64968 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

more stringent than the CLIA

requirements.

Subpart M—Personnel for Moderate and

High Complexity Testing

We have found the COLA personnel

requirements to be equal to the CLIA

personnel requirements.

Subpart P—Quality Assurance for

Moderate or High Complexity Testing or

Both

We have determined that COLA’s

requirements are equal to the CLIA

requirements of this subpart.

Subpart Q—Inspections

We have determined that COLA’s

inspection requirements are equal to the

requirements of this subpart.

Subpart R—Enforcement Procedures for

Laboratories

COLA meets the requirements of

subpart R to the extent it applies to

accreditation organizations. COLA

policy stipulates the action it takes

when laboratories it accredits do not

comply with its requirements. COLA

shall suspend, withdraw, revoke, or

limit accreditation of a laboratory as

appropriate and report the action to

HCFA within 30 days. COLA also

provides an appeals process for

laboratories that have had accreditation

denied.

We have determined that COLA’s

laboratory enforcement and appeal

policies are essentially equivalent to the

requirements of this subpart as they

apply to accreditation organizations.

IV. Federal Validation Inspections and

Continuing Oversight

The Federal validation inspections of

COLA accredited laboratories may be

conducted on a representative sample

basis or in response to substantial

allegations of noncompliance

(complaint inspections). The outcome of

those validation inspections, performed

by HCFA or our agent, or the State

survey agency, will be HCFA’s principal

means for verifying that the laboratories

accredited by COLA remain in

compliance with CLIA requirements.

This Federal monitoring is an ongoing

process.

V. Removal of Approval as an

Accrediting Organization

Our regulations provide that we may

remove the approval of an accreditation

organization, such as that of COLA, for

cause, before the end of the effective

date of approval. If validation

inspection outcomes and the

comparability or validation review

produce findings as described in

§ 493.573 (Continuing Federal oversight

of private nonprofit accreditation

organizations and approved State

licensure program), HCFA will conduct

a review of an approved accreditation

organization’s program. We also

conduct a review when the validation

review findings, irrespective of the rate

of disparity (as defined in § 493.2),

indicate systemic problems in the

organization’s processes that provide

evidence that the organization’s

requirements, taken as a whole, are no

longer equivalent to the CLIA

requirements, taken as a whole.

If HCFA determines that COLA has

failed to adopt or maintain requirements

that are equal to or more stringent than

the CLIA requirements, or systemic

problems exist in its inspection process,

a probationary period, not to exceed 1

year, may be given to COLA to adopt

equal or more stringent requirements.

HCFA will make a determination as to

whether or not COLA retains its

approved status as an accreditation

organization under CLIA. If approved

status is withdrawn, an accreditation

organization such as COLA may

resubmit its application if it revises its

program to address the rationale for the

denial, demonstrates that it can

reasonably assure that its accredited

laboratories meet CLIA condition level

requirements, and resubmits its

application for approval as an

accreditation organization in its

entirety. If, however, an approved

accreditation organization requests

reconsideration of an adverse

determination in accordance with

subpart D (Reconsideration of Adverse

Determinations—Deeming Authority for

Accreditation Organizations and CLIA

Exemption of Laboratories Under State

Programs) of part 488 (Survey,

Certification, and Enforcement

Procedures) of our regulations, it may

not submit a new application until

HCFA issues a final reconsideration

determination.

Should circumstances result in COLA

having its approval withdrawn, HCFA

will publish a notice in the Federal

Register explaining the basis for

removing its approval.

Authority: Section 353 of the Public Health

Service Act (42 U.S.C. 263a).

Dated: September 18, 2000.

Nancy-Ann Min-DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–27956 Filed 10–30–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–4010–GNC]

RIN 0938–AK26

Medicare Program; Criteria and

Standards for Evaluating Intermediary

and Carrier Performance During Fiscal

Year 2001

AGENCY: Health Care Financing

Administration (HCFA), Health and

Human Services (HHS).

ACTION: General notice with comment

period.

SUMMARY: This notice describes the

criteria and standards to be used for

evaluating the performance of fiscal

intermediaries and carriers in the

administration of the Medicare program

beginning October 1, 2000. The results

of these evaluations are considered

whenever we enter into, renew, or

terminate an intermediary agreement or

carrier contract or take other contract

actions, for example, assigning or

reassigning providers or services to an

intermediary or designating regional or

national intermediaries. We are

requesting public comment on these

criteria and standards.

EFFECTIVE DATE: The criteria and

standards are effective October 1, 2000.

COMMENTS: Comments will be

considered if we receive them at the

appropriate address as provided below

no later than 5 p.m. (EDT) on November

30, 2000.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address: Health Care Financing,

Administration, Department of Health

and Human Services, Attention: HCFA–

4010–GNC, P.O. Box 8016, Baltimore,

MD 21244–8016.

