Federal Register / Vol. 65, No. 194 / Thursday, October 5, 2000 / Notices 59433

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 demonstration currently operating

in Polk County, Florida and the

demonstration planned for San Antonio,

Texas involve competitive bidding of

categories of durable medical

equipment, prosthetics, orthotics, and

supplies (DMEPOS). The new set of

products to be offered for competitive

bidding in San Antonio are: Oxygen

equipment and supplies, hospital beds,

non-customized orthotic devices,

manual wheelchairs and accessories,

and nebulizer inhalation drugs. 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.

There are eight forms that are required

for this demonstration. Form A will be

used by the bidding supplier to provide

information about the characteristics of

the company. Form B will be used by

the bidding supplier to provide specific

information about the prices it bids for

specific product categories, and to

provide information about the attributes

of the supplier in relation to the specific

product category. Form C will be used

by HCFA or its agents to obtain

information on site regarding the

bidding supplier. Form D will be used

by HCFA or its agents to obtain financial

references on the bidding supplier from

banks and other financial sources. Form

E will be used by HCFA or its agents to

obtain information about the bidding

suppliers from referral sources such as

home health agencies and hospital

discharge planners. Form F will be used

to obtain information about the

suppliers’ financial status and to assure

that they have sufficient fiscal resources

to operate in a competitive environment

where the prices being paid for some

products are less than what have been

customarily paid. It is required only

from suppliers whose bids are in the

competitive range. Form G will be used

for nursing homes to identify their

suppliers of products and services who

have not been awarded Demonstration

Supplier status for services to

beneficiaries in their home. This is to

permit payment to those suppliers for

products and services furnished to

nursing homes. Form H will be used to

monitor the performance of

Demonstration Suppliers to assure their

adherence to the quality standards

established for the project.

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.

• Assure beneficiary access to high

quality medical equipment and

supplies.

• Prevent business transactions with

suppliers who engage in fraudulent

practices.

Frequency: On occasion;

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

Number of Respondents: 5,100;

Total Annual Responses: 1,700;

Total Annual Hours: 12,420.

(2) Type of Information Collection

Request: Revision of a currently

approved collection;

Title of Information Collection: EndStage Renal Disease (ESRD) Network

Business Proposal Forms and

Supporting Regulations in 42 CFR

405.2110 and 405.2112;

Form No.: HCFA–684A–I (OMB#

0938–0658);

Use: The submission of business

proposal information by current ESRD

networks and other bidders, according

to the business proposal instructions,

meets HCFA’s need for meaningful,

consistent, and verifiable data when

evaluating contract proposals;

Frequency: Other: Every 3 years;

Affected Public: Not-for-profit

institutions;

Number of Respondents: 18;

Total Annual Responses: 36;

Total Annual Hours: 1,080.

(3) Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection: EndStage Renal Disease (ESRD) Network

Semi-Annual Cost Report Forms and

Supporting Regulations in 42 CFR

405.2110 and 405.2112;

Form No.: HCFA–685 (OMB# 0938–

0657);

Use: Submission of semi-annual cost

reports allow HCFA to review, compare,

and project ESRD network costs. The

reports are used as an early warning

system to determine whether the

networks are in danger of exceeding the

total cost of the contract. Additionally,

HCFA can analyze line item costs to

identify any significant aberrations;

Frequency: Semi-annually;

Affected Public: Not-for-profit

institutions;

Number of Respondents: 18;

Total Annual Responses: 36;

Total Annual Hours: 108.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: September 20, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–25578 Filed 10–4–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier:HCFA–730/182 &

HCFA–R–77]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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

59434 Federal Register / Vol. 65, No. 194 / Thursday, October 5, 2000 / Notices

technology to minimize the information

collection burden.

(1) Type of Information Collection

Request: New Collection;

Title of Information Collection:

Employee Building Pass Application

and File;

Form No.: HCFA–730 & 182 (OMB#

0938–NEW);

Use: The purpose of this system and

the forms are to control United States

Government Building Passes issued to

all HCFA employees and non-HCFA

employees who require continuous

access to HCFA buildings in Baltimore

and other HCFA and HHS buildings.;

Frequency: Other; as needed;

Affected Public: Federal Government,

and business or other for-profit;

Number of Respondents: 150;

Total Annual Responses: 150;

Total Annual Hours: 37.50.

