WASHINGTON WIRE
April 13, 2007
Issue 127
Welcome to the Weekly Washington Wire on Health Care Policy!
In this issue, you'll find:
Senate Passes Bill on Stem Cell Research
Medicare Drug Negotiation Bill Passes Committee, Faces Hurdles on Senate Floor
Kennedy Introduces PDUFA Reauthorization with Drug Safety Provisions
Report Finds Medicare Waiting Period has Health, Financial Tolls
CMS Publishes Final Competitive Bidding Rule
Top Story
Senate Passes Bill on Stem Cell Research
On Wednesday, the Senate voted 63 to 34 to pass the Stem Cell Research Enhancement Act of 2007 (S. 5). The bill, sponsored by Senators Tom Harkin (D-IA) and Arlen Specter (R-PA), would lift the ban on the expansion of federal funding for stem cell research that has been in place since August 2001. The House passed a similar stem cell bill (H.R. 3) in January.
The bill faces an almost inevitable veto by the President who vetoed similar legislation last year. Currently, neither the House nor the Senate has the two-thirds majority necessary to override a presidential veto.
A competing stem cell bill, the Hope Offered Through Principled and Ethical Stem Cell Research (HOPE) Act (S.30), was also approved by Senate this week. The bill, sponsored by Senators Norm Coleman (R-MN) and Johnny Isakson (R-GA), promotes stem cell research through alternative methods which would not destroy human embryos, a practice many social conservatives associate with abortion. It is not known whether the House will take up the Coleman-Isakson bill.
It is unclear whether the Harkin-Specter stem cell bill will now be taken up by the House or be reconciled with the House stem-cell bill in conference committee. Supporters of the expansion of federal funds for stem cell research will also attempt to work the issue into other legislation throughout the 110th Congress.
Health Care News
Medicare Drug Negotiation Bill Passes Committee, Faces Hurdles on Senate Floor
On Thursday, the Senate Finance Committee Approved controversial legislation to permit Medicare to negotiate prescription drug prices. Allowing negotiations was a platform of many 2006 Democratic Congressional campaigns, but securing enactment of such legislation will prove to be difficult despite a Democratic majority in Congress.
The House approved legislation earlier this year that would require the Health and Human Services (HHS) Secretary to negotiate with drug marketers for Medicare prescription drug prices. The bill introduced by Senate Finance Committee Chairman Max Baucus (D-MT) would allow negotiations but not require them. The Chairman likely scaled back his proposal to potentially appease any wavering opponents; however, many Democrats feel the Senate proposal does not go far enough.
The President has indicated he will veto such legislation if it reaches his desk. However, Senate supporters face hurdles long before then, as a filibuster appears likely and it is unclear whether Democrats have the 60 votes needed to overcome a it.
The legislation is expected to reach the Senate floor next week.
Kennedy Introduces PDUFA Reauthorization with Drug Safety Provisions
Senate Health Education Labor and Pensions Committee Chairman, Edward Kennedy (D-MA), introduced much-anticipated legislation this week to reauthorize the Prescription Drug User Fee Act (PDUFA). The current program expires on September 30th.
As expected, the PDUFA reauthorization also includes drug safety reform legislation, introduced by Chairman Kennedy and Ranking Member Michael Enzi (R-WY) earlier this year, which proposes risk evaluation and mitigation strategy (REMS) requirements. Additionally, the Chairman has included provisions that would require the FDA to contract with federal and private databases in an effort to collect drug safety information and monitor adverse events.
The draft PDUFA reauthorization does not include provisions on generic biotech drug approvals. However, Senator Kennedy has not ruled out the possibility that such provisions may make it into future drafts of the bill. The Chairman has scheduled a mark-up hearing for April 18, 2007.
Report Finds Medicare Waiting Period has Health, Financial Tolls
A report issued by the Medicare Rights Center and the Commonwealth Fund issued this week found that 600,000 individuals with severe disabilities go into debt or forgo health care during the mandatory two-year waiting period for Medicare coverage.
