Alston & Bird Healthcare Week in Review, July 29, 2017

I. Regulations, Notices, & Guidance

• On July 24, 2017, the Food and Drug Administration (FDA) issued a guidance for sponsors, investigators, and institutional review boards (IRBs) entitled, IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. The guidance informs sponsors, investigators, IRBs, and other interested parties that the FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance explains that the FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. Comments may be submitted at any time.
• On July 24, 2017, the FDA issued a guidance entitled, M4E(R2): The CTD--Efficacy. The revised guidance standardizes the presentation of benefitrisk information in regulatory submissions, providing greater specificity on the format and structure of benefit-risk information. According to the FDA, this revision is intended to facilitate communication among regulators and industry. Comments may be submitted at any time.
• On July 24, 2017, the FDA announced the availability of recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone. According to the FDA, the document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient. Comments may be submitted at any time.
• On July 24, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Notification Process for Availability of Test Tools and Test Procedures Approved by the National Coordinator for the ONC Health IT Certification Program IT Certification Program. The notice announces a change in the notification process for the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology for the testing of health IT under the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program.
• On July 25, 2017, the FDA issued a guidance entitled, Consumer Antiseptic Wash Final Rule Questions and Answers. According to the FDA, the guidance is being issued in accordance with the Small Business Regulatory Enforcement Fairness Act to assist small businesses in better understanding and complying with the consumer antiseptic wash final rule, which established that certain active ingredients, including triclosan, used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE). The guidance explains the scope of the final rule, how and when manufacturers must comply with the final rule, and which consumer antiseptic wash active ingredients were deferred from the final rule. Comments may be submitted at any time.
• On July 25, 2017, the FDA issued a guidance entitled, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance. According to the FDA, the guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of the Generic Drug User Fee Amendments of 2012. The guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013. Comments may be submitted at any time.
• On July 25, 2017, the FDA issued a notice of proposed rulemaking entitled, Juice Products Association; Filing of Food Additive Petition. The notice announces that the FDA has filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D3 with absolute values and to update the specifications for vitamin D3.
• On July 26, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and Proposed CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. The proposed 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 proposed rule also: updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 3rd-year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. The proposed rule proposes case-mix methodology refinements, as well as a change in the unit of payment from 60-day episodes of care to 30-day periods of care, to be implemented for home health services beginning on or after January 1, 2019; and finally, this rule proposes changes to the Home Health Value-Based Purchasing Model and to the Home Health Quality Reporting Program. Comments are due by September 25, 2017.
• On July 26, 2017, the FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter. The final order announces that the FDA is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the balloon aortic valvuloplasty catheter’s classification. According to the FDA, the device is being classified into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
• On July 26, 2017, the FDA issued a final order entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays.  The final order announces that the FDA is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the assayed quality control material for clinical microbiology assays’ classification. According to the FDA, the device is being classified into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
• On July 27, 2017, CMS issued a proposed rule entitled, Medicaid Program; State Disproportionate Share Hospital Allotment Reductions. The Affordable Care Act requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2018. The proposed rule delineates a methodology to implement the annual allotment reductions. Comments are due by August 28, 2017.
• On July 27, 2017, CMS issued a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations. The notice announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. The extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children’s Health Insurance Program in those states.
• On July 27, 2017, the FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator. The final order announces that the FDA is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the adjunctive cardiovascular status indicator’s classification. According to the FDA, the device is being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
• On July 27, 2017, the FDA issued a final order entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss. The final order announces that the FDA is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. According to the FDA, the device is being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
• On July 27, 2017, the FDA issued a final order entitled, Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device. The final order announces that the FDA is classifying the cranial motion measurement device into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the cranial motion measurement device’s classification. According to the FDA, the device is being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
• On July 27, 2017, the FDA issued a final order entitled, Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator with Cutter-Coagulator. The final order announces that the FDA is classifying the closed loop hysteroscopic insufflator with cutter-coagulator into class II (special controls). The special controls that will apply to the device are identified in the final order, and will be part of the codified language for the closed loop hysteroscopic insufflator with cutter-coagulator classification. According to the FDA, the device is being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
• On July 27, 2017, the Department of Veterans’ Affairs issued a proposed rule entitled, Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions. The proposed rule proposes to amend the portion of the Schedule for Rating Disabilities that addresses the genitourinary system. The purpose of this change is to update current medical terminology, incorporate medical advances that have occurred since the last review, and provide welldefined criteria in accordance with actual, standard medical clinical practice. The proposed rule reflects the most up-to-date medical knowledge and clinical practice of nephrology and urology specialties, as well as comments from subject matter experts and the public garnered during a public forum held January 27-28, 2011. Comments are due by September 26, 2017.
• On July 28, 2017, CMS issued a notice entitled, Health Insurance Marketplace, Medicare, Medicaid, and Children’s Health Insurance Programs; Announcement of the Renewal of the Charter for the Advisory Panel on Outreach and Education (APOE). The notice announces the renewal of the charter of the Advisory Panel on Outreach and Education APOE (the Panel) in accordance with the Federal Advisory Committee Act.

