Alston & Bird Health Care Week in Review, October 1, 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 Department of Health and Human Services, together with the Departments of Labor and Treasury, issued the “Requirements Related to Surprise Billing, Part II” Interim Final Rule with Comment Period. Read more about the rule and other news below.

I. Regulations, Notices & Guidance

• On September 28, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled, Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment. The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).
• On September 28, 2021, FDA issued draft guidance entitled, Electronic Submission Template for Medical Device 510(k) Submissions. This draft guidance introduces submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510(k) electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
• On September 29, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2022. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2022. The calendar year 2022 AIC threshold amounts are $180 for ALJ hearings and $1,760 for judicial review.
• On September 29, 2021, FDA issued a notice entitled, Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022. This notice establishes the material threat MCM priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
• On September 29, 2021, FDA issued a notice entitled, Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022. This notice establishes the rare pediatric disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
• On September 29, 2021, FDA issued a notice entitled, Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022 This notice establishes the tropical disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
• On September 29, 2021, FDA issued final guidance entitled, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry. The guidance document provides FDA’s current thinking on certain criteria that help determine sameness of human gene therapy products for the purpose of orphan-drug designation and orphan-drug exclusivity. The guidance is intended to assist stakeholders, including industry and academic sponsors who seek orphan-drug designation and orphan-drug exclusivity, in the development of gene therapies for rare diseases.
• On September 29, 2021, FDA issued draft guidance entitled, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial. The draft guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease.
• On September 29, 2021, FDA issued draft guidance entitled, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. This draft guidance is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.
• On September 29, 2021, FDA issued draft guidance entitled, Microbiological Quality Considerations in Non-Sterile Drug Manufacturing. The purpose of this guidance is to assist manufacturers in assuring the microbiological quality of their non-sterile drugs (NSDs). This guidance discusses product development considerations, risk assessments, and certain current good manufacturing practice (CGMP) requirements that are particularly relevant to microbiological control in a manufacturing operation for an NSD.
• On September 29, 2021, FDA issued draft guidance entitled, Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices. The draft guidance provides recommendations to help clinical investigators comply with the safety reporting requirements of investigational new drug application (IND) studies and investigational device exemption (IDE) studies. The guidance is intended to help clinical investigators of drugs identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) and to help clinical investigators of devices identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and to IRBs.
• On September 29, 2021, FDA issued draft guidance entitled, Benefit-Risk Assessment for New Drug and Biological Products. The intent of this guidance is to provide drug sponsors and other stakeholders with a clearer understanding of how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions about new drug applications (NDAs) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biologics license applications (BLAs).
• On September 29, 2021, the Department of Veterans Affairs (VA) issued a final rule entitled, VA Acquisition Regulation: Simplified Procedures for Health-Care Resources. This rulemaking revises VA Acquisition Regulation (VAAR) coverage concerning Simplified Procedures for Health-Care Resources as well as an affected part concerning Solicitation Provisions and Contract Clauses.
• On September 30, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, Implementation of Executive Order on Access to Affordable Life-Saving Medications; Rescission of Regulation. HHS is rescinding the final rule entitled “Implementation of Executive Order on Access to Affordable Life-Saving Medications,” published in the December 23, 2020, Federal Register (2020 Rule). HHS is rescinding the 2020 Rule due to the excessive administrative costs and burdens that implementation would have imposed on health centers.
• On October 1, 2021, HHS, together with the Departments of Treasury and Labor, issued interim final rules entitled, Requirements Related to Surprise Billing; Part II. These interim final rules implement provisions of the No Surprises Act that provide for a Federal independent dispute resolution (IDR) (Federal IDR) process to permit group health plans and health insurance issuers offering group or individual health insurance coverage and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services, under certain circumstances. In addition to the interim final rules issued jointly by the Departments, this document also includes interim final rules issued by the Office of Personnel Management (OPM) to clarify how certain No Surprises Act provisions apply to health benefits plans offered by carriers under the Federal Employees Health Benefits (FEHB) Act. In addition to the interim final rules issued jointly by the Departments and OPM, this document includes interim final rules issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process.

