American Society of Transplant Physicians
 

Washington Round-Up

January 16, 1998

As the Second Session of the 105th Congress is almost upon us, here are a few public policy issues that Congress may address…

Frist to Send Dear Colleague Letter to Shalala on OPTN Regulations

Senator Bill Frist (R-TN) is currently circulating a “Dear Colleague” letter addressed to Secretary Shalala regarding the OPTN regulations that are currently under review. The ASTP has learned that in fact the regulations have been completed and that HHS will be publishing a final regulation versus a notice of proposed rulemaking (NPRM) with a comment period. The ASTP has learned the regulations are rumored to contain the following:

The Secretary of HHS will be given the authority to make policy decisions outside of the normal OPTN process for allocation;

The Secretary of HHS will have the right to approve the fee that UNOS charges to list on the computer; and

A provision to direct the OPTN to have geographic equity for the allocations of livers within a certain time frame.

Senator Frist’s office has contacted us and requested that we assist the Senator in obtaining co-signers for his letter to Secretary Shalala opposing the issuance of a final rule on this important issue. The ASTP Washington Staff will be working to help add co-sponsors in the next 10 days. Below, you will find a copy of the “Dear Colleague” letter. This will be on the agenda for the Public Policy Committee meeting on February 3rd and 4th, 1998.

DeWine Takes Initiative to Help Organ Transplant Recipients

Attached, you will find a copy of a “Dear Colleague” letter and one page fact sheet on S. 1481, the Immunosuppressive Drugs Coverage Act of 1997, which was just recently released by Senator Mike DeWine’s office. The Senator has increased efforts to obtain additional co-sponsors to his bill, which he introduced a few days before the Senate adjourned for 1997. The bill “makes sure that 75,000 people that have received an organ transplant covered by Medicare always have access to immunosuppressive drugs.” The ASTP Washington Staff has met with Senator DeWine’s staff and will meet with them again on January 23rd to discuss strategy and ASTP’s involvement. This will be an agenda item for the Public Policy Committee meeting on February 3rd and 4th.

Managed Care

In December, Democratic lawmakers restated their intention to make the enactment of managed care reforms a priority in 1998, but not before the Senate passes health care privacy legislation. In an article from the BNA Health Care Daily, the Senate will look at “legislation to protect the confidentiality of individual medical records. By taking up privacy first, lawmakers may buy some time to resolve key managed care issues.” Under the Health Insurance Portability and Accountability Act of 1996, Congress must enact medical record privacy legislation by August 1999. If Congress does not do this, the Department of Health and Human Services then becomes responsible for adopting privacy regulations by 2000.

1998: Tobacco Deal to Boost Biomedical Research Funding

By the end of the 1st session of the 105th Congress, several bills had been introduced regarding the use of created by the proposed tobacco settlements between tobacco firms and the federal government. Almost all of the bills would set up a trust fund for biomedical research. Those bills being offered include Senator John McCain’s bill which would set aside $67.5 billion over 25 years in part for research on helping tobacco users quit; Senator Orrin Hatch’s bill which would collect higher punitive damages from companies to endow a $95 billion trust for the National Institutes of Health (NIH); Senator Edward Kennedy’s bill which would raise cigarette taxes by $1.50 a pack for a fund where part of the money is spent on child health research; and Senators Connie Mack and Tom Harkins’ bill which would call for $100 billion trust to be funded from the settlement proceeds. NIH would then decide how to spend the monies.

Government to Give More Money to Biomedical Research

The New York Times reported in its January 5th edition that in his FY 1999 budget, President Clinton plans “to seek a substantial increase in federal spending on biomedical research, and members of Congress from both parties say they are virtually certain to approve an even bigger increase.” To review the article, please check the ASTP web site public policy section at www.astp.org.

