| July
14, 2006
This Week in Washington
1. Senate Democrats Introduce ADAP Medicare Legislation
2. NORA Bi-Monthly Meeting
3. DC CARE Consortium Hosts Therapeutic HIV Vaccine Forum
This Week in Washington
1. Senate Democrats Introduce ADAP Medicare Legislation
Senator Jeff Bingaman (D-NM) introduced the “Helping Fill the
Medicare Rx Gap Act of 2006” on July 12th in the Senate. There
is currently no companion bill in the House of Representatives.
The bill, S. 3650, is intended to help people
who are eligible for Medicaid to pay for a “gap” in coverage under
Medicare Part D (also called the “donut hole”). This gap in coverage
requires people eligible for coverage to pay 100% of the costs
of the monthly premium from $2,250 to $5,100 in “true out-of-pocket”
(TrOOP) costs totaling $2,850. The bill would allow AIDS Drug
Assistance Programs (ADAPs) to pay the TrOOP costs of individuals
who are eligible for both Medicare Part D and their state ADAP.
State ADAPs have currently been ruled ineligible by the Centers
for Medicare and Medicaid Services (CMS) to cover the out of pocket
gap, although state pharmacy assistance programs (SPAPs) are allowed
to provide coverage through the gap. The bill would also include
costs incurred by the Indian Health Service, federally qualified
health centers, certain eligible hospitals and some pharmaceutical
manufacturer patient assistance programs would also be allowed
to contribute to annual out of pocket thresholds under part D.
AIDS Action has worked with Senator Bingaman’s
staff to include ADAP in the new bill. The current cosponsors
of the bill are Senators Lautenberg (D-NJ), Menendez (D-NJ), Dorgan
(D-ND), Kennedy (D-MA), Stabenow (D-MI), Dayton (D-MN), Johnson
(D-SD), Clinton (D-NY), and Akaka (D-HI). Although all of the
sponsors are Democrats, Senate staffers have expressed hope that
some Republicans may ultimately support the bill.
The text of the bill is as follows:
S. 3650
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Helping Fill the Medicare Rx Gap
Act of 2006''.
SEC. 2. INCLUDING COSTS INCURRED BY THE INDIAN HEALTH SERVICE,
A FEDERALLY QUALIFIED HEALTH CENTER, AN AIDS DRUG ASSISTANCE PROGRAM,
CERTAIN HOSPITALS, OR A PHARMACEUTICAL MANUFACTURER PATIENT ASSISTANCE
PROGRAM IN PROVIDING PRESCRIPTION DRUGS TOWARD THE ANNUAL OUT
OF POCKET THRESHOLD UNDER PART D.
(a) In General.--Section 1860D-2(b) (4)(C) of the Social Security
Act (42 U.S.C. 1395w-102(b)(4)(C)) is amended--
(1) in clause (i), by striking ``and'' at the end;
(2) in clause (ii)--
(A) by striking ``such costs shall be treated as incurred only
if'' and inserting ``subject to clause (iii), such costs shall
be treated as incurred if
(B) by striking ``, under section 1860D-14, or under a State Pharmaceutical
Assistance Program''; and
(C) by striking the period at the end and inserting ``; and'';
and
(3) by inserting after clause (ii) the following new clause:
“(iii) such costs shall be treated as incurred and shall not be
considered
to be reimbursed under clause (ii) if such costs are borne or
paid--
“(I) under section 1860D-14;
“(II) under a State Pharmaceutical Assistance Program;
“(III) by the Indian Health Service, an Indian tribe or tribal
organization, or an urban Indian organization (as defined in section
4 of the Indian
Health Care Improvement Act);
“(IV) by a Federally qualified health center (as defined in section
1861(aa) (4)); “(V) under an AIDS Drug Assistance Program under
part B of title XXVI of the Public Health Service Act;
``(VI) by a subsection (d) hospital (as defined in section 1886(d)(1)(B))
that meets the requirements of clauses (i) and (ii) of section
340B(a)(4)(L) of the Public Health Service Act; or
``(VII) by a pharmaceutical manufacturer patient assistance program,
either directly or through the distribution or donation of covered
part D drugs, which shall be valued at the negotiated price of
such covered part D drug under the enrollee's prescription drug
plan or MA-PD plan as of the date that the drug was distributed
or donated.''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply to costs incurred on or after January 1, 2006.
