June 1999 Newsletter
Advantages of Stem Cell Research
Hightlights of the Remarks Made By Kevin Thurm, U.S. Deputy Secretary Of Health and Human Services, at the 1999 Annual Joint Meeting of the American Society of Transplantation and the American Society Of Transplant Surgeons
Because of you, we can preserve organs longer, enabling organs to move to patients in need, beyond the immediate area of the donation. And because of you, we continue to expand the frontiers of transplantation. The achievements are remarkable. And, we’re seeing survival rates for transplant recipients at an all-time high. The three-year patient survival rate for kidney recipients is now over 94 percent. And liver transplants are close behind, with a success rate of over 90 percent. The fact is – thanks to you and your colleagues — we can do things today that we couldn’t attempt – or perhaps even imagine — 10 years ago. At HHS we’re providing comprehensive support for your tremendous work and for further advancements in the field.
NIH Supports Forums for Stem Cell Research
First, we support cutting edge, basic and clinical research through our National Institutes of Health. In fact, this year, we’ve allocated over $200 million for NIH research and fellowships devoted entirely to organ transplantation. These resources are stimulating research on approaches to extend graft survival, islet cell transplantation for diabetes, and techniques that reduce the need for immunosuppressant drugs. NIH further supports the science of transplantation by providing forums for exploration of such complex issues as stem cell research and xenotransplantation.
Second, we’ve worked to strengthen both Medicare and Medicaid for the entire nation. As a result, millions of Americans have access to health care – including access to transplantation and follow-up care. Medicare already covers kidney, heart, liver, and lung transplants. And, starting in July, it will also begin coverage of pancreas transplantation simultaneous with or after a kidney transplant.
Third, we are licensing new products to improve the success of transplantation. For example, the Food and Drug Administration has approved the first monoclonal antibody to help prevent acute kidney transplant rejection. This is a significant step in improving transplant outcomes and reducing the need for re-transplantation.
And fourth, we actively support the organ donation and transplant community through our Division of Transplantation in the Health Resources and Services Administration. It administers the Organ Procurement and Transplantation Network and the Scientific Registry through contracts with the United Network for Organ Sharing and works with public and private organizations to promote donation. I’m proud of the great team of people at HHS whose work in the transplant field helps you and others to save lives every day.
And, I’m proud of what we’re achieving together – both HHS and everyone in the transplant community. The future is promising because of our mutual efforts and our teamwork. After working closely with physicians, hospitals, organ procurement organizations, families, and others, the Health Care Financing Administration issued a regulation in 1998 revising its Hospital Conditions of Participation, including relevant sections for organ, tissue and eye donation. This regulation requires Medicare-participating hospitals to notify local organ procurement organizations of all deaths and imminent deaths. Hospitals and organ procurement organizations are now working collaboratively to ensure that the families of all potential donors know about their option to donate.
Thanks to this regulation and the ongoing efforts of you and others in the transplant community and elsewhere, we are beginning to see results. In April, we were proud to join UNOS in announcing that the number of organ donors increased by 5.6 percent in 1998 – that’s the first substantial increase since 1995. Consequently, an additional 600 people received organ transplants last year.
AST has been a strong supporter of the Hospital Conditions of Participation regulation and other initiatives to increase organ donation. Just last month, the President of AST, Dr. John Neylan, joined Surgeon General Dr. David Satcher, to help honor donors and their families at our National Donor Recognition Ceremony which kicked-off National Organ and Tissue Donor Awareness Week. Together they recognized the individuals who have given the ultimate gift … the gift of life.
In our efforts to encourage organ donation and replication of successful programs, our partnership must aim to be creative and open-minded. Together, we’ve been thinking like a team, we’ve been acting like a team and — as a team — we must all be accountable for the results. Being accountable means that we must do all we can for every American. It means making a decision about donation and discussing this with your families. And for some of us it means more: it means doing everything within our power, to ensure that lives are not slipping through the cracks.
