AST Public Policy Committee Advances Agenda and Mobilizes Congressional Leaders

On September 14 and 15, 2005, the American Society of Transplantation’s Public Policy Committee traveled to Capitol Hill for two days of meetings with Congressional leaders and political appointees to further garner support for the society’s key government relations priorities. The Public Policy Committee also offered the society’s full support and resources to assist Congress in responding to Hurricane Katrina.

During visits to Capitol Hill, the society’s leadership thanked Senators Chuck Grassley
(R-IA), Mike DeWine (R-OH), Max Baucus (D-MT), and Chris Dodd (D-CT) for their official support of a study request to the U.S. General Accountability Office (GAO). The supporting senators requested that GAO examine the Medicare program’s transplant follow-up coverage for children transitioning to adulthood. In the past, this transition of care has presented problems and resulted in transplant failure. Senator DeWine’s office informed AST that the GAO has accepted the request and is in the process of conducting the study. AST identified this need and has been working closely with the Senate to urge GAO to examine this important issue.

The AST also personally thanked Congressman Mark Kirk (R-IL), chairman of the Congressional Kidney Caucus, for his sponsorship of AST’s recent Capitol Hill briefing, “Transplant 101.” Congressman Kirk and the Kidney Caucus partnered with AST to educate congressional staffers about solid organ transplantation. The society sponsors such Capitol Hill educational forums annually.

The society’s primary focus on Capitol Hill was to further garner support for funding the Organ Donation and Recovery Improvement Act (Public Law 108 216). This new organ donor law was enacted into law but lacked congressional funding for its implementation. AST and other transplant stakeholder organizations have been working to secure federal funding to implement this important initiative.

AST also met with federal decision makers on the House Ways and Means Committee to discuss congressional legislation seeking to repeal the current Medicare physician reimbursement system. The chairwoman of the Ways and Means Subcommittee on Health, Congresswoman Nancy Johnson (R-CT), has introduced a bill, H.R. 3617, the “Medicare Value Based Purchasing for Physicians’ Act of 2005.” This legislation seeks to implement a pay-for-performance framework that ties quality measurements to Medicare reimbursement.

The Public Policy Committee also met with the House Energy and Commerce Committee to discuss Chairman Barton’s (R-TX) draft legislation to reauthorize/reorganize the National Institutes of Health (NIH). The society is examining the draft bill, and crafting comments and an official response.

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On October 18, Dr. Mark Schnitzler represented AST at the House of Representatives staff briefing. The AST hosted its own briefing, “Transplant 101” in April. This briefing, titled “Organ Transplant Issues: Medicare, the Organ, and Patient Lives,” was a collaborative session with multiple organization sponsors such as the National Kidney Foundation, the American Society of Transplant Surgeons, the United Network for Organ Sharing, the North American Transplant Coordinators Organization, and Roche.

July 12, 2005 letter to the U.S. General Accountability Office (GAO)

The following letter was sent on July 12, 2005, to the U.S. General Accountability Office (GAO). During the last year, the AST Public Policy Committee has been working closely to develop this letter with the offices of: Senator Charles Grassley (R-IA) - Chairman of the Senate Finance Committee; Senator Christopher Dodd (D-MA) - Ranking Minority Member of the Senate Subcommittee on Children and Families; Senator Max Baucus (D-MT) - Ranking Minority Member of the Senate Finance Committee; and Senator Mike DeWine (R-OH) - Member of the Senate Health, Education, Labor and Pensions Committee and the Senate Appropriations Subcommittee on Health and Human Services.

The joint Senate letter requests that the U.S. GAO examine the transition of care and coverage issues facing many vulnerable pediatric Medicare program beneficiaries.

(Click here for pdf of the letter.)

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AST Government Relations Spends Much of the Spring on Capitol Hill

During the spring season on Capitol Hill, the AST engaged in a variety of very succesful government relations activities. As an example, the society’s Public Policy Committee implemented key initiatives such as:

• Conducting the first ever U.S. House of Representatives’ “Kidney Caucus” educational briefing (Transplant 101) on Capitol Hill;
• Testifying before the U.S. House of Representatives’ Committee on Appropriations regarding FY 2006 federal funding for organ transplantation programs;
• Working with the transplant community and Capitol Hill to mobilize significant support in the U.S. House and Senate to support full funding for the Organ Donation and Recovery Improvement Law; and
• Convening a two-day Capitol Hill “Fly In” for members of the AST Public Policy Committee to meet with and garner the support of key Congressional offices responsible for legislation and regulation impacting the field of solid organ transplantation.

