September 24, 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 issued a proposed rule to affirm protections against discrimination on the basis of race, color, national origin, sex, age, and disability in federally funded health programs and activities. Read more about these actions and other news below.


I. Regulations, Notices & Guidance

  • On July 25, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This guidance describes FDA’s enforcement of requirements for class I and unclassified devices under its unique device identification system (UDI system). The UDI system identifies devices through distribution and use. The UDI rule requires devices to bear a unique identifier on their label and packages and requires software regulated as devices to include special labeling. This guidance discusses several topics, including submission requirements to the Global Unique Device Identification Database (GUDID) and compliance policies.
  • On July 26, 2022, FDA issued final guidance entitled, Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings. This guidance provides recommendations regarding the inclusion of patients who have not received available therapy for their cancer in clinical trials of investigational cancer drugs and biological products in non-curative settings. Non-curative is generally defined as: (1) unresectable, locally advanced, or metastatic tumors or (2) hematologic malignancies with unfavorable long-term survival. This guidance describes information that should be included in the informed consent process and includes recommendations regarding evaluation of results from this proposed approach.
  • On July 27, 2022, FDA issued final guidance entitled, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products. This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements who are planning to conduct clinical studies in neonatal populations. This guidance explains that drug information and labeling needs to be specific to neonates and address subgroup classifications of neonates; include general pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations for clinical pharmacology studies in neonates; and include clinical pharmacology considerations for planned studies in neonates.
  • On July 27, 2022, FDA issued a notice entitled, Outsourcing Facility Fee Rates for Fiscal Year 2023. The notice announced the agency’s fiscal year (FY) 2023 rates for the establishment and reinspection fees for entities that compound human drugs and register as outsourcing facilities. The notice also clarifies how FDA calculated the two fees as well as the inflation and small business adjustment factors for both fees. In summary, the establishment fee for a non-small business is $18,661, the establishment fee for a small business is $5,941, and the reinspection fee is $17,823.
  • On July 27, 2022, the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) issued a notice entitled, Request for Information (RFI): Inviting Comments and Suggestions on an ODS Strategic Plan 2022-2026. This request for information solicits comments on the draft ODS Strategic Plan for the next five years. The strategic plan discusses ODS’s five goals: (1) expand the scientific knowledge and research on dietary supplements; (2) enhance the dietary supplement research workforce; (3) foster development and dissemination of research resources and tools; (4) translate research findings into information for all audiences; and (5) develop collaborative initiatives to address gaps in dietary supplement research. Comments must be received by August 31, 2022.
  • On July 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Medicare Program: Fiscal Year 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. This final rule updates Medicare hospice payments and the aggregate cap amount with a permanent mitigation policy to smooth the impact of year-to-year changes in hospice payments related to changes in the hospice wage index. This rule also updates the Hospice Quality Reporting Program (HQRP), specifically in regard to its patient assessment instruments, the Hospice Outcomes and Patient Evaluation (HOPE) and the CAHPS Hospice Survey.
  • On July 27, 2022, CMS released a final rule entitled, Medicare Program: FY 2023 Inpatient Psychiatric Facilities Prospective Payment System; Rate Update and Quality Reporting; Request for Information. This final rule updates Medicare payment policies and rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS). Specifically, CMS proposes to increase payment rates based on the IPF market basket update less a productivity adjustment. The agency also proposes a permanent cap policy to smooth the impact of year-to-year changes in IPF payments related to decreases in the IPF wage index.
  • On July 27, 2022, CMS released a final rule entitled, Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program. This final rule updates Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP). Specifically, CMS updates IRF PPS payments based on the IRF market basket update less a productivity adjustment along with a permanent cap on year-to-year wage index decreases. CMS also expands the IRF quality data reporting requirements and addresses two concerns raised in the RFI process.
