80_FR_16469 80 FR 16410 - Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York

80 FR 16410 - Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 59 (March 27, 2015)

Page Range16410-16412
FR Document2015-07113

This notice announces that laboratories located in and licensed by the State of New York that possess a valid permit under New York State Public Health Law Article 5, Title V, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years.

Federal Register, Volume 80 Issue 59 (Friday, March 27, 2015)
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16410-16412]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3308-N]


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.

-----------------------------------------------------------------------

SUMMARY: This notice announces that laboratories located in and 
licensed by the State of New York that possess a valid permit under New 
York State Public Health Law Article 5, Title V, are exempt from the 
requirements of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA) for a period of 6 years.

DATES: The exemption granted by this notice is effective from March 27, 
2015 to March 27, 2021.

FOR FURTHER INFORMATION CONTACT: Melissa Singer, (410) 786-3531.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    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)(17)(A) of the 
Social Security Act (the Act), the Medicare program will only pay for 
laboratory services if the laboratory has a CLIA certificate. Under 
section 1902(a)(9)(C) of the Act, state Medicaid plans generally 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 the purposes noted above to be eligible for 
payment for those tests from the Medicare or Medicaid programs. 
Regulations implementing section 353 of the PHSA are contained in 42 
CFR part 493.
    Section 353(p) of the PHSA 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 PHSA is implemented 
in subpart E of our regulations at 42 CFR part 493. Sections 493.551(b) 
and 493.553 provide that we may exempt from CLIA requirements, for a 
period not to exceed 6 years, all state-licensed or state-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 an exemption to an 
approved state licensure program. It also provides that the notice will 
include the following:
     The basis for granting the exemption.
     A description of how the state's laboratory requirements 
are equal to or more stringent than those of CLIA.
     The term of approval, not to exceed 6 years.

A. State of New York's Application for CLIA Exemption of Its 
Laboratories

    The State of New York has applied for exemption of its Clinical 
Laboratory Evaluation Program (CLEP) permit-holding laboratories from 
CLIA program requirements. New York State law is 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 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. The State of New York submitted all of the 
applicable information and attestations required by Sec.  493.551(a), 
Sec.  493.553, and Sec.  493.557(b) for state licensure programs 
seeking exemption of their licensed laboratories from CLIA program 
requirements. (Please note that although the CLEP issues ``permits'' 
rather than ``licenses'' or ``certificates,'' for the purposes of this 
notice, we will hereinafter refer to the CLEP as a ``state licensure 
program.'') Examples of documents and information submitted include a 
comparison of its laboratory licensure requirements with comparable 
CLIA condition-level requirements (that is, a crosswalk); and a 
description of the following: Its inspection process; its proficiency 
testing (PT) monitoring process; its data management and analysis 
system; its investigative and response procedures for complaints 
received against laboratories; and its policy regarding announced and 
unannounced inspections.

B. CMS Analysis of New York's Application and Supporting Documentation

    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 us and conduct a 
detailed and in-depth comparison of the state licensure program and 
CLIA's statutory and regulatory requirements to determine whether the 
state program meets the requirements at subpart E of part 493.
    In summary, the state generally must demonstrate that:
     It has state laws in effect that provide for a state 
licensure program that has requirements that are equal to or more 
stringent than CLIA condition-level requirements for laboratories.
     It has implemented a state licensure program with 
requirements that are equal to or more stringent than the CLIA 
condition-level requirements such that a laboratory licensed by the 
state program would meet the CLIA condition-level requirements if it 
were inspected against those requirements.
     The requirements under that state licensure program meet 
or exceed the requirements of Sec.  493.553, Sec.  493.555, and Sec.  
493.557(b) and is suitable for approval by us under Sec.  493.551(a). 
For example, among other things, the program would need to:
    ++ Demonstrate that it has enforcement authority and administrative 
structures and resources adequate to enforce its laboratory 
requirements.
    ++ Permit us or our agents to inspect laboratories within the 
state.
    ++ Require laboratories within the state to submit to inspections 
by us or our agents as a condition of state licensure.
    ++ Agree to pay any costs associated with our activities to 
validate its state licensure program, as well as 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 us or our agents to be out of compliance with requirements 
comparable to CLIA condition-level requirements, as specified in Sec.  
493.557(b).