If you prefer, you may deliver your

written comments (1 original and 3

copies) to one of the following

addresses:

Room 443–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC, or

Room C5–16–03, 7500 Security

Boulevard, Baltimore, Maryland.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. When

commenting, please refer to file code

HCFA–4010–GNC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 443–G of the Department’s

office at 200 Independence Avenue,

Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices 64969

SW., Washington, DC, on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

FOR FURTHER INFORMATION CONTACT: Sue

Lathroum, (410) 786–7409.

SUPPLEMENTARY INFORMATION:

I. Background

A. Part A—Hospital Insurance

Under section 1816 of the Social

Security Act (the Act), public or private

organizations and agencies participate

in the administration of Part A (Hospital

Insurance) of the Medicare program

under agreements with us. These

agencies or organizations, known as

fiscal intermediaries, determine whether

medical services are covered under

Medicare, determine correct payment

amounts and then make payments to the

health care providers (for example,

hospitals, skilled nursing facilities

(SNFs), community mental health

centers, etc.) on behalf of the

beneficiaries. Section 1816(f) of the Act

requires us to develop criteria,

standards, and procedures to evaluate

an intermediary’s performance of its

functions under its agreement.

Evaluations of Medicare fee-for-service

performance need not be limited to the

current fiscal year (FY), other fixed term

basis, or agreement term. We may

evaluate performance using a time frame

that does not mirror the FY or other

fixed term. The evaluation of

intermediary performance is part of our

contract management process.

B. Part B Medical Insurance

Under section 1842 of the Act, we are

authorized to enter into contracts with

carriers to fulfill various functions in

the administration of Part B

(Supplementary Medical Insurance) of

the Medicare program. Beneficiaries,

physicians, and suppliers of services

submit claims to these carriers. The

carriers determine whether the services

are covered under Medicare and the

payable amount for the services or

supplies, and then make payment to the

appropriate party. Under section

1842(b)(2) of the Act, we are required to

develop criteria, standards, and

procedures to evaluate a carrier’s

performance of its functions under its

contract. Evaluations of Medicare feefor-service performance need not be

limited to the current FY, other fixed

term basis, or contract term. We may

evaluate performance using a timeframe

that does not mirror the FY. The

evaluation of carrier performance is part

of our contract management process.

C. Development and Publication of

Criteria and Standards

In addition to the statutory

requirements, 42 CFR 421.120 and

421.122 provide for publication of a

Federal Register notice to announce

criteria and standards for intermediaries

prior to implementation. Section

421.201 provides for publication of a

Federal Register notice to announce

criteria and standards for carriers prior

to implementation. The current criteria

and standards were published in the

Federal Register on December 3, 1999 at

64 FR 67920.

To the extent possible, we make every

effort to publish the criteria and

standards before the beginning of the

Federal FY, which is October 1. If we do

not publish a Federal Register notice

before the new FY begins, readers may

presume that until and unless notified

otherwise, the criteria and standards

that were in effect for the previous FY

remain in effect. In those instances in

which we are unable to meet our goal

of publishing the subject Federal

Register notice before the beginning of

the FY, we may publish the criteria and

standards notice at any subsequent time

during the year. If we choose to publish

a notice in this manner, the evaluation

period for any such criteria and

standards that are the subject of the

notice will be revised to be effective on

the first day of the first month following

publication. Any revised criteria and

standards will measure performance

prospectively; that is, we will not apply

new measurements to assess

performance on a retroactive basis.

It is not our intention to revise the

criteria and standards that will be used

during the evaluation period once this

information has been published in a

Federal Register notice. However, on

occasion, either because of

administrative action or congressional

mandate, there may be a need for

changes that have direct impact upon

the criteria and standards previously

published, or that require the addition

of new criteria or standards, or that

cause the deletion of previously

published criteria and standards. If we

must make these changes, we will

publish a Federal Register notice prior

to implementation of the changes. In all

instances, necessary manual issuances

will be published to ensure that the

criteria and standards are applied

uniformly and accurately. Also, as in

previous years, this Federal Register

notice will be republished and the

effective date revised if changes are

warranted as a result of the public

comments received on the criteria and

standards.

II. Analysis of and Response to Public

Comments Received on FY 2000

Criteria and Standards

We received a total of 19 comments in

response to the Federal Register notice

published on December 3, 1999. All

comments were reviewed, but none

necessitated our reissuance of the FY

2000 Criteria and Standards. Medicare

program components were advised of

the concerns as appropriate. When

warranted, revisions have been

incorporated in this Federal Register

notice. We are responding to the

following performance evaluation

issues:

Comment: We were advised that the

Blue Cross and Blue Shield Medicare

contractors have a different scope of

work for fraud and abuse (F&A)

activities than the commercial

contractors. As a result, Blue Cross and

Blue Shield Plans’ performance would

need to be evaluated against the

negotiated scope of work, not our

manuals, since not all of our manual

requirements are addressed in the

contract amendment.

