Washington Highlights: July 10,
2009
AAMC Strongly Supports Joint Health Care Reform
Agreement
Contents
Prior Issues
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Vice President Joe Biden July 8 announced
a joint health care reform agreement with Senate Finance Committee
Chair Max Baucus (D-Mont.), the American Hospital Association (AHA),
the Catholic Health Association (CHA), and the Federation of American
Hospitals (FAH). The agreement phases in policies to expand health
coverage to 95 percent of all Americans. To help achieve this goal,
Medicare's hospital payment updates would be reduced by approximately
$100 billion over ten years. Additionally, the agreement allows
for up to $50 billion in Medicare and Medicaid Disproportionate
Share Hospital (DSH) payment reductions starting in 2015, depending
upon the rate of health care coverage increases. The agreement does
not include any reductions in Medicare payments for graduate medical
education (GME).
In a July 8 statement
strongly supporting the agreement, AAMC President and CEO Darrell
G. Kirch, M.D., praised the proposal for fulfilling two key AAMC
health reform principles: covering all Americans and preserving
the current safety net until new ones are in place. He stated that
the AAMC greatly appreciates "the thoughtful approach this agreement
takes to guarantee that the safety net remains intact during the
transition to a better system."
Earlier this year, President Obama had called for a nearly 75 percent
reduction in DSH payments. The recently released House health care
reform package included payment update reductions of nearly $119
billion, along with aggressive payment reductions for hospital readmissions
(approximately $16 billion in savings) [see Washington
Highlights, June 26].
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Medical School Deans, Teaching Hospital CEOs Urge
Congress to Increase GME Support
Members of the AAMC Council of Deans (COD) and Council of Teaching
Hospitals (COTH) sent a July 2 letter
to members of the House committees on Energy and Commerce, Ways
and Means, and Education and Labor; the Senate committees on Finance
and Health, Education, Labor, and Pensions (HELP); congressional
leadership; and the Obama Administration urging them to include
in any health care reform package AAMC-supported legislation to
expand Medicare support for graduate medical education (GME) [see
Washington
Highlights, May 8]. The letter was signed by 156 CEOs and
deans from nearly every state.
The letter states, "Our medical schools are increasing enrollment
but the number of physicians-in many specialties-will not meet the
needs of our communities unless teaching hospitals are able to expand
graduate medical education (GME) training." The letter continues,
"Creating more residency training slots supported, in part, by Medicare
is essential to increase the physician supply. We support the recently
introduced 'Resident Physician Shortage Reduction Act of 2009' (S.
973/H.R.
2251)." In the letter, the AAMC members express a strong commitment
to make comprehensive health care reform a reality.
Information:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
AAMC Comments on Draft House Reform Package
The AAMC July 3 submitted comments
on a draft health care reform package
issued by the House committees on Education and Labor, Energy and
Commerce, and Ways and Means [see Washington
Highlights, June 26]. Committee staff sought comments from
stakeholder groups as it works to finalize bill language before
the August recess. The AAMC comments praise the committees for working
to expand coverage while improving the delivery of health care.
In its comments, the AAMC also:
- Urges the House to add AAMC-supported language to increase the
number of Medicare-supported GME training slots (H.R.
2251 and H.R.
2350) [see Washington
Highlights, May 8];
- Opposes language directing the Government Accountability Office
(GAO) to evaluate residency training programs (e.g., faculty expertise
and curricular requirements) and assess the Accreditation Council
for Graduate Medical Education (ACGME) accreditation process;
- Urges a full repeal of the sustainable growth rate (SGR) used
to calculate Medicare physician payments;
- Expresses strong concern about language proposing a series of
major reductions to Medicare and Medicaid hospital payments; and
- Supports provisions to reauthorize Title VII health professions
training programs [see Washington
Highlights, June 26] and expand the National Health Service
Corps.
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
House Appropriations Subcommittee Approves FY
2010 Labor-HHS-Education Bill
The House Labor-HHS Appropriations Subcommittee July 10 approved
the FY 2010 Labor-Health and Human Services-Education Appropriations
bill. The bill includes
a $6.037 billion increase over FY 2009 for the Department of Health
and Human Services (HHS), which is $1.953 billion over President
Obama's FY 2010 request.
