Alston & Bird Healthcare Week in Review, July 20, 2018

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

• On July 17, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Innovative Approaches for Nonprescription Drug Products. This draft guidance describes innovative approaches that may be useful to consider for demonstrating safety and effectiveness for nonprescription drug product in cases where the drug facts labeling alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting.
• On July 18, 2018, the FDA issued guidance entitled, Use of Electronic Health Record Data in Clinical Investigations. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.
• On July 18, 2018, the FDA issued guidance entitled, Labeling for Biosimilar Products. This guidance is intended to help applicants develop draft labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance provides an overview of FDA’s recommendations for labeling for biosimilar products. This guidance finalizes the draft guidance issued on April 4, 2016.
• On July 20, 2018, the FDA issued a notice entitled, Guidances. The notice announces the availability of additional draft and revised product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications (ANDAs).  In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance.

Event Notices

• July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
• July 30, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/Alzheimer’s Association’s joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.
• August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
• August 3, 2018: The FDA announced a meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The committees will discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy.
• August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
• August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
• September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
• September 28, 2018: the FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.

II. Congressional Legislation & Committee Action

U.S. Senate  

• On July 17, 2018, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, Reducing Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients. Witnesses present included: Jeff Balser, M.D., Ph.D., President and Chief Executive Office Vanderbilt University Medical Center, Dean, Vanderbilt University School of Medicine; Steven Safyer, M.D., President and Chief Executive Officer, Montefiore Health System; David Lansky Ph.D., President and Chief Executive Officer, Pacific Business Group on Health; and Brent James, M.D., Clinical Professor, Department of Medicine, Stanford University School of Medicine, Member, National Academy of Medicine.

House of Representatives

• On July 17, 2018, the House Energy and Commerce Committee held a hearing entitled, Examining State Efforts to Improve Transparency of Health Care Costs for Consumers. Witnesses present included: Jaime King, Professor, University of California (UC) Hastings College of the Law, Associate Dean and Co-Director, UC San Francisco/UC Hastings Consortium on Law, Science, and Health Policy; and Michael Chernew, Leonard D. Schaeffer Professor of Health Care Policy, Director, Healthcare Markets and Regulation Lab, Department of Health Care Policy, Harvard Medical School.
• On July 17, 2018, the House Ways and Means Subcommittee on Oversight held a hearing entitled, Combating Fraud in Medicare: A strategy for Success. Witnesses present included: Seto Bagdoyan, Director, Forensic Audits & Investigative Service, Government Accountability Office; Gloria Jarmon, Deputy Inspector General for Audit Services, Office of Inspector General, U.S. Department of Health and Human Services; and Alec Alexander, Director, Center for Program Integrity, Centers for Medicare and Medicaid Services.
• On July 17, 2018, the House Ways and Means Subcommittee on Health held a hearing entitled, Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program. Witnesses present included: Eric Hargan, Deputy Secretary, Department of Health and Human Services; Gary M. Kirsh, MD, President, The Urology Group, on behalf of the Large Urology Group Practice Association; Mike Lappin, Chief Integration Office, Advocate AuroraHealth; Brian DeBusk, PhD, MBA, President and Chief Executive Officer, DeRoyal; and Claire M. Sylvia, Partner, Phillips & Cohen LLP.
• On July 18, 2018, the House Energy and Commerce Committee held a markup entitled, Energy and Commerce Committee Vote on H.R. 6351 and H.R. 6378. The Committee voted on H.R. 6351, Advancing U.S. Civil Nuclear Competitiveness and Jobs Act and H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPA). The Committee advanced PAHPA by a voice vote.
• On July 19, 2018, the House Energy and Commerce Committee held a hearing entitled, 21^st Century Cures Implementation: Examining Mental Health Initiatives.  The only witness present was Elinore McCance-Katz, Assistant Secretary, Substance Abuse and Mental Health Services.

III. Reports, Studies, & Analyses

• On July 18, 2018, the U.S. Government Accountability Office (GAO) released a report entitled, Drug Discount Program: Characteristics of Hospitals Participating and Not Participating in the 340B Program. GAO compared characteristics of hospitals that did and did not participate in the 340B program, focusing on the three types that comprised over 95 percent of participants in 2016. The GAO found that 340B hospitals were smaller in terms of number of inpatient beds, and a higher percentage were teaching hospitals. GAO also found that program participation increased for particular hospitals in states that expanded Medicaid.

IV. Other Health Policy News

• On July 19, 2018, all 49 Democratic Senators announced a resolution to authorize the Senate Legal Counsel to represent the United States Senate in litigation challenging the constitutionality of the Affordable Care Act. The resolution is available here.