Washington Highlights: August 31,
2007
AAMC Comments on CMS Clinical Research Proposal
Contents
Prior Issues
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The AAMC Aug. 15 submitted comments
to the Centers for Medicare and Medicaid Services (CMS) on the proposed
second reconsideration of the Clinical Research Policy. [see Washington
Highlights, July 27] The AAMC urges that the agency not
finalize the proposed national coverage decision, but instead approach
coverage of clinical trials through a rulemaking that will allow
for a longer comment period and a reasonable transition from the
current rules to the new ones.
If CMS decides to finalize the current proposal, the AAMC requests
(among other revisions) a reinstatement of the "deemed status"
that previously was accorded to certain federally-funded or reviewed
trials. In addition to these proposed changes, the AAMC comments
on the standards for clinical research. The AAMC also voices concern
about what will occur if a hospital or other provider bills CMS
for a study that is later found not to meet CMS standards and suggests
discussing the issue with the HHS Office of Inspector General.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
AAMC Endorses Rule Change for "Multi-PIs"
The AAMC Aug. 15 endorsed a change to regulations proposed by the
National Institutes of Health (NIH) on the definition of "principal
investigator" for the agency's research grant awards. The new
definition would allow for more than one "principal investigator"
on some research project grants and similar awards, as appropriate
for the scope and design of the project.
In its comment letter
to NIH, the AAMC reiterated its position that recognition of
"multi-PIs" could benefit interdisciplinary, multidisciplinary,
and other collaborative research. The AAMC also noted that the language
of the NIH's proposed rule reinforces the special prerogatives and
responsibilities of PIs. The AAMC emphasized "the unique importance
of the principal investigator in ensuring leadership and accountability,
in respect to both the science and the administration of research
projects, distinct from the many other vital roles played by other
members of a research team." The Association added, "In
the absence of such emphasis, 'principal' investigators could proliferate
in ways that actually would be counterproductive and even injurious
to the goals of strengthening collaborative research."
The NIH also proposed a change in rules that would allow the agency
to make multiple awards from a single application. The AAMC did
not endorse the latter change in rules, but requested more information
on the rationale for the change and for discussion of the alternatives.
The NIH published its notice of proposed rulemaking in the Federal
Register on June 25.
Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
NIH Issues Policy for Sharing of Data from Genome-Wide
Association Studies
The National Institutes of Health (NIH) Aug. 28 released its Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies. Such studies are expected to advance the health
of the nation by identifying genetic factors that influence health
and disease, improve the prediction of disease and outcomes, and
ultimately lead to the realization of personalized medicine. AAMC
previously provided comments
regarding this policy to the NIH and is gratified that the final
policy addressed these comments.
The protections that will maintain the privacy of individuals whose
information and specimens are included have been strengthened and
made explicit, and the legitimate interests of the investigators
who submit data to the registry have been recognized by lengthening
the period of exclusive publication rights to 12 months. Other important
principles on access to data and best practices regarding disposition
of intellectual property relating to genomic information also are
affirmed in the document. An additional suggestion by AAMC to provide
support for the efforts required of individual investigators and
institutions to comply with this policy was not specifically addressed.
However, future grant applications that will be subject to this
policy may request such support.
Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567
CMS "Clarifies" the Application of SCHIP "Crowd-Out
Procedures"
In an Aug. 17 letter to state health officials, the Centers for Medicare and Medicaid
Services (CMS) "clarify" that states seeking State Children's
Health Insurance Program (SCHIP) expansions must adopt "reasonable
procedures" to prevent the substitution of public coverage
for private coverage ("crowd-out"). The clarification
applies to any SCHIP plans or SCHIP-related 1115 demonstration waivers
that extend eligibility beyond 250 percent of the Federal Poverty
Level (FPL). CMS expects full state compliance within 1 year, "or
CMS may pursue corrective action."
According to the letter, such states must adopt "five general
crowd-out strategies:"
- A minimum 1-year waiting period between private coverage disenrollment
and SCHIP enrollment;
- SCHIP cost-sharing is "in approximation to the cost of
private coverage." SCHIP cost-sharing requirements must represent
at least 1 percent of family income (unless the state has imposed
a 5 percent family cap);
- Monitor health insurance status upon application (including
coverage provided by noncustodial parents);
- Verify family health insurance status (including coverage related
to noncustodial parents); and
- Prevent employers from making coverage policies that favor
a shift to public coverage.
States must also "make assurances" that:
- At least 95 percent of eligible children under 200 percent
FPL are enrolled in SCHIP or Medicaid;
- The number of potentially eligible but privately covered children
does not drop by more than 2 percent over 5 years; and
- They are "current" with all SCHIP/Medicaid reporting
requirements, and they generate monthly reports "relating
to the crowd-out requirements."
In the letter, CMS states that they "would not expect any
effect on current enrollees." CMS expects the "clarification"
to strengthen SCHIP "by the focus on effective and efficient
operation of the program for the core...targeted population."
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
CMS Issues Stark III Final Regulation
The Centers for Medicare and Medicaid Services (CMS) Aug. 27 issued
the final phase (III) of the Medicare physician self-referral regulations,
commonly referred to as "the Stark law."
The rule finalizes and responds to public comments regarding the
Phase II interim final rule published in 2004. It contains some
minor clarifications regarding the Academic Medical Center (AMC)
exception. For example, to determine whether a hospital meets the
requirement that a majority of physicians on the medical staff consists
of faculty members, the affiliated hospital "must include or
exclude all physicians holding the same class of privileges (e.g.,
physicians holding courtesy privileges)." CMS also clarifies
that "where a physician is paid by more than one component
of the academic medical center, each such payment arrangement must
meet the requirement that it not take into account the volume or
value of referrals or other business generated by the referring
physician within the academic medical center."
The AAMC is reviewing the complete regulations, which will be published
in the Federal Register on Sept. 5.
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
CBO Report Cites Health Care Costs' Role in Poor
Fiscal Forecasts
In its August budget
and economic update, the Congressional Budget Office (CBO) reported
that the costs per beneficiary under Medicare and Medicaid have
increased about 2.5 percentage points faster per year than the national
gross domestic product (GDP) over the past four decades, and are
a principle reason for CBO's pessimistic forecast. The report stated
"Over the long term, the budget remains on an unsustainable path.
Unless changes are made to current policies, growing demand for
resources caused by rising health care costs and the nation's expanding
elderly population will put increasing pressure on the budget."
If current trends hold, the report predicted Medicare and Medicaid
spending would rise from 4.6 percent of the GDP in 2007 to 5.9 percent
of GDP in 2017 - an increase of nearly 30 percent in just 10 years.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
Congressional Casualty List
Running for President
Rep. Duncan Hunter (R-Calif.), will not seek re-election
Running for Senate
Rep. Tom Allen (D-Maine) Rep. Mark Udall (D-Colo.)
Retiring
Rep. Dennis Hastert (R-Ill.)
Rep. Ray LaHood (R-Ill.)
Rep. Chip Pickering (R-Miss.)
Rep. Deborah Pryce (R-Ohio)
Rep. Rick Renzi (R-Ariz.)
Sen. Wayne Allard (R-Colo.)
Resigned
Rep. Marty Meehan (D-Mass.)
Died
Rep. Juanita Millender-McDonald (D-Calif.), succeeded by state
Rep. Laura Richardson (D)
Rep. Charlie Norwood (R-Ga.), succeeded by Paul Broun, M.D. (R)
Sen. Craig Thomas (R-Wyo.), succeeded by John Barrasso, M.D. (R)
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