[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Rules and Regulations]
[Pages 82941-82944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration Centers for Disease Control 
and Prevention

42 CFR Part 493

[HCFA-2024-FC2]
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, 
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.
    These effective dates are extended to allow the Department to 
revise quality control requirements and establish the qualification 
requirements necessary 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: December 29, 2000.
    Comment Date: We will consider comments if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on 
February 27, 2001.

ADDRESSES: Mail written comments (one original and three copies) to the 
following addresses:

Health Care Financing Administration, Department of Health and Human 
Services, Attention: HCFA-2024-FC2, P.O. Box 8018, Baltimore, MD 21244-
8018; and
Centers for Disease Control and Prevention, Department of Health and 
Human Services, Attention: HCFA-2024-FC2, 4770 Buford Hwy., N.E., MS 
F11, Atlanta, Georgia 30341-3724.

    To ensure that mailed comments are received in time for us to 
consider them, please allow for possible delays in delivering them.
    If you prefer, you may deliver your written comments (one original 
and three copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-8018.

    Comments mailed to the above addresses may be delayed and received 
too late for us to consider them.
    Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-2024-FC2. 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, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 to 5 p.m. (phone: 
(202) 690-7890). For 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, Cecelia Hinkel (HCFA), (410) 786-3531.

SUPPLEMENTARY INFORMATION:

Availability of Copies, and Electronic Access

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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 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 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 the subsequent final rule.
    On December 6, 1994, May 12, 1997, and October 14, 1998, we 
published in the Federal Register (59 FR 62606, 62 FR 25855, and 63 FR 
55031, 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

[[Page 82942]]

that had prevented the Department of Health and Human Services from 
establishing a review process for 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 October 14, 1998 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, 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 December 31, 2000, to December 31, 
2002, 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 December 31, 2000, to December 31, 
2002, the date for laboratories to meet certain CLIA quality control 
requirements by following manufacturers' FDA CLIA-cleared test system 
instructions.
     We are extending from December 31, 2000, to December 31, 
2002, the date by which individuals with doctoral degrees must obtain 
board certification to qualify as directors of laboratories that 
perform 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 December 31, 2000, 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 December 31, 2000, 
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 some of the previous extensions, we 
received comments that the current quality control requirements are not 
appropriate for some test methodologies, and that a comprehensive 
quality control regulation should be developed to address current 
quality control needs. A final rule addressing quality control issues 
raised by these commenters is close to completion; however, it will not 
be published by December 31, 2000. Commenters also 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, in order to not impede access. We must also, as 
the commenters 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 also 
considered 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.
    Due to the complexity of the issues that must be addressed, we are 
extending the December 31, 2000 sunset date for quality control 
standards in Sec. 493.1202 to December 31, 2002, and extending the 
effective date for Sec. 493.1203 from December 31, 2000 to December 31, 
2002, to allow laboratories to continue to meet current regulations 
until we make further determinations regarding quality control issues. 
We are extending the effective date for these sections to ensure that 
we have sufficient time to develop final rules concerning quality 
control that address new technology, including point-of-care testing, 
molecular methods and advances in testing in the specialties and 
subspecialties. 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, State programs with CLIA-exempt 
laboratories and HCFA-approved accreditation organizations. Time must 
be allocated for HCFA-approved State licensure programs and HCFA-
approved accreditation organizations to review their requirements and 
determine whether they must make changes to maintain their overall 
equivalency with the CLIA requirements. State programs with CLIA-exempt 
laboratories may need to make changes to their State laws and 
implementing regulations. Accreditation organizations may also need 
time to revise policies and requirements and have them approved by 
their organizations for adoption. An implementation period 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 laboratories' 
continued compliance with CLIA requirements and jeopardize the 
continued equivalency of State programs with CLIA-exempt laboratories 
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 a chemical, physical, biological, or clinical laboratory science 
from an accredited institution, must be certified by a board recognized 
by the Department as of December 31, 2000. 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 suggested 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.

[[Page 82943]]

    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, 2002. 
This extension will allow time for review of the qualifications 
required for laboratory director to determine whether modifications 
should be made for inclusion in the final rule being developed.
    In summary, we are extending the phase-in period in 
Sec. 493.1443(b)(3) from December 31, 2000, to December 31, 2002.

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 is nearly 
complete, the issues we are addressing are many and complex, 
particularly in light of changing technologies. Since we will be 
revising the quality control requirements 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 
currently 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 
contemplating revisions that 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 individuals with a doctoral degree who have 
laboratory training and experience, but do not have board certification 
to continue to qualify as laboratory directors of high complexity 
testing while we consider appropriate revisions to the CLIA 
regulations.
    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 not doing so and are therefore issuing this 
final rule with a 60-day comment period. To do otherwise would create 
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 persons affected by these requirements. 
Because current regulations will expire on December 31, 2000, 
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 
and personnel requirements in effect prior to December 31, 2000, 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 performing 
tests, or patients undergoing 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.

V. 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. 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 major 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)).

[[Page 82944]]

Sec. 493.1202  [Amended]

    2. In Sec. 493.1202, in the section heading, remove ``December 31, 
2000'' and add in its place ``December 31, 2002''.


Sec. 493.1203  [Amended]

    3. In Sec. 493.1203, in the section heading, remove ``December 31, 
2000'' and add in its place ``December 31, 2002''.


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 ``December 
31, 2000,'' and add in its place ``December 31, 2002,''.
    b. In Sec. 493.1443(b)(3)(ii)(C), remove ``December 31, 2000,'' and 
add in its place ``December 31, 2002,''.

(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: November 20, 2000.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention.
    Dated: November 28, 2000.
Michael M. Hash,
Acting Administrator, Health Care Financing Administration.
    Dated: December 18, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 00-33288 Filed 12-26-00; 1:13 pm]
BILLING CODE 4120-01-P