May 17,2000

Roth Raises Concern on Pending Medicare Coverage Cut Off of Some Drugs for Multiple Sclerosis and Cancer Patients

WASHINGTON -- In a letter to HCFA Administrator Nancy-Ann Min DeParle, Senate Finance Committee Chairman William V. Roth, Jr. (R-DE) today expressed great concern that Medicare may stop covering some drugs that are used by patients with multiple sclerosis and cancer.

Roth is concerned that due to an internal ruling by HCFA, some so-called "self-injected" drugs may no longer be covered by Medicare beginning on October 1, 2000. Under HCFA's ruling, any drug considered to be self-injectable would not be covered by Medicare, even if the patient was unable to self-administer the drug, as is the case with many multiple sclerosis and some cancer patients.

In the letter, Roth stated that he does not feel legislation is necessary to remedy the problem, and urged HCFA to take quick administrative action.

A copy of the letter is attached.

May 17, 2000

The Honorable Nancy-Ann Min DeParle
Health Care Financing Administration
Room 314G, Hubert H. Humphrey Building
200 Independence Ave, NW
Washington, DC 20201

Dear Ms. Min DeParle:

I am writing today to voice my concern 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, 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-injecteed. I would encourage you to consider such a suggestion and other like it in your attempts to clarify and improve Medicare's policy on injectable drugs.

Clearly some members feel that legislation is necessary to remedy this situation. Two bills related to this issue already have been introduced in the House. The Access to Innovation for Medicare for Patients Act (H.R. 2892, Dunn et al.), and the Medicare Drug Coverage Preservation Act of 2000 (H.R. 4149, Bilirakis, et al.).

I have great faith in your ability to resolve this problem administratively. I would ask you to move forcefully to address this problem in an equitable manner, consistent with the intent of last year Appropriations language. If your office can show the type of flexibility, creativity and openness you discussed in your May 4th Finance Committee testimony, legislative activity may be unnecessary. I would encourage you to move quickly to resolve this issue to the satisfaction of the parties involved. Please advise me at your earliest opportunity, but no later than June 1, how you intend to resolve this problem.


William V. Roth, Jr.