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