Washington Highlights: April
20, 2007 MedPAC Considers Health Workforce Shortages
ContentsPrior Issues  |
On April 13, Edward Salsberg, director of the AAMC Center for Workforce
Studies, presented before the Medicare Payment Advisory Committee
(MedPAC) on physician workforce,
including why the AAMC has recommended
an increase in the supply of physicians. MedPAC invited the AAMC
to be part of a panel last Friday to discuss the current status
of the supply of the nation's physicians and other clinicians, and
Medicare's role in addressing the issue.
Salsberg stressed the importance of increased Medicare-funded graduate
medical education (GME) positions to expanding the nation's physician
supply and assuring access to care. Kevin Grumbach, M.D., professor
and chair of the University of California at San Francisco Department
of Family and Community Medicine, also presented his research on
physician supply and urged greater federal support for primary care
physicians and services. Mary Mundinger, Dr.P.H., dean of Columbia
University's School of Nursing, urged greater reliance on nurse
practitioners and support for nurse practitioner education and practice.
During the session that followed, MedPAC commissioners asked questions
regarding Medicare's role in promoting an adequate supply and distribution
of well qualified health professionals. Some commissioners suggested
the shortage might be alleviated by eliminating inefficiencies and
unnecessary services from the nation's health care system.
Information:
Edward Salsberg, Associate Vice President
AAMC Division of Medical School Affairs
esalsberg@aamc.org
(202) 828-0415
MedPAC Approves Wage Index Recommendations, Discusses
Comparative Effectiveness
At its April 12-13 meeting,
the Medicare Payment Advisory Commission (MedPAC) approved recommendations
for a mandated report on the Medicare inpatient wage index. The
report is due June 30 and MedPAC will include it in its June report
to Congress. The Centers for Medicare and Medicaid Services (CMS)
is required by statute to take MedPAC's report into account for
the purpose of revising the wage index when it publishes the fiscal
year 2009 inpatient prospective payment system proposed rule.
MedPAC approved three recommendations, which if implemented, would
lead to a number of changes. On the legislative side, Congress would
repeal the current wage index statute and give CMS the authority
to establish a new wage index system. On the regulatory side, CMS
would establish a hospital compensation index that uses wage data
from all employers and industry-specific occupational weights; is
adjusted for geographic differences in the ratio of wages to benefits;
is adjusted at the county level and smoothes large differences between
counties; and is supplemented so that large changes in the wage
index values are phased in over a transition period. Finally, CMS
would use the hospital compensation index for the home health and
skilled nursing facilities prospective payment systems and evaluate
its use for other prospective payment systems.
In light of the dramatic changes in payments that would result
from the new approach, the commissioners emphasized the need for
a phase-in period to help hospitals that would experience losses
to adjust to the new system.
MedPAC staff analyses showed that the recommended approach would
have the greatest impact on those hospitals currently reclassified
under the system. Each individual hospital could lose between 2.8
percent and 6.9 percent on the wage index or between 1.3 percent
and 4.2 percent in inpatient payments.
According to MedPAC staff, the new approach would have a few advantages
over the current system. One is that it would reflect input prices
in the market rather than individual hospitals' costs, which would
make it more appropriate for a prospective payment system. It also
would diminish volatility from year to year, smooth cliffs between
adjacent areas, eliminate the need for an occupational mix adjustment
and decrease the problem of circularity - whereby a hospital that
controls its wages ends up getting a lower wage index in the coming
year.
As a result, MedPAC staff believes that the new approach would
decrease dramatically the need for an exception process, which is
viewed by many as a major problem with the current system. The disadvantage
of the new approach is that the data are based on a voluntary survey,
and wage index may be affected if some hospitals fail to participate.
Also during the meeting, a panel discussed the need for clinical
and cost-effectiveness comparison studies, as health expenditures
continue to grow at an unsustainable rate and new health care services
are introduced with little or no comparison to existing treatments.
Gail Wilensky, Ph.D., senior fellow at Project HOPE, emphasized
the importance of studying the clinical effectiveness of medical
procedures, rather than limit research to the clinical effectiveness
of drugs and devices as other countries have been doing. The commissioners
agreed there is a need to establish a new independent government
agency to conduct such studies. However, because cost-effectiveness
could be used to deny services, commissioners emphasized presenting
cost-effectiveness analyses in a manner that would not lead to a
denial of services.
Other topics covered during the meeting include:
- Review of the annual CMS estimate for updating physician payments.
Currently, a negative 9.9 percent update is expected for 2008 unless
Congress intervenes with a legislative solution;
- Update on using episode groupers and administrative claims data
for quality measurement;
- Physician and nurse practitioner supply (see related article);
- Resource use and quality measures;
- Hospital readmissions;
- Mandated report on home health pay for performance; and
- Skilled nursing facility quality.
Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498
Mary Patton, Senior Specialist
AAMC Health Care Affairs
mpatton@aamc.org
(202) 862-6297
Congressional Leaders Introduce Patent Reform
Bill
The chairs and senior members of the Senate and House Judiciary
Committees April 18 introduced legislation that would be the most
major reform of the U.S. patent system in 50 years. The Patent
Reform Act of 2007 was introduced by Senate Judiciary Committee
Chairman Patrick Leahy (D-Vt.), and Senator Orrin Hatch (R-Utah),
a senior member of the panel; and Rep. Howard Berman (D-Calif.),
chair of the House Judiciary Subcommittee on Courts, the Internet,
and Intellectual Property and Rep. Lamar Smith (R-Texas), ranking
member of the House Judiciary Committee.
The intent of the legislation is to improve the quality of patents
by streamlining processes within the U.S. Patent and Trademark
Office (PTO) and, to some extent, reducing the need for costly
and protracted litigation. A notable proposed reform is to move
from a "first to invent" to a "first inventor to
file" system-under which the PTO would give priority to the
first inventor to file a patent application-that would obviate
much of the need for costly "interference" proceedings
when two or more parties claim to have made the same invention
separately. This reform also would bring the PTO into closer alignment
with the other nations' patent systems.
The legislation also would establish a "second window"
for outside parties to contest the PTO's decision to grant a patent;
for example, by arguing that the patent merely extends prior art
in some obvious or non-inventive way. Many proponents of patent
reform assert that the current system is being abused by unwarranted
accusations of infringement, citing controversial cases in the
information technology and telecommunication industries. However,
others are concerned that proposed reforms would weaken patent
protections; the pharmaceutical and biotechnology industries are
especially dependent on intellectual property protections, and
opposed major provisions in earlier bills.
The bills are largely similar to measures introduced in the 109th
Congress, but did not make it through committee. House and
Senate Judiciary Committee staff has indicated that the members
are committed to passing legislation this session, emphasizing
the bipartisan and bicameral coordination used in crafting the
current legislation.
The AAMC, as part of a group led by the Association of American
Universities, developed a consensus
position on the previous patent reform bills. Several university
concerns articulated by the group already are reflected in the
proposed legislation, including continuation of the Cooperative
Research and Technology Enhance Act (P.L.
108-453), which protects inventions made by research teams
at multiple institutions.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
Senate Panel Passes FDA Legislation
The Senate Health, Education, Labor, and Pensions (HELP) Committee
April 18 passed legislation reauthorizing the Food and Drug Administration's
(FDA) prescription drug user fee program. The committee passed
"The Food and Drug Administration Revitalization Act"
(S.
1082) by a 15-5 vote. The bill also includes provisions to
address drug safety, medical device user fees, and pediatric drug
testing.
The bill reauthorizes the Prescription Drug User Fee Act (PDUFA),
which expires on Sept. 30, 2007. The bill calls for nearly $393
million in user fees in 2008, and expands the use of drug user
fees by nearly $30 million for post-approval drug safety programs.
The bill also includes an FDA-industry proposal to create a voluntary
user fee program under which drug companies can submit direct-to-consumer
television advertisements to the agency for review prior to distribution.
S. 1082 also includes a modified version of drug safety legislation
sponsored by HELP Chair Edward Kennedy (D-Mass.) and Ranking Member
Michael Enzi (R-Wyo.) [see Washington
Highlights, Feb. 16].
The revised proposal
establishes a computer-based system of surveillance of adverse
drug events for newly approved drugs. The bill also authorizes
the use of Risk Evaluation and Mitigation Strategies (REMS) for
certain drugs that require additional controls to reduce risk.
An earlier version of the bill had required REMS for all new drug
applications.
The bill also expands the ClinicalTrials.gov data bank at the
National Library of Medicine to include all phase II and later
trials, and to include medical device trials. Currently, only
clinical trials of drugs for serious and life threatening conditions
are required to be registered in the data bank. In addition, results
from clinical trials will be included in the data base. Information
would be added to the data base only after the drug or device
has been approved or cleared for marketing. Results information
would first come from existing FDA and National Institutes of
Health documents, as well as peer-reviewed scientific publications.
A negotiated rulemaking process would be used to determine when
and how to add results information not captured in these documents.
The bill also requires disclosure of conflicts of interest by
FDA advisory committee members prior to committee meetings, and
greater efforts by FDA to identify and recruit members of advisory
committees.
S. 1082 also reauthorizes the Medical Device User Fee Modernization
Act (MDUFMA), which is scheduled to expire Sept. 30, for an additional
5 years. The bill authorizes $287 million in user fess for 5 years,
with $48 million in 2008, coupled with an 8.5 percent fixed annual
increase and a further reduction of fees for small business.
