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 March 5, 2018, the Health Resources and Services Administration (HRSA) issued a notice entitled, Project Period Extensions with Funding: Health Center Program. The HRSA provided additional grant funds to four award recipients in Puerto Rico with project periods ending in fiscal year 2018 to extend their current project periods by 12 months to prevent interruptions in the provision of health care services while they recover from Hurricane Maria.
- On March 5, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies. The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice contains the current list of certified laboratories and IITFs.
- On March 7, 2018, the Food and Drug Administration (FDA) issued a rule entitled, Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds. The FDA is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds’ classification. The FDA is taking this action because the FDA has determined that classifying the device into class II (special controls) 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 March 7, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Notice of the Health Information Technology Advisory Committee 2018 Schedule. The Health Information Technology Advisory Committee (HITAC) will identify priorities for standards and make recommendations to the National Coordinator for Health Information Technology on a policy framework to advance interoperable health information technology. This notice includes the schedule for the HITAC’s assessment of policy recommendations.
- March 13-14, 2018: The HHS announced a meeting of the Advisory Committee on Human Research Protections. The meetings will cover various topics pertaining to or associated with the protection of human research subjects.
- March 15 & 27, 2018: The HHS announced two meetings for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). The meetings will be an orientation session for the ACICBL members and identify potential topics to work on for 2018.
- March 19, 2018: The FDA announced a public workshop entitled, Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. The workshop will discuss how to individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.
- March 19, 2018: The FDA announced a public workshop entitled, Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public Workshop. This workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring rare disease stakeholders together to discuss the challenges associated with the development and regulatory decision-making for rare disease treatments and to also discuss promising study designs and analytical methods that can help overcome these challenges.
- March 20, 2018: The FDA announced a public meeting entitled, Promoting the Use of Complex Innovative Designs in Clinical Trials. The topic to be discussed is the use of complex innovative designs in clinical trials of drugs and biological products to inform regulatory decision making.
- March 21, 2018: the FDA announced a public meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Committee. The Committee will function as a medical device panel to provide advice and recommendations to the FDA on classification of devices. The Committee will also provide advice and recommendations to the FDA on research programs in the Office of Blood Research and Review.
- March 22, 2018: The FDA announced a meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The PAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia.
- March 26-27, 2018: The HHS announced the March meetings of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) which will be held in Washington, DC. The link contains the dates of all 2018 PTAC meetings. The meetings will include voting and deliberations on proposals for physician- focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
- April 6, 2018: The FDA announced a public meeting entitled, S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Humans Use (ICH). The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Kobe, Japan. The topics to be address at the meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly meeting in Kobe, Japan.
- April 10, 2018: The Center for Disease Control and Prevention (CDC) announced a meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on the clinical laboratory workforce; implementation of next generation sequencing in clinical laboratories; laboratory interoperability; and using clinical laboratory data to improve quality and laboratory medicine practices.
- April 16, 2018: The FDA announced a public meeting entitled, Evaluating Inclusion and Exclusion Criteria in Clinical Trials. The purpose of the meeting is to bring together stakeholders to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.
- April 19, 2018: The FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The Committee provides advice and recommendations to FDA on regulatory issues. The Committee will discuss new drug application 210365, cannabidiol oral solution, sponsored by GW pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
- May 9, 2018: The FDA announced a public workshop entitled, Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation. The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity when approving a product with a tissue agnostic indication.
- May 14-16, 2018: The Centers for Medicare and Medicaid Services (CMS) announced the public meetings on the Healthcare Common Procedure Coding System (HCPCS) for 2018. The public meetings will cover CMS’ preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments.
II. Congressional Legislation & Committee Action
- On March 8, 2018, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, The Opioid Crisis: Leadership and Innovation in the States. Witnesses present included: the Honorable Larry Hogan, Governor of Maryland, and the Honorable Kate Brown, Governor of Oregon.
House of Representatives
- On March 8, 2018, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Examining US Public Health Preparedness for and Response Efforts to Seasonal Influenza. Witnesses present included: Anne Schuchat, M.D., Rear Admiral (RADM, US Public Health Service), Acting Director, Centers for Disease Control and Prevention (CDC); Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); Rick A. Bright, Ph.D., Deputy Assistant Secretary for Preparedness and Response, Director of the Biomedical Advances Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR); and Scott Gottlieb, M.D., Commissioner of Food and Drugs, US Food and Drug Administration (FDA).
III. Reports, Studies, & Analyses
- On March 9, 2018, the Center on Budget and Policy Priorities released a report entitled, Individual Market Stabilization Proposals Should Avoid Raising Costs for Consumers: Proposals Should Also Address Greatest Risks to the Market. The report discusses proposals for stabilizing insurance markets and anticipated consequences of such proposals.
IV. Other Health Policy News
- On March 8, 2018, the CMS Administrator Seema Verma sent a letter to Idaho Governor, C.L. “Butch” Otter, regarding Idaho’s effort to sell individual insurance plans that do not comply with the Affordable Care Act. The letter is available here.