-day training and certification to the local eligibility workers, so that the process will be uniform throughout the state. ADAP prescriptions can now be filled throughout the state at any California pharmacy which participates in the ADAP program (more than two thirds of them do).

Last year all the ADAP jurisdictions were given several months to get their databases to PMDC; the deadline was November 1. Much of the data was in poor condition. If the eligibility expiration date was not available, PMDC was given permission to set this date to one year after the county's records were centralized -- which gave the patient the benefit of the doubt (federal rules require that eligibility be re-established every year.)

Now, one year later, those expiration dates are arriving. For example, Berkeley got its records to PMDC early, by September of last year, so eligibility for those clients expired this year on September 1. (Berkeley's ADAP program made a commendable, but rare, effort to notify its clients in advance.) San Francisco had many ADAP clients lose eligibility on October 1, and did not notify them. In many areas, patients will get the rejections from their pharmacies in November. PMDC has estimated that about 1500 to 1800 patients will have prescriptions initially rejected this fall; that is about 15% of the 12,000 to 13,000 who are currently using the system.

Persons who signed up for ADAP within the last year, after the centralization of the program, are less affected. They have an ADAP card from the new, centralized system, and this card includes their expiration date, so at least they can mark their calendars and know when it is necessary to re-apply. Before, some counties did not have cards, and some of the cards that did exist were inaccurate. And clients did not receive the new cards when their records were centralized, but only when they re-enrolled in ADAP after that time.

Why are California ADAP clients (patients) not notified ahead of time when their eligibility is about to expire, and told what they need to do to remain in the program? There are several reasons. Many have asked not to receive calls or mail from the program, to guard their confidentiality. And PMDC itself is not set up to notify clients, even those willing to be contacted. It does notify the counties and other ADAP jurisdictions, but even San Francisco did not pass this warning on to its clients.

Perhaps the best solution would be for PMDC to fax a notice to be provided to the client with their prescription, one month before the eligibility period ends.


California ADAP Hints

  1. Keep all your ADAP documentation together where you can find it.

  2. If you are already in California ADAP, make sure you know your eligibility expiration date. If you do not know it, you can find it from PMDC. Call when they are open (see "Alert," at the beginning of this article), and be prepared to give them your ADAP member identification number.

    A good time to re-enroll is just after you have filled your last monthly prescription in your current eligibility period. Start early, because re-enrollment may require coordination with your doctor's office.

  3. If your prescriptions are rejected because you are no longer eligible, you need to (1) sign the pharmacist's paperwork to get emergency approval for those prescriptions (usually a 30 day supply), and (2) re-enroll in ADAP if you are still a California resident and still meet the income requirements. (See "Alert," at the beginning of this article.)

  4. You need to enroll or re-enroll at a center which handles ADAP enrollment; if you do not know where one is in your area, call a local AIDS service organization, or call PMDC. Then call the enrollment center to find out when a trained eligibility worker will be available, and to find out exactly what documentation you must bring. You must prove residency and income, and may need to provide some medical information as well. (See "Applying or Re-Applying to California ADAP," below.)

    Sparsely populated counties will usually have only one enrollment center. San Francisco, on the other hand, has over 20 (the public health centers, San Francisco General, many AIDS service organizations, etc.) -- even though San Francisco is a single ADAP jurisdiction.

    Once the eligibility worker faxes your enrollment application, PMDC can usually process it within a day or two.

  5. It helps to call in your prescription ahead of time. Unfortunately there is only a three-day window when you can pick up the medication before it runs out (assuming a 30-day prescription; the rule in California ADAP is that the pharmacist will not be authorized payment for a refill or new prescription for the same medicine, until the date when the old one is within 10% of running out). But you can call in your prescription before that three-day window, to give the pharmacist more time to resolve any problems that may occur. (Note that ADAP is probably the most complicated reimbursement system that your pharmacist will handle, because it can only be a payer of last resort; therefore ADAP must interact will all other applicable health plans.)

  6. You may want to deal with your pharmacy during hours that PMDC is open, so that you or the pharmacist can work out any problem then, instead of waiting until the next day when there may be somebody else on duty who is not familiar with the problem.

