Alston & Bird Health Care Week in Review, September 13, 2019

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

On September 9, 2019, a draft of House Speaker Nancy Pelosi’s (D-CA) drug-pricing bill was leaked. Under the draft plan, the government would be directed to negotiate prices on the 250 drugs that account for the highest costs to Medicare and the entire U.S. health system and that lack sufficient competition. However, some caution that the leaked document is an outdated draft, and that the proposal is still being finalized by key health committees, so final provisions are unknown. More information about the draft bill can be found below.

I. Regulations, Notices, & Guidance

• On September 9, 2019, the Food and Drug Administration (FDA) issued guidance entitled, User Fees and Refunds for De Novo Classification Requests. The Medical Device User Fee Amendments of 2017 (MDUFA IV), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2017, including De Novo classification requests (De Novo requests). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the medical device review process to meet certain performance goals and implement improvements for the medical device review process as outlined in the letter from the Secretary of Health and Human Services (HHS) to Congress. The purpose of this guidance document is to identify the types of De Novo requests subject to user fees; exceptions to user fees; and the actions that may result in refunds of user fees that have been paid. This document incorporates the impact of process improvements from MDUFA IV.
• On September 9, 2019, FDA issued guidance entitled, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals. This guidance outlines the performance goals and process improvements that were negotiated and agreed to under MDUFA IV for De Novo requests received Fiscal Year (FY) 2018-2022.
• On September 12, 2019, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals. The DEA is proposing the control of N- (1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4-amine (also known as 4-anilinopiperidine; N-phenyl-4- piperidinamine; 4-AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA). Benzylfentanyl and 4-anilinopiperidine are used in, and are important to, the illicit manufacture of the schedule II controlled substance fentanyl. If finalized, this action would subject handlers of benzylfentanyl and 4-anilinopiperidine to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of benzylfentanyl or 4- anilinopiperidine. As such, all transactions of chemical mixtures containing benzylfentanyl or 4-anilinopiperidine will be regulated at any concentration and will be subject to control under the CSA.
• On September 13, 2019, FDA issued guidance entitled, Format for Traditional and Abbreviated 510(k)s. The purpose of this document is to provide guidance on how to format an original submission for a traditional or abbreviated premarket notification (510(k)) submission. This guidance document provides only a general framework for the format and content of a traditional or abbreviated 510(k). It does not describe our recommendations for any specific device types, Special 510(k)s, or other premarket submission types, such as premarket approval applications (PMAs), Humanitarian Device Exemption (HDE) applications, De Novo requests, or investigational device exemption (IDE) applications.
• On September 13, 2019, FDA issued guidance entitled, Refuse to Accept Policy for 510(k)s. The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
• On September 13, 2019, FDA issued guidance entitled, The Abbreviated 510(k) Program. This guidance provides recommendations on an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s). The Abbreviated 510(k) Program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA's premarket review of 510(k) submissions. The alternative approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.
• On September 13, 2019, FDA issued guidance entitled, The Special 510(k) Program. This guidance provides FDA’s current thinking on premarket notifications (510(k)s) appropriate for review as a Special 510(k). The intent of this guidance is to describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence. This guidance clarifies the types of technological changes appropriate for review as Special 510(k)s.
• On September 13, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program: Extension of Prior Authorization for Repetitive Scheduled Non Emergent Ambulance Transports. This notice announces a one-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.

Event Notices         

• September 18, 2019: FDA announced a public workshop entitled, Implementing the Food and Drug Administration’s Predictive Toxicology Roadmap. The purpose of this public workshop is to highlight the work FDA has been doing to support and implement FDA’s Predictive Toxicology Roadmap.
• September 24, 2019: HRSA announced a public meeting entitled, Advisory Committee on Heritable Disorders in Newborns and Children. During this meeting, the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a discussion of the role of health information technology within state newborn screening programs and general updates on ACHDNC projects focused on newborn screening.
• September 26, 2019: FDA announced a public meeting entitled, Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. During the meeting, committee members will discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.
• September 26, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Substance Abuse and Mental Health Services Administration’s National Advisory Council. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members.
• September 27, 2019: HHS announced a public meeting entitled, National Clinical Care Commission. The National Clinical Care Commission (the Commission) is charged to evaluate and make recommendations to HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. This virtual meeting will consist of an update on the Data Call to federal agencies and Commission discussion on key topics for secondary research in support of the Report to Congress.
• September 27, 2019: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to address HIV-related health disparities among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform the Office of Minority Health (OMH) and the Office of Infectious Disease and HIV/AIDS Policy of efforts related to the federal Ending the HIV Epidemic Initiative.
• October 11, 2019: HRSA announced a public meeting entitled, Advisory Committee on Interdisciplinary, Community-Based Linkages. The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning activities under sections 750 – 760, Title VII, Part D of the Public Health Service Act. At this meeting, ACICBL members will discuss issues related to the pending Committee reports.
• October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
• November 6-7, 2019: CDC announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on an update from the Association of Public Health Opioids Task Force; an update on the clinical laboratory workforce; return of research results to research participants; and improving integration of laboratory information systems with electronic health records. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
• November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.