• August 10, 2017: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The CSAP NAC meeting will include the discussion of the substance use prevention workforce and the changing landscape of prevention. The meeting will also include updates on CSAP program developments.
• August 16, 2017: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). During the August 16, 2017, meeting, ACTPCMD will discuss issues related to the Committee reports under development.
• September 1, 2017: The National Institutes of Health (NIH) announced a meeting of the Council of Councils. The meeting will discuss a study of variability in scientific grant peer review and an NIH update and discussion on the common fund concept.
• September 12, 2017: The National Institutes of Health (NIH) announced a meeting of the National Advisory Council for Nursing Research. The Council will discuss program policies and issues.
• September 13, 2017: The FDA announced a public workshop entitled, Developing a Framework for Regulatory Use of Real-World Evidence. Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making. Topics will include an update on the FDA’s activities to address the use of RWE in regulatory decisions and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve data development activities, study designs, and analytical methods used to create robust RWE.
• September 11 – 14, 2017: HHS announced the National Committee on Vital and Health Statistics (NCVHS), Full Committee and Population Health Subcommittee Meetings. At the September 11-12, 2017 hearing, the Population Health Subcommittee will focus on Next Generation Vital Statistics. The purpose of the hearing is to assess the current state of the national vital statistics system (NVSS) to address concerns regarding sustainability and viability of the system infrastructure. The focus will be on the system’s capacity to provide timely, high quality, secure vital administrative and statistical data for identity establishment and protection, identification of trends in disease and epidemics, e.g., the recent surge in opioid-related deaths, and a host of critical uses for research, finance, planning, public records and services. At the September 13-14, 2017 full meeting, the Committee will hear presentations, hold discussions on several health data policy topics and begin to formulate its work plan for 2018. To inform the work plan, the Committee will be briefed by the Commission on Evidence-based Policymaking (CEP) regarding the release of its report and recommendations as well as hear from HHS leadership regarding data needs and gaps. A panel will be held to discuss the new topic “Beyond HIPAA,” an exploration of challenges that extend beyond HIPAA and the range of policy options that may be available to the Department related to privacy, security and access measures to protect individually identifiable health information in an environment of electronic networking and multiple uses of data. Additional discussions are planned on the Predictability Roadmap project in follow up to a Standards Subcommittee workshop focused on possible approaches to improve the predictability and improvements in the adoption and processes related to updating standards and operating rules for electronic administrative transactions (e.g. claims, eligibility, electronic funds transfer); and on terminology & vocabulary development, maintenance, and dissemination processes. The Committee also plans to finalize the update to its strategic plan and selection criteria for undertaking new Committee projects.
• September 13 – 14, 2017: The Centers for Disease Control and Prevention (CDC) announced a Sunshine Act meeting: Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH). The agenda for the Advisory Board meeting includes: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; Securities and Exchange Commission (SEC) Petitions Update; Site Profile reviews for Pantex Plant (Amarillo, Texas), Pacific Proving Grounds (Marshall Islands), Feed Materials Production Center (Fernald, Ohio), and possibly Nevada Test Site (Mercury, Nevada); SEC petitions for: Metals and Control Corp. (1968- 1997; Attleboro, Massachusetts), Los Alamos National Laboratory (1996-2005; Los Alamos, New Mexico), Idaho National Laboratory (1970-1980; Scoville, Idaho), Area IV of Santa Susanna Field Laboratory (1991-1993; Ventura County, California), Savannah River Site (1973-2007; Aiken, South Carolina), and possibly either Ames Laboratory (1971 – undetermined ending date; Ames, Iowa) or Grand Junction Facilities (1986-2010; Grand Junction, CO); and Board Work Sessions.
• October 10, 2017: The FDA announced a public workshop entitled, Voluntary Medical Device Manufacturing and Product Quality Program. The purpose of the public workshop is to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. The workshop is intended to discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to the FDA's oversight actions in response to demonstrated manufacturing quality performance.
• October 11 – 12, 2017: The FDA announced public advisory committee meeting of the Patient Engagement Advisory Committee (PEAC). The PEAC will discuss and make recommendations on the topic of patient input into medical device clinical trials. The meeting will provide the opportunity to bring patients, patient organization, the FDA, industry, and other medical and scientific experts together for a broader discussion on this important patient-related issue.
• November 1, 2017: The NIH announced a meeting of the National Cancer Institute (NCI). The meeting will focus on a strategic discussion of the NCIs clinical and translational research programs.
• November 28, 2017: The FDA announced a public workshop entitled, Cardiac Troponin Assays. The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of myocardial infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. According to the FDA, public input and feedback gained through this workshop may aid in the development of science-based approaches to aid in the efficient development of innovative, safe and effective, troponin diagnostic assays, which may lead to better patient care