[[Page 16411]]

    As specified in our regulations at Sec.  493.555 and Sec.  
493.557(b), our review of a state licensure 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 us with electronic 
data and reports with the adverse or corrective actions resulting from 
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 do the following:
    ++ Notify us 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 us 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 under its approved 
state licensure program within 10 days of a withdrawal of our approval 
of the state's licensure program, and the resulting loss of the 
laboratory's exemption from CLIA based on its licensure under that 
program.
    ++ Provide us with written notification of any changes in the 
state's licensure (or approval) and inspection requirements.
    ++ Disclose to us or our agent any laboratory's PT results in 
accordance with the state's confidentiality requirements.
    ++ Take appropriate enforcement action against laboratories that we 
or our agents find to be out of compliance with CLIA condition-level 
requirements in a validation survey, and report these enforcement 
actions to us.
    ++ Notify us of all newly licensed laboratories, and any changes in 
the specialties and subspecialties for which any laboratory performs 
testing, within 30 days.
    ++ Provide us, 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 the State 
of New York State 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 State of New York's CLEP requirements mapped to 
all the CLIA condition-level requirements. The state licensure 
program's inspection process and proficiency testing monitoring process 
were adequate. Other materials that were submitted demonstrated 
compliance with the other above-referenced requirements of subpart E of 
part 493. As a result, we concluded that the submitted documents 
supported exempting laboratories holding permits under the CLEP from 
the CLIA program requirements. Furthermore, a review of our validation 
inspections conducted by our regional office in New York, NY, supported 
this 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 (that is, complaint inspections). The outcome of those 
validation inspections has been, and will continue to be, our principal 
tool for verifying that the laboratories located within the state that 
hold valid permits are in compliance with CLIA requirements.
    Our regional office in New York, NY, 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). The validation inspections were primarily of 
the concurrent type; that is, our surveyors 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 State of New York CLEP inspection 
process covers all CLIA conditions applicable to each laboratory being 
inspected and also verified that the CLEP permit requirements meet or 
exceed CLIA condition-level requirements. Our validation surveys found 
the state inspectors highly skilled and qualified. The CLEP inspected 
laboratories in a timely fashion; that is, all laboratories were 
inspected within the required 24-month cycle. All parameters monitored 
by our regional office in New York, NY, 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 ongoing process.

C. Conclusion

    Based on review of the documents submitted by the New York state 
licensure program, CLEP, under the requirements of subpart E of part 
493, as well as the outcome of the validation inspections conducted by 
our regional office in New York, NY, we find that the State of New 
York's licensure program meets the requirements of Sec.  493.551(a), 
and that, as a result, we may exempt from CLIA program requirements all 
laboratories located within the State of New York that hold valid CLEP 
permits.
    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(b).

D. Laboratory Data

    In accordance with our regulations at Sec.  493.557(b)(8), the 
approval of this exemption for laboratories located within and 
permitted by the State of New York is conditioned on the State of New 
York's continued compliance with the assertions made in its 
application, especially the provision of information to us about 
changes to a laboratory's specialties or subspecialties based on the 
state's survey, and changes to a laboratory's certification status.

E. 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(a).
    The State of New York must pay for the following:

[[Page 16412]]

     Costs of federal inspections of laboratories in the state 
to verify that New York State's laboratory licensure program 
requirements are equivalent to or more stringent than those in the CLIA 
program, and that they 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 surveys, including 
investigations of 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, based on the portion of those services from which the 
State of New York received direct benefit or which contributed to the 
CLIA program in the state. Thus, the State of New York is being charged 
for a portion of our direct and indirect costs of administering the 
CLIA program. Such costs will be incurred by CMS, the Centers for 
Disease Control and Prevention (CDC), the Food and Drug Administration 
(FDA) and contractors working on behalf of these respective agencies.
    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 CMS, CDC, FDA, and their respective 
contractor costs should be borne by the State of New York.
    The State of New York has agreed to pay the state's pro rata share 
of the anticipated overhead costs and costs of actual validation 
(including 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, we grant approval of the State of New 
York's laboratory licensure program, CLEP, under subpart E. All 
laboratories located within the State of New York that hold valid CLEP 
permits are CLIA-exempt for all specialties and subspecialties until 
March 27, 2021.

    Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07113 Filed 3-26-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                  16410                           Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

                                                    Dated: March 6, 2015.                                 current and valid CLIA certificate to test            following: Its inspection process; its
                                                  Andrew M. Slavitt,                                      human specimens for the purposes                      proficiency testing (PT) monitoring
                                                  Acting Administrator, Centers for Medicare              noted above to be eligible for payment                process; its data management and
                                                  & Medicaid Services.                                    for those tests from the Medicare or                  analysis system; its investigative and
                                                  [FR Doc. 2015–07115 Filed 3–26–15; 8:45 am]             Medicaid programs. Regulations                        response procedures for complaints
                                                  BILLING CODE 4120–01–P                                  implementing section 353 of the PHSA                  received against laboratories; and its
                                                                                                          are contained in 42 CFR part 493.                     policy regarding announced and
                                                                                                             Section 353(p) of the PHSA provides                unannounced inspections.
                                                  DEPARTMENT OF HEALTH AND                                for the exemption of laboratories from
                                                                                                          CLIA requirements in states that enact                B. CMS Analysis of New York’s
                                                  HUMAN SERVICES
                                                                                                          legal requirements that are equal to or               Application and Supporting
                                                  Centers for Medicare & Medicaid                         more stringent than CLIA’s statutory                  Documentation
                                                  Services                                                and regulatory requirements. Section                     To determine whether we should
                                                                                                          353(p) of the PHSA is implemented in                  grant a CLIA exemption to laboratories
                                                  [CMS–3308–N]
                                                                                                          subpart E of our regulations at 42 CFR                licensed by a state, we review the
                                                  Medicare, Medicaid, and CLIA                            part 493. Sections 493.551(b) and                     application and additional
                                                  Programs; Clinical Laboratory                           493.553 provide that we may exempt                    documentation that the state submits to
                                                  Improvement Amendments of 1988                          from CLIA requirements, for a period                  us and conduct a detailed and in-depth
                                                  Exemption of Permit-Holding                             not to exceed 6 years, all state-licensed             comparison of the state licensure
                                                  Laboratories in the State of New York                   or state-approved laboratories in a state             program and CLIA’s statutory and
                                                                                                          if the state licensure program meets the              regulatory requirements to determine
                                                  AGENCY: Centers for Medicare &                          specified conditions. Section 493.559                 whether the state program meets the
                                                  Medicaid Services (CMS), HHS.                           provides that we will publish a notice                requirements at subpart E of part 493.
                                                  ACTION: Notice.                                         in the Federal Register when we grant                    In summary, the state generally must
                                                                                                          an exemption to an approved state                     demonstrate that:
                                                  SUMMARY:   This notice announces that                   licensure program. It also provides that                 • It has state laws in effect that
                                                  laboratories located in and licensed by                 the notice will include the following:                provide for a state licensure program
                                                  the State of New York that possess a                       • The basis for granting the                       that has requirements that are equal to
                                                  valid permit under New York State                       exemption.                                            or more stringent than CLIA condition-
                                                  Public Health Law Article 5, Title V, are                  • A description of how the state’s                 level requirements for laboratories.
                                                  exempt from the requirements of the                     laboratory requirements are equal to or                  • It has implemented a state licensure
                                                  Clinical Laboratory Improvement                         more stringent than those of CLIA.                    program with requirements that are
                                                  Amendments of 1988 (CLIA) for a                            • The term of approval, not to exceed              equal to or more stringent than the CLIA
                                                  period of 6 years.                                      6 years.                                              condition-level requirements such that a
