[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55219-55221]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-98]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2267-N]
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 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 and
licensed by 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, are exempt from the requirements of the Clinical
Laboratory Improvement Amendments of 1988 until September 28, 2013.
EFFECTIVE DATES: The exemption granted by the notice is effective until
September 28, 2013.
FOR FURTHER INFORMATION CONTACT: Sandra Farragut (410)786-3531.
SUPPLEMENTARY INFORMATION:
I. Background
Section 353 of the Public Health Service Act (PHSA), as amended by
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L.
100-578) enacted on October 31, 1988, generally provides that no
laboratory may perform tests on human specimens for the diagnosis,
prevention or treatment of any disease or impairment of, or assessment
of the health of human beings unless it has a certificate to perform
that category of tests issued by the Secretary of the Department of
Health and Human Services (HHS). Under section 1861(s) of the Social
Security Act (the Act), the Medicare program will only pay for
laboratory services if the laboratory has a CLIA certificate. Section
1902(a)(9)(C) of the Act requires that State Medicaid plans pay only
for laboratory services furnished by CLIA-certified laboratories. Thus,
although subject to specified exemptions and exceptions, laboratories
generally must have a current and valid CLIA certificate to test human
specimens for medical purposes noted above to be eligible for payment
for those tests 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 States that enact legal
requirements that are equal to or more stringent than CLIA's statutory
and regulatory requirements.
Section 353(p) of the PHS Act is implemented in subpart E of
regulations at 42 CFR part 493. 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 the specified conditions. Section 493.559
provides that we will publish a notice in the Federal Register when we
grant exemption to an approved 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.
The term of approval, not to exceed 6 years.
State of Washington's Application for CLIA Exemption of Its
Laboratories
The State of Washington has applied for exemption of its
laboratories from CLIA program requirements. The State of Washington
submitted all of the applicable information and attestations required
by Sec. 493.551, Sec. 493.553, and Sec. 493.557 for State licensure
programs seeking exemption of their licensed laboratories from CLIA
program requirements.
Examples of documents and information submitted are: 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 response
procedures for complaints received against laboratories; and its policy
regarding announcement and unannouncement of inspections.
CMS Analysis of Washington's Application and Supporting Documentation
In order to determine whether we should grant a CLIA exemption to
laboratories licensed by a State, we review the application and
additional documentation that the State submits to CMS and conduct a
detailed and in-depth comparison of State licensure program and CLIA
requirements to determine whether the State program meets the
requirements at subpart E of part 493.
In summary, the State generally must demonstrate that its State
licensure program meets the following requirements:
Have State laws in effect that provide for laboratory
requirements that are equal to or more stringent than CLIA condition-
level requirements for laboratories.
Have a State licensure program with requirements that are
equal to or more stringent than the CLIA condition-level requirements
such that the State program licenses laboratory would meet the CLIA
condition-level requirements if it were inspected against those
requirements.
Is shown to meet the requirements of Sec. 493.553, Sec.
493.555, and Sec. 493.557(b) and is approved by CMS under Sec.
493.551. For example, among other things, programs would need to:
[[Page 55220]]
--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).
--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 the following:
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 following:
--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.
--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 CMS to ensure that the
agreement obligates the State to do the following:
--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 CLIA condition-level requirements in a
validation survey 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.
--Provide CMS, as requested, inspection schedules for validation
purposes.
In keeping with the process described above, we evaluated the
application and supporting materials that were submitted by Washington
State to verify that the laboratories licensed through their program
will meet or exceed the requirements of 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.
We found that Washington State's laboratory licensure program
requirements mapped to all the CLIA condition-level requirements. Its
licensure program's inspection process and proficiency testing
monitoring processes were adequate. Other materials that were submitted
demonstrated compliance with the other above-referenced requirements of
subpart E of Part 493. As a result, CMS concluded that the submitted
documents supported exempting laboratories licensed under that program
from the CLIA program requirements. Furthermore, a review of CMS'
validation inspections conducted by the CMS office in Seattle,
Washington, supported the conclusion.
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.
The CMS Regional Office in Seattle, Washington has 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 State'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 State of 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 validation surveys 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' Seattle office to date
indicate that the State of Washington is meeting all requirements for
approval of CLIA exemption. This Federal monitoring will continue as an
on-going process.
Conclusion
Based on review of the documents submitted by the Washington State
laboratory licensure program pursuant to the requirements of subpart E
of part 493, as well as the outcome of the validation inspections
conducted by the CMS regional office in Seattle, we find that the
Washington State laboratory licensure program meets the requirements of
42 CFR Sec. 493.551(a), and that as a result, we may exempt from CLIA
program requirements all State licensed or approved laboratories.
Approval of the CLIA exemption for laboratories located in and
licensed by the State of 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 the State of Washington fails to pay the
required fee every 2 years as required under Sec. 493.646.
Laboratory Data
In accordance with our regulations at Sec. 493.557(b)(8), the
State of Washington will continue to agree to provide us with changes
to a laboratory's specialties or subspecialties based on the State's
survey. The State of Washington also will provide us with changes in a
laboratory's certification
[[Page 55221]]
status, such as a change from a regular certificate to a certificate of
waiver.
Required Administrative Actions
CLIA is a 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.
The State of Washington must pay for the following:
Costs of Federal inspection of laboratories in the State
to verify that Washington State'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 the State
of Washington on a semiannual basis.
The State of Washington's proportionate share of the costs
associated with establishing, maintaining, and improving the CLIA
computer system, a portion of those services from which the State of
Washington received direct benefit or contributed to the CLIA program
in the State. Thus, the State of 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)
and the Food and Drug Administration (FDA).
In order to estimate the State of 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 1.5 percent of the registered
laboratories are in the State of Washington. We determined that a
corresponding percentage of the applicable CDC, FDA, and CMS costs
should be borne by the State of Washington.
The State of 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.
II. Approval
In light of the foregoing, CMS grants approval of the State of
Washington's laboratory licensure program under Subpart E. All
laboratories located in and licensed by the State of Washington under
the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code
of Washington, are CLIA-exempt for all specialties and subspecialties
until September 28, 2013.
Authority: Section 353(p) of the Public Health Service Act (42
U.S.C. 263a).
Dated: July 20, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-18731 Filed 9-27-07; 8:45 am]
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