Senate
Health, Education, Labor and Pensions Committee Chair Edward
Kennedy (D-Mass.) on May 5 introduced the “Family Smoking
Prevention and Tobacco Control Act,” (S.
982) which likely will be marked up by his committee next
week. The bill would amend the Federal Food, Drug, and Cosmetic
Act (FFDCA) to grant the FDA the authority to restrict tobacco
marketing and sales to youth; require detailed disclosure
of ingredients; allow FDA to require changes to tobacco products;
and require larger, more specific health warnings. The FDA
activity would be funded by a user fee on cigarette manufacturers,
allocated by market share. The House on April 2 approved a
similar version of the bill in a 298-112 vote.
The ACC
highly encourages members to contact their senators in support
of this important bill. Please call the Capitol Switchboard
at (202) 224-3121 to ask your senator to S. 982, the “Family
Smoking Prevention and Tobacco Control Act.”
ACC
Responds to HHS Secretary Testimony
Health
and Human Services Secretary Kathleen Sebelius recently testified
on health care reform in front of the House Ways and Means
Committee. Sebelius discussed the impact of health care costs
on middle class families, and committed to supporting initiatives
that contain costs, provide universal coverage and improve
the quality of care. ACC CEO Jack Lewin, M.D., responded to
her testimony: “Leaders in both parties and the health
care community agree: The American health care system needs
to change. What we heard from Secretary Sebelius and committee
members is that change needs to come sooner rather than later.
The ACC has long advocated for several of the reforms Secretary
Sebelius testified about today including payment reforms and
the development of a health information technology infrastructure.”
Read
the full statement. To learn more about ACC’s health
care reform efforts, visit: qualityfirst.acc.org.
Senate
Panel Holds Roundtable on Access
The
Senate Finance Committee on May 5 held a roundtable to consider
ways to expand health insurance coverage. The roundtable,
which featured representatives from business, health care
associations, private payers and academia, was dominated by
discussion of a public plan option that would compete alongside
private plans. The session also touched on individual insurance
markets and the expansion of Medicaid. Statements
of the participants are available on the Senate Finance
Committee Web site. The Committee held a roundtable on delivery
system reform in late April, and is expected to hold a
similar walk through on financing in May, with the goal of
drafting a bipartisan health reform proposal to act on in
early June.
REGULATORY
FTC
Reprieve on Red Flags Rules The
Federal Trade Commission (FTC) has further delayed implementation
of new rules aimed at preventing identity theft until
August 1, thanks to efforts by the ACC, the American
Medical Association (AMA), Medical Group Management Association
(MGMA) and other medical associations. The groups have challenged
the rules’ inclusion of physicians as “creditors”
because they regularly defer payment for goods and services.
The FTC
released rules in November 2007 requiring all financial institutions
and “creditors” to develop and implement a written
program to protect consumers by identifying potentially suspicious
“red flags” that may signal identity theft. The
ACC and others had successfully delayed the implementation
until May 1. The ACC is taking advantage of this newest reprieve
to continue efforts to have physicians removed from the “creditor”
definition.
In the
meantime, the ACC recommends that practices begin preparing
a written identity theft detection and prevention program
that complies with the new rules as a contingency plan. The
AMA, MGMA, and MedAxiom have developed Red Flags Rule guidance
documents and sample policies that can be modified, which
can be accessed at: MGMA Red
Flags Rule Resource Center, AMA Red
Flags Rule Physician Resources. The FTC also is developing
a template that groups at low risk can use to develop their
programs, which will be available
on its Web site when complete. Contact Gretchen Wyatt at gwyatt@acc.org
with questions.
Update
on 2007 PQRI Feedback Reports
The Centers
for Medicare and Medicaid Services (CMS) will re-run 2007
data for the Physician Quality Reporting Initiative (PQRI)
for eligible professionals who did not receive a bonus for
submissions from July 1-Dec. 31, 2007. CMS will re-run the
data for those participants based on new analytics, and they
may become eligible for an incentive payment based on the
new data. Eligible professionals who received a bonus based
on the initial report will not receive a new report. The 2007
re-runs will be issued separately from the 2008 feedback reports
and incentive payment distributions. Initial 2007 feedback
reports are available through the end of this month at: http://www.qualitynet.org.