SEC. 3. PROVIDING A SAFE HARBOR FOR PHARMACEUTICAL MANUFACTURER
PATIENT
ASSISTANCE PROGRAMS.
(a) Safe Harbor.--Section 1128B (b)(3) of the Social Security
Act (42 U.S.C. 1320a-7b(b)(3)) is amended--
(1) in subparagraph (G), by striking ``and'' at the end;
(2) in subparagraph (H), as added by section 237(d) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003
(Public Law 108-173;
117 Stat. 2213)--
(A) by moving such subparagraph 2 to the left; and
(B) by striking the period at the end and inserting a semicolon;
(3) by redesignating subparagraph (H), as added by section 431(a)
of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (Public Law 108-173; 117 Stat. 2287), as subparagraph
(I);
(4) in subparagraph (I), as so redesignated--
(A) by moving such subparagraph 2 to the left; and
(B) by striking the period at the end and inserting ``; and'';
and
(5) by adding at the end the following new subparagraph:
``(J) any remuneration paid by a pharmaceutical manufacturer patient
assistance program, either in cash or through the distribution
or donation of covered Part D drugs (as defined in section 1860D-2(e)),
to an individual enrolled in a prescription drug plan under part
D of title XVIII or in an MA-PD plan under part C of such title.''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply to remuneration paid on or after January 1, 2006.
The text is not currently available online.
AIDS Action supports S. 3650 and urges the Senate and House to
quickly pass this legislation and the President to sign it into
law.
2. NORA Bi-Monthly Meeting
On Monday, July 10th the National Organizations Responding to
AIDS (NORA) held its bi-monthly meeting at the American Public
Health Institute in Washington D.C. NORA is composed of national
organizations that are interested in working on the elimination
of the HIV/AIDS epidemic. Speakers included AIDS Action Political
Affairs Director, Bill McColl, Government Affairs Director, Donna
Crews, and Executive Director, Rebecca Haag.
The meeting began with Mr. McColl giving the
members an update on the status of the reauthorization of the
Ryan White Care Act. Mr. McColl explained that the legislation
will likely pass this year. The big issue holding up the legislation
is disagreement on a formula for allocating money. Since neither
HIV nor AIDS data collection systems across the country are optimal
and more importantly their effectiveness varies from state to
state, coming up with a formula that pleases everyone and is equitable
is proving difficult. Congressional staffers, however, have spent
an enormous amount of time and energy working on the reauthorization
of the CARE Act, and are most likely “not going to let it go without
a fight,” McColl said.
The meeting continued with an update on the
fiscal year 2007 appropriations given by Donna Crews. She explained
that the bill has passed the House Appropriations full committee
with the inclusion of an increase on the minimum wage. The bill
has not yet been brought to the House floor since it contains
the controversial amendment that has proven difficult for the
House leadership to accept. The House version does have an additional
$4 billion over President Bush’s request with a $70 million increase
in funding for HIV medications and an $88 million increase in
prevention funding.
Ms. Crews explained that the Senate will mark
up their version of the bill during the week of the July 17th
with a subcommittee hearing on Tuesday, July 18th followed by
a full committee hearing on Thursday, July 20th. AIDS organizations
are working to have additional funding included in the Senate
version of the bill.
Next, keynote speaker and AIDS Action Executive Director Rebecca
Haag began by introducing herself to the NORA members as Ms. Haag
recently became Executive Director of AIDS Action on March 1st.
In her remarks she stressed establishing measurable outcomes to
evaluate progress and a more general policy approach to addressing
the epidemic. Haag worried that without a measurement of what
is being accomplished supporters may begin to wonder where their
money, time, and energy is going. “Measured progress gives people
hope,” said Ms. Haag. She explained that prevention is our best
weapon in the fight against AIDS until there is a cure. We have
to be able to talk about sex and substance abuse in this country
so that we can teach people how to protect themselves against
HIV.
