Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements, 81697-81698 [2016-27733]
Download as PDF
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Rules and Regulations
Medical gas
Color
Medical Air ................
Carbon Dioxide .........
Helium .......................
Nitrogen .....................
Nitrous Oxide ............
Oxygen ......................
Mixture or Blend ........
Yellow.
Gray.
Brown.
Black.
Blue.
Green.
Colors corresponding
to each component
gas.
normal use. Each such label as well as
materials used for coloring medical gas
containers must be reasonably resistant
to fading, durable when exposed to
atmospheric conditions, and not readily
soluble in water.
■ 6. Amend § 211.125 by adding a
sentence to the end of paragraph (c) to
read as follows:
Prevention Program Model; Medicare
Shared Savings Program Requirements.’’
DATES: This correcting document is
effective January 1, 2017.
FOR FURTHER INFORMATION CONTACT:
Terri Plumb, (410) 786–4481, Gaysha
Brooks, (410) 786–9649, or Annette
Brewer (410) 786–6580.
SUPPLEMENTARY INFORMATION:
§ 211.125
I. Background
Labeling issuance.
*
*
*
*
*
(c) * * * Labeling reconciliation is
also waived for 360° wraparound labels
on portable cryogenic medical gas
containers.
*
*
*
*
*
PART 211—CURRENT GOOD
MANUFACTURING PRACTICE FOR
FINISHED PHARMACEUTICALS
4. The authority citation for part 211
continues to read as follows:
■
Authority: 21 U.S.C. 321, 351, 352, 355,
360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
5. Amend § 211.94 by adding new
paragraph (e) to read as follows:
■
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27838 Filed 11–17–16; 8:45 am]
BILLING CODE 4164–01–P
§ 211.94 Drug product containers and
closures.
mstockstill on DSK3G9T082PROD with RULES
*
*
*
*
*
(e) Medical gas containers and
closures must meet the following
requirements—(1) Gas-specific use
outlet connections. Portable cryogenic
medical gas containers that are not
manufactured with permanent gas use
outlet connections (e.g., those that have
been silver-brazed) must have gasspecific use outlet connections that are
attached to the valve body so that they
cannot be readily removed or replaced
(without making the valve inoperable
and preventing the containers’ use)
except by the manufacturer. For the
purposes of this paragraph, the term
‘‘manufacturer’’ includes any individual
or firm that fills high-pressure medical
gas cylinders or cryogenic medical gas
containers. For the purposes of this
section, a ‘‘portable cryogenic medical
gas container’’ is one that is capable of
being transported and is intended to be
attached to a medical gas supply system
within a hospital, health care entity,
nursing home, other facility, or home
health care setting, or is a base unit used
to fill small cryogenic gas containers for
use by individual patients. The term
does not include cryogenic containers
that are not designed to be connected to
a medical gas supply system, e.g., tank
trucks, trailers, rail cars, or small
cryogenic gas containers for use by
individual patients (including portable
liquid oxygen units as defined at
§ 868.5655 of this chapter).
(2) Label and coloring requirements.
The labeling specified at § 201.328(a) of
this chapter must be affixed to the
container in a manner that does not
interfere with other labeling and such
that it is not susceptible to becoming
worn or inadvertently detached during
VerDate Sep<11>2014
17:25 Nov 17, 2016
Jkt 241001
81697
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 405, 410, 411, 414, 417,
422, 423, 424, 425, and 460
[CMS–1654–CN2]
RIN 0938–AS81
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2017; Medicare
Advantage Bid Pricing Data Release;
Medicare Advantage and Part D
Medical Loss Ratio Data Release;
Medicare Advantage Provider Network
Requirements; Expansion of Medicare
Diabetes Prevention Program Model;
Medicare Shared Savings Program
Requirements
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
This document corrects
technical errors in the final rule that
was placed on public inspection at the
Office of the Federal Register on
November 2, 2016 and scheduled for
publication in the Federal Register on
November 15, 2016. That rule is
entitled, ‘‘Medicare Program; Revisions
to Payment Policies under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2017; Medicare Advantage
Bid Pricing Data Release; Medicare
Advantage and Part D Medical Loss
Ratio Data Release; Medicare Advantage
Provider Network Requirements;
Expansion of Medicare Diabetes
SUMMARY:
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
In FR Doc 2016–26668, that was
placed on public inspection at the
Office of the Federal Register on
November 2, 2016 and scheduled for
publication in the Federal Register on
November 15, 2016, there were
technical errors that are identified and
corrected in this correcting document.
II. Summary of Errors in the
Regulations Text
In the CY 2017 PFS final rule, we
inadvertently omitted or included
language in § 410.79(b), (c)(1)(ii) and
(iv), (c)(2)(i) and § 424.59(a)(1) and (5),
(b)(4)(i), and (e)(2)(i).