II. Congressional Hearings

House of Representatives

• On September 10, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care. Witnesses present included: Wanda Irving, Patient Advocate; Patrice Harris, President, Board of Trustees at the American Medical Association; Elizabeth Howell, Director, Blavatnik Family Women’s Health Research Institute, Mt. Sinai; David Nelson, Chief of Obstetrics, Parkland Health and Hospital System, Assistant Professor of Obstetrics and Gynecology, University of Texas Southwestern Medical Center; and Usha Ranji, Associate Director, Women’s Health Policy, Kaiser Family Foundation.
• On September 11, 2019, the House Committee on Veterans’ Affairs Subcommittee on Health held a legislative hearing on: HR 3636; HR 2972; HR 3036; HR 2798; HR 2645; HR 2681; HR 3224; HR 2982; HR 2752; HR 2628; HR 2816; HR 1527; HR 1527; HR 1163; HR 3798; HR 3867; HR 4096; Draft bill, to establish the Veterans’ Affairs Office of Women’s Health, and for other purposes. Witnesses present included: Dr. Teresa Boyd, DO, Assistant Deputy Under Secretary for Health for Clinical Operations, Department of Veterans’ Affairs; Dr. Patricia Hayes, Chief Consultant, Office of Women’s Health Services; Dr. David Carroll, Executive Director, Office of Mental Health and Suicide Prevention; Mr. Jeremy Butler, CEO, Iraq and Afghanistan Veterans of America; Mr. Roscoe Butler, Associate Legislative Director, Paralyzed Veterans of America; and Ms. Joy Ilem, National Legislative Director, Disabled American Veterans.
• On September 11, 2019, the House Committee on Small Business held a hearing entitled, Utilization Management: Barriers to Care and Burdens on Small Medical Practice. Witnesses present included: Paul Harari, Professor, University of Wisconsin School of Medicine and Public Health, American Society for Radiation Oncology; David Walega, Associate Professor of Anesthesiology at Northwestern University Feinberg School of Medicine, American Society of Anesthesiologists; John Cullen, Valdez Medical Clinic, American Academy of Family Physicians; and Howard Rogers, Advanced Dermatology, American Academy of Dermatology Association.
• On September 11, 2019, the House Committee on Oversight and Reform Subcommittee on Civil Rights and Civil Liberties held a hearing entitled, The Administration’s Apparent Revocation of Medical Deferred Action for Critically Ill Children. Witnesses present included: Maria Isabel Bueso, Patient Advocate; Mr. Jonathan Sanchez, Patient Advocate; Ms. Shoba Sivaprasad Wadhia, Clinical Professor of Law, Director, Center for Immigrants’ Rights Clinic, Penn State Law School; Dr. Fiona S. Danaher, MD, MPH, Pediatrician, MGH Chelsea Pediatrics and MGH Child Protection Program, Co-Chari, MGH Immigrant Health Coalition, Massachusetts General Hospital for Children, Instructor in Pediatrics, Harvard Medical School; Mr. Anthony Marino, Director, Immigration Legal Services, Irish International Immigrant Center; Mr. Thomas Homan, Former Director, U.S. Immigration and Customs Enforcement; Mr. Timothy Robbins, Acting Executive Associate Director, Enforcement and Removal Operation, U.S. Immigration and Customs Enforcement, Department of Homeland Security; and Mr. Daniel Renaud, Associate Director, Field Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security.

