[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78368-78370]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de08-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2283-N]
RIN 0938-AP20
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories
in the State of New York
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces that CMS has granted exemption from CLIA
requirements to laboratories located within the State of New York that
possess a valid permit under Article Five of Title V of the Public
Health Law of the State of New York and its implementing regulations at
10 N.Y. Comp. Codes R. & Regs., Title V, Part 58.
DATES: Effective Date: The exemption granted by this notice is
effective, unless revoked, for 6 years from the date of publication of
this notice.
FOR FURTHER INFORMATION CONTACT: Val Coppola (410) 786-3531.
SUPPLEMENTARY INFORMATION:
I. Background
A. Federal Law
Section 353 of the Public Health Service Act (the Act), as amended
by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42
U.S.C. 263a) generally requires any laboratory that performs tests on
human specimens for the diagnosis, prevention or treatment of any
disease or impairment of, or assessment of the health of human beings
to possess a certificate to perform that category of tests issued by
the Secretary of the Department of Health and Human Services (HHS).
Under sections 1861(s) of the Social Security Act, the Medicare program
will only pay for laboratory services if the laboratory meets the
certification requirements under section 353 of the Public Health
Service Act. Section 1902(a)(9)(C) of the Social Security Act requires
that State Medicaid plans pay only for laboratory services furnished by
laboratories in compliance with section 353 of the Act. Subject to
specified exceptions, laboratories therefore must have a current and
valid CLIA certificate to be eligible for payment from the Medicare or
Medicaid programs. Regulations implementing section 353 of the 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 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, 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
approval 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.
B. New York State Law
This title is generally applicable to all clinical laboratories
operating within the state of New York except those operated by the
Federal Government and those operated by a licensed
[[Page 78369]]
physician, osteopath, dentist, midwife, nurse practitioner or
podiatrist who performs laboratory tests or procedures, personally or
through his or her employees, solely as an adjunct to the treatment of
his or her own patients. This notice is a repeat of New York State's
laboratory licensure program's CMS approval under CLIA, and announces
the beginning of a new period of exemption for its permitted
laboratories.
II. Notice of Approval of CLIA Exemption to the New York State
Laboratories
By this notice, we grant CLIA exemption to all laboratories located
in the State of New York that possess a valid and appropriate permit to
perform laboratory testing under New York's ``Clinical Laboratory
Evaluation Program.''
III. Evaluation of the New York Laboratory Licensure (Permit) Program,
the Clinical Laboratory Evaluation Program (CLEP)
The State of New York applied for exemption of its CLEP permit
holding laboratories from CLIA program requirements. The State of New
York 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 the documents and
information that were submitted and reviewed are: A comparison of its
laboratory licensure requirements with comparable CLIA condition-level
requirements and descriptions of its: inspection and proficiency
testing monitoring processes, data management and analysis system,
investigative and response procedures for complaints received against
laboratories, and policies regarding inspections.
IV. CMS and the Centers for Disease Control and Prevention (CDC)
Analysis of New York's Application and Supporting Documentation
In order to determine whether we should grant a CLIA exemption to
laboratories licensed by a State, we, with staff from CDC, review the
application and additional documentation that the State submits to CMS
and conducted a detailed and in-depth comparison of the CLEP State
licensure (permit) program and CLIA requirements to determine whether
the State program meets or exceeds the requirements at subpart E of
part 493.
In summary, the State generally must demonstrate that its State
licensure program meets the following requirements:
Has State laws in effect that provide for laboratory
licensure/permit program with requirements that are equal to or more
stringent than CLIA condition-level requirements for laboratories.
Has a State licensure program with requirements that are
equal to or more stringent than the CLIA condition-level requirements
such that a State program licensed 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, a program would need to:
--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 authority and procedures for laboratories
found to be out of compliance with its requirements.
--The State's ability to electronically provide CMS with reports and
data about adverse actions and corrective actions resulting from
unsuccessful proficiency testing participation 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, CMS, with the
assistance of CDC, reviewed and evaluated the application and
supporting materials that were submitted by CLEP to verify that the
CLEP permit holding laboratories 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 the CLEP requirements mapped to all the applicable
CLIA condition-level requirements. The New York State licensure
program's inspection process and proficiency testing monitoring
processes are equal to or more stringent than those of the CLIA
program. Other materials that were submitted demonstrated compliance
with the other above-
[[Page 78370]]
referenced requirements of subpart E of Part 493. As a result, CMS
concluded that the submitted documents supported exempting permit
holding laboratories under the CLEP from the CLIA program requirements.
Furthermore, a review of CMS' validation inspections conducted by the
CMS Regional Office in New York, New York supported that conclusion.
The Federal validation inspections of CLEP permit holding
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 within the
State that hold valid permits are in compliance with CLIA requirements.
The CMS Regional Office in New York has conducted validation
inspections of a representative sample (approximately 5 percent) of the
laboratories inspected by the New York State Office of Laboratory
Quality Assurance (LQA). For some of these validation inspections, CMS
surveyors simply accompanied New York 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
CLEP inspection process covers all CLIA conditions applicable to each
laboratory being inspected, and also verified that the CLEP licensure
(permit) requirements meet or exceed CLIA condition-level requirements.
The CMS validation surveys found the State inspectors highly skilled
and qualified. The CLEP inspected laboratories in timely fashion, that
is, all laboratories were inspected within the required 24-month cycle.
All parameters monitored by CMS' New York Regional Office to date
indicate that the State of New York is meeting all requirements for
approval of CLIA exemption.
This Federal monitoring will continue as an on-going process.
V. Conclusion
Based on review of the documents submitted by the New York State
laboratory licensure program, CLEP, 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 New York, we find
that the State of New York laboratory licensure program meets the
requirements of 42 CFR 493.551(a), and that as a result, we may exempt
from CLIA program requirements all State licensed (permitted) or
approved laboratories.
Approval of the CLIA exemption for laboratories located within and
permitted by the State of New York 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 New York fails to pay the
required fee every 2 years as required under Sec. 493.646.
VI. Laboratory Data
In accordance with our regulations at Sec. 493.557(b)(8), the
State of New York 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 New York also will provide us with changes in a
laboratory's certification status.
VII. 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.
Accordingly, the State of New York must pay for the following:
Costs of Federal inspection of laboratories in the State
to verify that New York State's CLEP 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 New York on a semiannual basis.
The State of New York'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
New York received direct benefit or contributed to the CLIA program in
the State. Thus, the State of New York is being charged for a portion
of CMS' direct and indirect costs as well as a portion of the costs
incurred by the CDC and the Food and Drug Administration (FDA) in
carrying out their responsibilities under CLIA.
In order to estimate the State of New York'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 New York. We determined that a
corresponding percentage of the applicable CDC, FDA, and CMS costs
should be borne by the State of New York.
The State of New York 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.
VIII. Approval
In light of the foregoing, CMS grants approval of the State of New
York's laboratory licensure program (CLEP) under Subpart E. All
laboratories located within the State of New York and hold valid CLEP
permits are CLIA-exempt for all specialties and subspecialties.
Authority: Section 353(p) of the Public Health Service Act (42
U.S.C. 263a).
Dated: November 7, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-30452 Filed 12-19-08; 8:45 am]
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