Alston & Bird Healthcare Week In Review, February 16, 2018

I. Regulations, Notices, & Guidance

• On February 12, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability. The FDA announced the availability of a guidance for industry entitled “Bacillus Calmette-Guérin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.” This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016.
• On February 14, 2018, the FDA issued a guidance entitled, Regulatory Classification of Pharmaceutical Co-Crystals; Guidance for Industry; Availability. The FDA announced the availability of a guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This guidance finalizes the draft guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals" published in August 2016.
• On February 15, 2018, the FDA issued a guidance entitled, Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability. The FDA announced the availability of a draft guidance for industry entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease” issued.

  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 1, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). VRBPAC will meet in open session to hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), CBER, FDA. Also the committee discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 influenza season. FDA intends to make background material available to the public no later than 2 business days before the meeting.
• March 2, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (the Council). The meeting will be dedicated to the Council’s deliberation and vote on a letter drafted by the Immediate Action subcommittee. The meeting agenda will be posted on the council’s website at http://www.hhs.gov/ash/carb/ when it has been finalized.
• 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 19, 2018: The FDA announced a public workshop entitled, Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public Workshop. This workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring rare disease stakeholders together to discuss the challenges associated with the development and regulatory decision-making for rare disease treatments and to also discuss promising study designs and analytical methods that can help overcome these challenges.
• 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 15, 2018, the Senate Finance Committee held a hearing entitled, The President’s Fiscal Year 2019 Budget. Health and Human Services Secretary Alex Azar testified.

House of Representatives

• On February 14, 2018, the House Ways and Means Committee held a hearing entitled, The Department of Health and Human Services’ Fiscal year 2019 Budget Request. Department of Health and Human Services Secretary Alex Azar testified.
• On February 14, 2018, the House Energy and Commerce Subcommittee on Oversight health a hearing entitled, Examining The Impact of Health Care Consolidation. Witnesses present included: Martin Gaynor, PhD, E.J. Barone University Professor of Economics and Health Policy, Heinz College, Carnegie Mellon University; Leemore Dafny, PhD, Bruce V. Rauner Professor of Business Administration, Harvard Business School; and Kevin A.  Schulman, MD, Professor of Medicine, Gregory Mario and Jeremy Mario Professor, Duke University, Visiting Scholar, Harvard Business School.
• On February 15, 2018, the House Judiciary Committee held a hearing entitled, The Effect of Sanctuary City Policies on the Ability to Combat the Opioid Epidemic. Witnesses present included: Detective Nick Rogers, President, Denver Police Protective Association; the Honorable A.J. Louderback, Sheriff, Jackson County Sheriff Office; Ms. Jessica Vaughan, Director of Policy Studies, Center for Immigration Studies; Professor Keith Humphreys, Department of Psychiatry, Stanford University School of Medicine.
• On February 15, 2018, The House Education and Workforce Subcommittees on Health, Employment, Labor, and Pensions; and Subcommittee on Workforce Protections held a hearing entitled, The Opioid Epidemic: Implications for America’s Workplaces. Witnesses present included: Lisa Allen, President and CEO, Ziegenfelder Company; Christina Andrews, PhD, Assistant Professor, University of South Carolina; Corwin Rhyan, MPP, Senior Health Care Analyst, Altarum Institute; and Kathryn Russo, Principal, Jackson Lewis P.C.
• On February 15, 2018, the House Energy and Commerce Subcommittee on health held a hearing entitled, Oversight of the Department of Health and Human Services. Health and Human Services Secretary Alex Azar testified.

III. Reports, Studies, & Analyses

• On February 13, 2018, the Government Accountability Office (GAO) released a report entitled, Federal Law Enforcement: DHS and DOJ Are Working to Enhance Responses to Incidents Involving Individuals with Mental Illness. The 21^st Century Cures Act includes a provision for GAO to review the practices that federal first responders, tactical units, and corrections officers are trained to use in responding to incidents involving individuals with mental illness. The report addresses challenges that federal law enforcement officers and agents face; applicable training, policies, and guidance; and existing leading practices, relevant tools, and efforts to leverage information.
• On February 16, 2018, the Government Accountability Office (GAO) released a portfolio entitled, Medicare Needs Better Controls To Prevent Fraud, Waste, and Abuse Related to Chiropractic Services. This portfolio presents an overview of Medicare program vulnerabilities identified in prior Office of Inspector General (OIG) audits, evaluations, investigations, and legal actions related to chiropractic services. Additionally, this portfolio offers recommendations to help Medicare prevent fraud, waste, and abuse related to those services.

Iv. Other Health Policy News

On February 12, 2018, the Trump Administration released its fiscal year 2019 budget proposal. The Budget proposes a total of $95.4 billion in discretionary budget authority for HHS and $1.12 billion in mandatory funding for the department for FY 2019. The HHS budget reflects and is inclusive of the Administration’s Addendum to the FY 2019 budget (to account for the revised spending cap levels in the Bipartisan Budget Act of 2018). The Administration intends expects it to save an estimated $637 billion over 10 years.