Alston & Bird Healthcare Week in Review, March 23, 2018

I. Regulations, Notices, & Guidance

• On March 19, 2018, the Food and Drug Administration (FDA) issued draft guidance entitled, Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507: Draft Guidance for Industry; Availability. The FDA is announcing the availability of a draft guidance for industry describing the FDA’s rationale on how to determine the number of employees for purposes of the “small business” definition in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the “small business” definition.
• On March 21, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Post-Approval Testing Standards for Closed-Circuit Escape Respirators. The HHS proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH).
• On March 22, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a noticed entitled, Medicaid Program: Announcement of Medicaid Drug Rebate Program National Rebate Agreement. This notice announces changes to the Medicaid National Drug Rebate Agreement (NDRA, or Agreement) for use by the Secretary of HHS and manufacturers under the Medicaid Drug Rebate Program (MDRP). The HHS is updating the NDRA to incorporate legislative and regulatory changes that have occurred since the Agreement was published in the February 21, 1991 Federal Register (56 FR 7049). The HHS is also updating the NDRA to make editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting.
• On March 22, 2018, the CMS issued a proposed rule entitled, Medicaid Program; Methods for Assuring Access to Covered Medicaid Services –Exemptions for States with High Managed Care Penetration Rates and Rate Reduction Threshold. This proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute. States have raised concerns over the administrative burden associated with the current requirements, particularly for states with high rates of Medicaid managed care enrollment. This proposed rule would provide burden relief and address those concerns.
• On March 23, 2018, the FDA issued guidance entitled, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. This draft guidance describes policies that the FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

Event Notices

• March 27, 2018: The HHS announced two meetings for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).  The meetings will be an orientation session for the ACICBL members and identify potential topics to work on for 2018.
• 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 6, 2018: The FDA announced a public meeting entitled, S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Humans Use (ICH). The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Kobe, Japan. The topics to be address at the meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly meeting in Kobe, Japan.
• April 10, 2018: The CDC announced a meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on the clinical laboratory workforce; implementation of next generation sequencing in clinical laboratories; laboratory interoperability; and using clinical laboratory data to improve quality and laboratory medicine practices.
• 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.
• April 17, 2018: The FDA announced a public meeting entitled, Patient-Focused Drug Development in Opioid Use Disorder. The purpose of the meeting is to obtain patients’ perspectives on treatment approaches for opioid use disorder. The meeting is part of FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.
• April 19, 2018: The FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The Committee provides advice and recommendations to FDA on regulatory issues. The Committee will discuss new drug application 210365, cannabidiol oral solution, sponsored by GW pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
• April 23, 2018: The FDA announced a public meeting of the Arthritis Advisory Committee. The committee will discuss the new drug application for baricitinib tablets submitted by Eli Lilly for the treatment of rheumatoid arthritis.
• May 9, 2018: The FDA announced a public workshop entitled, Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation. The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity when approving a product with a tissue agnostic indication.
• May 14-16, 2018: The CMS announced the public meetings on the Healthcare Common Procedure Coding System (HCPCS) for 2018. The public meetings will cover CMS’ preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments.
• June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

II. Congressional Legislation & Committee Action

U.S. Senate

• On March 20, 2018, the Senate Finance Committee held a nomination hearing to consider John Bartrum to be the Assistant Secretary for Financial Resources at the Department of Health and Human Services and Lynn Johnson to be Assistant Secretary for Family Support as the Department of Health and Human Services.

House of Representatives

• On March 20, 2018, House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, The Drug Enforcement Administration’s Role in Combating the Opioid Epidemic. DEA Acting Administrator Robert Patterson was the only witness present.
• On March 20, 2018, the House Education and Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Expanding Affordable Care Options: Examining the Department of Labor’s Proposed Rule on Association Health Plans. Witnesses present included John Arensmeyer, Founder & CEO, Small Business Majority; Christopher Condeluci, Principal and Sole Shareholder, CC Law & Policy PLLC; Michael McGrew, National Association of Realtors; and Catherine Monson, CEO, FastSigns International, Inc.
• On March 21, 2018, House Ways and Means Subcommittee on Health held a hearing entitled, Implementation of MACRA’s Physician Payment Policies. CMS Principal Deputy Administrator Demetrios Kouzoukas and CMS Chief Medical Officer Dr. Kate Goodrich were the only witnesses present.
• On March 21-22, House Energy and Commerce Subcommittee on Health held a hearing entitled, Combating the Opioid Crisis: Prevention and Public Health Solutions. The Subcommittee reviewed 25 legislative proposals and heard from 18 witnesses. A complete list of witnesses and legislation is available here.

III. Reports, Studies, & Analyses

• On March 19, 2018, the Congressional Budget Office (CBO) released its cost estimate of the Bipartisan Health Care Stabilization Act of 2018, which includes funds for cost-sharing reductions (CSRs). The CBO found the legislation would increase the federal deficit by $19.1 billion over the 2018-2017 period. Additional information about CBO’s cost estimates for CSRs is available here.

IV. Other Health Policy News

• On March 15, 2018, the Medicare Payment Advisory Commission (MedPAC) released its March Report. The report can be accessed here.