The bill includes $30.967 for NIH, an increase of $500 million
over the President's request, and $942 million over FY 2009. A statement from Appropriations Committee Chair David Obey (D-Wis.) indicates
that the Subcommittee is "rejecting the Administration's targeted
funding approach and ensuring that all institutes and centers receive
funding to offset biomedical research inflation."
According to the statement by Chairman Obey, the bill provides
"$530 million in HRSA to expand training programs across the health
professions and nursing fields, which provides a 34.9 percent increase
over 2009, and the same amount as the request."
The legislation also includes $6.643 billion for the Centers for
Disease Control and Prevention for public health activities. This
represents a $67 million increase over FY 2009. According to the
Chairman's statement, the Subcommittee has also dedicated "$204
million across HHS to continue the Subcommittee's aggressive campaign
to dramatically reduce life-threatening hospital infections," which
contribute to many deaths and increased health care costs for Americans.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
CMS Proposes Payment Changes for Hospital Outpatient
PPS and ASCs
The Centers for Medicare and Medicaid Services (CMS) July 1 posted
on its website a proposed
rule that contains changes to the outpatient prospective payment
system (OPPS) as well as proposed payment rates for Ambulatory Surgical
Centers (ASC). If finalized, CMS will implement the changes to both
the OPPS and the ASC payment system Jan. 1, 2010. Comments on the
proposed rule are due Aug. 31. The AAMC will be submitting comments.
CMS proposes to raise the base OPPS payment rate by the full market
basket increase of 2.1 percent.
The proposed rule changes the requirements for "direct supervision"
of hospital outpatient therapeutic services furnished in a hospital
and in on-campus provider-based departments (PBDs) of a hospital.
The new definition requires that the physician be present on the
same campus, in the hospital, or the on-campus PBD, and immediately
available to furnish assistance and direction through the performance
of the procedure. In the 2009 final OPPS rule, CMS clarified that
"direct supervision" was required that the physician had to be "on
the premises of the location" where the service was provided. Prior
to the 2009 final rule, many hospitals had understood that CMS required
general supervision of outpatient therapeutic services furnished
"incident to" a physician's service in the hospital and the on-campus
PBDs. Despite the confusion about the level of supervision, CMS
states that "we have not instructed contractors to delay initiation
of enforcement actions or to discontinue pursing pending enforcement
actions regarding the physician supervision of hospital outpatient
services."
The proposed rule also would allow physician assistants, nurse
practitioners, clinical nurse specialists, and certified nurse-midwives
to directly supervise all hospital outpatient therapeutic services
that they may perform under state law and scope of practice or hospital-granted
privileges.
CMS proposes a new methodology for calculating the payment rate
for separately payable drugs and biological. Under the new methodology
hospitals will receive the same payment rate as before, the average
sales price (ASP) plus 4.0 percent. If CMS had not made this proposal,
under the current methodology, separately payable drugs would be
reimbursed at ASP minus 2 percent. Recognizing that current methodology
underestimates the acquisition and overhead costs of separately
payable drugs and biologicals while overestimating the costs of
packaged drugs and biologicals, the new methodology will redistribute
some of the overhead cost of packaged drugs and biologicals to separately
payable drugs and biologicals.
The proposed rule does not add any additional measures to the hospital
outpatient quality reporting program. Thus, the reporting requirements
for the CY 2011 would remain the same. The proposed rule also does
not expand the Hospital Acquired Condition (HAC) program to the
hospital outpatient setting. While CMS is still committed to addressing
HACs in the hospital outpatient setting, the agency realizes there
are significant operational as well as structural challenges to
implementing such a program at this time.
CMS also proposes to increase the fixed-dollar outlier threshold
from $1,800 in CY 2009 to $2,225 in CY 2010.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
Jennifer Faerberg, Director, Health Care Affairs
AAMC Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498
NIH Issues Final Stem Cell Guidelines
The National Institutes of Health (NIH) July 6 released the final
NIH Guidelines
for Human Stem Cell Research, which were ordered by President Obama
as part of his March 9 executive order lifting restrictions on the
federal funding of human embryonic stem cell research [see Washington
Highlights, March 13]. NIH received more than 49,000 comments
on the April 13 draft guidelines. AAMC submitted comments
on the draft guidelines on May 22 [see Washington
Highlights, May 29].