Response: While it is true that there

are some differences between

performance expectations for Blue Cross

and Blue Shield Plans as opposed to

commercial contractors, the protocols

used for evaluation of F&A activities in

FY 2000 did not contain performance

expectations that were not already

contained in the Blue Cross and Blue

Shield Medicare contract.

Comment: We were advised that

references under the Fiscal

Responsibility Criterion relating to the

evaluation of a contractor’s adherence to

the Chief Financial Officers’ Act (CFO),

31 USC 503, et seq. are incorrect. The

expectation to comply with this law is

applicable to us, not the contractors.

The expectation should be reworded to

reflect that contractors assist the

Secretary with being compliant with the

CFO Act.

Response: We agree that the

requirement referenced in the above

comment is applicable to us and not to

the contractors. The FY 2001 Federal

Register notice has been revised to

correctly reflect language as contained

in the contract. Language in the Federal

Register notice now specifically

references the Federal Managers’

Financial Integrity Act (FMFIA), 31

U.S.C. 1105, et seq; rather than the CFO

Act and also states that contractors must

cooperate with us in complying with the

FMFIA.

Comment: We were advised that the

Agency issued a moratorium on the

review of all demand bills because of

the SNF prospective payment system

64970 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

(PPS). It was suggested that we

acknowledge that the standard would

not be evaluated until the Agency

issued instructions and intermediaries

had a chance to train staff on such.

Response: The moratorium on the

review of all demand bills was lifted,

and we issued appropriate instructions

in March 2000.

Comment: HCFA was advised that the

carrier Customer Service criterion states

that carriers are to achieve a monthly

All Trunks Busy (ATB) Rate of not more

than 5 percent. For callers choosing to

speak with a customer service

representative, 97.5 percent or more of

the calls are to be answered within 120

seconds; no less than 85 percent are to

be answered within the first 60 seconds.

A question was raised as to whether this

requirement applies only to call centers

servicing beneficiaries (and providers, if

the call centers are not separate).

Response: The telephone service

requirement referenced in the above

comment is applicable to call centers

servicing beneficiaries (and providers if

the centers are not separate). The

requirement is not applicable to call

centers that specifically service

providers.

III. Criteria and Standards—General

Basic principles of the Medicare

program are to pay claims promptly and

accurately and to foster good beneficiary

and provider relations. Contractors must

administer the Medicare program

efficiently and economically. The goal

of performance evaluation is to ensure

that contractors meet their contractual

obligations. We measure contractor

performance to ensure that contractors

do what is required of them by law,

regulation, contract and our directives.

We have developed a contractor

management program for FY 2001 that

outlines expectations of the contractor;

measures the performance of the

contractor; evaluates the performance

against the expectations; and, takes

appropriate contract action based upon

the evaluation of the contractor’s

performance. We work to develop and

refine measurable performance

standards in key areas in order to better

evaluate contractor performance. In

addition to evaluating performance

based upon expectations for FY 2001,

we may conduct follow-up evaluations

in areas when contractor performance

was out of compliance with laws,

regulations, and our performance

expectations during FY 2000, thus

having required the contractor to submit

a Performance Improvement Plan (PIP).

We have structured the FY 2001

Contractor Performance Evaluation into

five criteria designed to meet those

objectives. The first criterion is ‘‘Claims

Processing,’’ which measures

contractual performance against claims

processing accuracy and timeliness

requirements. Within the Claims

Processing criterion, we have identified

those performance standards that are

mandated by either legislation,

regulation, or judicial decision. These

standards include claims processing

timeliness, the accuracy of Explanations

of Medicare Benefits (EOMBs) or

Medicare Summary Notices (MSNs), the

rate of cases reversed by the

Administrative Law Judge (ALJ), the

timeliness of intermediary

reconsideration cases and the timeliness

of carrier reviews and hearings. Further

evaluation in the Claims Processing

criterion may include, but is not limited

to, the accuracy of bill and claims

processing, the level of electronic claims

payment, the percent of bills and claims

paid with interest, and the accuracy of

reconsiderations, reviews, and hearings.

The second criterion is ‘‘Customer

Service,’’ which assesses the

completeness of the service provided to

customers by the contractor in its

administration of the Medicare program.

Mandated standards in the Customer

Service criterion include timeliness of

carrier replies to beneficiary telephone

inquiries and the accuracy and clarity of

responses to written inquiries. In FY

2001, customer feedback may be used to

collect comparable data on customer

satisfaction and identify areas in need of

improvement. Further evaluation of

services under this criterion may

include, but is not limited to, a review

of beneficiary relations; provider

education; appropriateness of telephone

inquiry responses; and walk-in service.

