Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

Centers for Disease Control and Prevention

42 CFR Part 493

[HCFA-2024-FC]

RIN 0938-AI94

Medicare, Medicaid, and CLIA Programs; Extension of Certain

Effective Dates for Clinical Laboratory Requirements Under CLIA

AGENCY: Centers for Disease Control and Prevention (CDC) and Health

Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule extends certain effective dates for clinical

laboratory requirements in regulations published on February 28, 1992,

and subsequently revised December 6, 1994, and May 12, 1997, that

implemented provisions of the Clinical Laboratory Improvement

Amendments of 1988 (CLIA). This rule extends the phase-in date of the

quality control requirements applicable to moderate and high complexity

tests and extends the date by which an individual with a doctoral

degree must possess board certification to qualify as a director of a

laboratory that performs high complexity testing.

[[Page 55032]]

These effective dates are extended to allow the Department

additional time to issue revised quality control requirements and to

determine whether changes are needed in the qualification requirements

for individuals with doctoral degrees to serve as directors of

laboratories performing high complexity testing. These effective date

extensions do not reduce the current requirements for quality test

performance.

DATES: Effective Date: October 14, 1998.

Comment Date: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5:00 p.m. on

December 14, 1998.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Centers for Disease Control and Prevention,

Department of Health and Human Services, Attention: HCFA-2024-FC, 4770

Buford Hwy., NE., MS F11, Atlanta, Georgia 30341-3724.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room C5-09-26, Central Building, 7500 Security Boulevard, Baltimore, MD

21244-1850.

Comments may also be submitted electronically to the following e-

mail address: [email protected] For e-mail comment procedures see

the beginning of SUPPLEMENTARY INFORMATION. For further information on

ordering copies of the Federal Register containing this document and on

electronic access, see the beginning of SUPPLEMENTARY information.

FOR FURTHER INFORMATION CONTACT:

Rhonda S. Whalen (CDC), (770) 488-8155.

Diane Milstead (HCFA), (410) 786-3531.

SUPPLEMENTARY INFORMATION:

E-Mail, Comments, Procedures, Availability of Copies, and

Electronic Access

E-mail comments must include the full name and address of the

sender. All comments must be incorporated in the e-mail message because

we may not be able to access attachments. Electronically submitted

comments will be available for public inspection at the Independence

Avenue address below.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HCFA-2024-FC. Written 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 309-G of the Department's offices at 200 Independence Avenue, SW.,

Washington, DC, on Monday through Friday of each week from 8:30 a.m. to

5:00 p.m. (phone: (202) 690-7890).

Copies: To order copies of the Federal Register containing this

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As an alternative, you can view and photocopy the Federal Register

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This Federal Register document is also available from the Federal

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software and modem to call (202) 512-1661; type swais, then log in as

guest (no password required).

I. Background

On February 28, 1992, we published in the Federal Register (57 FR

7002) final regulations with an opportunity for public comment. These

regulations set forth the requirements for laboratories that are

subject to the Clinical Laboratory Improvement Amendments of 1988

(CLIA). These regulations established uniform requirements for all

laboratories regardless of location, size, or type of testing

performed. In developing the regulations, we included requirements that

would ensure the quality of laboratory services and be in the best

interest of the public health. We recognized that a rule of this scope

required time for laboratories to understand and to implement the new

requirements. Therefore, certain requirements were phased-in and given

prospective effective dates. We also planned to address the comments we

received on the February 28, 1992 rule and make modifications, if

necessary, in a subsequent final rule.

On December 6, 1994, and on May 12, 1997, we published in the

Federal Register (59 FR 62606 and 62 FR 25855, respectively) final

rules with opportunity for comment. These rules extended the phase-in

of the quality control requirements applicable to moderate and high

complexity tests and the date by which an individual with a doctoral

degree must possess board certification to qualify as a director of a

laboratory that performs high complexity testing. These changes were

made due to the resource constraints that had prevented the Department

of Health and Human Services from establishing the process to review

manufacturers' test system quality control instructions for CLIA

compliance and the inability of many laboratory directors to complete

certification requirements within the time period originally specified.

