[Federal Register Volume 63, Number 198 (Wednesday, October 14, 1998)]
[Rules and Regulations]
[Pages 55031-55034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27523]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 512-7800 (or toll free at 1-888-293-
6498) or by faxing to (202) 512-2250. The cost for each copy is $8.00.
As an alternative, you can view and photocopy the Federal Register
document at most libraries designated as Federal Depository Libraries
and at many other public and academic libraries throughout the country
that receive the Federal Register.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. Free public access is available on a Wide
Area Information Server (WAIS) through the Internet and via
asynchronous dial-in. Internet users can access the database by using
the World Wide Web; the Superintendent of Documents home page address
is http://www.access.gpo.gov/su__docs/, by using local WAIS client
software, or by telnet to swais.access.gpo.gov, then log in as guest
(no password required). Dial-in users should use communications
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
