WASHINGTON WIRE
June 15, 2007
Issue 136
In this issue, you'll find:
Opposition to FDA Bill Delays Markup
Subcommittee Examines Comparative Effectiveness
Top Story
Opposition to FDA Bill Delays Markup
A House subcommittee mark-up of FDA legislation was postponed this week, following significant concerns about the legislation expressed by GOP subcommittee members.
The House Energy and Commerce Health Subcommittee held a hearing on Tuesday to review draft reauthorization bills for the Prescription Drug User Fee Act (PDUFA). The hearing was supposed to prepare the subcommittee for the beginning of markup the following day, but a lack of support for the legislation from Republican lawmakers convinced Chairman Frank Pallone (D-NJ) by Wednesday morning to postpone the markup until June 19th.
Republican subcommittee members stated specific objection to provisions in the draft legislation that would prevent federal law from preempting state law as it pertains to the regulations of drugs. Opponents of this language, including a representative from the Food and Drug Administration (FDA), fear that such language compromises the FDA's ability to regulate the industry as well as open the door for an onslaught of lawsuits at the state level.
Other lawmakers express serious concern with the language on drug safety. The draft legislation would have restricted direct-to-consumer advertising and required Risk Evaluation and Mitigation Strategy (REMS) and warning labels for all new FDA-approved drugs.
Although the subcommittee markup has been posted until Tuesday, the full Committee Chairman, John Dingell (D-MI), has indicated he still plans to move the bill out of Committee by the end of next week.
Health Care News
Subcommittee Examines Comparative Effectiveness
At a recent Ways and Means Health Subcommittee hearing, most witnesses and lawmakers agreed that there is a current need for a public-private entity charged with overseeing comparative effectiveness research and determining which treatments are most effective for a particular medical condition.
Many at the hearing, including the Director of the Congressional Budget Office (CBO), touted comparative effectiveness research as a promising way to bring down increasing healthcare costs. However, the CBO has not provided a score on such proposals, suggesting that the savings may be realized after a 10-year budget window.
The Director of MedPAC also testified, stating the Commission favors the creation of an independent entity to set the research agenda and disseminate findings. However, some Members expressed concern that comparative effectiveness date could be used to determine coverage decisions, thus limiting consumers' access to some treatments and services.
Congressman Tom Allen (D-ME) and Congresswoman Jo Ann Emerson (R-MO) recently introduced legislation that would provide the Agency for Health Research and Quality (AHRQ) with $3 billion over five years to expand on comparative effectiveness research. The bill would also create an independent advisory board to set research priorities and recommend future research activities. To fund this, the legislation would require insurers, both public and private, to contribute to a "Comparative Effectiveness Trust Fund."
CMS Releases Memo on 75% Rule
A memorandum released by the Centers for Medicare and Medicaid Services (CMS) on June 8th found that since enforcement of Medicare's 75% Rule on inpatient rehabilitation began in 2004, utilization has decreased 19 percent.
The 75% Rule states that in order to be considered an inpatient rehabilitation hospital or unit under Medicare, and reimbursed at a higher rate, a certain percentage of patients must have one of thirteen diagnoses. The 75% Rule is currently being phased-in, with the threshold now at 60% and set to increase to 65% on July 1, 2007 and 75% on July 1, 2008.
CMS maintains that these findings show that the rule is effective in determining the most appropriate care for individuals in need of rehabilitation services and that those who do not require intensive inpatient care are successfully being diverted to less intensive settings.
However, many disability, consumer, and hospital groups are advocating against further implementation of the 75% Rule, stating the level of rehabilitative care an individual requires cannot be determined based on diagnoses alone. They state that the 75% Rule acts as an inappropriate quota system and results in denials of necessary inpatient rehabilitative care for many individuals with disabilities or injuries.
Legislation has been introduced in both the House and Senate (HR 1459 and S. 543) that would freeze further implementation of the 75% Rule at the current level.
The CMS memorandum can be found at http://www.cms.hhs.gov/InpatientRehabFacPPS/Downloads/IRF_PPS_75_percent_Rule_060807.pdf.
Upcoming Events
Hearings and Events
Monday June 18, 2007
Care for Returning Soldiers
President's Commission on Care for America's Returning Wounded Warriors
10 a.m., Atrium Ballroom, Reagan Bldg., 1300 Pennsylvania Ave. N.W.
Tuesday, June 19, 2007
Juvenile Diabetes Research and the Federal Government
Senate Homeland Security and Governmental Affairs Committee
9:30 a.m., 106 Dirksen
FDA Overhaul, Drug and Medical Device Fees
House Energy and Commerce - Subcommittee on Health
10 a.m., 2123 Rayburn
Protecting Patient Privacy
House Oversight and Government Reform - Subcommittee on Information Policy, Census, and National Archives
2 p.m., 2154 Rayburn
Fiscal 2008 Appropriations: Labor-HHS-Education
Senate Appropriations - Subcommittee on Labor, Health and Human Services, Education
4 p.m., 124 Dirksen
Thursday, June 21, 2007
Health Care and the Budget
Senate Budget Committee
10 a.m., 608 Dirksen
Fiscal 2008 Appropriations: Labor-HHS-Education
Senate Appropriations Committee
2 p.m., 106 Dirksen
Protecting Beneficiaries of Medicare Prescription Drug Benefit
House Ways and Means - Subcommittee on Health
2 p.m., 1100 Longworth
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.
Powers Pyles Sutter & Verville PC is a full service law firm specializing in health care and education law and located at 1501 M St., NW Seventh Floor, Washington DC 20005
© Copyright 2007, Powers Pyles Sutter & Verville PC
All rights reserved
