Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2018, 45592-45593 [2017-20883]

Download as PDF 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 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: 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: asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 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 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 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) E:\FR\FM\29SEN1.SGM 29SEN1 45593 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 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 CY 2014 ALJ Hearing ............................................................................................. Judicial Review ........................................................................................ 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, asabaliauskas on DSKBBXCHB2PROD with NOTICES HHS. ACTION: Notice of availability. 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 SUMMARY: VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 $140 1,430 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 Fmt 4703 Sfmt 4703 In the following table we list the CYs 2014 through 2018 threshold amounts. $150 1,460 Electronic Submissions Frm 00019 C. Summary Table of Adjustments in the AIC Threshold Amounts CY 2015 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: PO 00000 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. CY 2016 $150 1,500 CY 2017 $160 1,560 CY 2018 $160 1,600 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– E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45592-45593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20883]


-----------------------------------------------------------------------

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 (Sec.  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 Sec.  405.1006(b). 
Similarly, a party must meet the AIC requirements at Sec.  405.1006(c) 
at the time judicial review is requested for the court to have 
jurisdiction over the appeal (Sec.  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, Sec. Sec.  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 Sec.  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, 
Sec. Sec.  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)

[[Page 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
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