Event Notices

• October 13-14, 2021: FDA announced a virtual public workshop entitled, Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age. The purpose of the public workshop is to discuss the state of science, data gaps, and challenges in drug development for drugs intended to treat acute pain in patients less than 2 years of age.
• October 18, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the Frederick National Laboratory Advisory Committee to the National Cancer Institute. The meeting will discuss ongoing and new activities at the Frederick National Laboratory for Cancer Research.
• November 15-17, 2021: HHS announced a virtual public meeting of the Presidential Advisory Council on HIV/AIDS. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV infection and AIDS. The functions of the Council are solely advisory in nature.
• November 18, 2021: NIH announced a virtual public meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The meeting will feature a report from the AMP-AIM Working Group of Council.
• October 25, 2021: HHS announced a virtual public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. During this meeting, the Advisory Council will hear presentations about ways to support and strengthen the long-term services and supports direct care workforce, both paid and unpaid, to support access to care, improve the quality of caregiving, and meet the growing demand for long-term care dementia services.

II. Congressional Hearings

U.S. Senate

• On September 29, 2021, the Senate Committee on the Judiciary held a hearing entitled, Texas’s Unconstitutional Abortion Ban and the Role of the Shadow Docket. Witnesses present included: Donna Howard, Texas State Representative, District 48, and Chairwoman, Texas Women’s Health Caucus; Fatima Goss Graves, President And CEO, National Women's Law Center; Professor Stephen I. Vladeck, Charles Alan Wright Chair In Federal Courts, University of Texas School of Law; Jennifer Mascott, Professor, Antonin Scalia Law School, George Mason University; and Edmund Gerard LaCour Jr., Solicitor General, Attorney General’s Office, Alabama.

U.S. House of Representatives

• On September 28, 2021, the House Education & Labor Committee Civil Rights and Human Services Subcommittee and Health, Employment, Labor, and Pensions Subcommittee held a joint hearing entitled, How to Save a Life: Successful Models for Protecting Communities from COVID-19. Witnesses present included: Dr. Leana Wen, Professor & Distinguished Fellow Fitzhugh Mullan Institute for Health Workforce Equity, The George Washington University Milken Institute School of Public Health; Dr. Chris Pernell, Chief Strategic Integration and Health Equity Officer, University Hospital; and Dr. Viviana Martinez-Bianchi, Director of Health Equity and Associate Professor, Department of Family Medicine and Community Health, Duke University School of Medicine.
• On September 29, 2021, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Upgrading Public Health Infrastructure: The Need to Protect, Rebuild, and Strengthen State and Local Public Health Departments. Witnesses present included: Dr. Joseph Kanter, State Health Officer and Medical Director, Louisiana Department of Health; Dr. Jennifer Bacani McKenney, Health Officer, Wilson County Health Department (Kansas); Dr. Beth Resnick, Assistant Dean for Practice and Training; Senior Scientist, Bloomberg School of Public Health Johns Hopkins University; and Dr. Mysheika Roberts, Health Commissioner, Columbus Public Health (Ohio).
• On September 29-30, 2021, the House Committee on the Judiciary held a markup of R. 3429, the SHOP SAFE Act of 2021, and additional provisions. The following health-related provisions were marked up: H.R. 2883, the Stop Stalling Access to Affordable Medications; H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act; H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; and H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. All four bills, as amended, were ordered favorably reported to the House.
• On September 30, 2021, the House Committee on Oversight and Reform held a hearing entitled, A State of Crisis: Examining the Urgent Need to Protect and Expand Abortion Rights and Access. Witnesses present included: Maleeha Aziz, Community Organizer, Texas Equal Access Fund; Cori Bush, Member of Congress; Kat Cammack, Member of Congress; Judy Chu, Member of Congress; Pramila Jayapal, Member of Congress; Barbara Lee, Member of Congress; Dr. Ghazaleh Moayedi, Texas-based OB/GYN, Board Member, Physicians for Reproductive Health; Melissa Murray, Professor of Law, New York University; Loretta Ross, Co-Founder of the Reproductive Justice Movement, Associate Professor of the Study of Women and Gender, Smith College; Dr. Ingrid Skop, Texas-based OB/GYN; and Gloria Steinem, Feminist and Social Activist.