                                                  DATES: The exemption granted by this                    A. State of New York’s Application for                laboratory licensed by the state program
                                                  notice is effective from March 27, 2015                 CLIA Exemption of Its Laboratories                    would meet the CLIA condition-level
                                                  to March 27, 2021.                                                                                            requirements if it were inspected against
                                                                                                             The State of New York has applied for              those requirements.
                                                  FOR FURTHER INFORMATION CONTACT:                        exemption of its Clinical Laboratory                     • The requirements under that state
                                                  Melissa Singer, (410) 786–3531.                         Evaluation Program (CLEP) permit-                     licensure program meet or exceed the
                                                  SUPPLEMENTARY INFORMATION:                              holding laboratories from CLIA program                requirements of § 493.553, § 493.555,
                                                                                                          requirements. New York State law is                   and § 493.557(b) and is suitable for
                                                  I. Background and Legislative                           applicable to all clinical laboratories
                                                  Authority                                                                                                     approval by us under § 493.551(a). For
                                                                                                          operating within the State of New York                example, among other things, the
                                                     Section 353 of the Public Health                     except those operated by the federal                  program would need to:
                                                  Service Act (PHSA), as amended by the                   government and those operated by a                       ++ Demonstrate that it has
                                                  Clinical Laboratory Improvement                         licensed physician, osteopath, dentist,               enforcement authority and
                                                  Amendments of 1988 (CLIA) (Pub. L.                      midwife, nurse practitioner or podiatrist             administrative structures and resources
                                                  100–578, enacted on October 31, 1988),                  who performs laboratory tests or                      adequate to enforce its laboratory
                                                  generally provides that no laboratory                   procedures, personally or through his or              requirements.
                                                  may perform tests on human specimens                    her employees, solely as an adjunct to                   ++ Permit us or our agents to inspect
                                                  for the diagnosis, prevention or                        the treatment of his or her own patients.             laboratories within the state.
                                                  treatment of any disease or impairment                  The State of New York submitted all of                   ++ Require laboratories within the
                                                  of, or assessment of the health of,                     the applicable information and                        state to submit to inspections by us or
                                                  human beings unless it has a certificate                attestations required by § 493.551(a),                our agents as a condition of state
                                                  to perform that category of tests issued                § 493.553, and § 493.557(b) for state                 licensure.
                                                  by the Secretary of the Department of                   licensure programs seeking exemption                     ++ Agree to pay any costs associated
                                                  Health and Human Services (HHS).                        of their licensed laboratories from CLIA              with our activities to validate its state
                                                  Under section 1861(s)(17)(A) of the                     program requirements. (Please note that               licensure program, as well as the state’s
                                                  Social Security Act (the Act), the                      although the CLEP issues ‘‘permits’’                  pro rata share of the general overhead to
                                                  Medicare program will only pay for                      rather than ‘‘licenses’’ or ‘‘certificates,’’         develop and implement CLIA as
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                                                  laboratory services if the laboratory has               for the purposes of this notice, we will              specified in § 493.645(a), § 493.646(b),
                                                  a CLIA certificate. Under section                       hereinafter refer to the CLEP as a ‘‘state            and § 493.557(b).
                                                  1902(a)(9)(C) of the Act, state Medicaid                licensure program.’’) Examples of                        ++ Take appropriate enforcement
                                                  plans generally pay only for laboratory                 documents and information submitted                   action against laboratories found by us
                                                  services furnished by CLIA-certified                    include a comparison of its laboratory                or our agents to be out of compliance
                                                  laboratories. Thus, although subject to                 licensure requirements with comparable                with requirements comparable to CLIA
                                                  specified exemptions and exceptions,                    CLIA condition-level requirements (that               condition-level requirements, as
                                                  laboratories generally must have a                      is, a crosswalk); and a description of the            specified in § 493.557(b).


