Washington Highlights: August 21,
2009
Rehab Facility
Proposed Rule Changes Teaching Adjustment Methodology
Contents
Prior Issues
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The Centers for Medicare and Medicaid Services (CMS) Aug. 7 published
in the Federal Register its Medicare inpatient rehabilitation facility
(IRF) final
rule for federal fiscal year (FY) 2010. The final rule modifies
the methodology for calculating the teaching adjustment factor.
It also applies a 2.5 percent increase factor to IRF payment rates.
The changes will be effective Oct. 1, 2009.
The teaching adjustment is based on a regression analysis as well
as the IRF's ratio of resident-to-average daily census (RADC). CMS
adopted a proposal to change the methodology to reflect three years
of data, rather than one year of data to avoid year-to-year fluctuations
[see Washington Highlights,
May 8]. The AAMC supported the proposed methodology in its June
29 comment letter.
With this change, along with more recent data, CMS estimates that
the teaching adjustment will result in a 7 percent increase in per
discharge payments for facilities with an RADC ratio of 10 percent.
This teaching adjustment factor is lower than the one proposed,
but higher than the 4 percent increase that wou.d ocurred if CMS
had used only one year data - FY 2008 data. The proposed rule yielded
a 10.5 percent increase in per discharge payments for a facility
with a 10 percent RADC ratio, because FY 2008 data were not available
when the proposed rule was published.
Information:
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498
HHS Issues Health Information Breach Notification
Regulation
The Department of Health and Human Services (HHS) Office for Civil
Rights (OCR) Aug. 19 issued a "Breach Notification" interim
final rule with request for comments. As directed by the American Recovery
and Reinvestment Act (ARRA, P.L.
111-5), the rule requires health care providers and other entities
covered by the Health Insurance Portability and Accountability Act
(HIPAA) to notify affected individuals following a breach of unsecured
protected health information (PHI). Breaches affecting more than
500 individuals must be reported promptly to affected individuals,
the HHS Secretary, and the media. In smaller cases, HHS can be notified
on an annual basis. The Federal Trade Commission (FTC) has issued
companion breach notification regulations that apply to vendors
of personal health records and certain others not covered by HIPAA.
After considering public comments in response to an April 2009
guidance
and request for information [see Washington
Highlights, May 22],
HHS decided not to include the limited data set as a method for
rendering data as protected health information. However, in cases
of impermissible use or disclosure of a limited data set, a covered
entity or business associate must perform a risk assessment to determine
whether the risk of identifying a particular individual poses any
significant risk of harm. If there is no significant risk of harm
to the individual, then no breach has occurred and no notification
is required.
HHS also updated its guidance to specify encryption and destruction
to be technologies and methodologies that render protected health
information unusable, unreadable, or indecipherable to unauthorized
individuals. Entities subject to the HHS and FTC regulations that
secure health information as specified by the guidance through encryption
or destruction are relieved from notification requirements in the
event of a breach of such information. The HHS interim final regulations
are effective 30 days after publication in the Federal Register
(Aug. 24) and include a 60-day public comment period. The AAMC is
considering commenting.
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490
HIT Grant Money Released, Authority Delegated
to National Coordinator
The Department of Health and Human Services (HHS) Aug. 20 announced
the release of $1.2 billion in funding to health information technology
(HIT) extension centers
and to states
through grants supported by the American Recovery and Reinvestment
Act (ARRA, P.L.
111-5). This announcement followed Secretary of Health and Human
Services Kathleen Sebelius' delegation of authority Aug. 18 to the
National Coordinator for Health Information Technology, David Blumenthal,
M.D., to administer a majority of the HIT related grant and loan
programs funded through ARRA.
One grant opportunity makes $598 million available over three application
cycles (for an estimated total of 70 awards) for qualified entities
to serve as Regional Centers within the HIT Extension Program.
