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 announced the Enhancing Oncology Model (EOM) to improve cancer care and the House E&C Committee held a hearing on Medicare Advantage oversight. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On June 27, 2022, the Food and Drug Administration (FDA) issued a proposed rule entitled, Nonprescription Drug Product with an Additional Condition for Nonprescription Use. FDA is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.
- On June 27, 2022, FDA issued final guidance entitled, Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment; Guidance for Industry; Availability. This guidance is intended to facilitate the development of drugs and biologics for the adjuvant treatment of muscle-invasive bladder cancer and provides recommendations for the sponsor on this topic. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.
- On June 27, 2022, FDA issued final guidance entitled, Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment; Guidance for Industry; Availability. This guidance is intended to facilitate the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma and provides recommendations for the sponsor on this topic. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.
- On June 29, 2022, FDA issued a proposed rule entitled, General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma. FDA is proposing to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are post-amendments class III devices (product codes OYD and ONV, respectively), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “computer-aided devices which provide adjunctive diagnostic information about lesions suspicious for melanoma,” along with special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. If finalized, this order will reclassify these devices from class III to class II and the submission of a premarket approval application (PMA) for these devices will no longer be required, and instead the submission of a premarket notification (510(k)) will be required.
- On June 29, 2022, FDA issued draft guidance entitled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability. This guidance is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
- On June 30, 2022, FDA issued a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representatives may be self-nominated or may be nominated by a consumer organization.
- On June 30, 2022, the Department of Health and Human Services (HHS) issued draft guidance entitled, Use of a Single Institutional Review Board for Cooperative Research Draft Guidance. The guidance is intended primarily for institutions, institutional review boards (IRBs), investigators, institutional officials, and other human research protection staff. It is intended primarily to help entities implement the requirement for use of a single IRB for cooperative research. The guidance addresses questions about topics such as the definition of cooperative research and the responsibilities of reviewing IRBs pertaining to applicable state and local laws.
- On June 30, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs: Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital Conditions of Participation Updates. This proposed rule would establish conditions of participation that Rural Emergency Hospitals (REH) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to ensure that a high quality of care is furnished by REHs. This proposed rule also includes changes to the requirements a Critical Access Hospital (CAH) would have to meet to participate in the Medicare and Medicaid programs. Proposed payment policies and enrollment policies for REHs will be developed under separate rulemaking.
- On July 1, 2022, Centers for Disease Control and Prevention (CDC) issued a request for information (RFI) entitled, Manufacturers of Platforms for Nucleic Acid Amplification or Detection Suitable for Assay Development and Molecular Diagnostics for Detection of Agents that Cause Infectious Diseases. The agency intends to obtain information on available platforms for nucleic acid amplification or detection, which are used in many diagnostic tests. Rapid and accurate results that can specifically detect small amounts of pathogen material are essential to identifying and tracking diseases. The recent pandemic has demonstrated the need for tests that can be used in public health laboratories across the United States and internationally. Because the current diagnostic platform for nucleic acid detection that many CDC laboratories use will be retired in the future, CDC is interested in hearing from manufacturers regarding the availability of current and potential platforms that could support CDC’s overall diagnostics and surveillance.
- July 15, 2022: The National Institutes of Health (NIH) announced a public meeting of the NIH Clinical Center Research Hospital Board. The agenda will include NIH and Clinical Center (CC) leadership announcements, a CC CEO update and CEO status report on the 2019 CC Strategic Plan, a discussion on the role of the CC patient representative, patient survey data, and other business of the board.
- July 20-21, 2022: HHS announced a public meeting of the National Committee on Vital and Health Statistics (NCVHS). At this meeting, the Committee will receive updates from HHS officials, hold discussions on current health data policy topics, and discuss its work plan for the upcoming period. Specifically, the agenda will include updates from the Subcommittee on Standards on its June 2022 Listening Session on Standardization of Information for Burden Reduction and Post-Pandemic America (“Convergence 2.0”) and draft discussions; updates on developments on uptake of International Classification of Diseases, 11th Revision (ICD-11) and briefings on various data privacy, confidentiality, and security developments to inform the workplan; and updates on recent activities and upcoming plans from the Committee’s Workgroup on Sexual Orientation and Gender Identity/Social Determinants of Health Data (SOGI/SDOH). The Committee will reserve time for public comment toward the end of the agenda on both days.
