Alston & Bird Health Care Week in Review, December 17, 2021 | News & Insights

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:

This week, HHS issued $9 billion in Provider Relief Fund (PRF) Phase 4 payments to health care providers impacted by COVID-19. Read more about this action and other news below.

I. Regulations, Notices & Guidance

On December 14, 2021, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle. FDA is classifying the endoscopic transhepatic venous access needle into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic transhepatic venous access needle’s classification.
On December 14, 2021, FDA issued a final order entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief. FDA is classifying the nonimplanted nerve stimulator for functional abdominal pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nonimplanted nerve stimulator for functional abdominal pain relief’s classification.
On December 14, 2021, FDA issued a proposed order entitled, Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures. FDA is proposing to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, which is an unclassified, preamendments device.
On December 14, 2021, FDA issued a proposed rule entitled, Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures. FDA is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA).
On December 15, 2021, FDA issued a final order entitled, Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid. FDA is classifying the traumatic brain injury eye movement assessment aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the traumatic brain injury eye movement assessment aid’s classification.
On December 15, 2021, FDA issued draft guidance entitled, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. FDA is issuing this draft guidance to promote clarity regarding references to the terms “device” and “counterfeit device” in guidance, regulatory documents, communications, and other public documents.
On December 16, 2021, FDA issued a final order entitled, Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen. FDA is classifying the manual percutaneous surgical set assembled in the abdomen into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the manual percutaneous surgical set assembled in the abdomen’s classification.
On December 16, 2021, FDA issued draft guidance entitled, Inspection of Injectable Products for Visible Particulates. This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The draft guidance also clarifies that meeting an applicable U.S. Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.
On December 16, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed rule entitled, Solicitation of New Safe Harbors and Special Fraud Alerts. This annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute), as well as developing new OIG Special Fraud Alerts.
On December 16, 2021, the Department of Veterans Affairs (VA) issued a notice entitled, Reasonable Charges for Outpatient Medical Care or Services; v4.225, Calendar Year (CY) 2022 Update and National Average Administrative Prescription Drug Charge Update. This notice updates the data for calculating what VA refers to as the Reasonable Charges collected or recovered by VA for medical care or services provided or furnished by VA to a veteran. This notice also updates the National Average Administrative Prescription Costs for purposes of calculating VA’s charges for prescription drugs that were not administered during treatment but provided or furnished by VA to a veteran.
On December 17, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule with comment period entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical Education Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies. This final rule with comment period finalizes certain provisions of the fiscal year 2022 IPPS/LTCH PPS proposed rule. These provisions implement policies based on legislative changes relative to Medicare graduate medical education (GME) for teaching hospitals provided by sections 126, 127, and 131 of the Consolidated Appropriations Act (CAA), 2021; and changes, clarifications, and codifications for Medicare organ acquisition payment policies relative to organ procurement organizations (OPOs), transplant hospitals, and donor community hospitals. In addition, this final rule with comment period solicits comments on certain GME issues to inform potential future rulemaking.

Event Notices

January 12, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the Director, CDC, on the use of immunizing agents.
January 19-20, 2022: CDC announced a public meeting of the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID). The agenda will include updates and discussions on recent outbreaks; updates and discussions on CDC’s Center for Forecasting and Outbreak Analytics, advanced molecular detection program, Data Modernization Initiative, and CORE Health Equity Science and Intervention Strategy; and other updates and reports.
January 27-28, 2022: The National Institutes of Health (NIH) announced a public meeting of the Council of Councils. The meeting agenda will feature a call to order and introductions; announcements and updates; NIH Program updates; scientific talks and other business of the Committee.
February 8, 2022: NIH announced a public meeting of the National Advisory Council on Drug Abuse. The meeting agenda will include presentations and other business of the Council.
April 28-29, 2022: FDA announced a public workshop entitled, Wound Healing Scientific Workshop. The purpose of the workshop is to discuss nonhealing chronic wounds.
May 10-11, 2022: NIH announced a public meeting of the National Advisory Council on Aging. The agenda will include a call to order and report from the Director; discussion of future meeting dates; consideration of minutes of last meeting; reports from Task Force on Minority Aging Research, Working Group on Program; a Council Speaker; and Program highlights.
September 7-8, 2022: NIH announced a public meeting of the National Advisory Council on Aging. The agenda will include a call to order and report from the Director; discussion of future meeting dates; consideration of minutes of last meeting; reports from Task Force on Minority Aging Research, Working Group on Program; a Council Speaker; and Program highlights.
Various Dates: The Health Resources and Services Administration (HRSA) announced several public meetings of the National Advisory Council on Nurse Education and Practice (NACNEP). NACNEP provides advice and recommendations to the Secretary of HHS in policy, program development, and other matters of significance concerning the activities under Title VIII of the Public Health Service Act, including the range of issues relating to the nurse workforce, education, and practice improvement.
Various Dates: HRSA announced several public meetings of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). ACICBL provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning the activities under section 750-760, Title VII, Part D of the Public Health Service (PHS) Act.
Various Dates: HRSA announced several public meetings of the Advisory Committee on Training and Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on policy, program development, and other matters of significance concerning the activities under Section 747 of Title VII of the Public Health Service (PHS) Act, as it existed upon the enactment of Section 749 of the PHS Act in 1998.
Various Dates: HRSA announced several public meetings of the Council on Graduate Medical Education (COGME). The COGME provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning the activities listed in section 762(a) of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses; foreign medical school graduates; the nature and financing of undergraduate and graduate medical education; appropriation levels for certain programs under Title VII of the PHS Act; and deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians.

