Washington Highlights: January 23,
2009
House Panels Approve Economic Recovery Legislation
Contents
Prior Issues
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Three House committees approved portions of an economic recovery
package that include $3.9 billion for the National Institutes of
Health (NIH), a reversal of the FY 2009 cut to Indirect Medical
Education (IME) payments made under Medicare's capital reimbursement
system, a short-term extension of the current "Medicaid Moratorium,"
and state Medicaid relief.
The House Appropriations Committee Jan. 21 approved, 35-22, the
portion of the package that includes $358 billion in discretionary
spending. In addition to the NIH funding, the bill provides $600
million for primary care training through the Health Resources and
Services Administration (HRSA), as well as funds for the Agency
for Healthcare Research and Quality, comparative effectiveness research,
and the Biomedical Advanced Research and Development Authority [see
Washington Highlights,
Jan. 16].
At the mark-up, House Appropriations Chair David Obey (D-Wis.)
noted that it would be "irresponsible" for Congress to
proceed with plans to reform the health care system without investing
in such research and an expanded health care workforce. He also
noted that health care is one of the few sectors of the economy
in which jobs are increasing.
The House Ways and Means Committee Jan. 22 voted, 24-13, to approve
economic recovery legislation that includes AAMC-supported provisions
fully restoring FY 2009 capital IME payments to teaching hospitals
($175 million). It does not address the full elimination of the
capital IME payments scheduled for FY 2010.
Also on Jan. 22, the House Energy and Commerce Committee approved
its portion of the economic recovery package, which includes an
extension until July 1, 2009, of the current moratorium prohibiting
action related to the Medicaid GME proposed rule and Medicaid "IGT
final rule" [see Washington
Highlights, June
27, 2008]. Additionally, the legislation would provide a temporary
(Oct. 1, 2008 to Dec. 31, 2010) 4.9 percent increase in the Federal
Medical Assistance Percentage (FMAP) for all states. The bill establishes
criteria whereby certain "high unemployment states" could
receive additional FMAP increases. It also increases by 2.5 percent
states' disproportionate share hospital (DSH) allotments for FY
2009 and FY 2010.
The three bills establish incentives to promote the adoption and
"meaningful use" of health information technology (HIT).
The HIT provisions also include increased health information privacy
protections.
The three bills are expected to be combined and considered by the
full House Jan. 28. The Senate is working on similar legislation,
but as of press time, details were not available.
Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
House Sign-On Letter Urges Obama Administration
to Consider Hospital Relief in Stimulus Package
Led by Reps. Robert Brady (D-Pa.) and Joe Wilson (R-S.C.), a total
of 130 House members (including 21 Republicans) signed a Jan. 16
letter to
President Obama and his transition team, urging his strong support
for economic recovery language that addresses several critical hospital
issues.
Among the concerns raised by the letter is the immediate need to
block cuts to Medicare's Capital IME payments (scheduled for full
elimination by Oct. 1, 2009). The letter states that, "These unnecessary
cuts ignore how vital these capital payments are to investment in
the latest medical technology, ongoing maintenance and improvement
of hospital facilities and importance of medical education."
Information:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418
Senators Reintroduce Physician Payments Sunshine
Act
Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) Jan. 22
reintroduced the "Physician Payments Sunshine Act" (S. 301), which
will require drug and medical device manufacturers to disclose all
their payments and gifts to physicians, if the annual total to an
individual physician is more than $100 [see Washington
Highlights,
Sept. 14, 2007]. The legislation will require drug, device,
or medical supply manufacturers that receive payments through Medicare,
Medicaid, or the State Children's Health Insurance Program (SCHIP)
to disclose to the Department of Health and Human Services (HHS),
on a quarterly basis, anything of value given to doctors, such as
payments, gifts, honoraria, or travel. This would include funding
given for continuing medical education and research grants.
The bill requires companies to report the name of the physician,
the address of the physician's office, the value and the date of
the payment or gift, its purpose, and what, if anything, was received
in exchange. If a payment or other transfer of value was provided
to an entity that the physician is employed by, has tenure with,
has a significant ownership interest in, or to an organization in
which the physician has a significant professional membership interest
in, the company must report the entity and its primary place of
business or headquarters. Companies that knowingly fail to report
are subject to penalties up to $1 million, a change from the $100,000
maximum penalty in the previous bill.
The bill also requires HHS to establish no later than Nov. 1, 2009,
procedures for companies to submit information and procedures for
HHS to make the submitted information available to the public via
a searchable online registry. The registry must be available to
the public by Sept. 20, 2011. Reporting by companies would be mandatory
beginning March 31, 2011.
The newly reintroduced legislation clarifies preemption provisions
that were questioned in the previous version. The new bill specifies
that states have the authority to collect additional information
from companies as long as the information is not specifically covered
by federal law. Additionally, related state law, such as the current
ban on physician gifts in Massachusetts, would not be affected.
