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 request for information to gather public input on accessing health care, provider experiences, advancing health equity, and flexibilities provided during the COVID-19 public health emergency. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On September 6, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to serve on the Advisory Commission on Childhood Vaccines. This notice requests nominations for voting members to serve as Special Government Employees (SGEs) on the Advisory Commission on Childhood Vaccines (ACCV) to fill open positions. The ACCV advises the Secretary of HHS (Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP). Written nominations for membership on the ACCV will be received on a continuous basis.
- On September 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a Request For Information (RFI) entitled, Make Your Voice Heard: Promoting Efficiency and Equity Within CMS Programs. This RFI seeks public input on accessing healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency (PHE). Comments received in response to this RFI will be used to identify opportunities for improvement, encourage innovative, reduce burden, and increase efficiencies across CMS programs. Comments must be received by November 4, 2022.
- On September 7, 2022, the Food and Drug Administration (FDA) issued revised draft guidance entitled, General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products. This draft guidance will assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications, who are planning to conduct clinical studies in pediatric populations. Additionally, this guidance, once finalized, will assist investigators and Institutional Review Boards (IRBs) in the design, planning, and assessment of clinical studies in pediatric populations.
- On September 8, 2022, FDA issued final guidance entitled, Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products. To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. Specifically, FDA encourages applicants to include in their cover letters: (1) purposes of using RWD/RWE, (2) study designs using RWD to generate RWE, and (3) RWD sources used to generate RWE.
- On September 8, 2022, FDA issued draft guidance entitled, Statement of Identity and Strength--Content and Format of Labeling for Human Nonprescription Drug Products. This guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This guidance also provides recommendations on the inclusion of the drug product’s strength on the labeling. The recommendations are intended to help ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products.
- On September 8, 2022, FDA issued draft guidance entitled, Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products. This draft guidance is intended to assist industry in providing information in labeling about the quantities at which sodium, potassium, and phosphorus as constituents of active or inactive drug ingredients are present in human over-the-counter (OTC) and prescription drug products. There is currently no regulation requiring quantitative information specifically for sodium or potassium in prescription drugs, and this guidance will help provide information on quantities so healthcare providers and patients can account for the total amounts in a patient’s daily drug regimen.
- On September 8, 2022, HRSA issued a notice entitled, Notice of Intent to Make Temporary Changes in the State Title V Maternal and Child Health Block Grant Allocations. This notice announces HRSA’s response to comments and its plan to move forward in implementing temporary changes to the method of calculating poverty-based allocations under Title V of the Social Security Act for HRSA’s State Title V Maternal and Child Health (MCH) Services Block Grant, beginning in Fiscal Year (FY) 2023. Since FY 2017, the poverty-based allocation has been based on the U.S. Census Bureau’s 3-year American Community Survey (ACS) estimates using three pooled 1-year estimates. However, due to the COVID-19 pandemic, there were disruptions in the ACS data collection and the ACS 2020 experimental estimates were excluded from calculating the Block Grant allocations. This notice announces that the FY 2023 funding allocation will be based on the same poverty data used in the FY 2022 allocation, FY 2024 and 2025 will be use the previous three 1-year estimates while skipping 2020.
- September 13-14, 2022: The National Institutes of Health (NIH) announced a partially open meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). The open sessions agendas will include discussions of program policies and issues as well as NAEHSC discussions. The closed session agenda will include review and evaluation of grant applications.
- October 3, 2022: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The meeting will bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
- October 6, 2022: FDA announced a public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The committee will discuss the request for Emergency Use Authorization (EUA) 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. A focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population.
- October 19-20, 2022: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Community Preventive Services Task Force (CPSTF). The agenda will consist of deliberation on systematic reviews of literature on topics including mental health; nutrition, physical activity, and obesity; social determinants of health; and substance use.
- November 9-10, 2022: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. The agenda also includes presentations and CLIAC discussions on: (1) the clinical and public health response to the monkeypox outbreak, (2) efforts to address public health and clinical laboratory workforce challenges, and (3) reports from the CLIA Regulations Assessment Workgroup and the CLIA Certificate of Waiver and Provider performed Microscopy Procedures Workgroup.
II. Reports, Studies & Analyses
- On September 6, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, The Landscape of School-Based Mental Health Services. Children and adolescents are experiencing increasing rates of poor mental and emotional health. Recent policy measures, such as the Bipartisan Safer Communities Act and the American Rescue Plan Act, provide pathways to support school-based mental health services. This issue brief outlines the landscape of school-based mental health services, including services offered, provider types, funding sources, changes during the COVID-19 pandemic, barriers to access, and recent policy initiatives to address school-based mental health services. The authors note that although 96 percent of public schools report offering at least one type of mental health service for students, utilization of the services remains unclear. 33 percent of schools reported they do not believe they effectively provided mental health services in the 2021-2022 school year; only 12 percent strongly agreed, and 44 percent moderately agreed. Barriers to providing school-based services included insufficient staff coverage, inadequate funding, concerns about reactions from parents and stigmatizing students, and a lack of community support for providing services.
