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