October 4, 2019

Alston & Bird Healthcare Week in Review, October 4, 2019

Below is Alston & Bird’s Healthcare 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 October 3, 2019, President Donald Trump signed an Executive Order intended to protect and improve the Medicare program, with a focus on market-based approaches in the current system. Read more about the Executive Order below.


I. Regulations, Notices, & Guidance

  • On September 30, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Patient-Focused Drug Development; Methods to Identify what is Important to Patients. This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making.
  • On October 1, 2019, FDA issued guidance entitled, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. This guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The recommendations in the guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. Additionally, the guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2018.
  • On October 3, 2019, FDA issued guidance entitled, Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment. The purpose of this guidance is to help sponsors design and conduct nonclinical studies needed to support initiation of clinical trials, ongoing clinical development, and marketing approval of enzyme replacement therapy (ERT) products. This guidance incorporates the comments received for and finalizes the draft guidance of the same title issued May 13, 2015.
  • On October 3, 2019, FDA issued guidance entitled, Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus. This guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The guidance updates the recommendations related to the use of an appropriate multiantigen supplemental test contained in “Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV” dated December 2010. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2018.

Event Notices         

  • October 11, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Advisory Committee on Interdisciplinary, Community-Based Linkages. The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning activities under sections 750 – 760, Title VII, Part D of the Public Health Service Act. At this meeting, ACICBL members will discuss issues related to the pending Committee reports.
  • October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
  • October 21, 2019: The Department for Health and Human Services (HHS) announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, the Advisory Council will welcome six new members, and discuss ways to increase access to long-term services and supports that support people with dementia and their caregivers in their homes and the community including innovative state programs. Federal workgroups will also provide updates on work completed in the last quarter, as well as an overview of the 2019 Update to the National Plan to Address Alzheimer’s Disease.
  • October 31, 2019: FDA announced a public meeting entitled, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials. The purpose of the meeting is to provide information on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials” (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
  • November 5-6, 2019: HRSA announced a public meeting entitled, Meeting of the National Advisory Council on Nurse Education and Practice. During meeting, NACNEP will welcome new members to the Council and discuss strategic priorities for nursing education and practice in preparation for the development of the Council’s 17th Report to Congress.
  • November 13-14, 2019: FDA announced a public meeting entitled, Immunology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam.
  • November 6-7, 2019: CDC announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
  • November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
  • November 13, 2019: FDA announced a public meeting entitled, Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
  • November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.
  • November 22, 2019: FDA announced a public meeting entitled, Blood Products Advisory Committee. The committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.
  • December 16-17: CMS announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system . Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.

II. Congressional Hearings

There were no Congressional hearings this week.

III. Reports, Studies, & Analyses

  • On October 4, Kaiser Family Foundation (KFF) released a study entitled, Pre-Existing Condition Prevalence for Individuals and Families. The impending decision by the Fifth Circuit Court of Appeals in the Texas v. Azar case raises the prospect that insurers will once again be able to return to using people’s health status in determining their eligibility and premiums for health insurance, at least for coverage obtained from the non-group, or individual insurance, market. This study updates KFF’s prior work looking at the share of nonelderly adults with health conditions that would likely to have caused them to be denied coverage if they applied for non-group health insurance prior to the effective date of the ACA, as well as the percent of nonelderly families with at least one adult who has one or more declinable conditions. Consistent with their previous analysis, KFF estimates that 27 percent of nonelderly adults have a declinable health condition, which is about 53.8 million people in 2018. They further estimate that 45 percent of nonelderly families have at least one nonelderly adult member with a declinable health condition.

IV. Other Health Policy News

  • On October 2, HHS announced that it is awarding $13.5 million to conduct state and local planning and kick off community involvement for the proposed federal initiative, Ending the HIV Epidemic: A Plan for America, which seeks to reduce new HIV infections in America by 90 percent by 2030. Read more about the announcement here.
  • On October 3, President Trump signed an Executive Order that directs HHS to move towards using market-driven rates for traditional Medicare and paying the same amount for a service regardless of whether it is provided by a physician or other type of clinician like a physician’s assistant. The order also directs CMS to look at “rewarding care through site neutrality,” though a federal court told CMS its most recent attempt at site-neutral payment for some hospital outpatient clinic visits as unlawful. The Executive Order serves as a rebuttal to Democratic Medicare for All proposals, and says that rather than end the current Medicare program, the Trump administration will continue to protect and improve Medicare by building on those aspects of the program that work well, including the market-based approaches in the current system (i.e., Medicare Advantage). Read the Executive Order here.
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