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 announced that there will be an increased number of Medicare beneficiaries in accountable care relationships in 2023, and took actions aimed at improving nursing home safety and transparency. Read more about these items and other news below.
I. Regulations, Notices & Guidance
- On January 17, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Draft Guidance for Industry; Availability. This guidance is intended to assist sponsors in identifying the optimal dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials, nor does it address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, microbiota, or cancer vaccines.
- On January 17, 2023, the Department of Health and Human Services (HHS) issued a final rule entitled, World Trade Center Health Program: Addition of Uterine Cancer to the List of World Trade Center-Related Health Conditions. In accordance with the World Trade Center (WTC) Health Program’s regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List of WTC-Related Health Conditions. This rule is effective on January 18, 2023.
- On January 19, 2023, FDA issued a final order entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions. FDA is classifying the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions 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 computerized behavioral therapy device for treating symptoms of gastrointestinal conditions’ classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
- On January 19, 2023, FDA issued a final order entitled, Medical Devices; Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye. FDA is classifying the intense pulsed light device for managing dry eye 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 intense pulsed light device for managing dry eye’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
- On January 19, 2023, FDA issued a final rule entitled, Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic Xray, Laser, and Ultrasonic Products. FDA is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. FDA is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation-emitting electronic products and medical devices.
- On January 19, 2023, FDA issued draft guidance entitled, Mpox: Development of Drugs and Biological Products; Draft Guidance for Industry; Availability. FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug and biological product development programs, with a focus on recommendations to support initiation of clinical trials. Preventive vaccines are not addressed in this guidance.
- February 6-7, 2023: The National Institutes of Health (NIH) announced a public meeting of the Fogarty International Center (FIC) Advisory Board. The meeting agenda will include an update and discussion of current and planned FIC activities.
- February 8, 2023: NIH announced a public meeting of the National Institute on Drug Abuse (NIDA) National Advisory Council on Drug Abuse (NACDA). The meeting agenda will include presentations and other NACDA business.
- February 9, 2023: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). The agenda will include presentations on the state of the WTC Health Program, research activities, and uterine cancer coverage. There will be a presentation and discussion about substantive amendments to the existing Policy and Procedures for Adding Non-Cancer Health Conditions to the List of WTC-Related Health Conditions.
- February 9-10, 2023: HHS announced a public meeting of the 2025 Dietary Guidelines Advisory Committee. The meeting agenda will include (1) review of operations for the Committee members, (2) overview of the proposed scientific questions identified by HHS and the Department of Agriculture (USDA) to be examined by the Committee, (3) presentations on the evidence-based approaches for reviewing the scientific evidence, and (4) plans for future Committee work.
- February 9-10, 2023: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The meeting agenda will include: (1) a presentation of the final evidence-based review report on the Krabbe disease condition nomination for possible inclusion on the Recommended Uniform Screening Panel (RUSP). Following this presentation, the ACHDNC expects to vote on whether to recommend adding Krabbe Disease to the RUSP; (2) an update by the ACHDNC Prioritization and Capacity workgroup; (3) a possible presentation from CDC’s Enhancing Data Driven Disease Detection in Newborns (ED3N) project; (4) a potential update on the HRSA-funded Newborn Screening Interoperability Programs; (5) a presentation on the Blueprint for Change, which outlines an agenda for advancing the system of services for children and youth with special health care needs; (6) workgroup updates; and (7) a potential update on the Duchenne muscular dystrophy condition nomination and a potential vote on whether to move it forward to full evidence-based review, which, depending on the strength of the evidence, could lead to a future recommendation to add the condition to the RUSP.
- March 7, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). The purpose of the meeting is to discuss the Mandatory Guidelines for Federal Workplace Drug Testing Programs; updates to the Electronic Chain of Custody Form (ECCF), updates from the Department of Transportation (DOT), the Nuclear Regulatory Commission (NRC), the Department of Defense (DOD), and FDA; and a presentation by Dr. Svante Vikingsson on Fentanyl and Opioids Pulse Study results.