III. Waiver of Proposed Rulemaking
and Delay in Effective Date
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rule in the
Federal Register and provide a period
for public comment before the
provisions of a rule take effect. In
addition, section 553(d) of the APA
mandates a 30-day delay in effective
date after issuance or publication of a
rule. Sections 553(b)(B) and 553(d)(3) of
the APA provide for exceptions from the
APA notice and comment, and delay in
effective date requirements. Section
553(b)(B) of the APA authorizes an
agency to dispense with normal notice
and comment rulemaking procedures
for good cause if the agency makes a
finding that the notice and comment
process is impracticable, unnecessary,
or contrary to the public interest; and
includes a statement of the finding and
the reasons for it in the rule. In addition,
section 553(d)(3) of the APA allows the
agency to avoid the 30-day delay in
effective date where such delay is
contrary to the public interest and the
agency includes in the rule a statement
of the finding and the reasons for it.
In our view, this correcting document
does not constitute a rulemaking that
would be subject to these requirements.
This document merely corrects
technical errors in the CY 2017 PFS
final rule. The corrections contained in
this document are consistent with, and
do not make substantive changes to, the
policies and payment methodologies
E:\FR\FM\18NOR1.SGM
18NOR1
81698
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Rules and Regulations
that were proposed subject to notice and
comment procedures in the CY 2017
PFS final rule. As a result, the
correction made through this correcting
document is intended to resolve
inadvertent errors so that the rule
accurately reflects the policies in the
final rule.
Even if this were a rulemaking to
which the notice and comment and
delayed effective date requirements
applied, we find that there is good cause
to waive such requirements.
Undertaking further notice and
comment procedures to incorporate the
corrections in this document into the
CY 2017 PFS final rule or delaying the
effective date of the corrections would
be contrary to the public interest
because it is in the public interest to
ensure that the rule accurately reflects
the public comment period. Further,
such procedures would be unnecessary,
because we are not making any
substantive revisions to the final rule,
but rather, we are simply correcting the
Federal Register document to reflect the
policies in the final rule. For these
reasons, we believe there is good cause
to waive the requirements for notice and
comment and delay in effective date.
IV. Correction of Errors in the
Regulations Text
In FR Doc. 16–26668 appearing on
page 80170 in the Federal Register of
Tuesday, November 16, 2016, the
following corrections are made:
■ 1. On pages 80552 and 80553, correct
§ 410.79 by—
■ a. In paragraph (b):
■ i. Removing the definition of
‘‘Evaluation weight’’;
■ ii. Revising the definitions of ‘‘MDPP
supplier’’, ‘‘Medicare Diabetes
Prevention Program (MDPP)’’, and
‘‘Required minimum weight loss’’;
■ iii. In the definition of ‘‘National
Diabetes Prevention Program, removing
‘‘(DPP)’’ and adding in its place the term
‘‘(National DPP) ’’; and
■ b. Revising paragraphs (c)(1)(ii),
(c)(1)(iv) and (c)(2)(i).
The revisions read as follows:
§ 410.79 Medicare diabetes prevention
program expanded model: Conditions of
coverage.
mstockstill on DSK3G9T082PROD with RULES
*
*
*
*
*
(b) * * *
MDPP supplier refers to an entity that
has enrolled in Medicare to furnish
MDPP services.
Medicare Diabetes Prevention
Program (MDPP) refers to a model test
expanded under section 1115A(c) of the
Act that makes MDPP services available
to MDPP eligible beneficiaries.
*
*
*
*
*
VerDate Sep<11>2014
17:25 Nov 17, 2016
Jkt 241001
Required minimum weight loss refers
to the percentage by which the
beneficiary’s updated weight is less than
the baseline weight. The required
minimum weight loss percentage is 5
percent.
(c) * * *
(1) * * *
(ii) Have as of the date of attendance
at the first core session a body mass
index (BMI) of at least 25 if not selfidentified as Asian or a BMI of at least
23 if self-identified as Asian.
*
*
*
*
*
(iv) Have no previous diagnosis of
type 1 or type 2 diabetes (other than
gestational diabetes).
*
*
*
*
*
(2) * * *
(i) Core sessions and core
maintenance sessions. MDPP suppliers
must furnish to MDPP eligible
beneficiaries the MDPP core benefit.
Sixteen core sessions must be furnished
at least a week apart over the first 6
months. At least one core maintenance
session must be furnished in each of the
second 6 months. All core sessions and
core maintenance sessions must have a
duration of approximately one hour.
