General Publications February 22, 2019

Alston & Bird Healthcare Week in Review, February 22, 2019

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

  • On February 19, 2019, the Food and Drug Administration (FDA) issued a rule entitled, Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances. The FDA is classifying the auto titration device for oral appliances into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the auto titration device for oral appliances’ classification. The FDA is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
  • On February 21, 2019, the Department of Veterans Affairs (VA) issued a proposed rule entitled, Veterans Community Care Program. The VA proposes to amend its medical regulations to implement its authority for covered veterans to receive necessary hospital care, medical services, and extended care services from non-VA entities or providers in the community. Section 101 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Network Act of 2018 directs VA to implement a program to furnish such care and services to covered veterans through eligible entities and providers. This proposed rule would establish the criteria for determining when covered veterans may elect to receive such care and services through community health care entities or providers, as well as other parameters of this program.
  • On February 22, 2019, the FDA issued a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. The FDA is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance.
  • On February 22, 2019, the Department of Health and Human Services (HHS), Department of Treasury, and Department of Labor, issued a request for information (RFI) entitled, Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. This document is a RFI regarding grandfathered group health plans and grandfathered group health insurance coverage. Given the limited information available regarding such coverage, the Departments are issuing this RFI to gather input from the public in order to better understand the challenges that group health plans and group health insurance issuers face in avoiding a loss of grandfathered status, and to determine whether there are opportunities for the Departments to assist such plans and issuers, consistent with the law, in preserving the grandfathered status of group health plans and group health insurance coverage in ways that would benefit employers, employee organizations, plan participants and beneficiaries, and other stakeholders.
  • On February 22, 2019, the Office of the National Coordinator for Health Information Technology (ONC) issued a proposed rule entitled, 21st Century Cures Act: Interoperability Blocking, and the ONC Health IT Certification Program. This proposed rule would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The implementation of these provisions would advance interoperability and support the access, exchange, and use of electronic health information. The proposed rule would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.
  • On February 22, 2019, HHS issued a proposed rule entitled, Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers. This proposed rule is intended to move the health care ecosystem in the direction of interoperability, and to signal HHS’s commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers.

Event Notices   

  • February 27, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment National Advisory Council (NAC). The NAC will discuss recovery housing and expanding access to medication-assisted treatment.
  • March 8, 2019: The FDA announced a public meeting of the Microbiology Devices Panel. The panel will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV).
  • April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.

II. Congressional Legislation & Committee Action

U.S. Senate

  • There were no health-related hearings this week.

House of Representatives

  • There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On February 21, 2019, the Government Accountability Office (GAO) issued a report entitled, Advanced Care Planning: Selected States’ Efforts to Educate and Address Access Challenges. GAO was asked to identify issues related to completing and accessing advance care planning documents. The report describes, among other things, (1) the challenges individuals and providers face completing and accessing the documents and (2) state strategies for improving individuals and providers understanding of and access to advanced care planning documents.

IV. Other Health Policy News

  • On February 22, 2019, HHS issued the 2018 Annual Report, which provides an overview of the agency’s work. The report focuses on five strategic goals including: (1) reforming, strengthening, and modernizing the U.S. healthcare system; (2) protecting the health of Americans where they live, learn, work, and play; (3) strengthening the economic and social well-being of Americans across their lifespan; (4) fostering sound, sustained advances in the sciences; and (5) promoting effective and efficient management and stewardship of HHS.
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