Once individuals are "deemed" eligible for Social Security Disability Insurance, they must wait two years to begin receiving health care under Medicare. The report finds that 39 percent of the estimated 1.5 million people waiting for Medicare coverage go uninsured for at least some of this time, and 26 percent have no insurance throughout the waiting period.
The Medicare Rights Center, along with other disability-related organizations, is urging Congress to eliminate this waiting period in order to ensure individuals receive appropriate health care.
The report can be found at http://www.medicarerights.org/Too_Sick_To_Work_Too_Soon_For_Medicare.pdf.
CMS Publishes Final Competitive Bidding Rule
On Monday, April 2, 2007, the Centers for Medicare and Medicaid Services (CMS) published the final Medicare competitive bidding regulation for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS).
The competitive bidding program, mandated by the Medicare Modernization Act of 2003 (MMA), will replace Medicare's payment structure for certain DMEPOS. Suppliers interested in furnishing items included in the competitive bidding program will submit bids to CMS's contractor. CMS will award contracts to certain bidders, and will use the winning bids to establish a single Medicare payment amount for competitively bid items in a given area.
It is expected that when fully implemented in 2010, the program will save Medicare nearly $1 billion per year. However, many critics argue that the program will unfairly penalize small providers and create access problems for beneficiaries.
The competitive bidding program will initially take place in the following 10 Metropolitan Statistical Areas (MSAs):
- Charlotte-Gastonia-Concord, NC-SC
- Cincinnati-Middletown, OH-KY-IN
- Cleveland-Elyria-Mentor, OH
- Dallas-Fort Worth-Arlington, TX
- Kansas City, MO-KS
- Miami-Fort Lauderdale-Miami Beach, FL
- Orlando, FL
- Pittsburgh, PA
- Riverside-San Bernardino-Ontario, CA
- San Juan-Caguas-Guaynabo, PR
In 2009, the program will operate in 70 additional MSAs, and will expand to other MSAs after 2009.
Initially, the competitive bidding program will include the following 10 DMEPOS product categories, to be potentially expanding after 2009:
- Oxygen Supplies and Equipment
- Standard Power Wheelchairs, Scooters, and Related Accessories
- Complex Rehabilitative Power Wheelchairs and Related Accessories
- Mail-Order Diabetic Supplies
- Enteral Nutrients, Equipment, and Supplies
- Continuous Positive Airway Pressure (CPAP) Devices, Respiratory Assist Devices (RADs), and Related Supplies and Accessories
- Hospital Beds and Related Accessories
- Negative Pressure Wound Therapy (NPWT) Pumps and Related Supplies and Accessories
- Walkers and Related Accessories
- (Miami and San Juan Only) - Support Surfaces (group 2 and 3 mattresses and overlays)
The final rule can be viewed at http://frwebgate4.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=4764938852+0+0+0&WAISaction=retrieve
Upcoming Events
Hearings
Tuesday, April 17, 2007
Treatment of Injured Soldiers at Walter Reed Hospital
House Oversight and Government Reform - Subcommittee on National Security and Foreign Affairs
10 a.m., 2154 Rayburn
Treatment of Injured Soldiers at Walter Reed Hospital House Oversight and Government Reform - Subcommittee on National Security and Foreign Affairs10 a.m., 2154 Rayburn
Prescription Drug User Fee Act
House Energy and Commerce - Subcommittee on Health
10 a.m., 2123 Rayburn
Combating Autism
Senate Appropriations - Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
2 p.m., 124 Dirksen
Wednesday, April 18, 2007
Prescription Drug User Fees
Senate Health, Education, Labor and Pensions Committee
10 a.m., 628 Dirksen
Medicare Program Efficiency and Integrity
House Energy and Commerce - Subcommittee on Health
2 p.m., 2123 Rayburn
Access to VA Health Care
House Veterans' Affairs - Subcommittee on Health
2 p.m., 334 Cannon
Thursday, April 19, 2007
Bioidentical Hormones
Senate Special Aging Committee
10 a.m., 628 Dirksen
For More Information
For further information on any topics discussed or publications listed, or to get copies of anything mentioned in this alert, please call 202.466.6550 and ask for the Legislative Practice Group.
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