  • On July 28, 2022, FDA issued draft guidance entitled, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations. This draft guidance recommends content and formatting for patient labeling information for LASIK devices because of concerns that patients are not receiving and/or understanding information regarding the benefits and risks of LASIK devices.
  • On July 28, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Requests for Nominations: Lead Exposure and Prevention Advisory Committee (LEPAC). The agency is soliciting nominations for membership on the LEPAC. The LEPAC is composed of 15 Federal and non-Federal experts in fields associated with lead screening, prevention of lead exposure, and services for individuals and communities affected by lead exposure, who serve three-year terms. CDC is looking for individuals with expertise in epidemiology, toxicology, mental health, pediatrics, early childhood and special education, nutrition, and environmental health. Nominations are due by November 4, 2022.
  • On July 28, 2022, the Indian Health Service (IHS) issued a notice entitled, Special Diabetes Program for Indians (SDPI). The notice announced that SDPI is accepting applications for FY 2023 cooperative agreements that total nearly $136 million for approximately 325-450 awards. These awards are granted in light of the diabetes public health problem in the U.S. that disproportionately affects American Indian and Alaskan Native individuals. The notice also outlines program and application expectations. The application deadline is October 7, 2022.
  • On July 28, 2022, CMS released a proposed rule entitled, Request for Information: Medicare Program. This RFI seeks input from the public regarding various aspects of the Medicare Advantage (MA) program. CMS specifically seeks comment on health equity, expanding coverage and access to care, person-centered healthcare innovation, affordability and sustainability, and community partnerships as related to improving the MA program. Comments are due by August 31, 2022.
  • On July 28, 2022, CMS released a proposed rule entitled, Nondiscrimination in Health Programs and Activities. This proposed rule revises the agency’s interpretation of whether Medicare Part B constitutes as Federal financial assistance for purposes of civil rights enforcement. It also revises the agency’s nondiscrimination provisions to prohibit discrimination on the basis of sexual orientation and gender identity in CMS regulations relating to Medicaid and the Children’s Health Insurance Program (CHIP); Programs of All-Inclusive Care for the Elderly (PACE); health insurance; Exchange requirements; and other qualified health plan issuers.
  • On July 29, 2022, the Occupational Safety and Health Administration (OSHA) issued a notice entitled, Requests for Nominations: National Advisory Committee on Occupational Safety and Health (NACOSH). NACOSH is made up of 12 individuals who serve staggered terms and meet two times a year to advise HHS on matters relating to the Occupational Safety and Health Act of 1970. OSHA invites nominations for personnel in four areas: (1) one public representative; (2) one management representative; (3) one labor representative; and (4) one occupational safety professional representative. Nominations must be submitted by August 31, 2022.
  • On July 29, 2022, HRSA issued a notice entitled, Privacy Act; Systems of Records. The notice announces modifications to system of records 09-15-0055, “Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System”. Changes to the system include: (1) updates the system with HRSA Bureau’s current name (“Healthcare” Systems Bureau is now “Health” Systems Bureau); (2) expand the purpose description; (3) include four new categories of individuals; (4) clarify introductory language to specify that records must include all information needed for organ matching and placement and follow-up; and (5) add and revise routine uses authorizing disclosures to non-HHS parties. A full list of modifications can be found in the notice.
  • On July 29, 2022, HHS issued a notice entitled, Requests for Nominations: Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council is made up of at least 30 members. 16 spots will become vacant in calendar year (CY) 2023. Of the 16 spots, nine will be for voting member serving four-year terms and seven will be for non-voting liaison members appointed for two-year terms. The Advisory Council provides information and recommendations to HHS regarding programs and policies addressing antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Details on qualifications required for the nominees are listed in the notice. Nominations are due by September 19, 2022.
  • On July 29, 2022, CMS issued a final rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2023; etc. This final rule updates many provisions, including: (1) skilled nursing facility (SNF) payment rates; (2) the Patient Driven Payment Model (PDPM) parity adjustment; (3) the SNF Quality Reporting Program (QRP); and (4) the SNF Value-Based Purchasing (VBP) Program. The rule also creates a permanent cap policy to smooth the impact of year-to-year changes in SNF payments related to changes in the wage index as well as a risk adjustment factor for the SNF Readmission Measure for COVID-19 beginning in FY 2023. CMS also finalizes changes to the long-term care facility fire safety provisions and diet and nutrition provisions. This regulation is effective October 1, 2022.

