Department of Health and Human Services July 2021 – Federal Register Recent Federal Regulation Documents

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 proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rulemaking also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rulemaking proposes to update requirements for the ESRD Quality Incentive Program (QIP), including a proposed measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) and as well as proposals to suppress individual ESRD QIP measures under that proposed measure suppression policy. This proposed rule also announces an extension of time for facilities to report September through December 2020 ESRD QIP data under our Extraordinary Circumstances Exception (ECE) policy due to CMS operational issues, and proposes to not score facilities or reduce payment to any facility in PY 2022. In addition, this proposed rule includes requests for information on topics that are relevant to the ESRD QIP. Further, this rule also proposes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries. Finally, this proposed rule includes several requests for information to inform payment reform under the ESRD PPS.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIQRAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEOVU and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' This document describes the requirements for, and FDA's recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule.

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 (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled National Quitline Data Warehouse. The National Quitline Data Warehouse (NQDW) collects a core set of information from all U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smoker's Quitline, regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Muscular Dystrophy Questionnaire: Understanding the impact of COVID-19, flu, pain, fatigue, pregnancy and infertility, on adults with muscular dystrophy. The purpose of the proposed study is to describe the epidemiology of COVID-19 and flu and the experience with pain, fatigue, pregnancy, and infertility for adults living with muscular dystrophy who are identified through the Muscular Dystrophy Surveillance Tracking and Research Network (MD STARnet). Information will be used to develop interventions that improve the lives of people with muscular dystrophy and their families.

This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website.

The Department of Health and Humans Services (HHS) provides notice of the extension of the designation issued on February 1, 2021, under Executive Order 13910 (Executive Order) and section 102 of the Defense Production Act of 1950 (the Act), as amended, designating health and medical resources necessary to respond to the spread of the virus associated with Coronavirus Disease 2019 (COVID-19) that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies. These designated materials are subject to the hoarding prevention measures authorized under the Executive Order and the Act.

This proposed rule would set forth routine updates to the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also provides monitoring and analysis of the Patient-Driven Groupings Model (PDGM); solicits comments on a methodology for determining the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the PDGM case-mix adjustment methodology; and proposes to recalibrate the PDGM case-mix weights, functional levels, and comorbidity adjustment subgroups while maintaining the low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rulemaking proposes to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts; and make conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. This rulemaking also proposes changes to the Home Health Quality Reporting Program (QRP) to remove one measure, remove two claims-based measures and replace them with one claims-based measure, publicly report two measures, propose a modification to the effective date for the reporting of the Transfer of Health to Provider-Post Acute Care and Transfer of Health to Patient-Post Acute Care (TOH) measures and Standardized Patient Assessment Data Elements and requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements. Additionally, this proposed rule requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this proposed rule would incorporate into regulation certain Medicare provider and supplier enrollment policies. In addition, this rulemaking proposes to make permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and would update the home health conditions of participation to implement Division CC, section 115 of the Consolidated Appropriations Act, 2021 (CAA 2021) regarding occupational therapists completing the initial and comprehensive assessments reflect these changes. This proposed rule also would expand the Home Health Value-Based Purchasing (HHVBP) Model, beginning January 1, 2022, to the 50 States, territories, and District of Columbia. This rulemaking also proposes to end the original HHVBP Model one year early for the home health agencies (HHAs) in the nine original Model States, such that CY 2020 performance data would not be used to calculate a payment adjustment for CY 2022 under the original Model. Additionally, this proposed rule establishes survey and enforcement requirements for hospice programs as set forth in Division CC, section 407, of the CAA 2021.

The Administration on Disabilities (AoD) intends to reallot funds under the authority of the Development Disabilities Assistance and Bill of Rights Act of 2000 which states: ``If the Secretary determines that an amount of an allotment to a State for a period (of a fiscal year or longer) will not be required by the State during the period for the purpose for which the allotment was made, the Secretary may reallot the amount.''

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 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 Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposal to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of Adolescent and School Health (DASH) to conduct a research information collection project titled ``Teen and Parents Surveys of Health (TAPS)''. This project serves to inform the CDC's Division of Adolescent and School Health's (DASH) key school- based programmatic strategies of improving family- and school-level protective factors, bolstering health education, and increasing adolescent access to quality health services.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Board on Radiation and Worker Health (ABRWH) for the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). The ABRWH consists of not more than 20 members appointed by the President of the United States, and shall reflect a balance of scientific, medical, and worker perspectives. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the ABRWH's objectives. Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the ABRWH may be asked to consider. Federal employees will not be considered for membership.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications.'' Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as new drug applications (NDAs) or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration. When final, this draft guidance will expand upon the recommendation for in vivo adhesion studies in section V., Special Topics, subsection A., Product Adhesion Considerations, in the draft guidance for industry Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations issued on November 21, 2019.