Alston & Bird Health Care Week in Review, April 9, 2021

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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 its proposed FY 2022 payment updates for inpatient psychiatric and rehabilitation facilities, hospice, and skilled nursing facilities. Read more about the updates and other news below.

I. Regulations, Notices & Guidance

• On April 5, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers Guidance for Industry. FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.
• On April 7, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022). This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. This rule also proposes to update and clarify the IPF teaching policy with respect to IPF hospital closures and displaced residents and proposes a technical change to the 2016-based IPF market basket price proxies. In addition, this proposed rule would update quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program. These changes would be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2021 through September 30, 2022 (FY 2022).
• On April 7, 2021, CMS issued a proposed rule entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program. This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for FY 2022. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system’s case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. In addition, this proposed rule includes proposals for the IRF Quality Reporting Program (QRP).
• On April 8, 2021, CMS issued a proposed rule entitled, FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements. This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for FY 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns. In addition, this rule proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency and updates the hospice conditions of participation. The proposed rule would update the Hospice Quality Reporting Program. The proposed rule requests information on advancing to digital quality measurement, the use of Fast Healthcare Interoperability Resources, addresses the White House Executive Order related to health equity in the Hospice Quality Reporting Program and provides updates to advancing Health Information Exchange. Finally, this rule proposes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 public health emergency.
• On April 8, 2021, CMS issued a proposed rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022. This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for FY 2022. In addition, the proposed rule includes a proposed forecast error adjustment for FY 2022, proposes updates to the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), proposes to rebase and revise the SNF market basket, proposes to implement a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a methodology to recalibrate the PDPM parity adjustment. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a proposal to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores.
• On April 8, 2021, the Federal Communications Commission (FCC) issued a final rule entitled, COVID-19 Telehealth Program; Promoting Telehealth for Low-Income Consumers. This document establishes rules and processes to further distribute funding through the COVID-19 Telehealth Program to health care providers, in response to the COVID-19 pandemic, to build on Round 1 of the Program, and implement Congress’s direction under the Consolidated Appropriations Act, 2021 (CAA) for additional relief. The CAA funding is distributed through the Program to the health care providers who need it most, as determined by objective metrics.

Event Notices    

• April 15, 2021: FDA announced a public meeting entitled, Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The committee will discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).”
• May 5, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on dengue vaccine and rabies vaccines. No recommendation votes are scheduled.
• May 13-14, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). During the meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening.
• May 18-19, 2021: FDA announced a public meeting entitled, Potential Medication Error Risks with Investigational Drug Container Labels. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.
• June 16-17, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
• June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

II. Congressional Hearings

There were no health-related Congressional hearings this week.

III. Reports, Studies & Analyses

• On April 6, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Declines in Uncompensated Care Costs for The Uninsured under the ACA and Implications of Recent Growth in the Uninsured Rate. To understand the potential implications of coverage shifts for uncompensated care, this analysis uses the Medical Expenditure Panel Survey (MEPS) to examine how uncompensated care costs for the uninsured changed following implementation of the ACA’s coverage provisions in 2014.
• On April 6, 2021, KFF published an issue brief entitled, Sources of Payment for Uncompensated Care for the Uninsured. This brief estimates the level of public funding that was paid to help offset providers’ uncompensated care costs for the uninsured in 2017. To conduct the analysis, the authors relied on several secondary data sources, including government budget appropriations and expenditure data for major public programs that provided funds to cover the cost of care for the uninsured, as well as analyses of secondary data sources completed by others.
• On April 7, 2021, KFF published an issue brief entitled, The ACA Family Glitch and Affordability of Employer Coverage. This brief estimates that 5.1 million people fall into the Affordable Care Act (ACA) family glitch. A majority of them are children, and among adults, women are more likely to fall into the glitch than men. The authors also explore demographic characteristics of people who fall into the family glitch, present state-level estimates, and discuss how many people may benefit from policies aimed at addressing the family glitch.
• On April 8, 2021, the Congressional Budget Office (CBO) published a report entitled, Research and Development in the Pharmaceutical Industry. This report assesses trends in spending for prescription drug research and development (R&D) and the introduction of new prescription drugs. The report also examines factors that determine how much drug companies spend on R&D.

IV. Other Health Policy News

• On April 7, 2021, the Department of Health and Human Services (HHS) announced that more than half a million consumers have already signed up for health insurance through HealthCare.gov as a result of the Biden Administration’s Special Enrollment Period (SEP) for the COVID-19 Public Health Emergency. More information about this announcement can be found here.
• On April 7, 2021, HHS announced that all HRSA-funded health centers and Health Center Program look-alikes (LALs) will now be invited to participate in the Health Center COVID-19 Vaccine Program. These health centers will have the opportunity to join the program as soon as they are ready, increasing the total number of health centers that have been invited to 1,470 nationwide. This expansion will be made through the Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention (CDC). More information about the announcement can be found here.

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