Department of Health and Human Services November 4, 2016 – Federal Register Recent Federal Regulation Documents

Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26770
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26745
Type: Notice
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-26743
Type: Notice
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Withdrawal of 60-Day Notice of Proposed Information Collection: Unaccompanied Children Case Summary Form
Document Number: 2016-26686
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
On October 4, 2016 at 81 FR 68420, ACF published a 60 Day Notice of Proposed Information Collection entitled ``Unaccompanied Children Case Summary Form.'' ACF is withdrawing this notice from the Federal Register.
Announcement of the Award of Nine Single-Source Program Expansion Supplement Grants Under the Unaccompanied Children's (UC) Program
Document Number: 2016-26673
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the award of nine single-source program expansion supplement grants for a total of $21,164,141 under the UC's Program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26667
Type: Notice
Date: 2016-11-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS): Cooperative Research and Development Agreement (CRADA) and Licensing Opportunity for Ketamine for the Treatment of Depression and Other Anxiety-Related Disorders
Document Number: 2016-26628
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), University of Maryland at Baltimore (UMB) and their collaborators are seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the preclinical and clinical development of ketamine metabolite (2R, 6R-HNK) for the treatment of depression and other anxiety-related disorders.
Proposed Collection; 60-Day Comment Request; The Atherosclerosis Risk in Communities Study (National Heart Lung and Blood Institute)
Document Number: 2016-26627
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute of Mental Health Amended Notice of Meeting
Document Number: 2016-26625
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2016-26624
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2016-26615
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis Facilities
Document Number: 2016-26583
Type: Proposed Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions of the Life Safety Code and adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model
Document Number: 2016-26152
Type: Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
Document Number: 2016-25240
Type: Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.