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Dr. Bumgardner Testifies Before House on Federal Funding for Transplantation

On April 14, 2005, Dr. Ginny Bumgardner, member of the AST Board of Directors and Public Policy Committee, represented the Transplant Roundtable and presented oral testimony directly to the Chairman of the House Appropriations Subcommittee for HHS annual funding, Congressman Ralph Regula (ROH). The purpose of her testimony was to explain why critical funds are necessary to implement the Organ Donation and Recovery Improvement Law. Dr. Bumgardner was very well received by Chairman Regula. The Chairman had several follow-up questions that allowed Dr. Bumgardner to further explain to the Chairman the cost savings that solid organ transplantation can provide to the federal government. She was also able to answer some scientific inquiries and further explain immunosuppression to the Subcommittee Chairman. Overall,
Dr. Bumgardner’s testimony was compelling and successfully engaged the Chairman of the Subcommittee. Dr. Bumgardner is an Ohio constituent of Chairman, Regula.

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AST Provides First “Transplant 101” Educational Briefing on Capitol Hill before the Congressional Kidney Caucus

AST on April 22, 2005, provided the first educational briefing before the Congressional Kidney Caucus at the Rayburn House Office Building as part of the 109th Session of the U.S. Congress. The briefing included remarks by Congressman Mark Kirk (R-IL), chair of the Congressional Kidney Caucus, and information on topics such as kidney transplantation and the cost of dialysis.

“Introduction to Kidney Transplantation” was a 10-minute presentation given by David Cohen, M.D., the Medical Director for Kidney Transplant at Columbia University Medical Center, New York, N.Y.

Mark Shnitzler, Ph.D., Director of Transplant Outcomes and Policy Research, and Associate Professor, Internal Medicine and Community Health, at St. Louis University, St. Louis, presented “Cost of Dialysis vs. Transplantation and the Overall Economic Impact.”

“Receiving a Kidney Transplant” was presented by Barbara Murphy, M.D., Chief of Kidney/Renal Division, Mt. Sinai Medical Center, New York, N.Y. “The Patient Impact of Kidney Immunosuppression Medications” was presented by Roy First, M.D., Senior Director of Medical Affairs in Research and Development, Astellas Pharma U.S. Inc., Deerfield, Ill.

The briefing presentations were followed by a 20-minute question and answer session.

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AST Public Policy Committee Fly in to Brief Members of Congress and Advocate Full Funding of New Organ Donation Law

On April 18 and 19, 2005, the AST Public Policy Committee flew more than a dozen of its members to Washington, DC, for meetings with targeted members of Congress regarding the importance of providing funding to implement the Organ Donation and Recovery Improvement Act. The AST committee was successful in garnering significant support for federal funds to support this Act in FY 2006. The society also met with a variety of offices to discuss expanding coverage for immunosuppressive drugs and the current debate regarding stem cell research.

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AST Welcomes New Congress to Capitol Hill

As the 109th Session of Congress officially convened in January 2005, the American Society of Transplantation (AST) was already working to educate newly elected members of Congress and welcome back many of those Congressional leaders that have been active champions on key issues of concern to AST and the field of solid organ transplantation in the past. In early February 2005, the AST Washington office, located a block from the White House on Pennsylvania Avenue, delivered a copy of the Society’s “Position Statements and Key Messages” into the hands of every Congressional health care staff member in the U.S. House of Representatives and U.S. Senate. These policy statements have proven to be an invaluable resource and tool for communicating issues and educating federal decision makers regarding public policy issues impacting the field of transplantation.