As you know, we issued our final OPTN regulation last year. This regulation has been a subject of controversy. More important, I believe, it’s been a subject of misunderstanding. I’d like to take this opportunity to address some of the most important aspects of what this regulation DOES seek to do — and what it does NOT seek to do.
First — the regulation defines the role of HHS in the organ transplantation system. Under the National Organ Transplant Act, Congress clearly holds HHS accountable for overseeing the nation’s transplantation network. We take that charge seriously. We believe, as you do, that the system must be designed to benefit patients in the best way possible. And we want to help ensure that result. But we do NOT — and the regulation does NOT — place HHS in the path of medical judgment. The difficult, day-to-day decisions are decisions that you make. We recognize that, and we don’t seek to change it. That’s why our regulation does not mandate any particular allocation scheme. It lays out goals — goals which we feel confident are the goals of the Congress and the American people. But it calls on you — the transplant professionals — to design the medical policies for achieving those goals.
Second — the over-arching goal of the regulation is that organ allocation be as fair as it can be for patients. Americans do not want — nor did the National Organ Transplant Act establish — an organ transplant system based on fame or wealth or geography. We all want a system that does the best it can to provide organs to patients who most need them, based on medical criteria. And those are key words — “medical criteria.” We are not proposing some abstract idea of “fairness,” without regard to medical realities. Again, it is you who know how to design a system that can achieve those ends — and the regulation looks to you and others in the community to design those policies.
Third, and more specifically — if organ allocation is based on medical criteria, then that must leave out ARTIFICIAL geographic restrictions. I’m talking about arbitrary geographic divisions which can prevent a lifesaving organ from reaching those patients who would most benefit and also have the greatest medical urgency at the time of organ availability. HHS has said – on several occasions – that there should not be an arbitrary policy requiring that only the sickest patients be transplanted, but that patients with the greatest medical urgency, based on sound medical judgements, not geography, should be transplanted. There has been considerable misunderstanding about this aspect of our regulation. Some have asserted that we are insisting on a “single national list” of neediest patients, so that organs would be required to travel great distances, compromising their viability. That is simply not the case. Nothing in our regulation would require either a national list per se, nor dictate the transporting of organs in a way that would compromise their viability. In fact, the regulation specifically requires that organ viability must be preserved. So, again — the regulation looks to you in the transplant community to design policies that will work best for patients.
As the Deputy Secretary of Health and Human Services, most issues on which I work involve the well-being of individuals or communities. However, this is one of the most compelling. Organ donation and transplantation involves life and death. And that’s why it’s critical that we keep talking – and more important – we keep working, together.
AST Commends Representative
Thurman for Efforts to Improve Organ Donation
AST recently commended
Representative Karen Thurman (D-FL) for sponsoring legislation
to amend the
Family and Medical Leave Act, as well as the Public Health
Service Act, to allow leave time for individuals who give living
organ donations. A lack of leave time has served as a significant
impediment and disincentive for individuals willing to share
the gift-of-life. Rep. Thurman’s legislation includes a provision
allowing for the reimbursement of travel and subsistence expenses,
incurred by individuals donating or receiving organs which
will serve as a step forward for improving and increasing organ
donation. AST Public Policy Staff will continue to work with
Representative Thurman’s staff to improve the field of transplantation
medicine.
Senate
and House Appropriators Propose to Cut Overall FY 2000
Spending Levels
for Health Related Programs — AST Seeks Change and Aggressively
Pursues Increased Funding for Research
Members of the House
and Senate Appropriations Committee recently set the overall
FY 2000 spending
levels available for each of their respective thirteen subcommittees.
