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:

On Tuesday, CMS announced the creation of the CHART Model—an initiative intended to transform rural health care in the U.S. Read more about the new model and other news below.


I. Regulations, Notices & Guidance

  • On August 10, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. This guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications.
  • On August 10, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Basic Health Program; Federal Funding Methodology for Program Year 2021. This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2021 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 Affordable Insurance Exchanges.
  • On August 11, 2020, FDA issued guidance entitled, Male Breast Cancer: Developing Drugs for Treatment. This guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients.
  • On August 12, 2020, FDA issued guidance entitled, Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment. This draft guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This draft guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The draft guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the draft guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs.
  • On August 14, 2020, FDA issued a proposed rule entitled, Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators. The FDA is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification with the name “non-invasive bone growth stimulators” along with the proposed special controls that the FDA believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these devices will no longer be required to submit a premarket approval application (PMA), but are subject to premarket notification (510(k)) requirements and general and special controls.
  • On August 14, 2020, FDA issued guidance entitled, Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This guidance provides the current thinking of FDA’s medical product Centers—CDER, CBER, and the Center for Devices and Radiological Health—regarding civil money penalties that may be assessed under the FD&C Act for violations of the requirements to submit clinical trial registration and results information to the ClinicalTrials.gov data bank and certain certifications to FDA.
  • On August 14, 2020, FDA issued guidance entitled, Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway. This final guidance provides performance criteria for cutaneous electrodes in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for cutaneous electrodes for recording purposes will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  • On August 14, 2020, FDA issued guidance entitled, Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway. This final guidance provides performance criteria for conventional Foley catheters in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for Foley catheters will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of performance of the subject device to that of a predicate device.

Event Notices 

  • August 19, 2020: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Advisory Committee for Women’s Services. The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girls’ population. Additionally, the ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children, and the current ethnic/racial climate and related economic and health disparities on women, and directions around behavioral health services and access for women and children.
  • August 26, 2020: 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 COVID-19 vaccines.
  • August 26-27, 2020: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the Advisory Committee on Blood and Tissue Safety and Availability. The committee will discuss recommendations to improve the blood community’s response to future public health emergencies. In order to facilitate this discussion, key stakeholders from across the nation will present on their lessons learned during the latest pandemic. The committee will analyze strengths and weaknesses from the COVID-19 response on the blood community and blood supply.
  • August 31, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Hospital Outpatient Payment. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as CMS prepares the annual updates for the hospital outpatient prospective payment system.
  • September 8-9, 2020: FDA announced a public meeting entitled, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss the classification of several medical devices.
  • September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
  • September 22, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
  • September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.
  • October 2, 2020: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
  • 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.

II. Congressional Hearings

There were no Congressional events this week.

III. Reports, Studies & Analyses

  • On August 10, 2020, Health Affairs published a report entitled, Medicare Part D Plans Rarely Cover Brand-Name Drugs When Generics Are Available. This report explores how often brand-name drugs receive favorable formulary inclusion relative to generics by studying Medicare Part D formularies between 2012-19 for all Part D stand-alone prescription plans and Medicare Advantage prescription drug plans. The authors found that generic-only coverage has increased over time—84 percent of all product-plan combinations covered the generic and excluded the brand name drug in 2019, an increase from 69 percent in 2012. Brand-only coverage was rare, occurring for less than 1 percent of all plan-product combinations in 2019. The authors also found that, among the formularies that covered both brands and generics in 2019, generics were on the same cost-sharing tier or on a lower tier than brands in 99 percent of observations. According to the authors, most Part D plan formularies are designed to encourage the use of generics rather than their brand name counterparts. They recommend that policy makers continue to monitor Part D formulary coverage patterns to ensure consistent and generous coverage for generic drugs.
  • On August 14, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Food Insecurity and Health: Addressing Food Needs for Medicaid Enrollees as Part of COVID-19 Response Efforts. This brief provides an overview of food insecurity among Medicaid enrollees during the COVID-19 pandemic, examines participation in federal nutrition assistance programs by Medicaid enrollees, and identifies potential actions to address food insecurity among Medicaid enrollees as needs grow in response to the COVID-19 pandemic.

IV. Other Health Policy News

  • On August 10, 2020, HHS publicly posted the July through December COVID-19 Testing Plans from all states, territories, and localities on HHS.gov. The State Testing Plans serve as a roadmap developed in partnership with the Federal government for each jurisdiction's monthly 2020 testing strategy for SARS-CoV-2, the virus that causes COVID-19. The plans include details on responding to surges in cases and reaching vulnerable populations including minorities, immunocompromised individuals and older adults. More information about these testing plans can be found here.
  • On August 11, 2020, CMS announced the Community Health Access and Rural Transformation (CHART) Model, a new program intended to improve America’s rural health care system. The approximately 57 million Americans living in rural communities, including millions of Medicare and Medicaid beneficiaries, face unique challenges when seeking healthcare services, such as limited transportation options, shortages of health care services, and an inability to fully benefit from technological and care-delivery innovations. These challenges result in rural Americans facing worse health outcomes and higher rates of preventable diseases than those living in urban areas. Through the CHART Model, CMS aims to continue addressing these disparities by providing a way for rural communities to transform their health care delivery systems by leveraging innovative financial arrangements as well as operational and regulatory flexibilities. More information about this new initiative can be found here.
  • On August 12, 2020, CMS proposed updates to coverage policies for artificial hearts and ventricular assist devices (VADs), both of which are used to treat patients with life-threatening advanced heart failure. CMS is seeking comments on the proposed national coverage determination. More information about the proposed coverage updates can be found here.
  • On August 12, 2020, HHS issued a Notice of Funding Opportunity to expand and accelerate innovative uses of electronic health information via health information exchanges (HIEs) to support state and local public health agencies. With $2.5 million in funding from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) signed by President Trump on March 27, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) will award up to five cooperative agreements under the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange (STAR HIE) Program. Award recipients will focus on improving HIE services (such as last-mile connectivity and data services) in support of state and local public health agencies. The STAR HIE Program aims to strengthen existing state and local HIE infrastructure so that public health agencies are able to better access, share, and use health information as well as support communities that have been disproportionately impacted by the COVID-19 pandemic. More information about this funding opportunity can be found here.
  • On August 13, 2020, HHS announced combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 per month. SARS-CoV-2 is the virus that causes COVID-19. The investments in Aegis Sciences Corporation and in Sonic Healthcare USA will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher Scientific and increase staffing and infrastructure to allow the U.S. to perform an additional 1 million tests each week by early October. More information about this announcement can be found here.
  • On August 14, 2020, HHS announced an additional $1.4 billion in targeted distribution funding to almost 80 free-standing children’s hospitals nationwide to help address the financial hardships caused by COVID-19. This distribution will help to ensure children’s hospitals receive relief proportional to other hospitals across the nation and providers caring for children are able to continue operating safely in some of the nation’s most vulnerable communities. This funding is made possible through the bipartisan CARES Act and the Paycheck Protection Program and Health Care Enhancement Act, which allocated $175 billion in relief funds to hospitals and other healthcare providers, including those disproportionately impacted by this pandemic. More information about this funding distribution can be found here.

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