Additionally, the Society’s government relations team also met with many of the Congressional leaders that have jurisdiction over federal organ transplantation policies, including:

• Senate Majority Leader Bill Frist (R-TN);
• Speaker of the House of Represenatives Dennis Hastert (R-IL);
• Senator Ted Kennedy (D-MA), Ranking Minority Member of the Senate Committee on Health, Education, Labor and Pensions (HELP);
• Congressman Mark Kirk (R- IL), Co-chair of the Congressional Kidney Caucus;
• Congressman Mel Watt (D-NC), Chairman of the Congressional Black Caucus;
• Congressman Michael Bilirakis (R-FL), Chairman of the House Energy and Commerce Subcommittee on Health;
• Congressman Mike Castle (R-DE), Co-chair of the Congressional Diabetes Caucus;
• Senator Mike DeWine (R-OH), Member of the Senate Appropriations Committee and the HELP Committee;
• Senator Arlen Specter (R-PA), Chairman of the Senate Appropriations Subcommittee on Health and Human Services;
• Senator Richard Durbin (D-IL), Newly elected Senate Democratic Minority Whip;
• Senator Chris Dodd (D-CT), Ranking Minority Member of the Senate HELP Subcommittee on Children.

The AST also met with newly elected members of Congress, including Senator Barack Obama (D-IL), a new member of the U.S. Senate that has a particular interest in health care and pediatric insurance.

The beginning of a new Congress also means the reorganization of some of the Congressional leadership positions. AST has already begun to meet with the office of the new chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP), Senator Mike Enzi (R-WY). Enzi replaces Senator Judd Gregg (R-NH) as the new HELP Committee chairman.

In addition, the Society has also been working with the new Chairman of the House Energy and Commerce Committee, Congressman Joe Barton (R-TX).

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Public Policy Committee Flies into Capitol Hill

On April 18 and 19, 2005, the AST flew in a dozen members of the Society’s Public Policy Committee to meet with the health care leadership of the new Congress as well as the new Secretary of the Department of Health and Human Services (HHS), Mike Leavitt. The Society’s Public Policy team met with more than a dozen members of Congress, HHS, CMS, and HRSA to discuss pending legislation and regulation before these federal decision makers. Some of the issues discussed by AST on Capitol Hill and within the Administration included:

• Pending regulation from the Centers for Medicare & Medicaid Services (CMS) regarding conditions of participation (COPs) for transplant centers;
• Recently introduced legislation by Senators DeWine (R-OH) and Durbin (D-IL), the “Immunosuppressive Drug Coverage Expansion Act;”
• Federal funding to implement the new organ donor law, the “Organ Donation and Recovery Improvement Act of 2004;”
• Health disparities and minority affairs in the field of solid organ transplantation; and
• Pediatric insurance and coverage for immunosuppressive drugs.

The AST has also been working to develop Congressional staff briefings on Capitol Hill to present “Transplant Public Policy 101” briefings for targeted Capitol Hill staff, including the Congressional Kidney Caucus.

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AST Works with Key National Transplant Stakeholder Organizations to Fund Organ Donor Law

In April 2004, President Bush signed the “Organ Donation and Recovery Improvement Act” into law. As you know, AST had worked closely with Congress and HHS for more than four years to garner support and pass this important legislation into law. The bill authorized $25 million in new spending for organ donation related programs to be implemented by the HHS’ Health Resources and Services Agency (HRSA) Division on Transplantation (DOT). Unfortunately, the new law was signed after the federal funding cycle for FY 2005 was completed. As a result, the new organ donor law was not provided with adequate funds to implement many of the new policies, such as providing resources to support the travel and subsistence costs for living donors. The new law would have provided $25 million in new federal dollars to implement programs and studies to further advance the field of solid organ transplantation.

Since this law was not provided with adequate funds to implement many of the new programs, the AST has been working closely with the “Transplant Roundtable,” an informal group of the nation’s transplant stakeholder organizations, to collectively communicate our organization’s concerns that funding needs to be provided for the “Organ Donation and Recovery Improvement Act.” AST has been working collectively with the Transplant Roundtable to meet with and educate every member of the U.S. House and Senate that originally supported the “Organ Donation and Recovery Improvement Act” in this past session of Congress, with a special emphasis on those members of Congress that supported the bill and also serve on the Appropriations Committees necessary to fund the new law. The goal is to have Congress appropriate $25 million in the FY 2006 federal budget to implement the new organ donor law. AST has been working in coalition with 11 organizations to secure this goal, including:

• American Association for the Study of Liver Diseases;
• American Association of Kidney Patients; American Association of Tissue Banks;
• American Liver Foundation;
• American Society of Pediatric Nephrology;
• American Society of Transplant Surgeons;
• Association of Organ Procurement Organizations;
• Eye Bank Association of America;
• National Kidney Foundation; and the
• North American Transplant Coordinators Organization.

