Regulatory Roundup 2.0

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Date Published:
March 16, 2023
Reference Number:
2023-05094
Agency:
Food and Drug Administration
Date Final/Due:
March 16, 2023
Notice: Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)

This notice updates the guidance documents issued during the public health emergency (PHE). This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidance that the FDA is revising to continue in effect after the expiration of the PHE declaration.

LeadingAge Actions: Monitoring

Date Published:
February 09, 2023
Reference Number:
Docket No. FR-6250-P-01
Agency:
Housing and Urban Development Department
Date Final/Due:
April 10, 2023
Proposed rule: Affirmatively Furthering Fair Housing

The proposed rule operationalizes the 1968 Fair Housing Act’s statutory obligation to affirmatively further fair housing by creating a structure for certain HUD participants to create Equity Plans that include a Fair Housing Analysis, Fair Housing Goals, A Description of Community Engagement undertaken, and Fair Housing Strategies to affirmatively further fair housing.

LeadingAge Actions: Reviewing

Date Published:
December 20, 2022
Reference Number:
RIN 0938-AU96
Agency:
Centers for Medicare & Medicaid Services (CMS)
Date Final/Due:
Feb. 13, 2023
Proposed rule: Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications

This proposed rule would revise the Medicare Advantage (Part C), Medicare
Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for
the Elderly (PACE) regulations to implement changes related to Star Ratings, medication therapy
management, marketing and communications, health equity, provider directories, coverage
criteria, prior authorization, passive enrollment, network adequacy, identification of
overpayments, formulary changes, and other programmatic areas.

LeadingAge Actions: Reviewing

Date Published:
December 13, 2022
Reference Number:
CMS-0057-P
Agency:
Centers for Medicare & Medicaid Services (CMS)
Date Final/Due:
Mar. 13, 2023
Date Published:
December 01, 2022
Agency:
National Quality Forum (NQF)
Date Final/Due:
Dec. 7, 2022
MUC List Measures Proposed for Home Health and Skilled Nursing Facilities

The National Quality Forum (NQF) annually publishes a list of quality Measures Under Consideration(MUC) for future rule making and seeks public feedback on these measures. This information is then shared with relevant work groups of stakeholders who evaluate, discuss and make recommendations on the MUC measures.

LeadingAge Actions: Commented

Date Published:
November 29, 2022
Reference Number:
RIN: 0945-AA16
Agency:
Department of Health and Human Services
Date Final/Due:
Feb. 1, 2023
Proposed rule: Confidentiality of Substance Use Disorder (SUD) Patient Records

The proposed rule makes it make it easier for providers to share patients’ substance use disorder treatment records. Currently, a stricter regulatory regime protects the privacy of substance use disorder treatment records than that of standard medical records governed by the health privacy law known as HIPAA. Patients usually have to consent each time substance use records are shared. Under the proposal, providers would only need to get a patient’s consent one time to share substance use records.

LeadingAge Actions: Reviewing

Date Published:
November 02, 2022
Reference Number:
RIN 0938-AU77
Agency:
Centers for Medicare and Medicaid Services (CMS)
Date Final/Due:
Nov. 4, 2022
Final rule: Calendar Year (CY) 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements

This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2023 in accordance with existing statutory and regulatory requirements. This final rule also finalizes a methodology for determining the impact of 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 Patient Driven Groupings Model (PDGM) case-mix adjustment methodology and finalizes a corresponding permanent prospective adjustment to the CY 2023 home health payment rate.

LeadingAge Actions: Monitoring

Date Published:
October 07, 2022
Reference Number:
CMS-0058-NC
Agency:
Centers for Medicare & Medicaid Services (CMS)
Date Final/Due:
Dec. 6, 2022
Request for Information: National Directory of Healthcare Providers & Services

This request for information solicits public comments on establishing a National Directory of Healthcare Providers & Services (NDH) that could serve as a “centralized data hub” for healthcare provider, facility, and entity directory information nationwide.

LeadingAge Actions: Commented

Date Published:
September 27, 2022
Reference Number:
Docket No. FR-6350-N-01
Agency:
Department of Housing and Urban Development (HUD)
Date Final/Due:
Oct. 27, 2022
Request for Information: Green and Resilient Retrofit Program: Request for Information

This RFI from HUD is seeking feedback on its new Green and Resilient Retrofit grant program for multifamily assisted housing. In response to the passage of the Inflation Reduction Act of 2022, HUD is designing the new $1 billion GRRP program and expects to make multiple rounds of funding available to support energy, and water efficiency retrofits and climate resilience for HUD-assisted multifamily properties. Through this RFI, HUD is seeking input on funding rounds as well as on utility benchmarking. Information provided in response to this RFI will inform prioritization of work, treatment of cost-benefit analyses, and key design elements that will help ensure program goals are met.

LeadingAge Actions: Monitoring

Date Published:
September 09, 2022
Reference Number:
RIN 1615-AC74
Agency:
Department of Homeland Security
Date Final/Due:
*Effective 15-Dec-2022
Final rule: Public Charge Ground of Inadmissibility

This final rule is applicable to noncitizens who receive or wish to apply for benefits provided by the U.S. Department of Health and Human Services (HHS) and States that support low-income families and adults. The rule provides details on how DHS will interpret the “public charge” ground of inadmissibility, help ensure that noncitizens can access health-related benefits and other supplemental government services to which they are entitled by law without triggering harmful immigration consequences. By codifying in regulation the “totality of the circumstances” approach that is authorized by statute and which has long been utilized by DHS, the rule makes it clear that individual factors, such as a person’s disability or use of benefits alone will not lead to a public charge determination.

LeadingAge Actions: Monitoring