Alston & Bird Healthcare Week in Review - May 2020 #5

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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:

This week, HHS submitted a mandated report to Congress describing the Trump Administration’s national strategic testing plan for COVID-19. Read more about the report and other news below.


I. Regulations, Notices, & Guidance

  • On May 26, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents--2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol--According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation. The FDA is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The recommendations were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of patients.
  • On May 26, 2020, FDA issued guidance entitled, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request. This guidance provides these recommendations based on the device’s intended use with respect to the level (tier) of decontamination or bioburden reduction, based on the sponsor’s available data. Decontamination and bioburden reduction systems play an important role in the ongoing efforts to help address shortages of surgical masks and respirators intended for a medical purpose during COVID-19 or reduce the bioburden of surgical masks and filtering facepiece respirators (including N95 respirators) used as personal protective equipment (PPE) by healthcare personnel (hereinafter, “surgical masks and respirators”) for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of the Department of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
  • On May 26, 2020, FDA issued guidance entitled, Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications – Questions and Answers. FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act (42 U.S.C. 247d(a)(2)).
  • On May 26, 2020, FDA issued revised guidance entitled, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act (42 U.S.C. 247d(a)(2)).
  • On May 27, 2020, FDA issued revised guidance entitled, Orange Book Questions and Answers Guidance for Industry. This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products with Therapeutic Equivalence Evaluations publication (the Orange Book). This guidance provides answers to commonly asked questions that FDA has received from these interested parties regarding the Orange Book.
  • On May 28, 2020, FDA issued revised guidance entitled, Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide. FDA is issuing this guidance to help small businesses understand and comply with FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” which establishes new required cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require each cigarette package and advertisement to bear one of the new required warnings. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
  • On May 28, 2020, FDA issued revised guidance entitled, Submission of Plans for Cigarette Packages and Cigarette Advertisements. FDA is issuing this guidance to assist persons submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act, amending the Federal Cigarette Labeling and Advertising Act (FCLAA). This guidance provides recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the submission of cigarette plans for cigarette packages and cigarette advertisements.
  • On May 29, 2020, HHS issued a proposed rule entitled, Amendments to the HHS-operated Risk Adjustment Data Validation under the Patient Protection and Affordable Care Act’s HHS-operated Risk Adjustment Program. This rule proposes to adopt certain changes to the risk adjustment data validation error estimation methodology starting with the 2019 benefit year and beyond for states where HHS operates the risk adjustment program. The Patient Protection and Affordable Care Act (PPACA) established a permanent risk adjustment program under which payments are made to health insurance issuers that attract higher-than-average risk populations funded by payments from health insurance issuers that attract lower-than-average risk populations. To ensure the integrity of the HHS-operated risk adjustment program, CMS, on behalf of HHS, performs risk adjustment data validation, also known as HHS-RADV, to validate the accuracy of data submitted by issuers for the purposes of risk adjustment transfer calculations. Based on lessons learned from the first payment year of HHS-RADV, this rule proposes changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also proposes to change the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied starting with 2021 benefit year HHS-RADV. These proposals seek to further the integrity of the HHS-RADV program, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.

Event Notices

  • June 1-2, 2020: The Centers for Medicare and Medicaid Services (CMS) announced a public meeting entitled, New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding for Durable Medical Equipment and Accessories, Orthotics and Prosthetics, Supplies and Other Non-Drug and Non-Biological Items. The purpose of this meeting is to discuss CMS’s preliminary coding recommendations for new public requests for revisions to the HCPCS Level II code set for Durable Medical Equipment (DME) and Accessories, Orthotics and Prosthetics (O&P), Supplies, and other non-drug and non-biological items.
  • June 1-2, 2020: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on HIV/AIDS. Agenda items will include discussing COVID-19 and the impact on people living with, or at risk of, HIV and implementing the Ending the HIV Epidemic initiative post COVID-19.
  • June 4-5, 2020: FDA announced a public meeting entitled, Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice. The purpose of the web conference is to capture stakeholder experiences with current ICH E6 guidelines for good clinical practice (GCP) and to gather stakeholder input to further inform the development of an updated guideline, ICH E6(R3)
  • June 8, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
  • June 9, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. The meeting will focus on coronavirus vaccine development, reimbursement, and changes in billing and coverage with updates from members.
  • June 22, 2020: CMS announced a public meeting entitled, Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2021. The purpose of this meeting is to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year 2021.
  • June 24, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices. The meeting agenda will include discussions on SARS-CoV-2(COVID-19) Vaccines, influenza vaccines, and meningococcal vaccines. A recommendation vote is scheduled for influenza vaccines and a VFC vote is schedule for meningococcal vaccines.
  • June 26, 2020: HHS announced a public meeting entitled, Meeting of the National Clinical Care Commission. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
  • June 29-30, 2020: CMS announced a public meeting entitled, Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The Panel will provide input and recommendations on the establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test; the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and other aspects of the new payment system under section 1834A of the Act.
  • June 30, 2020: FDA announced a public meeting entitled, Modernizing the Food and Drug Administration's Data Strategy. The purpose of the meeting is to provide an opportunity to hear from FDA staff and outside experts on topics directly related to modernizing FDA's data strategy, including data quality, data stewardship, data exchange, and data analytics.

