[Congressional Record Volume 142, Number 105 (Wednesday, July 17, 1996)]
[Senate]
[Pages S8013-S8015]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ROCKEFELLER (for himself and Mr. Mack):
  S. 1963. A bill to establish a demonstration project to study and 
provide coverage of routine patient care costs for medicare 
beneficiaries with cancer who are enrolled in an approved clinical 
trial program; to the Committee on Finance.


        THE MEDICARE CANCER CLINICAL TRIAL COVERAGE ACT OF 1996

  Mr. ROCKEFELLER. Mr. President, today, I am introducing legislation 
to continue the effort to expand treatment options for older Americans 
who happen to have cancer. I am especially pleased my colleague from 
Florida, Senator Mack, is joining me as an original cosponsor. Senator 
Mack is a vigorous and persistent advocate for cancer research and 
improvements in patient care for those with cancer. He has been 
fighting this battle for a long time.
  Our bipartisan sponsorship, which is just a nice thing to happen 
around here anyway, is intended to say to the American people, 
especially to the millions of Medicare beneficiaries with cancer, that 
we in the Congress are, in fact, very, very serious about trying to be 
helpful.
  Over 1.3 million people will be diagnosed with cancer this year. Over 
11,000 of those people, newly diagnosed with cancer, will be people I 
represent, that is West Virginians. Cancer is, in fact, the second 
leading cause of death in West Virginia, second only to heart disease. 
This legislation is aimed at improving Medicare coverage, since 
Medicare beneficiaries account for more than half of all cancer 
diagnoses, and 60 percent of all cancer deaths.
  Our bill deals with the very specific problem faced by Medicare 
beneficiaries who are currently prevented from receiving care that may 
extend or save their lives. To put it very simply and very bluntly, 
Americans over the age of 65 who are struck with cancer believe they 
should get the best shot in fighting their disease. The Medicare Cancer 
Clinical Trial Coverage Act of 1996, which is the bill I am 
introducing, is a bill to do something very targeted to give older 
Americans their best shot at fighting cancer. With this bill we want to 
tackle the frustrating, often anguishing problem faced by older 
Americans who are unable to participate in cancer clinical trials. Let 
me explain.
  Consider the story of a West Virginian who was treated with an 
experimental drug for lung cancer, under a research trial approved by 
the National Cancer Institute. Because Medicare would not cover the 
cost of hospitalization required to administer the anticancer 
treatment, he decided he could only pay for one more treatment out of 
the money from his own pocket. This West Virginian could not bring 
himself to bankrupt his family, yet getting the additional treatments

[[Page S8014]]

might bring the gift of a longer life for him and, obviously, much more 
stability and happiness for his family. This is a terrible choice that 
should not have to be made by anybody in this country.
  While we still have a long way to go in discovering a cure for 
cancer, there are constantly popping up reports of exciting new 
advances in the treatment of cancer. The bad news is that millions of 
people with cancer cannot take advantage of these path-breaking 
treatments because they are provided in a setup which is called 
clinical trials. To insurers, including the Medicare Program, that 
labels them experimental. In other words, clinical trials are labeled 
experimental and, therefore, the basis for turning down coverage with 
no ifs, ands, or buts.
  Critics of coverage for clinical trials argue that care provided in 
trials is purely investigational and too costly. In fact, these trials 
can provide essential information about which treatments are effective 
and which ones are not. This is one of the best ways for the health 
care system to learn about the various advantages and disadvantages of 
treatment options, including what costs are involved before a certain 
course is expanded widely or prematurely.
  The bill I am introducing today with Senator Connie Mack is very 
careful in pursuing a solution. We lay out a framework for a major 
demonstration project to come up with the information and the 
experience needed to then modify Medicare's policy toward clinical 
trials. With this demonstration we want the Medicare Program to find 
out more about the costs of covering high-quality clinical trials for 
its beneficiaries with cancer, and then compare them to the benefits 
and other results learned through the demonstration. There is truly an 
urgent need to get on with this study, and then where the findings 
should take us in changing Medicare's policy toward clinical trials. 
With new cancer therapies rapidly unfolding, dealing with a disease 
that its victims are desperately trying to battle, peer-reviewed 
clinical trials may be the best and only available care.

