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, CMS issued a final rule to establish a Medicare special enrollment period for beneficiaries who missed a typical enrollment period and HHS announced that more than 50 percent of states have expanded access to 12 months of Medicaid and CHIP postpartum coverage. Read about these actions and other news below.
I. Regulations, Notices & Guidance
- On October 26, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Rare Disease Endpoint Advancement Pilot Meeting Program. FDA is announcing the Rare Disease Endpoint Advancement Pilot Meeting Program (RDEA Pilot Program) established under the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022. The program affords sponsors who are admitted into the RDEA Pilot Program additional engagement opportunities with the Agency to discuss efficacy endpoint development in rare disease drug and biological product development programs. Meetings under the program will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years (FYs) 2023 to 2027. For each sponsor whose RDEA program proposal (RDEA proposal or proposal) is admitted into the program, up to four meetings providing an opportunity for medical product developers to discuss rare disease endpoint development will be held between the sponsor and CDER or CBER. To promote innovation and evolving science, novel endpoints developed through the RDEA Pilot Program may be presented by FDA (e.g., in a guidance or public workshop or on a public-facing website) as case studies, including novel endpoints for drugs that have not yet been approved or biological products that have not yet been licensed by FDA for a given indication.
- On October 27, 2022, FDA issued draft guidance entitled, Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention; Draft Guidance for Industry; Availability. The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). Specifically, this guidance addresses FDA’s current thinking regarding clinical trial design considerations such as trial populations and efficacy endpoints for treatment of CDI, reduction of recurrence, and prevention.
- On October 28, 2022, FDA issued a notice entitled, Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement. FDA is announcing the opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products under an investigational new drug (IND) application, where warranted, based upon the anticipated clinical benefit of earlier patient access to the products. FDA is implementing this pilot program to facilitate CMC readiness for selected CBER and CDER regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable.
- On October 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and other Revisions to Medicare Enrollment and Eligibility Rules. This final rule implements certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, CMS is proposing to delete references to specific Medicare forms from the text of existing regulations at §§ 406.7 and 407.11 in order to provide greater administrative flexibility. Finally, this final rule updates the various federal regulations that affect a state’s payment of Medicare Part A and B premiums for beneficiaries enrolled in the Medicare Savings Programs and other Medicaid eligibility groups.
- On October 28, 2022, CMS issued a notice entitled, Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Extension of Timeline to Finalize a Rulemaking. On November 1, 2018, CMS published a proposed rule, Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021, that would revise the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) regulations to improve program efficiency and payment accuracy. The proposed rule discussed CMS’ authority to extrapolate in the recovery of RADV overpayments, starting with payment year 2011 contract-level audits; and not apply a fee-for-service (FFS) adjuster to the RADV overpayment determinations. This notice announces an additional 3 month extension of the timeline for publication of the final rule.
Event Notices
- November 3, 2022: The National Institutes of Health (NIH) announced a public meeting of the Advisory Committee to the Director (ACD). The meeting agenda will include a discussion of a new framework for peer review criteria, consideration of the proposed establishment of ACD working groups, and other business of ACD.
- November 17, 2022: FDA announced a public workshop entitled, Quantitative Brain Amyloid PET Imaging in Patients with Alzheimer’s Disease. The purpose of the public workshop is to evaluate the role of quantitative positron emission tomography (PET) measures of amyloid deposition in the brain in clinical trials and clinical use in patients with suspected or confirmed Alzheimer’s disease. The workshop will provide an overview of clinical and investigational uses of brain amyloid PET imaging, the regulatory history of marketed imaging drug products and devices for amyloid quantitation, clinical pharmacology of tracers, quantitation methodology, metrics and analytical validity, and use of quantitative amyloid in clinical trials with perspectives from industry, trade and professional organizations, academic investigators, and patient advocacy groups.
- November 29-December 1: CMS announced public meetings to discuss the Healthcare Common Procedure Coding System (HCPCS). The meetings are being held to discuss CMS’ preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set.
