July 27,2000

Roth Introduces Legislation to Help Medicare Beneficiaries Who Have MS or Cancer

WASHINGTON -- Senate Finance Committee Chairman William V. Roth, Jr. (R-DE) today introduced legislation that would help Medicare beneficiaries who have multiple schlerosis or cancer

Under current law, Medicare will not cover the cost of a drug if, under any circumstances, it can be self-administered, no matter how ill the patient may be. Roth's bill would allow the beneficiary's physician to make the determination of whether the patient can or cannot administer the drug themselves, and therefore, whether or not it would be covered.

In May, Roth urged the Health Care Financing Administration to find an administrative remedy to this problem, but determined that without legislative authority there is only a limited amount HCFA will do to address this problem.

Roth submitted the following statement for the record:

"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 judgement 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'm 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."