Based on these “allocations” or spending limits, the subcommittees
must then vote on specific funding levels for a variety of
government programs under their jurisdiction. On May 19, 1999,
members of the full House Appropriations Committee voted to
cut the amount available for the Labor, Health and Human Services
(HHS), and Education Subcommittee by $10 billion. This Subcommittee
has jurisdiction over many of the health care programs, including
the National Institutes of Health (NIH). Specifically, the
House Appropriations Subcommittee on Labor, HHS, and Education
received an allocation of $78.1 billion dollars compared to
last year’s allocation of $88.8 billion. The President’s FY
2000 request was $89.4 billion.
On May 25, 1999, members of the
full Senate Appropriations Committee voted to provide its Labor,
HHS Subcommittee with $80.3 billion; representing a cut of
approximately $8.5 million compared to last year. These proposed
cuts in both the House and Senate can be traced to the 1997
Balanced Budget Act, which placed a cap on total spending.
This adherence to the budget caps may force lawmakers to negotiate
areas facing the most severe cuts, such as Labor, HHS, and
Education, into last-minute negotiations and compromises.
Some Congressional leaders are calling
for a raising of the budget caps. Representative John Porter
(R-IL), Chairman of the House Appropriations Subcommittee on
Labor, HHS, and Education, has proposed that two percent of
all federal spending be added to the cap. Porter stated that
the Labor, HHS, and Education bill would not pass with $10
billion in budget cuts.
AST Public Policy Staff is working
aggressively on Capitol Hill and with other coalitions and
advocacy groups to join in the efforts to protest low funding
allocations and support a continued investment in biomedical
and health services research. These efforts include testifying
before Congress, AST grassroots communications with Congress
(i.e. letter writing, telephone calls, etc.), and regular meetings
with the House and Senate Appropriations Committees.
AAMC
Releases Analysis of BBA’s Detrimental Effect on Teaching
Hospitals
The Association
of American Medical Colleges (AAMC) released a new analysis
demonstrating financial
impact of the Balanced Budget Act of 1997 (BBA). During a briefing
on April 28, 1999, AAMC concluded that the budget cuts have
gone too far and are threatening the long-term financial stability
of U.S. teaching hospitals. The Association called upon Congress
to halt and restore the Medicare-related payment cuts by appropriating
$6-$7 billion to teaching hospitals. The AAMC analysis said
failure to stop budget cuts would typically result in total
margins of about one percent for some 260 of the nation’s biggest
teaching facilities. Of those facilities, 100 may be losing
money by 2002 according to AAMC.
The AAMC briefing marked the beginning
of their efforts to restore funding for teaching hospitals
according to the following:
• A return of Indirect
Medical Education (IME) payments to pre-BBA levels ($4.5 -
$4.7 billion) or a
halt in the implementation of further IME cuts;
• A return to Disproportionate
Share Hospital (DSH) payments to pre-BBA levels ($500 - $637
million);
• Pay 100 percent
of Graduate Medical Education (GME) payments associated with
Medicare managed care
enrollees starting in FY 2000 ($800 million); and
• Pay 100 percent
of DSH payments associated with Medicare managed care enrollees
directly to
eligible hospitals starting in FY 2000 (cost to be determined).
For more information
regarding AAMC’s
analysis, see http://www.aamc.org/newsroom/pressrel/990428.htm
or contact AST Public Policy Staff.
Medicare Reform
Debate Slows in Senate Finance Committee
The Senate Finance
Committee began its series of hearings on the context and evolution
of the
Medicare Program on April 28, 1999. Members of the Committee
were cautioned by the panelists, including representatives
from Columbia University, Princeton University, University
of North Carolina, and Dartmouth College, to take an incremental
approach to changing Medicare. None of the participants recommended
a wholesale shift to private-sector management or a defined
contribution approach. All witnesses urged the Senators to
find ways to increase Medicare’s flexibility. All agreed that
Medicare and the American health system in general need to
move toward organized systems of care.
Senator Jay Rockefeller
(D-WV), Medicare Commission Member, urged fellow Finance Committee
members to view the Commission’s work as only “the beginning
of a very important debate” and not simply pass the premium
support reform plan. Proponents of the premium support plan
remained quiet at this first hearing. Medicare Commission Chair
Senator John Breaux (D-LA) plans to present a summary of the
premium support proposal at an upcoming Finance Committee hearing.