- December 4-5, 2022: NIH announced a public meeting of the Board of Scientific Counselors (BSC) for the National Institute of Environmental Health Sciences (NIEHS). The meeting agenda will include a meeting overview and a number of question-and-answer sessions featuring various NIEHS working groups.
- December 5-6, 2022: NIH announced a public meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Advisory Board on Medical Rehabilitation Research (NABMRR). The meeting agenda will include a report from the NICHD director, and reports from a number of other stakeholders including the NABMRR Research Infrastructure Working Group.
- December 8, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH). The agenda will include the following: NIOSH program update; Department of Labor (DOL) program update; Department of Energy (DOE) program update; Special Exposure Cohort (SEC) petitions update; procedures review finalization/document approvals; Rocky Flats Plant Work Group update; and an update on review of SEC-00256 Pinellas Plant Evaluation Report.
- December 13, 2022: CDC announced a public meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussions on: electronic data systems for overseas medical evaluations; tuberculosis (TB) commercial diagnostics; TB screening in the Uniting for Ukraine response; CDC electronic directly observed therapy recommendations; and the TB Elimination Alliance.
II. Reports, Studies & Analyses
- On October 25, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report entitled, Payments Made to Providers Under the Covid-19 Accelerated and Advance Payments Program Were Generally in Compliance with the CARES Act and Other Federal Requirements. CMS can provide temporary relief loans through the accelerated payment program for certain Part A providers and through the advance payment program for certain Part B providers and suppliers when those providers and suppliers face cashflow challenges due to circumstances beyond their control. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which Congress passed on March 27, 2020, expanded these programs to more providers to relieve pandemic-caused financial strain through the COVID-19 Accelerated and Advanced Payments (CAAP) Program. OIG’s objective was to determine whether CAAP Program payments were made to providers in compliance with the CARES Act and other federal requirements. OIG found that CMS generally made CAAP Program payments to providers in compliance with the CARES Act and other federal requirements, which led them to offer no recommendations for improvement.
- On October 26, 2022, HHS OIG published a report entitled, CMS Generally Ensured That Medicare Part C and Part D Sponsors Did Not Pay Ineligible Providers for Services to Medicare Beneficiaries. OIG conducted a nationwide audit of Medicare Part C encounter data and Part D prescription drug event (PDE) data to identify ineligible providers associated with the data submitted to CMS by Part C and Part D sponsors. OIG’s objective was to determine whether CMS oversight of Medicare Part C and Part D sponsors ensured compliance with federal requirements for preventing payments for Medicare services to ineligible providers. OIG found that CMS generally ensured that sponsors complied with federal requirements, although some sponsors submitted encounter and PDE data to CMS indicating that ineligible providers rendered services and wrote prescriptions for Medicare beneficiaries. OIG recommended that CMS direct Part C and Part D sponsors to ensure that only eligible providers receive payments for Medicare services and that CMS strengthen its oversight of sponsors and provider identifiers to prevent deactivated and deceased providers from receiving payments for Medicare services.
- On October 26, 2022, the Kaiser Family Foundation (KFF) published a report entitled, How Does the ACA Expansion Affect Medicaid Coverage Before and During Pregnancy? In this report, KFF used Medicare claims data for women with a live birth in 2019 to examine whether Medicaid’s expansion helps women enroll earlier in the months leading up to pregnancy and childbirth. KFF found that women in Medicaid expansion states were more than twice as likely to be enrolled in Medicaid prior to becoming pregnant compared to women in non-expansion states. KFF also found that women in non-expansion states were also more likely to enroll in Medicaid later in their pregnancy than women in expansion states.
- On October 27, 2022, the Government Accountability Office (GAO) published a report entitled, Behavioral Health: Available Workforce Information and Federal Actions to Help Recruit and Retain Providers. This report describes: (1) available information on the behavioral health workforce; (2) key barriers to and incentives for recruiting and retaining behavioral health providers; and (3) HHS agencies’ actions to support recruiting and retaining behavioral health providers. GAO identified low reimbursement rates, lack of workforce diversity, and lack of qualified supervisors as barriers to recruiting and retaining behavioral health providers. GAO found that incentives such as loan repayment and scholarships for students seeking behavioral health professions help to address these barriers. GAO also found that HHS agencies have taken actions to support recruiting and retaining behavioral health providers. These actions include administering various workforce development programs to help recruit and retain qualified providers to work in underserved and mental health shortage areas.
