45590 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

maintained and distributed via 

modifications of codes, modifiers and 

descriptions, as a direct result of data 

received from applicants. Thus, 

information collected in the application 

is significant to codeset maintenance. 

The HCPCS codeset maintenance is 

an ongoing process, as changes are 

implemented and updated annually; 

therefore, the process requires continual 

collection of information from 

applicants on an annual basis. As new 

technology evolves and new devices, 

drugs and supplies are introduced to the 

market, applicants submit applications 

to CMS requesting modifications to the 

HCPCS Level II codeset. Applications 

have been received prior to HIPAA 

implementation and must continue to 

be collected to ensure quality decisionmaking. The HIPAA of 1996 required 

CMS to adopt standards for coding 

systems that are used for reporting 

health care transactions. The regulation 

that CMS published on August 17, 2000 

(45 CFR 162.10002) to implement the 

HIPAA requirement for standardized 

coding systems established the HCPCS 

Level II codes as the standardized 

coding system for describing and 

identifying health care equipment and 

supplies in health care transactions. 

HCPCS Level II was selected as the 

standardized coding system because of 

its wide acceptance among both public 

and private insurers. Public and private 

insurers were required to be in 

compliance with the August 2000 

regulation by October 1, 2002. Form 

Number: CMS–10224 (OMB control 

number: 0938–1042); Frequency: 

Annually; Affected Public: Private 

Sector: Business or other for-profit, Notfor-profit institutions; Number of 

Respondents: 100; Total Annual 

Responses: 100; Total Annual Hours: 

1100. (For policy questions regarding 

this collection contact Kimberley 

Combs-Miller at 410–786–6707). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Independent 

Rural Health Clinics/Freestanding 

Federally Qualified Health Clinics Cost 

Report; Use: Providers of services 

participating in the Medicare program 

are required under sections 1815(a), 

1833(e) and 1861(v)(1)(A) of the Social 

Security Act (42 U.S.C. 1395g) to submit 

annual information to achieve 

settlement of costs for health care 

services rendered to Medicare 

beneficiaries. In addition, regulations at 

42 CFR 413.20 and 413.24 require 

adequate cost data and cost reports from 

providers on an annual basis. The Form 

CMS–222–17 cost report is needed to 

determine a provider’s reasonable costs 

incurred in furnishing medical services 

to Medicare beneficiaries and 

reimbursement due to or from a 

provider. Form Number: CMS–222–17 

(OMB control number: 0938–0107); 

Frequency: Annually; Affected Public: 

Private Sector: Business or other forprofit, Not-for-profit institutions; 

Number of Respondents: 1,744; Total 

Annual Responses: 1,744; Total Annual 

Hours: 95,920. (For policy questions 

regarding this collection contact Yaakov 

Feinstein at 410–786–3137). 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Organ 

Procurement Organization/ 

Histocompatibility Laboratory Cost 

Report; Use: Providers of services 

participating in the Medicare program 

are required under sections 1815(a) and 

1861(v)(1)(A) of the Social Security Act 

(42 U.S.C. 1395g) to submit annual 

information to achieve settlement of 

costs for health care services rendered to 

Medicare beneficiaries. In addition, 

regulations at 42 CFR 413.20 and 413.24 

require adequate cost data and cost 

reports from providers on an annual 

basis. The Form CMS–216–94 cost 

report is needed to determine a 

provider’s reasonable costs incurred in 

furnishing medical services to Medicare 

beneficiaries and reimbursement due to 

or due from a provider. Form Number: 

CMS–216–94 (OMB control number: 

0938–0102); Frequency: Annually; 

Affected Public: Private Sector: Business 

or other for-profit, Not-for-profit 

institutions; Number of Respondents: 

102; Total Annual Responses: 102; Total 

Annual Hours: 4590. (For policy 

questions regarding this collection 

contact Amelia Citerone at 410–786– 

3901). 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Providers of 

services participating in the Medicare 

program are required under sections 

1815(a) and 1861(v)(1)(A) of the Social 

Security Act (42 U.S.C. 1395g) to submit 

annual information to achieve 

settlement of costs for health care 

services rendered to Medicare 

beneficiaries. In addition, regulations at 

42 CFR 413.20 and 413.24 require 

adequate cost data and cost reports from 

providers on an annual basis. The Form 

CMS–265–11 cost report is needed to 

determine a provider’s reasonable costs 

incurred in furnishing medical services 

to Medicare beneficiaries. Form 

Number: CMS–265–11 (OMB control 

number: 0938–0236); Frequency: 

Annually; Affected Public: Private 

Sector: Business or other for-profit, Notfor-profit institutions; Number of 

Respondents: 6,821; Total Annual 

Responses: 6,821; Total Annual Hours: 

443,365. (For policy questions regarding 

this collection contact Gail Duncan at 

410–786–7278). 