- July 20-21, 2022: HHS announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The agenda will include a final review of draft recommendations on the ethical and regulatory considerations for the use of artificial intelligence in human subject’s research, consideration of the current HHS policy of engagement and the interpretation of HHS support in 45 CFR 46, and the Office for Human Research Protections (OHRP) Draft Guidance on Use of a Single Institutional Review Board for Cooperative Research.
- On July 25, 2022: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The agenda will include updates from federal workgroups on efforts undertaken in the last quarter and an overview of the NIH budget for Alzheimer’s disease and related dementias (ADRD) research. The research, clinical care, long-term services and supports, and risk reduction subcommittees will present recommendations and the Council will vote on adopting them.
- July 28, 2022: The Administration for Community Living (ACL) announced a public meeting of the President’s Committee for People with Intellectual Disabilities (PCPID). The agenda will include discussion of survey responses, a collective discussion of emerging issues facing people with intellectual disabilities, and the preparation of the PCPID Report to the President, including its proposed content and format, and related data collection and analysis required to complete the writing of the report.
- August 4, 2022: NIH announced a public meeting of the National Heart, Lung, and Blood Institute (NHLBI) Sleep Disorders Research Advisory Board. The agenda will include an update to the Advisory Board and public stakeholders on the progress of sleep and circadian research activities across NIH, and the activities of professional societies.
- August 10, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the National Advisory Council. The agenda will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of March 24, 2022; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meetings; and council discussions.
- August 17-18, 2022: CDC announced a public meeting of the National Institute for Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on 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; Update on Review of SEC-00188 Sandia Petition Addendum 2; Evaluation of Issues in the Use of General Area Air Sampling for Argonne National Laboratory–West Internal Dose Assessment; and a Board Work Session.
- August 30, 2022: SAMHSA announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The agenda will include consideration of minutes from the SAMHSA CSAT NAC meeting of April 27, 2022, a discussion with SAMHSA leadership, and a discussion on the Office of Recovery. It will also cover updates on CSAT activities from the Office of the Director (OD); the Division of Pharmacologic Therapies (DPT); the State Opioid Response Program (SOR); the Division of State and Community Assistance (DSCA); the Division of Services Improvement (DSI), and a discussion on Behavioral Health Workforce.
- October 13, 2022: NIH announced a public meeting of the National Library of Medicine Board of Scientific Counselors. The agenda will include reports from investigators, a program discussion, and the review and evaluation of personal qualifications, performance, and competence of individual investigators.
II. Congressional Hearings
U.S. House of Representatives
- On June 27, 2022, the House Committee on Oversight and Reform held a hearing entitled, Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis. Witnesses present included: Dr. Rahul Gupta, Director, Office of National Drug Control Policy (ONDCP), Executive Office of the President (EOP).
- On June 28, 2022, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Protecting America's Seniors: Oversight of Private Sector Medicare Advantage Plans. Witnesses present included: Erin Bliss, Assistant Inspector General, Office of Evaluation and Inspection, Office of Inspector General (OIG), HHS; Leslie Gordon, Acting Director, Health Care, Government Accountability Office (GAO); and Dr. James E. Mathews, Executive Director, Medicare Payment Advisory Commission (MedPAC).
