Washington Highlights: July 11,
2008
Contents
Prior Issues
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Senate Clears Medicare Physician Payment Relief
for President
The Senate July 9 adopted by voice vote a House-passed Medicare
package (H.R.
6331) that averts scheduled reductions in the physician payment
update. The AAMC-supported provisions extend through Dec. 31, 2008,
the 0.5 percent update that expired July 1 [see Washington
Highlights, June 27].
They also establish a 1.1 percent update for calendar year (CY)
2009. Current law required the Centers for Medicare and Medicaid
Services (CMS) to reduce the physician update by 10.6 percent on
July 1; in the absence of legislative action, the agency projects
an additional 5.4 percent cut in CY 2009 (see
related story).
The bill now must be signed by President Bush, who has threatened
to veto H.R. 6331, largely because it includes significant changes
to the Medicare Advantage program and the Medicare prescription
drug benefit.
The cost of H.R. 6331 is partially offset by a phase-out of indirect
medical education (IME) payments made to Medicare Advantage plans.
The cuts do not affect the IME payments made directly to teaching
hospitals that treat Medicare Advantage beneficiaries. The bill
also extends the availability of incentive payments for physician
quality reporting through 2010.
In the preceding cloture vote (69-30)
to limit debate and avoid a filibuster over H.R. 6331, Majority
Leader Harry Reid (D-Nev.) was able to secure the support of 9 Republicans
who had previously opposed the bill: Senators Lamar Alexander (Tenn.);
Saxby Chambliss (Ga.); Bob Corker (Tenn.); John Cornyn (Texas);
Kay Bailey Hutchison (Texas); Johnny Isakson (Ga.); Mel Martinez
(Fla.); Arlen Specter (Penn.); and John Warner (Va.). The House
voted, 355-59,
to pass the bill on June 24.
Additional information on the measure is available on the House
Committee on Ways and Means website.
Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
CMS Releases 2009 Proposed Physician Fee Schedule
The Centers for Medicare and Medicaid Services (CMS) July 7 published
in the Federal
Register the proposed
rule for the 2009 Medicare Physician Fee Schedule. Based on
the current statutory formula, CMS expects the physician fee schedule
to be reduced by 5.4 percent as of Jan. 1, 2009. However, Congress
has passed legislation that - if signed by the President - will
replace the reduction with a 1.1 percent positive update (see
related story).
In addition, the proposed rule outlines several adjustments to the
Physician Quality Reporting Initiative (PQRI) including listing
the potential new measures for 2009. In 2009, CMS will accept PQRI
data via data registries and electronic health records. The rule
also expands the options for reporting on measure groups and for
the reporting periods available.
CMS also proposes applying quality and performance standards to
diagnostic tests performed in a physician's office.
The rule also makes several proposals related to the physician self-referral
regulation, including a proposed narrow exception for "incentive
payment and shared savings programs," otherwise known as "gainsharing."
Comments are due to CMS by Aug. 29. The AAMC will submit comments.
Information:
Mary Patton, Senior Specialist
AAMC Health Care Affairs
mpatton@aamc.org
(202) 862-6297
CMS Proposes Payment Changes for Hospital OPPS and ASCs
The Centers for Medicare and Medicaid Services (CMS) July 7 posted
on its website a proposed
rule that contains changes to the outpatient prospective payment
system (OPPS) as well as proposed payment rates for Ambulatory Surgical
Centers (ASC). If finalized, changes to both the OPPS and the ASC
payment system will be implemented Jan. 1, 2009. Comments on the
proposed rule are due Sept. 2. The AAMC will be submitting comments.
CMS proposes to raise the base OPPS payment rate by the full market
basket increase of 3.0 percent. After taking into account the proposed
market basket increase, as well as other changes from CY 2008 to
CY 2009, CMS estimates that major teaching hospitals would see an
overall average increase in OPPS payments of 3.9 percent in 2009,
compared to a 3.5 percent increase for both minor teaching hospitals
and non-teaching hospitals.