II. Revisions to the Regulations

The date extensions provided by the May 12, 1997 rule have proven

to be inadequate for the reasons set forth below. In addition, based on

our evaluation of comments submitted in response to the May 12, 1997

rule and on advice from the Clinical Laboratory Improvement Advisory

Committee (CLIAC) concerning the quality control requirements

appropriate to ensure quality testing, and the qualification

requirements for laboratory directors, we have found it necessary to

make the following revisions to our regulations:

We are extending from July 31, 1998, to December 31, 2000,

the current phase-in quality control requirements for moderate and high

complexity tests. The phase-in quality control requirements for

unmodified, moderate complexity tests cleared by the Food and Drug

Administration (FDA) (through 510(k) or premarket approval processes,

unrelated to CLIA) are less stringent than the requirements applicable

to high complexity and other moderate complexity tests.

We are extending from July 31, 1998, to December 31, 2000,

the date for laboratories to meet certain CLIA quality control

requirements by following manufacturers' FDA CLIA-cleared test system

instructions.

We are extending from July 31, 1998, to December 31, 2000,

the date by which individuals with doctoral degrees must obtain board

certification to

[[Page 55033]]

qualify as director of a laboratory that performs high complexity

tests.

These revisions are discussed in more detail below.

A. Quality Control Requirements

42 CFR 493.1202 contains the quality control requirements

applicable to moderate and high complexity tests and allows a

laboratory that performs tests of moderate complexity, using test

systems cleared by the FDA through the section 510(k) or premarket

approval processes, until July 31, 1998, to comply with the quality

control provisions of part 493, subpart K, by meeting less stringent

quality control requirements, as long as the laboratory has not

modified the instrument, kit, or test system's procedure.

Section 493.1203, effective beginning July 31, 1998, establishes a

mechanism for laboratories using commercial, unmodified tests to

fulfill certain quality control requirements by following

manufacturers' test system instructions that have been reviewed and

determined by the FDA to meet applicable CLIA quality control

requirements. Implementation of this review process, however, depended

upon the availability of sufficient additional resources necessary to

meet the projected workload. These resources were not available due to

financial and other constraints of the program.

Following the publication of the December 1994 and May 12, 1997

final rules, we received comments that the current quality control

requirements are not appropriate for some test methodologies and a

comprehensive quality control regulation should be developed to address

``today's'' quality control needs. While a final rule addressing

quality control issues raised by these commenters is under development,

it will not be completed by July 31, 1998. Commenters raised issues

that stressed the need to ensure that the quality control requirements

are practical and flexible enough to accommodate different testing

sites and test systems that range from current methodologies to new and

emerging technologies, so as to not impede access. We must also, as the

comments suggest, base the requirements on technical considerations as

well as their impact on patient care.

To assist us in determining the types of quality control

requirements necessary to monitor laboratory test performance, we will

also consider advice provided by the CLIAC, as well as information

obtained from a public meeting held in September 1996 for manufacturers

and others to make presentations on quality control.

Concurrently, the FDA process for product clearance, an integral

part of the CLIA quality control requirements published in 1992, is

undergoing comprehensive changes (see Federal Register notices

published January 21, 1998 (63 FR 3142) and February 2, 1998 (63 FR

5387)).

Due to the complexity of the issues that must be addressed, we are

extending the July 31, 1998, sunset date for quality control standards

in Sec. 493.1202 to December 31, 2000, and extending the effective date

for Sec. 493.1203 from July 31, 1998, to December 31, 2000, to allow

laboratories to continue to meet current regulations until we make

further determinations regarding these requirements. We are extending

the effective dates for these sections to December 31, 2000, to ensure

that we have sufficient time to publish final rules concerning quality

control. Extending the dates will allow sufficient time for publication

of final regulations. Subsequent to the publication of the final

regulations and prior to the actual implementation of the revised

requirements, we must develop new surveyor guidelines, design new

survey forms, reprogram the CLIA data system, conduct surveyor

training, and inform and educate the laboratory community, CLIA exempt

States and accreditation organizations. Time must be allocated for CLIA

exempt States and approved accreditation organizations to review their

requirements and determine whether they must make changes to maintain

their overall equivalency with the CLIA requirements. CLIA exempt

States may need to make changes to their State laws. Accreditation

organizations may also need time to revise policies and requirements

and have them approved by their organizations for adoption. Our

implementation delay will provide States and accreditation

organizations the time needed to make changes to their program

requirements and for their subsequent review by CDC and HCFA. Failure

to provide sufficient time for education and implementation could cause

confusion and interfere with the laboratory community's continued

compliance with CLIA requirements and jeopardize the continued

equivalency of CLIA exempt States and accreditation organizations.

