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Washington Highlights: July 20, 2007

House Passes HHS Funding Bill

The House of Representatives July 18 passed its FY 2008 Labor-HHS-Education appropriations bill (H.R. 3043) by a vote of 276 to 140 following three days of debate and votes on dozens of amendments to modify funding for specific programs. A total of 53 Republicans voted for the bill; the only Democrat to vote no was Rep. Melissa Bean (Ill.). The House Appropriations Committee approved H.R. 3043 on July 11 [see Washington Highlights, July 13] and filed the committee report (H. Rpt. 110-231) on July 13.

The AAMC July 17 signed a letter in in support of the appropriations bill's passage, joining nearly 1100 education, training, disability, public health, health and biomedical research, aging and child welfare organizations, elected officials, and labor unions representing the full range of stakeholders in the programs of the Departments of Education, Health and Human Services and Labor.

For the National Institutes of Health (NIH), the bill includes $29.650 billion, an increase of $750 million (2.6 percent) above the current year's funding level and $1.029 billion (3.6 percent) above the President's request. However, the bill also increases the amount of the transfer from NIH to the Global HIV/AIDS fund from the $99 million in FY 2007 to $300 million in FY 2008, which means the net increase in the NIH budget is $549 million (1.9 percent) over FY 2007.

The bill provides $228.3 million for Title VII health professions programs, a $43.6 million (23.6 percent) increase over FY 2007. The Title VII Centers of Excellence and Health Careers Opportunity Programs each receive $28.4 million, for a $16.6 million (139.3 percent) increase and $24.5 million (618.2 percent) increase, respectively. The primary care medicine and dentistry programs are level funded at $48.9 million, while the AHECs receive a $2.5 million (8.9 percent) increase over the current funding level. For the National Health Service Corps (NHSC), the bill provides $131.5 million, a $5.8 million (4.6 percent) increase over FY 2007.

The House passed (412-12) an amendment offered by Rep. John Lewis (D-Ga.) prohibiting funds from being used "to take any action to finalize (or otherwise implement)" specific proposals included in the FY 2008 Medicare Inpatient Prospective Payment System (IPPS) proposed rule published on May 3, 2007. Specifically, the amendment would prohibit altering hospital payments based on the rule's proposed Medicare severity diagnosis related group (MS-DRG) system. The amendment also prohibits the implementation of the proposed prospective "behavioral offset" related to the MS-DRGs. In its June 12 comment letter, the AAMC urged CMS to implement the new MS-DRGs over a 4-year transition and rescind the 2.4 percent behavioral offset.

The House defeated (181-249) an amendment offered by Rep. Joe Barton (R-Texas) to prevent funds from the bill from being transferred from NIH under the Secretary's program evaluation authority. A total of 19 Republicans, including most Republican members of the Labor-HHS Appropriations Subcommittee, joined 230 Democrats to vote against the amendment; no Democrats voted for it. Originally authorized in statute at 1 percent, the appropriators have increased the transfer authority in recent years to 2.4 percent of the budgets of NIH and other HHS agencies. The transferred funds are used to support approximately two-thirds of the budget for the Agency for Healthcare Research and Quality (AHRQ) as well as the National Center for Health Statistics and other programs at CDC and the department.

Prior to final passage, the House rejected (206-213) a motion by Rep. Jerry Lewis (R-Calif.), the ranking member of the House Appropriations Committee, to recommit the bill to the Appropriations Committee and a series of amendments offered by Republicans to cut the bill across-the-board by amounts ranging from 0.25 percent to 4.6 percent.

In a Statement of Administration Policy (SAP) issued July 17, the White House said it "strongly opposes H.R. 3043 because, in combination with the other FY 2008 appropriations bills, it includes an irresponsible and excessive level of spending and includes other objectionable provisions." The Administration notes this bill exceeds the President's request by nearly $11 billion.

