Alston & Bird Healthcare Week In Review, February 9, 2018

I. Regulations, Notices, & Guidance

• On February 5, 2018, the Drug Enforcement Agency (DEA) issued a temporary scheduling order entitled, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I. The DEA issued this temporary order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to public safety. As a result of the order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle or propose to handle fentanyl-related substances.
• On February 6, 2018, the Food and Drug Administration (FDA) issued a notice entitled, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics. The FDA announced that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance pursuant to the Paperwork Reduction Act of 1995. This information request is to support a previous FDA guidance for industry entitled, Expedited Programs for Serious Conditions - - Drugs and Biologics. The guidance provides a single resource for information on FDA’s policies related to the following expedited programs for serious conditions: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. This notice estimates the burden associated to comply with the expedited programs in the guidance.
• On February 6, 2018, the FDA issued a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. The FDA announced the availability of draft and revised product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, the 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 the FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
• On February 8, 2018, the FDA issued a notice entitled, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements. The FDA announced that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance pursuant to the Paperwork Reduction Act of 1995. Under current regulations, certain persons, manufacturers, packers, and distributors are required to submit safety reports in an electronic format. However, those who are subject to the safety reporting requirements may request a waiver from the electronic format. This notice estimates the burden associated with the submission of waiver requests for post marketing safety reports in electronic format.
• On February 9, 2018, the Health Resources and Services Administration (HRSA) issued a notice entitled, Low Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act. HRSA is updating income levels used to identify a “low income family” for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. This notice includes the updated income levels to reflect the Department of Health and Human Services (HHS) 2018 poverty guidelines.

Event Notices

• 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 14, 2018: The SAMHSA’s Center for Mental Health Services (Center) announced a public meeting to discuss the Center’s policy issues, present on SAMHSA’s policy lab, and a conversation with the Assistant Secretary for Mental Health and Substance Abuse Dr. Elinore McCance-Katz.
• February 14, 2018: The SAMHSA’s Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) announced a public meeting. The CSAP NAC will discuss workforce issues related to substance abuse and opioid use prevention.
• February 14-15, 2018: The CDC announced a meeting of the Community Preventative Services Task Force (CPSTF). The CPSTF will discuss the economics of multicomponent interventions to improve cancer screening for breast, colorectal, and cervical cancer; a proposal for housing interventions as a new topic area; school-based interventions to increase healthy lifestyle choices; prevention of intimate partner violence and sexual violence among youth; and a discussion on Community Guide economic methods. The agenda is subject to change without notice.
• February 16, 2018: The SAMHSA announced a meeting of the National Advisory Council. The meeting will include remarks from the Assistant Secretary for Mental Health and Substance Abuse Dr. Elinore McCance-Katz; updates from the HHS’ Operating Divisions; and updates from the ex-officio members.
• February 21-22, 2018: The CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on influenza vaccines, evidence based recommendations, anthrax vaccine, Japanese encephalitis vaccines, hepatitis vaccines, human papillomavirus vaccines, pneumococcal vaccines, meningococcal disease, and an update on vaccines and other biologics for prevention and treatment of healthcare-associated infections. A recommendation vote is scheduled for hepatitis vaccines and evidence based recommendations.  The meeting is open to the public, limited only by room seating. The public is welcome to comment at the meeting or submit written comments.
• February 22, 2018: The Health Resources and Service Administration (HRSA) announced a public meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. During the meeting, the Advisory Committee will discuss workgroup reports and updates, information regarding the National Ryan White HIV/AIS Program Conference, and Committee business-related items.
• February 28, 2018: the HHS announced the next meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation’s health status and health risk goals for the nation by the year 2030.
• March 6, 2018: The CDC’s National Center for Health Statistics announced a meeting of the ICD-10 Coordination and Maintenance Committee. The Committee will discuss many coding topics specified in the link. The meeting is open to the public and will be broadcast live via webcast.
• March 8, 2018: The FDA announced an upcoming public meeting of the Gastrointestinal Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to the FDA on regulatory issues. The Committee will discuss supplemental new drug applications (sNDA) 203214 supplement 18, XELJANZ tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy.
• March 19, 2018: The FDA announced a public workshop entitled, Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. The workshop will discuss how to individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.
• March 22, 2018: The FDA announced a meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The PAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia.
• March 26-27, 2018: The HHS announced the March meetings of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) which will be held in Washington, DC. The link contains the dates of all 2018 PTAC meetings.  The meetings 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.
• April 16, 2018: The FDA announced a public meeting entitled, Evaluating Inclusion and Exclusion Criteria in Clinical Trials. The purpose of the meeting is to bring together stakeholders to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.

II. Congressional Legislation & Committee Action

U.S. Senate

• On February 7, 2018, the Senate Committee on Aging held a hearing entitled, From Joint Pain to Pocket Pain: Cost and Competition Among Rheumatoid Arthritis Therapies.  Witnesses present included: Patricia Bernard, Rheumatoid Arthritis Patient; William Harvey, MD, MSc, FACR, Rheumatologist, Associate Professor, Clinical Director, Division of Rheumatology, Tufts University School of Medicine; Jack Hoadley, PhD, Health Policy Analyst and Researcher, Georgetown University; Terry Mahn, JD, Managing Principal, Regulatory and Government Affairs Practice Group Leader, Fish & Richardson, Washington, D.C., Advisory Board Member, Bloomberg BNA Pharmaceutical Law and Industry Report.
• On February 8, 2018, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, The Opioid Crisis: Impact on Children and Families. Witnesses present included: Becky Savage, Co-Founder, 525 Foundation; Stephen Patrick, MD, MPH, MS, FAAP, Assistant Professor of Pediatrics and Health Policy, Division of Neonatology Vanderbilt University Medical Center; William Bell, President and CEO, Casey Family Programs.

House of Representatives

• On February 6, 2018, the House Ways and Means Subcommittee on Health held a hearing entitled, Removing Barriers to Prevent and Treat Opioid Abuse and Dependence in Medicare. Witnesses present included: Phil Scott, Governor, State of Vermont; Dr. Ramsin Benyamin, MD, President and Founder, Millennium Pain Center, Board of Directors, American Board of Interventional Pain Physicians; Jason Kletter, PhD, President, BayMark Health Services and Bay Area Addiction Research and Treatment, Harold Paz, MD, MS, Executive Vice President and Chief Medical Officer, Aetna; Laura Hungiville, PharmD, Chief Pharmacy Officer, WellCare Health Plans, Inc.

III. Reports, Studies, & Analyses

• On February 8, 2018, the Government Accountability Office (GAO) released a report entitled, Substance-Affected Infants: Additional Guidance Would Help States Better Implement Protections for Children. Under current law, states are required to perform a range of prevention activities, including addressing the needs of infants born with prenatal drug exposure. According to GAO, the number of infants entering foster care have increased by 15 percent from 2012-2015. The increase has been attributed to the opioid epidemic. The report examines the extent to which states have adopted policies and procedures to notify child protective services of substance-affected infants; state efforts to develop plans of safe care; and steps HHS has taken to help implement the plans. The report recommends that HHS should provide additional guidance and technical assistance to states to address known challenges.

IV. Other Health Policy News

• On February 8, 2018, the Congressional Budget Office (CBO) released a cost estimate entitled, Estimated Direct Spending and Revenue Effects of Division E of Senate Amendment 1930, the Bipartisan Budget Act of 2018. The document provides cost estimates for the health-related provisions in the Bipartisan Budget Act of 2018, which passed early this morning.