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
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