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                                                                                  Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices                                           16411

                                                     As specified in our regulations at                      ++ Provide us, as requested,                       inspected and also verified that the
                                                  § 493.555 and § 493.557(b), our review                  inspection schedules for validation                   CLEP permit requirements meet or
                                                  of a state licensure program includes                   purposes.                                             exceed CLIA condition-level
                                                  (but is not necessarily limited to) an                     In keeping with the process described              requirements. Our validation surveys
                                                  evaluation of the following:                            above, we evaluated the application and               found the state inspectors highly skilled
                                                     • Whether the state’s requirements for               supporting materials that were                        and qualified. The CLEP inspected
                                                  laboratories are equal to or more                       submitted by the State of New York                    laboratories in a timely fashion; that is,
                                                  stringent than the CLIA condition-level                 State to verify that the CLEP permit-                 all laboratories were inspected within
                                                  requirements.                                           holding laboratories will meet or exceed              the required 24-month cycle. All
                                                     • The state’s inspection process                     the requirements of the following                     parameters monitored by our regional
                                                  requirements to determine the                           subparts of part 493: Subpart H,                      office in New York, NY, to date, indicate
                                                  following:                                              Participation in Proficiency Testing for              that the State of New York is meeting all
                                                     ++ The comparability of the full                     Laboratories Performing Nonwaived                     requirements for approval of CLIA
                                                  inspection and complaint inspection                     Testing; subpart J, Facility                          exemption. This federal monitoring will
                                                  procedures to those of CMS.                             Administration for Nonwaived Testing;                 continue as an ongoing process.
                                                     ++ The state’s enforcement                           subpart K, Quality Systems for
                                                                                                          Nonwaived Testing, subpart M,                         C. Conclusion
                                                  procedures for laboratories found to be
                                                  out of compliance with its requirements.                Personnel for Nonwaived Testing;                         Based on review of the documents
                                                     • The ability of the state to provide us             subpart Q, Inspection; and subpart R,                 submitted by the New York state
                                                  with electronic data and reports with                   Enforcement Procedures.                               licensure program, CLEP, under the
                                                  the adverse or corrective actions                          We found that the State of New York’s              requirements of subpart E of part 493, as
                                                                                                          CLEP requirements mapped to all the                   well as the outcome of the validation
                                                  resulting from PT results that constitute
                                                                                                          CLIA condition-level requirements. The                inspections conducted by our regional
                                                  unsuccessful participation in CMS-
                                                                                                          state licensure program’s inspection                  office in New York, NY, we find that the
                                                  approved PT programs and with other
                                                                                                          process and proficiency testing                       State of New York’s licensure program
                                                  data we determine to be necessary for
                                                                                                          monitoring process were adequate.                     meets the requirements of § 493.551(a),
                                                  validation review and assessment of the
                                                                                                          Other materials that were submitted                   and that, as a result, we may exempt
                                                  state’s inspection process requirements.
                                                                                                          demonstrated compliance with the other                from CLIA program requirements all
                                                     • The state’s agreement with us to
                                                                                                          above-referenced requirements of                      laboratories located within the State of
                                                  ensure that the agreement obligates the                 subpart E of part 493. As a result, we
                                                  state to do the following:                                                                                    New York that hold valid CLEP permits.
                                                                                                          concluded that the submitted                             Approval of the CLIA exemption for
                                                     ++ Notify us within 30 days of the                   documents supported exempting                         laboratories located within and
                                                  action taken against any CLIA-exempt                    laboratories holding permits under the                permitted by the State of New York is
                                                  laboratory that has had its licensure or                CLEP from the CLIA program                            subject to removal if we determine that
                                                  approval withdrawn or revoked or been                   requirements. Furthermore, a review of                the outcome of a comparability review
                                                  in any way sanctioned.                                  our validation inspections conducted by               or a validation review inspection is not
                                                     ++ Notify us within 10 days of any                   our regional office in New York, NY,                  acceptable, as described under § 493.573
                                                  deficiency identified in a CLIA-exempt                  supported this conclusion.                            and § 493.575, or if the State of New
                                                  laboratory in cases when the deficiency                    The federal validation inspections of              York fails to pay the required fee every
                                                  poses an immediate jeopardy to the                      CLIA-exempt laboratories, as specified                2 years as required under § 493.646(b).
                                                  laboratory’s patients or a hazard to the                in § 493.563, were conducted on a
                                                  general public.                                         representative sample basis, as well as               D. Laboratory Data
                                                     ++ Notify each laboratory licensed by                in response to any substantial                          In accordance with our regulations at
                                                  the state under its approved state                      allegations of noncompliance (that is,                § 493.557(b)(8), the approval of this
                                                  licensure program within 10 days of a                   complaint inspections). The outcome of                exemption for laboratories located
                                                  withdrawal of our approval of the state’s               those validation inspections has been,                within and permitted by the State of
                                                  licensure program, and the resulting                    and will continue to be, our principal                New York is conditioned on the State of
                                                  loss of the laboratory’s exemption from                 tool for verifying that the laboratories              New York’s continued compliance with
                                                  CLIA based on its licensure under that                  located within the state that hold valid              the assertions made in its application,
                                                  program.                                                permits are in compliance with CLIA                   especially the provision of information
                                                     ++ Provide us with written                           requirements.                                         to us about changes to a laboratory’s
                                                  notification of any changes in the state’s                 Our regional office in New York, NY,               specialties or subspecialties based on
                                                  licensure (or approval) and inspection                  has conducted validation inspections of               the state’s survey, and changes to a
                                                  requirements.                                           a representative sample (approximately                laboratory’s certification status.
                                                     ++ Disclose to us or our agent any                   5 percent) of the laboratories inspected
                                                  laboratory’s PT results in accordance                   by the New York State Office of                       E. Required Administrative Actions
                                                  with the state’s confidentiality                        Laboratory Quality Assurance (LQA).                      CLIA is a user-fee funded program.
                                                  requirements.                                           The validation inspections were                       The registration fee paid by laboratories
                                                     ++ Take appropriate enforcement                      primarily of the concurrent type; that is,            is intended to cover the cost of the
                                                  action against laboratories that we or                  our surveyors accompanied New York                    development and administration of the
                                                  our agents find to be out of compliance                 State’s inspectors, each inspecting                   program. However, when a state’s
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                                                  with CLIA condition-level requirements                  against his or her agency’s respective                application for exemption is approved,
                                                  in a validation survey, and report these                regulations. Analysis of the validation               we do not charge a fee to laboratories in
                                                  enforcement actions to us.                              data revealed no significant differences              the state. The state’s share of the costs
                                                     ++ Notify us of all newly licensed                   between the state and federal findings.               associated with CLIA must be collected
                                                  laboratories, and any changes in the                    The validation surveys verified that the              from the state, as specified in
                                                  specialties and subspecialties for which                State of New York CLEP inspection                     § 493.645(a).
                                                  any laboratory performs testing, within                 process covers all CLIA conditions                       The State of New York must pay for
                                                  30 days.                                                applicable to each laboratory being                   the following:


