Alston & Bird Health Care Week in Review, October 16, 2020

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 expanded the list of telehealth services that Medicare fee-for-service will pay for and announced payment updates to support faster COVID-19 diagnostic testing. Read more about these changes and other news below.

I. Regulations, Notices & Guidance

• On October 13, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
• On October 15, 2020, FDA issued guidance entitled, Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. FDA developed this draft guidance to propose select updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The existing guidance remains in effect, in its current form, until this draft guidance is finalized.
• On October 15, 2020, FDA issued guidance entitled, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Nitinol is a commonly used material in the medical device industry. Device manufacturers have used nitinol’s unique properties (i.e., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with conventional materials. Nitinol has been extensively used in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. The use of nitinol in other device areas is growing, particularly for products intended for use in minimally invasive procedures. The thermomechanical behavior and processing sensitivity of nitinol raise special considerations when compared to conventional metals such as stainless steel, titanium, or cobalt-chrome alloys. Due to the unique properties of nitinol, the FDA has developed this guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol. The recommendations in this document should be evaluated in conjunction with the intended use and technological characteristics of your device and any relevant device-specific guidances.
• On October 15, 2020, FDA issued guidance entitled, Testing for Biotin Interference in In Vitro Diagnostic Devices. FDA is providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs).  This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.  The recommendations apply to IVDs, including devices that are licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) and used in donor screening, that use biotin technology.
• On October 16, 2020, FDA issued guidance entitled, FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements. This Small Entity Compliance Guide is intended to help small businesses understand and comply with FDA's final rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (the Deeming Rule). The Deeming Rule extends FDA's tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.

Event Notices  

• October 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
• October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
• October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
• October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
• October 30, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Diabetes Mellitus Interagency Coordinating Committee. The topic for this meeting will be “Health Literacy and Numeracy: Considerations for Equity Approaches.”
• November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 6, 2020: FDA announced a public meeting entitled, Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.
• November 16, 2020: FDA announced a public meeting entitled, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs. The purpose of the meeting is to obtain early input from the public on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. FDA is seeking public input on a potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs.
• November 20, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include Mental/Behavioral Health, Sexual Health, Genetics and Genomics, and Provider Engagement.
• December 15-16, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a town hall entitled, Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments. The purpose of the meeting is to discuss FY 2022 applications for add-on payments for new medical services and technologies under the IPPS.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies & Analyses

• On October 12, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Health Insurer Financial Performance Amid the Coronavirus Pandemic. This brief analyzes data from 2013 to 2020 to examine how insurance markets performed through the first half of this year as the COVID-19 pandemic developed and worsened in the U.S. The authors use financial data reported by insurance companies to the National Association of Insurance Commissioners and compiled by Mark Farrah Associates to look at average medical loss ratios and gross margins in the individual (also known as non-group), fully-insured group (employer), and Medicare Advantage health insurance markets. A more detailed description of each market is included in the Appendix.
• On October 14, 2020, KFF published an issue brief entitled, Medicaid Enrollment & Spending Growth: FY 2020 & 2021. This brief analyzes Medicaid enrollment and spending trends for FY 2020 and FY 2021 based on data provided by state Medicaid directors as part of the 20th annual survey of Medicaid directors in all 50 states and the District of Columbia.

IV. Other Health Policy News

• On October 13, 2020, HHS, in collaboration with the Department of Defense (DOD), awarded a $481 million Other Transaction Agreement to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test that produces results in about 20 minutes. More information about this investment can be found here.
• On October 14, 2020, CMS expanded the list of telehealth services that Medicare Fee-For-Service will pay for during the COVID-19 Public Health Emergency. These new telehealth services include certain neurostimulator analysis and programming services, and cardiac and pulmonary rehabilitation services. The list of these newly added services is available here. CMS is also providing additional support to state Medicaid and Children’s Health Insurance Program agencies in their efforts to expand access to telehealth. More information about this announcement can be found here.
• On October 15, 2020, HHS, through the Health Resources and Services Administration (HRSA), announced nearly $500 million in awards to support, recruit and retain qualified health professionals and students through its National Health Service Corps (NHSC), Nurse Corps and other workforce development loan repayment and scholarship programs. More information about this funding can be found here.
• On October 15, 2020, HHS announced two challenges to improve maternal health. The first challenge will address care for women with hypertension who are pregnant and/or postpartum, while the second challenge will address breastfeeding initiation and continuation disparities among breastfeeding mothers. The partnership will bridge data gaps in maternal health outcomes across the country. More information about this announcement can be found here.
• On October 15, 2020, CMS announced new actions to pay for expedited COVID-19 test results. CMS previously took action in April 2020 by increasing the Medicare payment to laboratories for high throughput COVID-19 diagnostic tests from approximately $51 to $100 per test. Now, starting January 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected. Additionally, effective January 1, 2021, Medicare will pay a rate of $75 for laboratories that take longer than two days to complete these tests. More information about these changes can be found here.
• On October 16, 2020, CMS released data showing that 21 percent of Medicare beneficiaries report forgoing non-COVID-19 care due to the pandemic, and nearly all (98 percent) of beneficiaries have taken preventative measures to keep themselves safe from the virus. According to the survey, the most common type of forgone care because of the pandemic was dental care (43 percent), followed by regular check-up (36 percent), treatment for ongoing condition (36 percent), and diagnostic or medical screening test (32 percent).  The most common reason cited for forgoing care was not wanting to risk being at a medical facility (45 percent). More information about these data can be found here.
• On October 16, 2020, as part of the Trump Administration’s Operation Warp Speed (OWS), HHS and DOD announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs. More information about this partnership can be found here.

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