The Senate Appropriations Committee approved its FY 2008 Labor-HHS bill (S. 1710; S. Rpt. 110-107) on June 21 [see Washington Highlights, June 22]. No date has been set for floor consideration of the Senate bill.

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

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

Senate Clears HEA Budget Bill for Conference

The Senate July 19 passed the "College Cost Reduction Act of 2007" (H.R. 2669), a budget bill that reauthorizes provisions of the Higher Education Act (HEA) that have an effect on mandatory spending. The Senate substituted the text of its bill, the "Higher Education Access Act of 2007" (S. 1762), for the House-passed H.R. 2669. S. 1762 was approved by the Health, Education, Labor and Pensions (HELP) Committee June 20. [see Washington Highlights, June 22]. The House passed their version of the bill July 11 [see Washington Highlights, July 13].

The AAMC July 11 sent a comment letter to the chairs and ranking members of the House and Senate education committees regarding the HEA reauthorization packages. The letter addresses a number of issues important to medical schools and students, including expanding the economic hardship deferment, increasing Stafford loan limits, student loan oversight, and institutional accreditation.

The President threatened to veto the House version of H.R. 2669, because "it fails to target aid to the neediest students currently in college and creates new mandatory Federal programs and policies that are poorly designed and would have significant long-term costs to the taxpayer." In a July 18 Statement of Administrative Policy, the White House expressed "serious concern" with the Senate bill, but stopped short of a veto threat.

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

House, Senate Panels Approve Patent Reform

The Senate Judiciary Committee July 19 approved (13-5) the "Patent Reform Act of 2007" (S. 1145). The House Judiciary Committee approved its version (H.R. 1908) by a voice vote on July 18. The bills would significantly alter the U.S. patent system, replacing the current "first-to-invent" system with a more objective "first-inventor-to-file" system.

House Judiciary Subcommittee on Courts Chair Howard L. Berman (D-Calif.), along with the full committee Ranking Member Lamar Smith (R-Texas), shepherded through a manager's amendment that stripped a provision that would have created a "second window" for challenging patents more than a year after they are granted. Instead, language in the bill would strengthen the current re-examination process.

The panel approved an amendment, offered by Rep. Hank Johnson (D-Ga.), to give judges more discretion in apportioning damages in relation to the overall value of the product, or based on other alternative factors.

In the Senate, amendments introduced by Sen. Jon Kyl (R-Ariz.) to expand the ability of challenges to patents after they are granted and apportion damages according to the patent's contribution to the overall value of the product were both defeated.

Senate Judiciary Committee Ranking Member Arlen Specter (R-Pa.) tried to scale back a "best mode" requirement that has resulted in excessive litigation and unrealistic attempts to discern the state of mind of an inventor. The amendment was rejected, 9-10.

Sponsors in both chambers hope to consider the patent reform bills on the floor and in conference by fall.

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

Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

Finance Committee Passes SCHIP Reauthorization Bill, Raises Medicaid Moratorium

The Senate Finance Committee July 19 approved (17-4) legislation to reauthorize the State Children's Health Insurance Program (SCHIP). Describing the "Children's Health Insurance Program Reauthorization Act" as a "consensus package," Committee Chair Max Baucus (D-Mont.) thanked Ranking Member Charles Grassley (R-Iowa), Health Subcommittee Chair Jay Rockefeller (D-W.Va.), and Health Subcommittee Ranking Member Orrin Hatch (R-Utah) for helping craft the final language.

According to preliminary materials from the Congressional Budget Office and Finance Committee, the 5-year, $35 billion reauthorization agreement preserves the enrollment of 1.9 million beneficiaries who would likely lose coverage under current funding levels, enrolls 1.6 million SCHIP-eligible children not yet in the program, and expands SCHIP eligibility to 1.1 million more children. The funding increase is offset by an increase in federal tobacco taxes and a series of SCHIP cuts beginning in FY 2014. The package reconfigures the SCHIP allotment formula, reduces to 2 years the time states may access their allotments before redistribution, and establishes an Incentive Bonuses Pool to fund state Medicaid and SCHIP expansions that exceed "a defined baseline." The bill also establishes a Contingency Fund for addressing state funding shortfalls, streamlines the enrollment process, permits coverage of prenatal care, and transitions SCHIP parents into new block grants with expenditures matched at the Medicaid level. Childless adults will be transitioned out of the program.