III. Reports, Studies & Analyses

• On September 27, 2021, the Government Accountability Office (GAO) published a report entitled, Medicaid Behavioral Health: CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication. This report describes what states reported about how the certified community behavioral health clinics (CCBHC) demonstration affected state spending on behavioral health services; and examines CMS guidance for states on Medicaid CCBHC payments. GAO's review of payment guidance for the demonstration from CMS, an agency within HHS that oversees Medicaid at the federal level, found that the guidance lacked clear and consistent information on better aligning CCBHC payment rates with costs and preventing duplicate payments.
• On September 30, 2021, the HHS Office of Inspector General (OIG) published a report entitled, High-expenditure Medicare drugs often qualified for Orphan Drug Act incentives designed to encourage the development of treatments for rare diseases. This report provides an independent analysis on a specific subset of orphan drugs—those with the highest Medicare expenditures-and serves to both inform ongoing discussions and support congressional and decisionmakers' efforts to improve the Orphan Drug Program. OIG encourages the policymaking, oversight, and research communities to seek answers to the additional questions raised by their findings. In debating any potential changes, it will be vital to ensure that the program continues to successfully encourage the development of drugs to treat rare diseases and conditions while taking into consideration questions surrounding affordability, profitability, and the meaning of rare use.
• On September 30, 2021, the Bipartisan Policy Center published a report entitled, Bridging Health and Health Care. This report recognizes the need to better bridge the divide between the often-siloed worlds of health and health care and recommends policies designed to better integrate, coordinate, and ultimately improve the performance and outcomes of both. The recommendations focus on two key areas: 1) improving access to and coverage and financing of non-medical and preventive services; and 2) the health care workforce, with a focus on increasing access to care through improvements in the supply and distribution of key practitioners who are needed to improve the health status in underserved communities.
• On October 1, 2021, the Kaiser Family Foundation published a blog post entitled, Universal Paid Family and Medical Leave Under Consideration in Congress. The House of Representatives is considering a provision of the Build Back Better Act that would create a universal paid family and medical leave program. This post takes a look at this proposal, key policy questions, and what it could mean for women and families.

IV. Other Health Policy News

• On September 28, 2021, HHS awarded nearly $1 billion in American Rescue Plan funding to around 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. These awards will strengthen our primary health care infrastructure and advance health equity and health outcomes in medically underserved communities, including through projects that support COVID-19 testing, treatment, and vaccination. The awards were made through the Health Resources and Services Administration. More information about this funding can be found here.
• On September 28, 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the distribution of $825 million in grants to 231 Community Mental Health Centers (CMHCs) across the country. The funding reflects the Biden-Harris Administration’s commitment to supporting and expanding access to mental health and behavioral support as Americans continue to confront the impact of the COVID-19 pandemic. More information about these grants can be found here.
• On September 29, 2021, CMS released the 2022 premiums, deductibles and other key information for Medicare Advantage and Part D prescription drug plans in advance of the annual Medicare Open Enrollment to help Medicare enrollees decide on coverage that fits their needs. The average premium for Medicare Advantage plans will be lower in 2022 at $19 per month, compared to $21.22 in 2021, while projected enrollment continues to increase. As previously announced, the average 2022 premium for Part D coverage will be $33 per month, compared to $31.47 in 2021. More information about these plans can be found here.
• On September 29, 2021, CMS announced the Calendar Year (CY) 2022 participants in the Medicare Advantage (MA) Value-Based Insurance Design (VBID) Model. There is a more than two-fold increase in the number of Model enrollees covered by participating MA plans in 2022 compared to 2021. Through the VBID Model, CMS is testing a broad array of MA health plan innovations designed to enhance the quality of care for Medicare beneficiaries – including those with low income, such as dually eligible beneficiaries and those qualifying for Low Income Subsidy (LIS) – as well as to reduce costs for enrollees and the overall Medicare program. More information about the participants can be found here.
• On September 30, 2021, HHS’s Office for Civil Rights (OCR) issued guidance to help the public understand when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule applies to disclosures and requests for information about whether a person has received a COVID-19 vaccine. The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records. This is because the HIPAA Privacy Rule only applies to HIPAA covered entities (health plans, health care clearinghouses, and health care providers that conduct standard electronic transactions), and, in some cases, to their business associates. More information about this guidance can be found here.

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