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 Wednesday, CMS issued a proposed rule to allow commercial plans and states to enter into innovative, value-based purchasing arrangements with drug manufacturers. Read more about this rule and other news below.
I. Regulations, Notices, & Guidance
- On June 16, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. This guidance is the first of a series of four methodological guidance documents that FDA committed to develop to address, in a stepwise manner, how stakeholders can collect and submit information on the patient experience for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision making.
- On June 16, 2020, FDA issued guidance entitled, Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components. This guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.
- On June 16, 2020, FDA issued guidance entitled, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. This revised guidance provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to their donor educational materials, donor history questionnaires, and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance also incorporates certain other recommendations related to donor educational materials.
- On June 16, 2020, FDA issued guidance entitled, Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria. This revised guidance provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk.
- On June 16, 2020, FDA issued guidance entitled, Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the COVID-19 public health emergency. The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments. The guidance outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty. 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 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 June 17, 2020, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I. The Acting Administrator of the DEA is issuing this notice of intent to publish a temporary order to schedule N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle isotonitazene.
- On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicaid Program: Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Based Purchasing for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability Requirements. This proposed rule would advance CMS’ efforts to support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid. To ensure that the regulatory framework is sufficient to support such arrangements and to promote transparency, flexibility, and innovation in drug pricing without undue administrative burden, CMS is proposing new regulatory policies and clarifying certain already established policies to assist manufacturers and states in participating in VBPs in a manner that is consistent with the law and maintains the integrity of the Medicaid Drug Rebate Program (MDRP). This proposed rule also proposes revisions to regulations regarding: authorized generic sales when manufacturers calculate average manufacturer price (AMP); pharmacy benefit managers (PBM) accumulator programs and their impact on AMP and best price; state and manufacturer reporting requirements to the MDRP; new Medicaid Drug Utilization Review (DUR) provisions designed to reduce opioid related fraud, misuse and abuse; the definitions of CMS-authorized supplemental rebate agreement, line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, innovator multiple source drug for purposes of the MDRP; payments for prescription drugs under the Medicaid program; and coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children’s Health Insurance Program (CHIP).
- On June 18, 2020, the Federal Communications Commission (FCC) issued a rule entitled, Promoting Telehealth in Rural America. The FCC is announcing that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the rules for the Telecommunications Program and the Healthcare Connect Fund Program contained in the Commission’s Promoting Telehealth in Rural America Report and Order, FCC 19-78, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the new information collection requirements.
- 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.
- July 14, 2020: FDA announced a public meeting entitled, Meeting of the Oncologic Drugs Advisory Committee. The committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
- July 16, 2020: CDC announced a public meeting entitled, Meeting for the Board of Scientific Counselors, Center for Preparedness and Response. The agenda will include discussions on Center for Preparedness and Response Director Updates and Board of Scientific Counselors members’ perspectives on COVID-19 pandemic preparedness and response.
- July 22, 2020: CMS announced a public meeting entitled, Meeting of the Medicare Evidence Development and Coverage Advisory Committee. This meeting will focus on the home use of noninvasive positive pressure ventilation in patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). CMS is seeking the MEDCAC’s recommendations regarding the characteristics that define those patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD.
- July 23, 2020: FDA announced a public meeting entitled, Reauthorization of the Prescription Drug User Fee Act. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027.
- July 25, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The purpose of the meeting is to discuss opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
II. Congressional Hearings
U.S. House of Representatives
- On June 17, 2020, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, Health Care Inequality: Confronting Racial and Ethnic Disparities in COVID-19 and the Health Care System. Witnesses present included: Dr. Rhea Boyd, Pediatrician and Child Health Advocate, Palo Alto Medical Foundation; Dr. Oliver T. Brooks, President, National Medical Association (NMA); and Avik S. A. Roy, President, The Foundation for Research on Equal Opportunity (FREO).
- On June 18, 2020, the House Committee on Ways & Means Subcommittee on Select Revenue Measures held a hearing entitled, Tax Relief to Support Workers and Families During the COVID-19 Recession. Witnesses present included: Amy Matsui, Senior Counsel, The National Women’s Law Center; Indivar Dutta-Gupta, Co-Executive Director, Georgetown Center on Poverty and Inequality at the Georgetown University Law Center; Allison Bovell-Ammon, Director of Policy Strategy for Children’s HealthWatch at Boston Medical Center; Martha Rodriguez, Preschool Educator; and Kyle Pomerleau, Resident Fellow, American Enterprise Institute (AEI).
