The
ACC in late December issued comment letters to the Centers
for Medicare and Medicaid Services (CMS) on two national coverage
determinations (NCD). In the first
letter, the ACC commented on NCDs for three “never
events” for wrong surgical or other procedures performed
on a patient, or surgical or other procedures performed on
the wrong body part or wrong patient. According to the letter,
“[w]hile it is clear that the medical community must
continually strive to establish systems to ensure these surgical
‘never events’ are eliminated, the College would
encourage CMS to establish an appeals process to allow physicians
and other providers to gain recourse against any agency noncoverage
decisions that may be made inappropriately.”
In the
second
letter, the ACC, American College of Radiology, North
American Society for Cardiovascular Imaging, and the Society
for Cardiovascular Magnetic Resonance formally request a reconsideration
of the NCD for magnetic resonance imaging (MRI) to permit
local contractor discretion for the coverage of cardiac magnetic
resonance imaging for morphology and function with flow/velocity
quantification. The groups write that they “believe
that accepted clinical practice of flow and the ability of
treating physicians to make downstream decisions serve as
surrogate evidence of beneficial outcomes for patients.”
The primary rationale for requesting a reconsideration of
the coverage policy is that, when new CPT codes for cardiac
MR were introduced in 2008, CMS denied payment for the codes
that include flow/velocity quantification because one element
of the service (blood flow) is designated as non-covered in
an existing NCD. Modifying the coverage policy for cardiac
MRI would allow local contractors to determine medical necessity
for the full procedure.
Health
Spending Slows, CMS Report Finds
In
the slowest growth since 1998, health care spending in the
U.S. grew 6.1 percent in 2007 to $2.1 trillion, or $7,421
per person, down from 6.7 percent in 2006, according to a
report released on Tuesday by the Centers for Medicare and
Medicaid Services (CMS) in Health Affairs. The slower growth
in 2007 was attributed mostly to slower growth in both retail
prescription drug spending and Medicare spending associated
with administering Medicare benefits. However, even as health
care spending growth slowed, the health spending share of
the nation’s Gross Domestic Product (GDP) continued
to climb, reaching 16.2 percent in 2007, up by 0.2 percentage
point from 2006. In addition, health care spending continues
to outpace overall economic growth, which grew by 4.8 percent
in 2007. Read
the full report.
FDA
News Updates
The
Food and Drug Administration (FDA) recently approved Vasovist
Injection (gadofosveset trisodium), the first contrast imaging
agent for use in patients undergoing magnetic resonance angiography
(MRA). In the studies of the safety and efficacy of Vasovist,
MRAs performed with Vasovist detected more arterial disease
than MRA performed without Vasovist and the pictures were
of improved technical quality. For more information, view
the FDA Web site here.
The FDA
late last month listed more than 25 weight loss products that
should not be taken because they contain undeclared, active
pharmaceutical ingredients that could cause heart problems
like hypertension, myocardial infarction or stroke. According
to an FDA statement, the products may contain either higher-than-recommended
amounts or unapproved ingredients. The FDA is seeking a recall
of the products. View
the FDA statement.
Celgene
recently issued a “Dear Health care Professional”
letter describing a controlled clinical study suggesting that
Innohep may increase the risk for death, compared to unfractionated
heparin when used to treat elderly patients with renal insufficiency.
It recommended consideration of alternatives to Innohep when
treating these patients for deep vein thrombosis. Read the
complete FDA MedWatch 2008 Safety summary here.
The FDA
has approved Prism Pharmaceuticals’ Nexterone (amiodarone
HCl) injection for the treatment of frequently recurring ventricular
fibrillation and hemodynamically unstable ventricular tachycardia
in patients refractory to other therapy. Nexterone is a cosolvent-free
formulation of the antiarrhythmic agent Amiodarone IV. More
information is available here.
QUALITY
Lewin
Report Discusses New E-Rx Program The
Centers for Medicare and Medicaid Services’ e-Prescribing
incentive program began on Jan. 1. Under this program, physicians
who successfully e-prescribe under the program
requirements will receive incentive payments of 2 percent
in 2009. The size of the payment will decrease to 1 percent
in 2011 – 2012 and 0.5 percent in 2013. Tools and resources
to assist practices in adopting e-prescribing are available
on www.acc.org/HealthIT.
Co-chair
of the ACC Informatics Committee Michael Mirro, M.D., F.A.C.C.,
discusses health information technology (IT) as the January
contributor to ACC’s online forum, The
Lewin Report. Dr. Mirro writes, “Of the recent
activities to accelerate health IT adoption, the CMS e-prescribing
initiative will likely have the greatest impact. The current
adoption of health IT has been slow” and the “development
of e-prescribing incentives by CMS will clearly move the needle
for health IT.” Read Dr. Mirro’s post in full
here.
Drug
Industry’s New Marketing Guidelines Take Effect
The
pharmaceutical industry’s voluntary moratorium on branded
gifts officially began Jan. 1, with about 40 drug companies
agreeing to follow the code, the New
York Times reported in late December. Created by
the Pharmaceutical Research and Manufacturers of America,
the new code bans pharmaceutical companies from gifting pens,
staplers, flash drives and other non-educational items to
physician offices. The guidelines also prohibit pharmaceutical
sales representatives from providing restaurant meals to health
care professionals, but allow occasional in-office meals that
feature informational presentations. In addition, it requires
that companies ensure sales representatives are trained about
applicable laws, regulations and industry codes of practice,
among other provisions. The guideline requests that companies
set an annual limit on speaking and consulting arrangements
between drug manufacturers and physicians, but does not state
what that limit should be.
STATE
State-Level
Advocacy, Grassroots Outreach to Increase in 2009
After
launching its state advocacy and grassroots outreach division
last year, the ACC will increase its efforts and presence
on the state level in 2009. The College will pursue a multi-faceted
policy and legislative agenda that reflects the diverse needs
and interests of members and proactively work to expand state-based
programs that relate to cardiology. These efforts will include
enhanced lobby days and “Cardiologist for a Day”
programs, improved online advocacy tools, and increased collaboration
with the American Heart Association and other groups. In particular,
the College will work closely with chapters with emerging
advocacy programs.
In addition,
the State Advocacy Workgroup, which was formed by the Board
of Governors in 2008, will continue its mission of increasing
and improving state advocacy and outreach. The Workgroup has
identified six chapters that have the staff and resources
to be models for other states. Using ACC National Funding
Proposals, these chapters will build relationships with other
medical groups and the state legislature to influence policy.
The Chapters are Alabama, Arizona, Iowa, Kentucky, Rhode Island
and Washington.