Continuing its work of broadening the OPPS Ambulatory Payment
Classification (APC) payment groups, CMS proposes to create 5 composite
APC groups for imaging services. Composite APCs were first established
in CY 2008 for the purpose of bundling payment for multiple, major
procedures related to an outpatient encounter or episode of care
into a single APC payment. Currently, hospitals receive separate
payments when 2 or more imaging procedures are provided in a single
session. The proposed composite APC would provide a single APC payment
when 2 or more imaging procedures using the same imaging modality
are provided in a single session. Payment for the composite APC
would be calculated from estimated costs on claims for multiple
imaging services provided in a single session. According to CMS,
this payment methodology would encourage efficiency and would better
reflect the cost of second and subsequent imaging procedures.
CMS proposes to pay for separately payable drugs and biologicals
at the average sales price (ASP) plus 4.0 percent, a 1.0 percent
payment reduction from the payment rate hospitals currently receive.
CMS also proposes to create 4 new APCs for hospital emergency visits
provided in those emergency departments that are not open 24 hours,
7 days a week. Currently, these visits are reimbursed at the same
rate as clinic visits.
Under the Hospital Outpatient Quality Reporting Program, CMS proposes
to expand the reporting requirements by adding 4 claims-based imaging
efficiency measures. Currently there are 7 quality measures. CMS
also proposes the implementation of new validation requirements
for the outpatient program. The new requirements would move away
from the current inpatient prospective payment system validation
requirement of reviewing 5 charts per hospital and achieving an
80 percent reliability rating on the data element level. Instead,
the proposal would randomly sample 50 cases from 800 hospitals each
year and retain the 80 percent reliability rating on the measure
level. Only those hospitals randomly selected would be at risk of
having their payments reduced if they do not meet the validation
requirement.
Information:
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498
Jennifer Faerberg, Director
AAMC Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221
HHS Issues RFI on Human Subjects Protection Training
and Education
The Department of Health and Human Services (HHS)'s Office for
Human Research Protections (OHRP) July 1 issued a "Request
for Information [RFI] and Comments on the Implementation of Human
Subjects Protection Training and Education Programs." The request
follows a 1998 report from the HHS Office of the Inspector General
and a more recent recommendation of the Secretary's Advisory Committee
on Human Research Protections that researchers and institutional
review board (IRB) members be adequately trained on human subjects
protections.
This RFI seeks information and comment about:
- Whether individuals involved in the conduct or review of human subjects
research at institutions holding OHRP-approved Federalwide Assurances
(FWAs) understand and meet their regulatory responsibilities for protecting
human subjects;
- Whether the OHRP should issue additional guidance recommending that
institutions engaged in HHS-supported human subjects research implement
training and education programs for certain individuals involved in
the conduct, review, or oversight of human subjects research;
- Whether HHS should develop a regulation requiring the implementation
of such training and education programs.
Comments to OHRP are due by Sept. 29. AAMC will comment and will
be seeking input from members of the academic community. Additional
information is available on the HHS website.
Information:
Irena Tartokovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134
House Committee Examines VA Patient Notice Protocols
The House Committee on Veterans Affairs July 9 held a hearing
to examine the Department of Veterans
Affairs (VA) procedures for notifying patients of new potential
side effects associated with a prescription medication, specifically
Varenicline, a smoking cessation treatment. A number of veterans
using Varenicline were participating in an ongoing VA Cooperative
study to compare whether combining treatments for smoking cessation
and post traumatic stress disorder (PTSD) is more effective in stopping
smoking than delivering smoking cessation therapies separately.
The hearing addressed issues raised in a June 17 Washington
Times article entitled "VA testing drugs on war veterans:
Experiments raise ethical questions." The article described
a Feb. 5 psychotic episode of Iraqi War veteran James G. Elliott
that ended with a police stand-off and Mr. Elliott being Tasered.
The episode was allegedly caused by Varenicline, a smoking cessation
medication that may have the potential to cause suicidal thoughts
and aggressive behavior compounded by pre-existing psychiatric illness.
Mr. Elliott had been receiving treatment for PTSD and participated
in VA Cooperative Study Program No. 519 "designed to determine
whether integrating smoking cessation and PTSD therapies is more
effective in stopping smoking than smoking cessation therapies delivered
separately through a smoking cessation clinic, the usual way care
is provided at VA." The study involved all smoking cessation
treatments as prescribed by the patients’ physicians. These treatments
include counseling (alone and in combination with), nicotine patches,
and Varenicline.
