Alston & Bird Health Care Week in Review, April 22, 2022

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, CMS issued the FY 2023 IPPS/LTCH PPS proposed rule with comment period. Read more about this rule and other news below.

I. Regulations, Notices & Guidance

• On April 18, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule with comment period entitled, Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) and Proposed Policy Changes and Fiscal Year 2023 Rates. This proposed rule would: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition, it would establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; provide estimated and newly established performance standards for the Hospital Value-Based Purchasing (VBP) Program; and propose updated policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital-Acquired Condition (HAC) Reduction Program, PPS-Exempt Cancer Hospital Reporting (PCHQR) Program, and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP). It would also revise the hospital and critical access hospital (CAH) conditions of participation (CoPs) for infection prevention and control and antibiotic stewardship programs; and codify and clarify policies related to the costs incurred for qualified and non-qualified deferred compensation plans. Lastly, this proposed rule would provide updates on the Rural Community Hospital Demonstration Program and the Frontier Community Health Integration Project.

• On April 19, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Transfer of ARPA-H to NIH. HHS Secretary Becerra announced the transfer of the Advanced Research Projects Agency for Health (ARPA-H) to the National Institutes of Health (NIH) as authorized by title II of division H of the Consolidated Appropriations Act, 2022.

• On April 20, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability. FDA is required to report annually on the status of post marketing requirements (PMRs) and post marketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products.

• On April 20, 2022, FDA issued a notice entitled, Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. Such a requirement could reduce the amount of unused opioid analgesics in patients’ homes, thereby reducing opportunities for nonmedical use, accidental exposure, and overdose, and possibly reducing the development of new opioid addiction.

• On April 20, 2022, the Administration for Community Living (ACL) issued a notice entitled, Availability of Program Application Instructions for MIPPA Program Funds. The Medicare Improvement for Patients and Providers Act (MIPPA) program supports states through grants to provide outreach and assistance to Medicare beneficiaries with limited incomes and assets to ensure the beneficiaries have access to all Medicare related benefits available to them.

• On April 21, 2022, FDA issued final guidance entitled, Drug Products, Including Biological Products, That Contain Nanomaterials; Guidance for Industry; Availability. This guidance finalizes the draft guidance issued December 18, 2017, developed to provide industry with FDA’s current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance also includes recommendations for applicants and sponsors of investigational, premarket, and post market submissions for these products.

• On April 21, 2022, FDA issued final guidance entitled, Guidance Documents Related to Coronavirus Disease 2019; Availability. The guidance identified in this notice addresses issues related to the COVID-19 PHE.

• On April 22, 2022, FDA issued a final rule entitled, Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use. FDA is classifying the autofluorescence detection device for general surgery and dermatological use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the autofluorescence detection device for general surgery and dermatological use’s classification.

Event Notices  

• May 12, 2022: HHS announced a public meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. The agenda will include a discussion of full and draft recommendations by the Commission’s six Subcommittees on ways to advance equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander communities. The Subcommittees are: Belonging, Inclusion, Anti-Asian Hate, Antidiscrimination; Data Disaggregation; Language Access; Economic Equity; Health Equity; and Immigration and Citizenship Status.

• May 18-19, 2022: FDA announced a public meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) Advisory Committee. The agenda will include an overview of the Science Advisory Board Subcommittee Site Visit Report and a response to this review. Additionally, the Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, Center for Tobacco Products, and the Office of Regulatory Affairs will each briefly discuss their specific research strategic needs and potential areas of collaboration. Finally, there will be updates from the NCTR Research Divisions and a public comment session.

• May 19-20, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Center for Advancing Translational Sciences Notice of Meeting. The agenda includes a report from the Institute Director, an invited speaker presentation, program updates, and a clearance of concepts discussion.

• May 24, 2022: NIH announced a public meeting of the National Advisory Council for Nursing Research. The agenda will include discussion of program policies and issues.

• June 1-2, 2022: CDC announced a public meeting of the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). On day one, the agenda will include: 1) CPR Division Updates; 2) COVID-19 Response Update; and 3) Review of CPR’s Preparedness and Response Strategies and Science Priorities Update. On day two the agenda will include: 1) State and Local Readiness Public Health Emergency Preparedness (PHEP) Discussion; 2) Strategic Capacity Building and Innovation Program Review Working (SRWG) Update; 3) Polio Containment Workgroup (PCWG) Update; and 4) BSC Discussion of Future Meeting Topics.