- On September 6, 2022, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), published a report entitled, Reducing Medicare's Payment Rates for Intermittent Urinary Catheters Can Save the Program and Beneficiaries Millions of Dollars Each Year. A 2018 report by the Medicare Payment Advisory Commission (MedPAC) found that Medicare paid substantially more than commercial payers for intermittent urinary catheters and recommended that Medicare incorporate such items into its competitive bidding program, to reduce rates. In this report, OIG evaluated claims from fiscal year (FY) 2020 to compare the suppliers’ acquisition costs to Medicare payment amounts. OIG found that Medicare Part B and its beneficiaries paid $407 million for all intermittent urinary catheters while suppliers paid only $121 million to acquire them, meaning Medicare payments were 3.4 times suppliers' acquisition costs. OIG recommended that CMS lower Medicare's payment rates for intermittent urinary catheters while ensuring beneficiaries retain access to them.
- On September 7, 2022, OIG released a data brief entitled, Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks. This data brief describes providers' billing for telehealth services and identifies ways to safeguard Medicare from fraud, waste, and abuse; it is part of a series that examines the use of telehealth in Medicare and identifies program integrity concerns. In its investigation, OIG identified 1,714 providers whose billing for telehealth services during the first year of the pandemic met at least 1 of 7 measures to identify types of billing for Medicare services that may indicate fraud, waste, or abuse. The agency calls for further scrutiny of the identified providers as well as for strong, targeted oversight of telehealth services. OIG recommends that CMS also: (1) provide additional education to providers on appropriate billing for telehealth services, (2) improve transparency of "incident to" services when clinical staff primarily delivered the telehealth service, and (3) identify telehealth companies that bill Medicare.
- On September 7, 2022, OIG released a data brief entitled, Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic. This data brief examines the dramatic increase of use of telehealth services and characteristics of beneficiaries during the first year of the pandemic; it is part of a series that examines the use of telehealth in Medicare and identifies program integrity concerns. OIG found that beneficiaries in urban areas and certain states, dually-eligible beneficiaries, Hispanic beneficiaries, younger beneficiaries, and female beneficiaries were more likely than others to use telehealth. Additionally, beneficiaries almost always used telehealth from home or non-health-care settings, and one-fifth used audio-only services. Using this data, OIG recommends that CMS, HHS, Congress, and other stakeholders consider permanent changes to Medicare telehealth services and balance concerns about access, quality of care, health equity, and program integrity. Specifically, OIG recommends that CMS: (1) take appropriate steps to enable a successful transition from current pandemic-related flexibilities to long-term policies, (2) extend the use of audio-only telehealth services and evaluate their impact, (3) identify audio-only telehealth services provided in Medicare, and (4) use telehealth to advance health equity.
- On September 7, 2022, the Congressional Budget Office (CBO) issued a cost estimate entitled, Estimated Budgetary Effects of Public Law 117-169, to Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14. CBO estimates that P.L. 117-169, Tax-Related Portions of the Inflation Reduction Act of 2022, will result in a net decrease in the deficit of $58.1 billion between 2022-2031, resulting from an increase in direct spending of $50.6 billion and an increase in revenue of $108.7 billion. The cost estimate also details the estimated increases and decreases of health-care specific provisions.
- On September 7, 2022, the Congressional Research Service (CRS) released a report entitled, Abortion Training for Medical Students and Residents. This report notes that the U.S. Supreme Court’s decision, Dobbs v. Jackson Women’s Health Organization, may have implications for medical training in states with restrictive abortion policies and in turn, have broader effects on access to abortion services. Students may seek training in areas where abortion is permitted which will increase costs for trainees and the programs. This report discusses the federal government’s role in paying for medical training and some options to assist programs with accommodating increased demand for training.
- On September 9, 2022, OIG released a report entitled, The IHS Telehealth System Was Deployed Without Some Required Cybersecurity Controls. OIG initiated this review to determine whether the Indian Health Service (IHS) implemented select cybersecurity controls to protect its national telehealth system. OIG found that although the telehealth system increased access to health care services during the COVID-19 pandemic, IHS did not implement certain IT controls prior to deploying the system, such as a risk assessment, a contingency plan, a finalized authorization to operate (ATO), or a system security plan. As such, IHS’ telehealth systems were susceptible to vulnerabilities and cybersecurity threats. OIG recommended that the IHS develop a strategy for identifying, implementing, and testing cybersecurity controls and that IHS implement policies and procedures to remediate known telehealth vulnerabilities in a timely manner.