The third criterion is ‘‘Payment

Safeguards,’’ which evaluates whether

the Medicare Trust Fund is safeguarded

against inappropriate program

expenditures. Intermediary and carrier

performance may be evaluated in the

areas of medical review (MR), Medicare

secondary payer (MSP), F&A (also

referred to as benefits integrity (BI)),

overpayments (OP) , provider

enrollment (PE), and audit and

reimbursement (A&R). Mandated

performance standards in the Payment

Safeguards criterion are the accuracy of

decisions on SNF demand bills, and the

timeliness of processing Tax Equity and

Fiscal Responsibility Act (TEFRA) target

rate adjustments, exceptions, and

exemptions. Further evaluation in this

criterion may include, but is not limited

to, review of the efficient and effective

compilation and analysis of data to

bring about continuous improvement in

a contractor’s efforts to safeguard

Medicare program dollars.

Intermediaries and carriers may also be

evaluated on any Medicare Integrity

Program (MIP) activities if performed

under their Part A agreement or Part B

contract.

The fourth criterion is ‘‘Fiscal

Responsibility,’’ which evaluates the

contractor’s efforts to protect the

Medicare program and the public

interest. Contractors must effectively

manage Federal funds for both the

payment of benefits and costs of

administration under the Medicare

program. Proper financial and budgetary

controls, including internal controls,

must be in place to ensure contractor

compliance with its agreement with

HHS and HCFA. Additional functions

reviewed under this criterion may

include, but are not limited to,

adherence to approved budget,

compliance with the BPRs, and

financial reporting requirements.

The fifth and final criterion is

‘‘Administrative Activities,’’ which

measures a contractor’s administrative

management of the Medicare program.

A contractor must efficiently and

effectively manage its operations to

ensure constant improvement in the

way it does business. Proper systems

security (general and application

controls), Automated Data Processing

(ADP) maintenance, and disaster

recovery plans must be in place. A

contractor’s evaluation under the

Administrative Activities criterion may

include, but is not limited to,

establishment, application,

documentation, and effectiveness of

internal controls, which are essential in

all aspects of a contractor’s operation

and the degree to which the contractor

cooperates with us in complying with

the FMFIA. Administrative Activities

evaluations may also include reviews

related to implementation of change

management instructions and data and

reporting requirements.

We have also developed separate

measures for evaluating unique

activities of Regional Home Health

Intermediaries (RHHIs). Section

1816(e)(4) of the Act requires us to

designate regional agencies or

organizations, which are already

Medicare intermediaries under section

1816, to perform bill processing

functions with respect to freestanding

home health agency (HHA) bills. The

law requires that we limit the number

of these regional intermediaries (RHHIs)

to not more than 10; see 42 CFR 421.117

and the final rule published in the

Federal Register on May 19, 1988 at 53

FR 17936 for more details about the

RHHIs.

We have developed separate measures

for RHHIs in order to evaluate the

Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices 64971

distinct RHHI functions. These

functions include the processing of bills

from freestanding HHAs, hospital

affiliated HHAs, and hospices. Through

an evaluation using these criteria and

standards, we may determine whether

the RHHI functions should be moved

from one intermediary to another in

order to ensure effective and efficient

administration of the program benefit.

Below, we list the criteria and

standards to be used for evaluating the

performance of intermediaries and

carriers. In several instances, we

identify a Medicare manual as a source

of more detailed requirements.

Intermediaries and carriers have copies

of various Medicare manuals referenced

in this notice. Members of the public

also have access to our manualized

instructions.

Medicare manuals are available for

review at local Federal Depository

Libraries (FDLs). Under the FDL

Program, government publications are

sent to approximately 1,400 designated

public libraries throughout the United

States. Interested parties may examine

the documents at any one of the FDLs.

Some may have arrangements to transfer

material to a local library not designated

as a FDL. To locate the nearest FDL,

individuals should contact any public

library.

In addition, individuals may contact

regional depository libraries, which

receive and retain at least one copy of

nearly every Federal government

publication, either in printed or

microfilm form, for use by the general

public. These libraries provide reference

services and interlibrary loans; however,

they are not sales outlets. Individuals

may obtain information about the

location of the nearest regional

depository library from any library.

Information may also be obtained from

the following web site: www.hcfa.gov/

pubforms/progman.htm. Some manuals

may be obtained from the following web

site: www.hcfa.gov/pubforms/

p2192toc.htm. Finally, all of our

Regional Offices (RO) maintain all

Medicare manuals for public inspection.

To find the location of the nearest

available HCFA RO, you may call the

individual listed at the beginning of this

notice. That individual can also provide

information about purchasing or

subscribing to the various Medicare

manuals.

IV. Criteria and Standards for

Intermediaries

A. Claims Processing Criterion

The Claims Processing criterion

contains 4 mandated standards.

Standard 1: 95 percent of clean

electronically submitted non-Periodic

Interim Payment (PIP) bills paid within

statutorily specified time frames. Clean

bills are defined as bills that do not

require Medicare intermediaries and/or

carriers to investigate or develop

external to their Medicare operations on

a prepayment basis. Specifically, clean,

non-PIP electronic claims can be paid as

early as the 14th day (13 days after the

date of receipt) and must be paid by the

31st day (30 days after the date of

receipt).

