59702 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 

++ Copies of the organization’s 

survey forms. 

++ A description of the accreditation 

survey review process and the 

accreditation status decision-making 

process, including the process for 

addressing identified deficiencies with 

the accreditation requirements, and the 

procedures used to monitor the 

correction of deficiencies found during 

an accreditation survey. 

++ Procedures for coordinating 

surveys with another accrediting 

organization (when the organization 

does not accredit all modalities) 

provided by an applicant for 

accreditation which the supplier 

provided. 

++ Comprehensive information about 

the individuals who perform 

evaluations for the accreditation 

organization, including all of the 

following information: 

—Detailed information about the size 

and composition of accreditation 

teams for each category of advanced 

medical imaging service supplier 

accredited. 

—The number of professional and 

technical staff that are available for 

survey. 

—The education, current employment 

and experience requirements 

surveyors must meet. 

—The content and length of any 

orientation program. 

—The frequency and types of in-service 

training provided to survey personnel. 

—The evaluation systems used to 

monitor the performance of 

individual surveyors and survey 

teams. 

—Policies and procedures regarding an 

individual’s participation in the 

survey or accreditation decision 

process of any organization with 

which the individual is professionally 

or financially affiliated. 

++ Policies and procedures used 

when an organization has a dispute 

regarding survey findings or an adverse 

decision. 

• A description of the organization’s 

data management and analysis 

capabilities in support of its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• The organization’s procedures for 

investigating and responding to 

complaints against accredited facilities, 

including policies and procedures 

regarding coordination of these 

activities with relevant licensing bodies 

and CMS. 

• A description of the organization’s 

policies and procedures for withholding 

or removal of accreditation status for 

facilities that fail to meet the 

organization’s accreditation standards 

and other actions taken by the 

organization in response to 

noncompliance with its accreditation 

criteria. These policies and procedures 

must include notifying CMS of facilities 

that fail to meet the requirements of the 

accrediting organization as required by 

CMS. 

• The information submitted for 

notification of these organizations 

include— 

++ A list of all accredited suppliers 

that the accrediting organization has 

accredited to include the type and 

category of accreditation currently held 

by each supplier, and the expiration 

date of each supplier’s current 

accreditation; and 

++ A list of all accreditation surveys 

scheduled to be performed by the 

organization; 

• The accreditation organization must 

also submit the following supporting 

documentation: 

++ A written presentation that 

demonstrates the organization’s ability 

to furnish us with electronic data in 

ASCII comparable code. 

++ A resource analysis that 

demonstrates that the organization’s 

staffing, funding, and other resources 

are adequate to perform the required 

surveys and related activities. 

++ A statement acknowledging that, 

as a condition for approval the 

organization will agree to the following: 

—Provide a statement agreeing to notify 

us, in writing, of any supplier that 

had its accreditation revoked, 

withdrawn, revised, or any other 

remedial or adverse action taken 

against it by the accreditation 

organization within 30 calendar days 

of any such action taken. 

—Notify all accredited suppliers within 

10 calendar days of our withdrawal of 

the organization’s approval of 

designation authority. 

—Notify us, in writing, at least 30 

calendar days in advance of the 

effective date of any proposed 

changes in accreditation 

requirements. 

—Permit its surveyors to serve as 

witnesses if we take an adverse action 

based on accreditation findings. 

—Notify us, in writing, within 2 

calendar days of a deficiency 

identified in any accreditation entity 

where the deficiency poses an 

immediate jeopardy to the supplier’s 

beneficiaries or a hazard to the 

general public. 

—Provide, on an annual basis, summary 

data specified by us that relates to the 

past years’ accreditations and trends. 

—Attest that the organization will not 

perform any accreditation surveys of 

Medicare participating suppliers with 

which it has a financial relationship 

with or interest. 

(For further information regarding the 

application requirements see the 

November 25, 2009 (74 FR 62189) and 

November 30, 2009 (74 FR 62579) 

notices.) 