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New Secretary Takes Helm at Department of Health and Human Services (HHS)

After four years of heading the largest civilian department in the federal government, Secretary Tommy Thompson stepped down as the chief executive of the Department of Health and Human Services (HHS). Thompson’s leadership and initiatives on issue areas such as organ donation provided positive visibility and progress for the field of solid organ transplantation.

On January 26, 2005, Michael O. Leavitt was sworn in as the 20th secretary of the HHS department. Leavitt will manage more than 66,000 employees and a budget that accounts for almost one out of every four federal dollars. Prior to his current service, Leavitt served as administrator of the U.S. Environmental Protection Agency and governor of Utah. Leavitt served three terms as the governor of Utah and was the nation’s longest serving governor. During his eleven years of service, Utah was recognized six times as one of America’s best managed States. He has served as the chairman of the National Governor’s Association, Western Governors Association, and Republican Governors Association.

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AST Public Policy Committee on Capitol Hill in Preparation for New Congress

On December 6 and 7, members of the AST Public Policy Committee traveled from across the country to meet in Washington, D.C., in preparation for the opening of the new 109th Session of Congress, scheduled to convene in January 2005. The purpose of the strategically-timed visit to Capitol Hill was to meet with the current and newly appointed Congressional leaders following the November national elections. The society’s Public Policy Committee met with a dozen targeted Congressional offices and the Department of Health and Human Services (HHS) to discuss health care public policy that will likely be addressed by the U.S. House of Representatives, U.S. Senate, and the White House in 2005.

During AST’s time on Capitol Hill, the society met with a variety of Congressional offices, including those federal decision-makers that were recently elected to new leadership positions by their respective parties, including:

• Congressman Mel Watt (DNC) — Congressman Watt is the newly elected chairman of the Congressional Black Caucus. He replaces outgoing chairman, Congressman Elijah Cummings (D-MD). AST worked very successfully in the past with Congressman Cummings to enact federal law allowing for increased federal employee leave time to serve as a living donor. The society is optimistic and excited to work with Congressman Watt on similar health care public policy issues, particularly in the area of health care disparities;
• Senator Richard Durbin (DIL) — Senator Durbin was elected to serve as the new Senate Minority Whip, the second highest-ranking Democratic leadership position in the U.S. Senate. Senator Durbin’s office had specifically requested a meeting with the AST Public Policy Committee to discuss the issue of policies addressing the use of HIVinfected organs. AST has worked closely and partnered with Senator Durbin’s office on a variety of organ donation initiatives in the legislative and regulatory arenas; and
• Congressman Mike Castle (R-DE) — Congressman Castle was selected to serve as the new co-chair of the Congressional Diabetes Caucus. He will join existing co-chair, Congresswoman Diana DeGette (D-CO) in leading many of the diabetes-related initiatives in the new Congress. In the past, the society has publicly recognized the leadership of the Diabetes Caucus for their work in the area of kidney transplantation and pediatric transplantation issues. The Public Policy Committee is looking forward to working with Congressman Castle and continuing its close relationship with Congresswoman DeGette.

In addition to meeting with some of the key leaders for the new 109th Session of Congress, the AST Public Policy Committee also met with those members of Congress that have consistently worked as champions with the society to improve and strengthen the field of solid organ transplantation, including:

• Senator Ted Kennedy (DMA) — Ranking Minority Member, Senate Committee on Health, Education, Labor, and Pensions (HELP);
• Senator Bill Frist, M.D. (R-TN) — Majority Leader of the Senate;
• Senator Kit Bond (R-MO) — Fourth highest-ranking member of the Senate Appropriations Committee; and
• Senator Chris Dodd (D-CT) — Ranking Minority Member, Senate Subcommittee on Children and Families.