- On June 17, 2020, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Telehealth: Lessons from the COVID-19 Pandemic. Witnesses present included: Karen Rheuban, M.D., Professor of Pediatrics, Senior Associate Dean of Continuing Medical Education and Director at the Center for Telehealth at the University of Virginia (UVA); Joseph Kvedar, M.D., President, American Telemedicine Association and Professor at Harvard Medical School (ATA); Sanjeev Arora, M.D., M.A.C.P., F.A.C.G., Distinguished and Regents’ Professor, University of New Mexico Health Sciences Center and Founder and Director, Project ECHO/ECHO Institute (UNM); and Andrea Willis, M.D., M.P.H., F.A.A.P., Senior Vice President, Chief Medical Officer, BlueCross BlueShield of Tennessee (BCBS).
III. Reports, Studies, & Analyses
- On June 15, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Limits and Opportunities of Federal Reporting on COVID-19 in Nursing Facilities. This brief explores the extent to which state and federal data on coronavirus in long-term-care (LTC) facilities differ and discusses the likely causes for these differences. While federal reporting offers promise for analyzing the intersection of COVID-19 and LTC facilities, state data will continue to play a role in highlighting the scope of the crisis across facility types and trends in COVID-19 within these facilities over time.
- On June 16, 2020, KFF published an issue brief entitled, Under the Radar: States Vary in Regulating and Reporting COVID-19 in Assisted Living Facilities. This analysis examines how states are regulating assisted living facilities in response to the COVID-19 pandemic, based on state-issued guidance for assisted living facilities on three key measures identified by CMS pertaining to visitors to facilities, daily staff screening, and universal use of PPE by facility staff, for each of the 50 states and DC. In addition, the authors tally state-level data on COVID-19 cases and deaths in assisted living facilities among states reporting such data as of June 8, 2020. The estimates reported here represent a subset of the COVID-19 cases and deaths data for long-term care facilities overall, as reported in other KFF analyses.
- On June 17, 2020, KFF published an issue brief entitled, Options to Support Medicaid Providers in Response to COVID-19. This brief provides an overview of how states currently reimburse providers and the challenges for Medicaid providers that have emerged from the pandemic and state budget issues. It presents new data on state actions to date to help bolster Medicaid providers dealing with the effects of COVID-19 and discusses support available for Medicaid providers from the federal provider relief fund.
- On June 18, 2020, RAND Corporation published a report entitled, Health Care Resource Allocation Decision-making During a Pandemic. The authors created a rapid response guidance checklist to support health care resource allocation decision-making during the COVID-19 crisis. The Core Guidance Checklist was created from a consensus discussion process with bioethicists, health system leaders, clinicians, patient advocates, and representatives of affected communities. It is intended for use by decision-makers within health systems, as well as state-level policymakers, to strengthen resource allocation, policy development and implementation, and improve the decisions that result. The Core Guidance Checklist can be used to guide evaluation of allocation guidance policy—both the content and the consequent decision-making—to spur improvements and to increase public trust.
- On June 18, 2020, the Government Accountability Office (GAO) published a report entitled, Public Health Preparedness: HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review HHS’s responder surge capacity. This report examines the workforce planning for National Disaster Medical System (NDMS) responders to assist with public health emergencies, and training provided to these responders. To conduct this work, GAO reviewed agency NDMS planning documentation, including NDMS staffing decisions, team structures, and training materials; compared HHS actions to key workforce planning practices; and interviewed HHS officials.
IV. Other Health Policy News
- On June 15, 2020, a bipartisan group of 30 U.S. senators sent a letter to Senate leadership, calling for the expansion of access to telehealth services during the COVID-19 pandemic to be made permanent. In their letter, the senators highlight the growing use and benefits of telehealth during the ongoing coronavirus pandemic, as patients seek to avoid traveling to hospitals and other providers and instead receive care at home. More information about the letter and the text of the letter can be found here.
- On June 18, 2020, HHS announced awards totaling $107.2 million to 310 recipients to increase the health workforce in rural and underserved communities. Recipients across 45 states and U.S. territories received funding to improve the quality, distribution and diversity of health professionals serving across the country. These programs provide financial and professional support to physicians, faculty, dentists, nurses and students as they pursue careers in health care settings. Awardees will be able to develop and retain clinicians in high-need areas to meet the vital health needs of the most disadvantaged communities. More information about this funding can be found here.
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