[Federal Register Volume 63, Number 249 (Tuesday, December 29, 1998)]
[Notices]
[Pages 71654-71655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34398]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[Form # HCFA-R-0269]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Health Care Financing 
Administration (HCFA), Department of Health and Human Services (DHHS), 
is publishing the following summary of a proposed collection for public 
comment. Interested persons are invited to send comments regarding this 
burden estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    We are, however, requesting an emergency review of the information 
collections referenced below. In compliance with the requirement of 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have 
submitted to the Office of Management and Budget (OMB) the following 
requirements for emergency review. We are requesting an emergency 
review because the collection of this information is needed prior to 
the expiration of the normal time limits under OMB's regulations at 5 
CFR, Part 1320 and is essential to the mission of the Agency. The 
Agency cannot reasonably comply with the normal clearance procedures 
because of a statutory deadline imposed by section 4319 of the Balanced 
Budget Act of 1997. Without this information, HCFA would not be able to 
properly implement all of the requirements set forth in the statute 
prior to the statute's sunset provision. Specifically, the statute 
mandates evaluations of competitive bidding projects, along with 
evaluation reporting requirements. The statutory requirement includes 
an evaluation of competitive bidding impacts on access to care, quality 
of care, and diversity of product selection. The first evaluation 
project will measure these characteristics before competitive bidding 
as well as after the competitively bid fees become effective. The 
baseline and follow-up measurements will be compared. To ensure valid 
comparisons, marketplace changes that may be attributable to 
competitive bidding should not affect the baseline measurements. 
Therefore, the baseline measurements must be completed before the 
competitive bidding contracts are established in the Spring of 1999. If 
HCFA were to follow the normal clearance procedures, resulting in a 
delay in the baseline measurements, it would have difficulty 
determining whether competitive bidding causes reductions in access, 
quality, or product selection.
    HCFA is requesting OMB review and approval of this collection by 
January 11, 1999, with a 180-day approval period. Written comments and 
recommendations will be accepted from the public if received by the 
individual designated below by January 8, 1999.
    During this 180-day period, we will publish a separate Federal 
Register notice announcing the initiation of an extensive 60-day agency 
review and public comment period on these requirements. We will submit 
the requirements for OMB review and an extension of this emergency 
approval.
    Type of Information Collection Request: New collection.
    Title of Information Collection: Evaluation of Competitive Bidding 
Demonstration for Durable Medical Equipment (DME) and Prosthetics, 
Orthotics, and Supplies (POS)--Data Collection Plan for Baseline 
Beneficiary Surveys, Oxygen Consumer Survey, Medical Equipment and 
Supplies Consumer Survey and Supporting Statute Section 4319 of the 
Balanced Budget Act of 1997.
    Form No.: HCFA-R-0269.
    Use: Section 4319 of the Balanced Budget Act (BBA) mandates HCFA to 
implement demonstration projects under which competitive acquisition 
areas are established for contract award purposes for the furnishing of 
Part B items and services, except for physician's services. The first 
of these demonstration projects implements competitive bidding of 
categories of durable medical equipment, prosthetics, orthotics, and 
supplies (DMEPOS). Under the law, suppliers can receive payments from 
Medicare for items and services covered by the demonstration only if 
their bids are competitive in terms of quality and price. Each 
demonstration project may be conducted in up to three metropolitan 
areas for a three year period. Authority for the demonstration expires 
on December 31, 2002. The schedule for the demonstration anticipates 
about a six month period required between mailing the bidding forms to 
potential bidders and the start of payments for DMEPOS under the 
demonstration. HCFA intends to operate the demonstration in two rounds, 
the first of two years, and the second of one year. HCFA has announced 
that it intends to operate its first demonstration in Polk County, 
Florida, which is the Lakeland-Winter Haven Metropolitan Area.
    This evaluation is necessary to determine whether access to care, 
quality of care, and diversity of product selection are affected by the 
competitive bidding demonstration. Although secondary data will be used 
wherever possible in the evaluation, primary data from beneficiaries 
themselves is required in order to gain an understanding of changes in 
their level of satisfaction and in the quality and selection of the 
medical equipment.
    The purpose of the data collection plan is to describe the baseline 
data collection procedures and the plan for analyzing the data to be 
collected.
    The baseline beneficiary surveys will take place February to May 
1999, prior to the competitive bidding demonstration. We will sample 
beneficiaries from enrollment files provided by the durable medical 
equipment regional carrier (DMERC). The sample will be stratified into 
two groups: beneficiaries who use oxygen and beneficiaries who are non-
oxygen users, i.e., users of the other four product categories covered 
by the demonstration (hospital beds, enteral nutrition, urological 
supplies, and surgical dressings) but not oxygen. To draw a comparison, 
we will sample in both the demonstration site (Polk County, Florida) 
and a comparison site (Brevard County, Florida) that matches Polk 
County on characteristics such as number of Medicare beneficiaries and 
DME/POS utilization.
    Information collected in the beneficiary survey will be used by the 
University of Wisconsin-Madison (UW-M), Research Triangle Institute 
(RTI), and Northwestern University (NU) to evaluate the Competitive 
Bidding Demonstration for DME and POS.