In a statement,
AAMC President and CEO Darrell G. Kirch, M.D., said, "The AAMC is
pleased that the NIH has issued clear guidelines on stem cell research,
and established a pathway for existing lines to be considered for
federal funding. We hope to work with the NIH to ensure that this
process is transparent and moves forward in an expeditious manner
for the benefit of all patients."
NIH has made two major changes in the final guidelines. The first
is that NIH will create a stem cell registry that lists lines eligible
for federal funding. For embryos donated on or after the July 7
effective date of the guidelines, the only way to establish federal
funding eligibility will be to use stem cell lines on the NIH registry
or demonstrate compliance with the listed procedural requirements
and to provide supporting information to NIH for administrative
review.
The second major change is a process to review the eligibility
of stem cell lines created before the guidelines became final. Lines
created before July 7, 2009 will undergo review by a working group
of the Advisory Committee to the Director, which will advise NIH
on whether the "core ethical principles and procedures used in the
process for obtaining informed consent for the donation of the embryo
were such that the cell line should be eligible for NIH funding."
Lines deemed eligible will be listed on the NIH Registry and not
need additional review.
NIH also will use the working group to assess foreign derived
stem cell lines, created both before and after the effective date
of the guidelines. NIH said the separate process is required "because
donation of embryos in foreign countries is governed by the laws
and policies of the respective governments of those nations. Although
such donations may be responsibly conducted, such governments may
not or cannot change their national donation requirements to precisely
comply with the NIH Guidelines."
NIH has not altered the ban on federal funding for research using
stem cell lines derived from somatic cell nuclear transfer, parthenogenesis,
or from embryos created expressively for research purposes. The
agency has amended the final guidelines to allow explicitly for
the donation of embryos that have undergone Pre-implantation Genetic
Diagnosis (PGD).
Other notable provisions include:
- Clarification that embryo donors must be made aware of all embryo
disposal options "available in the health care facility where
treatment was sought" rather than all available options, regardless
of whether they were available;
- A revision of the guidelines to state explicitly that there
should be documentation that "no payments, cash or in kind, were
offered for donated embryos;"
- Clarification that "a general authorization for research donation
when consenting for reproductive treatment would comply with the
Guidelines, so long as specific consent for the donation is obtained
at the time of donation;" and
- Clarification that while the IVF physician and the researcher
seeking embryo donation should be different individuals, "this
is not always possible, nor is it required, in the NIH's view,
for ethical donation."
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
Senate HELP Committee Continues Health Care Reform
Deliberations
The Senate Health, Education, Labor, and Pensions (HELP) Committee
July 7 resumed daily consideration of the draft Affordable Health
Choices Act, after returning from Congress's week-long Independence
Day recess. After completing amendments to Title II (quality), Title
III (prevention), and Title IV (workforce) of the bill June 25 [see
Washington
Highlights, June 26], the panel primarily focused on issues
related to coverage. The committee July 2 released an additional
"chairman's mark"
that modifies Title I (coverage) and Title VI (biologics).
Senate HELP Democrats are reportedly considering including compromise
legislation for biosimilars in their health reform package. The
compromise legislation would allow for a baseline of 9 years of
data exclusivity for an original biologic, but up to 13 years with
possible extensions. Previously, legislation has been proposed in
both the House and Senate, the Promoting Innovation and Access to
Life-Saving Medicine Act (S.
726, H.R.
1427), that would allow for 5 years of data exclusivity for
original biological products, with another year possible [See Washington
Highlights, March 13]. Legislation has also been introduced
in the House, the Pathway to Biosimilars Act (H.R.
1548), that would allow 12 years of data exclusivity, with another
2 years of extensions possible.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
SBIR Reauthorization Proceeds
Congress moved closer to reauthorizing the Small Business Innovation
Research (SBIR) program as the House July 8 approved legislation
extending the program.
