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Washington Highlights: May 11, 2007

Hospital Associations Urge Rescind of Proposed Inpatient Cuts

The AAMC May 3, along with the American Hospital Association, Federation of American Hospitals, National Association of Public Hospitals, Premier and VHA, sent a letter urging Centers for Medicare and Medicaid Services (CMS) Acting Administrator Leslie Norwalk to rescind the following provisions contained in the Medicare inpatient PPS proposed rule:

  • the 2.4 percent reduction in payments to account for purported coding adjustments;
  • the elimination of the 0.8 percent capital PPS update for urban areas; and
  • the elimination of the 3 percent add-on to capital PPS payments for hospitals in large urban areas.

The proposed rule was published April 13 on the CMS web site and in the Federal Register May 3. Comments are due June 12.

The proposed rule would significantly modify the current diagnosis-related group (DRG) system by replacing the 535 current DRGs with 745 new "Medicare-Severity" DRGs (MS-DRGs). The purpose of the change is to have the DRGs more fully account for the severity of patients' conditions. The current proposal is a continuation of last year's rulemaking in which CMS proposed a new DRG system but withdrew it in the final rule as a result of numerous negative comments.

The proposed rule includes a 2.4 percent cut in both FYs 2008 and 2009 to eliminate what CMS asserts will be the effect of coding or classification changes that do not reflect real changes in the severity of patients treated. The estimated 5-year impact of the 2-year cuts is $24 billion. The estimated 5-year impact of the two capital cuts contained in the proposed rule is $1 billion.

The group letter notes that "there is no rational behind imposing such dramatic cuts to hospital payments . . . they are not mandated; they are not supported by Congress and they are unnecessary."

Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

Senators Support NIH Increase, Title VII Restoration

In letters to the Senate Appropriations Committee leadership, Senators expressed support for an increase in National Institutes of Health (NIH) funding and restoration of Title VII funding to FY 2005 levels.

In an April 26 letter organized by Senators Ted Kennedy (D-Mass.), Orrin Hatch (R-Utah), Christopher Dodd (D-Conn.), and Richard Burr (R-N.C.), 48 Senators requested a 6.7 percent increase in NIH funding for each of the next 3 years. The letter, addressed to Senate Appropriations Chair Robert Byrd (D-W.V.) and Ranking Member Thad Cochran (R-Miss.), and Labor, Health and Human Services, and Education Appropriations Subcommittee Chair Tom Harkin (D-Iowa) and Ranking Member Arlen Specter (R-Pa.), notes that "the extraordinary effort to double our investment in the NIH has yielded an unprecedented number of scientific advances that have improved health outcomes and contributed significantly to the economic growth of this nation." The letter further notes that "many of the benefits of the doubling will be lost unless FY 2008 is the beginning of an annual commitment by the Congress to provide adequate funding for health research."

A May 4 letter to Senators Harkin and Specter urges restoring funding for the Title VII health professions programs to the FY 2005 level of $300 million. A total of 39 Senators signed the letter, led by Senators Jack Reed (D-R.I.) and Pat Roberts (R-Kan.). The letter describes how "dramatically reduced funding" for the programs has had a "devastating effect on the country's neediest communities."

Information:

Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

Medicare Rehab Facility PPS Proposed Rule Published

The Centers for Medicare and Medicaid Services (CMS) May 8 published in the Federal Register its Medicare inpatient rehabilitation facility (IRF) proposed rule for FY 2008. Under the proposed rule, payment rates to IRFs would be updated by an increase factor equal to the rehabilitation, psychiatric and long-term care hospital (RPL) market basket of 3.3 percent. If finalized, the policies will become effective Oct. 1. Comments on the proposed rule are due July 2.

Overall the estimated payments per discharge for IRFs in FY 2008 are projected to increase by 2.4 percent. This is largely due to a 0.9 percent reduction in the standard payment amount that CMS is implementing to finance the outlier pool, which accounts for 3 percent of total payments. Because last year's outlier payments exceeded 3 percent, the proposed rule would increase the outlier threshold from $5,534 in FY 2007 to $7,522 in FY 2008.

To determine whether a facility qualifies as an IRF, thereby qualifying for higher PPS payments than inpatient hospitals, CMS is implementing the 75 percent rule. This standard, when fully phased in, requires that at least 75 percent of an IRF's patient population has one of 13 designated medical conditions for which intensive inpatient rehabilitation services are medically necessary. Many observers have argued that the 13 conditions are outdated and need to be revised.

The 75 percent rule is being phased in over a 4-year period. Currently, for providers with cost reporting periods that start on or after July 1, 2006 and before July 1, 2007, the compliance threshold is 60 percent. It is 65 percent for cost reporting periods starting on or after July 1, 2007 and before July 1, 2008. The phase-in period ends with cost reporting periods beginning on or after July 1, 2008, when the 75 percent threshold goes into effect.

In addition, a provision of the 75 percent rule allowing comorbidities that meet certain regulatory criteria used in determining the compliance threshold also is scheduled to expire with the full implementation of the rule on July 1, 2008. However, the agency is asking for comments on whether this provision should be continued.

Information:
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498

House Passes Student Loan Oversight Bill

The House May 9 overwhelmingly passed (414-3) the "Student Loan Sunshine Act" (H.R.890) to establish conflict of interest requirements for lenders and institutions of higher education. The bill is a compromise between Rep. Buck McKeon's (R-Calif.) "Financial Aid Accountability and Transparency Act of 2007" (H.R.1994) and the Democratic version of the "Student Loan Sunshine Act," introduced Feb. 7 by House Education and Labor Chair George Miller (D-Calif.).