- March 8, 2023: FDA announced a public workshop entitled, Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence. The public workshop is part of an agreement between the Duke-Margolis Center for Health Policy and FDA. The purpose of this public workshop is to discuss existing negative control methodologies for studies based on real-world data and to outline advantages and disadvantages of the use of negative controls for evaluating the safety and effectiveness of regulated medical products. Additionally, the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will propose projects to develop negative control methods and implement new tools for use in the Sentinel System, Biologics Effectiveness and Safety (BEST) System, and with federal partners.
- March 14, 2023: SAMHSA announced a public meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will provide information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
- March 28-29, 2023: FDA announced a public meeting of the Drug Safety and Risk Management (DSARM) Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC). The committees will discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.
II. Reports, Studies & Analyses
- On January 17, 2023, the Congressional Research Service (CRS) published a report entitled, Health Insurance Premium Tax Credit and Cost-Sharing Reductions. The report describes current law and applicable regulations and guidance, in regard to how the premium tax credit (PTC) and cost-sharing reduction (CSR) requirements apply Affordable Care Act (ACA) Marketplace beneficiaries in 2023. Specifically, the report describes PTC eligibility, the determination of required premium contributions and PTC amounts, Reconciliation of Advanced PTC credit payments, preliminary tax credit data, and PTC enrollment data. Further, the report explains the purpose of CSR requirements and provides detail on how each ACA Marketplace plan limits the total dollar amount an insured consumer will be required to pay out of pocket for use of covered services in a plan year.
- On January 17, 2023, the Bipartisan Policy Center (BPC) published a report entitled, Filling the Gaps in the Behavioral Health Workforce. With the U.S. currently experiencing a growing shortage of licensed behavioral health care specialists including psychiatrists, psychologists, and clinical social workers, BPC conducted this report to examine how policymakers can help fill gaps in the behavioral health workforce. In the report, BPC recommended that policymakers nurture a greater role for behavioral health support specialists (BHSSs)—peer specialists, community health workers, and paraprofessionals—in delivering nonclinical behavioral health services. BPC also recommended that policymakers augment the behavioral health care that patients receive by passing legislation to support networks that exist within communities to provide behavioral health services.
- On January 18, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, ASPR Could Improve Its Oversight of the Hospital Preparedness Program To Ensure That Crisis Standards of Care Comply With Federal Nondiscrimination Laws. OIG performed this assessment to determine whether the Administration for Strategic Preparedness and Response’s (ASPR’s) oversight of the Hospital Preparedness Program (HPP) could be improved to ensure recipients adopting Crisis Standards of Care (CSCs) comply with federal nondiscrimination laws. OIG found that although ASPR has taken steps to improve its oversight of the HPP by promoting the adoption of nondiscriminatory CSCs that comply with federal nondiscrimination laws, the agency could take other steps. OIG recommended that ASPR consider additional updates to HPP cooperative agreements to advance compliance with nondiscrimination laws. For example, the updates could help encourage recipients to engage with advocacy groups in decision making related to crisis care planning.
- On January 18, 2023, the Government Accountability Office (GAO) published a report entitled, Public Health Preparedness: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens. This report examines the extent to which HHS’s oversight framework for enhanced potential pandemic pathogen research is effective; and gaps that exist in HHS’s broader oversight of such research. In 2017, HHS developed an oversight policy (the Framework) that requires funding agencies to refer proposed research that is “reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens” to HHS for an additional review of associated risks and benefits. After its assessment, GAO found that HHS’s Framework does not fully meet the key elements of effective oversight identified in past work. For example, the Framework does not provide a standard to help funding agencies interpret what “reasonably anticipated” means. Thus, GAO encouraged HHS to work with HHS funding agencies to develop and document a standard for “reasonably anticipated” to ensure consistency in identifying research for departmental review that could be defined as reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens. GAO also recommended that HHS work with funding agencies to identify and share non-sensitive information with researchers, Congress, and the public about the departmental review process for research involving enhanced potential pandemic pathogens.