Event Notices

  • August 23, 2022: CDC announced a partially open meeting for the Board of Scientific Counselors (BSC), National Center for Injury Prevention and Control (NCIPC). The open session agenda will include an update on NCIPC’s Motor Vehicle Injury Prevention Research Priorities and discussions on NCIPC’s new research priorities in Drowning Prevention Research. The closed session agenda will review and evaluate grant applications.
  • September 8, 2022: NIH National Institute on Alcohol Abuse and Alcoholism (NIAAA) announced a virtual meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The meeting will be closed to the public for the first hour to review and evaluate grant applications. The agenda for the open portion will include presentations and discussions on other business of the Council.

II. Congressional Hearings

U.S. House of Representatives

  • On July 27, 2022, the House Committee on Ways and Means held a markup entitled, Improving Seniors Timely Access to Care Act of 2022. The committee considered this bill on Medicare Advantage plans and prior authorization requirements. H.R. 8487, the Improving Seniors Timely Access to Care Act of 2022, as amended, was ordered favorably reported to the House of Representatives.

U.S. Senate

  • On July 26, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Fighting Fentanyl: The Federal Response to a Growing Crisis. Witnesses present included: Miriam E. Delphin-Rittmon, Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA); Carole Johnson, Administrator, HRSA; Christopher Jones, Acting Director, National Center for Injury Prevention and Control (NCIPC), CDC; and Kemp Chester, Senior Policy Advisor for Supply Reduction and International Relations, Office of National Drug Control Policy (ONDCP), the White House.

III. Reports, Studies & Analyses

  • On July 25, 2022, the Congressional Research Service (CRS) released a report entitled, State Laws Restricting or Prohibiting Abortion. This report provides an overview of existing or recently passed state laws prohibiting or limiting abortion prior to 24 weeks’ gestational age (which is considered the point of viability but may change given medical advancements) in light of the recent Supreme Court decision Dobbs v. Jackson Women’s Health Organization which overruled Roe v. Wade. The report also discusses “trigger laws” which also restrict abortion and go into effect following the overturning of Roe.
  • On July 27, 2022, the Government Accountability Office (GAO) released a report entitled, Older Adults and Adults with Disabilities: Federal Programs Provide Support for Preventing Falls, but Program Reach is Limited. As falls were the leading cause of death from unintentional injury among older adults in 2020, GAO examined (1) what federal programs provide falls prevention, home assessments, or home modifications for older adults and adults with disabilities, (2) what federal agencies know about how participants’ outcomes, and (3) how federal agencies coordinate their efforts and provide consumer information to those at risk of falls. GAO found that nine federal programs served a limited number of participants. The agency made three recommendations. It recommended CDC expand falls data to adults of all ages and that the Administration for Community Living (ACL) identify a collaborative mechanism to facilitate sustained information sharing across federal programs and disseminate information among its disability network to inform state and local planning efforts.
  • On July 27, 2022, the Kaiser Family Foundation (KFF) released an issue brief entitled, How Would the Prescription Drug Provisions in the Senate Reconciliation Proposal Affect Medicare Beneficiaries? This brief examines how the U.S. Senate Committee on Finance’s forthcoming reconciliation bill would impact Medicare beneficiaries. The legislation addresses longstanding and bipartisan concerns of high drug prices impeding health care affordability. Overall, the brief summarizes that the prescription drug provisions would reduce the federal deficit by $288 billion over 10 years, reduce out-of-pocket spending for beneficiaries, and limit increases in drug prices for Medicare and private insurers. It also recognizes arguments that the provisions may stifle innovation and increase launch prices.
  • On July 28, 2022, the HHS Office of the Inspector General (OIG) released a report entitled, Medicare Continues To Make Overpayments for Chronic Care Management Services, Costing the Program and Its Beneficiaries Millions of Dollars. OIG examined the extent to which CMS recovered Medicare overpayments in response to OIG audit reports. OIG verified that CMS collected $120 million of the $498 million in Medicare overpayments identified in OIG audit reports issued between October 2014 and December 2016. Of the $498 million, CMS reported that it collected $272 million and that it had not collected $226 million. However, only $120 million of the $272 million collected was sufficiently documented (the remaining $152 million was not). OIG recommended that CMS: (1) continue its efforts to recover the $226 million in uncollected overpayments, (2) account for the $152 million that was collected, (3) revise regulations accordingly, and (4) develop a plan for resolving cost reports.
  • On July 28, 2022, KFF released a report entitled Insulin Out-of-Pocket Costs in Medicare Part D. The study found that in the aggregate, Part D enrollees out-of-pocket spending on insulin quadrupled between 2007 and 2020, totaling nearly $1 billion in 2020 and an average of $54 per insulin product. The report estimated that if insulin copays were capped at $35 as proposed in recent legislation, Part D enrollees would save an average of $19 or 35 percent per insulin prescription.