On May 5, 1999,
the Finance Committee held a hearing entitled, “Medicare Financing: The Partnership
of Taxpayers and Beneficiaries.” During this hearing, Governor
Paul Cellucci (MA) testified on behalf of the National Governor’s
Association as to the role that Medicare has on states with
individuals eligible for both Medicare and Medicaid and the
susceptibility to cost shifts from Medicare. He concluded that
Medicare reform should support state flexibility to develop
mechanisms to contain growth in Medicaid spending and should
support federal-state partnerships to integrate Medicare and
Medicaid. Richard Foster, Chief Actuary at the Health Care
Financing Administration also testified and confirmed the need
to take further steps to address the continuing financial pressures
facing Medicare.
The third Finance Committee hearing
on Medicare Reform was on Wednesday, May 12, 1999 and focused
on key issues in Medicare Reform including premiums and Medicare
subsidies for Graduate Medical Education (GME), Disproportionate
Share Hospitals (DSH), and rural health care infrastructure.
AST Public Policy Staff will report on the last two hearings
on Medicare Reform in the next issue of the AST Washington
Round-Up.
Commerce Committee
Holds Hearing on Reauthorization of AHCPR
On April 29, 1999, the House Commerce
Committee held a hearing on reauthorization of the Agency for
Health Care Policy and Research (AHCPR), which directly funds
the collection and analysis of critical health data information
needed by Congress to make sound decisions on health care access,
quality, and cost-effectiveness issues. AHCPR also provides
technical assistance to private sector organizations that seek
its expertise to support their initiatives.
Dr. John Eisenberg,
Administrator of AHCPR, and experts from both the public and
private sectors
testified as to the research and quality initiatives that result
from the agency’s work. All participants called for the reauthorization
and increase in funding for AHCPR. Commerce Committee Chairman
Tom Bliley (R-VA) told AST Public Policy Staff that the Committee
plans to seek authorizing legislation that “would give the
agency more direction in using new technologies including electronic
commerce to enhance the latest medical breakthroughs in the
public and private sectors and to help ensure that patients
receive high quality, effective and appropriate care.”
Managed Care Reform
Still Being Debated
In the latter weeks in April, Representative
Greg Ganske (R-IA) release an early draft of a managed care
proposal being drafted by himself, fellow health care professionals,
and Commerce Committee members, Representatives Charlie Norwood
(R-GA) and Tom Coburn (R-OK). The three were tasked by Commerce
Chairman Thomas Bliley (R-VA) and Health Subcom mittee Chairman
Michael Bilirakis (R-FL) to draft a consensus bill for presentation
to the Committee.
Certain requirements for a point-of-service
option and a choice of providers, a prudent layperson standard
for emergency care coverage, provisions on access to pediatricians
and OB-GYNs, and a ban on gag rules are all included in the
draft. The proposal also includes guaranteed internal and external
appeals procedures and liability provisions similar to previous
legislation introduced by Ganske (HR 719) and Norwood (HR 216).
Senator Edward Kennedy (D-MA), Ranking
Member on the Senate Health, Education, Labor and Pensions
(HELP) Committee, announced that he will seek legislative vehicles
upon which managed care language might be amended should the
Senate Finance Committee not take action on managed care reform
legislation in the near future. The Senate Finance Committee
has worked on a managed care bill focusing on internal and
external appeals, but is also devoted to other important issues
such as Medicare overhaul proposals. AST Public Policy Staff
will continue to report on the managed care debate as new developments
occur.
Bennett Introduces
Medical Privacy Legislation
Senator Bob Bennett (R-UT) introduced
The Medical Information Protection Act on April 26, 1999, which
seeks to safeguard personal records, penalize the wrongful
disclosure of these records, and ensure access to the records
by patients and legitimate health care operations and research.