    (Every transaction between the pharmacy and PMDC has a claim number. In case of a rejection, the pharmacy can phone and give the claim number to the PMDC staff, which can usually identify the problem immediately.)

  7. You often get better service for ADAP prescriptions from independent pharmacies, or from a particular stores in a chain which has much AIDS experience. Chain stores, which often rotate pharmacists all over the state, account for a disproportionate share of the complaints from patients.

  8. You can receive ADAP prescriptions by mail (usually from Stadtlanders Pharmacy, which is set up to handle ADAP's complex billing coordination). In many areas this may be necessary to preserve confidentiality.

  9. If you are too ill to come to the pharmacy, a person with the appropriate power of attorney can sign the emergency authorization form for you -- or someone else can bring you the form to sign, then return it to the pharmacy to pick up the prescription. A few pharmacies could come to you to get your signature and deliver the medication.

  10. Clients who do not use any ADAP drug for over 90 days will be automatically suspended, but can be re-instated if they show that they are still eligible and are using the drugs in a medically accepted way.


Applying or Re-Applying to California ADAP

Each enrollment center will use the same 15-page Enrollment Procedures and Guidelines for Determining ADAP Eligibility manual, and will have an eligibility worker trained in its use. Some points to note:

  • Currently (October 1998) all California ADAP recipients must have a Federal Annual Adjusted Gross Income under $50,000. Those between $32,200 and $50,000 might have a co- payment, depending on family size. The preferred documentation for establishing income is either the Federal or California income tax return; however, other documentation can be used, including current pay stubs, SSI/SSA check stubs, private disability insurance statement, letter of financial support from family or guardian, benefit determination worksheet from your social worker, or signed and notarized income affidavit from the applicant. A copy of this documentation must be kept with your file at the eligibility center.

    If you do have an ADAP copayment, the amount will depend on your taxable income. Often the payment will be lower if you use your California tax return, instead of your Federal tax return.

    Note that ADAP is income-based, while Medicaid (Medi-Cal) is asset-based.

  • Applicants must provide identification and establish residency. "Suitable forms of identification may include a driver's license, immigration card, state identification, school identification, or United States passport" (quotes are from the Enrollment Procedures... manual, April 1998). Also, applicants must reside in California; if residence cannot be established with the identification, "applicants must present a rental or lease agreement, phone bill, utility bill or another similar document that will demonstrate that the applicant maintains a residence in California." A P.O. box cannot be used for the residency requirement -- but may be used as a mailing address. Persons without this documentation (such as homeless, living with and supported by family or partner, etc.) "may prove residency by providing a letter (on agency letterhead) from their AIDS case manager, AIDS service provider, or social service provider, providing the location and time period services have been/continue to be provided to the client."

  • Medical information. Applicants must provide a letter of diagnosis signed by a practicing and licensed California physician, with an original signature (the original diagnosis letter should not be necessary if you re-apply at the same ADAP enrollment center at which you previously applied, since your documentation should be on file there). To improve the data collected by the program, applicants are asked to provide the date of original diagnosis, date and value of most recent CD4 count, and name, address, and phone number of prescribing physician.

    The eligibility worker must also know if the applicant has asymptomatic HIV, symptomatic HIV, or an AIDS diagnosis.

  • Insurance. Since ADAP is the payer of last resort, all other payment options must be used first. This means that if a person is receiving 100% Medi-Cal benefits (including in a Medi-Cal managed care program), without a Medi-Cal share-of-cost, they are not eligible for ADAP (since they have no out-of-pocket prescription expenses). ADAP can pay co-payment of private insurance, but only in cases of financial hardship. And it can pay when the private insurance prescription drug benefit has been maxed out.

  • Clients who are not getting Medi-Cal, but may be eligible for it, must apply for Medi-Cal, and provide proof of application within 30 days of their ADAP application, or their ADAP eligibility will be suspended until this is done.

