59704 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2010 through 2014 threshold amounts. 

CY 2010 CY 2011 CY 2012 CY 2013 CY 2014 

ALJ Hearing ......................................................................... $130 $130 $130 $140 $140 

Judicial Review .................................................................... 1,260 1,300 1,350 1,400 1,430 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 23, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–23655 Filed 9–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3111–N] 

Medicare, Medicaid, and CLIA 

Programs; Clinical Laboratory 

Improvement Amendments of 1988 

Exemption of Laboratories Licensed 

by the State of Washington 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

laboratories located in and licensed by 

the State of Washington that possess a 

valid license under the Medical Test 

Site law, Chapter 70.42 of the Revised 

Code of Washington, 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 September 27, 

2013 to September 27, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Farragut, (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), which was enacted on 

October 31, 1988, generally provides 

that no laboratory may perform tests on 

human specimens for the diagnosis, 

prevention or treatment of any disease 

or impairment of, or assessment of the 

health of, human beings unless it has a 

certificate to perform that category of 

tests issued by the Secretary of the 

Department of Health and Human 

Services (HHS). Under section 1861(s) 

of the Social Security Act (the Act), the 

Medicare program will only pay for 

laboratory services if the laboratory has 

a CLIA certificate. Section 1902(a)(9)(C) 

of the Act requires that state Medicaid 

plans pay only for laboratory services 

furnished by CLIA-certified laboratories. 

Thus, although subject to specified 

exemptions and exceptions, laboratories 

generally must have a current and valid 

CLIA certificate to test human 

specimens for medical purposes noted 

above to be eligible for payment for 

those tests from the Medicare or 

Medicaid programs. Regulations 

implementing section 353 of the 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 and 493.553 

provide that we may exempt from CLIA 

requirements, for a period not to exceed 

6 years, all state-licensed or -approved 

laboratories in a state if the state 

licensure program meets the specified 

conditions. Section 493.559 provides 

that we will publish a notice in the 

Federal Register when we grant 

exemption to an approved state 

licensure program. It also provides that 

the notice will include the following: 

• The basis for granting the 

exemption. 

• A description of how the laboratory 

requirements are equal to or more 

stringent than those of CLIA. 

• The term of approval, not to exceed 

6 years. 

State of Washington’s Application for 

CLIA Exemption of Its Laboratories 

The State of Washington has applied 

for exemption of its laboratories from 

CLIA program requirements. The State 

of Washington submitted all of the 

applicable information and attestations 

required by § 493.551, § 493.553, and 

§ 493.557 for state licensure programs 

seeking exemption of their licensed 

laboratories from CLIA program 

requirements. 

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 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. 

CMS Analysis of Washington’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 conducts 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 


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Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 59705 

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. 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 licensure. 

++ Agree to pay any costs associated 

with our activities to validate their 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 out of compliance with 

requirements comparable to CLIA 

condition-level requirements, as 

specified in § 493.557(b). 

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 proficiency testing (PT) 

results that constitute unsuccessful 

participation in CMS-approved PT 

programs and with other data we 

determine to be necessary for validation 

review and assessment of the state’s 

inspection process requirements. 

• The state’s agreement with us to 

ensure that the agreement obligates the 

state to 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 Washington State to verify 

that the laboratories licensed through its 

program will meet or exceed the 

requirements of the following subparts 

of part 493: Subpart H, Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing; Subpart 

J, Facility Administration for 

Nonwaived Testing; Subpart K, Quality 

Systems for Nonwaived Testing, 

Subpart M, Personnel for Nonwaived 

Testing; Subpart Q, Inspection; and 

Subpart R, Enforcement Procedures. 

We found that Washington State’s 

laboratory licensure program 

requirements mapped to all the CLIA 

condition-level requirements. Its 

licensure program’s inspection process 

and proficiency testing monitoring 

processes were adequate. Other 

materials that were submitted 

demonstrated compliance with the other 

above-referenced requirements of 

subpart E of part 493. As a result, we 

concluded that the submitted 

documents supported exempting 

laboratories licensed under that program 

from the CLIA program requirements. 

Furthermore, a review of our validation 

inspections conducted by our regional 

office in Seattle, Washington, 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 

(complaint inspections). The outcome of 

those validation inspections has been, 

and will continue to be our principal 

tool for verifying that the laboratories 

located in, and licensed by the state are 

in compliance with CLIA requirements. 

Our regional office in Seattle, 

Washington, has conducted validation 

inspections of a representative sample 

(approximately 5 percent) of the 

laboratories inspected by the 

Washington State Office of Laboratory 

Quality Assurance (LQA). The 

validation inspections were primarily of 

the concurrent type; that is, our 

surveyors accompanied Washington 

State’s inspectors, each inspecting 

against his or her agency’s respective 

regulations. Analysis of the validation 

data revealed no significant differences 

between the state and federal findings. 