MDPP suppliers must address at least 16
different curriculum topics in the core
sessions and at least 6 different
curriculum topics in the core
maintenance sessions.
*
*
*
*
*
■ 2. On page 80558, correct § 424.59 by
revising paragraphs (a)(1) and (5),
(b)(4)(i), and (e)(2)(i) to read as follows:
§ 424.59 Requirements for Medicare
diabetes prevention program suppliers.
(a) * * *
(1) At the time of enrollment has full
CDC DPRP recognition.
*
*
*
*
*
(5) Submits a roster of all coaches
who will be furnishing MDPP services
on the entity’s behalf that includes the
coaches’ first and last names, SSN, and
NPI.
(b) * * *
(4) * * *
(i) Has attended one, four or nine core
sessions, or
*
*
*
*
*
(e) * * *
(2) * * *
(i) Become eligible to bill for MDPP
services again if it meets the
requirements of paragraph (a)(1) of this
section, and enrolls again in Medicare
as an MDPP supplier subject to
paragraph (a) of this section.
*
*
*
*
*
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
Dated: November 14, 2016.
Madhura Valverde,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2016–27733 Filed 11–15–16; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 151211999–6343–02]
RIN 0648–XF002
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; Georges Bank Cod Trimester
Total Allowable Catch Area Closure
and Possession and Trip Limit
Reductions for the Common Pool
Fishery
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; area closure
and inseason adjustment.
AGENCY:
This action closes the Georges
Bank Cod Trimester Total Allowable
Catch Area to Northeast multispecies
common pool vessels and adjusts the
Georges Bank cod possession and trip
limit for common pool vessels for the
remainder of Trimester 2, through
December 31, 2016. The common pool
fishery is projected to catch 90 percent
of its Trimester 2 quota for Georges
Bank cod. The closure and possession
and trip limit reductions are intended to
prevent an overage of the common
pool’s quota for this stock.
DATES: This action is effective
November 15, 2016, through December
31, 2016.
FOR FURTHER INFORMATION CONTACT: Liz
Sullivan, Fishery Management
Specialist, (978) 282–8493.
SUPPLEMENTARY INFORMATION: Federal
regulations at 50 CFR 648.82(n)(2)(ii)
require the Regional Administrator to
close a common pool Trimester Total
Allowable Catch (TAC) Area for a stock
when 90 percent of the Trimester TAC
is projected to be caught. The closure
applies to all common pool vessels
fishing with gear capable of catching
that stock for the remainder of the
trimester.
As of November 5, 2016, the common
pool fishery has caught approximately
87 percent of the Trimester 2 TAC (4.2
mt) for Georges Bank (GB) cod. We
SUMMARY:
E:\FR\FM\18NOR1.SGM
18NOR1
Agencies
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Rules and Regulations]
[Pages 81697-81698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27733]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460
[CMS-1654-CN2]
RIN 0938-AS81
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2017;
Medicare Advantage Bid Pricing Data Release; Medicare Advantage and
Part D Medical Loss Ratio Data Release; Medicare Advantage Provider
Network Requirements; Expansion of Medicare Diabetes Prevention Program
Model; Medicare Shared Savings Program Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical errors in the final rule that
was placed on public inspection at the Office of the Federal Register
on November 2, 2016 and scheduled for publication in the Federal
Register on November 15, 2016. That rule is entitled, ``Medicare
Program; Revisions to Payment Policies under the Physician Fee Schedule
and Other Revisions to Part B for CY 2017; Medicare Advantage Bid
Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio
Data Release; Medicare Advantage Provider Network Requirements;
Expansion of Medicare Diabetes Prevention Program Model; Medicare
Shared Savings Program Requirements.''
DATES: This correcting document is effective January 1, 2017.
FOR FURTHER INFORMATION CONTACT: Terri Plumb, (410) 786-4481, Gaysha
Brooks, (410) 786-9649, or Annette Brewer (410) 786-6580.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc 2016-26668, that was placed on public inspection at the
Office of the Federal Register on November 2, 2016 and scheduled for
publication in the Federal Register on November 15, 2016, there were
technical errors that are identified and corrected in this correcting
document.
II. Summary of Errors in the Regulations Text
In the CY 2017 PFS final rule, we inadvertently omitted or included
language in Sec. 410.79(b), (c)(1)(ii) and (iv), (c)(2)(i) and Sec.
424.59(a)(1) and (5), (b)(4)(i), and (e)(2)(i).
