Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41477

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.

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);

Hadams@hcfa.gov (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 selfadministered. 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 selfadministered) 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 selfadministered) 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 selfadminister or who actually selfadminister?

• 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 selfadministration, then safely by whom?

Should this be determined on a patientby-patient basis?

Financial

The financial issues vary from the

stand point of the manufacturer,

program, and patient.

41478 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

• How to address possible incentives

for drug manufacturers to make drugs

only in the form that cannot be selfadministered. 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 selfadministration; 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 HAdams@hcfa.gov, 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Availability of Funds for Loan

Repayment Program for Repayment of

Health Professions Educational Loans

AGENCY: Indian Health Service, HHS.

ACTION: Revised notice of availability of

funds for loan repayment program for

repayment of health professions

educational loans for Fiscal Year (FY)

2000.

SUMMARY: The announcement for FY

2000 Availability of Funds for Loan

Repayment Program for Repayment of

Health Professions Educational Loans

was announced in 64 FR 53681 on

October 4, 1999. The Indian Health

Service (IHS) is republishing the full

notice, for the convenience of the

public, and in order to add that the IHS

Area Offices and Service Units may

provide additional funding to make

awards to participants in the Loan

Repayment Program (LRP), and to

describe the policy for administering

these funds.

The Administration’s budget request

for fiscal year (FY) 2000 includes

$11,000,000 for the Indian Health

Service Loan Repayment Program for

health professionals educational loans

(undergraduate and graduate) in return

for full-time clinical service in Indian

health programs. It is anticipated that

$11,000,000 will be available to support

approximately 275 competing awards

averaging $40,000 per award.

This program announcement is

subject to the appropriation of funds.

This notice is being published early to

coincide with the recruitment activity of

the IHS, which competes with other

Government and private health

management organizations to employ

qualified health professionals. Funds

must be expended by September 30 of

the fiscal year. This program is

authorized by Section 108 of the Indian

Health Care Improvement Act (IHCIA)

as amended, 25 U.S.C. 1601 et seq. The

IHS invites potential applications to

request an application for participation

in the Loan Repayment Program.

DATES: Applications for the FY 2000

Loan Repayment Program will be

accepted and evaluated monthly

beginning January 14, 2000, and will

continue to be accepted each month

thereafter until all funds are exhausted.

Subsequent monthly deadline dates are

scheduled for Friday of the second full

week of each month. Notice of awards

will be mailed on the last working day

of each month.

Applicants selected for participation

in the FY 2000 program cycle will be

expected to begin their service period

no later than September 30, 2000.

Applications shall be considered as

meeting the deadline if they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date.

(Applicants should request a legibly

dated U.S. Postal Service post mark or

obtain a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks are

not acceptable as proof of timely

mailing.)

Applications received after the

monthly closing date will be held for