During the Committee mark-up, Sen. Jeff Bingaman (D-N.M.) offered and withdrew an amendment to extend the temporary one-year "moratorium" on the Medicaid final rule regarding cost limits/units of government and the Medicaid proposed rule "clarifying" that GME costs and payments are not eligible for Federal matching payments. Chairman Baucus assured Sen. Bingaman that "we will deal with it" in the future.

Having viewed the Committee's reauthorization package before the mark-up, Secretary of Health and Human Services (HHS) Michael Leavitt July 17 sent a letter to Chairman Baucus warning that President Bush would veto the legislation. Chairman Baucus responded in a July 17 letter, stating that "I am frankly surprised by your opposition" to the bill.

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

Congressional TriCaucus Introduces Health Disparities Bill

Rep. Hilda Solis (D-Calif.) July 12 introduced the Congressional TriCaucus-sponsored "Health Equity and Accountability Act of 2007" (H.R. 3014), which seeks to reduce health disparities and improve racial and ethnic health equity. The bill includes provisions to enhance health workforce diversity, culturally and linguistically appropriate care, and data collection and analysis. The Senate "Minority Health Improvement and Health Disparity Elimination Act" (S. 1576) contains some similar provisions [see Washington Highlights, June 15].

Of particular interest to academic medicine, the House bill:

  • Reauthorizes the National Health Service Corps and certain Title VII health professions programs, including the Centers of Excellence, Health Careers Opportunity Program, and Area Health Education Centers;

  • Adds to Title VII a program authorizing grants to community health centers to establish or expand accredited medical residency training programs;

  • Requires health professions schools to collect and report annually to the Secretary data on race, ethnicity, and language proficiency of enrolled students; and

  • Reauthorizes and strengthens the National Center for Minority Health and Health Disparities' oversight of NIH research related to health disparities.

The Congressional TriCaucus is comprised of the three House minority caucuses. In announcing the bill, Rep. Solis, who chairs the Congressional Hispanic Caucus Task Force on Health and the Environment, was joined by Rep. Madeleine Bordallo (D-Guam), chair of the Congressional Asian Pacific American Caucus Health Task Force, and Rep. Donna Christensen (D-V.I.), chair of the Congressional Black Caucus Health Braintrust. The measure was referred to the Committees on Energy and Commerce, Ways and Means, Education and Labor, Natural Resources, and the Judiciary.

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

CMS Proposes Payment Changes for Hospital OPPS and Ambulatory Surgical Centers


The Centers for Medicare and Medicaid Services (CMS) July 16 posted on its website a proposed rule that contains changes to the outpatient prospective payment system (OPPS) as well as proposed payment rates for Ambulatory Surgical Centers (ASC). At the same time, the agency published a final rule that contains other changes to the ASC payment system. Both rules are scheduled to be published in the Federal Register on Aug. 2 and will be implemented Jan. 1, 2008.

CMS proposes to raise the base OPPS payment rate by the full market basket increase of 3.3 percent. Due largely to the packaging proposals, CMS estimates that major teaching hospitals would see an overall average increase in OPPS payments of 3.5 percent in 2008, compared to a 3.3 percent increase for minor teaching hospitals and 3.7 percent increase for non-teaching hospitals.

The proposed rule would increase the number of services included under a single Ambulatory Payment Classification (APC) group. While some services that are provided during an outpatient visit currently are "packaged" with the primary outpatient procedure described below, a number of other services that are provided during the same visit are paid under separate APCs. CMS is proposing to "package" more of these services together, decreasing the number of APCs for which a hospital would be paid. CMS estimates that the net impact of the proposed changes would have no effect on overall payments to hospitals, but major teaching hospitals would see a slight increase.

