[Congressional Record Volume 146, Number 100 (Thursday, July 27, 2000)]
[Senate]
[Page S7849]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ROTH:
  S. 2957. A bill to amend title XVIII of the Social Security Act to 
preserve coverage of drugs and biologicals under part B of the medicare 
program; to the Committee on Finance.


               medicare self-administered medications act

  Mr. ROTH. Mr. President, today I am introducing a bill to address a 
serious problem regarding Medicare's treatment of self-injectable 
drugs. Section 1862(s) of the Social Security Act defines covered 
``medical and other health services'' for purposes of coverage under 
Medicare Part B. Included in the definition are:

       (2)(A) services and supplies (including drugs and 
     biologicals which cannot, as determined in accordance with 
     regulations, be self-administered) furnished as incident to a 
     physician's professional service, of kinds which are commonly 
     furnished in physicians' offices and are commonly either 
     rendered without charge or included in the physicians' bills 
     . . .

  Regulations at 42 C.F.R. 410.29 provide further limitations on drugs 
and biologicals, but they do not define the phrase ``cannot be self-
administered.'' Individual Medicare carriers have reportedly applied 
different policies when considering whether a drug or biological can or 
cannot be self-administered. Some carriers have based the determination 
on the typical means of administration while others have assessed the 
individual patient's ability to administer the drug.
  On August 13, 1997, HCFA issued a memorandum to Medicare carriers 
which was intended to clarify program policy. The memorandum stated 
that the inability to self-administer is to be based on the typical 
means of administration of the drug, not on the individual patient's 
ability to administer the drug. The memorandum stated that: ``The 
individual patient's mental or physical ability to administer any drug 
is not a consideration for this purpose.''
  As a result of this memorandum, certain patients, for example 
patients with multiple sclerosis or some forms of cancer, no longer had 
Medicare coverage for certain drugs. However, implementation of this 
policy directive has been halted for FY2000. On November 29, 1999, the 
President signed into law the Consolidated Appropriations Act for 2000. 
Section 219 of General Provisions in Title II, Department of Health and 
Human Services contains a provision relating to the memorandum. The 
provision prohibits the use of any funds to carry out the August 13, 
1997, transmittal or to promulgate any regulation or other transmittal 
or policy directive that has the effect of imposing (or clarifying the 
imposition of ) a restriction on the coverage of injectable drugs 
beyond those applied on the day before issuance of the transmittal.
  The definition of covered services continues to be of concern to 
policymakers. On March 23, 2000, the House Commerce Committee, 
Subcommittee on Health & Environment held a hearing on this issue. I 
understand that there was a very productive discussion of other policy 
options during the question and answer period. One witness, Dr. Earl 
Steinberg of Johns Hopkins University, suggested having the 
beneficiary's physician determine whether a medication can or cannot be 
self-injected. The bill I am introducing today follows that expert 
advice and introduces the judgment of the physician into the decision 
process.
  On May 17, 2000 I sent a letter to HCFA Administrator DeParle, 
requesting her serious attention to this problem. I went further to ask 
her to propose an administrative remedy for the inequity that existed. 
In her reply, she stated that she was ``very troubled by the 
predicament of beneficiaries whose drugs are not covered under the 
law.'' But it is clear from Administrator DeParle's letter, that 
without legislative authority there is only a limited amount HCFA will 
do to address this problem.
  The bill I am introducing today allows a Medicare beneficiary's own 
physician to make the determination of whether the beneficiary can or 
cannot administer their medication. I would ask for my colleagues' 
support in this legislation. This issue is of vital importance to some 
of our most gravely ill Medicare beneficiaries. These beneficiaries, 
many with advanced cases of multiple sclerosis or cancer, deserve our 
help and they deserve it today. I ask consent that the full text be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2957

       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 Self-Administered 
     Medications Act of 2000''.

     SEC. 2. PRESERVATION OF COVERAGE OF DRUGS AND BIOLOGICALS 
                   UNDER PART B OF THE MEDICARE PROGRAM.

       (a) In General.--Section 1861(s)(2) of the Social Security 
     Act (42 U.S.C. 1395x(s)(2)) is amended, in each of 
     subparagraphs (A) and (B), by striking ``(including drugs and 
     biologicals which cannot, as determined in accordance with 
     regulations, be self-administered)'' and inserting 
     ``(including drugs and biologicals for which the usual method 
     of administration of the form of drug or biological is not 
     patient self-administration or, in the case of injectable 
     drugs and biologicals, for which the physician determines 
     that self-administration is not medically appropriate)''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to drugs and biologicals administered on or after 
     October 1, 2000.
                                 ______