Alston & Bird Healthcare Week In Review, January 19, 2018

I. Regulations, Notices, & Guidance

• On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health. The FDA is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). The FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. The FDA is also proposing regulations that would establish new procedural requirements for requesting internal agency supervisory review within CDRH for decisions made by CDRH that are not addressed in FDASIA and the Cures Act. This action is also part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the FDA to achieve its public health mission and fulfill statutory obligations.
• On January 17, 2018, the Department of Health and Human Services (HHS), and other agencies, issued an interim final rule entitled, Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects. Federal departments and agencies listed in the document made revisions to the Federal Policy for the Protection of Human Subjects.  This interim final rule delays the effective date from January 19, 2018 to July 19, 2018.
• On January 18, 2018, the FDA issued draft guidance entitled, Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products--Content and Format; Draft Guidance for Industry; Availability. Currently, the labeling regulations for human drug and biological products require that the Highlights of Prescribing Information (Highlights) contain a product title and the year of U.S. approval. This draft guidance provides recommendations on the content and format of the product title to bring greater consistency to the presentation of these required elements and to help ensure these elements provide clear and useful information to the health care provider.
• On January 18, 2018, the FDA issued guidance entitled, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability. This final guidance describes the conditions under which FDA will not take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application. It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy.
• On January 18, 2018, the FDA issued guidance entitled, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product, among other conditions. This final guidance sets forth FDA’s policies regarding this provision of section 503A, including the terms commercially available, essentially a copy of a commercially available drug product, and regularly or in inordinate amounts. The FDA also issued guidance entitled, Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act, which sets forth FDA’s policies concerning the essentially a copy provision of section 503B.
• On January 18, 2018, the FDA issued draft guidance entitled, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about volatile products being recalled. This draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.
• On January 19, 2018, the HHS Office for Civil Rights (OCR) issued a proposed rule entitled, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority. In this proposed rule, HHS proposes to revise regulations previously promulgated to ensure that persons or entities are not subject to certain practices or policies that violate conscience, coerce, or discriminate, in violation of federal law. HHS proposes to grant overall responsibility to the OCR for ensuring that HHS programs and activities comply with federal laws protecting the rights of conscience and prohibiting associated discriminatory policies and practices. The OCR will have the authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance, and use enforcement tools otherwise available in civil rights law to address violations and resolve complaints. The OCR will ensure that recipients of federal financial assistance comply with their legal obligation by requiring recipients to maintain certain records; cooperate with OCR’s investigations, reviews, or other enforcement actions; submit written assurances and certifications of compliance to OCR; and provide notice to individuals and entities about their conscience and associated anti-discrimination rights.

• January 23, 2018: The National Institutes of Health (NIH) announced a public webinar entitled, “Machine Learning in Toxicology: Fundamentals of Application and Interpretation.” The webinar is organized on behalf of the Interagency Coordinating Committee on the Validation of the Alternative Methods (ICCVAM) by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. Interested parties can register for the webinar by December 18, 2018.
• January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
• January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
• January 24, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council provides advice, information, and recommendations to the Secretary of HHS. The Advisory Council will meet to discuss strategies to combat antibiotic-resistant bacteria.
• January 25, 2018: The FDA announced a public hearing on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including appropriate use and labeling.
• 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 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/AIDS Program Conference, and Committee business-related items.
• 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 announcement. 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.

II. Congressional Legislation & Committee Action

• On January 17, 2018, the Senate Governmental Affairs Committee held a hearing entitled, Unintended Consequences: Medicaid and the Opioid Epidemic. Witnesses included: Sam Adolphsen, Former Chief Operating Officer at the Department of Health and Human Services in the State of Maine, and Vice President, Rockwood Solutions; J. Otto Schalk, Prosecuting Attorney, Harrison County State of Indiana; Emmanuel Tyndall, Inspector General, State of Tennessee; David A. Hyman, M.D., Professor of Law, Georgetown University Law Center; and Andrew Kolodny, M.D., Co-director of Opioid Policy Research, The Heller School for Social Policy and Management, Brandeis University.
• On January 17, 2018, the Senate Finance Committee held an executive session entitled, Open Executive Session to Consider the Nomination of Alex Azar II and Kevin McAleenan and Subcommittee Assignments. The Committee favorably reported the nomination of Alex Azar for Secretary of HHS by a roll call vote of 15 ayes and 12 nays.
• On January 17, 2018, the Senate Health, Education, Labor, and Pensions Committee held a hearing entitled, Facing 21st Century Public Health Threats: Our Nation’s Preparedness and Response Capabilities, Part I. Witnesses include: Robert Kadlec, M.D., Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, D.C.; Scott Gottlieb, M.D., Commissioner U.S. Food and Drug Administration, Silver Spring, MD; and Stephen C. Redd, M.D., RADM, Director, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Atlanta, GA.   

• On January 17, 2018, the House Ways and Means Oversight Subcommittee held a hearing entitled, The Opioid Crisis: The Current Landscape and CMS Actions to Prevent Opioid Misuse. Gary Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, Department of Health and Human Services; Elizabeth Curda, Director, Health Care, Government Accountability Office; and Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare and Medicaid Services.

• On January 17, 2018 the Government Accountability Office (GAO) released a report entitled, MEDICARE PART B: Medicare Represented at Least Half of the Market for 22 of the 84 Most Expensive Drugs in 2015.The report examines Medicare’s share of the Part B drug market. Based on 2015 Medicare fee for service (FFS) claims data, GAO identified the 50 Part B drugs with the highest total expenditures and the 50 drugs with the highest expenditures per beneficiary.  In total, GAO analyzed 84 drugs because some were in both groups. GAO found that in 2015, Medicare's FFS program represented 50 percent or more of the market for 22 of the 84 most expensive Part B drugs GAO analyzed. These 22 drugs collectively represented $7.4 billion in spending, or about 30 percent of all Medicare spending on Part B drugs in 2015.
• On January 17, 2018, the HHS Office of Inspector General (OIG) issued a report entitled, Ensuring Beneficiary Health and Safety in Group Homes Through State Implementation of Comprehensive Compliance Oversight. The report provides suggested model practices to CMS and States for comprehensive compliance oversight of group homes to help ensure better health and safety outcomes.

IV. Other Health Policy News

• On January 17, 2018, the Bipartisan Policy Center BPC held a discussion, entitled Reinventing Rural Health Care: A Case Study of 7 Upper Midwest States. The discussion was centered around the findings from the BPC and the Center for Outcomes Research and Education’s (CORE) recent report entitled, “Reinventing Rural Health Care: A Case Study of Seven Upper Midwest States” and general rural health care delivery issues.