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Washington Highlights: August 3, 2007

House, Senate Pass SCHIP Reauthorization Packages

The House Aug. 1 and the Senate Aug. 2 passed their respective State Children's Health Insurance Program (SCHIP) reauthorization bills, largely along party lines. The Senate version (H.R. 976) is nearly identical to the $35 billion, "Children's Health Insurance Program Reauthorization Act of 2007" (S. 1893), adopted by the Senate Finance Committee on July 19 [see Washington Highlights, July 20].

The House-passed "Children's Health and Medicare Protection Act" (H.R. 3162) is an amended version of the bill passed by the House Ways and Means Committee on July 27. [see Washington Highlights, July 27]. Before floor consideration of H.R. 3162, House Democrats reduced the bill's cost by limiting the availability of "performance bonus payments" for certain Medicaid/SCHIP expansions to 5 years (a savings of $20.4 billion over 10 years). They also reduced the 10-year cost of the Medicare physician payment "fix" from $102.7 billion to $67 billion, presumably by increasing the level of physician payment cuts in the out-years. Physicians would still receive a 0.5 percent update in calendar years 2008 and 2009.

The House and Senate must now reconcile their disparate SCHIP packages. President Bush has issued Statements of Administrative Policy reiterating his intention to veto any SCHIP bill based on either the House-passed or Senate-passed language because the legislation "clearly favors government-run health care over private health insurance."

Information:
Christiane Mitchell, Senior Legislative Affairs Manager
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

CMS Announces Payment Reforms for Inpatient Hospital Services in 2008

The Centers for Medicare and Medicaid Services (CMS) Aug.1 issued on its web site the FY 2008 Inpatient Prospective Payment System Final Rule [see Washington Highlights, May 11].

A preliminary review of the final rule reveals that the agency is implementing the so-called "behavioral offset" that was included in the proposed rule, but will phase in the reduction over 3 rather than 2 years, so that there will be a 1.2 percent reduction in FY 2008, a 1.8 percent in FY 2009, and a 1.8 percent in 2010 instead of a 2.4 cut for both FY 2008 and FY 2009.

Overall, payments will increase by an average of 3.5 percent for FY 2008, but teaching hospitals with fewer than 100 residents will see an increase of 3.7 percent while those with more than 100 residents will experience a 4.4 percent increase.

CMS did not finalize the proposed policy to remove vacation and sick leave from the FTE calculation at this time. However, CMS is continuing to look for a way to finalize the proposed policy in future rulemakings in a manner that would be less administratively burdensome. The agency is proposing a few options and is seeking comments from hospitals.

The final rule also eliminates the large urban add-on payment, and adopts a policy of discontinuing the teaching adjustments to capital payments over a 3-year period.

Information:
Karen Fisher, Senior Associate Vice President
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

Rehab Facilities Receive a 3.2 Percent Update Under FY 2008 Final Rule

The Centers for Medicare and Medicaid Services (CMS) July 31 issued its Medicare inpatient rehabilitation facility (IRF) final rule for FY 2008 on its web site. The rule is expected to be published in the Federal Register Aug. 7. The final rule provides for an update to IRF payment rates, equal to the 3.2 percent rehabilitation, psychiatric, and long-term care hospital (RPL) market basket increase.

Overall, however, the estimated payments per discharge for IRFs in FY 2008 are projected to increase by 2.4 percent. This is largely due to a 0.7 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 final rule increases the outlier threshold from $5,534 in FY 2007 to $7,362 in FY 2008, which is less than the $7,522 in the proposed rule.

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. When fully phased in, this standard requires that at least 75 percent of an IRF's patient population has 1 of 13 designated medical conditions for which intensive inpatient rehabilitation services are medically necessary.

The 75 percent rule is being phased in over a period that started in July 2004. 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.

Currently, a provision of the 75 percent rule allows comorbidities that meet certain regulatory criteria to be used in conjunction with the 13 designated medical conditions to meet the requirements of the rule. This provision is scheduled to expire with the full implementation of the rule on July 1, 2008. CMS decided not to extend the provision, stating that it is the principal diagnosis that most accurately denotes whether a patient has a medical condition that requires admission to an IRF.

In other areas the final rule:

  • establishes a wage index policy for rural areas without hospital wage data by which the average wage index from all contiguous counties can be used to represent a reasonable proxy for the rural area within that State (this policy does not apply to Puerto Rico); and
  • clarifies short-stay transfer policy to indicate that short-stay transfer cases that meet the criteria to qualify for outlier payments are eligible to receive the additional payments.

The policies will become effective Oct. 1, 2007.

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

Congress Clears Competitiveness Bill for President

Both the House and Senate Aug. 2 approved the conference agreement (H. Rept. 110-289) for the "America COMPETES Act" (H.R. 2272), which seeks to improve national competitiveness by enhancing research and education in math and the physical sciences. The bill cleared the House, 367-57, and the Senate by unanimous consent. The House had approved the bill May 21 [see Washington Highlights, May 25], while the Senate approved its version (S. 761) on April 25 [see Washington Highlights, April 27].

