Alston & Bird Healthcare Week in Review, November 3, 2017

I. Regulations, Notices, & Guidance

• On October 30, 2017, the Center for Disease Control (CDC) issued a request for information entitled, Large-Scale, Sustainable Approaches to Help People Quit Using Tobacco by Employing Evidence-based Treatment Options. The CDC is requesting information from the public to inform future activities regarding cost-effective treatments to help people quit using tobacco.
• On October 30, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation. The FDA announced this draft guidance to clarify, update, and extend an earlier guidance entitled E9 Statistical Principles for Clinical Trials in two areas. First, the guidance provides a framework for discussion on how the aims of a trial relate to the proposed statistical analysis. Second, the guidance discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products.
• On October 31, 2017, the Substance Abuse and Mental Health Services Administration (SAMSHA) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumental Initial Facilities which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies. The notice lists all the HHS-certified laboratories and Instrumental Testing Facilities (IITF) currently certified for federal workplace drug testing programs.
• On November 1, 2017, the FDA issued a notice entitled, Request for Nominations on the Pediatric Advisory Committee. The FDA notice is requesting any industry organizations to nominate a nonvoting representative to the Pediatric Advisory Committee. The Committee gives recommendations to the FDA Commissioner regarding pediatric research and medical devices for pediatric populations, among other duties. Any industry organization interested must send a letter to the FDA by December 2, 2017.
• On November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule entitled, CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. The final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. The rule also: updates the HH PPS case-mix weights using updated data; implements the third year of a 3-year phase-in of a reduction to the 60-day episode payment to account for estimated case-mix growth unrelated to normal case-mix growth between calendar year (CY) 2012 and CY 2014; and discusses CMS’s efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, the rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). CMS is not finalizing the Home Health Groupings Model (HHGM) in the rule.
• On November 1, 2017, the CMS issued a final rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. The final rule revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018. The final rule describes changes to the amounts and factors for determining payment rates for Medicare services through OPPS and ASC. In addition, the final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting Program. The rule will become effective January 1, 2018. Comments on the rule are due December 31, 2017.
• On November 1, 2017, the CMS issued a rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program.  The rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018. It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also sets forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021. The rule will be effective January 1, 2018.
• On November 2, 2017, the CMS issued a notice entitled, Medicaid Program: Final FY 2015 and Preliminary FY 2017 Disproportionate Share Hospital Allotments, and Final FY 2015 and Preliminary FY 2017 Institutions for Mental Diseases Disproportionate Share Hospital Limits. The notice announced the disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2015 and the preliminary allotments for FY 2017. The notice also announced the FY 2015 and FY 2017 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states’ DSH allotments.
• On November 2, 2017, the CMS issued a final rule with comment period entitled, Medicare program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition year. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). CMS began implementing the Quality Payment program for (CY) 2017. This final rule updates future years of the Quality Payment Program. The rule also contains an interim final rule with comment period that addresses extreme and uncontrollable circumstances MIPS clinicians may face as a result of Hurricanes Irma, Harvey, and Maria. Comments are due January 1, 2018. The regulation will be effective January 1, 2018.
• On November 3, 2017, the CMS issued a final rule entitled, Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program. This rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, and is intended to update payment systems to reflect changes in medical practice and the relative value of services. In addition, the final rule includes policies necessary to begin expanding the Medicare Diabetes Prevention Program model. The regulations are effective January 1, 2018.

• October 30, 2017: The NIH announced a meeting of the Frederick National laboratory Advisory Committee to the National Cancer Institute. The agenda includes a discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research.
• October 31, 2017: The FDA announced a public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss NDA 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.
• November 1, 2017: HHS announced that the Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session entitled, Partnering to Prevent Hypoglycemia. The purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications.
• November 2-3, 2017: the NIH announced the Center for Scientific Review Special Emphasis Panel will hold a closed meeting to review and evaluate grant applications.
• November 3, 2017: HHS announced that the Agency for Healthcare Research and Quality (AHRQ) will hold a public meeting in accordance with section 10(a) of the Federal Advisory Committee Act. The purpose on the meeting is to advise the HHS Secretary and the Director of AHRQ to conduct its mission including providing guidance on priorities for health care research, the field of health care research including training needs and information dissemination on health care quality.
• November 6 – 7, 2017: The FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). On November 6, 2017, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On November 7, 2017, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products, Center for Veterinary Medicine, and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.
• 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 work in learning 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 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.
• 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 to bring together the Committee members to update one another 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 11, 2017: The 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: On October 30, 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 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.

II. Congressional Legislation & Committee Action

• On October 31, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Implementation of the 21^st Century Cures Act: Achieving the Promise of Health Information Technology.  The witnesses included Jon White, Deputy National Coordinator for Health Information Technology at HHS; Kate Goodrich, Director of the Center For Clinical Standard and Quality And Chief Medical Officer at CMS; James Cannatti, Senior Counselor For Health Information Technology in the HHS OIG.

• On November 3, 2017, the House of Representatives passed H.R. 3922, the CHAMPION Act, which would extend funding for the Children’s Health Insurance Program (CHIP) for five years and Community Health Centers for two years. The bill was approved a 242-174

• On October 27, 2017 the Congressional Budget Office (CBO) released its report on R. 849, Protecting Seniors’ Access to Medicare Act. H.R. 849 would repeal provisions of the Affordable Care Act (ACA) that established the Independent Payment Advisory Board (IPAB). The CBO estimates that enacting H.R. 849 would increase direct spending by $17.5 billion over the 2018-2027 period.
• On October 30, 2017, the Government Accountability Office (GAO) released a report entitled, Opioid Use Disorders: HHS Needs Measures to Assess the Effectiveness of Efforts to Expand Access to Medication-Assisted Treatment (MAT). The report recommends that HHS take two actions: (1) establish performance measures with targets related to expanding access to MAT, and (2) establish timeframes for its evaluation of its efforts to expand access to MAT.
• On November 1, 2017 the President’s Commission on Combating Drug Addiction and the Opioid Crisis released its recommendations. The report provides recommendations to: consolidate federal funding; prioritize opioid addiction prevention strategies; provide for full-spectrum opioid addiction treatment; and improve research and development for pain management and addiction research.

Iv. Other Health Policy News

• The Medicare Payment and Advisory Commission (MedPAC) held its November meetings this week. The sessions covered a wide-range of topics including finding alternatives to the Merit-based Incentive Payment System. MedPAC’s agenda can be accessed here.
• On November 1, 2017, the House Majority Leader Kevin McCarthy released the 2018 Congressional calendar.