Witnesses included Mr. Elliott; VA Secretary James B. Peake, M.D.;
and Paul Seligman, M.D., M.P.H, Associate Director of Safety Policy
and Communication, Center for Drug Evaluation and Research, Food
and Drug Administration (FDA). Joel Kupersmith, M.D., VA Chief Research
and Development Officer, accompanied Dr. Peake.
The hearing drew mixed questions and statements from committee
members. Debate began with the title of the hearing, "Why Does
the VA Continue to Give a Suicide-Inducing Drug to Veterans with
PTSD?" which Ranking Member Steve Buyer (R-Ind.) described
as inflammatory. All of the Members seemed to recognize the importance
of clinical research at the VA. As the hearing progressed, the committee's
attention turned to VA's patient notification procedures when new
potential side effects that many be associated with prescribed medications.
Committee Chair Bob Filner (D-Calif.) questioned whether drugs with
potential side effects that have not been scientifically validated
should be prescribed to vulnerable veteran populations.
On Nov. 20, 2007, the FDA issued an "early communication"
to health care providers indicating that concerns had arisen about
Varenicline having a possible side effect involving mental health.
The VA stated that it "immediately" notified all VA practitioners.
On Feb. 1, 2008, the FDA issued a "Public Health Advisory"
to providers with more information on potential side effects of
which clinicians and patients should be aware. VA distributed this
alert to pharmacists in its system that same day and to VA Institutional
Review Boards (IRBs) on Feb. 5. While VA procedures called for providers
to notify patients, Mr. Elliott was never made aware of the new
potential side effects. Participants in the VA Cooperative study
were later notified of the potential mental health risks in a Feb.
29 letter. The Committee and Dr. Peake shared concerns "about
the time that elapsed at a number of study sites between the receipt
of the letters and consent addendums by IRBs, and when they were
received by veterans." Dr. Peake suggested a central VA IRB
would prevent such delays.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
Department of Education Publishes Notice of Proposed
Rulemaking for CCRAA
The Department of Education July 1 published in the Federal
Register a notice of proposed rulemaking for new regulations
that implement the "College Cost Reduction and Access Act"
(CCRAA, P.L.
110-84). Effective July 1, 2009, the new regulations eliminate
the 20/220 pathway of the economic hardship deferment, define public
service for a new loan forgiveness program, and implement the income-based
repayment program authorized by the legislation.
The economic hardship deferment allows medical residents to postpone
repayment of their student loans using up to 3 annual deferments
without the additional interest penalties of forbearance. Despite
the statutory elimination of the 20/220 pathway for economic hardship
under the CCRAA, the Department used the Secretary's authority to
continue the pathway for economic hardship in its Nov. 2007 regulations.
However, citing a $1.1 billion cost over 10 years, the Department
announced March 4 it will not accept applications beyond July 1,
2009, when the income-based repayment program begins. The AAMC urged
reinstatement of the 20/220 pathway in a March 12 joint letter
with the AMA [see Washington
Highlights, March 14].
The income-based repayment program will be available for all residents,
regardless of income or debt. The new program will require a minimum
student loan payment capped at 15 percent of the borrower's monthly
income that exceeds 150 percent of the applicable poverty line.
The calculation for married borrowers' repayments will include spousal
income.
A new loan forgiveness program will absolve Direct student loans
for borrowers who work 10 years in certain "public service"
jobs and make loan payments during that time. Among other professions,
public service will include all 501(c)(3) employers, "faculty
teaching in high-needs areas as determined by the Secretary,"
and service at private organizations providing "public health"
or "emergency management" services. Residents with other
federal student loans will be able to consolidate under the Direct
loan program to participate in the loan forgiveness program.
The rule follows 5 months of negotiated rulemaking [see Washington
Highlights, April 18]
with outside stakeholders including Carrie Steere-Salazar, chair
of the AAMC Committee on Student Financial Assistance (COSFA) and
director of students services at UCLA, San Francisco. Ms. Steere-Salazar
represented the AAMC and the graduate/professional education community
on the committee.
The public comment period for the proposed rule ends Aug. 15.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
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