Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2019, 8282-8296 [2020-02845]

Download as PDF 8282 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices B. Federal Reserve Bank of San Francisco (Applications and Enforcement Section) 101 Market Street, San Francisco, California 94105–1579: 1. GUVJEC Investment Corporation, Baltimore, Maryland; to become a bank holding company by acquiring Farmington Bancorp, Bothell, Washington, and thereby indirectly acquire Farmington State Bank, Farmington, Washington. Board of Governors of the Federal Reserve System, February 10, 2020. Michele Taylor Fennell, Assistant Secretary of the Board. [FR Doc. 2020–02921 Filed 2–12–20; 8:45 am] BILLING CODE P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may Board of Governors of the Federal Reserve System, February 10, 2020. Michele Taylor Fennell, Assistant Secretary of the Board. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9120–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2019 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: ACTION: Notice This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS. SUMMARY: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2020–02922 Filed 2–12–20; 8:45 am] BILLING CODE P Addenda Contact I CMS Manual Instructions ............................................................................................................... II Regulation Documents Published in the Federal Register ......................................................... III CMS Rulings ................................................................................................................................. IV Medicare National Coverage Determinations .............................................................................. V FDA-Approved Category B IDEs .................................................................................................. VI Collections of Information ............................................................................................................ VII Medicare-Approved Carotid Stent Facilities ............................................................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites ........................ IX Medicare’s Active Coverage-Related Guidance Documents ....................................................... X One-time Notices Regarding National Coverage Provisions ........................................................ XI National Oncologic Positron Emission Tomography Registry Sites ............................................ XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ........................ XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ............................................... XIV Medicare-Approved Bariatric Surgery Facilities ........................................................................ XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ................................ All Other Information ......................................................................................................................... Ismael Torres ..................... Terri Plumb ......................... Tiffany Lafferty ................... Wanda Belle, MPA ............. John Manlove ..................... William Parham .................. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ JoAnna Baldwin, MS .......... JoAnna Baldwin, MS .......... David Dolan, MBA .............. David Dolan, MBA .............. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ David Dolan, MBA .............. Annette Brewer .................. SUPPLEMENTARY INFORMATION: jbell on DSKJLSW7X2PROD with NOTICES express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551–0001, not later than March 3, 2020. A. Federal Reserve Bank of Atlanta (Kathryn Haney, Assistant Vice President) 1000 Peachtree Street, NE, Atlanta, Georgia 30309. Comments can also be sent electronically to Applications.Comments@atl.frb.org: 1. The Persons Family Trust, Macon Georgia, George Ogden Persons, III, Macon, Georgia, Jim Gillis Persons, Atlanta, Georgia, and Katherine Persons Kelly, Richmond, Virginia, as cotrustees; together with George Ogden Persons, III, Jim Gillis Persons, Katherine Persons Kelly, Mary K. Persons, Macon, Georgia, James G. Persons, Jr., Atlanta, Georgia, and Robert P. Persons and Harper Lee Kelly, both of Richmond, Virginia; as members of a group acting in concert to retain voting shares of Persons Banking Co., Inc., Macon, Georgia, and thereby indirectly retain voting shares of Persons Banking Company, Forsyth, Georgia. I. Background The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–3365 786–3365 786–2749 786–2749 786–3365 786–6580 communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners E:\FR\FM\13FEN1.SGM 13FEN1 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently. Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 II. Format for the Quarterly Issuance Notices This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ‘‘real time’’ accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 8283 need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information. III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. Dated: January 30, 2020. Kathleen Cantwell Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\13FEN1.SGM 13FEN1 VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.003</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8284 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 8285 EN13FE20.004</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.005</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8286 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 8287 EN13FE20.006</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.007</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8288 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 8289 EN13FE20.008</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.009</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8290 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 8291 EN13FE20.010</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.011</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8292 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 8293 EN13FE20.012</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\13FEN1.SGM 13FEN1 EN13FE20.013</GPH> jbell on DSKJLSW7X2PROD with NOTICES 8294 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\13FEN1.SGM 13FEN1 8295 EN13FE20.014</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices 8296 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices [FR Doc. 2020–02845 Filed 2–12–20; 8:45 am] Written/Paper Submissions BILLING CODE 4120–01–C Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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 Docket No. FDA–2018–D– 2494 for ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2494] Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions.’’ This guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. DATES: The announcement of the guidance is published in the Federal Register on February 13, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: Electronic Submissions 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 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’’). VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jhumur Banik, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993–0002, 240–402–5239. SUPPLEMENTARY INFORMATION: I. Background Atherectomy is an interventional procedure performed to remove atherosclerotic plaque from diseased arteries. FDA has developed this guidance for members of industry who submit and FDA staff who review premarket submissions for atherectomy devices used in the peripheral vasculature. This guidance is intended to provide recommendations for information to include in premarket notifications (510(k)) for peripheral vascular atherectomy devices (e.g., descriptive characteristics, labeling, biocompatibility, sterility, non-clinical, animal, and clinical performance testing). FDA considered comments received on the draft guidance that appeared in the Federal Register of July 27, 2018 (83 FR 35658). FDA revised the guidance as appropriate in response to the comments. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Peripheral E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8282-8296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9120-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2019