II. Congressional Legislation & Committee Action

• On July 26, 2017, the Senate Special Aging Committee held a hearing on a cure for Type I Diabetes, focusing on research and the artificial pancreas. The anticipated witnesses include Paul Sparks, Actor; Griffin Rodgers, Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Charlie Albair, Patient; Lorynn Watt, Patient; and Angie and Jonathan Platt, Chair Mom of the JDRF 2017 Children’s Congress and Member of the Children’s Congress.

• On July 25, 2017, the House Natural Resources Indian, Insular and Alaska Native Affairs Subcommittee held a hearing entitled, Assessing Current Conditions and Challenges at the Lyndon B. Johnson Tropical Medical Center in American Samoa. The witnesses included Thomas Bussanich, Director of Budget, Office of Insular Affairs, Department of the Interior; Mr. Taufete’s John Faumuina, CEO-Director, Lyndon B. Johnson Tropic Medical Center, Fagu’alu, American Samoa; Dr. Reese Tuato’o, Chief of Internal Medicine, Lyndon B. Johnson Tropical Medical Center, Fag’alu, American Samoa; Ms. Sandra King Young, Medicaid Director, American Samoa Medicaid Agency, Office of the Governor, Pago Pago, American Samoa; and Mr. Motusa Tuileama Nua, Director, Department of Public Health, Pago Pago, American Samoa.
• On July 25, 2017, the House Veteran’s Affairs Disability Assistance and Memorial Affairs Subcommittee held a hearing entitled, PTSD Claims: Assessing Whether VBA is Effectively Serving Veterans. The sole witness included, Mr. Ronald S. Burke, Deputy Under Secretary, Office for Field Operations, Veterans Benefits Administration, VA.
• On July 26, 2017, the House Energy and Commerce Health Subcommittee held a hearing entitled, Examining the Extension of Special Needs Plans. The witnesses present at the hearing included Chris Wing, Chief Executive Officer, SCAN Health Plan (SCAN); Dr. Larry Atkins, President, National MLTSS Health Plan Association; and Melanie Bella, Consultant and Former Director, Federal Coordinated Health Care Office, CMS.
• On July 27, 2017, the House Judiciary Regulatory Reform, Commercial and Antitrust Law Subcommittee held a hearing entitled, Antitrust Concerns and the FDA Approval Process. The witnesses present at the hearing included Dr. Scott Gottlieb, Commissioner, FDA; Markus Meier, Acting Director, Bureau of Competition, Assistance Director, Health Care, Federal Trade Commission (FTC); David Olson, Associate Professor of Law, Boston College Law School; Erika Lietzan, Associate Professor of Law, University of Missouri School of Law; Alden Abbott, Deputy Director and Senior Legal Fellow, The Heritage Foundation; and Dr. Aaron Kesselheim, Associate Professor of Medicine, Harvard Medical School.

