[Federal Register: April 29, 2005 (Volume 70, Number 82)]
[Notices]
[Page 22317-22320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap05-47]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2207-N]
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988; Continuance of Exemption of
Laboratories Licensed by the State of Washington
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces that laboratories located in the State
of Washington that possess a valid license under the Medical Test Site
Licensure Law, Chapter 70.42 of the Revised Code of Washington (RCW),
continue to be exempt from the requirements of the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) until April 30, 2007.
DATES: The continuance granted by this notice is effective until April
30, 2007.
FOR FURTHER INFORMATION CONTACT: Sandra Farragut, (410) 786-3531.
SUPPLEMENTARY INFORMATION:
I. Background
Section 353 of the Public Health Service Act (PHS Act), as amended
by the Clinical Laboratory Improvement Amendments of 1988, Pub. L. 100-
578 (CLIA), provides that no laboratory may perform tests on human
specimens unless it has a certificate to perform these tests issued by
the Secretary of the Department of Health and Human Services (HHS).
Under section 1861(s) of the Social Security Act, the Medicare program
will pay for laboratory services only if the laboratory has a CLIA
certificate. Section 1902(a)(9)(C) of the Social Security Act requires
that State Medicaid plans pay only for laboratory services furnished by
CLIA-certified laboratories. Thus, although subject to specified
exemptions, laboratories generally must have a current and valid CLIA
certificate to test human specimens and to be eligible for payment from
the Medicare or Medicaid programs. Regulations implementing section 353
of the PHS Act are contained in 42 CFR part 493.
Section 353(p) of the PHS Act provides for the exemption of
laboratories from CLIA requirements in a State that applies
requirements that are equal to or more stringent than those of CLIA.
Regulations in 42 CFR part 493 subpart E implement section 353(p)
of
[[Page 22318]]
the PHS Act. Sections 493.551 and 493.553 provide that we may exempt
from CLIA requirements, for a period not to exceed 6 years, all State
licensed or approved laboratories in a State if the State Licensure
Program meets specified conditions. Section 493.559 provides that we
will publish a notice in the Federal Register when we grant exemption
to a State Laboratory licensure program. It also provides that the
notice will include the following: the basis for granting the
exemption, a description of how the laboratory requirements are equal
to or more stringent than those of CLIA, and the term of approval, not
to exceed 6 years.
On July 1, 1997 (62 FR 35513), we published a notice in the Federal
Register announcing that the State of Washington had applied for
exemption of its laboratories from CLIA requirements; that the
evaluation of this application demonstrated that all requirements for
exemption were met; and that the Washington State Laboratory licensure
program was granted an approval of CLIA exemption for laboratories in
its program.
II. Requirements for Granting CLIA Exemption
In order to determine whether we should grant or continue an
approval of an existing CLIA exemption to laboratories licensed by a
State, we conduct a detailed and in-depth comparison of State licensure
program and CLIA requirements to determine whether the State program
meets the requirements at Sec. 493.551 and Sec. 493.553. In summary,
the State must--
Have laws in effect that provide for requirements that are
equal to or more stringent than CLIA requirements;
Have a State licensure program that licenses or approves
laboratories that meet State requirements that meet or exceed CLIA
requirements, and, therefore, meet the condition-level requirements of
the CLIA regulations;
Meet the requirements and be approved in accordance with
Sec. 493.555 and Sec. 493.557(b);
Demonstrate that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements;
Permit CMS or CMS agents to inspect laboratories within
the State;
Require laboratories within the State to submit to
inspections by CMS or CMS agents as a condition of licensure;
Agree to pay the cost of the validation program
administered by CMS and the cost of the State's pro rata share of the
general overhead to develop and implement CLIA as specified in Sec.
493.645(a), Sec. 493.646(b), and Sec. 493.557(b); and
Take appropriate enforcement action against laboratories
found by CMS or CMS agents not to be in compliance with requirements
comparable to condition-level requirements, as specified in Sec.
493.557(b).
As specified in our regulations at Sec. 493.555 and Sec.
