[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Pages 41477-41478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16887]



[[Page 41477]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-1141-N]


Medicare Program; Open Public Meeting on July 25, 2000 To Discuss 
the Coverage of Drugs and Biologicals That Cannot Be Self-Administered

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice of meeting.

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SUMMARY: This notice announces a second public meeting to obtain input 
on the Medicare program policy for drugs and biologicals that are 
furnished as an incident to a physician's professional service and 
which cannot be self-administered. This meeting follows the public 
meeting held on May 18, 2000 at the Health Care Financing 
Administration headquarters on the same subject. The meeting will 
provide an opportunity for providers, suppliers, beneficiaries, 
beneficiary advocates, and other interested parties to furnish 
information and to address issues about the Medicare program's policy 
concerning the self-administration of drugs and biologicals.

DATES: The meeting is scheduled for July 25, 2000 from 9:30 a.m. until 
1:30 p.m.

ADDRESSES: The meeting will be held at the Hyatt Regency O'Hare, 9300 
West Bryn Mawr, Rosemont, IL, 60018, located three miles from the 
airport in Chicago. Special arrangements have been made with the Hyatt 
Regency to hold a limited number of rooms for out of town guests 
interested in attending. To reserve your room, please call the Hyatt 
directly at (847) 696-1234. When calling to make a reservation 
reference the Health Care Financing Administration Town Hall Meeting.

FOR FURTHER INFORMATION CONTACT: Heidi Adams, (410) 786-1620 
(telephone); (410) 786-0169 (fax); [email protected] (e-mail). We will 
accept written comments at the following address: Health Care Financing 
Administration, Heidi Adams, C4-07-07, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.

SUPPLEMENTARY INFORMATION:

Background

    As suggested by the report language accompanying section 219 of the 
Department of Health and Human Services Appropriations Act, 2000 
(Public Law 106-113), we are announcing the second of two town hall 
meetings to discuss our current policy regarding Medicare coverage of 
drugs and biologicals that are furnished as an incident to a 
physician's professional service and which cannot be self-administered. 
The first meeting was held on May 18, 2000. It raised several issues, 
in addition to other policy considerations that we believe should be 
addressed.
    The scope of benefits provided to Medicare beneficiaries who are 
eligible under the Supplemental Medical Insurance program (Part B) 
includes coverage for certain ``medical and other health services.'' 
Among those services are two specific provisions that include limited 
coverage of drugs and biologicals. Sections 1861(s)(2)(A) and (B) 
provide, in pertinent part, that:

    (A) services and supplies (including drugs and biologicals which 
cannot, as determined in accordance with regulations, be self-
administered) furnished as an 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;
    (B) hospital services (including drugs and biologicals which 
cannot, as determined in accordance with regulations, be self-
administered) incident to physicians' services rendered to 
outpatients * * *

    Coverage of drugs and biologicals under these provisions are only 
covered in the context of items furnished ``incident to a physician's 
service.'' Moreover, historically, the determination of whether a drug 
``cannot be self-administered'' has been based on the characteristics 
of the drug itself and not the patient's capacity to self-administer.
    When considering self-administration and its effect on the coverage 
of drugs under Medicare, compelling concerns about Medicare beneficiary 
access to needed drugs were raised by presenters during the town hall 
meeting held on May 18, 2000. A report of the May 18, 2000 meeting may 
be found on the HCFA website (www.hcfa.gov). In addition, other 
important policy issues including financial, equity, and ethical issues 
are implicated. Due to time constraints, however, it may not be 
possible to present all view points on each issue at the public 
meeting.

Equity

    In the area of equity, the main question is around the limitations 
on coverage.
     If considering ``usual medical practice'' for specific 
drugs, then what percentage of patients should constitute a usual 
practice? Should the universe of patients that is considered be:
    + Every patient;
    + Every Medicare patient;
    + Every patient in the carrier's area; or
    + Every Medicare patient in the carrier's area.
     Should coverage be limited to beneficiaries whose 
condition is such that they could not self-administer any drug; for 
example, the disabled and those with dementia?
     Is it appropriate to consider only the patient's ability 
to self-administer, exclusive of any other considerations, such as 
those in this list?
     Should there be information collected on certain drugs to 
estimate a percentage of patients who could self-administer or who 
actually self-administer?
     Should psychiatric drugs be considered under special 
criteria, since patient compliance may be particularly problematic?
     Should coverage be limited only to injectable drugs?
     Should the policy consider whether another person, who is 
not a health-care professional (for example, the patient's spouse) can 
administer the drug to the beneficiary?
     Should the policy consider whether the drug is used to 
treat an acute illness or injury as compared to a chronic condition 
that requires drug therapy over an extended period?