Dated: September 26, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–20921 Filed 9–28–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1698–N] 

Medicare Program; Request for 

Nominations to the Medicare Advisory 

Panel on Clinical Diagnostic 

Laboratory Tests 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice requests 

nominations to fill vacancies on the 

Medicare Advisory Panel on Clinical 

Diagnostic Laboratory Tests (the Panel). 

The purpose of the Panel is to advise the 

Secretary of the Department of Health 

and Human Services (DHHS) and the 

Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

issues related to clinical diagnostic 

laboratory tests (CDLTs). As announced 

in the notice published in the Federal 

Register on June 16, 2017, entitled 

‘‘Medicare Program; Rechartering, 

Membership, and Announcement of the 

Advisory Panel on Clinical Diagnostic 

Laboratory Tests Meeting on August 1, 

2017’’ (82 FR 27705), the Secretary 

approved the rechartering of the Panel 

on April 25, 2017 for a 2-year period 

effective through April 25, 2019. 

DATES: The agency will receive 

nominations on a continuous basis. 

ADDRESSES: All nominations should be 

sent electronically to the following 

email address: CDLTPanel@

cms.hhs.gov. 

Web site: For additional information 

on the Panel and updates to the Panel’s 

activities, we refer readers to our Web 

site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/ 

AdvisoryPanelonClinicalDiagnostic

LaboratoryTests.html. 

FOR FURTHER INFORMATION CONTACT: 

Persons wishing to nominate 

individuals to serve on the Panel or to 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45591 

obtain further information may submit 

an email to the following email address: 

CDLTPanel@cms.hhs.gov. 

News Media: Representatives should 

contact the CMS Press Office at (202) 

690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Advisory Panel on Clinical 

Diagnostic Laboratory Tests is 

authorized by section 1834A(f)(1) of the 

Social Security Act (the Act) (42 U.S.C. 

1395m–1), as established by section 

216(a) of the Protecting Access to 

Medicare Act of 2014 (Pub. L. 113–93, 

enacted on April 1, 2014) (PAMA). The 

Panel is subject to the Federal Advisory 

Committee Act (FACA), as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory panels. 

Section 1834A(f)(1) of the Act directs 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) to consult with an expert 

outside advisory panel established by 

the Secretary, composed of an 

appropriate selection of individuals 

with expertise in issues related to 

clinical diagnostic laboratory tests. Such 

individuals may include molecular 

pathologists, researchers, and 

individuals with expertise in laboratory 

science or health economics. 

The Panel will provide input and 

recommendations to the Secretary and 

the Administrator of CMS, on the 

following: 

• The establishment of payment rates 

under section 1834A of the Act for new 

clinical diagnostic laboratory tests, 

including whether to use crosswalking 

or gapfilling processes to determine 

payment for a specific new test; and 

• The factors used in determining 

coverage and payment processes for 

new clinical diagnostic laboratory tests. 

• Other aspects of the new payment 

system under section 1834A of the Act. 

A notice announcing the 

establishment of the Panel and soliciting 

nominations for members was 

published in the October 27, 2014 

Federal Register (79 FR 63919 through 

63920). In the August 7, 2015 Federal 

Register (80 FR 47491), we announced 

membership appointments to the Panel 

along with the first public meeting date 

for the Panel, which was held on August 

26, 2015. Subsequent meetings of the 

Panel were also announced in the 

Federal Register. As previously noted, 

the Secretary approved the rechartering 

of the Panel on April 25, 2017, for a 2- 

year period effective through April 25, 

2019. 

The Panel charter provides that Panel 

meetings will be held up to 4 times 

annually and the Panel Chair will serve 

for a period of 3 years, which may be 

extended at the discretion of the 

Administrator or his or her duly 

appointed designee. Additionally, the 

Panel Chair facilitates the meeting and 

the Designated Federal Official (DFO) or 

DFO’s designee must be present at all 

meetings. 

II. Request for Nominations; Criteria for 

Nominees 

We are requesting nominations for 

members to serve on the Panel. The 

Panel shall consist of up to 15 

individuals with expertise in issues 

related to clinical diagnostic laboratory 

tests, which may include molecular 

pathologists, laboratory researchers, and 

individuals with expertise in laboratory 

science or health economics, with 

regard to issues related to the 

development, validation, performance, 

safety, and application of such tests. 

