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 released a proposed rule that aims to streamline the enrollment process for Medicaid, CHIP, and the Basic Health Program (BHP), and HHS awarded $79.1 million in funding for overdose prevention grants. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On August 30, 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a request for information (RFI) entitled, Request for Information: SAMHSA's Role in Possible Agency Actions Regarding Mental Health and Substance Use Wellbeing in the Context of Climate Change and Health Equity. SAMHSA is seeking input from members of the public about how it can best address the behavioral health impacts of climate change and health equity considerations. Behavioral health includes mental health conditions and substance use disorders (SUDS). SAMHSA specifically seeks input on suggested priorities, resources, partners, and collaborating agencies and organizations. Comments on this RFI must be received by October 31, 2022.
- On August 31, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Secretarial Review and Publication of the 2021 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement. This notice acknowledges the HHS Secretary’s receipt and review of the National Quality Forum (NQF) 2021 Annual Activities Report to Congress. This notice also includes comments from the HHS Secretary regarding the NQF report.
- On August 31, 2022, HHS issued an RFI entitled, Request for Information and Comments on the 2005 Public Health Service Policies on Research Misconduct. HHS’ Office of Research Integrity (ORI) seeks the perspectives of individuals, research funding agencies, institutional officials, organizations, institutions, and other members of the general public on the 2005 Public Health Service Policies on Research Misconduct to help structure ORI’s future plans to revise the regulation. To this end, ORI is issuing this RFI to collect input on the current regulation. Responses to the RFI must be received electronically no later than 5:00 p.m. ET on October 31, 2022.
- On August 31, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Streamlining the Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes. This rule proposes changes to simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, the Children’s Health Insurance Program (CHIP), and the Basic Health Program (BHP). This proposed rule aims to remove barriers and facilitate enrollment of new applicants, particularly those dually eligible for Medicare and Medicaid; align enrollment and renewal requirements for most individuals in Medicaid; establish beneficiary protections related to returned mail; create timeliness requirements for redeterminations of eligibility in Medicaid and CHIP; make transitions between programs easier; eliminate access barriers for children enrolled in CHIP by prohibiting premium lock-out periods, waiting periods, and benefit limitations; and modernize recordkeeping requirements to ensure proper documentation of eligibility and enrollment. Comments are due no later than November 7, 2022.
- October 4-5, 2022: HHS announced a public meeting of the Tick-Borne Disease Working Group (TBDWG). For this meeting, the TBDWG will (1) review the final draft of chapters for the group’s tickborne activities and research report and (2) further discuss plans for developing the next report to the HHS Secretary and Congress on federal tickborne activities and research, taking into consideration the 2018 and 2020 report.
- October 20, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH) under the National Institute for Occupational Safety and Health (NIOSH). The agenda will include discussions on the following: Work Group and Subcommittee reports; an update on the status of Special Exposure Cohort (SEC) petitions; and plans for the December 2022 Advisory Board Meeting.
- October 20, 2022: The Food and Drug Administration (FDA) announced a public meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the AvertD Test sponsored by SolvD, Inc.
- October 24, 2022: CDC announced a public meeting of the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The meeting agenda will include an update by the NCHS Director, in addition to updates on NCHS data collection, analysis, and reporting activities, including upcoming changes to the National Hospital Ambulatory Medical Care Survey (NHAMCS); status of a National Ambulatory Medical Care Survey (NAMCS) pilot and plans for obtaining clinician visit data; a new project to improve metadata and catalogs for the public to access restricted use data files; and new releases of linked data sets.
- October 26, 2022: FDA announced a public meeting of the Cardiovascular and Renal Drugs Advisory Committee. The Committee will discuss new drug application (NDA) 216951, for the hypoxia inducible factor prolyl hydroxylase inhibitor, daprodustat tablets, submitted by GlaxoSmithKline, LLC, for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis.
- October 28, 2022: FDA announced a public meeting of the Oncologic Drugs Advisory Committee During the meeting, the Committee will discuss biologics license application 761176, for I-omburtamab solution for injection, submitted by YmAbs Therapeutics, Inc. The proposed indication (use) for this product is for the treatment of neuroblastoma with central nervous system/leptomeningeal metastases.
- November 8, 2022: FDA announced a public meeting of the Pulmonary-Allergy Drugs Advisory Committee. The Committee will discuss the new drug application 214070, for a fixed dose combination of budesonide and albuterol sulfate metered dose inhaler, submitted by AstraZeneca and Bond Avillion 2 Development LP. The proposed indication is as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
II. Reports, Studies & Analyses
- On August 31, 2022, Alston & Bird published another edition of its Healthy Byte series entitled, How Could RTM Code Changes Impact Health Care Professionals? Alston & Bird’s Sean Sullivan and Tania Khan discuss CMS’ 2023 Medicare Physician Fee Schedule (PFS) proposed rule, which intends to replace two previously finalized remote therapeutic monitoring codes (RTM) from the 2022 final rule, with four new codes. The replacement codes are intended to clear up confusion caused by the original codes around treatment management and who can perform clinical labor. Sean Sullivan and Tania Khan highlight the changes to the RTM codes, and the potential benefits and possible downsides for providers and clinical staff.