Ethical Concerns

    The ethical issues raised related to dilemmas physicians face in 
determining treatment practices as they try to follow the Medicare 
practices and policies when treating their patients with drug 
therapies.
     In developing criteria for application of this policy, is 
there a way to address the physician's dilemma of administering 
medication based on Medicare coverage status versus the most 
appropriate medical treatment.
     If the criterion is solely that physicians monitor the 
effects of the drug, then on what basis would oral drugs be excluded? 
What meaning would ``cannot be self-administered'' have over and above 
the meaning for ``incident to a physician's service''?
     Should the criterion be solely the method of 
administration? Or should the nature of the chemical compound and its 
possible side effects also be considered?
     If the criterion is safe self-administration, then safely 
by whom? Should this be determined on a patient-by-patient basis?

Financial

    The financial issues vary from the stand point of the manufacturer, 
program, and patient.

[[Page 41478]]

     How to address possible incentives for drug manufacturers 
to make drugs only in the form that cannot be self-administered. How 
should oral versus injectable drugs be evaluated?
     Considering the marketplace, how should Medicare's policy 
concerning self-administered drugs take into account a possible 
competitive disadvantage for oral and subcutaneous drugs that are self-
administrable?
    The purpose of the meeting on July 25, 2000 is to obtain focused 
input on how this statutory provision should reasonably be interpreted; 
how the evolution of medical technology has affected physician practice 
in self-administration; how different interpretations of the provision 
might affect considerations of fairness and equity among beneficiary 
populations; and how physician practice may be affected by different 
interpretations. We are holding the second meeting to allow the public 
to address in more detail the issues raised during the first meeting by 
way of panel presentations and discussion. Due to time constraints, and 
the need to focus on the above topics, we are unable to undertake a 
discussion of options or ideas that require a statutory change.

Format

    We will begin the meeting with a brief summary of the first meeting 
and a brief exposition of policy concerns that should be considered 
when addressing the issue of drugs and biologicals that cannot be self-
administered. This will be followed by 15-minute panel presentations by 
participants who submit a prior request to speak.
    Panels will be organized in the following manner to address the 
general categories of policy concerns:
    1. Financial, including incentives/marketplace advantage to 
manufacturers of non self-administrable forms of drugs.
    2. Beneficiary equity.
    3. Physicians' ethical dilemmas, including prescription of drugs 
based on coverage status versus the most appropriate medical treatment.
    After the last panel has concluded its presentations the meeting 
will move to an open dialogue.

Presentations

    Individuals interested in making a presentation at the meeting or 
who need special arrangements should contact Heidi Adams at (410) 786-
1620, or via e-mail at [email protected], no later than July 14, 2000. 
Individuals should identify the topics they wish to discuss during 
their presentation. Because of time constraints, only a limited number 
of individuals will be able to make presentations. In an effort to 
assure that all viewpoints are represented, we will notify participants 
who are selected to make a presentation. We will not assign 
presentation times until after July 14, 2000.

Registration

    The Center for Health Plans and Providers will handle registration 
for the meeting. Individuals may register by sending a fax to the 
attention of Heidi Adams at (410) 786-0169. At the time of 
registration, please provide your name, address, telephone number, 
company name, and fax number.
    Receipt of your fax will constitute confirmation of your 
registration. Meeting materials will be provided at the time of the 
meeting. If you have questions regarding registration, please contact 
Heidi Adams.
    We will accept written comments, questions, or other materials 
specifically dealing with the issue that are received no later than 5 
p.m. on July 14, 2000 at the address noted above.
    While the meeting is open to the public, attendance is limited to 
space available. Individuals must register in advance as described 
above. Individuals requiring sign language interpretation for the 
hearing impaired or other special accommodations should contact Heidi 
Adams at least 10 days before the meeting.

    Authority: Section 1102 of the Social Security Act (42 U.S.C. 
1302) and 5 CFR 1320.3(h)(4).

(Catalog of Federal Domestic Assistance Program No. 93.773 
Medicare--Hospital Insurance Program; and No. 93.774, Medicare--
Supplementary Medical Insurance Program)
    Dated: June 28, 2000.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 00-16887 Filed 7-3-00; 8:45 am]
BILLING CODE 4120-01-P