Alston & Bird Healthcare Week in Review, December 1, 2017

I. Regulations, Notices, & Guidance

• On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that should be provided in premarket notification submissions for x-ray imaging devices that are for pediatric populations or general x-ray imaging devices for which pediatric application is anticipated. FDA intends for the guidance to minimize uncertainty during the premarket review process for x-ray imaging devices for pediatric use.
• On November 28, 2017, the FDA issued a guidance entitled, Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices. The FDA has developed this guidance to implement a section of the 21^st Century Cures Act (Cures Act) that requires FDA to revise “V. Demonstrating Insignificant Risk of an Erroneous Result” of the guidance “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” that was issued on January 30, 2008. This guidance updates FDA’s rationale regarding the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.
• On November 30, 2017, The Department of Health and Human Services (HHS) issued a notice entitled, Request for Nominations: Presidential Advisory Council on HIV/AIDS. The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the HHS. Qualified individuals will be nominated to the Secretary for consideration for appointment as members of the PACHA.  Members are invited to serve for up to four-year terms. PACHA provides advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV infection and AIDS.
• On November 30, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule entitled, Medicare Program; Cancellation of Advancing Care Coordination through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Model. The final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement (CJR) model, including: giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (Advanced APM) track. An interim final rule with comment period is issued in conjunction with the rule in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.
• On December 1, 2017, the CMS issued a notice entitled, Medicare, Medicaid, and Children’s Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2018. This notice announces a $569.00 calendar year (CY) 2018 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program; revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. The fee is required with any enrollment application submitted on or after January 1, 2018 and on or before December 31, 2018.   

• December 4-5, 2017: The NIH announced meetings of the Eunice Kennedy Shriver National Institute of Child Health and Human Development committee of the National Advisory Board on Medical Rehabilitation Research. The meetings will cover a variety updates and reports conducted regarding rehabilitation research.
• December 5, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The purpose of the meeting is receive an update on progress relevant to the Action Plan for the Muscular Dystrophies.
• December 5, 2017: The Federal Advisory Committee on Minority Health announced it will hold a meeting conducted via telephone conference call. The topics to be discussed during the teleconference include finalizing recommendations regarding improving access and quality of data related to the opioid usage and health disparities. The finalized recommendations will be given to the Deputy Assistant Secretary for Minority Health.
• December 5-6, 2017: The NIH announced it will host a public workshop about Methods for Evaluating Experiments in Obesity. The workshop seeks to discuss, among other things, population-based data sources that have been used in studies for obesity prevention and control.
• December 7, 2017: The HHS announced a public meeting of the National Preparedness and Response Science Board (NPRSB). Pursuant to the Public Health Service Act, the NPRSB can provide advice and guidance to the HHS Secretary and/or the Assistant Secretary for Preparedness and Response (ASPR) on other matters related to public health emergencies. The meeting will deliberate and vote on the future of the NPRSB Work Group Draft Letter to the ASPR.
• 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 21^st 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 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 part 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.

II. Congressional Legislation & Committee Action

• On November 29, 2017, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing to consider the nomination of Alex Azar to serve as Secretary of Health and Human Services. Nominee Alex Azar testified before the Committee.
• On November 29, 2017, the Senate Veterans’ Affairs Committee held a markup entitled, Caring for Our Veterans Act of 2017. The Committee considered the Caring for Our Veterans Act of 2017 (no bill number assigned). The measure passed by a 13-1 vote.
• On November 30, 2017, the Senate HELP Committee held a hearing entitled, the Front Lines of the Opioid Crisis: Perspectives from States, Communities, and Providers. The witnesses present included: Omar Abubaker, D.M.D, Ph.D., Professor and S. Elmer Bear Chair, Virginia Commonwealth University School of Dentistry; Rebecca Boss, MA, Director, Rhode Island Department of Behavioral Healthcare; Andrea Magermans, Managing Director of the Wisconsin Prescription Drug Monitoring Program, Wisconsin Department of Regulation and Licensing; The Honorable John C. Tilley, Secretary, Kentucky Justice and Public Safety Cabinet.

• On November 28, 2017, the House Oversight and Government Reform Committee held a hearing entitled, Combating the Opioid Crisis. The witnesses present included: The Honorable Chris Christie, Governor of New Jersey; Richard Baum, Acting Director, Office of National Drug Control Policy; Lean Wen, M.D., Health Commissioner, Baltimore, MD; Caleb Alexander, M.D., Johns Hopkins Bloomberg School of Public Health, Center for Drug Safety and Effectiveness.
• On November 29, 2017, the House Committee on Veterans Affairs’ Subcommittee on Oversight and Investigations held a hearing entitled, Examining the VA’s Failure to Address Provider Quality and Safety Concerns. The witnesses present included: Gerald Cox, M.D., M.H.A., Acting Deputy Secretary, Health for Organizational Excellence (HOE), U.S. Department of Veterans Affairs; Humayun Chaudhry, D.O., M.S., M.A.C.P., M.A.C.O.I., President and Chief Executive Officer (CEO), Federation of State Medical Boards (FSMB); and Randall Williamson, Director of Health Care, U.S. Government Accountability Office (GAO).
• On November 30, 2017, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Implementing the 21^st Century Cures Act: An Update from FDA and NIH. The witnesses present included: The Honorable Francis Collins, M.D., Director, National Institutes of Health and the Honorable Scott Gottlieb, M.D., Commissioned, Food and Drug Administration.

• On November 27, 2017, the Health and Human Services Office of Inspector General issued a report entitled, Excluding Non-covered Versions When Setting Payment for Two Part B Drugs Would have Resulted in Lower Drug Costs for Medicare and its Beneficiaries. This report discusses the impact of CMS’ decisions to include certain drugs for Medicare Part B coverage.

Iv. Other Health Policy News

• On November 27, 2017, the Center for Consumer Information and Insurance Oversight (CCIIO) issued a letter entitled, 2019 Draft Letter to Issuers in the Federally-facilitated Exchanges. The letter provides updates on operational and technical guidance for the 2019 plan year for issuers offering Qualified Health Plans (QHPs), including stand-alone dental plans in the Federally-facilitated Exchanges (FFEs) or the Federally-facilitated Small Business Health Options Programs (FF-SHOPs).