The validation surveys verified that the 

State of Washington inspection process 

covers all CLIA conditions applicable to 

each laboratory being inspected and also 

verified that the state laboratory 

licensure requirements meet or exceed 

CLIA condition-level requirements. Our 

validation surveys found the state 

inspectors highly skilled and qualified. 

The LQA inspected laboratories in a 

timely fashion; that is, all laboratories 

were inspected within the required 24- 

month cycle. All parameters monitored 

by our Seattle office to date indicate that 

the State of Washington is meeting all 

requirements for approval of CLIA 

exemption. This federal monitoring will 

continue as an on-going process. 

Conclusion 

Based on review of the documents 

submitted by the Washington state 

licensure program pursuant to the 

requirements of subpart E of part 493, as 

well as the outcome of the validation 

inspections conducted by our regional 

office in Seattle, we find that the State 

of Washington’s 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 or 

-approved laboratories. 

Approval of the CLIA exemption for 

laboratories located in and licensed by 

the State of Washington laboratory 

licensure program is subject to removal 

if we determine that the outcome of a 


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comparability review or a validation 

review inspection is not acceptable, as 

described under § 493.573 and 

§ 493.575, or if the State of Washington 

fails to pay the required fee every 2 

years as required under § 493.646. 

Laboratory Data 

In accordance with our regulations at 

§ 493.557(b)(8), the approval of this 

exemption for laboratories located in 

and licensed by the State of Washington 

is conditioned on the State of 

Washington’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, 

such as a change from a CLIA certificate 

of compliance to a CLIA certificate of 

waiver. 

Required Administrative Actions 

CLIA is a user-fee funded program. 

The registration fee paid by laboratories 

is intended to cover the cost of the 

development and administration of the 

program. However, when a state’s 

application for exemption is approved, 

we do not charge a fee to laboratories in 

the state. The state’s share of the costs 

associated with CLIA must be collected 

from the state, as specified in § 493.645. 

The State of Washington must pay for 

the following: 

• Costs of federal inspections of 

laboratories in the state to verify that 

Washington 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 Washington on a semiannual 

basis. 

• The State of Washington’s 

proportionate share of the costs 

associated with establishing, 

maintaining, and improving the CLIA 

computer system, based on the portion 

of those services from which the State 

of Washington received direct benefit or 

which contributed to the CLIA program 

in the state. Thus, the State of 

Washington 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 Washington’s 

proportionate share of the general 

overhead costs to develop and 

implement CLIA, we determined the 

ratio of laboratories in the state to the 

total number of laboratories nationally. 

Approximately 1.5 percent of the 

registered laboratories are in the State of 

Washington. We determined that a 

corresponding percentage of the 

applicable CMS, CDC, FDA, and their 

respective contractor costs should be 

borne by the State of Washington. 

The State of Washington 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 Washington’s 

laboratory licensure program under 

subpart E. All laboratories located in 

and licensed by the State of Washington 

under the Medical Test Site law, 

Chapter 70.42 of the Revised Code of 

Washington, are CLIA-exempt for all 

specialties and subspecialties until 

September 27, 2019. 

Authority: Section 353(p) of the Public 

Health Service Act (42 U.S.C. 263a). 

Dated: August 8, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–23659 Filed 9–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0656] 

Secure Supply Chain Pilot Program; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document that appeared in the Federal 

Register of August 20, 2013 (78 FR 

51192). The document announced the 

start of the Secure Supply Chain Pilot 

Program (SSCPP). The document was 

published with an incorrect email 

address for the SSCPP mailbox. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Katharine Neckers, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Building 51, Rm. 4259, 

301–796–3339, email: 

Katharine.Neckers@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR 

Doc. 2013–20215, appearing on page 

51192 in the Federal Register of August 

20, 2013, the following correction is 

made: 

On page 51194, in the second column, 

under ‘‘IV. Process for Applying to 

Participate in the Pilot,’’ in the third full 

paragraph, the sentence that reads ‘‘For 

communications other than the 

submission of the SSCPP application 

(Form FDA 3676), please contact the 

CDER SSCPP mailbox at 

SSCPPMailbox@fda.hhs.gov’’ is 

corrected to read ‘‘For communications 

other than the submission of the SSCPP 

application (Form FDA 3676), please 

contact the CDER SSCPP mailbox at 

CDERSSCPP@fda.hhs.gov.’’ 

Dated: September 24, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–23563 Filed 9–26–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 30-Day Comment 

Request; Evaluation of a Kidney 

Disease Education and Awareness 

Program in the Hispanic Community 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on July 19, 2013, 

Volume 78, pages 43214–43215, and 

allowed 60-days for public comment. 

One public comment was received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Kidney Disease Education 

Program, the National Institute of 

Diabetes and Digestive and Kidney 

Diseases, the National Institutes of 

Health (NIH), may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 


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