II. Congressional Hearings

U.S. Senate

On December 14, 2021, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing entitled, Nomination of Dr. Robert Califf to be Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services. Witnesses present included the Honorable Robert Califf, MD.

III. Reports, Studies & Analyses

On December 15, 2021, HHS OIG published a report entitled, Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder. The report found that about 1 million Medicare beneficiaries were diagnosed with opioid use disorder in 2020. Yet less than 16 percent of these beneficiaries received medication to treat their opioid use disorder, raising concerns that beneficiaries face challenges accessing treatment. Furthermore, less than half of the beneficiaries who received medication to treat their opioid use disorder also received behavioral therapy. These findings show a need to increase the number of Medicare beneficiaries receiving treatment for opioid use disorder.
On December 15, 2021, the Kaiser Family Foundation (KFF) published a report entitled, Tracking Social Determinants of Health During the COVID-19 Pandemic. The public health and economic effects of the pandemic continue to affect the well-being of many Americans. This brief provides an overview of social determinants of health and a look at how adults are faring across an array of measures as of late September and early October 2021—a time when a portion of the population remained unvaccinated, and hospitalizations and deaths due to the delta variant were surging in some areas even as they waned in others.
On December 16, 2021, the Congressional Budget Office (CBO) published a cost estimate entitled, Estimated Budgetary Effects of Title III, Committee on Environment and Public Works, for the Senate Amendment to H.R. 5376, the Build Back Better Act. CBO estimates that enacting this title would result in a net increase in the deficit totaling $63.7 billion over the 2022-2031 period. That increase in the deficit would result from an increase in direct spending of $71.6 billion and an increase in revenues of nearly $8.0 billion.
On December 16, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19: Agencies Are Taking Steps to Improve Future Use of Defense Production Act Authorities. The report found that federal agencies used the Defense Production Act (DPA) and other actions over 100 times to help address COVID-19 medical supply needs through September 2021. Agencies used DPA authorities to 1) prioritize contracts so those orders can get preference over others, (2) fund projects to expand domestic production of supplies, and (3) enter into partnerships with private companies. GAO plans to monitor agencies' efforts.

IV. Other Health Policy News

On December 14, 2021, HHS, through the Health Resources and Services Administration (HRSA), announced the distribution of approximately $9 billion in Provider Relief Fund (PRF) Phase 4 payments to health care providers who have experienced revenue losses and expenses related to the COVID-19 pandemic. The average payment being announced for small providers is $58,000, for medium providers is $289,000, and for large providers is $1.7 million. More than 69,000 providers in all 50 states, Washington, D.C., and eight territories will receive Phase 4 payments. More information on this funding can be found here.
On December 14, 2021, HHS, through CMS, announced that it is taking critical steps to ensure pregnant and postpartum individuals have access to equitable, comprehensive maternity care. In support of Vice President Kamala Harris’ Call to Action to Reduce Maternal Mortality and Morbidity announced on December 7, 2021, CMS is encouraging hospitals to implement evidence-based patient safety practices for managing obstetric emergencies along with interventions to address other key contributors to maternal health disparities. More information on this announcement can be found here.
On December 15, 2021, CMS announced that the COVID-19 pandemic had a dramatic impact on the nation’s health sector in 2020, driving a 9.7% growth in total national healthcare spending, bringing spending to $4.1 trillion. This statistic is one of many health care expenditures presented in the 2020 National Health Expenditures (NHE) Report, prepared by the Office of the Actuary at CMS. The NHE measures total annual U.S. spending for the delivery of health care goods and services by type of good or service (hospital, physician, prescription drugs, etc.); type of payer (private health insurance, Medicare, Medicaid, etc.); and type of sponsor (businesses, households and federal/state governments). The NHE report also includes spending on government public health, investment in structures and equipment, and non-commercial research. The report also contains information on insurance enrollment and uninsured estimates. More information on this report can be found here.
On December 16, 2021, HHS, through CMS, announced that it is adding more consumer resources to support consumers’ access to coverage during the extended Marketplace Open Enrollment Period for HealthCare.gov – with approximately $10.2 million in additional funding awarded to current Navigator grantees in Federally-facilitated Marketplace (FFM) states. This funding will help support Navigator grantees’ outreach, education, and enrollment efforts around the extended Marketplace Open Enrollment Period. Navigator grant awardees include community and consumer-focused non-profits, faith-based organizations, hospitals, trade and professional associations, and Tribes or Tribal organizations. More information on this announcement can be found here.

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