B. Laboratory Director Qualifications

Section 493.1443(b)(3) provides that a director of a laboratory

performing high complexity testing, who has an earned doctoral degree

in chemical, physical, biological, or clinical laboratory science from

an accredited institution, must be certified by a board recognized by

the Department as of July 31, 1998. The phase-in was designed to allow

the Department adequate time to review requests for approval of

certification programs and to ensure that a laboratory director with a

doctoral degree had sufficient time to successfully complete the

requirements for board certification.

As stated previously in the preamble to the December 1994 final

rule, a number of comments to the February 1992 final rule suggested

that board certification not be a mandatory requirement for currently

employed individuals. In addition, CLIAC has suggested, and we are

still considering, the development of alternative provisions to qualify

currently employed individuals with a doctoral degree on the basis of

laboratory training or experience, in lieu of requiring board

certification.

We are extending the date by which an individual with a doctoral

degree must possess board certification to qualify as a director of a

laboratory that performs high complexity testing to December 31, 2000.

This extension will allow time for review of the qualifications

required for laboratory directors to determine whether modifications

should be made for inclusion in the final rule being developed to

address other CLIA personnel issues raised by commenters on the

February 1992 final rule.

In summary, we are extending the phase-in period in

Sec. 493.1443(b)(3) from July 31, 1998, to December 31, 2000.

III. Waiver of Proposed Rulemaking and Delayed Effective Date

We ordinarily publish a notice of proposed rulemaking in the

Federal Register and invite public comment on proposed rules. The

notice of proposed rulemaking includes a reference to the legal

authority under which the rule is proposed and the terms and substance

of the proposed rule or a description of the subjects and issues

involved. This procedure can be waived, however, if an agency finds

good cause that a notice-and-comment procedure is impracticable,

unnecessary, or contrary to the public interest and incorporates a

statement of the finding and its reasons in the rule issued.

The revisions in this final rule are essential, because if the

dates for quality control requirements are not extended, many

laboratories performing moderate complexity testing will be faced

unnecessarily with meeting more stringent and burdensome quality

control requirements at a time when we are actively working to revise

these same quality control requirements. While this activity has begun,

the issues

[[Page 55034]]

we are addressing are many and complex, particularly in light of

changing technologies. Since we will be revising the quality control

requirements in rulemaking that should occur in the reasonably near

future, to impose more stringent requirements now is unreasonable,

unnecessary, and confusing. With respect to the personnel standards

addressed in this rule, if the date is not extended, those individuals

qualified as laboratory directors under the phase-in requirements based

on their doctoral degree and laboratory training and work experience

would no longer qualify to serve as directors of laboratories

performing high complexity testing. Since we are considering revisions

to the regulations which would allow individuals with a doctoral degree

to qualify under alternative provisions that would recognize their

laboratory training and experience, we would not want to disenfranchise

these currently employed directors at this time. Extending the dates

governing laboratory director qualifications will provide the

opportunity for us to determine whether alternative provisions should

be developed to qualify individuals with a doctoral degree who have

laboratory training and experience, but do not have board

certification. Accordingly, we believe that it is impracticable,

unnecessary, and not in the public interest to engage in proposed

rulemaking and believe there is good cause for doing so and to issue

this final rule with a 60-day comment period. To do otherwise would

create unnecessary confusion among laboratories in understanding the

requirements they must meet with respect to quality control and

laboratory director qualifications. It could also impose unnecessary

burdens on laboratories and hardships on individuals affected by these

requirements.