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rule in the
Federal Register and provide a period for public comment before the
provisions of a rule take effect. In addition, section 553(d) of the
APA mandates a 30-day delay in effective date after issuance or
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the APA notice and comment, and delay in
effective date requirements. Section 553(b)(B) of the APA authorizes an
agency to dispense with normal notice and comment rulemaking procedures
for good cause if the agency makes a finding that the notice and
comment process is impracticable, unnecessary, or contrary to the
public interest; and includes a statement of the finding and the
reasons for it in the rule. In addition, section 553(d)(3) of the APA
allows the agency to avoid the 30-day delay in effective date where
such delay is contrary to the public interest and the agency includes
in the rule a statement of the finding and the reasons for it.
In our view, this correcting document does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects technical errors in the CY 2017 PFS final rule. The
corrections contained in this document are consistent with, and do not
make substantive changes to, the policies and payment methodologies
[[Page 81698]]
that were proposed subject to notice and comment procedures in the CY
2017 PFS final rule. As a result, the correction made through this
correcting document is intended to resolve inadvertent errors so that
the rule accurately reflects the policies in the final rule.
Even if this were a rulemaking to which the notice and comment and
delayed effective date requirements applied, we find that there is good
cause to waive such requirements. Undertaking further notice and
comment procedures to incorporate the corrections in this document into
the CY 2017 PFS final rule or delaying the effective date of the
corrections would be contrary to the public interest because it is in
the public interest to ensure that the rule accurately reflects the
public comment period. Further, such procedures would be unnecessary,
because we are not making any substantive revisions to the final rule,
but rather, we are simply correcting the Federal Register document to
reflect the policies in the final rule. For these reasons, we believe
there is good cause to waive the requirements for notice and comment
and delay in effective date.
IV. Correction of Errors in the Regulations Text
In FR Doc. 16-26668 appearing on page 80170 in the Federal Register
of Tuesday, November 16, 2016, the following corrections are made:
0
1. On pages 80552 and 80553, correct Sec. 410.79 by--
0
a. In paragraph (b):
0
i. Removing the definition of ``Evaluation weight'';
0
ii. Revising the definitions of ``MDPP supplier'', ``Medicare Diabetes
Prevention Program (MDPP)'', and ``Required minimum weight loss'';
0
iii. In the definition of ``National Diabetes Prevention Program,
removing ``(DPP)'' and adding in its place the term ``(National DPP)
''; and
0
b. Revising paragraphs (c)(1)(ii), (c)(1)(iv) and (c)(2)(i).
The revisions read as follows:
Sec. 410.79 Medicare diabetes prevention program expanded model:
Conditions of coverage.
* * * * *
(b) * * *
MDPP supplier refers to an entity that has enrolled in Medicare to
furnish MDPP services.
Medicare Diabetes Prevention Program (MDPP) refers to a model test
expanded under section 1115A(c) of the Act that makes MDPP services
available to MDPP eligible beneficiaries.
* * * * *
Required minimum weight loss refers to the percentage by which the
beneficiary's updated weight is less than the baseline weight. The
required minimum weight loss percentage is 5 percent.
(c) * * *
(1) * * *
(ii) Have as of the date of attendance at the first core session a
body mass index (BMI) of at least 25 if not self-identified as Asian or
a BMI of at least 23 if self-identified as Asian.
* * * * *
(iv) Have no previous diagnosis of type 1 or type 2 diabetes (other
than gestational diabetes).
* * * * *
(2) * * *
(i) Core sessions and core maintenance sessions. MDPP suppliers
must furnish to MDPP eligible beneficiaries the MDPP core benefit.
Sixteen core sessions must be furnished at least a week apart over the
first 6 months. At least one core maintenance session must be furnished
in each of the second 6 months. All core sessions and core maintenance
sessions must have a duration of approximately one hour. MDPP suppliers
must address at least 16 different curriculum topics in the core
sessions and at least 6 different curriculum topics in the core
maintenance sessions.
* * * * *
0
2. On page 80558, correct Sec. 424.59 by revising paragraphs (a)(1)
and (5), (b)(4)(i), and (e)(2)(i) to read as follows:
Sec. 424.59 Requirements for Medicare diabetes prevention program
suppliers.
(a) * * *
(1) At the time of enrollment has full CDC DPRP recognition.
* * * * *
(5) Submits a roster of all coaches who will be furnishing MDPP
services on the entity's behalf that includes the coaches' first and
last names, SSN, and NPI.
(b) * * *
(4) * * *
(i) Has attended one, four or nine core sessions, or
* * * * *
(e) * * *
(2) * * *
(i) Become eligible to bill for MDPP services again if it meets the
requirements of paragraph (a)(1) of this section, and enrolls again in
Medicare as an MDPP supplier subject to paragraph (a) of this section.
* * * * *
Dated: November 14, 2016.
Madhura Valverde,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2016-27733 Filed 11-15-16; 11:15 am]
BILLING CODE 4120-01-P