IV. Other Health Policy News

  • On July 25, 2022, HHS announced a proposed rule implementing Section 1557 of the Affordable Care Act (ACA) (Section 1557) that prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in federally funded health programs and activities. The proposed rule affirms protections against discrimination on the basis of sex, sexual orientation, and gender identity and for seeking reproductive health care services. Provisions of the rule include: (1) clarification that the nondiscrimination requirements apply to health insurance issuers that receive federal financial assistance (including Medicare Part B), (2) inclusion of “pregnancy termination” as a prohibited basis for discrimination, (3) requirements for staff training on the provision of language assistance services, and more. More information on this announcement can be found here.
  • On July 26, 2022, HHS announced the agency’s approval to extend of Medicaid and CHIP coverage from 60 days to 12 months after pregnancy in Connecticut, Massachusetts, and Kansas. As a result, up to an additional 19,000 people annually will now have extended coverage. These states now join California; Florida; Illinois; Kentucky; Louisiana; Maine; Michigan; Minnesota; New Jersey; New Mexico; Oregon; South Carolina; Tennessee; Virginia; Washington state; and Washington, D.C. in efforts to address the maternal morbidity and mortality crisis in the U.S. More information on this announcement can be found here.
  • On July 26, 2022, HHS Office of the Assistant Secretary for Health (OASH) announced its investment of $8.5 million in initiatives designed to reduce pregnancy-related deaths and complications that disproportionately impact minority populations and those living in rural areas. Specifically, OASH announced winners of the HHS Racial Equity in Postpartum Care Challenge and three new funding opportunities. More information on this announcement can be found here.
  • On July 26, 2022, CMS unveiled its Maternity Care Action Plan to improve health outcomes and reduce inequities for people during pregnancy, childbirth, and the postpartum period. This program will support the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis and other CMS actions, such as the extension of Medicaid and CHIP coverage, efforts to ensure full access to reproductive health care services, and the proposal for a “Birthing-Friendly” hospital designation to be made public on the CMS website. More information on this announcement can be found here.
  • On July 27, 2022, HRSA announced the availability of nearly $15 million to grow the nursing workforce, improve access to nursing education, and advance health equity. The $15 million will be distributed across two funding opportunities for: (1) a new initiative in the nursing preceptor workforce and (2) initiatives to increase the number of nursing students in acute care settings for training on social determinants of health. More on this announcement can be found here.
  • On July 28, 2022, HHS, with the Departments of Labor (DOL) and of the Treasury, clarified that most private health plans are required to provide birth control coverage and family planning counseling at no cost under the ACA. This guidance reiterated the agencies’ enforcement policies and is part of the Biden-Harris Administration’s commitment to ensuring accessible reproductive health care. More on this announcement can be found here.
  • On July 28, 2022, HHS announced its plan to allocate an additional 786,000 doses of the JYNNEOS vaccine, increasing the supply of monkey pox vaccine doses to states and jurisdictions to nearly 1.1 million. In addition to vaccines, the Administration is working to increase testing capacity and bolster public health education and prevention strategies. More on this announcement can be found here.
  • On July 29, 2022, HHS announced an agreement to purchase 66 million doses of Moderna’s bivalent COVID-19 vaccine booster candidate for potential use in the fall and winter. These doses can specifically target the BA.4 and BA.5 Omicron subvariants. This agreement follows the government’s recent purchase of 105 million bivalent COVID-19 vaccine boosters from Pfizer. The purchases are efforts to combat the highly dynamic COVID-19 virus and ensure Americans have access to the most protective vaccines. Due to the lack of additional COVID-19 funding from Congress, earlier this month, the Administration pulled $10 billion from other COVID-19 response efforts in order to pay for these additional vaccines and treatments. More on this announcement can be found here.

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