Alston & Bird Health Care Week In Review, April 15, 2022

Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in health care 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 distributed $1.75 billion in PRF Phase 4 payments and announced $226.5 million for the Community Health Worker Training Program. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On April 11, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. This guidance provides performance criteria for Orthopedic Fracture Fixation Plates in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  
  
• On April 11, 2022, FDA issued final guidance entitled, Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. This guidance provides performance criteria for surgical sutures in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for surgical sutures will have the option to use the performance criteria provided in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  
  
• On April 11, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2023; Request for Information on Revising the Requirements for Long-Term Care Facilities to Establish Mandatory Minimum Staffing Levels. This proposed rule would update: payment rates; forecast error adjustment; diagnosis code mappings; the Patient Driven Payment Model (PDPM) parity adjustment, the SNF Quality Reporting Program (QRP), SNF Value-Based Purchasing (VBP) Program. It also proposes to establish a permanent cap policy. This proposed rule also includes a request for information related to long-term care (LTC) facilities. CMS requests comments on these proposals as well as on related subjects and announces the application of a risk adjustment for the SNF Readmission Measure for COVID-19 beginning in FY 2023.
  
  
• On April 12, 2022, FDA issued final guidance entitled, Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability. These device-specific guidance documents provide performance criteria for premarket notification (510(k)) submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled "Safety and Performance Based Pathway." As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices.
  
  
• On April 12, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention, humanized murine monoclonal antibodies that neutralize type-1 interferon (IFN) activity, is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
  
  
• On April 13, 2022, FDA issued draft guidance entitled, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Optic Use; Draft Guidance for Industry; Availability. This guidance is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or optic use in seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the reference listed drug (RLD) with respect to the pH adjuster(s). This draft guidance describes how FDA intends to evaluate a request for a waiver of Agency requirements, for a Q1 or Q2 difference in pH adjuster, including recommendations on the type of information to provide in support of such a waiver request. This draft guidance also includes recommendations on the timing and process for submitting such waiver requests.
  
  
• On April 13, 2022, FDA issued draft guidance entitled, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability. The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the "Plan") to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the U.S.
  
  
• On April 14, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Request for Information: AHRQ's Proposed Patient-Centered Outcomes Research Trust Fund Strategic Framework; Extension of Comment Period. In the Federal Register of February 18, 2022, AHRQ announced that it was seeking input from the public on its proposed strategic framework for AHRQ's Patient-Centered Outcomes Research Trust Fund investments. This notice extends the comment period 35 days from April 19, 2022, to May 24, 2022.
  
  
• On April 14, 2022, FDA issued final guidance entitled, Bioavailability Studies Submitted in NDAs or INDs--General Considerations; Guidance for Industry; Availability. This guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This guidance finalizes the draft guidance of the same title issued on February 26, 2019.
  
  
• On April 14, 2022, FDA issued draft guidance entitled, Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry; Availability. This draft guidance addresses FDA's recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in adults.
  
  
• On April 15, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention, Novel Methods of MHC-I - LILRB Checkpoint Inhibition, is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
  
  
• On April 15, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention, Expression of Prefusion-stabilized Spike S Glycoprotein of SARS CoV-2 from Avian Paramyxovirus Type 3 (APMV3), is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Event Notices

• April 20, 2022:  The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccine booster doses. A recommendation vote(s) is scheduled.
  
  
• May 10, 2022:  NIH announced a public meeting of the National Advisory Council on Drug Abuse. The agenda will include presentations and other business of the Council.
  
  
• May 12-13, 2022:  The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). Agenda items include the following: a final evidence-based review report on the guanidinoacetate methyltransferase (GAMT) deficiency condition nomination for possible inclusion on the Recommended Uniform Screening Panel (RUSP). Following this report, the ACHDNC expects to vote on whether to recommend the Secretary add GAMT deficiency to the RUSP; An update on the Krabbe disease condition nomination; A possible vote on whether to move Krabbe disease forward to full evidence-based review; A presentation on homocystinuria newborn screening status; and a presentation on the Newborn Screening Family Education Program.
  
  
• May 18, 2022: NIH announced a public meeting of the National Institute of Dental & Craniofacial Research (NIDCR). The agenda will include the Report of the Director, NIDCR and concept clearances.
  
  
• May 19-20, 2022:  NIH announced a public meeting of the Council of Councils. The agenda will include NIH Program Updates; Scientific Talks and Other Business of the Committee.
  
  
• May 23-24, 2022:  NIH announced a public meeting of the National Advisory Council on Minority Health and Health Disparities. The agenda will include administrative matters, a director's report, presentations, and other business of the Council.
  