The AAMC endorsed the previous version of the Physician Payments
Sunshine Act in the 110th Congress [see Washington
Highlights, May
16, 2008]. The bill has two cosponsors and has been referred
to the Senate Committee on Finance.
Information:
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525
Obama Administration Undertakes Regulatory Review
Rahm Emanuel, Assistant to President Obama and Chief of Staff,
issued a Jan. 20 memorandum
to heads of executive departments and agencies with instruction
for regulatory activity moving forward. The memorandum directs federal
departments and agencies to:
- Not send to the Office of the Federal Register any proposed
or final regulations unless approved by an Obama appointee;
- Withdraw all proposed or final regulations that have not been
published in the Federal Register so they can be reviewed and
approved; and,
- Consider a 60 day extension in the effective date of regulations
that have been published but have not yet taken effect "for
the purpose of reviewing questions of law and policy raised by
those regulations."
This memorandum will be published in the Federal Register.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
HHS Consolidates Registration of Institutional
Review Boards
The Department of Health And Human Services (HHS) Office for Human
Research Protections (OHRP) Jan. 15 announced new regulations
to require the registration of institutional review boards (IRBs)
that review human subjects research conducted or supported by HHS
and that are designated under an assurance of compliance approved
for federal-wide use by OHRP. The registration will require IRBs
to submit information previously provided on a voluntary basis.
The Federal Drug Administration (FDA) Jan. 15 issued a final
rule allowing the operation of a single HHS IRB registration
system. The final rule is effective July 14. All IRBs must comply
with the initial registration requirement and, if necessary, make
required revisions to their registrations by Sept. 14, 2009.
OHRP states that the IRB registration system is compatible with
FDA IRB registration requirements. IRBs may register on the OHRP
website.
Information:
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FDA Releases Final Guidance on Adverse Event Reporting
The Food and Drug Administration (FDA) Jan. 15 released its final
guidance document on clinical trial adverse event reporting. The
new guidance clarifies the types of unanticipated problems that must
be reported to the institutional review board (IRB), and suggests
that for multi-site studies the sponsor instead of the investigator
assume responsibility of assessing whether an adverse event is an
unanticipated problem.
According to the guidance, investigators and sponsors should only
consider an adverse event to be an unanticipated problem if the
adverse event is "unexpected, serious, and would have implications
for the conduct of the study," therefore requiring considerable,
safety-related protocol or consent changes.
The guidance describes the categories of unanticipated problems
that need to be reported to the IRB. The final document lists two
categories of unanticipated problems not mentioned in the initial
draft guidance issued in April 2007: when the adverse event
is not associated with the study drug but is not common in the studied
population; and when there is a clinically significant increase
in rate of occurrence of an anticipated serious adverse event.
The guidance also clarifies requirements for reporting of "unanticipated
adverse device effect" (UADE) to the sponsor and IRB.
Information:
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FDA Seeks Comments on Participation in Clinical
Drug Trials
The Food and Drug Administration (FDA) Jan. 13 published a Federal
Register notice
requesting information and comments from medical product manufacturers,
institutional review boards (IRBs), academic researchers, and patient
groups on issues related to the participation of elderly, children,
racially and ethnically diverse communities, and medically underserved
populations in clinical trials.
Written or electronic comments should be submitted online
or to the Division of Dockets Management by Feb. 27, 2009.
Information:
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Besser to Serve as Acting Director of CDC
Richard Besser, M.D., was named Acting Director of the Centers
for Disease Control and Prevention (CDC) upon the departure of outgoing
Director Julie Gerberding, M.D., M.P.H., who stepped down Jan. 22,
after six years. Dr. Besser, a board certified pediatrician, has
a strong background in public health, and has worked with the CDC
for many years. Dr. Besser has served in the CDC's Epidemic Intelligence
Service, working on tracking food borne diseases and various other
infectious disease issues. He has also been a leader in the fight
to prevent overprescribing of antibiotics. Additionally, Dr. Besser
worked on public health emergency preparedness and emergency response,
as the Director of the Coordinating Office for Terrorism Preparedness
and Emergency Response.
On the Hill...
Secretary of State Hillary Clinton was sworn in Jan. 21 shortly
after the Senate voted to confirm her nomination. New York Gov.
David Paterson (D) is expected to name Rep. Kirsten Gillibrand (D)
to fill the Senate seat vacated by Secretary Clinton.
Retired Army Gen. Eric K. Shinseki took the oath of office Jan.21
as the nation's seventh Secretary of Veterans Affairs, assuming
the leadership of the Department of Veterans Affairs following his
Jan. 20 confirmation by the Senate.
The Senate Jan. 21 unanimously approved Arne Duncan as Education
Secretary. Duncan had previously served as Chief Executive Officer
of the Chicago Public Schools.
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