493.557(b), our review of a State laboratory program includes (but is
not necessarily limited to) an evaluation of--
Whether the State's requirements for laboratories are
equal to or more stringent than the CLIA condition-level requirements;
The State's inspection process requirements to determine--
--The comparability of the full inspection and complaint inspection
procedures to those of CMS;
--The State's enforcement procedures for laboratories found to be out
of compliance with its requirements; and
--The ability of the State to provide CMS with electronic data and
reports with the adverse or corrective actions resulting from
proficiency testing (PT) results that constitute unsuccessful
participation in CMS-approved PT programs and with other data we
determine to be necessary for validation review and assessment of the
State's inspection process requirements;
The State's agreement with us to ensure that the agreement
obligates the State to--
--Notify CMS within 30 days of the action taken against any CLIA-exempt
laboratory that has had its licensure or approval withdrawn or revoked
or been in any way sanctioned;
--Notify CMS within 10 days of any deficiency identified in a CLIA-
exempt laboratory in cases when the deficiency poses an immediate
jeopardy to the laboratory's patients or a hazard to the general
public;
--Notify each laboratory licensed by the State within 10 days of CMS'
withdrawal of the exemption;
--Provide CMS with written notification of any changes in its licensure
(or approval) and inspection requirements;
--Disclose to CMS or a CMS agent any laboratory's PT results in
accordance with a State's confidentiality requirements;
--Take the appropriate enforcement action against laboratories found by
CMS not to be in compliance with requirements comparable to CLIA
condition-level requirements and report these enforcement actions to
CMS;
--Notify CMS of all newly licensed laboratories, including changes in
the specialties and subspecialties for which any laboratory performs
testing, within 30 days; and
--Provide CMS, as requested, inspection schedules for validation
purposes.
III. Evaluation of Washington's Request for Continued CLIA Exemption of
Its Laboratories
Washington has applied for continued exemption of its laboratories
from CLIA program requirements.
We evaluated the application to verify Washington's assurance of
continued compliance with the following subparts of part 493: Subpart
H, Participation in Proficiency Testing for Laboratories Performing
Nonwaived Testing; Subpart J, Facility Administration for Nonwaived
Testing; Subpart K, Quality Systems for Nonwaived Testing, Subpart M,
Personnel for Nonwaived Testing; Subpart Q, Inspection; and Subpart R,
Enforcement Procedures.
The Washington State Laboratory Licensure Program was found to
continue to meet the requirements of subparts H, J, K, M, Q, and R.
We also verified the State of Washington's assurance that it
requires the laboratories it licenses to meet the requirements for the
following subparts of part 493 as explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The State of Washington submitted a comparison of its laboratory
licensure requirements with comparable CLIA condition-level
requirements (that is, a crosswalk); a description of its inspection
process; proficiency testing monitoring process; its data management
and analysis system; its investigative and complaint response
procedures; its current list of licensed laboratories; and its policy
regarding announcement and unannouncement of inspections. We have
determined that the State of Washington has complied with the
requirements under subpart E of part 493 and that the requirements of
its laboratory licensure program are equal to the condition-level
requirements in subparts H, J, K, M, Q, and R of part 493.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Washington State program's requirements are equal to the CLIA
[[Page 22319]]
requirements at Sec. 493.801 through Sec. 493.865.
Subpart J--Facility Administration for Nonwaived Testing
The Washington State Program's requirements are equal to the CLIA
requirements at Sec. 493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
The Quality Control (QC) requirements of the Washington State
Laboratory Licensure Program have been evaluated against the
requirements of the CLIA regulations. The Washington State Program has
modified its survey process and made revisions to its requirements
encompassing general QC as well as specialty and subspecialty QC
requirements in order to reflect the new QC requirements of the CLIA
regulations. As such, we have determined that the Washington State
Program's requirements are equal to the requirements of the CLIA
regulations.
Subpart M--Personnel for Nonwaived Testing
The Washington State Program requirements are equal to the CLIA
requirements at Sec. 493.1403 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing.
Subpart Q--Inspections
The Washington State Laboratory Licensure Program requires
laboratories to comply with the inspection requirements of Sec.
493.1773 and Sec. 493.1780 of this subpart, as applicable. Thus, we
have determined that the Washington State Program's requirements are
equal to the requirements of the CLIA regulations.
Subpart R--Enforcement Procedures
The Washington State Program meets the requirements of subpart R to
the extent that subpart R applies to State laboratory licensure
programs. Accordingly, we have determined that the Washington State
Program's enforcement and appeal policies are equal to the requirements
of the CLIA regulations.
IV. Validation Inspections
The Federal validation inspections of CLIA-exempt laboratories, as
specified in Sec. 493.563, were conducted on a representative sample
basis as well as in response to any substantial allegations of
noncompliance (complaint inspections). The outcome of those validation
inspections has been and will continue to be CMS' principal tool for
verifying that the laboratories located in and licensed by the State
are in compliance with CLIA requirements.
Staff in the CMS Regional Office in Seattle, Washington have
conducted validation inspections of a representative sample
(approximately 5 percent) of the laboratories inspected by the
Washington State Office of Laboratory Quality Assurance (LQA). The
validation inspections were primarily of the concurrent type; that is,
CMS surveyors accompanied Washington's inspectors, each inspecting
against his or her agency's respective regulations. Analysis of the
validation data revealed no significant differences between the State
and Federal findings. The validation surveys verified that the
Washington inspection process covers all CLIA conditions applicable to
each laboratory being inspected, and also verified that the State
laboratory licensure requirements meet or exceed CLIA condition-level
requirements. The CMS survey staff found the State inspectors highly
skilled and qualified. The LQA inspected laboratories in timely
fashion, that is, all laboratories were inspected within the required
24-month cycle. All parameters monitored by CMS staff to date indicate
that Washington is meeting all requirements for approval of CLIA
exemption. This Federal monitoring will continue as an on-going
process.