House Labor, HHS, and Education Information

Roll Call reported on December 18, 1998, that no one filed to run against Congressman John Porter (R-IL), chair of the House Labor, HHS, and Education Subcommittee….Carol Murphy, a former Agriculture Appropriations Subcommittee staffer, will replace Sue Quantius as Staff Assistant to the House, Labor, HHS, and Education Appropriations Subcommittee…Finally, the ASTP has received a Congressional witness testimony slot to speak in front of the Subcommittee.

Congressional Task Force on Organ Donation

Kathleen Teixeira of Congressman Joe Moakley’s office is the coordinator in the House for the Task Force. In the Senate, Jennifer Van Horn of Senator Bill Frist’s office handles the coordinating activities.

What Else is Happening…

American Medical Association Offers Resolutions for a Healthy 1998

On December 22, 1997, the American Medical Association (AMA) released its “New Year’s Resolutions for a Healthier America” for 1998. Of the five resolutions offered, number two was to “Share the gift of life. Become an organ donor.” The following is how the resolution read: “Today more than 50,000 Americans are waiting for an organ transplantation to save their lives. Last year, just 5,000 Americans donated organs to share life with others. This race against time is particularly dramatic for minorities awaiting transplants. For example, African Americans comprise 35% of the waiting list for a kidney transplant but represent only about 12% of organ donors. The AMA urges all Americans to do whatever is legally necessary in your own state to become an organ donor and discuss your wishes with your family and physician. There is no greater gift.”

FDA Makes Xenotransplantation Announcement

The Food and Drug Administration (FDA) announced a new workshop called “Developing U.S. Public Health Service Policy on Xenotransplantation.” The topic to be discussed is the current and evolving U.S. Public Health Service (U.S. P.H.S.) policy on xenotransplantation. For copies of transcripts or other information, please call Timothy W. Beth at (301) 827-6333, or e-mail him at Beth@a1.cber.fda.gov.

Varmus Has New Link on NIH Home Page

Dr. Harold Varmus, NIH Director, has a new area on the NIH home page. The site contains links to events of special importance to the Director, selected speeches and testimony, a link to the Varmus Laboratory, and biographical information. The address is: www.nih.gov/welcome/director/varmus.htm

Congressional Schedule for 1998

On January 27, 1998, the second session of the 105th Congress will begin. Below is the proposed Congressional schedule for 1998:

• Reconvene: January 27, 1998
• President’s Day Recess: February 14-23, 1998
• Spring Break: April 2-20, 1998
• Memorial Day Recess: May 23-31, 1998
• Independence Day Recess: June 27 – July 13, 1998
• August Recess: August 8 – September 8, 1998
• *Target Adjournment of the 105th Congress: October 9, 1998

The Honorable Donna Shalala
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Dear Secretary Shalala:

We understand that the Department of Health and Human Services may soon issues a final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), following the proposed rule of September, 1994. While we applaud progress on the rulemaking, we are very concerned with the possibility that the final rule could permit your Department to unilaterally direct the allocation of life-saving organs.

When Congress developed the National Organ Transplant Act, it did so with knowledge that the path prescribed for management of the federal internet in transplantation was unique. Recognizing the limitations of statute and regulation to respond adequately to the fast pace of biotechnological advances, Congress directed the Secretary to contract with a private entity that would devise allocation policy. In order to foster public trust, we believe it is important that allocation remain one step removed from the political sphere. We do not believe the Secretary should unilaterally determine allocation policy via the impending rule.

We are also concerned that the upcoming action may be an interim final rulemaking, despite the fact that the final rule may contain significant new provisions that did not appear in the proposed rule. Because organ transplantation is a highly-sensitive and consensus-driven field, we believe any major changes from the proposed rule should have ample opportunity for public comment before they are implemented.

Finally, we want to commend and applaud your Department on the recent series of meetings between officials of the Department, HRSA, and UNOS, which were held in an effort to resolve several important issues such as the release of sensitive medical data. We believe that communication between the Department and the OPTN needs to be improved, and that doing so will significantly reduce the ongoing friction between the two. We feel that building on this type approach is the best way to find the most fair and effective structure of America's system of organ transplantation.

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