Standard 2: 95 percent of clean paper

non-PIP bills paid within specified time

frames. Specifically, clean, non-PIP

paper claims can be paid as early as the

27th day (26 days after the date of

receipt) and must be paid by the 31st

day (30 days after the date of receipt).

Standard 3: Reversal rate by

Administrative Law Judge (ALJ) is

acceptable. We have defined an

acceptable reversal rate by an ALJ as one

that is at or below 5.0 percent.

Standard 4: 75 percent of

reconsiderations are processed within

60 days and 90 percent are processed

within 90 days.

Additional functions may be

evaluated under this criterion. These

functions include, but are not limited to,

the—

• Bill processing accuracy;

• Establishment and maintenance of

relationship with Common Working File

(CWF) Host;

• Management of shared processing

sub-contract;

• Analysis and validation of data; and

• Accuracy of processing

reconsideration cases with clear

responses and appropriate customerfriendly tone and clarity.

B. Customer Service Criterion

We may review the intermediary’s

efforts to enhance customer satisfaction

through the use of customer feedback.

Results of the feedback may be used to

establish comparable data on customer

satisfaction and to identify areas in need

of improvement. The results may be

summarized for publication in the

Report of Contractor Performance (RCP)

and shared with individual contractors.

Functions that may be evaluated

under this criterion include, but are not

limited to—

• Accuracy, timeliness and

appropriateness of responses to

telephone inquiries;

• Accuracy and timeliness of

responses to written inquiries with

appropriate customer-friendly tone and

clarity;

• Establishment and maintenance of

relationships with professional and

beneficiary organizations;

• Use of focus groups; and

• Conduct of educational and

outreach efforts.

C. Payment Safeguards Criterion

The Payment Safeguard criterion

contains two mandated standards.

Standard 1—Decisions on SNF

demand bills are accurate.

Standard 2—TEFRA target rate

adjustments, exceptions, and

exemptions are processed within

mandated time frames. Specifically,

applications must be processed to

completion within 75 days after receipt

by the contractor or returned to the

hospitals as incomplete within 60 days

of receipt.

Intermediaries may also be evaluated

on any MIP activities if performed

under their Part A agreement. These

functions and activities include, but are

not limited to—

• Medical Review.

• Applying analytical skills and

focusing resources on particular

providers or claim types that represent

unnecessary or inappropriate care.

• Developing local and national data

that identify aberrancies and form the

basis of corrective actions, such as

educating the provider, or become the

basis of medical review policies or

review screens as directed by Medicare

program manuals and BPR

requirements.

• Making decisions that comply with

current coverage guidelines.

• Developing means of addressing

aberrancies identified during the

analysis of all local and national data.

• Medicare Secondary Payer.

• Identifying and recovering mistaken

Medicare payments in accordance with

appropriate Medicare Intermediary

Manual instructions and other pertinent

HCFA general instructions.

• Accurately reporting savings and

following claim development

procedures.

• Prioritizing and processing

recoveries in compliance with

instructions.

• Fraud and Abuse (also known as

BI).

• Identifying fraud cases that exist

within the intermediary’s service area

and taking appropriate actions to

dispose of these cases.

• Investigating allegations of fraud

made by beneficiaries, providers, HCFA,

Office of Inspector General (OIG), and

other sources.

• Putting in place effective fraud

detection and deterrence programs.

• Overpayments.

• Collecting Medicare debts timely.

• Accurately reporting overpayments

to HCFA.

64972 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

• Adhering to our instructions for

management of Medicare Trust Fund

debts.

• Provider Enrollment.

• Complying with assignment of staff

to the provider enrollment function and

training the staff in procedures and

verification techniques.

• Complying with the operational

standards relevant to the process for

enrolling providers.

• Audit and Reimbursement.

• Performing the activities specified

in our general instructions for

conducting audit and settlement of

Medicare cost reports.

• Settling Medicare cost reports

timely and accurately in establishing

interim provider payments.

D. Fiscal Responsibility Criterion

We may review the intermediary’s

efforts to establish and maintain

appropriate financial and budgetary

internal controls over benefit payments

and administrative costs. Proper

internal controls must be in place to

ensure that contractors comply with

their agreements with us.

Additional matters to be reviewed

under the Fiscal Responsibility criterion

may include, but are not limited to—

• Adherence to approved program

management and MIP budgets;

• Compliance with the BPRs;

• Compliance with financial

reporting requirements and;

• Control of administrative cost and

benefit payments.

E. Administrative Activities Criterion

We may measure an intermediary’s

administrative ability to manage the

Medicare program. We may evaluate the

efficiency and effectiveness of its

operations, its system of internal

controls, and its compliance with our

directives and initiatives.

We may measure an intermediary’s

efficiency and effectiveness in managing

its operations to ensure constant

improvement in the way it does

business. Proper systems security

(general and application controls), ADP

maintenance, and disaster recovery

plans must be in place. An intermediary

must also test system changes to ensure

the accurate implementation of our

instructions.

