Department of Health and Human Services January 2022 – Federal Register Recent Federal Regulation Documents

This proposed rule includes proposed payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs, as well as proposed 2023 user fee rates for issuers offering qualified health plans (QHPs) through federally- facilitated Exchanges and State-based Exchanges on the Federal platform. This proposed rule also proposes requirements related to prohibiting discrimination based on sexual orientation and gender identity; guaranteed availability; the offering of QHP standardized options through Exchanges on the Federal platform; requirements for agents, brokers, web-brokers, and issuers assisting consumers with enrollment through Exchanges that use the Federal platform; verification standards related to employer sponsored coverage; Exchange eligibility determinations during a benefit year; special enrollment period verification; cost-sharing requirements; Essential Health Benefits (EHBs); Actuarial Value (AV); QHP issuer quality improvement strategies; accounting for quality improvement activity (QIA) expenses and provider incentives for medical loss ratio (MLR) reporting and rebate calculation purposes; re-enrollment, and requirements related to a new State Exchange improper payment measurement program. This proposed rule also seeks comment on how HHS can advance health equity through QHP certification standards and otherwise in the individual and group health insurance markets, and how HHS might address plan choice overload in the Exchanges.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring William Kulakevich for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kulakevich was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Kulakevich's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kulakevich was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 16, 2021 (30 days after receipt of the notice), Mr. Kulakevich had not responded. Mr. Kulakevich's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of the Chief Scientist (OCS) has modified their organizational structure. The new organizational structure was approved by the Deputy Secretary of Health and Human Services and effective on November 24, 2021.

HRSA, a sub-agency of the Department of Health and Human Services, is announcing a change in the NPDB Basis for Action Code Lists for Federal Licensure, and State Licensure or Certification Actions to individuals and entities authorized to report and request information from the NPDB. These changes will contain updated codes and code use guidance applicable to organizations submitting Federal Licensure, or State Licensure or Certification Actions. The code modifications and guidance are intended to provide improved report accuracy and promote a better understanding of the use and application of the basis of action codes available for report submission. The modifications are based in part upon recommendations made through a collaborative effort with NPDB industry partners: the Federation of State Boards of Physical Therapy, the National Council of State Boards of Nursing, the Federation of State Medical Boards, the Association of State and Provincial Psychology Boards, the National Board for Certification in Occupational Therapy, the Association of Social Work Boards, and the National Association of Boards of Pharmacy. Basis for Action codes help to accurately describe the basis for licensure actions reported. Basis for Action codes have no impact on the licensure action reported or the applicability of NPDB reporting criteria. New, modified, and retired codes have no impact on historical reporting. The coding of previously submitted reports will remain unchanged.

The National Center for Advancing Translational Sciences (NCATS) will host a public online forum to enable public discussion of the Center's proposals to reorganize its Office of Rare Diseases Research and Office of Grants Management and Scientific Review to the Division of Rare Diseases Innovation and the Division of Extramural Activities, respectively. The proposals seek to recognize the importance of rare diseases research to the Center and to align its extramural activities with those of other Institutes and Centers at the National Institutes of Health. The online forum will allow members of the public to review the reorganization proposals and submit comments.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council 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. During the January 24, 2022 meeting the Advisory Council will hear about the National Plan to Address Alzheimer's Disease: 2021 Update, as well as update from federal agencies. The Advisory Council will also hear presentations about dementia risk reduction for veterans and research on the potential relationship between COVID-19 and dementia. The Advisory Council will also hear about a recent report on the current capacity of the dementia care workforce. A panel will present on dementia assessment tools for special populations, such as individuals with intellectual and developmental disabilities. Finally, the Advisory Council will hear from a panel on the inclusion of caregivers in clinical care settings, including those in rural communities.