Alston & Bird Health Care Week in Review, September 18, 2020

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 Monday, CMS issued Part I of the CY 2022 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies. Read more about the notice and other news below.

I. Regulations, Notices & Guidance

• On September 14, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Alternative Payment Model Incentive Payment Advisory for Clinicians; Request for Current Billing Information for Qualifying Participants. This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
• On September 14, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance is not intended for development programs evaluating products to treat or prevent postinfectious COVID-19 conditions such as multisystem inflammatory syndrome in children or to development programs for preventative vaccines. This guidance does not address considerations for clinical trial design other than those pertaining to the measurement and analysis of COVID-19-related symptoms among outpatients.
• On September 15, 2020, FDA issued guidance entitled, Recognition and Withdrawal of Voluntary Consensus Standards. FDA developed this document to provide guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows when we receive a request for recognition of a voluntary consensus standard for medical products. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.
• On September 15, 2020, FDA issued guidance entitled, Geriatric Information in Human Prescription Drug and Biological Product Labeling. This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. The goal of this guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients.
• On September 15, 2020, FDA issued guidance entitled, Eosinophilic Esophagitis: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of drugs and therapeutic biologics for the treatment of eosinophilic esophagitis (EoE). Specifically, this guidance addresses FDA’s current thinking regarding clinical trials and development programs for EoE drugs, including recommendations for the necessary attributes of patients for enrollment, trial designs, efficacy considerations, safety assessments, and pediatric considerations.
• On September 17, 2020, FDA issued a proposed rule entitled, Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management. FDA is proposing to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "quantitative cytomegalovirus (CMV) nucleic acid tests for transplant patient management" to identify these devices along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for the device. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices as manufacturers of these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a premarket notification (510(k)) and obtain clearance, before marketing their device.
• On September 18, 2020, FDA issued guidance entitled, Investigational COVID-19 Convalescent Plasma. The guidance document provides recommendations to healthcare providers and investigators on the use of investigational convalescent plasma for the treatment of the Coronavirus Disease 2019 (COVID-19) during the public health emergency. The guidance announced in this notice supersedes the guidance of the same title dated April 2020 and updated in May 2020. The guidance includes a discussion to facilitate the availability of investigational convalescent plasma when blood establishments, hospitals, and healthcare providers collect plasma that does not meet the Conditions of Authorization of the Emergency Use Authorization (EUA). The guidance also provides recommendations for healthcare providers who wish to administer and study convalescent plasma under an investigational new drug (IND) application.
• On September 18, 2020, HHS issued a rule entitled, Removing Financial Disincentives to Living Organ Donation. This final rule amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove financial barriers to organ donation by expanding the scope of reimbursable expenses incurred by living organ donors to include lost wages, and child-care and elder-care expenses incurred by a caregiver. HHS is committed to reducing the number of individuals on the organ transplant waiting list by increasing the number of organs available for transplant. This final rule is associated with Section 8 of the Executive Order (E.O.) 13879 titled “Advancing American Kidney Health,” issued on July 10, 2019, which directed HHS to propose a regulation allowing living organ donors to be reimbursed for related lost wages, child-care expenses, and elder-care expenses through the Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program authorized under section 377 of the Public Health Service (PHS) Act, as amended.

Event Notices

• September 22, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
• September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.
• October 2, 2020: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
• October 8, 2020: FDA announced a public meeting entitled, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder.
• October 26, 2020: CDC announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
• October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
• October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
• October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
• November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. On November 9, 2020, the committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.

II. Congressional Hearings

U.S. Senate

• On September 16, 2020, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Review of Coronavirus Response Efforts. Witnesses present included: Dr. Robert Redfield, Director, CDC; Dr. Bob Kadlec, Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS); and Admiral (ADM) Brett Giroir, MD, Assistant Secretary for Health, HHS.

III. Reports, Studies & Analyses

• On September 16, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, COVID-19 Racial Disparities in Testing, Infection, Hospitalization, and Death. This analysis builds on a continually growing body of research on racial disparities in COVID-19 by examining testing, infection, hospitalization, and death by race and ethnicity among patients in the Epic health record system. It contributes to the research in this area by providing insight into the experiences of a large patient population across a range of states and health systems, examining variation in the level of care patients required at the time they tested positive for COVID-19 by race and ethnicity, and assessing the extent to which underlying sociodemographic characteristics and health conditions explain racial disparities in hospitalization and death.
• On September 18, 2020, RAND Corporation published a report entitled, Nationwide Evaluation of Health Care Prices Paid by Private Health Plans. Using data from 2016 to 2018, the authors document variation in facility prices for the commercially insured population, reporting differences in standardized negotiated prices and prices relative to Medicare reimbursement rates for the same procedures and facilities. The data come from all but one state in the United States and cover $33.8 billion in hospital spending from three sources: self-insured employers, state-based all-payer claims databases, and health plans. Prices reflect the negotiated allowed amount paid per service, including amounts from both the health plan and the patient, with adjustments for the intensity of services provided. The authors calculate how much employers and employees are paying for hospital services, examine recent price trends, and identify strategies employers can use to address high hospital prices.

IV. Other Health Policy News

• On September 14, 2020, CMS released Part I of the Contract Year (CY) 2022 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies (the Advance Notice), which contains key information about the Part C CMS-Hierarchical Condition Categories (HCC) risk adjustment model and the use of encounter data for CY 2022. This announcement of Medicare Advantage and Part D payment methodologies is being made approximately three months earlier than usual to provide Medicare Advantage organizations and Part D sponsors more time to take this information into consideration as they prepare their bids for 2022. The earlier release will help Medicare Advantage and Part D plans to better address estimating 2022 plan costs, in light of the uncertainty associated with the COVID-19 pandemic. More information about Part I of the Medicare Advantage Advance Notice can be found here.
• On September 14, 2020, HHS awarded approximately $25 million to 80 award recipients across 36 states and two territories as part of the Rural Communities Opioid Response Program (RCORP). RCORP is a multi-year Health Resources and Services Administration (HRSA) initiative to reduce morbidity and mortality of substance use disorder (SUD) and opioid use disorder (OUD) in high-risk rural communities. More information about this announcement can be found here.
• On September 15, 2020, CMS issued guidance for states on how to advance value-based care (VBC) across their healthcare systems, with a particular emphasis on Medicaid populations, and to share pathways for adoption of such approaches. This guidance includes an assessment of key lessons learned from early state and federal experiences in implementing VBC reforms, as well as a comprehensive toolkit of available federal authorities for states to adopt for innovative payment reform efforts within their individual programs. The guidance stresses the importance of multi-payer alignment in VBC to drive care transformation, and supports state efforts to align new payment models in Medicaid with Medicare and other private payers. More information about the new guidance can be found here.
• On September 16, 2020, HHS and the Department of Defense (DOD) released two documents outlining the Trump Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible. The documents, developed by HHS in coordination with DoD and the CDC, provide a strategic distribution overview along with an interim playbook for state, tribal, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their respective jurisdictions. More information about the vaccine distribution plan can be found here.
• On September 16, 2020, CMS released updated Medicaid and Children’s Health Insurance Program (CHIP) data that is used for monitoring program performance and analyzing state and federal payments for services. The Transformed Medicaid Statistical Information System (T-MSIS) data provides information on key topics including service utilization and spending, and supports research and analysis that helps improve quality of care for beneficiaries. More information about the updated data can be found here.
• On September 18, 2020, CMS released a request for information (RFI) to solicit public feedback on its efforts to track the performance of Medicaid-funded home and community-based services (HCBS). More information about the RFI can be found here.

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