- On August 31, 2022, the HHS Office of the Inspector General (OIG) published a report entitled, The Health Resources and Services Administration Should Improve Its Oversight of the Cybersecurity of the Organ Procurement and Transplantation Network. OIG aimed to determine whether the Health Resources and Services Administration (HRSA) implemented selected cybersecurity controls over the Organ Procurement and Transplantation Network (OPTN) to protect the confidentiality, integrity, and availability of transplant data, in accordance with federal requirements. OIG found that HRSA could improve its oversight of United Network for Organ Sharing (UNOS) to ensure that UNOS performs adequate reviews of local user access of the OPTN, and that certain key cybersecurity policies and procedures were finalized and in place.
- On September 1, 2022, the Congressional Research Service (CRS) published a report entitled, Selected Health Provisions of the Inflation Reduction Act. The report provides an overview of many of the key provisions in the Inflation Reduction Act, including Medicare prescription drug price negotiation, Medicare Parts B and D drug inflation rebates, Medicare insulin caps, and premium tax credits.
- On September 2, 2022, HHS OIG published a report entitled, HHS Did Not Fully Comply With Federal Requirements and HHS Policies and Procedures When Awarding and Monitoring Contracts for Ventilators. OIG’s objective was to determine whether the Administration for Strategic Preparedness and Response (ASPR) awarded and monitored contracts for the production of ventilators in accordance with federal requirements and HHS policies and procedures. OIG found that ASPR did not consistently award and monitor contracts for ventilators for use in responding to the COVID-19 pandemic in accordance with federal requirements and HHS policies and procedures. Specifically, OIG found that ASPR did not establish roles and responsibilities for communication with other emergency response teams, did not always accurately report contract data, and did not always properly monitor contractor performance.
III. Other Health Policy News
- On August 29, 2022, HHS announced investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis. The funding aims to help reduce disparities in maternal and birth outcomes, expand and diversify the workforce caring for pregnant and postpartum individuals, increase access to obstetrics care in rural communities, and support states in tackling inequities in maternal and infant health. The awards will be distributed by HRSA. The awards are designed to support state-led maternal health innovation, improve maternal care in rural communities, increase access to community-based doulas, and address infant mortality. More information on this funding can be found here.
- On August 29, 2022, HHS announced it will provide approximately $11 million to support the first U.S.-based fill and finish manufacturing of JYNNEOS – a vaccine approved to prevent smallpox and monkeypox – at Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, Michigan. The funding will allow for the purchase of additional equipment necessary for JYNNEOS production and the recruitment and training of additional staff to operate the line. Vaccine production at this facility is expected to be underway later in 2022, which is months quicker than is typical for similar projects. More information on this action can be found here.
- On August 30, 2022, CMS announced that it had found that the Medicare Shared Savings Program (MSSP) saved Medicare money while not sacrificing quality of care. CMS found that the program saved Medicare $1.66 billion in 2021 compared to spending targets, which marked the fifth consecutive year the program has generated overall savings and high-quality performance results. CMS expressed that it was encouraged with its findings because they support CMS’ goal to have 100 percent of beneficiaries with Traditional Medicare in an accountable care relationship by 2030. More information on this announcement can be found here.
- On August 31, 2022, HHS announced the awarding of $79.1 million in funding for overdose prevention grants, which will be distributed through SAMHSA. This funding comes as part of the Biden Administration’s efforts to combat the nation’s mental health and substance use crisis, which has seen more than 107,000 Americans die from drug overdoses in 2021, an increase of more than 15 percent from 2020. Funds will be divided amongst a number of programs and grants. These awards include funding to support the First Responders-Comprehensive Addiction and Recovery Support Services Act, which provides resources to first responders so they can carry and administer opioid reversal drugs. Additionally, grants will be given to support emergency medical services (EMS) in rural areas and to train graduate-level students entering medical professions in how to treat patients with opioid use disorders (OUD). Funds will also be allocated to expand access to medications for opioid use disorder (MOUD), as well as to treat pregnant and postpartum women who need substance-use treatment services. More information on this funding can be found here.
- On September 1, 2022, HHS announced that it awarded $40.22 million in youth mental health grants throughout the month of August. This includes $5.3 million from American Rescue Plan (ARP) Act funding intended to address pandemic-related stressors that have increased mental health conditions among younger Americans. HHS also announced $47.6 million in new grant funding opportunities developed from the Bipartisan Safer Communities Act. The grants awarded in August and the grant opportunities announced on September 1, 2022 are part of HHS’ latest effort to answer President Biden’s State of the Union call to address the nation’s mental health crisis, including its impact on children. More information on this funding can be found here.
- On September 2, 2022, HHS announced $2 million in funding to the American Academy of Pediatrics (AAP) to establish a National Center of Excellence on Social Media and Mental Wellness. The purpose of the Center is to develop and disseminate information, guidance, and training on the impact—including risks and benefits—that social media use has on children and young people, especially the risks to their mental health. It will also examine clinical and social interventions that can be used to prevent and mitigate the risks. The Center will focus on three priorities: 1) education and resources around the risks and benefits of social media use for children and youth; 2) culturally and linguistically appropriate technical assistance focusing on active learning, consultation, and support on how to best assist children and youth when interfacing with the digital world in a way that enhances their mental health while reducing harm; and 3) best practices and research updates. More information on this funding can be found here.
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