Approval of the CLIA exemption for laboratories located in and
licensed by Washington is subject to removal if we determine that the
outcome of a comparability review or a validation review inspection is
not acceptable, as described under Sec. 493.573 and Sec. 493.575, or
if Washington fails to pay the required fee every 2 years as required
under Sec. 493.646.
V. Laboratory Data
In accordance with Sec. 493.557(b)(8), Washington will continue to
agree to provide us with changes to a laboratory's specialties or
subspecialties based on the State's survey. Washington also will
provide us with changes in a laboratory's certification status, such as
a change from a regular certificate to a certificate of waiver.
VI. Required Administrative Actions
CLIA is a totally user-fee funded program. The registration fee
paid by laboratories is intended to cover the cost of the development
and administration of the program. However, when a State's application
for exemption is approved, we do not charge a fee to laboratories in
the State. The State's share of the costs associated with CLIA must be
collected from the State, as specified in Sec. 493.645.
Washington must pay for the following:
Costs of Federal inspection of laboratories in the State
to verify that Washington's laboratory licensure program requirements
are enforced in an appropriate manner. The average Federal hourly rate
is multiplied by the total hours required to perform Federal validation
surveys within the State.
Costs incurred for Federal investigations and surveys
triggered by complaints that are substantiated. We will bill Washington
on a semiannual basis.
Washington's proportionate share of the costs associated
with establishing, maintaining, and improving the CLIA computer system,
a portion of those services from which Washington received direct
benefit or contributed to the CLIA program in the State. Thus,
Washington is being charged for a portion of CMS' direct and indirect
costs as well as a portion of the costs incurred by the Centers for
Disease Control and Prevention (CDC).
In order to estimate Washington's proportionate share of the
general overhead costs to develop and implement CLIA, we determined the
ratio of laboratories in the State to the total number of laboratories
nationally. Approximately 1.6 percent of the registered laboratories
are in Washington. We determined that 1.6 percent of the applicable CDC
and CMS costs should be borne by Washington.
Washington has agreed to pay us the State's pro rata share of the
overhead costs and anticipated costs of actual validation and complaint
investigation surveys. A final reconciliation for all laboratories and
all expenses will be made. We will reimburse the State for any
overpayment or bill it for any balance.
VII. Approval
CMS grants continued approval of the CLIA exemption for all
laboratory specialties and subspecialties to all laboratories located
in and licensed by the State of Washington effective April 30, 2001 to
April 30, 2007.
The State of Washington applied timely for re-approval, that is, to
continue approval for exemption beyond the period ending April 30,
2001. Review of the application for continued approval, and evaluation
of the outcomes of the validation inspections indicated that continued
approval for 6 more years was in order. The actual publication of the
continued approval was delayed, however, due to the timing of the
publication of changes to the CLIA regulations, and subsequently the
time period necessary
[[Page 22320]]
for the State of Washington to publish corresponding changes to the
Washington State Medical Test Site Rules, which were effective March
19, 2005.
VIII. Collection of Information Requirements
This document does not impose information collection, and
recordkeeping requirements, which are subject to the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 35). Consequently, it need not
be reviewed by the Office of Management and Budget under the authority
of the PRA.
VIX. Regulatory Impact Statement
This notice announces the continuance of the exemption of
laboratories licensed by the State of Washington from the requirements
of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The
State has established that the quality of laboratory services required
under its Laboratory licensure program continues to be equal or more
stringent than those required by the CLIA program. Washington also has
established that it has a comparable program to monitor and evaluate
compliance with its laboratory licensure program requirements. The
effect of the continued exemption from CLIA requirements is that
laboratories will remain under State, rather than Federal, regulation,
with no discernible difference in the operations of the programs.
Consequently, we anticipate that our continued approval of Washington's
CLIA exemption will not affect the laboratories or the quality and
availability of services provided.
We have examined the impact of this notice as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This notice
does not reach the economic threshold and thus is not considered a
major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. We are not preparing an
analysis for the RFA because we have determined that this notice will
not have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a notice may have a significant impact on
the operations of a substantial number of small rural hospitals. This
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 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this notice will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This notice will have no consequential effect
on the governments mentioned or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on State
or local governments, the requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
Authority: Section 353(p) of the Public Health Service Act (42
U.S.C. 263a).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: April 8, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-8286 Filed 4-22-05; 8:45 am]
BILLING CODE 4120-01-P