II. Congressional Hearings

U.S. House of Representatives

  • On May 27, 2020, the House Committee on Ways and Means held a hearing entitled, The Disproportionate Impact of COVID-19 on Communities of Color. Witnesses present included: Ibram X. Kendi, PhD, Founding Director, The Antiracist Research & Policy Center at American University; Dr. Raynald Samoa, MD, Endocrinologist, City of Hope, Los Angeles, CA; Dr. Thomas Dean Sequist, MD, MPH, Chief Patient Experience and Equity Officer at Mass General Brigham and professor of medicine and health care policy at Harvard Medical School; Dr. Alicia Fernandez, MD, Professor of Medicine at University of California San Francisco; Dr. James Hildreth, PhD, MD, President and Chief Executive Officer, Meharry Medical College; and Dr. Douglas Holtz-Eakin, PhD, President, The American Action Forum.
  • On May 28, 2020, the House Committee on Education and Labor Subcommittee on Workforce Protections held a hearing entitled, Examining the Federal Government’s Actions to Protect Workers from COVID-19. Witnesses present included: Ms. Loren Sweatt, Principal Deputy Assistant Secretary, Occupational Safety and Health Administration (OSHA); and Dr. John Howard, MD, MPH, JD, LLM, MBA, Director, National Institute for Occupational Safety and Health (NIOSH).

III. Reports, Studies, & Analyses

  • On May 26, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Five Things to Know about the Cost of COVID-19 Testing and Treatment. The COVID-19 pandemic and resulting economic downturn is hitting the United States at a time when unexpected medical bills were already a primary concern for many Americans. Throughout the crisis, states, Congress, the Trump Administration, and private insurance plans have taken various actions to mitigate some affordability challenges that could arise from, or prevent timely access to, COVID-19 testing and treatment. This brief answers key questions on the affordability of COVID-19 testing and treatment for people who are uninsured and those insured through private coverage, Medicare, and Medicaid. The authors also explore broader concerns around deductibles, assets, and job loss.
  • On May 27, 2020, RAND Corporation published a report entitled, Public Options for Individual Health Insurance: Assessing the Effects of Four Public Option Alternatives. There is growing interest at the state and federal levels in a "public option" for individual market insurance. In 2019, members of Congress introduced four bills that would create a federal public option, at least 18 states considered legislation for a public option or a Medicaid buy-in option, and several Democratic Party presidential candidates included public options in their platforms. Some proposals for a public option would create government-run insurance plans to compete with private insurance, and others would create plans administered by insurance carriers operating under government oversight and rate regulation. The authors of this report consider public option alternatives that vary based on the rates providers are paid, whether the option is implemented on or off Health Insurance Marketplaces, and whether premium tax credits are available to higher-income individuals. For each of the four scenarios, the authors use a microsimulation approach to estimate how adding a federal public option for individual market insurance could affect overall insurance coverage, individual market enrollment, premiums for individual market enrollees, and government spending. The trends and policy implications may be of interest to state and federal policymakers considering a public option.

IV. Other Health Policy News

  • On May 24, 2020, HHS submitted a mandated report to Congress describing the Trump Administration’s national strategic testing plan for COVID-19. The 81-page plan, which was required by the Paycheck Protection Program and Health Care Enhancement Act, puts much of the testing responsibility on states and provides guidance and information on testing technologies, platforms, and inventories. In the report, the Administration recommends that states have an objective of testing a minimum of 2% of their population in May and June, pending additional new data on infections and impact of reducing mitigation. States are required to submit a testing plan for May and June to HHS by May 30 and a plan for the remainder of 2020 on June 15.
  • On May 26, CMS announced that over 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage plans with prescription drug coverage have applied to offer lower insulin costs through the Part D Senior Savings Model for the 2021 plan year. Across the nation, participating enhanced Part D prescription drug plans will provide Medicare beneficiaries access to a broad set of insulins at a maximum $35 copay for a month’s supply, from the beginning of the year through the Part D coverage gap. More information on this announcement can be found here.
  • On May 28, 2020, HHS announced that it has awarded $15 million to 52 Tribes, Tribal organizations, urban Indian health organizations, and other health services providers to Tribes across 20 states to prepare, prevent, and respond to COVID-19 in rural tribal communities. More information about this funding can be found here.

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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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