Congress faces an August 21, 1999 deadline to enact a federal
law to protect the privacy of personal medical records. Failure
to do so will result in the Secretary of Health and Human Services
promulgating regulations as mandated by the Health Insurance
Portability and Accountability Act of 1996.
Bennett’s legislation, S. 881, is
cosponsored by Senator Connie Mack (R-FL) and has been referred
to the Senate Committee on Health, Education, Labor and Pensions.
Other competing bills on the same issue include: The Medical
Information Privacy and Security Act, S. 573, introduced by
Senator Patrick Leahy (D-VT); and Senate HELP Committee Chairman
James Jeffords’ (R-VT) bill, The Health Care PIN Act, S. 578.
The difference between these pieces of legislation revolves
around the level of state preemption. Bennett’s proposal would
pre-empt all state laws, except for those dealing with state-protected
private health information about a minor; whereas, the Jeffords
bill would pre-empt state laws that were enacted after the
effective date of the law, giving states 18 months to enact
more protective laws. The Leahy measure would not pre-empt
any state laws or regulations that offers greater privacy safeguards
and would serve as a foundation that states would have the
option of building upon.
The Senate HELP
Committee will hold a full committee markup on Jeffords’ bill
on May 19, 1999. Markup is when the committee will vote on
provisions, alternative
proposals, and legislative language before sending it to the
Senate floor.
Prescription Drug
Benefit Legislation Introduced
Late April, Senators Edward Kennedy
(D-MA) and John Rockfeller IV (D-WV) and Representatives Henry
Waxman (D-CA) and Pete Stark (D-CA) introduced a plan to add
a prescription drug benefit to Medicare. The legislation seeks
to require the Secretary of Health and Human Services to secure
contracts with private entities, such as pharmacy benefit management
groups or insurance companies, to provide drug benefits to
Medicare recipients.
All beneficiaries would be offered
prescription coverage, but those who choose private coverage
could voluntarily withdraw from the federal benefit. Under
the bill, beneficiaries could get $1,700 per year in drug coverage,
with 20 percent coinsurance and a $200 initial deductible.
Low-income patients whose salaries are 35 percent over the
poverty threshold or lower would get special assistance. Medicare
would fund drug costs exceeding $3,000.
Critics have financial concerns
regarding this bill. Exact cost estimates are not available,
however, sponsors estimate that the plan would cost $15-$25
billion annually. A competing proposal is said to be in the
drafting stages by Senators Olympia Snowe (R-ME) and Ron Wyden
(D-OR) that would be patterned after the nationally-available
benefit in fee-for-service coverage offered to federal workers
under the Federal Employees Health Benefit Plan. Their proposal
would seek to allow private plans to compete for the business
of beneficiaries.
Washington-Round-up
Editors
Editor
James B. Young, MD
Cleveland Clinic
Foundation
216-444-2270
Associate Editors
M. Roy First, MD
University of Cincinnati Medical
Center
513-558-5465
Associate Editors Wayne Hancock,
MD, PhD
LeukoSite, Inc.
617-621-9350
Managing Editor
Beth Jenkins
1999/2000
AST Public Policy Committee
John Neylan,
MD, Chair (02)
Emory University
William Harmon, MD, Co-Chair
(01)
Children’s Hospital,
Harvard Medical School
David Cohen, MD (01)
Columbia-Presbyterian Medical Center
David M. Briscoe, MD(03)
Children’s Hospital
Jeffrey Crippin, MD(03)
Baylor University Medical Center
E Steve Woodle, MD (03)
University of Chicago
James B. Young, MD (02)
Cleveland Clinic Foundation
ex officio Mohamed H. Sayegh,
MD (02)
Brigham & Womens
Hosp/Harvard
Washington Representatives
William Applegate Jill Rathbun 1200
19th Street, NW Suite 300 Washington, DC 20036
202/429-5114 • 202/857-1115
E-mail: bill_applegate@dc.sba.com