FDA
News Updates
The Food
and Drug Administration (FDA) on April 30 approved the first
hypertension treatment polypill, Novartis Pharmaceuticals
Corp.’s Exforge HCT, which contains amlodipine, valsartan
and hydrochlorothiazide. The drug, which was not approved
as an initial treatment, was approved for use in patients
currently taking all three individual drugs, or as an add-on
or switch therapy in patients who are not well-controlled
on any two of its drug classes. ACC.09 featured the results
of a trial with a five-drug antihypertension polypill, which
was found to as effective as taking all five drugs individually.
More
coverage of Exforge is available from MedPage Today.
A trial
summary from the ACC.09 study is available on Cardiosource.
Meanwhile,
the FDA recently refused to approve Northfield Laboratories,
Inc.’s PolyHeme blood-substitute product because it
failed to meet the “pre-specified primary efficacy endpoint”
and its risks outweighed its potential benefits. More
coverage is available from the Chicago Tribune.
Hospital
Payments to Remain Flat The
Wall
Street Journal reported on May 2 that the Centers
for Medicare and Medicaid Services (CMS) has proposed increasing
payments to hospitals by only 0.2 percent beginning Oct. 1,
down from 2.7 percent in 2009 and 2008 and 3.4 percent in
2007. The small update is mainly a result of hospitals “inflating
how sick patients are in order to get higher reimbursements,”
according to the Journal. Acting CMS Administrator Charlene
Frizzera said that the proposal was mandated by Congress and
more cuts could follow.
QUALITY
ACC
Response: Relationships with Industry
Recently
there have been a number of proposals to dramatically reduce
or eliminate industry support for the activities of medical
professional societies. In April, an article published in
the Journal of the American Medical Association called
for medical associations to sever most funding from industry,
with the exception of journal advertising and exhibit hall
fees. The Institute of Medicine released a report April 28
that also addresses this topic. The ACC joined several other
medical professional societies in issuing a joint statement
on this report.
The ACC
takes a stringent approach to ensuring responsible, transparent
relationships, in which industry support has no influence
on educational content, quality measures or scientific research:
The
ACC adheres to Accreditation Council for Continuing Medical
Education standards for industry support of educational
content.
Members
of guidelines writing groups disclose any relevant conflicts
of interest (for themselves and their immediate family)
in writing and verbally at the beginning of each and every
meeting. They recuse themselves from votes on issues involving
their conflicts.
The
College publicly displays the disclosures of our Trustees,
Governors, Committee Chairs, and members of guidelines and
clinical document committees on acc.org.
There
is a strict separation between ACC fundraising staff (who
work directly with industry) and education staff (who develop
educational content). Industry supporters never influence
the content of ACCF educational programs or products.
The
College eschewed an estimated $.5 million in industry sponsorship
for lanyards, portfolio bags and more at our 58th Annual
Scientific Session to avoid the appearance of inappropriate
influence by industry at our most important educational
and scientific event of the year.
The ACC
is leading the way to professional standards for relationships
between medical professional societies and industry. Share
your views on the topic on The Lewin Report.
Symposium
to Highlight Payment Reform, CV Disease
In partnership
with Avalere Health, the ACC presents “Raising the Bar:
Payment Reform and Cardiovascular Disease” on June 12,
2009, in Washington, D.C. The event will feature ACC CEO Jack
Lewin, M.D., William Oetgen, M.D., M.B.A., F.A.C.C, from Georgetown
University, Len Nichols, Ph.D., from the New America Foundation,
Francois de Brantes, M.S., M.B.A., from Bridges to Excellence,
among other health care leaders. The symposium will examine
payment reform through the lens of cardiovascular disease
and focus on payment models that promise to shift toward value-based
purchasing. View
registration and agenda information.