The society also met with Jim Burdick, M.D., Director of the Transplant Division of the HHS, Health Resources, and Services Administration.

Some of the key issues that AST discussed with federal decision-makers during the daylong visit to Capitol Hill included:

• Pediatric uninsured issues regarding organ transplant failure when children’s Medicare program coverage has ended;
• Minority health care disparities, including progress and challenges in the field of solid organ transplantation; and
• FY 2006 funding for the new Organ Donor and Recovery Improvement Law.

During the society’s visits on Capitol Hill, Congressional aides discussed a variety of policy agenda areas that may be addressed by the new 109th Congress, including:

• Medicaid Program Reform Legislation — Many Congressional leaders have discussed reforming the program. The newly appointed Secretary of HHS, Mike Leavitt, is the former Governor of Utah and has previously been involved with such reform of state health care programs;
• Reauthorization of the Children’s Health Act — This act was last reauthorized in 2000. At that time, AST worked closely with Congresswoman DeGette and Majority Leader Frist to include provisions addressing “The Special Needs of Children in Transplantation;”
• Medicare Modernization Act (MMA) technical corrections legislation — A follow-up bill to include various amendments to the new Medicare prescription drug law;
• Reauthorization of the National Institutes of Health (NIH) — If addressed by Congress, such a reauthorization would include a review and overhaul of many programmatic aspects of the NIH operations; and
• The annual “must-pass” federal appropriations/ funding for the operations of the Department of Health and Human Services (HHS), to include NIH, CMS, CDC, HRSA, etc.

Each year the society’s leadership and members of the Public Policy Committee dedicate significant time and resources to educating, cultivating, and building relationships with those Congressional and Executive Branch entities that have oversight and jurisdiction governing the science and medicine impacting the gift-of-life.

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HHS Secretary Tommy Thompson Resigns, President Bush Nominates Former Governor of Utah

On December 3, 2004, Thompson resigned, following four years as the nation’s chief health care executive. Secretary Thompson was a passionate supporter of organ donation initiatives and personally led a variety of Administration supported programs seeking to increase donation and streamline the nation’s system for solid organ transplantation. AST partnered with Secretary Thompson on many of his transplantation initiatives, including national organ donor leave programs in the private sector and assisting in garnering national media attention for the Secretary’s regional transplant collaborative meetings across the country. Secretary Thompson served as the keynote speaker during the American Transplant Congress (ATC) and was awarded the “AST Leadership in Transplantation Public Policy Award” during the society’s Capitol Hill Congressional leader reception in 2002.

On December 13, 2004, President Bush nominated Mike Leavitt to replace Thompson as Secretary of HHS. Leavitt is the current Administrator of the Environmental Protection Agency (EPA) and a former three-term Governor of Utah. During a press conference at the White House, President Bush stated that Leavitt was an “ideal choice to lead one of the largest departments of the United States Government.” Leavitt praised Bush and said he “looks forward to the implementation of the Medicare prescription drug program in 2006, medical liability reform and finding ways to reduce the cost of health care.” Similar to Tommy Thompson’s background, Mike Leavitt was a multi-term Governor and former chair of the National Governor’s Association. Leavitt will be taking over an agency with a $500 billion budget and 67,000 employees.

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National Elections Change Political Landscape: Transplantation Champion Elected to Senate Leadership Post

On November 2, 2004, President Bush was re-elected to serve four more years in the White House. In addition to the President’s new mandate, Republicans also gained seats in the U.S. House of Representatives and U.S. Senate. Based on the November elections, the new 109th Session of Congress (scheduled to convene in January 2005) will be comprised of 55 Republicans, 44 Democrats and 1 Independent in the Senate and 231 Republicans, 202 Democrats and 1 Independent in the House of Representatives.