III. Reports, Studies, & Analyses

• On September 9, 2019, the American Medical Association (AMA) and Manatt Health released an analysis entitled, National Roadmap on State-Level Efforts to End the Opioid Epidemic. The study identifies effective state policies used to combat the opioid epidemic. The analysis looked at the response to the epidemic in four states and determined which polices increased access to evidence-based treatment for people with a substance use disorder. The AMA and Manatt originally reviewed policies in Colorado, Mississippi, North Carolina, and Pennsylvania and used those analyses along with additional work to develop recommendations for state health care policy.
• On September 9, 2019, the Government Accountability Office (GAO) released a report entitled, Investigational Drugs: FDA and Drug Manufacturers Have Ongoing Efforts to Facilitate Access for Some Patients. When investigational drugs show promise for treating serious or life-threatening diseases, patients are often interested in obtaining access to them. Congress included a provision in the FDA Reauthorization Act of 2017 for GAO to review actions taken to facilitate access to these drugs. This report describes actions FDA and drug manufacturers have taken to broaden eligibility criteria for clinical trials, actions FDA has taken to facilitate access to investigational drugs outside of clinical trials, and information drug manufacturers have communicated to patients and physicians about access to investigational drugs outside of clinical trials.
• On September 12, 2019, GAO released a report entitled, Medicaid: Efforts to Identify, Predict, or Manage High-Expenditure Beneficiaries. This report describes approaches selected states used to identify or predict high-expenditure Medicaid beneficiaries; strategies selected states used to manage beneficiaries' health care costs while ensuring quality of care; and resources CMS provided to states to help them identify, predict, or better manage high-expenditure beneficiaries. GAO interviewed officials from CMS, as well as Medicaid officials from a nongeneralizable sample of seven states (Indiana, Nevada, Pennsylvania, South Carolina, South Dakota, Vermont, and Washington) and five MCOs.
• On September 12, 2019, the Kaiser Family Foundation (KFF) released an analysis entitled, Health Tracking Poll - September 2019: Health Care Policy in Congress And On The Campaign Trail. This latest KFF Health Tracking Poll finds most Americans say many health care policy items included in the survey should be at the top of a busy Congressional agenda this fall. Majorities of the public say lowering prescription drug costs (70%), making sure the Affordable Care Act’s protections for people with pre-existing conditions continue (69%), lowering the amount people pay for health care (64%), and protecting people from surprise medical bills (56%) are all “top priorities” for Congress to work on in the coming year. Fewer (32%) say expanding government financial help to those who buy their own insurance coverage on the ACA marketplaces to include more people is a “top priority,” which is similar to the share who rank the other, more partisan health care actions as top priorities. Three in ten say implementing a national Medicare-for-all plan or repealing and replacing the ACA should be top priorities for Congress.
• On September 12, 2019, KFF released an issue brief entitled, How Will Medicare-for-all Proposals Affect Medicaid. This analysis examines current Medicare-for-all proposals and takes a look at how these proposals might affect the low-income and vulnerable populations covered by Medicaid and the broader implications for states of eliminating the Medicaid program.

IV. Other Health Policy News

• On September 9, 2019, a draft of House Speaker Nancy Pelosi’s (D-CA) drug-pricing bill was leaked. Under the draft plan, the government would be directed to negotiate prices on the 250 drugs that account for the highest costs to Medicare and the entire U.S. health system and that lack sufficient competition. The bill also includes a controversial proposal to use a third-party arbiter to determine the price of medicines if negotiations fail. Instead, it would rely on parameters established by the use of international reference pricing. The plan would also penalize drug companies for failing to offer the negotiated price to other payers, would cap seniors' annual out-of-pocket spending in the Medicare Part D prescription drug benefit and would drastically reduce the percentage of a medication’s costs the government pays for when seniors enter the catastrophic phase of the Medicare drug program. However, some caution that the leaked document is an outdated draft, and that the proposal is still being finalized by key health committees, so final provisions are unknown. More information about the draft bill can be found here.
• On September 11, 2019, HHS announced that it awarded more than $50 million to fund 77 health centers across 23 states, Puerto Rico, and the Commonwealth of the Northern Mariana Islands. This funding provides operational support for new organizations to become HRSA Health Center Program grantees and for existing health centers to establish new service delivery sites. More information about this action can be found here.
• On September 12, 2019, HHS announced approximately $351 million in funding to 56 states, territories, and nonprofit organizations through its Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV Program) and approximately $23 million in funding to three new programs aimed at improving maternal health outcomes. More information about the funding decision can be found here.