The Senate July 10 was expected to approve its version of the bill,
the SBIR/STTR Reauthorization Act of 2009 (S.
1233). The Senate bill includes a provision to increase the
allocation for the SBIR program from 2.5 percent to 3.5 percent
of any federal agency budget that provides more than $100 million
for research, including the National Institutes of Health. The AAMC
joined nearly 100 groups on a June 23 letter opposing the provision
[see Washington
Highlights, June 26].
Meanwhile, the House July 8 approved the Enhancing Small Business
Research and Innovation Act of 2009 (H.R.
2965), which does not increase the set-aside. The bill passed
by a vote of 386-41.
The two chambers now must reconcile differences in the bills through
conference negotiations.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
HHS Launches New IRB Registration System
The Department of Health and Human Services (HHS) web-based electronic
system for Federal-wide Assurance (FWA) and Institutional Review
Board (IRB) registrations will be available for submissions starting
July 14 [see Washington
Highlights,
Jan. 23].
The IRB registration system will be compatible with the requirements
of both the HHS and Food and Drug Administration (FDA) regulations.
The HHS IRB registration requirements were added as a new subpart
E to the HHS protection of human subjects regulations (45 CFR part
46).
FDA's IRB registration system and Office for Human Research Protections'
(OHRP's) system for electronic submission of FWA documents and IRB
registration documents will be shut down during the period of July
8 through July 13 to migrate the current FWA records to an updated
electronic submission system.
In addition, beginning on July 14, IRB registration information
for both rules will be collected on the OMB-approved modified IRB
registration form (OMB
No. 0990- 0279).
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
President Obama Announces Intent to Nominate
Francis Collins as NIH Director
President Obama July 8 announced
his intent to nominate Francis S. Collins, M.D., Ph.D., to be the
new director of the National Institutes of Health (NIH). Dr. Collins
served as the Director of NIH's National Human Genome Research Institute
(NHGRI) for 15 years and is known for his leadership of the International
Human Genome Sequencing Consortium.
Dr. Collins received a B.S. in Chemistry from the University of
Virginia, a Ph.D. in Physical Chemistry from Yale University, and
an M.D. with Honors from the University of North Carolina at Chapel
Hill School of Medicine. Prior to coming to NIH in 1993, he spent
nine years on the faculty of the University of Michigan, where he
was an investigator of the Howard Hughes Medical Institute. He has
been elected to the Institute of Medicine and the National Academy
of Sciences, and was awarded the Presidential Medal of Freedom in
November 2007.
AAMC President and CEO Darrell G. Kirch, M.D., issued a statement
on the nomination, praising President Obama's choice: "America is
very fortunate to have a scientist of Dr. Collins' experience, understanding,
and vision willing to serve as leader of the world's foremost biomedical
and behavioral research enterprise. The AAMC looks forward to working
with Dr. Collins as he leads the NIH forward in this period of tremendous
scientific potential and fiscal, administrative, and research challenges."
On the Agenda in Washington...
July 14-15: ONC HIT Policy Committee's Certification/Adoption
Workgroup to Hear Testimony on the Certification Process
Time 9 a.m. - 4 p.m. on July 14, 9-10 a.m. on July 15;
Park Hyatt Washington Hotel, 24th and M Streets NW
The Certification/Adoption Workgroup is scheduled to hear testimony
from stakeholder groups, including purchasers, vendors, and users,
on the certification process.
July 16: ONC HIT Policy Committee to Discuss Definition of
"Meaningful Use"
Time 10 a.m. - 2 p.m., Park Hyatt Washington Hotel, 24th
and M Streets NW
The HIT Policy Committee will discuss the draft definition of
"meaningful use" as modified since its June meeting.
July 30: VA House Oversight and Investigations Subcommittee
to Examine Gulf War Illness Research
Time 10 a.m., 334 Cannon Building
Oversight and Investigations Subcommittee of the House Veterans'
Affairs Committee will hold a hearing titled "The Implications of
VA's Limited Scope of Gulf War Illness Research."
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