July
17, 2000
Newsletter Archive
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HCFA
PROPOSES FEE SCHEDULE CHANGES FOR 2001. HCFA
is proposing a number of changes in the Medicare
physician fee schedule for 2001. HCFA estimates
no net financial effect on cardiologists from
these changes; however, the continued phase-in
of practice expense changes will cause a three
percent decline in the average cardiologist's
fees. Those declines will probably be offset by
an estimated two percent increase for inflation
and other factors. Payment changes will vary among
procedures and cardiologists who have different
practice profiles.
The
most significant change for cardiologists is a
reduction in the global period from 90 days to
0 days for many electrophysiology procedures.
Payment for the procedures will be reduced but
HCFA claims that this will be a revenue neutral
change because follow-up visits or treatment for
related cardiovascular diseases will be separately
billable.
Staff
is reviewing the changes for the EP and other
codes and will be developing a more complete summary
shortly. If you would like a copy of that summary,
please contact Wayne Powell at wpowell@acc.org
or 800 435-9203.
Legislative Affairs
Federal
News
In June, the House and the Senate each passed
its own version of the FY 01 Labor, Health and
Human Services and Education appropriations bill.
The Senate spending bill would provide $20.5 billion
for the National Institutes of Health (NIH), while
the House bill would provide $18.8 billion. Now,
a conference committee must not only resolve
the differing spending allocations for NIH, but
the bill's overall spending allocation as well.
It is predicted that the conference will not take
place until September.
On
July 10, the House attached an amendment to the
FY 01 Agriculture appropriations bill that would
allow citizens, wholesalers, and pharmacists who
travel abroad to bring back Food and Drug Administration-approved
medicines unhindered.
In
related prescription drug news, on June 28 House
Republicans narrowly won passage of their Medicare
outpatient prescription drug plan. The "Medicare
Rx Act of 2000" (H.R. 4680), would provide
about $40 billion to subsidize private insurance
company provision of drug-only policies to Medicare
beneficiaries. The bill would aim to attract at
least two plans to a region. If no insured agreed
to enter a particular area, the government could
offer additional subsidies until the plan agreed
to provide coverage. While the type of plan offered
to seniors under the GOP plan would vary by region,
the standard plan would require beneficiaries to
pay a $250 annual deductible and a monthly premium
of about $35. Half of seniors' drug costs would
be covered up to $2,100, and all costs above $6,000
would be covered. Subsidies would be provided to
low-income seniors. Both the Health Insurance Association
of America and the American Association of Retired
Persons have failed to endorse the bill, and the
president has called it "flawed and unworkable."
Reportedly, some Republicans who supported the bill
still have reservations about it.
The
Patient Access Coalition, of which the College
serves as co-chair, is planning a national patients'
rights advocacy week for July 24-28 in an effort
to persuade key lawmakers to support the enactment
of a real patients' bill of rights this year.
The coalition will be targeting five states:
Michigan, Pennsylvania, Missouri, Delaware,
and Washington. If you live in one of these
states, watch your fax machine for an ACC action
alert later this week.
State
News
The Massachusetts
legislature unanimously approved legislation (H
4525) that would give physicians "wide
latitude" in determining what constitutes "medical
necessity" for their patients. The measure
also contains significant consumer protections,
creating a state HMO "watchdog" agency,
mandating annual HMO report cards, creating an independent
review process for patient appeals of HMO decisions
and establishing a commission to study the state's
uninsured. However, even if H 4525 is enacted,
a fall ballot referendum is still pending and if
approved, would radically restructure the state
health care system by requiring that all Massachusetts
residents have health coverage by July 2002. While
a vocal patient advocate coalition supports the
legislative measure and wants to scrap the ballot
question, the Massachusetts' Secretary of State
is of the opinion that the state constitution will
not permit the referendum to be repealed. A group
of lawyers is investigating the possibility of making
a legal challenge to the referendum.
