Alston & Bird Healthcare Week in Review, November 17, 2017

I. Regulations, Notices, & Guidance

• On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II) extends FDA’s authority to collect user fees from fiscal year 2018-2022 and introduces a number of technical revisions that affect what fees are collected and how fees are collected. The draft guidance concerns FDA’s implementation of BsUFA II and certain intended changes in policies and procedures surrounding its application. Comments are due by January 16, 2018.
• On November 16, 2017, the FDA issued a draft guidance entitled, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. The FDA announced that the draft guidance, when finalized, will provide stakeholders with FDA’s rational for expedited development and review of certain products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions; how the Center for Biologics and Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design; and the opportunities for sponsors of regenerative medicine therapies to interact with CBER staff.
• On November 16, 2017, the FDA issued a draft guidance entitled, Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability. The draft guidance will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with the FDA’s rational regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies. Specifically, per the 21^st Century Cures Act (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; intended uses or specific attributes that would result in a device used with regenerative therapy products to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and the application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.
• On November 16, 2017, the FDA issued a draft guidance entitled, Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; guidance for Industry; Availability. The draft guidance  provides tissue establishments and health care professionals with FDA’s rational on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products regulations.
• On November 16, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program. The proposed rule would revise the Medicare Advantage Program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) and the 21^st Century Cures Act; to improve program quality, accessibility, and affordability; improve CMS customer experience; address program integrity policies related to payments based on prescriber, provider and supplier status in Medicare Advantage, Medicare Cost Plan, Medicare Part D and the PACE programs; provide a proposed update to the official Medicare Part D and the PACE programs; provide a proposed update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premium adjustments.
• On November 17, 2017, the CMS issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2018. The notice announced the monthly actuarial rates for aged and disabled beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2018. In addition, the notice announced the monthly premium for aged and disabled beneficiaries, the deductible for 2018, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2018 are $261.90 for aged enrollees and $295.00 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2018 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees plus $3.00. The Part B deductible for 2018 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, that beneficiary will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.
• On November 17, 2017, the CMS issued a notice entitled, Medicare Program; CY 2018 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This is an annual notice announcing Medicare’s Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2018. The premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2018 for these individuals will be $422. The premium for certain other individuals as described in this notice will be $232.
• On November 17, 2017, the CMS issued a notice entitled, Medicare Program; CY 2018 Inpatient Hospital Deductible and Hospital and Extended Care services Coinsurance Amounts. The notice announced the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2018 under Medicare’s Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formula used to determine these amounts. For CY 2018, the inpatient hospital deductible will be $1,340. The daily coinsurance amounts for CY 2018 will be: $335 for the 61^st through the 90^th day of hospitalization in a benefit period; $670 for lifetime reserve days; and $167.50 for the 21^st through the 100^th day of extended care services in a skilled nursing facility in a benefit period.

• November 12-14: The National Institute of Environmental Health Sciences issued a notice of meeting. The meeting will cover AHRQ’s current research, programs, and initiatives and also include an update on health care systems and an update on AHRQ’s data platform.
• November 16, 2017: The FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.
• November 28, 2017: The National institutes of Health (NIH) announced a public meeting of the National Cancer Institute Board of Scientific Advisors and the National Cancer Advisory Board (NCAB). The meeting will discuss global cancer research and epidemiology population science.
• November 30, 2017: The FDA announced a public meeting entitled, Assessment of FDA Hiring and Retention. The purpose of the meeting is to share findings from a recently completed assessment of FDA’s hiring process. The meeting will also outline near-term actions FDA will take to improve the hiring process, an update on the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act hiring and retention commitments, and to solicit input on FDA hiring processes.
• November 30-December 1, 2017: The FDA announced a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. On November 30, the Committee will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. On December 1, 2017, the Committee will meet in open session to discuss strategies to reduce the risk of transfusion-transmitted Zika virus.
• 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 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 11-12, 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 Department of Health and Human Services (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 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.
• 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 14, 2017 the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Gene Editing Technology: Innovation and Impact. The witnesses included Mathew Porteus, Ph.D., M.D., Associate Professor of Pediatrics at Stanford University; Katrine Bosley, CEO and President of Editas Medicine; and Jeffrey Kahn, Ph. D., M.D.
• On November 15, 2017, the Senate Appropriations Subcommittee on Military Construction, Veterans Affairs and Related Agencies held a hearing entitled, VA Efforts to Prevent and Combat Opioid Overmedication. Witnesses included Honorable Michael Missal, Inspector General of the U.S. Department of Veterans Affairs; Laurence Meyer, M.D., Chief Officer for Specialty Care at the Veterans Health Administration accompanied by Friedhelm Sandbrink, M.D., Acting National Program Director for Pain Management at the U.S. Department of Veterans Affairs; and Marvin Simcakoski, father of a deceased veteran, Stevens Point, Wisconsin.
• On November 15, 2017, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Encouraging Healthy Communities: Perspective from the Surgeon General. United States Surgeon General, Vice Admiral Jerome Adams, M.D. MPH testified before the Committee.

• There were no health care-related hearings.

• On November 14, 2017 the Congressional Budget Office (CBO) issued a working paper entitled, Effects of Medicare Advantage Enrollment on Beneficiary Risk Scores.  The paper explores the mechanisms contributing to differences in Medicare Advantage and fee-for-service risk scores.

IV. Other Health Policy News

• The Senate Committee on Health, Education, Labor and Pensions will hold a hearing for President Trump’s HHS nominee, Alex Azar, November 29, 2017.