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 May 1, CMS released a second round of regulatory waivers and rule changes intended to help the nation’s health care system deal with the COVID-19 outbreak. Read more about these actions and other news below.
I. Regulations, Notices, & Guidance
- On April 24, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides (“digital pathology slides”) (hereinafter these devices will be referred to as "remote digital pathology devices") during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency (PHE) related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
- On April 27, 2020, FDA issued guidance entitled, eCopy Program for Medical Device Submissions. The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions. Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), requires the submission of eCopies with the issuance of this final guidance. This guidance describes how the FDA is implementing the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.
- On April 29, 2020, FDA issued guidance entitled, Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency. This guidance communicates the FDA's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.
- On April 29, 2020, FDA issued guidance entitled, Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market without Premarket Authorization. This guidance document describes how FDA intends to prioritize their enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.
- On April 30, 2020, FDA issued guidance entitled, FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements. This Small Entity Compliance Guide is intended to help small businesses understand and comply with FDA's final rule deeming tobacco products to be subject to the Federal FD&C Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (the Deeming Rule). The Deeming Rule extends FDA's tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.
- On April 30, 2020, FDA issued guidance entitled, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency. Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA is issuing this guidance to clarify the scope of the PHE exemption and exclusion under the DSCSA for the duration of the PHE declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020, to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19. In addition, this guidance announces FDA’s policy regarding the exercise of its discretion in the enforcement of authorized trading partner requirements under section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the FD&C Act for certain distributions during the COVID-19 public health emergency involving other trading partners that may not be authorized trading partners.
- On May 1, 2020, FDA issued guidance entitled, Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide. On April 1, 2019, FDA published a final rule in the Federal Register entitled “Classification of Posterior Cervical Screw Systems” (84 FR 12088). This final rule created the classification regulation 21 CFR 888.3075 for posterior cervical screw systems and established special controls. 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, as amended by Public Law 110-28) to assist small entities to comply with the requirements established in 21 CFR 888.3075.
- On May 1, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Coordinating Care From Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions. This document reopens the comment period for the January 21, 2020 request for information (RFI) entitled "Coordinating Care From Out-of-State Providers for Medicaid-Eligible Children With Medically Complex Conditions." That document requested information to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. CMS wishes to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and nonemergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. CMS intends to use the information received in response to the RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions.
- On May 1, 2020, CMS issued an interim final rule with comment period entitled, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program. This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of COVID-19. Recognizing the critical importance of expanding COVID-19 testing, CMS is amending several Medicare policies on an interim basis to cover FDA-authorized COVID-19 serology tests, to allow any healthcare professional authorized to do so under State law to order COVID-19 diagnostic laboratory tests (including serological and antibody tests), and to provide for new specimen collection fees for COVID-19 testing under the Physician Fee Schedule and Outpatient Prospective Payment System, during the PHE for the COVID-19 pandemic. Recognizing the urgency of this situation, and understanding that some pre-existing CMS rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on beneficiaries and the American public, CMS is amending several CMS policies and regulations in response to the COVID-19 PHE and recent legislation, as outlined in this IFC. These changes apply to physicians and other practitioners, hospice providers, federally qualified health centers, rural health clinics, hospitals, critical access hospitals (CAHs), community mental health centers (CMHCs), clinical laboratories, teaching hospitals, providers of the laboratory testing benefit in Medicaid, Opioid treatment programs, and quality reporting programs (QRPs) for inpatient rehabilitation facilities (IRFs), long-term care hospitals (LTCHs), skilled nursing facilities (SNFs), home health agencies (HHAs) and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers.
- May 12, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Cancer Institute. The purpose of this meeting is to go over Director’s Report; RFA, RFP, and PAR Concept Reviews; and Scientific Presentations.
- May 15, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The meeting agenda will include updates from the HICPAC Long-term Care/Post-acute Care Workgroup related to COVID-19 in U.S. long-term care facilities
- May 18, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Commission on Childhood Vaccines. During this meeting, the ACCV will discuss a draft National Vaccine Injury Compensation Program Notice of Proposed Rulemaking.
- May 20, 2020: NIH announced a public meeting entitled, Meeting of the National Institute of Biomedical Imaging and Bioengineering. The purpose of the meeting is to go over the Report from the Institute Director and other Institute Staff.
- June 1-2, 2020: 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 8, 2020: 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 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: 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 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
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On April 29, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, How State Medicaid Programs are Managing Prescription Drug Costs: Results from a State Medicaid Pharmacy Survey for State Fiscal Years 2019 and 2020. Medicaid provides health coverage for millions of Americans, including many with substantial health needs who rely on Medicaid drug coverage for both acute problems and for managing ongoing chronic or disabling conditions. Though optional, all states provide pharmacy benefit coverage and administer the benefit in different ways within federal guidelines regarding, for example, pricing and rebates. To better understand how the Medicaid pharmacy benefit is administered across the states, KFF and Health Management Associates conducted a survey of all 50 states and the District of Columbia in 2019. The survey was designed to capture information on state policies and strategies for managing the pharmacy benefit as well as planned changes for FY 2020 and future priorities and challenges.
- On April 29, 2020, the Bipartisan Policy Center published a report entitled, Loosening COVID-19 Social Distancing Interventions: Lessons Learned from Abroad. The Bipartisan Policy Center initiated a study to assess how countries around the world are attempting to relax social distancing interventions as they transition from the initial pandemic wave. Focus countries included Austria, the Czech Republic, Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, the United Kingdom, South Korea, Taiwan, China, Singapore, and Hong Kong. This white paper includes a case study of Germany’s response and approach to loosening social distancing interventions, preliminary insights from a cross-country analysis, as well as implications and initial recommendations for the United States with respect to loosening social distancing interventions.
- On April 30, 2020, the Government Accountability Office (GAO) published its Priority Open Recommendations for the HHS. Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits.
IV. Other Health Policy News
- On April 26, 2020, CMS announced that that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to healthcare providers and suppliers through these programs and in light of the $175 billion recently appropriated for healthcare provider relief payments. More information on this announcement can be found here.
- On April 27, 2020, HHS, through the Health Resources and Services Administration (HRSA), launched a new COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement. Providers can access the portal at COVIDUninsuredClaim.HRSA.gov.
- On April 27, 2020, President Trump and the White House Coronavirus Taskforce unveiled the Opening Up America Again Testing Overview and Testing Blueprint designed to facilitate State development and implementation of the robust testing plans and rapid response programs described in the President’s Opening Up America Again Guidelines. The President’s Blueprint sets forth the partnership between Federal, State, local, and tribal governments, along with the private-sector and professional associations, all of which will play important roles in meeting the Nation’s testing needs.
- On April 30, 2020, CMS announced a new independent Commission that will conduct a comprehensive assessment of the nursing home response to the COVID-19 pandemic. The Commission will provide independent recommendations to the contractor to review and report to CMS to help inform immediate and future responses to COVID-19 in nursing homes. More information on the new Commission can be found here.
- On April 30, 2020, HHS announced that it has awarded $20 million to increase telehealth access and infrastructure for providers and families to help prevent and respond to COVID-19. The funds will increase capability, capacity and access to telehealth and distant care services for providers, pregnant women, children, adolescents and families, and will assist telehealth providers with cross-state licensure to improve access to health care during the pandemic. More information on this funding can be found here.
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