Department of Health and Human Services July 2018 – Federal Register Recent Federal Regulation Documents

This proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. It also proposes updates to the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; proposes a rebasing of the HH market basket (which includes a decrease in the labor-related share); proposes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 hereinafter referred to as the ``BBA of 2018''; proposes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and proposes to define ``remote patient monitoring'' and recognize the cost associated as an allowable administrative cost. Additionally, it proposes case-mix methodology refinements to be implemented for home health services beginning on or after January 1, 2020, including 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 BBA of 2018; includes information on the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020, as required by section 50401 of the BBA of 2018; solicits comments regarding payment for home infusion therapy services for CY 2021 and subsequent years; proposes health and safety standards for home infusion therapy; and proposes an accreditation and oversight process for home infusion therapy suppliers. This rule proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model to remove two OASIS-based measures, replace three OASIS-based measures with two new proposed composite measures, rescore the maximum number of improvement points, and reweight the measures in the applicable measures set. Also, the Home Health Quality Reporting Program provisions include a discussion of the Meaningful Measures Initiative and propose the removal of seven measures to further the priorities of this initiative. In addition, the HH QRP offers a discussion on social risk factors and an update on implementation efforts for certain provisions of the IMPACT Act. This proposed rule clarifies the regulatory text to note that not all OASIS data is required for the HH QRP. Finally, it would require that accrediting organization surveyors take CMS-provided training.

This proposed rule would remove the regulatory text that allows a state to make payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We are concerned that these provisions are overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. As we noted in our prior rulemaking, section 1902(a)(32) of the Act provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's postmarketing adverse drug experience reporting and recordkeeping requirements.

The Administration for Children and Families (ACF) is proposing an increase in the number of sites for data collection activities to be conducted as part of the Evaluation of Employment Coaching for TANF and Other Low-Income Populations. The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs approved this information collection in March 2018 (0970-0506). As approved, we planned to include three employment programs. We have since identified three additional employment programs to include in the study. This Notice provides the opportunity for public comment on the addition of three sites. This study will provide an opportunity to learn more about the potential of coaching to help clients achieve self-sufficiency and other desired employment-related outcomes. The programs included in the study are Temporary Assistance for Needy Families (TANF) agencies and other public or private employment programs that serve low-income individuals. Selected sites include a robust coaching component and have the capacity to conduct a rigorous impact evaluation, among other criteria. This study will provide information on whether coaching helps people obtain and retain jobs, advance in their careers, move toward self-sufficiency, and improve their overall well-being. To meet these objectives, this study includes an impact and implementation study. The impact study involves participants being randomly assigned to either a ``program group,'' who will be paired with a coach, or to a ``control group,'' who will not be paired with a coach. The effectiveness of the coaching will be determined by differences between members of the program and control groups in outcomes such as obtaining and retaining employment, earnings, measures of self-sufficiency, and measures of self-regulation. The implementation study will document coaching practices, describe lessons learned from implementing coaching, and enhance interpretation of the impact study findings. The proposed information collection activities have not changed since OMB/OIRA approval. The only change to this information collection is to add three additional sites. Respondents: Program staff and individuals enrolled in the Evaluation of Employment Coaching for TANF and Other Low-Income Populations. Program staff may include coaches, case managers, workshop instructors, job developers, supervisors, and managers. All participants will be able to opt out of participating in the data collection activities.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by 60 room seating and 100 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, August 13, 2018. Persons who desire to make an oral statement, may request it at the time of the public comment period on August 21, 2018 at 3:20 p.m., EDT.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance revises the draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention'' issued on November 23, 2007.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components with revised recommendations to reduce the risk of transmission of Zika virus (ZIKV) by blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance announced in this notice supersedes the document of the same title dated August 2016 (August 2016 Guidance).

This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2016 and the preliminary federal share DSH allotments for FY 2018. This notice also announces the final FY 2016 and the preliminary FY 2018 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/ Alzheimer's Association's joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.

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 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.

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 (PRA).

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.