We have complete our review and 

believe that RadSiteTM has provided us 

with demonstrated evidence of their 

qualifications and ability to accredit the 

categories of advanced diagnostic 

imaging services to include 

computerized tomography, nuclear 

medicine, positron emission 

tomography, and magnetic resonance 

imaging as defined in sections 

1834(e)(1)(B) and 1848(b)(4)(B) of the 

Act. Therefore this notice announces 

our approval of RadSiteTM to accredit 

suppliers furnishing the TC of all 

advanced imaging modalities (that is, 

computerized tomography, nuclear 

medicine, positron emission 

tomography, and magnetic resonance 

imaging) on or after September 27, 2013. 

Authority: Section 1834(e) of the Act. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, MedicareSupplementary Medical Insurance Program) 

Dated: September 19, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–23664 Filed 9–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4167–N] 

Medicare Program; Medicare Appeals: 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2014. The 

calendar year 2014 AIC threshold 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 59703 

amounts are $140 for ALJ hearings and 

$1,430 for judicial review. 

DATES: This notice is effective on 

January 1, 2014. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hosna (Katherine.Hosna@cms.hhs.gov), 

(410) 786–4993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1869(b)(1)(E) of the Social 

Security Act (the Act), as amended by 

section 521 of the Medicare, Medicaid, 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), 

established the amount in controversy 

(AIC) threshold amounts for 

Administrative Law Judge (ALJ) hearing 

requests and judicial review at $100 and 

$1,000, respectively, for Medicare Part 

A and Part B appeals. Section 940 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), amended section 

1869(b)(1)(E) of the Act to require the 

AIC threshold amounts for ALJ hearings 

and judicial review to be adjusted 

annually. The AIC threshold amounts 

are to be adjusted, as of January 2005, 

by the percentage increase in the 

medical care component of the 

consumer price index (CPI) for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. Section 

940(b)(2) of the MMA provided 

conforming amendments to apply the 

AIC adjustment requirement to 

Medicare Part C/Medicare Advantage 

(MA) appeals and certain health 

maintenance organization and 

competitive health plan appeals. Health 

care prepayment plans are also subject 

to MA appeals rules, including the AIC 

adjustment requirement. Section 101 of 

the MMA provides for the application of 

the AIC adjustment requirement to 

Medicare Part D appeals. 

A. Medicare Part A and Part B Appeals 

The statutory formula for the annual 

adjustment to the AIC threshold 

amounts for ALJ hearings and judicial 

review of Medicare Part A and Part B 

appeals, set forth at section 

1869(b)(1)(E) of the Act, is included in 

the applicable implementing 

regulations, 42 CFR 405.1006(b) and (c). 

The regulations require the Secretary of 

the Department of Health and Human 

Services (the Secretary) to publish 

changes to the AIC threshold amounts 

in the Federal Register 

(§ 405.1006(b)(2)). In order to be entitled 

to a hearing before an ALJ, a party to a 

proceeding must meet the AIC 

requirements at § 405.1006(b). Similarly, 

a party must meet the AIC requirements 

at § 405.1006(c) at the time judicial 

review is requested for the court to have 

jurisdiction over the appeal 

(§ 405.1136(a)). 

B. Medicare Part C/MA Appeals 

Section 940(b)(2) of the MMA applies 

the AIC adjustment requirement to 

Medicare Part C appeals by amending 

section 1852(g)(5) of the Act. The 

implementing regulations for Medicare 

Part C appeals are found at 42 CFR part 

422, subpart M. Specifically, § 422.600 

and § 422.612 discuss the AIC threshold 

amounts for ALJ hearings and judicial 

review. Section 422.600 grants any party 

to the reconsideration, except the MA 

organization, who is dissatisfied with 

the reconsideration determination, a 

right to an ALJ hearing as long as the 

amount remaining in controversy after 

reconsideration meets the threshold 

requirement established annually by the 

Secretary. Section 422.612 states, in 

part, that any party, including the MA 

organization, may request judicial 

review if the AIC meets the threshold 

requirement established annually by the 

Secretary. 