    California's Medicaid (Medi-Cal) eligibility allows ownership of one vehicle, one home which is used as one's primary residence, and up to $2,000 in additional assets (bank accounts, IRAs, a second vehicle, etc.) It also requires a medical disability. Any income is allowed; however, anything over $620 per month is Medi-Cal "share-of-cost" -- meaning that this income must be used for the medical expenses, before Medi-Cal will pay. In cases of financial hardship, California ADAP's payments can help pay Medi-Cal share of cost (see Eligibility Guidelines, AIDS Drug Assistance Program, updated November 21, 1997). In California financial hardship is not difficult to show, especially in cities where rent alone can be more than the $620 a month income which Medicaid rules expect people with large medical expenses to live on.

  • Persons getting Medicare often can get ADAP in addition, since Medicare usually does not cover outpatient prescriptions.

  • Rules for persons with private insurance are complex. ADAP can pay co-payments if the client can demonstrate that there would be a financial hardship. ADAP will pay after the prescription benefit has been exhausted, and will pay for drugs covered by ADAP but not by the private insurance. However, "applicants who must access their prescription benefits from a preferred provider not participating in the PMDC Pharmacy Network are not eligible for ADAP."

    Also, applicants with private medical insurance must complete and sign an Assignment of Benefits and Release of Information form -- so that their insurance company can be billed first, before ADAP pays. They cannot keep their private insurance from knowing their HIV status and also receive ADAP.

  • Children. ADAP clients must usually be 18 years of age or older. Children under 18 may be considered on a case-by-case basis, if no other program will cover them (usually Medi-Cal or California's HIV Children Program would be used).

  • The eligibility worker will fax the application to PMDC, but must also mail the original signed Assignment of Benefits and Release of Information.

    Jail inmates can use ADAP, but only if they are accused only of county or local offenses. They cannot use ADAP if they are charged with or convicted of any state or federal offense -- even if they are housed in a county or city jail. Supposedly these prisoners have other HIV treatment programs available.

    [There are efforts to change this rule. Previously, prisoners in California could get drugs through ADAP if they were being held on city or county charges or convictions (regardless of additional state or federal charges or convictions; California refuses to use ADAP to pay for state or federal prisoners, even if they are housed in a local jail). But inconsistency resulted, since San Francisco deemed city/county time as served first, while Los Angeles considered the local time to be served last. The immediate goal is to devise a more rational rule that can be applied consistently.]

  • Grievance process. Applicants who have been denied eligibility or service may file a formal grievance with the California Office of AIDS through their local ADAP Coordinator of their county or other health jurisdiction. (However, we believe that most problems can be handled much faster, usually within a day, by calling PMDC -- and appealing to its management, if one is not satisfied with the decision of the eligibility specialist or pharmacy technician at PMDC who first handles the problem.)

    If you are treated unprofessionally by pharmacy staff, PMDC can usually get the problem corrected, since the pharmacies and chains must contract with them to sell medications through the ADAP program. PMDC has had good results even with the chains.

    Ultimately appeals are limited, since California does not consider ADAP an "entitlement" program.


Contacting PMDC

If you are denied eligibility or services which you believe you should receive, the problem can often be resolved quickly by PMDC, the management contractor for the California ADAP. PMDC can be called toll-free at 888-311-7632 (888-311-PMDC), fax 800-848-4241). PMDC is open 9 a.m. to 7 p.m. Monday through Friday, 9 a.m. to 5 p.m. Saturday, and 11 a.m. to 4 p.m. Sunday.

(Before calling, you might want to check for additional information at a Web site, http://www.pmdc.org [not available yet as this article goes to press]. The Web site will be more current than this article, and may have answers which will help you understand and state the problem better.)

At PMDC, most enrollment problems can be handled by an Enrollment and Eligibility Specialist (select on the main menu of the voicemail). There is also a Pharmacy Technician choice (usually fused by the pharmacist or pharmacy worker).

If you are not satisfied with the answer of the eligibility specialist, you can appeal to the Enrollment Eligibility Coordinator (and CFO) of PMDC, Eric Flowers. Choose the Executive Directory submenu on the PMDC voicemail. Pharmacy issues can be appealed to Sylester Flowers, a pharmacist and president and CEO of PMDC.



ISSN # 1052-4207

Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.




  
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