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                                                  16412                           Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

                                                     • Costs of federal inspections of                      Dated: March 10, 2015.                              overlapping 2-year terms. Members
                                                  laboratories in the state to verify that                Andrew M. Slavitt,                                    shall be invited to serve for two terms
                                                  New York State’s laboratory licensure                   Acting Administrator, Centers for Medicare            (up to 4 years total). Members are
                                                  program requirements are equivalent to                  & Medicaid Services.                                  selected from among authorities in
                                                  or more stringent than those in the CLIA                [FR Doc. 2015–07113 Filed 3–26–15; 8:45 am]           clinical and administrative medicine,
                                                  program, and that they are enforced in                  BILLING CODE 4120–01–P                                biologic and physical sciences, public
                                                  an appropriate manner. The average                                                                            health administration, health care data
                                                  federal hourly rate is multiplied by the                                                                      and information management and
                                                  total hours required to perform federal                 DEPARTMENT OF HEALTH AND                              analysis, the economics of health care,
                                                  validation surveys within the state.                    HUMAN SERVICES                                        medical ethics, and other related
                                                     • Costs incurred for federal surveys,                Centers for Medicare & Medicaid                       professions, as well as advocates for
                                                  including investigations of complaints                  Services                                              patients. Of the pool of 100 members, a
                                                  that are substantiated. We will bill the                                                                      maximum of 94 members shall be at-
                                                                                                          [CMS–3318–N]                                          large standing members (this includes 6
                                                  State of New York on a semiannual
                                                  basis.                                                  Medicare Program; Renewal of the                      members who shall be patient
                                                     • The State of New York’s                            Medicare Evidence Development &                       advocates) and 6 shall be members
                                                  proportionate share of the costs                        Coverage Advisory Committee                           representing industry interests. The
                                                  associated with establishing,                           (MEDCAC)                                              Secretary or designee appoints a Chair
                                                  maintaining, and improving the CLIA                                                                           and Vice-Chair from among the pool of
                                                                                                          AGENCY: Centers for Medicare &                        at-large members.
                                                  computer system, based on the portion                   Medicaid Services (CMS), HHS.
                                                  of those services from which the State                  ACTION: Notice.                                       II. Provisions of This Notice
                                                  of New York received direct benefit or
                                                  which contributed to the CLIA program                   SUMMARY:   This notice announces the                     This notice announces the renewal of
                                                  in the state. Thus, the State of New York               renewal of the Medicare Evidence                      the MEDCAC charter by the Secretary,
                                                  is being charged for a portion of our                   Development & Coverage Advisory                       effective November 24, 2014. The
                                                  direct and indirect costs of                            Committee (MEDCAC).                                   MEDCAC charter is effective for 2 years.
                                                  administering the CLIA program. Such                    FOR FURTHER INFORMATION CONTACT:                      Among other things, the new charter
                                                  costs will be incurred by CMS, the                      Maria Ellis, (410) 786–0309. Additional               states that the committee will hold four
                                                  Centers for Disease Control and                         information on the MEDCAC, including                  to eight meetings over the life of the
                                                  Prevention (CDC), the Food and Drug                     a copy of the Charter, is available at                committee. Formerly, the charter
                                                  Administration (FDA) and contractors                    http://www.cms.gov/Regulations-and-                   allowed up to 16 meetings over the life
                                                  working on behalf of these respective                   Guidance/Guidance/FACA/                               of the committee.
                                                  agencies.                                               MEDCAC.html. A copy of the charter                       The MEDCAC functions on a
                                                                                                          may also be obtained by submitting a                  committee basis. The MEDCAC hears
                                                     To estimate the State of New York’s
                                                                                                          request to Maria Ellis via phone or via
