Basic Health Program; Final Administrative Order, 56328-56347 [2018-24673]

Download as PDF 56328 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 screenings? If yes, please explain the scheduling issue that is a barrier and provide recommendations for how it could be overcome. 6. Does concern about the confidentiality of medical information pose a barrier to participation? If this is a barrier, then please provide recommendations or suggestions for how it can be overcome. 7. Does concern that the early identification of dust-related lung disease might adversely affect a miner’s career (e.g., prevent career advancement or the ability to get a new coal mining job) pose a barrier to participation? If this is a barrier, then please provide recommendations or suggestions for how it can be overcome. 8. Does concern that early identification of dust-related lung disease might affect subsequent eligibility for compensation through Federal or State programs pose a barrier to participation? If this is a barrier, then please describe the specific compensation programs and how eligibility for them can be affected by early detection of dust-related lung disease. Please also provide recommendations or suggestions for how this barrier could be overcome. 9. Does concern that personal finances will require a miner to continue working despite early identification of dust-related lung disease pose a barrier to participation? If this is a barrier, please provide recommendations or suggestions for how it can be overcome. 10. Are there any other barriers to participation that NIOSH should be aware of? Interested parties may participate in this activity by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you do not wish to be disclosed. Although your name, contact information, or other information that identifies you in the body of your comments will be on public display, NIOSH will review all submissions and may choose to redact or withhold VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 submissions containing private or proprietary information such as Social Security numbers, medical information, and/or inappropriate language. Comments may be submitted on any topic related to this action. All public comments will be posted in the docket for this action at https:// www.regulations.gov. John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2018–24700 Filed 11–9–18; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–2416–N] Basic Health Program; Final Administrative Order Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of Final Administrative Order. AGENCY: This notice serves to announce that a Final Administrative Order related to the Basic Health Program (BHP) was issued to the States of New York and Minnesota on August 24, 2018. DATES: The Final Administrative Order was effective August 24, 2018. FOR FURTHER INFORMATION CONTACT: Christopher Truffer, (410) 786–1264; Meg Barry, (410) 786–1536. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background and Provisions of the Notice The CMS Administrator issued a Final Administrative Order to set forth the revised payment methodology that applies to the Basic Health Program for 2018 only (HHS Revised BHP Payment Methodology). The Administrative Order is an agency action under 5 U.S.C. 551(13), issued pursuant to 5 U.S.C. 555(b) and (e). The HHS Revised BHP Payment Methodology modifies the existing PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 methodology for 2018, which is set forth in the payment notice entitled ‘‘Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018’’ (81 FR 10091, February 29, 2016) (February 2016 Payment Notice). The modification involves the application of a Premium Adjustment Factor (PAF) that considers the premium increases in other states that became effective after the Centers for Medicare & Medicaid Services (CMS), an operating division of the U.S. Department of Health and Human Services (HHS), discontinued payments to issuers for cost-sharing reductions (CSRs) provided to enrollees in qualified health plans (QHPs) offered on health insurance Exchanges. On July 6, 2018, pursuant to an amended stipulated order issued in State of New York v. U.S. Department of Health and Human Services, 18–cv– 00683 (S.D.N.Y. filed Jan. 26, 2018), CMS issued a Draft Administrative Order on which New York and Minnesota (the States) had an opportunity to comment. The States each submitted comments on August 6, 2018. CMS considered those comments in issuing the Final Administrative Order, which adopts the HHS Revised BHP Payment Methodology for 2018 as set forth in the Draft Administrative Order. II. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, 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.) is not required. III. Addendum We are publishing the Final Administrative Order as an addendum to this Notice. Dated: November 2, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. BILLING CODE 4120–01–P E:\FR\FM\13NON1.SGM 13NON1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56329 ADDENDUM HHS "'"'v'"'"" which set and the HHS forth VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.099</GPH> amozie on DSK3GDR082PROD with NOTICES1 Ad:mir:istrathre Order. 56330 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices The result I. is standard health to enroll m state's make determine VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.100</GPH> amozie on DSK3GDR082PROD with NOTICES1 value 56331 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices other States with nr•?vi.llen to residents to other BHP VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.101</GPH> amozie on DSK3GDR082PROD with NOTICES1 BHP 56332 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices in resJJonse to HilS the best int~~rnTPctll!'inn to II. the HHS cornpcment of their VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.102</GPH> amozie on DSK3GDR082PROD with NOTICES1 calculated under 56333 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices or take other than BHP result re~cJoe:n the docket On June to amend the III. modification and the HHS Revised BHP BliP uav.u"'""" v<II'"'"U~I~ the BHP f'il'l"m"'PI'If in BHP enrollee in BHP VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.103</GPH> amozie on DSK3GDR082PROD with NOTICES1 enrolled 56334 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices IRF • • • • • • • • • • • VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.104</GPH> amozie on DSK3GDR082PROD with NOTICES1 the BHP 56335 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices the for PTC rate cell in that the number ofBHP cell rate cell \"""·ll·"·"'·" number CSR calculate the the BHP PMT In to nre:ser1tlv no available The UI<:altiUUI ini"T..I'>l:!"'\\l ~>nru''"''" in other "'""'"'"''""' to make that CMS l#m.uuc~;;:s the """""'"',. amount "shall to rt<>t't11'111"\!>liH''t\ in residents VerDate Sep<11>2014 17:34 Nov 09, 2018 the Jkt 247001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.105</GPH> amozie on DSK3GDR082PROD with NOTICES1 • 56336 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices • • • VerDate Sep<11>2014 • 1.188. • 1.188. 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.106</GPH> amozie on DSK3GDR082PROD with NOTICES1 PAF VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 56337 EN13NO18.107</GPH> amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56338 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices v. VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.108</GPH> amozie on DSK3GDR082PROD with NOTICES1 10 VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 56339 EN13NO18.109</GPH> amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices VerDate Sep<11>2014 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.110</GPH> amozie on DSK3GDR082PROD with NOTICES1 56340 VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 56341 EN13NO18.111</GPH> amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices VerDate Sep<11>2014 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.112</GPH> amozie on DSK3GDR082PROD with NOTICES1 56342 VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 56343 EN13NO18.113</GPH> amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices VerDate Sep<11>2014 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.114</GPH> amozie on DSK3GDR082PROD with NOTICES1 56344 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56345 VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.115</GPH> amozie on DSK3GDR082PROD with NOTICES1 Difference VerDate Sep<11>2014 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 E:\FR\FM\13NON1.SGM 13NON1 EN13NO18.116</GPH> amozie on DSK3GDR082PROD with NOTICES1 56346 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices ACTION: [FR Doc. 2018–24673 Filed 11–9–18; 8:45 am] BILLING CODE 4120–01–C The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2017–N–0558; FDA– 2017–N–1315; FDA–2011–N–0776; FDA– 2018–N–3038; FDA–2018–N–0405; FDA– 2014–N–1048; FDA–2011–N–0908; FDA– 2011–N–0920; and FDA–2018–N–1857] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Notice. Food and Drug Administration, HHS. 56347 Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Disclosures in Professional and Consumer Prescription Drug Promotion .............................................................. Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads .......................... Reclassification Petitions for Medical Devices ........................................................................................................ Request for Samples and Protocols ........................................................................................................................ Medical Device Recall Authority .............................................................................................................................. Food Safety, Health, and Diet Survey ..................................................................................................................... Medical Device Labeling Regulations ..................................................................................................................... GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food ..................................................................................................................................................................... Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals ................................................................................................................................................................. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24609 Filed 11–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4100] Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. amozie on DSK3GDR082PROD with NOTICES1 ACTION: VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 The public meeting will be held on December 11, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by January 31, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information. DATES: The public meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security ADDRESSES: The Food and Drug Administration (FDA or the Agency) is announcing a public meeting entitled ‘‘Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.’’ This public meeting is intended to fulfill commitments made by FDA under the sixth authorization of the SUMMARY: Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Date approval expires 0910–0860 0910–0861 0910–0138 0910–0206 0910–0432 0910–0345 0910–0485 0910–0581 9/30/2020 9/30/2020 9/30/2021 9/30/2021 9/30/2021 10/31/2020 10/30/2021 10/31/2021 0910–0751 10/31/2021 0910–0789 10/31/2021 information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241 740.htm. You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration we request that electronic comments be submitted on or before January 31, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on January 31, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56328-56347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2416-N]