In
Michigan,
Gov. Engler signed into law a five-bill legislative
package that will cut in half the required timeframe
for internal reviews of denied HMO claims. The
new laws also provide for an external review process
of denied claims, financial solvency requirements
for HMOs, an annual HMO report card, and the transfer
of the regulation of HMOs from he Public Health
Code to the Insurance Code. The main bill in the
package, SB 1209, decreases the HMO internal review
of a denied claim from 90 days to 45 days and establishes
an independent review process by insurance regulators
once the internal grievance procedure is exhausted.
In
California,
the newly established Department of Managed Care,
under the direction of Daniel Zingale, officially
took over regulation of HMOs from the Department
of Corporations (DOC) on July 1. The new director
reportedly sees himself first as a patient advocate,
who promised HMOs that he would "act with a
quicker wrist and a sharper scalpel when you don't
put patients first," but also supports a "preventive
regulation" strategy. His department will have
twice the staff and as much as three times the budget
of DOC. Three new advisory boards have already been
staffed and a patient advocate for the Department
has been appointed. The Department must bring consumer
resources on-line, educate the public as to its
function, and enforce numerous new managed care
laws that took effect at the beginning of this year.
While there is some optimism that Mr. Zingale and
his department will bring about more effective regulation
of HMOs, their actions will be closely watched.
Regulatory and
Legal Affairs
A
Food and Drug Administration (FDA) panel of experts
recommended against allowing Mevacor® or Pravachol®
cholesterol-lowering "statins," to be
sold over-the-counter (OTC). A joint meeting
of the FDA's Nonprescription Drugs Advisory Committee
and the Endocrinologic and Metabolic Drugs Advisory
Committee on July 13 concluded that there is not
sufficient evidence to demonstrate that Mevacor®
can be used safely and effectively by consumers
without a prescription. The Committees considered
an application for OTC use for Pravachol®
on July 14 and concluded that industry must conduct
additional label comprehension studies and better
define its target population prior to granting
OTC statins.
Edward
Frohlich, M.D., F.A.C.C. (New Orleans, LA) delivered
ACC testimony at an FDA public hearing on OTC
drugs in June (see July 3 Advocacy Weekly). The
ACC's testimony did not address specific drugs
or classes of drugs, such as statins, but instead
addressed appropriate issues for the FDA to consider
in making any OTC switches for cardiovascular
drugs. The ACC is in the process of developing
a specific position on OTC status for statins.
The Health Care Financing Administration (HCFA)
announced a Medicare demonstration program to
help seniors stop smoking. According to HCFA,
Medicare spent $14.2 billion, or nearly 10 percent
of the Medicare budget, in 1993 to treat smoking-related
illnesses. By law, Medicare cannot cover smoking
cessation therapy, but a successful demonstration
project may "prompt Congress to consider"
such a benefit, according to HCFA Administrator
Nancy-Ann DeParle. The demonstration will begin
in Alabama, Florida, Missouri, and Ohio and last
for three years. More information about the program
is available in HCFA's press release, available
online at http://www.hcfa.gov/news/pr2000/p000712a.htm
The
Nuclear Regulatory Commission (NRC) heard testimony
on July 10 regarding the export of high-enriched
uranium (HEU), needed to perform nuclear cardiac
scans, to Canada. In June,1999, the NRC granted
a five-year export license to Atomic Energy of Canada
Limited (AECL) and MDS Nordion (MDSN), based in
Kenata, Ontario. Over 65% of the technetium-99m
(Tc-99m) used in North America is produced in Canada
by AECL and then processed and supplied to U.S.
pharmaceutical manufacturers by MDSN. Under the
terms of the export license the NRC required a yearly
status report on steps being taken to convert HEU
to low-enriched uranium (LEU). The hearing focused
on the disagreement over whether MDSN is making
progress in this regard.
Advocacy Weekly is a product of
the Advocacy Division of the American College of
Cardiology. Questions or comments regarding this
publication should be directed to the Advocacy Division
at 800-435-9203 or to advocacydiv@acc.org.
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