[Federal Register: December 29, 2000 (Volume 65, Number 251)]
[Rules and Regulations]
[Page 82941-82944]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de00-14]
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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:
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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