On the hospital outpatient quality front, CMS is proposing to implement the hospital outpatient quality reporting program. The program was spurred by an amendment to the "Tax Relief and Health Care Act of 2006" (P.L. 109-432), which included a requirement that hospitals must submit quality data on hospital outpatient departments to CMS. Failure to provide the information will result in a reduction of their annual payment update factor of 2.0 percentage points. The quality reporting program would function similarly to the inpatient prospective payment system (IPPS) reporting program and would utilize the same data submission and validation requirements. Hospitals would be required to submit data for discharges beginning Jan.1, 2008. CMS has proposed ten measures for the initial program year that focus on Emergency Department transfers, Perioperative care, Community Acquired Pneumonia and Diabetes care. CMS also has included a list of thirty measures that are being considered for future years.

The ASC final rule includes major revisions to the ASC payment system to be implemented starting Jan. 1, 2008. The final rule adds about 790 procedures for ASC payment, many of which are currently performed in physician's offices. Payment rates for services performed in ASCs are included in the OPPS/ASC proposed rule and would be phased-in over a 4-year period, with full implementation taking place in CY 2011.

Comments on the proposed rule are due Sept. 14, 2007.

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

House Science Committee Considers Future of Bayh-Dole

The House Science and Technology Subcommittee on Technology and Innovation July 17 held a hearing on technology transfer at universities. Entitled "Bayh-Dole: the Next 25 Years," the hearing focused on the "Patent and Trademark Law Amendments Act of 1980" (P.L. 96-517), more commonly known as "Bayh-Dole," which guides universities in retaining title to intellectual property arising from federally sponsored research. Witnesses agreed that changes in institutional or agency implementation of Bayh-Dole are preferable to amending the statute.

Subcommittee Chair David Wu (D-Ore.) presided, joined by Ranking Member Phil Gingrey, M.D. (R-Ga.). Witnesses included:

  • Arundeep Pradahn, Director of Technology and Research Collaborations at Oregon Health Sciences University and director of the Association of University Technology Managers (AUTM);

  • Susan Butts Senior Director of External Science and Technology Programs, Dow Chemical Company and a participant on the federal Government University Industry Research Roundtable;

  • Wayne Johnson, Vice-President, Worldwide University Relations, Hewlett-Packard Corp.;

  • Mark Lemley, Director of the Stanford University Program in Law, Science & Technology; and

  • Mark Allen, Professor, Electrical and Computing Engineering, Georgia Institute of Technology and a co-founder and Chief Technology Officer of CardioMEMS, Inc, a medical device company.

As noted by Mr. Pradhan, under Bayh-Dole university-based inventions have resulted in more than 28,000 active licenses and more than 5,000 spin-off companies, contributing to the creation of over 260,000 jobs. There was general agreement among the witnesses that the economic circumstances motivating the original legislation have changed substantially, though concerns about U.S. competitiveness in a global economy remain a central issue.

Dr. Butts, Mr. Johnson, and Dr. Lemley, while generally laudatory of the overall effects of Bayh-Dole, criticized universities as increasingly difficult partners in research collaborations with industry. A central impediment, according to the witnesses, is the disposition of property rights from such collaborations. Mr. Johnson stated in particular that it is often easier for information technology companies to collaborate with universities in other countries.

None of the witnesses recommended legislative changes to Bayh-Dole, but called instead for changes in institutional or agency behaviors implementing the statutes. Chairman Wu noted that the subcommittee would in the near future review the Stevenson-Wydler Act, which governs collaborations between industry and federal laboratories.

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

Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

VA Secretary Resigns

Secretary of Veterans Affairs Jim Nicholson July 17 announced he has tendered his resignation to President George W. Bush, effective no later than Oct. 1, 2007. Secretary Nicholson plans to return to the private sector, though indicated he has no definite plans. Secretary Nicholson, a Vietnam Veteran, was sworn in to his current position on Feb. 1, 2005.