Panel members serve on a voluntary 

basis, without compensation, according 

to an advance written agreement; 

however, for the meetings, we reimburse 

travel, meals, lodging, and related 

expenses in accordance with standard 

Government travel regulations. 

Nominees must demonstrate personal 

experience with clinical diagnostic 

laboratory tests and services through a 

past or present history of direct 

employment with an organization that 

furnishes clinical diagnostic laboratory 

tests. (For purposes of this Panel, 

consultants or independent contractors 

shall not be representatives of clinical 

laboratories.) 

We have special interest in ensuring, 

while taking into account the nominee 

pool, that the Panel membership is 

balanced under the FACA guidelines; 

therefore nominees will be evaluated 

based on expertise and factors needed to 

keep the balance of the Panel. These 

factors include, but are not limited to, 

geographic locations within the United 

States or territories; race; ethnicity; sex; 

disability; points of view; and area of 

expertise (for example, medical, 

scientific, financial, technical, 

administrative). Additionally, all 

nominees must have at least 5 years of 

experience with clinical diagnostic 

laboratory tests or genetic testing. 

Based upon either self-nominations or 

nominations submitted by interested 

organizations, the Secretary, the CMS 

Administrator, or the Secretary’s or 

CMS Administrator‘s designee, appoints 

new members to the Panel from among 

candidates determined to have the 

required expertise. Nominations will be 

considered as vacancies occur on the 

Panel. Nominations should be updated 

and resubmitted every 3 years to 

continue to be considered for Panel 

vacancies. New appointments are made 

in manner that ensures a balanced 

membership under FACA guidelines. 

Our appointment schedule will assure 

that we have the full complement of 

members for each Panel meeting. 

It is not necessary for a nominee to 

possess expertise in all of the areas 

listed, but each must have a minimum 

of 5 years of experience and currently 

have full-time employment in his or her 

area of expertise. Generally, members of 

the Panel serve overlapping terms up to 

3 years, based on the needs of the Panel 

and contingent upon the rechartering of 

the Panel. A member may serve after the 

expiration of his or her term until a 

successor has been sworn in. Any 

member appointed to fill a vacancy for 

an unexpired term will be appointed for 

the remainder of that term. 

Any interested person or organization 

may nominate one or more qualified 

individuals. Self-nominations will also 

be accepted. Each nomination must 

include the following: 

• Letter of Nomination stating the 

reason why the nominee should be 

considered. 

• Curriculum vitae or resume of the 

nominee that includes the following: 

++ Email address where the nominee 

can be contacted. 

++ Title and current position. 

++ Professional affiliation. 

++ Home and business address. 

++ Home and business telephone and 

or fax numbers. 

++ List of areas of expertise. 

• Written and signed statement from 

the nominee indicating that the 

nominee is willing to serve on the Panel 

under the conditions described in this 

notice and further specified in the 

Charter. 

• Brief (1 page; double-spaced) 

biographical summary of the nominee’s 

experience. 

The top nominees will be contacted 

for interest and availability. Phone 

interviews of nominees may also be 

requested after review of the 

nominations. The Secretary, the CMS 

Administrator, or the Secretary’s or 

CMS Administrator’s designee will 

make the final decision about who will 

serve on the committee. Formal letters 

of invitation to serve on the Panel will 

be extended by the CMS Administrator. 

To permit an evaluation of possible 

sources of conflict of interest, potential 

candidates will be asked to provide 

detailed information concerning such 

matters as financial holdings, 

consultancies, and research grants or 

contracts. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
45592 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

III. Copies of the Charter 

To obtain a copy of the Panel’s 

Charter, we refer readers to our Web site 

at https://www.cms.gov/Regulationsand-Guidance/Guidance/FACA/ 

AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.) 

Dated: September 22, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–20923 Filed 9–28–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4181–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2018 

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, 2018. The 

calendar year 2018 AIC threshold 

amounts are $160 for ALJ hearings and 

$1,600 for judicial review. 

DATES: This notice is applicable on 

January 1, 2018. 

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) 

hearings 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 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)(iii) 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 422, subpart M 

and apply to these appeals pursuant to 

42 CFR 417.600(b). The Medicare Part C 

appeals rules also apply to health care 

prepayment plan appeals pursuant to 42 

CFR 417.840. 

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 

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) 


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