Alston & Bird Health Care Week in Review, July 2, 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, the Biden Administration released a long-anticipated rule intended to restrict the practice of surprise billing. Read more about the regulation and other news below.

I. Regulations, Notices & Guidance

• On June 28, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Proposed Model Expansion; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; Inpatient Rehabilitation Facility Quality Reporting Program Requirements; and Long-term Care Hospital Quality Reporting Program Requirements. This proposed rule would set forth routine updates to the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also provides monitoring and analysis of the Patient-Driven Groupings Model (PDGM); solicits comments on a methodology for determining 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 PDGM case-mix adjustment methodology; and proposes to recalibrate the PDGM case-mix weights, functional levels, and comorbidity adjustment subgroups while maintaining the low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rulemaking proposes to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts; and make conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. This rulemaking also proposes changes to the Home Health Quality Reporting Program (QRP); proposes to make permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE); would update the home health conditions of participation to implement Division CC, section 115 of the Consolidated Appropriations Act, 2021 (CAA 2021) regarding occupational therapists completing the initial and comprehensive assessments reflect these changes; and would expand the Home Health Value-Based Purchasing (HHVBP) Model, beginning January 1, 2022, to the 50 States, territories, and District of Columbia.
• On June 28, 2021, CMS issued a proposed rule entitled, Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule. This proposed rule sets forth proposed revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs); proposes repeal of separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; proposes to expand the annual open enrollment period and Navigator duties; proposes a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level (FPL); proposes to repeal the recent establishment of a Direct Enrollment option for Exchanges; and proposes to modify regulations and policies related to section 1332 waivers.
• On July 1, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. This guidance provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease.
• On July 1, 2021, FDA issued guidance entitled, Providing Regulatory Submissions in Alternate Electronic Format. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this guidance to provide recommendations on an alternate electronic format for submissions covered under such exemptions and waivers.
• On July 1, 2021, FDA issued guidance entitled, Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as NDAs or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration.
• On July 1, 2021, CMS issued a proposed rule entitled, End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. This proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rulemaking also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rulemaking proposes to update requirements for the ESRD Quality Incentive Program (QIP), including a proposed measure suppression policy for the duration of the COVID-19 public health emergency (PHE) as well as proposals to suppress individual ESRD QIP measures under that proposed measure suppression policy. This proposed rule also announces an extension of time for facilities to report September through December 2020 ESRD QIP data under CMS’s Extraordinary Circumstances Exception (ECE) policy due to CMS operational issues. The rule also proposes to not score facilities or reduce payment to any facility in PY 2022. In addition, this proposed rule includes requests for information on topics that are relevant to the ESRD QIP. Further, this rule also proposes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries. Finally, this proposed rule includes several requests for information to inform payment reform under the ESRD PPS.
• On July 1, 2021, the Department of Health and Human Service (HHS), Office of Personnel Management (OPM), Department of the Treasury, and the Department of Labor (DOL) issued an interim final rule with comment period entitled, Requirements Related to Surprise Billing; Part I. This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). These interim final rules amend and add provisions to existing rules under the Internal Revenue Code, the Employee Retirement Income Security Act, the Public Health Service Act, and the Federal Employees Health Benefits Act. These interim final rules implement provisions of the No Surprises Act that protect participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from surprise medical bills when they receive emergency services, non-emergency services from nonparticipating providers at participating facilities, and air ambulance services from nonparticipating providers of air ambulance services, under certain circumstances. In this rulemaking, HHS, DOL, and the Treasury (collectively, the Departments) are issuing interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage. HHS is also issuing in this rulemaking additional interim final rules that apply to emergency departments of hospitals and independent freestanding emergency departments, health care providers and facilities, and providers of air ambulance services related to the protections against surprise billing. OPM is issuing in this rulemaking interim final rules that specify how certain provisions of the No Surprises Act apply to health benefits plans offered by carriers under the Federal Employees Health Benefits Act (FEHBA).
• On July 2, 2021, CMS issued a final rule entitled, Basic Health Program; Federal Funding Methodology for Program Year 2022. This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges, and incorporates the effects on such payment amounts the American Rescue Plan Act of 2021 (ARP).