  Cancer researchers themselves--and there is a long list of 
associations and organizations who support this legislation--are eager 
to have more older Americans involved in these trials. More needs to be 
learned about the biological responses to various treatments within 
different age groups, and this bill can help fill that particular gap.
  In our bill we confine the demonstration to covering a select group 
of high-quality clinical trials. Our criteria say the trials covered 
under this demonstration have to be the result of top-notch peer review 
procedures.
  This legislation does not write any new policies for Medicare into 
stone, but it does lay the foundation for a Medicare policy toward 
cancer treatments that factors in what clinical trials now have to 
offer. We give the program 5 years to conduct the demonstration, and 
then we call on the Secretary of HHS to tell Congress how Medicare 
should or perhaps should not be changed in its policy toward cancer and 
other kinds of clinical trials.
  Many researchers, physicians, patients, and many of us in Congress 
have already been pushing for more coverage for clinical trials by 
Medicare and other insurers. In its 1994 report to Congress, a very 
long-named advisory group--something called the National Cancer 
Advisory Board's Subcommittee to Evaluate the National Cancer Program--
emphasized the need for private insurance and Medicare coverage for 
approved clinical trials. And we use that report in our bill to create 
the criteria for what kinds of trials should be covered in the Medicare 
demonstration that Senator Mack and I are proposing.
  I continue to believe that all Americans should be guaranteed access 
to quality health care. I would love to see Congress acting immediately 
to ensure that any American struck by cancer, whether age 21 or age 71, 
could get coverage for treatment in a clinical trial if that is judged 
the best option for them. Those are highly ambitious goals, and today 
Senator Mack and I offer this bill as one more incremental step in 
their direction.
  I actually started some years ago with legislation to improve cancer 
care for Medicare patients. That legislation ended up being enacted in 
1993. It was really sort of embarrassingly simple. My legislation 
required Medicare coverage of oral anticancer drugs if those drugs 
would otherwise have been covered by Medicare if administered 
intravenously in a doctor's office. Obviously, the result being cost 
savings and almost simple beyond belief. But, nevertheless, it was not 
allowed prior to my legislation.
  We changed the law, and now it is allowed. A lot of money is being 
saved, and people are being helped because they can take an oral drug 
at home rather than having an injection in a doctor's office. As a 
result, many Medicare beneficiaries with cancer can take advantage of 
drugs that they were, in a sense, walled off from before.
  The other part of my bill set an uniform standard for Medicare 
coverage of anticancer drugs. Prior to the enactment of my legislation, 
there was significant variation in Medicare coverage of anticancer 
drugs because individual Medicare carriers made their own decisions on 
coverage. A GAO report found that Medicare's unreliable and 
inconsistent coverage of accepted off-label uses of cancer drugs forced 
oncologists to alter their preferred treatment. Now there is clear and 
consistent Medicare policy regarding coverage of anticancer drugs.
  In conclusion, I think it is time again for Congress to take another 
small, yet crucial, step in improving coverage for elderly cancer 
patients who deserve every chance they have to battle this horrible 
disease.
  I hope to get the help of colleagues on both sides of the aisle--and 
I am sure Senator Mack shares this wish with me--to get more supporters 
to recognize that this urgent need has to be attended to as soon as 
possible.
  Mr. President, I ask unanimous consent that a copy of our bill and a 
summary of the legislation, along with a list of its supporters, be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record as follows:

                                S. 1963

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Medicare Cancer Clinical 
     Trial Coverage Act of 1996''.

     SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION PROJECT.

