I. Regulations, Notices, & Guidance
- On December 4, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services (CMS) With Coverage Decisions. The guidance modifies FDA’s current policy on categorization of investigational device exemption (IDE), which assists the CMS in determining whether or not an IDE device should be should be covered by CMS.
- On December 6, 2017, the FDA issued a draft guidance entitled, Pediatric Rare Diseases – A collaborative Approach for Drug Development Using Gaucher Disease as a Model. The purpose of the guidance is to facilitate drug development in pediatric rare diseases. In particular, it discusses a new possible approach to enhance the efficiency of drug development in pediatric rare diseases using Gaucher disease as an example. This new approach consists of a controlled, multi-arm, multi-company clinical trial, which aims to facilitate the development of multiple drug products in a timely manner while minimizing the number of patients necessary to be treated with a placebo. The general principles presented in the guidance should be viewed as a proposal only, and the principles underlying the proposal may be extended to other areas of drug development in rare diseases.
- On December 7, 2017, FDA issued a guidance entitled, Use of Serological Tests to Reduce the Risk of Transmission of Trypansosma cruzi (T. Cruzi) Infection in Blood and Blood Components; Guidance for Industry. The guidance provides recommendations to blood collections establishments regarding the use of serological tests to reduce the risk of transmission T. Cruzi infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product. The guidance supersedes the guidance entitled “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of T. Cruzi Infection in Whole Blood and Blood Components Intended for Transfusion” dated December 2010 and finalizes the November 2016 amendments. It also incorporates recommendations for blood testing, deferral, and donor reentry from the 2016 amendments.
- On December 8, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non Emergent Ambulance Transports. This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. The extension began December 5, 2017 and ends on December 1, 2018.
- December 7-8, 2017: The NIH announced the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC is a federally chartered external advisory group composed of scientists from the public and private sector. The BSC will provide input to the NTP on programmatic activities and issues. The meeting is open to the public.
- December 7-8, 2017: The NIH announced a public meeting of the Sleep Disorders Research Advisory Board. The meeting will evaluate sleep and circadian research activities and discuss plans for the proposed revision of the NIH Sleep Disorders Research Plan and potential opportunities for the inter-agency coordination activities.
- December 8, 2017: The Health resources and Services Administration (HRSA) announced a meeting for the Advisory Commission on Childhood Vaccines (ACCV). The ACCV agenda items include a review of petitions to add injuries to the vaccine injury table, and updates from the Department of Justice, CDC, and FDA.
- December 11, 2017: The Center for Disease Control and Prevention (CDC) announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussion on 1) update on preliminary tuberculosis funding formula; 2) update on whole genome sequencing data sharing plan; and 3) an update on the three-month Isoniazid/Rifapentine regime guidelines.
- December 11, 2017: The HHS announced the next meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objections for 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure.
- December 11-12, 2017: The FDA announced a public workshop entitled, Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward; Public Workshop; Request for Comments. The workshop will host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products.
- December 15, 2017: The FDA announced a public workshop entitled, Medical Gas Regulation Workshop I.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
- December 18, 2017: The FDA announced a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA may be used to inform regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act.
- December 18-20, 2017: The HHS announced the next meeting of the Physician-Focused Payment Model Technical Advisory Committee which will be held in Washington, D.C. The meeting 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.
- January 9-10, 2018: The HHS announced a meeting of the National Committee on Vital and Health Statistics (Committee). Committee members will discuss several health data policy topics and begin work outlined in their 2018 work plan. In addition, an environmental scan report will be reviewed and discussed by the Committee as art of the Health Information Privacy and Security Beyond HIPAA project.
- January 10, 2018: The FDA announced a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the agency on FDA’s regulatory issues. The meeting will be open to the public.
- January 11-12, 2018: The CDC announced a public meeting for the Board of Scientific Counselors (BSC) and the National Center for Health Statistics (BSC, NCHS). The meeting will provide an update on the National Health and Nutrition Examination Survey Reports and activities; provide an update on the Division of Health Care Statistics Reports and Activities; provide an update on vital statistics activities; and an update on the international activities of the NCHS.
- January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
- January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
- January 25, 2018: The FDA announced a public hearing on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including appropriate use and labeling.
- February 13, 2018: The CMS announced a Town Hall meeting to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to the meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
- February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
- On December 5, 2017, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Addressing the Opioid Crisis in America: Prevention, Treatment and Recovery. The witnesses present included: the Honorable Patrick Kennedy, Former Congressman (D-RI), President’s Commission on Combatting Drug Addiction and the Opioid Crisis; Francis Collins, M.D., Ph.D., Director, National Institutes of Health; Elinore McCance-Katz, M.D., Ph.D., Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration; Debra Houry, M.D., M.P.H. Director, National Center for Injury Prevention and Control, Center for Disease Control and Prevention.
- On December 7, 2017 the Senate HELP Committee held a hearing entitled, Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation. The witnesses present included: Francis Collins, M.D., Ph.D., Director, National Institutes of Health; and Scott Gottlieb, M.D., Commissioner, Food and Drug Administration.
- No health care-related hearings this week.
- On December 6, 2017, the CMS Office of the Actuary released 2016 National Health Expenditures. According to the Office of the Actuary, in 2016, overall national health spending increased only 4.3 percent compared to 5.8 percent growth in 2015. The report found that following the Affordable Care Act’s coverage expansion and significant retail prescription drug spending, health expenditures grew in 2014 and 2015, and decelerated in 2016.
- On December 7-8, 2017, the Medicare Payment Advisory Commission (MedPAC) held their December meetings. MedPAC’s agenda can be found here.