In this issue, you'll find:
Senate Confirms Crawford As FDA Commissioner
On Monday, July 18, 2005 the Senate voted 78 to 16 to confirm Lester Crawford as Commissioner of the Food and Drug Administration (FDA). The vote followed decisions by several Senators to lift their holds on the confirmation process.
Senators Clinton (D-NY) and Murray (D-WA) had put a hold on the vote in response to the FDA's delay in making a decision on the sale of emergency birth control pill - "Plan B." However, the Senators agreed to the vote after Health and Human Services (HHS) Secretary Michael Leavitt stated an FDA decision would be made by September 1, 2005 on the sale of Plan B. Senators Clinton and Murray voted against the confirmation of Crawford.
Additionally, Senator Coburn (R-OK) lifted his hold on the Crawford confirmation although refrained from the actual vote. Senator Coburn had held up the confirmation because of concern that the FDA has not required warning labels on condoms regarding their inability to protect against certain sexually transmitted diseases.
Fourteen Senators voted against confirming Crawford as Commissioner including Chairman of the Finance Committee Charles Grassley (R-IA). Senator Grassley, referring to the FDA's recent controversy over drug safety, stated that Mr. Crawford has not proven to be the "leader to fix the FDA."
Chairman and Ranking Member of the Senate Health, Education, Labor and
Pensions (HELP) Committee, Michael Enzi (R-WY) and Edward Kennedy
(D-MA), voted to confirm Crawford, stating that the public needs a
full-fledged commissioner during this vital time for the agency.
Outpatient Hospital Departments Receive Proposed Increases, Drug Reimbursement Altered
On July 18, 2005, the Centers for Medicare and Medicaid Services (CMS) released the Hospital Outpatient Department Prospective Payment System proposed rule, which sets reimbursement for 4,200 hospital outpatient departments. Overall, payments would rise 3.2 percent in calendar year 2006. The payment increases and other reimbursement changes would give outpatient departments $27.5 billion in Medicare reimbursement in 2006, up from $26.1 billion in 2005.
proposal will also continue to reduce Medicare beneficiaries'
coinsurance rates for hospital outpatient services. The coinsurance
rate will decline to 40 percent of a hospital's Medicare payment for
treating the beneficiary. The rate, once as high as 50 percent, is
gradually being reduced to 20 percent. CMS also said that under the
proposed rule it would reimburse physicians for Part B drugs,
biologicals, and radiopharmaceuticals at 106 percent of the
manufacturer's average sales price, a similar methodology for drugs
currently reimbursed through physician offices. The current
reimbursement rate is 83 percent of the average wholesale price. Under
the rule, CMS also would pay providers an additional 2 percent over the
price of a drug to cover pharmacy costs. The agency would begin
collecting claims data in 2006 to set exact payment rates for this
service beginning in 2008.
Senate Committee Approves Reimportation Legislation
On Thursday, July 21, 2005, by a 14 to 8 vote, the Senate Commerce Committee approved legislation that would allow for the reimportation of prescription drugs.
legislation would allow licensed pharmacists and wholesalers to import
FDA-approved medications from FDA-approved pharmacies in specified
countries. Seemingly frustrated by mark-up delays, Senators Olympia
Snowe (R-ME) and Byron Dorgan (D-ND) bypassed the Senate HELP Committee
and attached the legislation to a bill reauthorizing the Federal Trade
Congress Aims to Halt Implementation of 75% Rule
Senators Rick Santorum (R-PA) and Bill Nelson (D-NE) and Representatives Frank LoBiondo (R-NJ), Nita Lowey (D-NY) and John Tanner (D-TN) have introduced legislation in the Senate and House respectively that aims to halt further implementation of Medicare's so-called "75 percent rule" on inpatient rehabilitation facilities.
Adopted by CMS in 2004, the 75 percent rule states that rehabilitation hospitals must admit a percentage of patients who fall in one of 13 diagnostic categories in order to be reimbursed as an inpatient rehabilitation facility under Medicare. CMS plans to increase the necessary percentage of patients with one of the 13 conditions from the current 50 percent to 75 percent over the next four years.
of the 75 percent rule state that further implementation will not only
threaten access for those who do not have one of the 13 diagnoses, but
will also threaten the long-term stability of the rehabilitation
hospital system. Both the Senate and House legislation would freeze the
compliance rate of the 75 percent rule at 50 percent as well as create
a National Advisory Council on Medical Rehabilitation to advise HHS in
House Committee Examines Potential Changes at NIH
On Thursday, July 19, 2005, the House Energy and Commerce Committee, Subcommittee on Health, held a hearing to examine the pending reauthorization of the National Institutes of Health (NIH).
Committee Chairman, Joe Barton (R-TX), stated his interest in creating a more consolidated agency by reducing the NIH's 27 institutes and centers into just four appropriations areas. While the Chairman described his proposed legislation as a means to improve the agency's management, other members of the committee expressed fear that such a change would instead have the opposite effect.
the subcommittee hearing, Dr. Elias A. Zerhouni, Director of the NIH,
stated that he did not support increased centralization of his agency
but did recognize a need for greater coordination. He stated his
interest in the establishment of a system of checks and balances within
the agency as Congress moves forward with reauthorization.
Committee on Small Business
2360 Rayburn House Office Building
To Explore the Impact on Small Pharmacies When Governments Compel Pharmacists to Dispense Drugs to Which They May be Morally Opposed
Tuesday, July 26, 2005
Committee on Armed Services - Subcommittee on Military Personnel
2118 Rayburn House Office Building
Military Mental Health Services
Committee on Appropriations- -Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies
2362-A Rayburn House Office Building
Food and Drug Administration FY 2006 Appropriations
Wednesday, July 27, 2005
Medicaid Advisory Commission Meeting
Renaissance Hotel, 999 9th Street, NW, Washington, DC
Committee on Ways and Means - Subcommittee on Health
1100 Longworth House Office Building
Health Care Information Technology
Committee on Finance
215 Dirksen Senate Office Building
Improving Quality in Medicare: The Role of Value-Based Purchasing
Committee on Government Reform - Subcommittee on Federal Workforce and Agency Organization
2154 Rayburn House Office Building
Using Information Technology to Improve Healthcare
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