Our evaluation of an intermediary

under the Administrative Activities

criterion may include, but is not limited

to, reviews of its—

• Systems security;

• ADP maintenance (configuration

management, testing, change

management, security, etc.);

• Disaster recovery plan;

• Change management plan

implementation;

• Data and reporting requirements

implementation; and

• Internal controls establishment and

use, including the degree to which the

contractor cooperates with the Secretary

in complying with the FMFIA.

V. Criteria and Standards for Carriers

A. Claims Processing Criterion

The Claims Processing criterion

contains five mandated standards.

Standard 1: 95 percent of clean

electronically submitted claims

processed within statutorily specified

time frames. Specifically, clean

electronic claims can be paid as early as

the 14th day (13 days after the date of

receipt) and must be paid by the 31st

day (30 days after the date of receipt).

Standard 2: 95 percent of clean paper

claims processed within specified time

frames. Specifically, clean paper claims

can be paid as early as the 27th day (26

days after the date of receipt) and must

be paid by the 31st day (30 days after

the date of receipt).

Standard 3: 98 percent of EOMBs and

MSNs are properly generated.

Standard 4: 95 percent of review

determinations are accurate and clear

with appropriate customer-friendly tone

and clarity, and are completed within

45 days.

Standard 5: 90 percent of carrier

hearing decisions are accurate and clear

with appropriate customer-friendly tone

and clarity, and are completed within

120 days.

Additional functions may be

evaluated under this criterion. These

functions include, but are not limited to,

the—

• Claims Processing accuracy;

• Management of shared processing

sub-contract;

• Establishment and maintenance of

relationship with the CWF Host; and

• Analysis and validation of data.

B. Customer Service Criterion

The Customer Service criterion

contains two mandated standards.

Standard 1—Telephone inquiries are

answered timely.

Carriers are to achieve a monthly ATB

Rate of not more than 10%. For callers

choosing to speak with a customer

service representative, 97.5% or more of

telephone calls are to be answered

within 120 seconds; no less than 85%

are to be answered within the first 60

seconds.

Standard 2—Accuracy and timeliness

of responses to written inquiries with

appropriate customer-friendly tone and

clarity. Responses to beneficiary written

inquiries are written at an appropriate

reading level.

We may review the carrier’s efforts to

enhance customer satisfaction through

the use of customer feedback. Results of

the feedback may be used to establish

comparable data on customer

satisfaction and to identify areas in need

of improvement. The results may be

summarized for publication in the RCP

and shared with individual contractors.

Additional functions may be

evaluated under this criterion. These

functions include, but are not limited to,

the carrier’s—

• Accuracy and appropriateness of

responses to telephone inquiries;

• Establishment and maintenance of

relationships with professional and

beneficiary organizations;

• Use of focus groups;

• Conduct of educational and

outreach efforts; and

• Walk-in services.

C. Payment Safeguards Criterion

Carriers may be evaluated on any MIP

activities if performed under their Part

B contracts. In addition other carrier

functions and activities that may be

reviewed under this criterion include,

but are not limited to—

• Medical Review.

• Applying their analytical skills and

focusing resources on particular

providers or claim types that represent

unnecessary or inappropriate care.

• Developing effective means of

addressing aberrancies identified

through analyzing data to target prepay

and postpay review.

• Using medical coverage guidelines

to determine if each medical review

screen is supported by sufficient

documentation.

• Developing means of addressing

aberrancies identified during the

analysis of all local and national data.

• Medicare Secondary Payer.

• Identifying and recovering mistaken

Medicare payments in accordance with

the appropriate Medicare Carriers

Manual instructions, and other

pertinent HCFA general instructions.

• Accurately reporting savings and

following claim development

procedures.

• Prioritizing and processing

recoveries in compliance with

instructions.

• Fraud and Abuse (also known as

BI).

• Identifying fraud and abuse cases

that exist within the carrier’s service

area and taking appropriate actions to

dispose of these cases.

• Investigating allegations of fraud

and/or abuse made by beneficiaries,

providers, HCFA, OIG, and other

sources.

Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices 64973

• Putting in place effective fraud and

abuse detection and deterrence

programs.

• Overpayments.

• Collecting Medicare debts timely.

• Accurately reporting overpayments

to HCFA.

• Adhering to our instructions for

management of Medicare Trust Fund

debts.

• Provider Enrollment

• Complying with assignment of staff

to the provider enrollment function and

training staff in procedures and

verification techniques.

• Complying with the operational

standards relevant to the process for

enrolling providers.

D. Fiscal Responsibility Criterion

We may review the carrier’s efforts to

establish and maintain appropriate

financial and budgetary internal

controls over benefit payments and

administrative costs. Proper internal

controls must be in place to ensure that

contractors comply with their

agreements with us.