[[Page 71655]]

Results of the evaluation will be presented to HCFA and to Congress, 
who will use the results to determine whether the demonstration should 
be extended to other sites.
    The research questions to be addressed by the surveys focus on 
access, quality, and product selection. Our collection process will 
include fielding a survey for oxygen users and a survey for non-oxygen 
users before the demonstration begins and again once the new 
demonstration prices have been put into effect. The same data 
collection process will be followed in the comparison site (Brevard 
County). In the analysis of the data, we will also control for 
socioeconomic factors. This will allow us to separate the effects of 
the demonstration from beneficiary-or site-specific effects.
    In the survey, we will also ask beneficiaries about the types of 
equipment that they use. This will allow us to determine if certain 
users are affected while others are not. For example, we will be able 
to evaluate whether oxygen users experience a greater increase or 
decrease in access and quality than beneficiaries who receive enteral 
nutrition.
    The information that this survey will provide about access, 
quality, and product selection will be very important to the future of 
competitive bidding within the Medicare program. This is the first 
Medicare demonstration that allows competitive bidding for services and 
equipment provided to beneficiaries. A negative impact on access, 
quality, or product selection would have significant implications for 
the future of competitive bidding within the Medicare program.
    Frequency: Two times for each affected beneficiary.
    Affected Public: Individuals or Households.
    Number of Respondents: 2,560.
    Total Annual Responses: 2,560.
    Total Annual Hours: 724.4.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access HCFA's 
Web Site address at http://www.hcfa.gov/regs/prdact95.htm, OR E-mail 
your request, including your address, phone number, and HCFA form 
number(s) referenced above, to P[email protected], or call the Reports 
Clearance Office on (410) 786-1326.
    Interested persons are invited to send comments regarding the 
burden or any other aspect of these collections of information 
requirements. However, as noted above, comments on these information 
collection and recordkeeping requirements must be mailed and/or faxed 
to the designee referenced below, by January 8, 1999:
    Health Care Financing Administration, Office of Information 
Services, Security and Standards Group, Division of HCFA Enterprise 
Standards, Room: N2-14-26, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850, Fax Number: (410) 786-0262, Attn: John Burke; and
    Office of Information and Regulatory Affairs, Office of Management 
and Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Fax Number: (202) 395-6974 or (202) 395-5167, Attn: Allison 
Herron Eydt, HCFA Desk Officer.

    Dated: December 21, 1998.
John P. Burke III,
HCFA Reports Clearance Officer, HCFA, Office of Information Services, 
Security and Standards Group, Division of HCFA Enterprise Standards.
[FR Doc. 98-34398 Filed 12-28-98; 8:45 am]
BILLING CODE 4120-03-P