• On July 24, 2017, the Congressional Budget Office (CBO) released a cost estimate of H.R. 3178, the Medicare Part B Improvement Act of 2017. The CBO estimates that enacting H.R. 3178 would reduce direct spending by $4 million over the 2018-2027 period.
• On July 26, 2017, the CBO released a cost estimate of H.R. 1628, the Better Care Reconciliation Act of 2017. The cost estimate includes an estimate of the direct spending and revenue effects of selected provisions from H.R. 1628; the net budgetary effects of the insurance coverage provisions of selected provisions from H.R. 1628; and effects of selected provisions from H.R. 1628 on health insurance coverage for people under age 65.
• On July 27, 2017, the Office of Inspector General (OIG) released a report entitled, Some Hospitals in Medicare Jurisdiction F Claimed Residents as More Than One Full-Time Equivalent. The report found that some hospitals in Medicare Jurisdiction F did not always claim Medicare graduate medical education (GME) reimbursement for residents in accordance with Federal requirements. Specifically, the OIG found that 41 hospitals claimed residents for the same period as more than 1 full-time equivalent (FTE) on cost reports covering fiscal years (FYs) 2012 and 2013. As a result, 21 of the 41 hospitals received excess Medicare GME reimbursement totaling $365,000.
• On July 27, 2017, the OIG released a report entitled, Some Hospitals in Medicare Jurisdiction E Claimed Residents as More Than One Full-Time Equivalent. The report found that some hospitals in Medicare Jurisdiction E did not always claim Medicare GME reimbursement for residents in accordance with Federal requirements. Specifically, we found that 65 hospitals claimed residents for the same period as more than 1 FTE on cost reports covering FYs 2012 and 2013. As a result, 36 of the 65 hospitals received excess Medicare GME reimbursement totaling $435,000.

IV. Other Health Policy News

• On July 24, 2017, CMS announced that it has developed a Market Saturation and Utilization Data Tool that includes interactive maps and a dataset that shows national-, state-, and county-level provider services and utilization data for selected health service areas. The tool is available through the CMS website at: https://data.cms.gov/market-saturation.
• On July 25, 2017, CMS issued an informational bulletin entitled, Annual Re-determination of Medicare Part D Low-Income Subsidy Deemed Status (Re-deeming). CMS is currently preparing for the annual redetermination of Medicare Part D low-income subsidy (LIS) deemed status, also known as “re-deeming.” The informational bulletin is being provided to help states understand the process and their role in ensuring that dual eligible beneficiaries have timely, affordable, and comprehensive coverage under the Medicare Part D prescription drug benefit.
• On July 26, 2017, CMS posted an update to the Health Insurance Exchanges Issuer County Map. The map is of projected issuer participation on the Health Insurance Exchanges in 2018 based on the known issuer public announcements through July 26, 2017.
• On July 28, 2017, CMS announced the release of a Pediatric measure set as part of the Core Quality Measures Collaborative(CQMC). According to CMS, the set of nine measures is intended for use at the provider level for individual or groups of clinicians and is intended to add focus to quality improvement efforts, reduce the burden of reporting of quality measures, and offer consumers actionable information for decision-making.

V. ACA Repeal News

• The Senate voted on the Health Care Freedom Act (HCFA) – the updated GOP legislation to partially repeal the Affordable Care Act. The amendment failed by a vote of 51-49. Sens. Susan Collins (R-ME), John McCain (R-AZ), and Lisa Murkowski (R-AK) voted against the HCFA along with all 48 Democrats.