According to the announcement, awards will range between $1 million
and $30 million. Preliminary applications for the first cycle of
awards ($189 million) are due Sept. 8, with successful applicants
required to submit a full application by Nov. 3. Preliminary applications
for the following two cycles are due Dec. 22, 2009, and June 1,
2010. A second funding announcement makes $564 million available
for State Cooperative Agreements
to promote HIT through planning and implementation projects to advance
health information exchange.
Under the secretary's delegation
of authority, the National Coordinator now will have administrative
authority over grant programs including, among others, demonstration
programs that integrate information technology into clinical education;
HIT technical implementation assistance, including development of
a research center and the regional extension centers; and grants
to states and Indian tribes for loan programs to facilitate the
adoption of electronic health records (EHRs).
Other agencies recently have issued requests for proposals for
additional HIT funding supported by ARRA. The Social Security Administration
opened a solicitation
that will allocate $24 million to accelerate disability claims processing
by automating the exchange of health records through the Nationwide
Health Information Network. The deadline for this program is Sept.
18. Additionally, the Department of Labor recently announced
the release of $125 million for health care workforce training,
specifically soliciting applications that focus on health information
technology career training. Applications for this program are due
Oct. 5.
Information:
Lori K. Mihalich-Levin, J.D., Senior Policy Analyst
AAMC Health Care Affairs
lmlevin@aamc.org
(202) 828-0599
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525
HIT Policy and Standards Committees Adopt Additional
Recommendations
The Health Information Technology (HIT) Policy Committee and the
HIT Standards Committee met on Aug. 14 and 20 respectively, to hear
formal recommendations of the committees' workgroups. The Policy
Committee adopted by consensus the Certification/Adoption Workgroup's
five detailed recommendations regarding the certification process
and the Health Information Exchange Workgroup's four high-level
recommendations regarding information exchange requirements. The
Policy Committee's Meaningful Use Workgroup did not present any
recommendations to the committee at this meeting but announced a
timeline for the workgroup's activities over the next 12 months,
including an October meeting to discuss the concerns of specialists
and meaningful use criteria for 2013 and 2015.
The Policy Committee's certification recommendations added detail
to those adopted at the July 16 meeting [see Washington
Highlights, July 17]
by advising, among other things, that the Office of the National
Coordinator for Health Information Technology (ONC) adopt a "preliminary
certification" process so that vendors may begin certifying
based on proposed "meaningful use" critiera, and that
CMS use a single certification for both HIT incentive payment and
Stark exception purposes.
The Standards Committee adopted recommendations from all three
of its workgroups and chartered a fourth workgroup on implementation
guidance. Recommendations included: adoption of the Clinical Quality
Workgroup's grids linking meaningful use measures to Health Information
Technology Expert Panel (HITEP) datatypes; a revised implementation
chart from the Clinical Operations Workgroup incorporating one new
measure for quality reporting; and recommendations from the Privacy
and Security Workgroup linking meaningful use objectives and policy
measures to privacy and security requirements. The Standards Committee
accepted the Clinical Quality Workgroup's recommendations with the
understanding that the workgroup would continue to identify performance
standards for the seven meaningful use measures for which no standards
currently exist.
Recommendations adopted by these committees are intended to be
considered by ONC and CMS in drafting regulations that will be released
in December. Tony Trenkle, Director of CMS's Office of E-Health
Standards and Services, noted at the Policy Committee meeting, however,
that the CMS regulation regarding HIT incentive payments was already
in the regulation clearance process.
The agendas and all slide presentations from the workgroup presentations
are available on the HIT Policy Committee
and HIT Standards Committee
Web sites. More detailed summaries of the meetings are available
on the AAMC HIT Web
site.
Information:
Lori K. Mihalich-Levin, J.D., Senior Policy Analyst
AAMC Health Care Affairs
lmlevin@aamc.org
(202) 828-0599
NSF Issues Responsible Conduct of Research Training
and Oversight Requirements
The National Science Foundation (NSF) Aug. 20 announced
the final implementation plan for ensuring that undergraduate students,
graduate students, and postdoctoral researchers participating in
NSF-funded research projects receive appropriate training and oversight
in the responsible and ethical conduct of research (RCR). A draft
plan was issued in February for public comment.