Although some Congressional leadership changes will occur as a result of the elections, most House and Senate leaders will remain in their current posts. One of the biggest surprises of the national elections was the defeat of the Senate Democratic Leader, Tom Daschle (D-SD), by former Congressman John Thune (R-SD). Daschle is the first Senate leader to be defeated since 1952. With the fall of Senator Daschle, Democrats elected Senator Harry Reid (D-NV) as the new Democratic Leader. In addition to Senator Reid, the Democrats also elected Senator Richard Durbin (D-IL) as the new Minority Whip, the Senate’s second highest Democratic leadership position. Durbin, serving his second six year term as the senior senator from Illinois, has been a very vocal and active champion for solid organ transplantation public policy. In 2000, the AST worked closely with Senator Durbin, the Department of Health and Human Services, and the widow of former Chicago Bears football player Walter Payton to develop a national public service announcement on the importance of organ donation. In addition, Senator Durbin has introduced and sponsored several bills seeking to improve immunosuppressive drug coverage by the Centers for Medicare and Medicaid Services.

In addition to Senator Durbin’s elevation to the No. 2 Democratic post, other key leaders and advocates for organ transplantation and donation remain intact, including Senate Majority Leader Bill Frist, M.D. (R-TN). With the passage and enactment of the Majority Leader’s “Organ Donation and Recovery Improvement Act” during this last session of Congress, the AST will be working with Frist and Durbin in the new 109th Session of Congress to fully fund and implement this new law.

Other key changes that may occur in the new year include the possibility that the Secretary of the Department of Health and Human Services (DHHS), Tommy Thompson, may leave the Department after serving more than four years as the nation’s top healthcare official. Thompson and his officials focused significant attention on transplant and donation public policy issues, including regional collaborative meetings, the Advisory Committee on Organ Transplantation (ACOT), and the Workplace Partnership Initiative. Secretary Thompson also attended and addressed several meetings of the American Transplant Congress (ATC). If Thompson decides to depart DHHS, several names have been mentioned as possible replacements, including Mark McClellan, who currently heads the Centers for Medicare and Medicaid Services (CMS).

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Educating, Cultivating, and Mobilizing Congressional Support During the Summer Months

As the nation prepares for the November elections and the 108th Session of Congress comes to a close, the AST Public Policy Committee continued to raise its significant visibility and educational efforts on Capitol Hill. On August 12 and 13, 2004, a dozen members of the society’s Public Policy Committee traveled to the nation’s capitol for meetings with key targeted offices, including:

• Secretary of the Department of Health and Human Services, Tommy Thompson;
• United States Senate Majority Leader, Bill Frist (RTN);
• Director of the Transplantation Division, Health Resources, and Services Administration, Dr. James Burdick;
• Congresswoman Diana DeGette (D-CO), Chair of the Congressional Diabetes Caucus; and
• Congressman Ruben Hinojosa (D-TX), Co-Chair of the Congressional Hispanic Caucus.

In addition to the efforts of the AST Public Policy Committee, the Chair of the society’s advocacy arm, Dr. Jeff Crippin, traveled again to Capitol Hill on September 22, 2004, to meet with:

• Senator Kit Bond (R-MO), Chair of the Senate Aging Subcommittee and Full Appropriations Committee (jurisdiction over federal funding for HHS and NIH);
• Congressman Kenny Hulshof (R-MO), active member of the House Ways and Means Committee (jurisdiction over Medicare and Medicaid programs); and
• Congressman Sherrod Brown (D-OH), Ranking Minority Member of the House Energy and Commerce Subcommittee on Health (jurisdiction over Medicare and Medicaid programs).

The primary issues of focus for the AST’s summer advocacy campaigns included:

• Pediatric insurance coverage for immunosuppresive medications;
• Minority health care-related issues in transplantation;
• Funding for the National Institutes of Health; and Full funding of the “Organ Donation and Recovery Improvement Act.”

In addition to these recent efforts, AST’s President, Dr. Jay Fishman, was also on Capitol Hill earlier in the summer participating in the Senate Republican Conference’s Minority Healthcare Quality Forum with the Senate Majority Leader, Director of the Agency for Healthcare Quality and Research, Director of the CDC, Deputy Secretary of HHS, and the Director of the NIH Center for Minority Health Affairs. The society also joined other national transplant stakeholder organizations earlier this summer to sponsor two briefings on organ transplantation for targeted health care officials in the United States House of Representatives and the United States Senate. The AST Public Policy Committee also took time over the summer to review its goals and strategies for the 109th Congress, scheduled to convene in January 2005.