[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Notices]
[Page 18341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-1128-N]
RIN 0938-AK01


Medicare Program; Process for Requesting Recognition of New 
Technologies and Certain Drugs, Biologicals, and Medical Devices for 
Special Payment Under the Hospital Outpatient Prospective Payment 
System

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

ACTION: Notice.

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SUMMARY: We expect to implement a prospective payment system for 
hospital outpatient services for the Medicare program on July 1, 2000. 
This system will recognize new technology as discrete payment groups 
within the ambulatory payment classification (APC) system. This payment 
system will also provide for additional payments to hospitals at 
amounts higher than the amounts that would otherwise be paid for 
certain specified items, such as: orphan drugs; drugs, biologic agents, 
and brachytherapy devices used for the treatment of cancer; 
radiopharmaceutical drugs and biologic products; and certain new or 
innovative medical devices. We have identified items or services for 
inclusion in the new technology APC groups, as well as items 
potentially eligible for special additional payments. This notice 
addresses the process that interested parties must use to submit 
additional items for consideration.

FOR FURTHER INFORMATION CONTACT: Diane Milstead, (410) 786-3355.

SUPPLEMENTARY INFORMATION: We expect to implement a prospective payment 
system (PPS) for hospital outpatient services for Medicare on July 1, 
2000. One aspect of this system will be to develop a process to 
recognize new technologies on an ongoing basis in a timely manner, and 
to establish special payments for a number of specified items, in 
accordance with section 201 of the Balanced Budget Refinement Act of 
1999 (BBRA) (Pub. L. 106-113), enacted on November 29, 1999. New 
technologies refer to services and items that have emerged since 1996, 
and therefore are not reflected in the cost data that are being used to 
develop our PPS. Additionally, section 201(b) of the BBRA requires us 
to make additional payments to hospitals for a period of 2 to 3 years 
for specific items at amounts higher than the amounts that would 
otherwise be paid under the hospital outpatient PPS for items in the 
following categories: (a) current orphan drugs, as designated under 
section 526 of the Federal Food, Drug, and Cosmetic Act; (b) current 
drugs, biologic agents, and brachytherapy devices used for the 
treatment of cancer; (c) current radiopharmaceutical drugs and 
biologicals; and (d) new or innovative medical devices, new drugs, and 
biologic agents, in instances when we were not paying for the item as a 
hospital outpatient service as of December 31, 1996, and when the cost 
is ``not insignificant'' in relation to the hospital outpatient PPS 
payment amount. In this context, ``current'' refers to those items for 
which we are making hospital outpatient payment on the first date the 
new PPS is implemented.
    We will include these items and services within payment groups 
called ambulatory payment classifications (APCs), which will be used in 
the payment system for hospital outpatient services. In addition to the 
APC-related payments, however, hospitals may receive additional payment 
for specified items. In order to appropriately assign items to the new 
technology APCs and make special payments for the relevant drugs, 
biologicals, and medical devices, we must be able to identify the 
specific items and services, and ensure that HCFA Common Procedure 
Coding System (HCPCS) codes are established for them. To facilitate 
this activity, we have placed on our Internet site at http://www.hcfa.gov/medicare/   hopsmain.htm the following information:
    (a) A list of those items and services that we have already 
identified as potentially eligible for special payments or treatment as 
a new technology service; and
    (b) The procedures interested parties must follow to bring to our 
attention additional items that may be eligible.
    If you cannot access this information on our Internet site, you may 
request a paper copy by contacting Joan Briscoe in the Division of 
Practitioner and Ambulatory Care at (410) 786-4495.

    Authority: Section 1833(t) of the Social Security Act (42 U.S.C. 
1395l(t)).


(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: February 21, 2000.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
    Approved: March 31, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 00-8744 Filed 4-6-00; 8:45 am]
BILLING CODE 4120-01-P