- On June 29, 2022, the House Committee on Energy and Commerce Subcommittee on Health held a legislative hearing entitled, Investing in Public Health: Legislation to Support Patients, Workers, and Research. Witnesses present included: Kirsten Bibbins-Domingo, Professor of Epidemiology and Biostatistics and the Lee Goldman, M.D. Professor of Medicine, University of California, San Francisco; Dr. Kevin Croston, CEO, North Memorial Health; Tanika Gray Valbrun, Founder and President, The White Dress Project; Michael D. Shannon, Executive/President of Government Solutions, IPTalons, Inc.; Desiree Sweeney, CEO, NEW Health; and Dr. Leslie R. Walker-Harding, Chair Department of Pediatrics/Associate Dean, University of Washington; Chief Academic Officer/Senior Vice President, Seattle Children’s Hospital. Legislation considered by the Subcommittee included: H.R. 2007, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, H.R. 3773, thePediatricians Accelerate Childhood Therapies (PACT) Act of 2021, H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act, H.R. 5442, the Fix Nondisclosure of Influence in Health Research Act, H.R. 5478, the Protecting the Integrity of our Biomedical Research Act of 2021, H.R. 6305, the Protect America’s Biomedical Research Enterprise Act of 2021, H.R. 7565, the NIH Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone Act (NIH IMPROVE) of 2022, H.R. 7845, the NIH Clinical Trial Diversity Act of 2022, H.R. 8151, the Building a Sustainable Workforce for Healthy Communities Act, H.R. 8163, the Improving Trauma Systems and Emergency Care Act, and H.R. 8169, the Rural Telehealth Access Task Force Act.
- On June 29, 2022, the House Committee on Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing entitled, Privacy in the Age of Biometrics. Witnesses present included: Candice Wright, Director, Science, Technology Assessment, and Analytics, GAO; Dr. Charles H. Romine, Director, Information Technology Laboratory, National Institute of Standards and Technology; and Dr. Arun Ross, Professor, Department of Computer Science and Engineering, Michigan State University; Site Director, NSF Center for Identification Technology Research.
- On June 30, 2022, the House Committee on Appropriations Subcommittees on the Departments of Labor, Health and Human Services, Education, and Related Agencies and the Departments of Transportation, and House and Urban Development, and Related Agencies held a markup entitled, FY 2023 Transportation, and Housing and Urban Development, and Related Agencies; Labor, Health and Human Services, Education, and Related Agencies Appropriations Bills and Revised Report on the Suballocation of Budget Allocations for FY 2023. The Subcommittees considered the fiscal year (FY) 2023 Transportation, and Housing and Urban Development, and Related Agencies and the Labor, Health and Human Services, Education, and Related Agencies appropriations bills.
III. Reports, Studies & Analyses
- On June 27, 2022, OIG published a report entitled, An Estimated 91 Percent of Nursing Home Staff Nationwide Received the Required COVID-19 Vaccine Doses, and an Estimated 56 Percent of Staff Nationwide Received a Booster Dose. This report is the result of OIG assessing the COVID-19 vaccination status of 1,000 nursing home staff as of March 27, 2022. OIG estimated that 91 percent of staff nationwide had received the required vaccine doses, 56 percent of staff nationwide had received a booster dose, and 6 percent of staff nationwide had been granted a religious exemption.
- On June 27, 2022, GAO published a report entitled, Electronic Health Information: HHS Needs to Improve Communications for Breach Reporting. This report examines (1) the number of breaches and affected individuals reported to HHS since 2015; (2) the extent to which HHS established a review process to assess whether covered entities had implemented recognized security practices; and (3) the extent to which improvements can be made related to HHS’s breach reporting requirements. Based on its findings, GAO recommended that HHS establish a feedback mechanism to improve the effectiveness of its breach reporting process.
- On June 28, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Recent Trends in Mental Health and Substance Use Concerns Among Adolescents. The report examines the state of adolescent mental health and substance use in recent years, highlighting differences observed by sex, racial and ethnic groups, and sexual orientation. KFF found that deaths due to drug overdose among adolescents nearly doubled from 2019 (282 deaths) to 2020 (546 deaths). In the same time period, the largest increases in these deaths were among adolescent males (deaths more than doubled), as well as Black (deaths more than tripled) and Hispanic (deaths more than doubled) adolescents. The report also found an increased percentage of adolescents reported experiencing anxiety or depression in 2020 as compared to 2016.
