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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Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45593 

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 Medicare 

Appeals Council decision if, in part, the 

AIC meets the threshold amount 

established annually by the Secretary. 

II. Provisions of the Notice—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 2018 

The AIC threshold amount for ALJ 

hearings will remain at $160 and the 

AIC threshold amount for judicial 

review will rise to $1,600 for CY 2018. 

These amounts are based on the 59.989 

percent increase in the medical care 

component of the CPI, which was at 

297.600 in July 2003 and rose to 476.130 

in July 2017. The AIC threshold amount 

for ALJ hearings changes to $159.99 

based on the 59.989 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 2018 AIC threshold 

amount for ALJ hearings is $160.00. The 

AIC threshold amount for judicial 

review changes to $1,599.89 based on 

the 59.989 percent increase over the 

initial threshold amount of $1,000. This 

amount was rounded to the nearest 

multiple of $10, resulting in the CY 

2018 AIC threshold amount of $1,600.00 

for judicial review. 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2014 through 2018 threshold amounts. 

CY 2014 CY 2015 CY 2016 CY 2017 CY 2018 

ALJ Hearing ............................................................................................. $140 $150 $150 $160 $160 

Judicial Review ........................................................................................ 1,430 1,460 1,500 1,560 1,600 

III. 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 12, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–20883 Filed 9–28–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–2165] 

Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations.’’ The 

purpose of this guidance is to assist 

sponsors in reproductive toxicity 

assessments (mainly of embryo-fetal 

development) for oncology 

pharmaceuticals and to provide 

recommendations for product labeling 

on duration of contraception following 

cessation of therapy to minimize 

potential risk to a developing embryo/ 

fetus. The guidance also clarifies FDA’s 

current thinking on when nonclinical 

studies for reproductive toxicology 

assessment may not be needed (e.g., for 

pharmaceuticals intended for use in 

postmenopausal women only). The 

intended outcome of this guidance is to 

provide for more consistent labeling for 

oncology pharmaceuticals and to reduce 

the conduct of nonclinical studies that 

are not informative on product use. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 28, 

2017. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov/. Follow 

the instructions for submitting 

comments. Comments submitted 

electronically, including attachments, to 

https://www.regulations.gov/ will be 

posted to the docket unchanged. 

Because your comment will be made 

public, you are solely responsible for 

ensuring that your comment does not 

include any confidential information 

that you or a third party may not wish 

to be posted, such as medical 

information, your or anyone else’s 

Social Security number, or confidential 

business information, such as a 

manufacturing process. Please note that 

if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov/. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 


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