  
• June 9-10, 2022:  FDA announced a public meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The morning session of June 9, 2022 will include presentations of the effectiveness and product-specific safety results from the clinical trials in BLA 125755. The afternoon session will include presentations of safety concerns relevant to both products, followed by committee discussion of BLA 125755. On June 10, 2022, the morning session will include presentations of the effectiveness and product-specific safety results from the clinical trials in BLA 125717. The afternoon session will include committee discussion of BLA 125717.
  
  
• June 23, 2022:  CMS announced a public meeting for the Medicare program entitled, Medicare Program; Public Meeting on June 23, 2022 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2023. This public meeting is being held 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 (CY) 2023. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
  
  
• July 12-13, 2022:  FDA announced a public meeting of the Patient Engagement Advisory Committee. On July 12 and 13, 2022, the Committee will discuss and make recommendations on the topic of "Augmented Reality (AR) and Virtual Reality (VR) Medical Devices." AR/VR devices are increasingly applied to healthcare settings across the patients' care continuum. From diagnostics to clinical decision making, to surgical support, and to directly treating patients, AR/VR devices are used across multiple medical specialties. These devices have novel attributes and considerations for the end users that impact FDA's evaluation of the device's safety and effectiveness.
  
  
• July 18-19, 2022:  CMS announced a public meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The agenda will include discussion on the Calendar Year (CY) 2023 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes and other CY 2023 CLFS issues designated in the Panel's charter.

II. Reports, Studies & Analyses

• On April 12, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Many Workers, Particularly at Small Firms, Face High Premiums to Enroll in Family Coverage, Leaving Many in the 'Family Glitch'. This analysis uses the KFF Employer Health Benefits Survey (EHBS) to look at the shares of workers that might pay significant amounts to enroll families and how these shares vary across firms. These are the workers most likely to benefit from a fix to the family glitch.
  
  
• On April 14, 2022, the Congressional Budget Office (CBO) gave a presentation entitled, Variation in Prices for Hospitals' Services. The presentation covered the variation among states in prices for hospitals' inpatients services, inpatient price variation within metropolitan areas, the relationship between hospitals' wages and commercial insurers' prices for inpatient services, and concentration in hospital markets and commercial insurers' prices.

III. Other Health Policy News 

• On April 12, 2022, HHS Secretary Xavier Becerra renewed the determination that a public health emergency (PHE) exists. The full notice of the renewal can be found here.
  
  
• On April 13, 2022, HRSA announced more than $1.75 billion in Provider Relief Fund (PRF) payments to 3,680 providers across the country. With this disbursement, HRSA has distributed approximately $13.5 billion from the PRF to nearly 86,000 providers and nearly $7.5 billion in American Rescue Plan (ARP) Rural payments to more than 44,000 providers since November 2021. Providers can use PRF payments received in the first half of 2022 to cover losses and expenses until June 30, 2023. With these latest payments, approximately 92 percent of all Phase 4 applications have been processed. Remaining applications require additional manual review and HRSA is working to process them as quickly as possible. More information on this funding can be found here.
  
  
• On April 13, 2022, CMS announced key actions to reduce maternal morbidity and mortality. CMS is released more details about the proposed "Birthing-Friendly" hospital designation intended to drive improvements in maternal health outcomes. The new designation would assist consumers in choosing hospitals that have demonstrated a commitment to maternal health and the delivery of high-quality maternity care. Additional information about the initial requirements for the designation will be released in the coming days as a part of the Hospital Inpatient Prospective Payment System (IPPS) proposed rule. More information about this new initiative can be found here.
  
  
• On April 13, 2022, HHS announced approximately $16 million to strengthen Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Programs through seven awards supporting eight states. These awards will advance data and technology innovations to support positive maternal and child health outcomes in states and communities and focus on addressing health disparities. In addition, HRSA announced the availability of up to $9 million through the State Maternal Health Innovation and Data Capacity Program to expand the State Maternal Health Innovation and Implementation Program. This program supports state-level development and implementation of proven strategies to improve maternal health and address maternal health disparities. The new funding will continue to build state capacity to deliver high-quality maternity care services, provide training for maternal care clinicians, and enhance the quality of state-level maternal health data through better collection, reporting and analysis.  The program will fund up to nine cooperative agreements, and each will receive up to $1 million over five years. More information on this funding can be found here.
  
  
• On April 15, 2022, HHS announced the availability of $226.5 million in American Rescue Plan funding to launch the Community Health Worker Training Program. This new program will increase the number of community health workers who play a critical role in connecting people to care, including COVID-19 care; mental health and substance use disorder prevention, treatment and recovery services; chronic disease care; and other important health services. More information on this funding can be found here.

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