- On January 19, 2023, HHS OIG published a report entitled, More Than a Thousand Nursing Homes Reached Infection Rates of 75 Percent or More in the First Year of the COVID-19 Pandemic; Better Protections Are Needed for Future Emergencies. This report examines the extent to which nursing homes had residents who were diagnosed with COVID-19 or likely COVID-19, and the characteristics of nursing homes with extremely high infection rates. This is the second report in a series of three reports. The first report focused on the characteristics of Medicare beneficiaries in nursing homes who were diagnosed with COVID-19, and the third will feature specific challenges nursing homes faced during the COVID-19 pandemic and the strategies they used to deal with them. OIG found that more than 1,300 nursing homes had extremely high infection rates—75 percent or more— during case surges in the spring and fall of 2020. Also, for-profit nursing homes made up a disproportionate percentage of nursing homes with extremely high infection rates. OIG concluded that significant changes are needed in nursing home operations to better protect residents and prepare for future health emergencies.
- On January 19, 2023, HHS published a report entitled, Marking the 50th Anniversary of Roe: Biden-Harris Administration Efforts to Protect Reproductive Health Care. This report outlines the actions HHS has taken regarding reproductive health policy following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. HHS identified six key priorities in its efforts to protect and expand access to reproductive care, which include: (1) protecting access to abortion services; (2) safeguarding access to birth control; (3) protecting patient privacy; (4) promoting access to accurate information; (5) ensuring non-discrimination in healthcare delivery; and (6) advancing evidence-based decision-making at FDA. The report also emphasizes actions HHS has taken following Dobbs, such as issuing guidance to clarify protections for birth control coverage under the ACA and reaffirming the Biden Administration’s commitment to upholding the right to abortion in emergency settings under the Emergency Medical Treatment and Active Labor Act (EMTALA).
III. Other Health Policy News
- On January 17, 2023, HHS released the Biden Administration’s first-ever National Strategy to Advance Equity, Justice, and Opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) Communities. In coordination with the release, Biden Administration officials outlined the plans that 32 federal agencies will advance plans that build on the Biden Administration’s previous actions to promote safety and equity for AA and NHPIs. At the release, community leaders also discussed additional steps the federal government can take to address critical priorities for AA and NHPI communities, including data disaggregation, language access, and combatting anti-Asian hate. The White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) is also soliciting public feedback on the proposed federal agency plans. More information on this announcement can be found here.
- On January 17, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that over 13.2 million Medicare beneficiaries will be in an accountable care relationship for 2023, including in the Medicare Shared Savings Program (MSSP), the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, and the Kidney Care Choices (KCC) Model. CMS also noted that more than 700,000 health care providers and organizations will participate in at least one of the three aforementioned accountable care initiatives. For the MSSP specifically, the 456 participating ACOs and 10.9 million assigned beneficiaries represent a decrease in participants from 2022. However, CMS stated that they expect participation will increase in 2024 due to policies included in the calendar year (CY) 2023 Medicare Physician Fee Schedule (PFS) final rule. CMS included provisions in the PFS final rule that will assign an additional four million Medicare beneficiaries to the program in the coming years, while growing MSSP participation among providers in rural and underserved communities. In 2023, the ACO REACH Model will include 132 ACOs, and over 130,000 providers delivering care to more than two million Medicare beneficiaries. Finally, the KCC model will see an 87 percent increase in participating providers and a 62 percent increase in the number of beneficiaries in 2023. CMS’ announcement can be found here.
- On January 18, 2023, the Biden Administration announced that it was taking further actions to improve nursing home transparency, safety, quality, and accountability. CMS will reinforce safeguards against unnecessary administration of medications and treatments by conducting targeted, off-site audits to determine whether nursing homes are accurately assessing and coding individuals with a schizophrenia diagnosis. The use of antipsychotic medications among nursing home residents is an indicator of nursing home quality and used in a nursing home’s Five-Star rating; however, it excludes residents with schizophrenia. If a CMS audit identifies that a facility has a pattern of inaccurately coding residents as having schizophrenia, the facility’s Five-Star Quality Measure Rating on the Care Compare site will be negatively impacted. For audits that reveal inaccurate coding, CMS will downgrade the facility’s Quality Measure ratings to one star, which would subsequently drop their Overall Star Rating. Additionally, CMS will begin posting citations under dispute on Care Compare. With the aim to increase transparency of nursing home information, CMS will begin publicly displaying survey citations that facilities are disputing. Currently, when a facility disputes a survey deficiency, that deficiency is not posted to Care Compare until the dispute process is complete. This new information will begin appearing on Care Compare on January 25, 2023. More information on these actions can be found here.
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