Washington Highlights: December
10, 2004
President Signs
Omnibus Completing FY 2005 Appropriations Process
Contents
Prior Issues
|
The President Dec. 8 signed the FY 2005 omnibus appropriations
bill, completing the FY 2005 appropriations process. The bill, which
passed both the House and Senate on Nov. 20, had been held up in
the Senate until the House passed a resolution (H.
Con. Res. 528) removing a controversial tax-related provision
on Dec. 6.
The final spending bill includes $28.4 billion for the
National Institutes of Health, an increase of 2.1 percent; $299.6
million for the Title VII health professions programs, a 1.8 percent
increase; and $27.7 billion for veterans health care, an increase
of 4.7 percent. For additional information on programs of interest
to medical schools and teaching hospitals, see Washington
Highlights, Dec. 3.
Principi Resigns, Nicholson Nominated to be VA
Secretary
The White House Dec. 8 announced the resignation of Secretary of
Veterans Affairs Anthony Principi, and Dec. 9 announced the nomination
of Jim Nicholson as his successor. Secretary Principi, who has served
as Secretary since February 2000, said, "it is now time for
me to move on to fresh opportunities and different challenges."
Jim Nicholson is a decorated Vietnam veteran and former chairman
of the Republican National Committee. Most recently, Mr. Nicholson
has served as the U.S. Ambassador to the Vatican.
OIG Issues Report on Paying for Training Residents
in Nonhospital Sites
The Department of Health and Human Services Office of Inspector
General (IG) Dec. 8, issued a report entitled "Alternative
Medicare Payment Methodologies for the Costs of Training Medical
Residents in Nonhospital Settings" (A-02-04-01012)
as required by Section 713 of the Medicare Modernization Act (MMA).
The report identifies five alternative methodologies for paying
the costs of training residents in nonhospital settings, but notes
that each "has both positive and negative aspects." Therefore,
before adopting any of the methodologies, the IG urges Congress
and the Centers for Medicare and Medicaid Services (CMS) to further
analyze the current financial arrangements between teaching hospitals
and nonhospital settings; study the potential impact of any revisions
to the current policy; and clarify the definition of "all or
substantially all" of the costs associated with training residents
in nonhospital settings.
In the interim, the IG recommends that
CMS work with Congress to extend a current moratorium, currently
set to expire on Dec. 31, which allows teaching hospitals to count
for purposes of determining Medicare Direct Graduate Medical Education
(DGME) and Indirect Medical Education (IME) payments osteopathic
and allopathic family practice residents training in nonhospital
settings without regard to the financial arrangements between the
hospitals and the supervisory physicians who practice at those settings.
To undertake this study, the IG requested information on the numbers
and types of residents who rotate to nonhospital settings and to
rural and underserved areas from approximately 1,300 hospitals,
of which 1,200 responded. IG staff also visited 63 hospitals, and
as part of each visit, went to two nonhospital sites, generally
one family practice program and one other type of program. In addition,
IG staff met with Congressional staff, CMS, the AAMC, and other
interested organizations.
The IG identified the following five alternative methodologies
for consideration by Congress and CMS for paying the costs of training
residents in nonhospital settings:
- Maintain current regulations requiring teaching hospitals
to pay "all or substantially all" of the teaching cost,
but clarify its definition of direct teachings costs, including
the treatment of volunteer time.
- Determine a percentage of each teaching hospital's
per resident amount that would be a proxy for the nonhospital setting's
teaching and overhead costs. Hospitals would be required to pay
this amount to the nonhospital setting and to continue to pay the
residents' salaries and fringe benefits.
- Dedefine in regulation "all or substantially all"
of the training costs as the residents salaries and fringe benefits
and other costs as determined by each teaching hospital and nonhospital
setting.
- Make direct payments to nonhospital sites.
- Make direct Medicare payments to supervisory physicians
at nonhospital settings.