Effective Jan. 4, 2010, NSF will require that, at the time of proposal
submission to NSF, a proposing institution's authorized organizational
representative certify that the institution has a plan to provide
appropriate training and oversight in the responsible and ethical
conduct of research to undergraduates, graduate students, and postdoctoral
researchers who will be supported by NSF to conduct research. While
training plans are not required to be included in submitted proposals,
NSF reserves the right to review such plans upon request.
NSF said it does not intend to issue NSF-specified standards "and
recognizes that training needs may vary depending on specific circumstances
of research or the needs of students intending to pursue careers
in a variety of science and engineering settings after completing
their education. Therefore, it is the responsibility of each institution
to determine both the content and the delivery method for the training
that will meet the institution's particular needs for RCR training
in all areas at that institution for which NSF provides support."
The NSF also noted that "each institution must decide if development
of content or pedagogical method is required, or if appropriate
content and training can be provided from some existing sources
or capabilities, and take appropriate action to implement its decisions."
NSF formally will implement the new RCR requirement via an update
to the NSF Proposal and Award Policies and Procedures Guide to be
issued in October.
Information:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
McCaskill, Bennet Introduce Senate PAYGO Bill
Senators Claire McCaskill (D-Mo.) and Michael Bennet (D-Colo.)
Aug. 6 introduced "pay-as-you-go" (PAYGO) legislation
that is more stringent than that supported by the President and
House Democratic leaders.
The Statutory Pay-As-You-Go Act of 2009 (S.
1600) would require the costs of new mandatory spending and
tax cuts to be offset by reductions in other mandatory programs
or tax increases elsewhere. All legislation Congress passes during
the year will be added up on a PAYGO "scorecard." If Congress
fails to offset the cost of all new entitlement increases or tax
cuts passed during the year, the "scorecard" will show
a deficit, and it will trigger across the board cuts in entitlement
spending.
Unlike the version (H.R.
2920) passed by the House July 22 [see Washington
Highlights, July 24],
the Senate bill also would require offsets for four policies that
President Obama wants to exempt. The President proposed excluding
legislation preventing cuts to Medicare physician payments, extending
the 2001 and 2003 tax cuts, permanently limiting the alternative
minimum tax, and extending the current estate tax. House Majority
Leader Steny Hoyer (D-Md.) has said it is not politically realistic
to think that Congress will offset extensions of these programs.
The prospects for the legislation in the Senate are uncertain.
Budget Committee Chair Kent Conrad (D-N.D.) does not support exempting
the four policies, and has said that he would like to see PAYGO
legislation included in a larger debt and deficit-reduction proposal.
Six first-term Democratic senators co-sponsored the legislation:
Amy Klobuchar (Minn.), Jon Tester (Mont.), Mark Udall (Colo.), Mark
Warner (Va.), Jeanne Shaheen (N.H.), and Mark Begich (Alaska).
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
FDA Issues Final Rules to Help Patients Gain Access
to Investigational Drugs
The Food and Drug Administration (FDA) Aug. 12 and 13 published
two final rules that seek to clarify the options in gaining access
to investigational drugs and biologics for seriously ill patients
who are not eligible to participate in clinical trials. The "expanded
access rule" describes individual and group access options,
specifies safeguards to protect patients, and preserves the role
of clinical trials in developing safety and effectiveness data on
drugs available under expanded access. In the "charging
rule," the FDA clarifies the charging authorization process
and specifies cost recovery options for the drug manufacturers.
The rules will go into effect Oct. 13.
The "Expanded Access to Investigational Drugs for Treatment
Use" final rule amends existing regulations to expand and
clarify circumstances under which seriously ill patients are allowed
to access the investigational drug. It explains the procedures and
standards for the treating physicians and the patients who want
access to investigational drugs that showed promise in the early
phases of a clinical trial. The rule specifies that expanded access
should be considered only when approved therapies are not available
or options are exhausted and potential benefits justify potential
risks. Such access must not interfere with investigational drug
development. A drug's safety and effectiveness for marketing approval
should be demonstrated in clinical trials.