Title IV of the bill reauthorizes for 5 years the Best Pharmaceuticals
for Children Act (BPCA), which generally provides 6 months of
additional exclusivity to encourage drug manufactures to study
the safety and efficacy of drugs in children. The bill also reauthorizes
the Pediatric Research Equity Act, which would consolidate an
internal FDA committee to review all issues of pediatric-related
labeling and assessments to improve coordination with the pediatric
exclusivity provisions of the BPCA.
The committee adopted amendments by Senator Richard Burr (R-N.C.)
to require deadlines for FDA-industry negotiations on drug labeling
changes and by Senator Tom Coburn (R-Okla.), a physician, to subject
"medical" marijuana to FDA approval, including a review
of its safety and efficacy.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
CMS Issues Revisions to Informed Consent Interpretive
Guidelines
The Centers for Medicare and Medicaid Services (CMS) April 13
issued revisions
to the Hospital Interpretive Guidelines for Informed Consent.
The revisions, effective immediately, appear to be an improvement
to the current guidelines, as they are far less prescriptive.
The required elements include the name of the hospital, practitioner,
and specific procedure, as well as a statement that the procedure
or treatment's anticipated benefits, material risks, and alternative
therapies have been explained to the patient's legal representative.
The guidelines also state that a well-designed informed consent
process "might include" the following:
- Name of the practitioner who conducted the informed consent discussion
with the patient or the patient's representative.
- Date, time, and signature of the person witnessing the patient
or the patient's legal representative signing the consent form.
- Listing of the material risks of the procedure or treatment that
were discussed with the patient or the patient's representative.
- Statement, if applicable, that physicians other than the operating
practitioner, including but not limited to residents, will be performing
important tasks related to the surgery.
- Statement, if applicable, that qualified medical practitioners
who are not physicians who will perform important parts of the surgery
or administration of anesthesia will be performing only tasks that
are within their scope of practice and for which they have been
granted privileges by the hospital.
The guidelines also contain a section about procedures in which
residents will perform important parts of the surgery. For such
surgeries, CMS encourages that discussion with the patient touch
on a number of issues, including "that physicians who are
in approved post graduate residency training programs will perform
portions of the surgery, based on their availability and level
of competence," and that "residents performing surgical
tasks will be under the supervision of the operating practitioner/teaching
surgeon."
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
HHS Announces HIT Director
Secretary of Health and Human Services (HHS) Mike Leavitt April
18 announced the appointment of Robert M. Kolodner, M.D., to head
the Office of the National Coordinator for Health
Information Technology (ONC) at HHS. Dr. Kolodner has been
serving as the Interim National Coordinator for Health IT since
Sept. 20, 2006.
Dr. Kolodner joined HHS from the Department of Veterans Affairs'
(VA) Veterans Health Administration, where he was Chief Health
Informatics Officer. In that role, he was chief advisor to the
VA's Under Secretary for Health on information technology issues
and oversaw the development of the VA's renowned electronic health
record. Dr. Kolodner received his M.D. from Yale University School
of Medicine and completed his psychiatric residency at Washington
University School of Medicine.
HHS Appoints New AHRQ Advisory Committee Members
Secretary of Health and Human Services (HHS) Mike Leavitt April
9 appointed six new members and reappointed two members to the National
Advisory Council
for the Agency for Healthcare Research and Quality (AHRQ). One reappointed
member, J. James Rohack, M.D., will take over as chair of the group.
Dr. Rohack is Senior Staff Cardiologist and Medical Director at
Scott and White Clinic in Temple, Tex. The other reappointed member
is Andrew J. Fishmann, M.D., Director of Intensive Care at the Good
Samaritan Hospital in Los Angeles.
The new council members are:
- Jane F. Barlow, M.D., M.B.A., Well-being Director, IBM Corporation,
Somers, N.Y.
- Timothy J. Brei, M.D., Clinical Assistant Professor of Pediatrics,
the James Whitcomb Riley Hospital for Children, Indianapolis.
- M. Carolina Hinestrosa, M.A., M.P.H., Executive Vice President of
Programs and Planning, National Breast Cancer Coalition, Washington,
DC.
- Thomas P. Miller, J.D., Resident Scholar, American Enterprise Institute,
Washington, DC.
- Neil R. Powe, M.D., M.P.H., M.B.A., Professor of Medicine, Epidemiology
and Health Policy and Management, Johns Hopkins University School
of Medicine, Baltimore, MD.
- Anthony C. Wisniewski, J.D., Executive Director of Health Policy,
U.S. Chamber of Commerce, Washington, DC.
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