Event Notices

• July 7-9, 2021: CMS announced a public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set. The purpose of the meeting is to discuss preliminary coding recommendations for new revisions to the HCPCS Level II code set.
• July 28-29, 2021: CMS announced a public meeting entitled, Meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the HHS Secretary and CMS Administrator on issues related to clinical diagnostic laboratory tests.
• July 14, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting entitled, Meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ’s recent accomplishments in Health Systems Research, Practice Improvement, and Data and Analytics. The agenda will also include discussions on Strategic Opportunities for FY 2022, Opportunities to Advance Telehealth, and Advancing Patient Safety.
• July 14, 2021: HHS announced a public meeting entitled, Meeting of the National Committee on Vital and Health Statistics, Subcommittee on Privacy, Confidentiality and Security. At the hearing, the Subcommittee will hear from invited experts on the range of security challenges affecting the health care industry and business partners. The Subcommittee will also hear about the range of policy options that may be available to the Department of Health and Human Services (HHS) and data stewards to improve the security posture of those organizations holding individually identifiable information (III), including federal, state, local, and tribal organizations.
• July 19, 2021: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council will discuss the implications of and opportunities presented by the approval of aducanumab. The Council will also hear updates from federal workgroups on efforts undertaken in the last quarter. The risk reduction subcommittee will present a summary of their work and recommendations. The research, clinical care, and long-term services and supports subcommittees will present recommendations and the Council will vote on adopting them.
• August 12, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) announced a public meeting. The meeting is open to the public and will include consideration of minutes from the SAMHSA CSAT NAC meeting of March 31, 2021; an update on CSAT activities; a discussion with SAMHSA leadership; and discussion of recovery and recovery support. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council.
• September 21, 2021: FDA announced a public workshop entitled, Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs. The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).

II. Congressional Hearings

U.S. House of Representatives

• On July 1, 2021, the House Committee on Oversight and Investigations Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Building Trust And Battling Barriers: The Urgent Need To Overcome Vaccine Hesitancy. Witnesses present included: Joshua Garza, COVID-19 survivor; Dr. Georges C. Benjamin, Executive Director, American Public Health Association; Dr. Katy Milkman, Professor of Operations, Information, and Decisions, The Wharton School of Business; Dr. Jerome Adams, former Surgeon General of the United States; and Sophia Bush, actress, activist, and entrepreneur.

III. Reports, Studies & Analyses

• On June 29, 2021, the Bipartisan Policy Center published a report entitled, Positioning America’s Public Health System for the Next Pandemic. Since August 2020, the Bipartisan Policy Center’s Future of Health Care Initiative leaders have been developing and supporting recommendations to improve the resilience of the nation’s health care and public health systems to address the threat of COVID-19 and beyond. In January 2021, the Future of Health Care leaders released a report outlining high-priority immediate actions that the administration and Congress should take in combating COVID-19. In this report, the leaders have developed additional recommendations to ensure that the public health system, specifically, not only continues to respond to COVID-19, but that it is well-prepared to respond to and mitigate the consequences of a future pandemic. The recommendations focus on three areas: (1) creating clarity and accountability in federal leadership and operations during a pandemic; (2) improving public health information technology and data systems; and (3) committing the United States to more and consistent funding of public health to prepare for inevitable public health crises.

IV. Other Health Policy News

• On June 28, 2021, CMS announced Daniel Tsai as Deputy Administrator and Director of Center for Medicaid and CHIP Services (CMCS). Tsai comes from the Commonwealth of Massachusetts where he served as the Assistant Secretary for MassHealth and Medicaid Director. His tenure has focused on building a robust and sustainable Medicaid program that ensures equitable coverage and reshapes how health care is delivered for two million individuals and families in the state. More information about Mr. Tsai can be found here.
• On June 28, 2021, the HHS Office of Minority Health (OMH) announced $250 million in grant awards to 73 local governments as part of a new, two-year initiative to identify and implement best practices for improving health literacy to enhance COVID-19 vaccination and other mitigation practices among underserved populations. The Advancing Health Literacy (AHL) to Enhance Equitable Community Responses to COVID-19 initiative is part of the Biden/Harris Administration's National Strategy for the COVID-19 Response and Pandemic Preparedness. More information about this program can be found here.

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