Ms. Haag concluded the meeting by asking members
of NORA to work together to become part of a broader discussion
moving forward in the leadership of HIV. We need political leadership,
national leadership, community leadership, and individual leadership
to say in x number of years we will no longer have an HIV epidemic.
Ms. Haag spoke to the idea that success in fighting the AIDS epidemic
is inextricably tied to larger societal issues such as poverty
and access to health care. “How effective is routine testing without
routine health care?” she asked.
3. DC CARE Consortium Hosts Therapeutic HIV
Vaccine Forum
On Thursday, July 13th DC CARE Consortium hosted a forum to discuss
Therapeutic HIV Vaccine Research. The main focus of this session
was a current study being conducting by the Vaccine Research Center
(VRC) at National Institutes of Health (NIH). This was the first
in an upcoming series of monthly meetings to advance education
on current HIV vaccine research.
The trial, VRC 101, is the first therapeutic
HIV vaccine developed by the VRC. The main purpose of this forum
was to introduce the significance of therapeutic vaccine research
and explain the scientific background and rational of this study.
The meeting commenced with an opening
by Diane Johnson, recruitment manager for VRC who introduced Joe
Casazza, MD, principal investigator of the trial.
He began his presentation by defining therapeutic vaccination
and why it could be an effective tool in HIV treatment.
A therapeutic vaccine is one used to treat a chronic infection
by improving the body’s own immune system response. This type
of vaccine is given after an infection to minimize the course
of disease. In other words, VCR 101 would be given to people who
are already HIV positive. This type of vaccine has the best potential
for success in treating diseases punctuated by periods of remission
that can be suppressed by medications, such as HIV.
Dr. Casazza went on to explain that the goal of therapeutic HIV
vaccination is to help suppress the HIV virus, delaying the need
to use antiretroviral medications. He pointed out that CD4 T cells
can drop within quickly as 6 months of HIV infection. An effective
Therapeutic HIV vaccine must generate HIV specific CD4 T cells
and CD8 T cells. Current preventive vaccines do a poor job of
generating CD8 cells. It is the depletion of CD8 cells in particular
that result in an increase of viral load.
The VCR 101 vaccine is a combination of an HIV-1 DNA plasmid vaccine
and a replication deficient adenovirus vaccine. In combination,
these vaccines have shown a good safety profile and strong immune
response, specifically a dramatic increase CD8 T cells. There
is currently a global preventative Phase 2 clinical trial using
this same vaccine, but Dr. Casazza believes that there is also
great promise in using this vaccine as a therapeutic treatment
tool in HIV positive individuals.
This early phase 1 trial is being conducted solely in the DC metropolitan
area at NIH with only 15 volunteers. As a Phase 1 trial, the study
will provide needed safety information about the vaccination plan
in HIV-infected volunteers, before it can be used in larger trials.
The study consists of 12-14 visits during 48 weeks. In the first
two months of the trial participants would be given the DNA plasmid
vaccine and at month 6 the replication deficient adenovirus vaccine.
The remaining time in the trial will be used for assessing safety.
After Dr. Casazza’s presentation, the remaining discussion was
centered on recruitment efforts. Attendees were given inclusion
and exclusion participation criteria for the trial as well as
participant recruitment materials. NIH is looking for HIV positive
people between the ages of 18 and 50 with a CD4 count > 350
cells who are already on HIV medication. The VRC staff members
encouraged those at the meeting to share information with their
organizations and anyone they know who may be eligible or interested
in participating in the study.
To gain more information please call the Vaccine Research Center
at 1-866-833-LIFE or email VRCForLife@mail.nih.gov.
The AIDS Action Weekly Update
The Weekly Update is written
with a mind toward the interests of our members. If you are interested
in membership with AIDS Action, we invite you to contact members@aidsaction.org.
AIDS Action works
to end the HIV epidemic by advancing public policies that
prevent new infections, provide care for people living with
HIV, and support the search for a cure. AIDS Action serves
as the national voice for people living with HIV and represents
AIDS service organizations, health departments, and a diverse
network of community-based organizations across the country. |
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