III. Other Health Policy News
- On September 6, 2022, HHS announced a $19.8 million contract with AmerisourceBergen that allows the Strategic National Stockpile (SNS) to expand its distribution capacity to more locations nationwide that can be supported with direct federal shipments of vaccine and treatments for monkeypox. This distribution capability will also allow for significantly greater and more efficient distribution of vaccines and antiviral drugs to communities and at-risk individuals of contracting monkeypox. More on this announcement can be found here.
- On September 7, 2022, HHS Secretary Xavier Becerra signed a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the FDA Commissioner to issue EUAs for in vitro diagnostics to expand the availability of tests for monkeypox. The decision to expand the availability of tests for monkeypox aims to help communities respond to the ongoing public health emergency (PHE) declared on August 4, 2022. More on this announcement can be found here.
- On September 7, 2022, a federal district court in Texas ruled that mandatory pre-exposure prophylaxis (PrEP) coverage to prevent HIV infection violates the Religious Freedom Restoration Act (RFRA). The opinion, Braidwood Management Inc. v. Becerra, challenged: (1) the legality of the preventive-care mandates imposed by regulators under the Affordable Care Ac (ACA), but also (2) the legality of the U.S. Preventative Services Task Force (USPSTF) under the Appointments Clause of the Constitution. The USPSTF grades preventive services to be used by physicians in their medical decision making; it also issues recommendations that both commercial and public payers employ to support their coverage policies, that organizations use to rate quality of care, and that courts use to ascertain negligence and malpractice. The ACA built upon these grades to mandate plans cover preventative services receiving a certain grade with no cost-share to the beneficiary. More on this court ruling can be found here.
- On September 8, 2022, the U.S. Department of Homeland Security (DHS) issued a final rule applicable to noncitizens who receive or wish to apply for HHS and state benefits for low-income families and adults. The rule details how DHS will interpret the “public charge” ground of inadmissibility to ensure noncitizens can access health-related benefits and other government services, without triggering harmful immigration consequences. Under the “public charge” rule, immigrants who utilize government benefits may be denied visas or lawful permanent residence. Specifically, this rule ensures DHS will not penalize individuals who choose to access government benefits, including Medicaid, the Children’s Health Insurance Program (CHIP), or other health benefits. This rule will be effective December 23, 2022. More on this announcement can be found here.
- On September 8, 2022, CMS and the Consumer Financial Protection Bureau (CFPB) sent a letter to nursing homes and their debt collectors to urge them to examine their debt collection practices and ensure they comply with federal law that prohibits nursing homes from requiring family members or caregivers to guarantee payment for a resident’s nursing home stay. This letter follows a series of efforts by the Biden Administration to improve nursing home care for older Americans and people with disabilities, such as their initiation of a public input process for future rulemaking to improve staffing levels in nursing homes. More on this announcement can be found here.
- On September 8, 2022, HHS approved the extension of Medicaid and CHIP coverage for 12 months after pregnancy in Indiana and West Virginia. As a result, up to an additional 15,000 people annually in these two states will now be eligible for Medicaid or CHIP for a full year after pregnancy, joining previous expansion efforts in 23 other states and D.C. Extending access will help support safe pregnancies and childbirth, eliminate pregnancy-related health disparities, and improve maternal and child health outcomes. This extension of coverage was made possible by a new state plan authority established by the American Rescue Plan (ARP), under which states may extend postpartum coverage in their Medicaid and CHIP programs from the current mandatory 60-day period to 12 months. More on this announcement can be found here.
- On September 9, 2022, HHS released new data on the progress of the national 988 Suicide and Crisis Lifeline (988 Lifeline), a three-digit phone service that was formerly the National Suicide Prevention Lifeline. The data, when compared with data from August 2021, found: (1) a 45 percent increase in volume and (2) substantial improvements in answer rates and wait times over the first month of the implementation the 988 Lifeline. Specifically, in August 2022, the 988 Lifeline answered 152,000 more calls, chats and texts compared to August 2021 and decreased the average speed to answer calls, chats, and texts from 2.5 minutes to 42 seconds. HHS also announced a new Substance Abuse and Mental Health Services Administration (SAMHSA) grant opportunity to better support 988 Lifeline services in tribal communities. Additionally, throughout September, National Suicide Prevention Month, HHS will award $25.3 million in suicide prevention grants to address pandemic-related mental health concerns. More on this announcement can be found here.
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