Basic Health Program; Final Administrative Order

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

ACTION: Notice of Final Administrative Order.

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

SUMMARY: This notice serves to announce that a Final Administrative 
Order related to the Basic Health Program (BHP) was issued to the 
States of New York and Minnesota on August 24, 2018.

DATES: The Final Administrative Order was effective August 24, 2018.

FOR FURTHER INFORMATION CONTACT: Christopher Truffer, (410) 786-1264; 
Meg Barry, (410) 786-1536.

SUPPLEMENTARY INFORMATION:

I. Background and Provisions of the Notice

    The CMS Administrator issued a Final Administrative Order to set 
forth the revised payment methodology that applies to the Basic Health 
Program for 2018 only (HHS Revised BHP Payment Methodology). The 
Administrative Order is an agency action under 5 U.S.C. 551(13), issued 
pursuant to 5 U.S.C. 555(b) and (e).
    The HHS Revised BHP Payment Methodology modifies the existing 
methodology for 2018, which is set forth in the payment notice entitled 
``Basic Health Program; Federal Funding Methodology for Program Years 
2017 and 2018'' (81 FR 10091, February 29, 2016) (February 2016 Payment 
Notice). The modification involves the application of a Premium 
Adjustment Factor (PAF) that considers the premium increases in other 
states that became effective after the Centers for Medicare & Medicaid 
Services (CMS), an operating division of the U.S. Department of Health 
and Human Services (HHS), discontinued payments to issuers for cost-
sharing reductions (CSRs) provided to enrollees in qualified health 
plans (QHPs) offered on health insurance Exchanges.
    On July 6, 2018, pursuant to an amended stipulated order issued in 
State of New York v. U.S. Department of Health and Human Services, 18-
cv-00683 (S.D.N.Y. filed Jan. 26, 2018), CMS issued a Draft 
Administrative Order on which New York and Minnesota (the States) had 
an opportunity to comment. The States each submitted comments on August 
6, 2018. CMS considered those comments in issuing the Final 
Administrative Order, which adopts the HHS Revised BHP Payment 
Methodology for 2018 as set forth in the Draft Administrative Order.

II. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, 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.) is not required.

III. Addendum

    We are publishing the Final Administrative Order as an addendum to 
this Notice.

    Dated: November 2, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
 BILLING CODE 4120-01-P

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[FR Doc. 2018-24673 Filed 11-9-18; 8:45 am]
 BILLING CODE 4120-01-C

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