The IG also noted that during the visits to nonhospital sites it
found "instances of noncompliance with Medicare regulations,"
with 21 percent of nonhospital sites lacking a written agreement
with the hospital that claimed the residents.
In the Acting IG's cover letter to CMS Administrator Mark McClellan,
M.D., the letter requests CMS' "final management decision,
including any action plan…within 60 days."
Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Government Relations
ldavisboyle@aamc.org
(202) 828-0526
NIH Reminds Institutions About Safety in rDNA
Research
The National Institutes of Health (NIH) Dec. 6 issued a memorandum
reminding grantee institutions of their compliance obligations for
safety and oversight of research involving recombinant DNA (rDNA).
The memo from Amy P. Patterson, M.D., director of NIH's Office of
Biotechnology Activities, reiterates that institutions receiving
any NIH funding for rDNA research must adhere to NIH guidelines,
including establishing local Institutional Biosafety Committees
(IBCs). Dr. Patterson notes that agency staff are planning site
visits to selected institutions in 2005 to help educate the community
about these requirements. "In the meantime," Dr. Patterson
advises, "institutions are strongly encouraged to take stock
of the portfolio of recombinant DNA research they are conducting
and to verify that research projects are being registered and, as
appropriate, approved by a duly-constituted [IBC]."
The memo does not mention the forthcoming role that IBCs are expected
to play in the oversight of biological "dual use" research
- i.e., research that potentially could be misused for terrorism
or other malign purposes. In March, Health and Human Services Secretary
Thompson announced the creation of a National Science Advisory Board
for Biosecurity (NSABB) that will help set policies on dual use
research, working with IBCs [see Washington
Highlights, March 12]. The
appointment of members to the NSABB has not yet been announced.
Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
NIH ACD Discusses Clinical Trials and Public Trust
The National Institutes of Health (NIH) Advisory Committee to the
Director (ACD) received a comprehensive set of recommendations focused
on improving public trust and participation in clinical trials at
its Dec. 2-3 meeting. Developed by the NIH Council of Public Representatives
(COPR) from a broadly inclusive workshop held on Oct. 27, the recommendations
were presented by COPR members Lawrence Sadwin, Craig Beam, and
Debra Hall, Ph.D. They said that the report is intended to help
improve clinical research by building trust and relationships among
the patients and other stakeholders in this research. Among the
recommendations, the COPR encourages NIH to plan for community involvement
in its clinical research, partner with community-sanctioned organizations,
and assist in developing research projects that address community
needs. The public representatives noted that participants in clinical
trials often are not even informed of the study's outcomes. Better
communication before, during, and after a trial - including statements
of thanks and appreciation for study participants - is needed. The
COPR members noted that the trust of study participants depends
in part on there being no conflicts of interest among researchers.
ACD member R. Sanders Williams, M.D., dean of Duke University School
of Medicine, and others noted that such conflicts cannot be entirely
eliminated, but require mechanisms for disclosing and effectively
managing them.
On other topics, the ACD approved of a concept to provide health
insurance for individual post-doctoral fellows, and for NIH to identify
the appropriate level of benefit. The cost of providing health benefits
would be offset by relatively slight reductions in the number of
post-doctoral fellowships awarded, although the ACD noted that the
action would create a fiscal "ripple effect" for post
docs supported on research grants or other mechanisms. Dushanka
Kleinman, D.D.S., M.Sc.D., NIH assistant director for Road Map Coordination,
presented a summary of NIH Roadmap activities in the first year
of implementation, including establishing four national centers
for biomedical computing, seven grants to develop a patient reported
outcomes measurement information system, a score of interdisciplinary
research exploratory centers, and the Director's Pioneer Awards,
among many other accomplishments. The ACD recommended that NIH not,
as some have proposed, limit Pioneer Awards to relatively new researchers,
but rather blind the initial review of proposals to focus solely
on innovative science.
Information
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
|