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice

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

SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from October through December 2019, 
relating to the Medicare and Medicaid programs and other programs 
administered by CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.

----------------------------------------------------------------------------------------------------------------
                   Addenda                                         Contact                          Phone No.
----------------------------------------------------------------------------------------------------------------
I CMS Manual Instructions...................  Ismael Torres....................................   (410) 786-1864
II Regulation Documents Published in the      Terri Plumb......................................   (410) 786-4481
 Federal Register.
III CMS Rulings.............................  Tiffany Lafferty.................................   (410) 786-7548
IV Medicare National Coverage Determinations  Wanda Belle, MPA.................................   (410) 786-7491
V FDA-Approved Category B IDEs..............  John Manlove.....................................   (410) 786-6877
VI Collections of Information...............  William Parham...................................   (410) 786-4669
VII Medicare-Approved Carotid Stent           Sarah Fulton, MHS................................   (410) 786-2749
 Facilities.
VIII American College of Cardiology-National  Sarah Fulton, MHS................................   (410) 786-2749
 Cardiovascular Data Registry Sites.
IX Medicare's Active Coverage-Related         JoAnna Baldwin, MS...............................   (410) 786-7205
 Guidance Documents.
X One-time Notices Regarding National         JoAnna Baldwin, MS...............................   (410) 786-7205
 Coverage Provisions.
XI National Oncologic Positron Emission       David Dolan, MBA.................................   (410) 786-3365
 Tomography Registry Sites.
XII Medicare-Approved Ventricular Assist      David Dolan, MBA.................................   (410) 786-3365
 Device (Destination Therapy) Facilities.
XIII Medicare-Approved Lung Volume Reduction  Sarah Fulton, MHS................................   (410) 786-2749
 Surgery Facilities.
XIV Medicare-Approved Bariatric Surgery       Sarah Fulton, MHS................................   (410) 786-2749
 Facilities.
XV Fluorodeoxyglucose Positron Emission       David Dolan, MBA.................................   (410) 786-3365
 Tomography for Dementia Trials.
All Other Information.......................  Annette Brewer...................................   (410) 786-6580
----------------------------------------------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: 

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners

[[Page 8283]]

(NAIC), health insurers, and other stakeholders. To implement the 
various statutes on which the programs are based, we issue regulations 
under the authority granted to the Secretary of the Department of 
Health and Human Services under sections 1102, 1871, 1902, and related 
provisions of the Social Security Act (the Act) and Public Health 
Service Act. We also issue various manuals, memoranda, and statements 
necessary to administer and oversee the programs efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS website or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website offers a more convenient tool for the public to find the full 
list of qualified providers for these specific services and offers more 
flexibility and ``real time'' accessibility. In addition, many of the 
websites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the website. These listservs 
avoid the need to check the website, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a 
website proves to be difficult, the contact person listed can provide 
information.

III. How To Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at https://www.cms.gov/manuals.

    Dated: January 30, 2020.
Kathleen Cantwell
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2020-02845 Filed 2-12-20; 8:45 am]
 BILLING CODE 4120-01-C
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