C. Health Maintenance Organizations, 

Competitive Medical Plans, and Health 

Care Prepayment Plans 

Section 1876(c)(5)(B) of the Act states 

that the annual adjustment to the AIC 

dollar amounts set forth in section 

1869(b)(1)(E) of the Act applies to 

certain beneficiary appeals within the 

context of health maintenance 

organizations and competitive medical 

plans. The applicable implementing 

regulations for Medicare Part C appeals 

are set forth in 42 CFR part 422, subpart 

M, and as discussed previously, apply 

to these appeals. The Medicare Part C 

appeals rules also apply to health care 

prepayment plan appeals. 

D. Medicare Part D (Prescription Drug 

Plan) Appeals 

The annually adjusted AIC threshold 

amounts for ALJ hearings and judicial 

review that apply to Medicare Parts A, 

B, and C appeals also apply to Medicare 

Part D appeals. Section 101 of the MMA 

added section 1860D–4(h)(1) of the Act 

regarding Part D appeals. This statutory 

provision requires a prescription drug 

plan sponsor to meet the requirements 

set forth in sections 1852(g)(4) and (g)(5) 

of the Act, in a similar manner as MA 

organizations. As noted previously, the 

annually adjusted AIC threshold 

requirement was added to section 

1852(g)(5) of the Act by section 

940(b)(2)(A) of the MMA. The 

implementing regulations for Medicare 

Part D appeals can be found at 42 CFR 

part 423, subparts M and U. The 

regulations at § 423.562(c) prescribe 

that, unless the Part D appeals rules 

provide otherwise, the Part C appeals 

rules (including the annually adjusted 

AIC threshold amount) apply to Part D 

appeals to the extent they are 

appropriate. More specifically, 

§ 423.1970 and § 423.1976 of the Part D 

appeals rules discuss the AIC threshold 

amounts for ALJ hearings and judicial 

review. Section 423.1970(a) grants a Part 

D enrollee, who is dissatisfied with the 

independent review entity (IRE) 

reconsideration determination, a right to 

an ALJ hearing if the amount remaining 

in controversy after the IRE 

reconsideration meets the threshold 

amount established annually by the 

Secretary. Sections 423.1976(a) and (b) 

allow a Part D enrollee to request 

judicial review of an ALJ or MAC 

decision if, in part, the AIC meets the 

threshold amount established annually 

by the Secretary. 

II. Annual AIC Adjustments 

A. AIC Adjustment Formula and AIC 

Adjustments 

As previously noted, section 940 of 

the MMA requires that the AIC 

threshold amounts be adjusted 

annually, beginning in January 2005, by 

the percentage increase in the medical 

care component of the CPI for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. 

B. Calendar Year 2014 

The AIC threshold amount for ALJ 

hearing requests will remain at $140 

and the AIC threshold amount for 

judicial review will rise to $1,430 for CY 

2014. These amounts are based on the 

42.754 percent increase in the medical 

care component of the CPI, which was 

at 297.600 in July 2003 and rose to 

424.836 in July 2013. The AIC threshold 

amount for ALJ hearing requests 

changes to $142.75 based on the 42.754 

percent increase over the initial 

threshold amount of $100 established in 

2003. In accordance with section 

1869(b)(1)(E)(iii) of the Act, the adjusted 

threshold amounts are rounded to the 

nearest multiple of $10. Therefore, the 

CY 2014 AIC threshold amount for ALJ 

hearings is $140.00. The AIC threshold 

amount for judicial review changes to 

$1,427.54 based on the 42.754 percent 

increase over the initial threshold 

amount of $1,000. This amount was 

rounded to the nearest multiple of $10, 

resulting in the CY 2014 AIC threshold 

amount of $1,430.00 for judicial review. 


pmangrum on DSK3VPTVN1PROD with NOTICES
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 


pmangrum on DSK3VPTVN1PROD with NOTICES