Alston & Bird Healthcare Week In Review, January 26, 2018

I. Regulations, Notices, & Guidance

• On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder. The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug I Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services (HHS), by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The DEA is amending its regulations to incorporate the statutory and regulatory changes.
• On January 24, 2018, the Food and Drug Administration (FDA) issued draft guidance entitled, Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in the Code of Federal Regulations or the Preventive Controls Requirements. The draft guidance describes the FDA’s rationale on the concept of “same level of public health protection” (SLPHP), and FDA’s expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached.
• On January 25, 2018, the FDA issued guidance entitled, Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff: Availability; Extension of Comment Period. The FDA is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
• On January 25, 2018, the FDA issued draft guidance entitled, Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period. The FDA is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled "Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies." The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
• On January 25, 2018, the Center for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program; Request for Nominations to the Advisory Panel on Hospital Outpatient Payment. The CMS is requesting nominations to fill vacancies on the Advisory Panel on Hospital Outpatient Payment. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.
• On January 25, 2018, the CMS issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances – October through December 2017. The quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2017 relating to the Medicare and Medicaid programs and other programs administered by CMS.

Event Notices

• January 30, 2018: The FDA announced a public hearing entitled, Opioid Policy Steering Committee: Prescribing Intervention –Exploring a Strategy for Implementation. The purpose of the hearing is to receive stakeholder input on how the FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing and limit abuse of opioid analgesics.
• January 31, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public listening session to solicit information concerning the Confidentiality of Substance Use Disorder Patient Records regulations. The listening session will provide an opportunity for the public to provide input to SAMHSA concerning the effects of regulatory and sub regulatory guidance.
• 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: 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 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.

II. Congressional Legislation & Committee Action

U.S. Senate

• On January 23, 2018, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Facing 21^st Century Public Health Threats: Our Nation’s Preparedness and Response Capabilities, Part 2. Witnesses included: Tom Inglesby, MD, Director, Center for Healthy Security at Johns Hopkins Bloomberg School of Public Health; John Dreyzehner, MD, MPH, FACOEM, Commissioner, Tennessee Department of Health; Brent MacGregor, Senior Vice President, Commercial Operations, Seqirus, Co-Chair, Alliance for Biosecurity; and Steven Krug, MD, FAAP, Head, Pediatric Emergency Medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago, Professor of Pediatrics, Northwestern University Feinberg School of Medicine.
• On January 25, 2018, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled, Combatting the Opioid Crisis: Exploiting Vulnerabilities in International Mail. Witnesses included: Joseph P. Murphy, Chief, International Postal Affairs, Office of Specialized and Technical Agencies Bureau of International Organizations, US Department of State (DOS); Robert Cintron, Vice President, Network Operations, United States Postal Service (USPS); Todd C. Owen, Executive Assistant Commissioner, Office of Field Operations, US Customs and Border Protection (CBP), US Department of Homeland Security (DHS); William Siemer, Acting Deputy Inspector General, Office of the Inspector General (OIG), United States Postal Service (USPS);  Daniel D. Baldwin, Section Chief, Office of Global Enforcement, Drug Enforcement Administration (DEA), US Department of Justice (DOJ);  Gregory C. Nevano, Deputy Assistant Director, Illicit Trade, Travel, and Finance Division, Homeland Security Investigations, US Immigration and Customs Enforcement (ICE), US Department of Homeland Security (DHS).

House of Representatives

• No health care-related hearings this week.

III. Reports, Studies, & Analyses

• On January 23, 2018, the Health Care Cost Institute (HCCI) issued a report entitled, 2016 Health care Cost and Utilization Report. The report covers the period from 2012 through 2016 and includes claims data from four national insurance companies: Aetna, Humana, Kaiser Permanente, and United HealthCare. The report shows that spending per privately insured person grew by 4.6 percent, faster than in previous years.
• On January 23, 2018, the Government Accountability Office (GAO) issued a report entitled, Federal Health-Insurance Marketplace: Analysis of Plan Year 2015 Application, Enrollment, and Eligibility-Verification Process. The GAO was asked to examine enrollment into the federally facilitated market place (FFM) for plan year 2015, the most current data available at the time of GAO’s review. The report examines the extent to which indications of potentially improper or fraudulent enrollments existed in the FFM’s application, enrollment, and eligibility-verification process for the 2015 enrollment period.

IV. Other Health Policy News

• On January 25-26, 2018 the Medicaid and CHIP Payment and Access Commission (MACPAC) held their January meeting. The full agenda is available here.