- On June 28, 2022, the American Hospital Association (AHA) published the first section of a three-part report entitled, Strengthening the Health Care Workforce: Strategies for Now, Near, and Far. The report recognizes the urgency, severity, and national scope of health care workforce challenges. The first section, entitled Supporting the Team, examines the well-being of the workforce and considerations for hospital and health system leaders to improve best approaches and efforts in three areas: (1) burnout and general well-being of the workforce, (2) behavioral health of the workforce, and (3) workplace violence prevention. Stress, trauma, burnout, and behavioral health challenges among health care teams were exacerbated by the COVID-19 pandemic. Additionally, the report cites findings that reveal staff in health care and social services fields experience the highest rates of injury caused by workplace violence. Each of the three areas listed above describes opportunities and recommendations to enhance assessment, initiation and growth of workplace culture and principles, sustainability, and leadership.
- On June 29, 2022, OIG released a report entitled, The Food and Drug Administration’s Foreign For-Cause Drug Inspection Program Can Be Improved To Protect the Nation’s Drug Supply. The report was initiated to determine if FDA’s foreign drug inspection process has improved since programmatic changes were implemented in 2017. OIG inspected 132 total for-cause drug inspections, which FDA imitates when it has reason to believe as facility has serious quality problems or to evaluate if facilities have implemented corrections to previously identified violations. OIG found that FDA’s timeframes for foreign for-cause inspections generally improved after programmatic changes, that FDA did not always follow its policies and procedures through the foreign for-cause drug inspection process, and that FDA could not provide documentation to support that lead investigators completed required training to conduct the inspections. As such, OIG made several recommendations to improve timeliness, review investigators’ qualifications, conduct an analysis of individuals involved in the inspection process, and streamline the process for writing and reviewing the resulting Establishment Inspection Report.
- On June 30, 2022, the Congressional Budget Office (CBO) published a report entitled, Federal Subsidies for Health Insurance Coverage for People Under 65: 2022 to 2032. In this report, the latest in an annual series, CBO and the staff of the Joint Committee on Taxation (JCT) provided projections of health insurance coverage for people under age 65 and the federal costs of that coverage. Net federal subsidies for that coverage are projected to total $997 billion in 2022 and $1.6 trillion in 2032. Measured as a share of gross domestic product (GDP), the subsidies are an estimated 4.0 percent and 4.3 percent, respectively.
IV. Other Health Policy News
- On June 27, 2022, HHS announced a new model through the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) aimed at improving cancer care for Medicare patients and lowering health care costs. CMMI designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs. Building on the lessons learned from the Innovation Center’s Oncology Care Model (tested from July 1, 2016 – June 30, 2022), EOM is a voluntary model that will run for five years, from July 2023 through June 2028. Model participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer. More information on this announcement can be found here.
- On June 28, 2022, HHS announced an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox. The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aide their planning and response efforts. Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone. More information on this action can be found here.
- On June 30, 2022, HHS announced nearly $3 million in new funding to bolster training and technical assistance for the nationwide network of Title X family planning providers. HHS’ Office of Population Affairs is announcing two one-time supplemental awards. The Reproductive Health National Training Center (RHNTC) will receive $2 million to support Title X grantee staff and the National Clinical Training Center for Family Planning (NCTCFP) will receive $750,000 to support Title X clinical service providers. The awards will help Title X grantees increase training and technical assistance to address the challenges that the recent Supreme Court decision may have on their Title X Family planning service delivery. More information on this funding can be found here.
- On July 1, 2022, HHS announced over $155 million in awards to expand training for primary care residents in underserved and rural communities. As part of President Biden’s Unity Agenda to address the nation’s mental health crisis, these awards from the Health Resources and Services Administration (HRSA) will be distributed to 72 health centers that operate primary care medical and dental residency programs that include high need specialties such as psychiatry, to meet the needs of historically underserved communities with a stronger workforce. Specifically, $135 million in American Rescue Plan funds will support existing and new teaching health centers to support additional resident positions, and $20 million in FY 2022 funds will support existing Teaching Health Center Graduate Medical Education residency programs to continue resident training in the upcoming academic year. More information on this funding can be found here.
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