Additional matters to be reviewed

under the Fiscal Responsibility criterion

may include, but are not limited to—

• Adherence to approved program

management and MIP budgets;

• Compliance with the BPRs;

• Compliance with financial

reporting requirements; and

• Control of administrative cost and

benefit payments.

E. Administrative Activities Criterion

We may measure a carrier’s

administrative ability to manage the

Medicare program. We may evaluate the

efficiency and effectiveness of its

operations, its system of internal

controls, and its compliance with our

directives and initiatives.

A carrier must efficiently and

effectively manage its operations to

assure constant improvement in the way

it does business. Proper systems

security (general and application

controls), ADP maintenance, and

disaster recovery plans must be in place.

Also, a carrier must test system changes

to ensure accurate implementation of

our instructions.

Our evaluation of a carrier under this

criterion may include, but is not limited

to, reviews of its—

• Systems security;

• ADP maintenance (configuration

management, testing, change

management, security, etc.);

• Disaster recovery plan;

• Change management plan

implementation;

• Data and reporting requirements

implementation; and

• Internal controls establishment and

use including the degree to which the

contractor cooperates with the Secretary

in complying with the FMFIA.

VI. Criterion and Standards for RHHIs

The following standards are mandated

for the RHHI criterion:

Standard 1: 95 percent of clean

electronically submitted non-PIP HHA/

hospice bills are paid within statutorily

specified time frames. Specifically,

clean, non-PIP electronic claims can be

paid as early as the 14th day (13 pays

after the date of receipt) and must be

paid by the 31st day (30 days after the

date of receipt).

Standard 2: 95 percent of clean paper

non-PIP HHA/hospice bills are paid

within specified time frames.

Specifically, clean, non-PIP paper

claims can be paid as early as the 27th

day (26 days after the date of receipt)

and must be paid by the 31st day (30

days after the date of receipt).

Standard 3: 75 percent of HHA/

hospice reconsiderations are processed

within 60 days and 90 percent are

processed within 90 days.

We may use this criterion to review a

RHHI’s performance with respect to

handling the HHA/hospice workload.

This includes processing HHA/hospice

bills timely and accurately; properly

paying and settling HHA cost reports;

and timely and accurately processing

reconsiderations from beneficiaries,

HHAs, and hospices, interim rate

setting, and accuracy of MR coverage

decisions.

VII. Action Based on Performance

Evaluations

We evaluate a contractor’s

performance against applicable program

requirements for each criterion. Each

contractor must certify that all

information submitted to us relating to

the contract management process,

including, without limitation, all files,

records, documents and data, whether

in written, electronic, or other form, is

accurate and complete to the best of the

contractor’s knowledge and belief. A

contractor will also be required to

certify that its files, records, documents,

and data have not been manipulated or

falsified in an effort to receive a more

favorable performance evaluation. A

contractor must further certify that, to

the best of its knowledge and belief, the

contractor has submitted, without

withholding any relevant information,

all information required to be submitted

with respect to the contract management

process under the authority of

applicable law(s), regulation(s),

contracts, or HCFA manual provision(s).

Any contractor that makes a false,

fictitious, or fraudulent certification

may be subject to criminal and/or civil

prosecution, as well as appropriate

administrative action. This

administrative action may include

debarment or suspension of the

contractor, as well as the termination or

nonrenewal of a contract.

If a contractor meets the level of

performance required by operational

instructions, it meets the requirements

of that criterion. Any performance

measured below basic operational

requirements constitutes a program

deficiency. The contractor will be

required to develop and implement a

PIP for each program deficiency

identified. The contractor will be

monitored to ensure effective and

efficient compliance with the PIP, and

to ensure improved performance when

requirements are not met. The

contractor will also be monitored when

a program vulnerability in any

performance area is identified. A

program vulnerability exists when a

contractor’s performance complies with

basic program requirements, but one or

more weaknesses are present that could

result in deficient performance if left

ignored.

The results of performance

evaluations and assessments under all

five criteria will be used for contract

management activities and will be

published in the contractor’s annual

performance report. We may initiate

administrative actions as a result of the

evaluation of contractor performance

based on these performance criteria.

Under sections 1816 and 1842 of the

Act, we consider the results of the

evaluation in our determinations

when—

• Entering into, renewing, or

terminating agreements or contracts

with contractors;

• Deciding other contract actions for

intermediaries and carriers (such as

deletion of an automatic renewal

clause). These decisions are made on a

case-by-case basis and depend primarily

on the nature and degree of

performance. More specifically, they

depend on the—

• Relative overall performance

compared to other contractors;

• Number of criteria in which

deficient performance occurs;

• Extent of each deficiency;

• Relative significance of the

requirement for which deficient

performance occurs within the overall

evaluation program; and

• Efforts to improve program quality,

service, and efficiency.

• Deciding the assignment or

reassignment of providers and

64974 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

designation of regional or national

intermediaries for classes of providers.

We make individual contract action

decisions after considering these factors

in terms of their relative significance

and impact on the effective and efficient

administration of the Medicare program.

