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 7, CMS issued its final Notice of Benefit and Payment Parameters for the 2021 benefit year. Read more about the regulation and other news below.
I. Regulations, Notices, & Guidance
- On May 1, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Investigational COVID-19 Convalescent Plasma. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
- On May 4, 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 4, 2020, FDA issued revised guidance entitled, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA is issuing this guidance to provide a policy to help accelerate the availability of COVID-19 tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States. 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).
- On May 5, 2020, FDA issued guidance entitled, Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components. This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 2.1 dated April 2020, prepared by the AABB Donor History Task Force. This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).
- On May 6, 2020, FDA issued guidance entitled, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency. FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency. Section 506J of the FD&C Act requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during 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 Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
- On May 7, 2020, FDA issued guidance entitled, Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease. The purpose of this guidance is to assist sponsors in all phases of the clinical development of drugs and biological products to treat or prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT).
- On May 7, 2020, HHS issued a final rule entitled, Patient Protection and Affordable Care Act: Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It also finalizes changes related to essential health benefits and will provide states with additional flexibility in the operation and establishment of Exchanges. The rule includes changes related to cost sharing for prescription drugs; notice requirements for excepted benefit health reimbursement arrangements offered by non-Federal governmental plan sponsors; Exchange eligibility and enrollment; exemptions from the requirement to maintain coverage; quality rating information display standards for Exchanges; and other related topics. This final rule also repeals regulations relating to the Early Retiree Reinsurance Program.
- 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: The Centers for Medicare & 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 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.
U.S. House of Representatives
- On May 6, 2020, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, COVID-19 Response. Witnesses present included: Tom Friedan, President and CEO of Resolve to Save Lives, and former Director of the CDC; and Dr. Caitlin Rivers, Senior Scholar at the Johns Hopkins Center for Health Security, Assistant Professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health.
- On May 7, 2020, the Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing entitled, Shark Tank: New Tests for COVID-19. Witnesses present included: Francis Collins, Director, National Institutes of Health (NIH); and Dr. Gary Disbrow, Acting Director, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), United States Department of Health and Human Services (HHS).
III. Reports, Studies, & Analyses
- On May 5, 2020, RAND Corporation published a research brief entitled, Critical Care Surge Capacity in U.S. Hospitals: Strategies for Responding to the COVID-19 Pandemic. RAND researchers assembled a list of strategies to help U.S. hospitals create critical care surge capacity. The list was created using a review of scientific literature about past outbreaks and the current COVID-19 pandemic, a survey of frontline clinicians conducted in collaboration with the American College of Emergency Physicians, and two roundtables conducted via teleconference with leading emergency and critical care physicians and public health and preparedness experts from around the country. The strategies are organized into two tiers: (1) Tier 1 strategies to build contingency capacity include adaptations to medical care spaces, staffing constraints, and supply shortages without significant impact on medical care delivery; and (2) Tier 2 strategies to build crisis capacity include changes that will have significant impact on routine care delivery and operations.
- On April 5, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, FAQs on Medicare Coverage and Costs Related to COVID-19 Testing and Treatment. These FAQs review current policies for Medicare coverage and costs associated with testing and treatment for COVID-19, including regulatory changes issued by CMS since the declaration of the public health emergency (first issued on January 31, 2020 and renewed on April 21, 2020), and legislative changes adopted in three recent bills: the Coronavirus Preparedness and Response Supplemental Appropriations Act; the Families First Coronavirus Response Act; and the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
- On April 7, 2020, KFF published an issue brief entitled, Low-Income and Communities of Color at Higher Risk of Serious Illness if Infected with Coronavirus. Emerging national and state-level data suggest that serious illness resulting from coronavirus disproportionately affects people in communities of color, due to the underlying health and economic challenges that they face. Similarly, adults with low incomes are more likely to have higher rates of chronic conditions compared to adults with high incomes, which could increase their risk of serious illness if infected with coronavirus. To provide greater insight into the characteristics of people at greater risk of illness if infected with the novel coronavirus, KFF built on a prior analysis of higher risk adults in the U.S. to break down these numbers by race/ethnicity and household income in 2018. Their definition of higher risk includes: non-elderly adults between the ages of 18 and 64 with heart disease, chronic obstructive pulmonary disease, uncontrolled asthma, diabetes, or a body mass index greater than 40, following the risk factors identified by the CDC.
IV. Other Health Policy News
- On May 7, 2020, HHS announced that it extended the deadline for healthcare providers to attest to receipt of payments from the Provider Relief Fund and accept the Terms and Conditions. Providers will now have 45 days, increased from 30 days, from the date they receive a payment to attest and accept the Terms and Conditions or return the funds. More information about this announcement can be found here.
- On May 7, 2020, HHS announced that it has awarded nearly $583 million to 1,385 HRSA-funded health centers in all 50 states, the District of Columbia, and eight U.S. territories to expand COVID-19 testing. Nearly 88 percent of HRSA-funded health centers report testing patients, with more than 65 percent offering walk-up or drive-up testing. Health centers are currently providing more than 100,000 weekly COVID-19 tests in their local communities. The funding for these awards comes from the Paycheck Protection Program and Health Care Enhancement Act, which was signed into law on April 24th. More information about the awards can be found here.
- On May 7, 2020, HHS announced that it has deployed 50 portable kidney dialysis machines and supplies to New York City and Long Island Intensive Care Units (ICUs) to provide surge capacity for facilities caring for patients with COVID-19, which has caused acute kidney injury and therefore required dialysis in a share of ICU cases. More information about this action can be found here.