Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare 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 December 6, Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) released the updated version of their bipartisan Prescription Drug Pricing Reduction Act of 2019. Read more about the bill and other news below.


I. Regulations, Notices, & Guidance

  • On November 25, 2019, the Food and Drug Administration (FDA) issued a proposed rule entitled, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products. This guidance describes FDA’s compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of August 8, 2016, specifically, modifications to battery-operated tobacco products solely to comply with UL 8139 and modifications to liquid nicotine products solely to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine containers. This guidance will enable tobacco manufacturers to upgrade their battery-operated tobacco products to UL 8139. It will also enable manufacturers to comply with the CNPPA requirements for flow restrictors for liquid nicotine containers. FDA is issuing this guidance to address battery safety concerns and youth exposure to liquid nicotine toxicity.
  • On November 27, 2019, FDA issued guidance entitled, Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products. The purpose of this draft guidance is to provide recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human insulin mix products, and recombinant insulin analog products that are intended for the treatment of patients with Type 1 or Type 2 diabetes mellitus.
  • On November 29, 2019, the Department of Health and Human Services (HHS) issued a notice entitled, Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children’s Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2020 through September 30, 2021. This notice announces the calculated Federal Medical Assistance Percentages (FMAP) rates, in accordance with sections 1101(a)(8) and 1905(b) of the Social Security Act (the Act), that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Kinship Guardianship Assistance payments, and the Enhanced Federal Medical Assistance Percentages (eFMAP) rates for the Children’s Health Insurance Program (CHIP) expenditures.
  • On December 2, 2019, the National Institutes of Health (NIH) issued a notice entitled, Notice to Announce the National Institute of Mental Health (NIMH) Draft Strategic Plan for Research; Request for Comments. The National Institute of Mental Health (NIMH) is updating its Strategic Plan for Research to guide the Institute’s research efforts and priorities over the next five years. The purpose of this notice is to seek comments from the public about the draft 2020 NIMH Strategic Plan for Research.
  • On December 4, 2019, FDA issued guidance entitled, Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment. There is pharmaceutical and stakeholder interest in the development of new drugs for patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). This draft guidance provides FDA’s recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS. This draft guidance includes key considerations in trial design including enrollment criteria and efficacy endpoint selection. The draft guidance also provides general recommendations on design features and statistical considerations. This draft guidance also provides the FDA’s current recommendations on the use of patient-reported outcome instruments to evaluate patient symptoms to demonstrate a clinically meaningful change with treatment.

Event Notices

  • December 10, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED); including updates on the following focus areas: data, access and engagement, treatment and recovery, justice, and finance; and discussion on pediatric behavioral health federal work.
  • December 16-17, 2019: CMS announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.
  • December 17, 2019: FDA announced a public meeting entitled, Oncologic Drugs Advisory Committee. The general function of the Oncologic Drugs Advisory Committee is to provide advice and recommendations to FDA on regulatory issues. During the morning session, the committee will discuss supplemental new drug application (sNDA) 208558/010 for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. During the afternoon session, the committee will discuss supplemental biologics license application (sBLA) 125514/066 for KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe & Dohme Corp.
  • January 14, 2020: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.
  • January 15, 2019: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. They will also discuss NDA 209653, for an extendedrelease oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

II. Congressional Hearings

House of Representatives

  • On December 4, 2019, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Building Consumer Confidence by Empowering FDA to Improve Cosmetic Safety. Witnesses present included: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA; M. Isabelle Chaudry, J.D., Senior Policy Manager, National Women’s Health Network; Scott Farber, Senior Vice President, Government Affairs, Environmental Working Group; Leigh O’Donnell, Executive Director, The Handcrafted Soap and Cosmetic Guild; and Gregg Renfrew, Founder and CEO, Beautycounter, LLC.
  • On December 4, 2019, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Flu Season: U.S. Public Health Preparedness and Response. Witnesses present included: Nancy Messonnier, M.D. (CAPT, USPHS, RET), Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention; Anthony S. Fauci, M.D., Director, National Institute for Allergy and Infectious Diseases, NIH; Robert P. Kadlec, M.D., M.T.M.&H., M.S., Assistant Secretary for Preparedness and Response, HHS; and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, FDA.
  • On December 4, 2019, the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy held a hearing entitled, The Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, and the Food and Drug Administration’s Compliance Policy. Witnesses present included: Mitch Zeller, Director, Center for Tobacco Products, FDA.

Senate

  • On December 3, 2019, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a vote on the Nomination of Dr. Stephen M. Hahn, M.D., to serve as FDA Commissioner. Members of the HELP Committee voted in favor of approving Dr. Stephen Hahn by a vote of 18-5.

III. Reports, Studies, & Analyses

  • On November 26, 2019, Kaiser Family Foundation published an issue brief entitled, A Look at Recent Proposals to Control Drug Spending by Medicare and its Beneficiaries. This brief describes proposed and recent changes to control Medicare drug spending and lower beneficiaries’ out-of-pocket drug costs, including proposals from the Trump Administration and legislation introduced during the 116th The authors review the implications of these changes for various stakeholders and explain their estimated effects on Medicare and beneficiary spending, to the extent such effects are known, based primarily on estimates from the Congressional Budget Office (CBO). The brief focuses on drug pricing proposals related to Medicare specifically, rather than broader proposals that are not solely focused on Medicare—including those related to drug importation, expediting generic drug availability, patents, and price transparency.
  • On December 2, 2019, the HHS Office of Inspector General (OIG) released its Semiannual Report to Congress. The report summarizes OIG activities for the last half of Fiscal Year (FY) 2018 (April 1, 2018-September 30, 2018), and some achievements for the full year. According to the report, HHS OIG expects $2.91 billion in investigative recoveries and $521 million in audit recoveries for FY 2018.

IV. Other Health Policy News

  • On December 4, 2019, in an expected move, hospital groups filed a lawsuit against the Trump administration over the recently published Hospital Price Transparency Rule that would establish requirements for hospitals operating in the United States to establish, update, and make public a list of their standard charges for the items and services that they provide. The rule would come into effect on January 1, 2021. The hospital groups are arguing that the rule is a violation of the First Amendment and say that mandating the public disclosure of negotiated charges would simply create confusion around out-of-pocket costs for patients. Read more about the lawsuit here.
  • On December 5, 2019, Speaker Nancy Pelosi (D-CA) announced that the House will vote on H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, the week of December 9. According to a summary released the same day, the updated bill increases the number of seniors who qualify for financial support for prescription drugs and other health expenses by raising the income eligibility threshold for Medicare’s Low-Income Subsidy Program and Medicare Savings Program. It also adds guaranteed issue protections for supplemental Medigap plans; directs $10 billion to community health centers; doubles investments in the Maternal, Infant and Early Childhood Home Visiting program; reauthorizes and expands the Health Profession Opportunity Grant demonstration; and includes $10 billion to fight opioid abuse over the next five years.
  • On December 6, 2019, Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) released the updated version of their bipartisan Prescription Drug Pricing Reduction Act of 2019. The updated legislation includes improvements that the chairman, ranking member and other committee members discussed when the committee reported the bipartisan bill in July. The revised Part D benefit redesign reduces the amount of spending that beneficiaries are responsible for during the initial coverage phase from 25 percent to 20 percent and requires drug companies to provide a new discount of 7 percent on brand-name drugs during initial coverage and 14 percent during the catastrophic phase. The revised bill also adds myriad provisions that smooth beneficiary out-of-pocket costs, reforms pharmacy direct and indirect remuneration (DIR) fees, delays the Medicaid DSH cuts for an additional two years, and funds various health extenders.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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