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

Dated: March 6, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–07115 Filed 3–26–15; 8:45 am] 

BILLING CODE 4120–01–P 

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) permitholding 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 § 493.551(a), 

§ 493.553, and § 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 conditionlevel 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 § 493.553, § 493.555, 

and § 493.557(b) and is suitable for 

approval by us under § 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 § 493.645(a), § 493.646(b), 

and § 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 § 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 

§ 493.555 and § 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 CMSapproved 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 permitholding 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 § 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 § 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 § 493.573 

and § 493.575, or if the State of New 

York fails to pay the required fee every 

2 years as required under § 493.646(b). 

D. Laboratory Data 

In accordance with our regulations at 

§ 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 

§ 493.645(a). 

The State of New York must pay for 

the following: 

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

• 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3318–N] 

Medicare Program; Renewal of the 

Medicare Evidence Development & 

Coverage Advisory Committee 

(MEDCAC) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

renewal of the Medicare Evidence 

Development & Coverage Advisory 

Committee (MEDCAC). 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, (410) 786–0309. Additional 

information on the MEDCAC, including 

a copy of the Charter, is available at 

http://www.cms.gov/Regulations-andGuidance/Guidance/FACA/

MEDCAC.html. A copy of the charter 

may also be obtained by submitting a 

request to Maria Ellis via phone or via 

email at Maria.Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 14, 1998, we published 

a notice in the Federal Register (63 FR 

68780) announcing the establishment of 

the Medicare Coverage Advisory 

Committee (MCAC). The Secretary 

signed the initial charter for the MCAC 

on November 24, 1998. The MCAC was 

originally established to provide 

independent guidance and expert 

advice to CMS on specific clinical 

topics. In 2007, the Charter was 

renewed and the name MCAC was 

modified to Medicare Evidence 

Development and Coverage Advisory 

Committee (MEDCAC) to more 

accurately reflect the Committee’s role. 

The MEDCAC is advisory, with the final 

decision on all issues resting with CMS. 

Under the current charter, the MEDCAC 

advises the Secretary of the Department 

of Health and Human Services (DHHS) 

(the Secretary) and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) on the quality of 

evidence on clinical topics under 

review by CMS. 

The MEDCAC consists of a pool of 

100 appointed members who serve 

overlapping 2-year terms. Members 

shall be invited to serve for two terms 

(up to 4 years total). Members are 

selected from among authorities in 

clinical and administrative medicine, 

biologic and physical sciences, public 

health administration, health care data 

and information management and 

analysis, the economics of health care, 

medical ethics, and other related 

professions, as well as advocates for 

patients. Of the pool of 100 members, a 

maximum of 94 members shall be atlarge standing members (this includes 6 

members who shall be patient 

advocates) and 6 shall be members 

representing industry interests. The 

Secretary or designee appoints a Chair 

and Vice-Chair from among the pool of 

at-large members. 

II. Provisions of This Notice 

This notice announces the renewal of 

the MEDCAC charter by the Secretary, 

effective November 24, 2014. The 

MEDCAC charter is effective for 2 years. 

Among other things, the new charter 

states that the committee will hold four 

to eight meetings over the life of the 

committee. Formerly, the charter 

allowed up to 16 meetings over the life 

of the committee. 

The MEDCAC functions on a 

committee basis. The MEDCAC hears 

public testimony; reviews medical 

literature, technology assessments and 

other relevant evidence; and advises 

CMS on the strength and weaknesses of 

that evidence. The MEDCAC also 

advises CMS of any evidence gaps that 

may exist and recommends the types of 

evidence that should be developed to 

fill those evidentiary gaps. The 

Committee may be asked to develop 

recommendations about specific issues 

related to Medicare coverage, and/or to 

review and comment upon proposed or 

existing Medicare coverage policies. The 

Committee may also be asked to 

comment on pertinent aspects of 

coverage proposals being considered 

and other policies. The Committee 

works from an agenda provided by a 

designated Federal official, which lists 

specific issues to be reviewed. 

Authority: 5 U.S.C. App. 2, section 10(a)(1) 

and (a)(2). 

Dated: March 20, 2015. 

Patrick Conway, 

Deputy Administrator for Innovation and 

Quality and CMS Chief Medical Officer, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2015–07105 Filed 3–26–15; 8:45 am] 

BILLING CODE 4120–01–P 

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