       (a) Establishment.--Not later than January 1, 1997, the 
     Secretary of Health and Human Services (in this Act referred 
     to as the ``Secretary'') shall establish a demonstration 
     project which provides for payment under the medicare program 
     under title XVIII of the Social Security Act (42 U.S.C. 1395 
     et seq.) of routine patient care costs--
       (1) which are provided to an individual diagnosed with 
     cancer and enrolled in the medicare program under such title 
     as part of the individual's participation in an approved 
     clinical trial program; and
       (2) which are not otherwise eligible for payment under such 
     title for individuals who are entitled to benefits under such 
     title.
       (b) Application.--The beneficiary cost sharing provisions 
     under the medicare program, such as deductibles, coinsurance, 
     and copayment amounts, shall apply to any individual 
     participating in a demonstration project conducted under this 
     Act.
       (c) Approved Clinical Trial Program.--For purposes of this 
     Act, the term ``approved clinical trial program'' means a 
     clinical trial program which is approved by--
       (1) the National Institutes of Health;
       (2) a National Institutes of Health cooperative group or a 
     National Institutes of Health center;
       (3) the Food and Drug Administration (in the form of an 
     investigational new drug or device exemption);
       (4) the Department of Veterans Affairs;
       (5) the Department of Defense; or
       (6) a qualified nongovernmental research entity identified 
     in the guidelines issued by the National Institutes of Health 
     for center support grants.
       (d) Routine Patient Care Costs.--
       (1) In general.--For purposes of this Act, ``routine 
     patient care costs'' shall include the costs associated with 
     the provision of items and services that--
       (A) would otherwise be covered under the medicare program 
     if such items and services were not provided in connection 
     with an approved clinical trial program; and
       (B) are furnished according to the design of an approved 
     clinical trial program.
       (2) Exclusion.--For purposes of this Act, ``routine patient 
     care costs'' shall not include the costs associated with the 
     provision of--
       (A) an investigational drug or device, unless the Secretary 
     has authorized the manufacturer of such drug or device to 
     charge for such drug or device; or
       (B) any item or service supplied without charge by the 
     sponsor of the approved clinical trial program.

[[Page S8015]]

     SEC. 3. STUDY, REPORT, AND TERMINATION.

       (a) Study.--The Secretary shall study the impact on the 
     medicare program under title XVIII of the Social Security Act 
     of covering routine patient care costs for individuals with a 
     diagnosis of cancer and other diagnoses, who are entitled to 
     benefits under such title and who are enrolled in an approved 
     clinical trial program.
       (b) Report To Congress.--Not later than January 1, 2001, 
     the Secretary shall submit a report to Congress that contains 
     a statement regarding--
       (1) any incremental cost to the medicare program under 
     title XVIII of the Social Security Act resulting from the 
     provisions of this Act; and
       (2) a projection of expenditures under the medicare program 
     if coverage of routine patient care costs in an approved 
     clinical trial program were extended to individuals entitled 
     to benefits under the medicare program who have a diagnosis 
     other than cancer.
       (c) Termination.--The provisions of this Act shall not 
     apply after June 30, 2001.
                                                                    ____


          Medicare Cancer Clinical Trial Coverage Act of 1996


                              current law

       Medicare generally does not pay for the costs of patient 
     care if they are incurred in the course of a clinical trial. 
     An exception adopted last year allows Medicare coverage of 
     investigational medical devices used in clinical trials, and 
     of the associated medical care, if the FDA determines that 
     the investigational device is similar to a previously 
     approved or cleared device.


                            proposed change

       The Secretary of HHS would be required to conduct a 
     demonstration project, beginning no later than January 1, 
     1997, which would study the feasibility of covering patient 
     costs for beneficiaries diagnosed with cancer and enrolled in 
     certain approved clinical trials. Eligibility for coverage 
     would be dependent on approval of the trial design by one of 
     several high quality peer-review organizations, including the 
     National Institutes of Health, the Food and Drug 
     Administration, the Department of Defense, and the Department 
     of Veterans Affairs. No later than January 1, 2001, the 
     Secretary would be required to report to the Congress 
     concerning any incremental costs of such coverage and the 
     advisability of covering other diagnoses under the same 
     circumstances. The demonstration project would sunset on June 
     30, 2001.
       Supported by:
       National Coalition for Cancer Survivorship; Candlelighters 
     Childhood Cancer Foundation; Cancer Care, Inc.; National 
     Alliance of Breast Cancer Organizations (NABCO); US TOO 
     International Y-ME National Breast Cancer Organization; 
     American Cancer Society; American Society of Clinical 
     Oncology; American Society of Pediatric Hematology/Oncology; 
     Association of American Cancer Institutes; Association of 
     Community Cancer Centers; Cancer Research Foundation of 
     America; North American Brain Tumor Coalition; Leukemia 
     Society of America; National Breast Cancer Coalition; 
     National Childhood Cancer Foundation; National Coalition for 
     Cancer Research; Oncology Nursing Society; Prostate Cancer 
     Support-group Network; and Society of Surgical Oncology.
                                 ______