81 FR 81697 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 223 (November 18, 2016)

Page Range		81697-81698
FR Document		2016-27733

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.''

Federal Register, Volume 81 Issue 223 (Friday, November 18, 2016)

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Rules and Regulations]
[Pages 81697-81698]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27733]


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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

Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Rules and Regulations 81697

Medical gas Color normal use. Each such label as well as Prevention Program Model; Medicare
materials used for coloring medical gas Shared Savings Program Requirements.’’
Medical Air ................ Yellow. containers must be reasonably resistant DATES: This correcting document is
Carbon Dioxide ......... Gray. to fading, durable when exposed to effective January 1, 2017.
Helium ....................... Brown. atmospheric conditions, and not readily
Nitrogen ..................... Black. FOR FURTHER INFORMATION CONTACT:
Nitrous Oxide ............ Blue.
soluble in water. Terri Plumb, (410) 786–4481, Gaysha
Oxygen ...................... Green. ■ 6. Amend § 211.125 by adding a Brooks, (410) 786–9649, or Annette
Mixture or Blend ........ Colors corresponding sentence to the end of paragraph (c) to Brewer (410) 786–6580.
to each component read as follows: SUPPLEMENTARY INFORMATION:
gas.
§ 211.125 Labeling issuance. I. Background
PART 211—CURRENT GOOD * * * * *
(c) * * * Labeling reconciliation is In FR Doc 2016–26668, that was
MANUFACTURING PRACTICE FOR placed on public inspection at the
also waived for 360° wraparound labels
FINISHED PHARMACEUTICALS Office of the Federal Register on
on portable cryogenic medical gas
containers. November 2, 2016 and scheduled for
■ 4. The authority citation for part 211 publication in the Federal Register on
continues to read as follows: * * * * * November 15, 2016, there were
Dated: November 15, 2016. technical errors that are identified and
Authority: 21 U.S.C. 321, 351, 352, 355,
360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Leslie Kux, corrected in this correcting document.
Associate Commissioner for Policy.
■ 5. Amend § 211.94 by adding new II. Summary of Errors in the
paragraph (e) to read as follows: [FR Doc. 2016–27838 Filed 11–17–16; 8:45 am]
Regulations Text
BILLING CODE 4164–01–P
§ 211.94 Drug product containers and In the CY 2017 PFS final rule, we
closures. inadvertently omitted or included
* * * * * DEPARTMENT OF HEALTH AND language in § 410.79(b), (c)(1)(ii) and
(e) Medical gas containers and HUMAN SERVICES (iv), (c)(2)(i) and § 424.59(a)(1) and (5),
closures must meet the following (b)(4)(i), and (e)(2)(i).
requirements—(1) Gas-specific use Centers for Medicare & Medicaid
Services III. Waiver of Proposed Rulemaking
outlet connections. Portable cryogenic and Delay in Effective Date
medical gas containers that are not
manufactured with permanent gas use 42 CFR Parts 405, 410, 411, 414, 417, Under 5 U.S.C. 553(b) of the
outlet connections (e.g., those that have 422, 423, 424, 425, and 460 Administrative Procedure Act (APA),
been silver-brazed) must have gas- the agency is required to publish a
[CMS–1654–CN2]
specific use outlet connections that are notice of the proposed rule in the
attached to the valve body so that they RIN 0938–AS81 Federal Register and provide a period
cannot be readily removed or replaced for public comment before the
(without making the valve inoperable Medicare Program; Revisions to provisions of a rule take effect. In
and preventing the containers’ use) Payment Policies Under the Physician addition, section 553(d) of the APA
except by the manufacturer. For the Fee Schedule and Other Revisions to mandates a 30-day delay in effective
purposes of this paragraph, the term Part B for CY 2017; Medicare date after issuance or publication of a
‘‘manufacturer’’ includes any individual Advantage Bid Pricing Data Release; rule. Sections 553(b)(B) and 553(d)(3) of
or firm that fills high-pressure medical Medicare Advantage and Part D the APA provide for exceptions from the
gas cylinders or cryogenic medical gas Medical Loss Ratio Data Release; APA notice and comment, and delay in
containers. For the purposes of this Medicare Advantage Provider Network effective date requirements. Section
section, a ‘‘portable cryogenic medical Requirements; Expansion of Medicare 553(b)(B) of the APA authorizes an
gas container’’ is one that is capable of Diabetes Prevention Program Model; agency to dispense with normal notice
being transported and is intended to be Medicare Shared Savings Program and comment rulemaking procedures
attached to a medical gas supply system Requirements for good cause if the agency makes a
within a hospital, health care entity, AGENCY: Centers for Medicare & finding that the notice and comment
nursing home, other facility, or home Medicaid Services (CMS), HHS. process is impracticable, unnecessary,
health care setting, or is a base unit used ACTION: Final rule; correction. or contrary to the public interest; and
to fill small cryogenic gas containers for includes a statement of the finding and
use by individual patients. The term SUMMARY: This document corrects the reasons for it in the rule. In addition,
does not include cryogenic containers technical errors in the final rule that section 553(d)(3) of the APA allows the
that are not designed to be connected to was placed on public inspection at the agency to avoid the 30-day delay in
a medical gas supply system, e.g., tank Office of the Federal Register on effective date where such delay is
trucks, trailers, rail cars, or small November 2, 2016 and scheduled for contrary to the public interest and the
cryogenic gas containers for use by publication in the Federal Register on agency includes in the rule a statement
individual patients (including portable November 15, 2016. That rule is of the finding and the reasons for it.
liquid oxygen units as defined at entitled, ‘‘Medicare Program; Revisions In our view, this correcting document
§ 868.5655 of this chapter). to Payment Policies under the Physician does not constitute a rulemaking that
mstockstill on DSK3G9T082PROD with RULES

(2) Label and coloring requirements. Fee Schedule and Other Revisions to would be subject to these requirements.
The labeling specified at § 201.328(a) of Part B for CY 2017; Medicare Advantage This document merely corrects
this chapter must be affixed to the Bid Pricing Data Release; Medicare technical errors in the CY 2017 PFS
container in a manner that does not Advantage and Part D Medical Loss final rule. The corrections contained in
interfere with other labeling and such Ratio Data Release; Medicare Advantage this document are consistent with, and
that it is not susceptible to becoming Provider Network Requirements; do not make substantive changes to, the
worn or inadvertently detached during Expansion of Medicare Diabetes policies and payment methodologies

VerDate Sep<11>2014 17:25 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\18NOR1.SGM 18NOR1

Document Created: 2018-02-14 08:32:00
Document Modified: 2018-02-14 08:32:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; correction.
Dates		This correcting document is effective January 1, 2017.
Contact		Terri Plumb, (410) 786-4481, Gaysha Brooks, (410) 786-9649, or Annette Brewer (410) 786-6580.
FR Citation		81 FR 81697
RIN Number		0938-AS81
CFR Citation		42 CFR 405 42 CFR 410 42 CFR 411 42 CFR 414 42 CFR 417 42 CFR 422 42 CFR 423 42 CFR 424 42 CFR 425 42 CFR 460

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 223 (November 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services