The conference agreement authorizes a total of $22 billion in funding for FYs 2008 - 2010 for the National Science Foundation (NSF), with the goal of doubling NSF funding within 7 years. The agreement also seeks to double within 7 years funding for the Department of Energy's (DOE) Office of Science, while funding for the National Institute of Standards and Technology is scheduled to double within 10 years. The increases correspond with the President's American Competitiveness Initiative (ACI) and the Democratic leadership's Innovation Agenda.

The measure also authorizes increased funding for science, technology, engineering, and mathematics (STEM) education programs at NSF, DOE, and the Department of Education; provides support for young investigators and researchers pursuing innovative, high-risk research in STEM fields; and directs the President to convene a National Science and Technology Summit, responsible for identifying key STEM research and technology challenges. Provisions addressing the role of the National Aeronautics and Space Administration and the National Oceanic and Atmospheric Administration in national competitiveness also are included in the agreement.

Both the House and the Senate passed their respective bills with broad bipartisan support. In April, the White House issued Statements of Administration Policy expressing concern with the bills' "excessive authorization levels" and expansion of overlapping STEM education programs that "have not been proven effective," despite general support for the bills.

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

House Approves FDA Spending Bill

The House Aug. 2 approved its FY 2008 Agriculture-Rural Development-Food and Drug Administration Appropriations bill (H.R. 3161). The bill provides $1.7 billion for the Food and Drug Administration (FDA), an increase of $128 million (8.2 percent) over FY 2007. The FDA budget is supplemented by revenue generated from user fees, adding approximately $500 million to the appropriated levels. The bill also prohibits FDA advisory committee waivers for conflicts of interest. The bill passed the House, 237-18, with 13 Members voting "present." A total of 165 Members, mostly Republicans, did not vote on final passage. The Appropriations Committee had approved the bill July 19 [see Washington Highlights, July 27].

In a July 31 Statement of Administration Policy, the President threatens to veto the bill because of its "excessive level of spending," and expresses strong opposition to the bill's proposal to lift a ban on prescription drug importation, among other provisions.

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

House Approves NSF Spending Bill

The House July 26 approved, 281-149, its FY 2008 Commerce-Justice-Science Appropriations bill (H.R. 3093). The measure provides $6.509 billion for the National Science Foundation (NSF), an increase of $593.4 million (10 percent) over FY 2007. The House Appropriations Committee had approved the bill July 12 [see Washington Highlights, July 13].

The White House issued a July 24 Statement of Administration Policy threatening to veto the bill, because "it includes an irresponsible and excessive level of spending and includes other objectionable provisions." With respect to NSF, the statement commends the overall funding increase, as proposed in the President's American Competitiveness Initiative, but objects to increases for the NSF education programs.

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

NIH Examines Peer Review Research System

The AAMC July 30 participated in the first of several town hall meetings being convened by the Working Group on National Institutes of Health (NIH) Peer Review of the Advisory Committee to the NIH Director. The working group is co-chaired by Keith Yamamoto, Ph.D., Executive Vice Dean at the UCSF School of Medicine and Lawrence Tabak, D.D.S., Ph.D., Director of the National Institute of Dental and Craniofacial Research.

NIH Director Elias Zerhouni, M.D., introduced the meeting by stating that the NIH is seeking broad input and innovative suggestions to help the agency enhance its system of research support and peer review to meet the challenges of science that is increasingly broad, complex, and interdisciplinary. He said the goal is to design a system that will fund the best scientists doing the best research with the least possible burden and bias.

The working group will prepare a report and make suggestions by the end of 2007 for pilot projects, which are with anticipated to be implanted in the spring of 2008. AAMC is currently drafting its suggestions for the working group which, has extended the deadline for comments until Sept. 7, 2007.

Information:
Howard Dickler, Director
AAMC Division of Biomedical and Health Sciences Research
hdickler@aamc.org
(202) 828-0567

HHS Committee Discusses Informed Consent

The Secretary's Advisory Committee on Human Research Protections (SACHRP) at the Department of Health and Human Services (HHS) July 31 invited an expert panel to discuss informed consent issues. Howard Dickler, M.D., AAMC Director for Clinical Research, presented a review of problematic features of informed consent documents that have been reported in the literature. These include omission of elements required by regulation, ever increasing length, and use of difficult and dense language that exceeds the comprehension of the majority of U.S. citizens.

Dr. Dickler also reported on the outcome of a strategic planning meeting, entitled "Universal Use of Short and Readable Informed Consent Documents: How Do We Get There?" convened by the AAMC May 30, 2007. Participants included bioethicists, Institutional Review Board (IRB) chairs, IRB administrators, university counsels, and research deans/vice presidents, as well as representatives of various government agencies including the Office of Human Research Protection, the Food and Drug Administration, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Association of Human Research Protection Programs. The group identified obstacles that must be overcome and proposed an approach that recognizes informed consent as a process that requires a "toolkit," of which the informed consent document is only a part. This would allow the document to focus on the research question and the specific items required by federal regulation; supplemental materials (handbooks, websites, and appendices) would be used for tasks such as educating participants on the research project and explaining what constitutes standard care. The group also identified a series of next steps and urged AAMC to pursue this approach vigorously.

The SACHRP welcomed Dr. Dickler's report with enthusiasm and added its plea that the AAMC proceed with implementation strategies.

Information:
Howard Dickler, Director
AAMC Division of Biomedical and Health Sciences Research
hdickler@aamc.org
(202) 828-0567