Department of Health and Human Services June 2, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the process for publishing FDA Emergency Use Authorizations (EUAs) for medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA believes that this process will allow the Agency to rapidly publish EUAs that have been issued for medical devices under the Federal Food, Drug, and Cosmetic Act.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the ``Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)'' (OMB Control No. 0920-1204, expiration date 11/30/2020). The ACBS is an in-depth asthma survey conducted on a subset of BRFSS respondents with an asthma diagnosis. The goal of this survey is to strengthen the existing body of asthma data and to address critical questions surrounding the health and experiences of persons with asthma.

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 Medical Monitoring Project Facility Survey, a one-time survey of the characteristics of HIV care facilities in order to collect information on the nation's existing HIV care infrastructure and the capacity of facilities to implement the strategies of the U.S. Ending the HIV Epidemic Federal Initiative.

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 ``Assessments of adults' professional experiences for improving programs to decrease sexual risk and related behaviors and adverse health outcomes among youth,'' a generic information collection package that supports qualitative and quantitative data collection from adults who help implement programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy or influence related risk and protective factors; data will be collected for needs assessment and program refinement.

This rule proposes to adopt certain changes to the risk adjustment data validation error estimation methodology starting with the 2019 benefit year and beyond for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. The Patient Protection and Affordable Care Act (PPACA) established a permanent risk adjustment program under which payments are made to health insurance issuers that attract higher-than-average risk populations funded by payments from health insurance issuers that attract lower-than-average risk populations. To ensure the integrity of the HHS-operated risk adjustment program, CMS, on behalf of HHS, performs risk adjustment data validation, also known as HHS-RADV, to validate the accuracy of data submitted by issuers for the purposes of risk adjustment transfer calculations. Based on lessons learned from the first payment year of HHS-RADV, this rule proposes changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also proposes to change the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied starting with 2021 benefit year HHS-RADV. These proposals seek to further the integrity of the HHS-RADV program, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.

This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.