                                                  proportionate share of the general                                                                            public testimony; reviews medical
                                                                                                          email at Maria.Ellis@cms.hhs.gov.
                                                  overhead costs to develop and                                                                                 literature, technology assessments and
                                                                                                          SUPPLEMENTARY INFORMATION:
                                                  implement CLIA, we determined the                                                                             other relevant evidence; and advises
                                                  ratio of laboratories in the state to the               I. Background                                         CMS on the strength and weaknesses of
                                                  total number of laboratories nationally.                   On December 14, 1998, we published                 that evidence. The MEDCAC also
                                                  Approximately 1.5 percent of the                        a notice in the Federal Register (63 FR               advises CMS of any evidence gaps that
                                                  registered laboratories are in the State of             68780) announcing the establishment of                may exist and recommends the types of
                                                  New York. We determined that a                          the Medicare Coverage Advisory                        evidence that should be developed to
                                                  corresponding percentage of the                         Committee (MCAC). The Secretary                       fill those evidentiary gaps. The
                                                  applicable CMS, CDC, FDA, and their                     signed the initial charter for the MCAC               Committee may be asked to develop
                                                  respective contractor costs should be                   on November 24, 1998. The MCAC was                    recommendations about specific issues
                                                  borne by the State of New York.                         originally established to provide                     related to Medicare coverage, and/or to
                                                     The State of New York has agreed to                  independent guidance and expert                       review and comment upon proposed or
                                                  pay the state’s pro rata share of the                   advice to CMS on specific clinical                    existing Medicare coverage policies. The
                                                  anticipated overhead costs and costs of                 topics. In 2007, the Charter was                      Committee may also be asked to
                                                  actual validation (including complaint                  renewed and the name MCAC was                         comment on pertinent aspects of
                                                  investigation surveys). A final                         modified to Medicare Evidence                         coverage proposals being considered
                                                  reconciliation for all laboratories and all             Development and Coverage Advisory                     and other policies. The Committee
                                                  expenses will be made. We will                          Committee (MEDCAC) to more                            works from an agenda provided by a
                                                  reimburse the state for any overpayment                 accurately reflect the Committee’s role.              designated Federal official, which lists
                                                                                                          The MEDCAC is advisory, with the final                specific issues to be reviewed.
                                                  or bill it for any balance.
                                                                                                          decision on all issues resting with CMS.
                                                  II. Approval                                            Under the current charter, the MEDCAC                   Authority: 5 U.S.C. App. 2, section 10(a)(1)
                                                                                                          advises the Secretary of the Department               and (a)(2).
                                                     In light of the foregoing, we grant
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          of Health and Human Services (DHHS)                     Dated: March 20, 2015.
                                                  approval of the State of New York’s                     (the Secretary) and the Administrator of              Patrick Conway,
                                                  laboratory licensure program, CLEP,                     the Centers for Medicare & Medicaid
                                                  under subpart E. All laboratories located                                                                     Deputy Administrator for Innovation and
                                                                                                          Services (CMS) on the quality of                      Quality and CMS Chief Medical Officer,
                                                  within the State of New York that hold                  evidence on clinical topics under                     Centers for Medicare & Medicaid Services.
                                                  valid CLEP permits are CLIA-exempt for                  review by CMS.                                        [FR Doc. 2015–07105 Filed 3–26–15; 8:45 am]
                                                  all specialties and subspecialties until                   The MEDCAC consists of a pool of
                                                  March 27, 2021.                                                                                               BILLING CODE 4120–01–P
                                                                                                          100 appointed members who serve


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Document Created: 2015-12-18 11:36:42
Document Modified: 2015-12-18 11:36:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe exemption granted by this notice is effective from March 27, 2015 to March 27, 2021.
ContactMelissa Singer, (410) 786-3531.
FR Citation80 FR 16410 

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