• June 8-9, 2022: CDC announced a public meeting of the Community Preventive Services Task Force. The agenda will consist of deliberation on systematic reviews of literature. Topics will include Cancer Screening; Nutrition, Physical Activity, and Obesity; Social Determinants of Health; Mental Health; and Substance Use.

• June 21-22, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). The open portion of the meeting will include a discussion of the Mandatory Guidelines for Federal Workplace Drug Testing Programs, updates on the Drug Free Workplace Program as well as updates from the Department of Transportation, the Nuclear Regulatory Commission, a presentation by Dr. Barry Sample on Workforce Drug Testing for Marijuana in 2021, and a presentation by Dr. Svante Vikingsson on Hydroxy Cocaine and Cocaine Ratios in Hair.

II. Reports, Studies & Analyses

• On April 18, 2022, Alston & Bird published a report entitled, Healthy Byte: How Can Providers Comply with Unwinding COVID-era Waivers?. In this Healthy Byte, Alston & Bird’s Sean Sullivan discusses the unwinding of the COVID-19 public health emergency and the numerous CMS waivers, including some related to telehealth in nursing facilities.

• On April 20, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Help with Medicare Premium and Cost-Sharing Assistance Varies by State. To provide greater insight into the number and characteristics of beneficiaries enrolled in these programs in the U.S. overall and in each state, KFF created profiles of each state showing enrollment of Medicare beneficiaries in the Medicare Savings Programs and the Part D Low-Income Subsidy, and their demographic characteristics including race/ethnicity, age, and gender. This issue brief provides an overview of these programs and highlights findings from the state-level profiles.

• On April 20, 2022, the Government Accountability Office (GAO) published a report entitled, HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference. This report examines scientific integrity policies and procedures, and how allegations of political interference in scientific decision-making are addressed at CDC, FDA, NIH, and the Office of the Assistant Secretary for Preparedness and Response (ASPR). The report also examines the procedures in place to address such allegations and the extent to which agencies received them. It examines training provided by selected agencies on scientific integrity policies and procedures, including those related to political interference.

• On April 21, 2022, KFF published an issue brief entitled, Tracking Social Determinants of Health During the COVID-19 Pandemic. This brief provides an overview of how adults are faring across an array of measures of social determinants of health as of March 2 – March 14, 2022 based on data from the Census Bureau’s Household Pulse Survey, which was designed to quickly compile data about how people’s lives have been impacted by the coronavirus pandemic. For this analysis, KFF looked at a range of measures over the course of the pandemic.

III. Other Health Policy News

• On April 19, 2022, HHS announced that it is awarding nearly $105 million in grant funding, provided by the American Rescue Plan, to 54 states and territories in advance of the transition of the National Suicide Prevention Lifeline from the current 10-digit number to the 988 three-digit dialing code in July. Strengthening crisis care infrastructure is a core priority of President Biden’s Mental Health Strategy, which he announced at the State of the Union as part of his national Unity Agenda. More information on this funding can be found here.

• On April 20, 2022, HHS announced actions to promote competition and transparency in the nation’s health care system that can improve the safety and quality of nursing homes and hospitals. CMS released data publicly on mergers, acquisitions, consolidations, and changes of ownership from 2016-2022 for hospitals and nursing homes enrolled in Medicare. This data is a new tool for researchers, state and federal enforcement agencies, and the public to better understand the impacts of consolidation on health care prices and quality of care. HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) is also releasing a related report — an analysis of the new CMS data examining trends in changes of ownership over the past six years. More information on these actions can be found here.

• On April 21, 2022, HHS announced the availability of nearly $90 million in American Rescue Plan funding to support new data-driven efforts for HRSA Health Center Program-supported health centers and look-alikes (HRSA-designated health centers) to identify and reduce health disparities. HRSA’s modernized data collection and reporting initiative, called Uniform Data System Patient-Level Submission (UDS+), is designed to collect data on social determinants of health, while also streamlining and improving data quality reporting for health centers. This effort will enable health centers to tailor their efforts to improve health outcomes and advance health equity, more precisely targeting the needs of specific communities or patients. More information about this funding can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.