Alston & Bird Healthcare Week In Review, February 2, 2018

I. Regulations, Notices, & Guidance

• On January 29, 2018, the Centers for Medicare and Medicaid Services (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 document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance providers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of the moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered "newly enrolling" when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.
• On January 29, 2018, the Food and Drug Administration (FDA) announced the availability of draft guidance entitled, Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability. The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP).
• On January 30, 2018, the Department of Veterans Affairs (VA) issued a proposed rule entitled, Medical care in foreign countries and filing for reimbursement for community care not previously authorized by VA. The VA is proposing to amend its medical regulations related to hospital care and medical services in foreign countries. The VA is proposing to amend its regulations to simplify and clarify their rules. The VA also proposes to amend its medical regulations related to filing claims for reimbursement of medical expenses that were not previously authorized by the VA.
• On January 31, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies. The HHS notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) that are currently certified by the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). This notice contains the list of all HHS-certified laboratories and IITFs that meet the Mandatory Guidelines.
• On February 2, 2018, the FDA announced a final order entitled, Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders. The FDA is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in the order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders’ classification. The FDA is taking this action because they have determined that classifying the device into special controls will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

Event Notices

• February 7-8, 2018: the National Vaccine Advisory Committee (NVAC) announced their February meeting. The sessions will consist of presentations on vaccine innovation, including the current status of adjuvants in vaccines, universal influenza, and an overview of the Secretary of the HHS’ Report to Congress on Vaccine Innovation in response to the 21^st Century Cures Act.
• February 5-9, 2018: The CDC announced the Adapting Clinical Guidelines for the Digital Age meeting. Adapting Clinical Guidelines for the Digital Age is an initiative to improve patient care and health outcomes by working to ensure that clinical guidelines are not only evidence-based but also are used in practice. The scope of the meeting will encompass the following: gathering individual perspectives and experiences about guideline creation and summarizing the evidence; informational framework for guideline translation; dissemination modalities and communication methods; translation and implementation support; and evidence.
• February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II. The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
• 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 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 also 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 January 30, 2018, the Senate Health, Education, Labor and Pensions (HELP) Subcommittee on Primary Health and Retirement Security held a hearing entitled, Roundtable on Small Business Health Plans. Witnesses present included: Mike Strum, Principal and Consulting Actuary, Milwaukee, WI; Brad Johnson, Representing the Casper Area Chamber of Commerce and the Wyoming Chamber Health Benefits Plan, Casper, WY; Chris Condeluci, CC Law & Policy, Washington, DC; Jennifer Kimmich, Co-Owner of The Alchemist Brewery, Stowe, VT; and Tess Stack Kuenning, CNS, MS, RN, President and Chief Executive Officer, Bi-State Primary Care Association, Montpelier, VT.

House of Representatives

• On January 30, 2018, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Examining Implementation of the Compounding Quality Act. Witnesses present included: Scott Gottlieb, MD, Commissioner, Food and Drug Administration; George Williams, MD, President Elect, American Academy of Ophthalmology (AAO); Bruce Brod, MD, Chair, Congressional Policy Committee, American Academy of Dermatology (AAD); Shawn Hodges, Vice President, International Academy of Compounding Pharmacists (IACP); Jacob Olson, President and CEO, Skywalk Pharmacy, on behalf of National Community Pharmacists Association (NCPA); Jenn Adams, Senior Vice President and President, Clinical Product Solutions, PharMEDium Services; Molly Ventrelli, Vice President, Regulatory Affairs, Fresenius Kabi; Elizabeth Jungman, Director, Public Health, The Pew Charitable Trusts; and Nancy Dargan, Patient of New England Compounding Center (NECC).

III. Reports, Studies, & Analyses

• On January 29, 2018, the Kaiser Family Foundation released a poll tracking the public’s interest in health-related topics. The poll found that health care is a top issue for many voters in the 2018 midterm elections. However, it is a much higher priority for Democratic voters and independent voters than Republican voters. Additionally, health care is a lower priority than other issues among voters living in areas where there are competitive 2018 House, Senate, or Governor races.

IV. Other Health Policy News

• On February 1, 2018, the CMS released the 2019 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. The CMS announced, among other things, a 1.84 percent payment increase to Medicare Advantage plans. Comments are due by Monday, March 5, 2018. The final 2019 Rate Announcement and final Call Letter will be published Monday, April 2, 2019.  The 2019 Advance Notices (Part I and Part II) and Draft Call Letter may be accessed here by selecting “2019 Advance Notices.”