In addition, if the cost incurred by the

intermediary or carrier to meet its

contractual requirements exceeds the

amount that we find to be reasonable

and adequate to meet the cost that must

be incurred by an efficiently and

economically operated intermediary or

carrier, these high costs may also be

grounds for adverse action.

VIII. Response to Public Comments

Because of the large number of items

of correspondence we normally receive

on Federal Register documents

published for comment, we are unable

to acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the Dates section of

this preamble, and, if we proceed with

a subsequent document, we will

respond to the comments in the

preamble of that document.

In accordance with the provisions of

Executive Order 12866, this notice was

reviewed by the Office of Management

and Budget.

IX. Federalism

We have reviewed this notice under

the threshold criteria of Executive Order

13132, Federalism. We have determined

that the notice does not significantly

affect the rights, roles, and

responsibilities of States.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance, and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: September 8, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care, Financing

Administration.

[FR Doc. 00–27955 Filed 10–30–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The invention listed below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of federally

funded research and development.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting J. R. Dixon, Ph.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7056 ext 206; fax 301/402–0220; email jd212g@NIH.GOV). A signed

Confidential Disclosure Agreement is

required to receive a copy of any patent

application.

Entitled: ‘‘USE OF 14–3–3σ AS A

DIAGNOSTIC MARKER AND

THERAPEUTIC TARGET’’—A Method

to Diagnosis and Determine the

Prognosis of Breast and/or Ovarian

Cancers.

Inventors: Drs. Olga Aprelikova (NCI)

and Edison T. Liu (NCI) DHHS Ref. No.

E–307–00/0, Filed with the USPTO on

September 7, 2000.

Breast cancer is one of the most

significant cancerous diseases that

affects women. At the current rate,

American women have a 1 in 8 risk of

developing breast cancer by age 95

(American Cancer Society, 1992).

Treatment of breast cancer at later stages

is often futile and disfiguring, making

early detection a high priority in

medical management of the disease.

Ovarian cancer, although less frequent

than breast cancer is often rapidly fatal

and is the fourth most common cause of

cancer mortality in American women.

Genetic factors contribute to an illdefined proportion of breast cancer

incidence, estimated to be about 5% of

all cases but approximately 25% of

cases diagnosed before age 40. Breast

cancer has been subdivided into two

types, early-age onset and late-age onset,

based on an inflection in the agespecific incidence curve around age 50.

Mutation of one gene, BRCA1, is

thought to account for approximately

45% of familial breast cancer, but at

least 80% of families with both breast

and ovarian cancer.

The 14–3–3σ checkpoint control gene

is significantly downregulated in

BRCA1 -/-cells. The cell cycle profile of

these cells treated with ionizing

radiation showed an inability to sustain

G2/M growth arrest typical for 14–3–3σ

deprived cells. In addition, 14–3–3σ has

been identified as a p53 inducible gene

after DNA damage. Thus, BRCA1

synergistically activates p53 dependent

transcription of 14–3–3σ gene. These

observations demonstrate the role of 14–

3–3σ, and the interaction of BRCA1,

p53, and 14–3–3σ in neoplastic

conditions, such as breast cancer or

ovarian cancer.

The technology disclosed in the E–

307–00/0 patent application is directed

to a method to identify an agent that

modulates 14–3–3σ. The 14–3–3σ

checkpoint control gene is significantly

downregulated in BRCA1 -/-cells. The

method includes incubating the agent

and a sample of interest, wherein the

sample is capable of expressing 14–3–

3σ, under conditions sufficient to allow

the compound of interest to interact

with the sample, and determining the

effect of the compound on the

expression or activity of 14–3–3σ. The

effect of an agent on the interaction of

14–3–3σ with p53 and/or BRCA1 can

also be assessed. A method is also

provided for determining the prognosis

of a subject diagnosed with a 14–3–3σassociated disorder. The method

includes contacting a sample from the

subject with a reagent that binds to 14–

3–3σ, detecting binding of the reagent to

14–3–3σ; and correlating the binding of

the reagent to the sample with the

prognosis of the disorder. The method

can also include detecting p53 and/or

BRCA1 mutations.

The above mentioned invention is

available for licensing on an exclusive

or non-exclusive basis.

Dated: October 23, 2000.

Jack Spiegel,

Director, Division of Technology Development

& Transfer, Office of Technology Transfer.

[FR Doc. 00–27890 Filed 10–30–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Office of the Director, National

Institutes of Health; Amended Notice

of Meeting

Notice is hereby given of a change in

the meeting of the Director’s Council of

Public Representatives, October 31–

November 1, 2000, National Institutes of

Health, 9000 Rockville Pike, Building

31, Conference Room 6, Bethesda, MD

20982 which was published in the

Federal Register on October 10, 2000,

65 FR 60200–60201.

The dates, times, and location of the

meeting are the same but the agenda has

changed to discuss human research

protections and medical applications

research. The meeting is open to the

public.