Among other provisions, the Sunshine Act would:

  • Require institutions to develop and administer a code of conduct for their financial aid offices;
  • Require institutions to disclose all relationships with lenders;
  • Ban all gifts, opportunity pools, and revenue-sharing between lenders and institutions;
  • Prohibit financial aid administrators' participation on lender advisory boards (other college officials may participate without compensation or reimbursement of expenses);
  • Require "preferred lender lists" to include at least 3 unaffiliated lenders and the process that was used to develop the list; and
  • Prohibit staffing of campus financial aid offices by lenders or their employees, excluding services provided in exit interviews for borrowers.

Senate Health, Education, Labor, and Pensions Chair Edward Kennedy (D-Mass.) Feb. 1 introduced his version of the "Student Loan Sunshine Act" (S. 486). Sen. Kennedy plans to address this issue as part of the broader Higher Education Act reauthorization.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

Senate Passes FDA User Fee Bill

After a week of debate and numerous amendments, the Senate May 9 overwhelmingly passed legislation to renew the user fees that drug companies pay to the Food and Drug Administration (FDA) to review their products. The vote on the "Prescription Drug User Fee Amendments of 2007" (S. 1082) was 93-1, with Senator Bernie Sanders (I-Vt.) voting against it. The Senate HELP Committee approved the bill on April 18 [see Washington Highlights, April 20].

The bill reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Modernization Act (MDUFMA), providing about $450 million in drug and device user fee revenue to FDA in FY 2008. Since authority for the user fees expires on Sept. 30, many observers consider this bill "must-pass" legislation. As a result, it is being used as a vehicle for a number of provisions to address drug safety and pediatric drug testing.

The drug safety portion of the bill expands the ClinicalTrials.gov data bank at the National Library of Medicine to include all phase II and later drug trials and medical device trials. In addition, results from clinical trials will be included in the data base after the drug or device has been approved for marketing. Results information would first come from existing FDA documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured in these documents.

Among the amendments the Senate approved were two contradictory proposals related to drug importation. The Senate May 7 passed an amendment offered by Senator Byron Dorgan (D-N.D.) to permit drug importation from other countries after passing an amendment by Senator Thad Cochran (R-Miss.) that would require the Secretary of Health and Human Services to certify the safety of imported drugs. Since the Administration has been unwilling to make such certifications, the Cochran amendment in effect blocks drug importation.

The Senate leadership also reached an agreement to defer action on an expedited approval process for generic or follow-on versions of biotechnology drugs, waiting to add this proposal to the bill during the House-Senate conference. The Senate HELP Committee is expected to hold a hearing on the issue in June.

The legislation now moves to the House, where Energy and Commerce Committee John Dingell (D-Mich.) reportedly will take up the drug and device user fees as separate bills. Committee members are said to be discussing whether to include other issues, such as drug safety, as was done in the Senate bill. Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) introduced a free-standing drug safety bill (H.R. 1561) on March 19.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

House Panel Examines Department of Education's Oversight of Student Loans

The House Education and Labor Committee May 10 held a hearing to examine the "Accountability for the Department of Education's Oversight of Student Loans." Committee Chair George Miller (D-Calif.) criticized the department's failure to address the recent unethical practices brought to light in an investigation by New York Attorney General Andrew Cuomo. Secretary of Education Margaret Spellings testified that these incidents were out of the department's jurisdiction for oversight because they involved private loans as opposed to those guaranteed or sponsored by the federal government. In response, Chairman Miller argued that they are irreducibly coupled.

Secretary Spellings also indicated that she would continue to pursue student loan reform though the regulatory process with her recently appointed Taskforce on Student Loans. The taskforce was created after the Department's Negotiating Committee on Student Loans failed to reach a consensus on proposed regulations. In a March 8 letter, the AAMC urged that committee "not inadvertently encourage lenders to circumvent well-established safeguards and market directly to student without the guidance of trained professionals" [see Washington Highlights, March 16].

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

Comparative Effectiveness Bill Introduced

Reps. Tom Allen (D-Maine) and Jo Ann Emerson (R-Mo.) May 7 introduced the "Enhanced Health Care Value for All Act" (H.R. 2184), which is designed to enhance comparative effectiveness research on health care items and services. Section 1013 of the Medicare Modernization Act (P.L. 108-173) authorizes this research at the Agency for Healthcare Research and Quality (AHRQ). The bill authorizes a $3 billion Health Care Comparative Effectiveness Research Trust Fund for AHRQ to support and conduct this research, financed through contributions from Medicare Parts A and B Trust Funds, the Medicare Prescription Drug Program, and health plans.

The bill also establishes a Comparative Effectiveness Advisory Board to recommend how to organize the various types of comparative effectiveness research, set research priorities, and determine whether to establish a federally-funded research and development center. It also creates a Health Services Research Coordinating Council to identify a national health services research agenda and coordinate all health services research supported by federal agencies.

Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525

Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

Rep. Meehan Submits Resignation

Rep. Martin Meehan (D-Mass.) May 9 officially announced his departure from the House, effective July 1. Rep. Meehan will become chancellor of the University of Massachusetts at Lowell. He chairs the Armed Services Subcommittee on Oversight and Investigations and is a member of the Judiciary Committee. A special primary election will be held Sept. 4, with a general election on Oct. 16.