(2) Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection:

Limitation on Liability and Information

Collection Requirements Referenced in

42 CFR 411.404, 411.406, and 411.408;

Form No.: HCFA–R–77 (OMB# 0938–

0465);

Use: The Medicare program requires

to provide written notification of

noncovered services to beneficiaries by

the providers, practitioners, and

suppliers. The notification gives the

beneficiary, provider, practitioner, or

supplier knowledge that Medicare will

not pay for items or services mentioned

in the notification. After this

notification, any future claim for the

same or similar services will not be paid

by the program and the affected parties

will be liable for the noncovered

services.;

Frequency: Other; as needed;

Affected Public: Individuals or

households;

Number of Respondents: 890,826;

Total Annual Responses: 3,563,304;

Total Annual Hours: 296,942.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: September 11, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–25581 Filed 10–4–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

OIG Compliance Program for

Individual and Small Group Physician

Practices

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register notice

sets forth the recently issued

Compliance Program Guidance for

Individual and Small Group Physician

Practices developed by the Office of

Inspector General (OIG). The OIG has

previously developed and published

voluntary compliance program guidance

focused on several other areas and

aspects of the health care industry. We

believe that the development and

issuance of this voluntary compliance

program guidance for individual and

small group physician practices will

serve as a positive step towards assisting

providers in preventing the submission

of erroneous claims or engaging in

unlawful conduct involving the Federal

health care programs.

FOR FURTHER INFORMATION CONTACT:

Kimberly Brandt, Office of Counsel to

the Inspector General, (202) 619–2078.

SUPPLEMENTARY INFORMATION:

Background

The creation of compliance program

guidances is a major initiative of the

OIG in its effort to engage the private

health care community in preventing

the submission of erroneous claims and

in combating fraudulent conduct. In the

past several years, the OIG has

developed and issued compliance

program guidances directed at a variety

of segments in the health care industry.

The development of these types of

compliance program guidances is based

on our belief that a health care provider

can use internal controls to more

efficiently monitor adherence to

applicable statutes, regulations and

program requirements.

Copies of these compliance program

guidances can be found on the OIG web

site at http://www.hhs.gov/oig.

Developing the Compliance Program

Guidance for Individual and Small

Group Physician Practices

On September 8, 1999, the OIG

published a solicitation notice seeking

information and recommendations for

developing formal guidance for

individual and small group physician

practices (64 FR 48846). In response to

that solicitation notice, the OIG received

83 comments from various outside

sources. We carefully considered those

comments, as well as previous OIG

publications, such as other compliance

program guidance and Special Fraud

Alerts, in developing a guidance for

individual and small group physician

practices. In addition, we have

consulted with the Health Care

Financing Administration and the

Department of Justice. In an effort to

ensure that all parties had a reasonable

opportunity to provide input into a final

product, draft guidance for individual

and small group physician practices was

published in the Federal Register on

June 12, 2000 (65 FR 36818) for further

comments and recommendations.

Components of an Effective Compliance

Program

This compliance program guidance

for individual and small group

physician practices contains seven

components that provide a solid basis

upon which a physician practice can

create a voluntary compliance program:

• Conducting internal monitoring and

auditing;

• Implementing compliance and

practice standards;

• Designating a compliance officer or

contact;

• Conducting appropriate training

and education;

• Responding appropriately to

detected offenses and developing

corrective action;

• Developing open lines of

communication; and

• Enforcing disciplinary standards

through well-publicized guidelines.

Similar components have been

contained in previous guidances issued

by the OIG. However, unlike other

guidances issued by OIG, this guidance

for physicians does not suggest that

physician practices implement all seven

components of a full scale compliance

program. Instead, the guidance

emphasizes a step by step approach to

follow in developing and implementing

a voluntary compliance program. This

change is in recognition of the financial

and staffing resource constraints faced