The "Charging for Investigational Drugs Under an Investigational
New Drug Application" final rule amends the existing charging
rule to explain when a drug manufacturer can charge a patient for
an investigational drug in a clinical trial or expanded access program.
Written authorization to charge must be obtained from FDA by the
sponsor. The rule describes direct and indirect cost recovery conditions
and options.
Information:
Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
HRSA Engages Health Community in Workforce Summit
The Health Resources and Services Administration (HRSA) Aug. 10-12
hosted a conference titled "The Healthcare Workforce Crisis:
A Summit on the Future of Primary Care in Rural and Urban America."
The meeting engaged health care organizations, associations, providers,
state officials, and academic health centers in discussions to generate
new and innovative ideas to address health professions shortages
and maldistribution.
HRSA Administrator Mary Wakefield, Ph.D., R.N., opened
and closed the summit by encouraging "breaking the mold"
thinking and community engagement on workforce development issues.
Lloyd Michener, M.D., a member of the AAMC Board of Directors and
Clinical Professor and Chair of the Department of Community and
Family Medicine, Duke University Medical Center, gave a keynote
address on "Workforce for Healthy Communities," describing
how innovative partnerships have helped some areas of North Carolina
streamline their health care system and reduce the demand for physicians
in underserved areas. Ed Salsberg, M.P.A., Director, AAMC Center
for Workforce Studies, presented physician workforce trends at a
plenary session that focused on primary care needs in relation to
health care reform.
Additional sessions addressed workforce disparities, health care
reform efforts in Massachusetts, Medicare Graduate Medical Education
(GME) policy, the National Health Service Corps, and the health
professions training programs. Presentations from the sessions are
expected to be available online
in early September. HRSA encourages comments on the conference and
suggestions to address the health care workforce crisis to be submitted
via email to: workforcesummit@hrsa.gov.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
On the Agenda in Washington
Aug. 24-26: NIH State-of-the-Science Conference on Family
History and Improving Health
Aug. 24 and 25 - 8:30 a.m., Aug. 26 - 9 a.m.; Natcher Conference
Center, 45 Center Drive, National Institutes of Health, Bethesda,
Md.
The NIH's National Human Genome Research Institute and the Office
of Medical Applications of Research will convene a State-of-the-Science
conference to assess the available scientific evidence related to
key questions regarding family history and improving health. Additional
information, including materials and registration instructions,
is available on the NIH Consensus Development Program Web
site.
Aug. 24: NIH National Advisory Child Health and Human Development
Council
10 a.m. to 11 a.m.; Building 31, Room 2A03, National Institutes
of Health, Bethesda, Md.
The NIH's National Advisory Child Health and Human Development Council
Subcommittee on Planning and Policy will hold a meeting
including a report of the director, budget updates, and legislative
updates. The meeting will be closed to the public beginning at 11
a.m. Additional information will be posted on the Institute's Web
site when it becomes available.
Aug. 24: Meeting of National Vaccine Advisory Committee
on Flu Outbreak
3 p.m.; Teleconference, contact Andrea Krull at 202-690-5566
or nvpo@hhs.gov
HHS's National Vaccine Advisory Committee (NVAC) will hold the second
of two teleconference
meetings regarding the H1N1 "swine flu" outbreak,
including activities of various HHS agencies and Federal advisory
committees that address vaccine issues, as well as perspectives
from representatives of state and local health associations. Pre-registration
is required.
Sept. 1: Meeting of CDC Advisory Committee to the Director
4:30 p.m.; Teleconference, dial-in 800-593-9961, access code
3699611
The Advisory Committee to the Director of the Centers for Disease
Control and Prevention will hold a conference call meeting
to discuss and decide on recommendations from its Ethic Subcommittee
about travel restrictions for individuals with infectious diseases;
the National Biosurveillance Advisory Subcommittee about its final
report on biosurveillance recommendations; and the Health Disparities
Subcommittee about its mission.
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