Also, because current regulations will expire on the July 31, 1998,

additional urgency has been placed on the implementation of this rule.

We, therefore, believe there is good cause to waive a delay in the

effective date of this rule. To do otherwise would create unnecessary

confusion among laboratories in understanding the requirements they

must meet with respect to quality control and laboratory director

qualifications. It could also impose unnecessary burdens on

laboratories and hardships on individuals affected by these

requirements.

IV. Regulatory Impact Statement

Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612), we prepare a regulatory flexibility analysis unless we

certify that a rule will not have a significant economic impact on a

substantial number of small entities. For purposes of the RFA, all

laboratories are considered to be small entities. Individuals and

states are not included in the definition of a small entity.

In addition, section 1102(b) of the Act requires us to prepare a

regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. That

analysis must conform to the provisions of section 604 of the RFA. For

purposes of section 1102(b) of the Act, we define a small rural

hospital as a hospital that is located outside of a Metropolitan

Statistical Area and has fewer than 50 beds.

Extending the phase-in periods will continue the quality control

requirements in effect prior to July 31, 1998, allow adequate time for

addressing all concerns with respect to revising quality control

requirements, and not change costs, savings, burden, or opportunities

to manufacturers, laboratories, individuals administering tests, or

patients receiving the tests.

For these reasons, we have determined, and the Secretary certifies,

that this regulation does not result in a significant impact on a

substantial number of small entities and does not have a significant

effect on the operations of a substantial number of small rural

hospitals. Therefore, we are not preparing analyses for either the RFA

or section 1102(b) of the Act.

The Unfunded Mandates Reform Act of 1995 also requires (in section

202) that agencies prepare an assessment of anticipated costs and

benefits for any rule that may result in annual expenditures by State,

local, or tribal governments, in the aggregate, or by the private

sector, of $100 million. The final rule has no consequential effect on

State, local, or tribal governments. We believe the private sector

costs of this rule fall below these thresholds, as well.

In accordance with the provisions of Executive Order 12866, this

regulation was reviewed by the Office of Management and Budget.

Response to Comments

Because of the large number of items of correspondence we normally

receive on Federal Register documents published for comment, we are not

able to acknowledge or respond to them individually. However, we will

consider all comments we receive on the date extensions described in

this rule by the date and time specified in the ADDRESSES section of

this preamble, and, if we proceed with a subsequent document, we will

respond to the comments in the preamble to that document.

List of Subjects in 42 CFR Part 493

Grant programs-health, Health facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping requirements.

42 CFR chapter IV, part 493 is amended as set forth below:

PART 493--LABORATORY REQUIREMENTS

1. The authority citation for part 493 continues to read as

follows:

Authority: Sec. 353 of the Public Health Service Act, secs.

1102, 1861(e), and the sentence following sections 1861(s)(11)

through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a,

1302, 1395x(e), and the sentence following 1395x(s)(11) through

1395x(s)(16)).

Sec. 493.1202 [Amended]

2. In Sec. 493.1202, in the section heading, remove ``July 31,

1998.'' and add in its place ``December 31, 2000.''.

Sec. 493.1203 [Amended]

3. In Sec. 493.1203, in the section heading, remove ``July 31,

1998.'' and add in its place ``December 31, 2000.''.

Sec. 493.1443 [Amended]

4. Section 493.1443 is amended as set forth below:

a. In Sec. 493.1443(b)(3)(ii) introductory text, remove ``July 31,

1998,'' and add in its place ``December 31, 2000,''.

b. In Sec. 493.1443(b)(3)(ii)(C), remove ``July 31, 1998,'' and add

in its place ``December 31, 2000,''.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program; Catalog of Federal Domestic Assistance Program

No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,

Medicare--Supplementary Medical Insurance Program)

Dated: May 20, 1998.

Claire V. Broome,

Acting Director, Centers for Disease Control and Prevention.

Dated: May 20, 1998.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.

Dated: August 5, 1998.

Donna E. Shalala,

Secretary.

[FR Doc. 98-27523 Filed 10-13-98; 8:45 am]

BILLING CODE 4120-03-P

BILLING CODE 4160-18-P