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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[Form #HCFA-R-0264-a,b,c,d,e]

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, causing a statutorily ordered

deadline to be missed. Also, an unanticipated event has occurred, which

may contribute to the missing of the statutory deadline. In particular,

HCFA inadvertently referenced the incorrect statutory section in the

location of the previous notice justifying the need for emergency

clearance, published in the Federal Register on October 16, 1998, at 63

FR 55631. While the correct section of statute mandating the collection

was denoted elsewhere in the notice, a commentor pointed out that the

statutory citation specifically justifying the need for emergency

clearance was incorrect. Therefore, HCFA is correcting its oversight by

republishing its request for OMB review and approval of this

collection. Lastly, emergency clearance is requested because public

harm will likely result if the normal clearance procedures are

followed. Studies by the Government Accounting Office and the Office of

the Inspector General have found that Medicare payments for items of

durable medical equipment are far greater than prices paid by other

insurers and are sometimes greater than prices available to the general

public at retail outlets. And, the payments provided under Medicare fee

schedules often represent unreasonably high markups from actual prices

paid by suppliers. The use of the standard OMB approval process will

cause the nonfulfillment the statutory requirements set forth in

section 4319 of the Balanced Budget Act of 1997 that seek to address

these issues, resulting in public harm by allowing the unnecessary loss

of public Medicare trust fund dollars.

HCFA is requesting OMB review and approval of this collection

within six working days, with a 180-day approval period. Written

comments and recommendations will be accepted from the public if

received by the individual designated below within five working days.

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: Collection of DMEPOS Supplier Data

in Support of the Medicare DMEPOS Competitive Bidding Demonstration

using form (HCFA-R-0264) and Supporting Statute Section 4319 of the

Balanced Budget Act of 1997;

Form No.: HCFA-R-0264;

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

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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.

There are five forms that are required for the demonstration. The

first, HCFA-R-0264A, will be filled out by suppliers to describe the

attributes of their organization, including quality of services and

financial data. Form HCFA-R-0264B will be filled out by suppliers for

each of the categories of DMEPOS for which they bid, and includes

information about their supply of that category of equipment or

supplies, and the prices that they bid for each item in that category.

Form HCFA-R-0264C will be used by site inspectors who gather

information at the facilities of bidders. Form HCFA-R-0264D is used to

gather data by telephone from referral sources of business for the

bidding suppliers, and form HCFA-R-0264E is used to gather data by

telephone from banks and other financial institutions for financial and

business references.

The competitive bidding demonstration for DMEPOS has the following

objectives:

Test the policies and implementation methods of

competitive bidding to determine whether or not it should be expanded

as a Medicare Program.

Reduce the price that Medicare pays for medical equipment

and supplies.

Limit beneficiary out-of-pocket expenditures for

copayments.

Improve beneficiary access to high quality medical

equipment and supplies.

Prevent business transactions with suppliers who engage in

fraudulent practices.

HCFA plans to mail the bidding package, including the referenced

forms A and B, to potential bidders at the first demonstration sites in

Polk County, Florida on November 16, 1998, and to request bidder

submissions by December 16, 1998. The remaining forms C, D and E will

be used for inspections and reference checking in the three months

following the bid submissions. These forms will be used by HCFA or its

agents to gather information regarding bidders who have made

financially attractive bids and are being evaluated for quality,

financial stability, and other attributes for consideration as

demonstration suppliers.

Frequency: Two times at each demonstration site;

Affected Public: Business or other for-profit, and not-for-profit

institutions;

Number of Respondents: 2,040;

Total Annual Responses: 2,040;

Total Annual Hours: 25,260

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, within five working days:

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

or

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: November 10, 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. 98-30661 Filed 11-16-98; 8:45 am]

BILLING CODE 4120-03-P