Department of Health and Human Services July 18, 2019 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The National Health Service Corps Loan Repayment Program, OMB No. 0915-0127-Revision
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products and Related Authorities
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Proposed Information Collection Activity; ORR Data Collection for the Annual Survey of Refugees (OMB #0907-0033)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous five fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 30 to 45 minutes per respondent.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.'' This draft guidance describes the FDA's current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone (GnRH) analogues to treat advanced prostate cancer.
Medicare and Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Efficiency, and Transparency
This proposed rule would reform the Medicare and Medicaid long-term care requirements that the Centers for Medicare & Medicaid Services has identified as unnecessary, obsolete, or excessively burdensome. This rule would increase the ability of health care professionals to apportion resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing high quality care.
Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements
This final rule amends the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, we are repealing the prohibition on the use of pre-dispute, binding arbitration agreements. We are also strengthening the transparency of arbitration agreements and arbitration in LTC facilities. This final rule supports residents' rights to make informed choices about important aspects of their health care.
Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements
This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implement the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This proposed rule also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the ``BBA of 2018'', and proposes a 30-day payment amount for CY 2020. Additionally, this proposed rule proposes to: Modify the payment regulations pertaining to the content of the home health plan of care; allow physical therapy assistants to furnish maintenance therapy; and change the split percentage payment approach under the HH PPS. This proposed rule would also solicit comments on the wage index used to adjust home health payments and suggestions for possible updates and improvements to the geographic adjustment of home health payments. In addition, it proposes public reporting of certain performance data under the Home Health Value-Based Purchasing (HHVBP) Model. We are proposing to publicly report the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. It also proposes changes with respect to the Home Health Quality Reporting Program to remove one measure, to adopt two new measures, modify an existing measure, adopt new standardized patient assessment data beginning with the CY 2022 HH QRP, codify the HH QRP policies in a new section, and to remove question 10 from all the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it would set forth routine updates to the home infusion therapy payment rates for CY 2020 and propose payment provisions for home infusion therapy services for CY 2021 and subsequent years.
Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures
This proposed rule proposes to implement two new mandatory Medicare payment models under section 1115A of the Social Security Actthe Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model). The proposed RO Model would promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model would test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants. The proposed ETC Model would be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model would include ESRD facilities and certain clinicians caring for beneficiaries with ESRD or Managing Clinicianslocated in selected geographic areas as participants. CMS would assess the performance of participating Managing Clinicians and ESRD facilities on their rates of home dialysis and kidney and kidney-pancreas transplants during each Measurement Year (MY), and would subsequently adjust certain of their Medicare payments upward or downward during the corresponding performance payment adjustment period based on their home dialysis rate and transplant rate. CMS would also positively adjust certain Medicare payments to participating ESRD facilities and Managing Clinicians for home dialysis and home dialysis-related claims in the initial 3 years of the ETC Model. We believe that these two proposed models would test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.
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