- On October 27, 2022, the Bipartisan Policy Center (BPC) published a report entitled, Improving and Strengthening Employer-Sponsored Insurance. 58.1 percent of non-elderly Americans (158 million people) receive health care benefits through their employers as of 2019, which makes employer-sponsored insurance (ESI) the nation’s largest source of health coverage. In this report, BPC explored strategies intended to strengthen ESI as it may be considered a reasonable way to address health care cost challenges. BPC recommended that policymakers increase transparency in the health care system and empower employers to help lower costs by giving them payment and pricing tools that would help create a higher value ESI system that prioritizes employee health outcomes. Also, BPC recommended that policymakers and other stakeholders address problems in the private health care market by equalizing market power dynamics to foster a more competitive ESI system. Finally, BPC recommended that policymakers consider other legislative and regulatory steps to make health insurance more affordable.
- On October 27, 2022, NIH published a report entitled, Annual Report to the Nation on the Status of Cancer. The Annual Report to the Nation on the Status of Cancer is a collaborative effort between the National Cancer Institute (NCI), NIH; CDC; the American Cancer Society (ACS); and the North American Association of Central Cancer Registries (NAACCR). The report highlights that overall cancer death rates continued to decline among men, women, children, and adolescents and young adults in every major racial and ethnic group in the United States from 2015 to 2019. The declines in death rates were steepest in lung cancer and melanoma (by 4 to 5 percent per year each) among both men and women. Death rates increased for cancers of the pancreas, brain, and bones and joints among men, and for cancers of the pancreas and uterus among women. Additionally, NIH found that from 2014 to 2018, new cases of cancer remained stable for men and children but increased for women, adolescents, and young adults.
III. Other Health Policy News
- On October 25, 2022, HHS announced that there were significant gains in health insurance coverage during the 2021 and 2022 HealthCare.gov Open Enrollment periods among populations with historically higher uninsured rates, such as Black and Latino consumers. Black consumers saw a 49 percent increase in enrollment from 2020, Latino consumers saw a 53 percent increase in enrollment from 2020, and American Indian and Alaska Native consumers saw a 32 percent enrollment increase from 2020. HHS attributed the higher insured rates to CMS’ substantial increase in funding for Marketplace outreach and education, as well as the enhanced and expanded premium tax credits made available by the American Rescue Plan (ARP). More information on this announcement can be found here.
- On October 26, 2022, CMS announced that consumers will be able to preview their health care coverage options and see the savings available to them in the 2023 Marketplace. It also announced that consumers will have a greater number of plan choices, but will see slightly higher premiums for 2023. The announcement highlighted that 92 percent of enrollees will have access to options from three or more insurance companies. Additionally, CMS touted that the Inflation Reduction Act (IRA), which was passed in August, will save thirteen million Americans an average of $800 per year on their health insurance. The Marketplace Open Enrollment Period on HealthCare.gov runs from November 1, 2022 to January 15, 2023. Consumers who enroll by midnight on December 15, 2022 can receive full year coverage that starts January 1, 2023. More information on this announcement can be found here.
- On October 27, 2022, HHS announced that more than half of all states have expanded access to 12 months of Medicaid and Children’s Health Insurance Program (CHIP) coverage after pregnancy. Georgia and Pennsylvania became the 25th and 26th states to expand postpartum coverage, resulting in over 57,000 additional individuals newly eligible for Medicaid or CHIP coverage for a full year after pregnancy. The option for states to add the expanded postpartum benefit was created in the American Rescue Plan Act. Additionally, CMS implemented an update in the “Maternal Health” section of Hospital Compare by releasing data that indicates if a hospital participates in a state or federal program designed to improve maternal and child health. More information on this announcement can be found here.
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