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, PAHPA reauthorization legislation was marked up in both the House Energy and Commerce and Senate HELP Committees and HHS distributed $47.8 million in funding to combat substance use disorders. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On July 17, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections. CDC announced the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections. The Draft Guidelines update CDC’s Guideline for Infection Control In Health Care Personnel, 1998. The updated recommendations are intended for use by the leaders and staff of healthcare facilities and systems. These updated recommendations are designed to help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
- On July 19, 2023, the Department of Health and Human Services (HHS) issued a notice entitled, Request for Comments on the Draft HHS Scientific Integrity Policy. The draft HHS Scientific Integrity Policy is being released for public comment as part of the implementation for the Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-based Policymaking. The draft policy includes specific provisions prohibiting political interference, ensuring independent review of scientific activities, facilitating the free flow of scientific information, prohibiting suppression or delay of scientific findings for non-scientific reasons, forbidding censorship or alteration of scientific findings, and protecting against retaliation. The draft policy also establishes clear procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference. Comments are due by September 1, 2023.
- July 31, 2023: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias (ADRD) for people with the disease and their caregivers. The Advisory Council’s subcommittees will present recommendations for adoption by the full Advisory Council. The meeting will also include a presentation on the Alzheimer’s disease bypass budget from the National Institutes of Health (NIH), a National Healthy Brain Initiative Road Map Series update by CDC, and federal updates.
- August 3, 2023: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussion of nirsevimab for prevention of respiratory syncytial virus (RSV). A recommendation vote and a Vaccines for Children (VFC) program vote are scheduled.
- August 22, 2023: the Food and Drug Administration (FDA) announced a virtual listening session entitled, Public Meeting and Listening Session for Developing FDA’s Center for Tobacco Products’ Strategic Plan. The purpose of the listening session is to obtain feedback on the proposed strategic goals that are being used to develop FDA’s Center for Tobacco Products’ (CTP) comprehensive Strategic Plan. FDA will provide information on the proposed goals and offer the public an opportunity to provide open public comment.
- August 27, 2023: NIH announced a public meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences (BSC, NIEHS). The meeting agenda will include a discussion of reviews conducted by the BSC.
- August 29, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Advisory Committee for Women’s Services (ACWS). The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girls’ population. Additionally, the ACWS will be addressing priorities regarding maternal behavioral health.
- August 29, 2023: SAMHSA announced a public meeting of the Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting will include consideration of the meeting minutes from the April 25, 2023, SAMHSA, CMHS NAC meeting; updates from the CMHS Director; an update from SAMHSA’s Assistant Secretary; a discussion on the Transitional Age Youth Policy Academy; a discussion on ACWS/Gender Based Violence; and a discussion on potential innovations.
- September 12-13, 2023: HHS announced the third meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). The Committee will meet to provide subcommittee updates, including presentations by each subcommittee. There will also be deliberation by the full Committee regarding progress made since the second public meeting, including protocol development, evidence review and synthesis, systematic review findings, and plans for future Committee work. The Committee will also hear comments from the public at this meeting.
II. Hearings & Markups
U.S. House of Representatives
- On July 18, 2023, the House Committee on Energy and Commerce held a hearing entitled, Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology. Witnesses present included: Dr. Natalia Rost, President Elect, American Academy of Neurology (AAN); Dr. Thomas MacGillivray, President, Society of Thoracic Surgeons (STS); Dr. Lishan Aklog, Chairman and Chief Executive Officer (CEO), PAVmed; Dr. Todd Brinton, Corporate Vice President, Advanced Technology Chief Scientific Officer, Edwards Lifesciences; Sue Wronsky, Alzheimer’s Association Advocate; and Dr. Brian Miller, Nonresident Fellow, American Enterprise Institute, Assistant Professor of Medicine, Johns Hopkins University School of Medicine.
- On July 18, 2023, the House Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing entitled, Why Expanding Medicaid to DACA Recipients Will Exacerbate the Border Crisis. Dr. Ellen Montz, Deputy Administrator and Director, Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare & Medicaid Services (CMS), was the hearing’s only witness.
- On July 19, 2023, the House Committee on Small Business Subcommittee on Oversight, Investigations, and Regulations held a hearing entitled, Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses. Witnesses present included: Dr. Henry Anthony Punzi, Medical Director, Trinity Hypertension and Metabolic Research Institute, Punzi Medical Center; Dr. Brian Miller, Nonresident Fellow, American Enterprise Institute, Assistant Professor of Medicine, Johns Hopkins University School of Medicine; and Matthew Fiedler, Senior Fellow, Schaeffer Initiative for Health Policy, Economic Studies Program, Brookings Institution.
- On July 19, 2023, the House Committee on Energy and Commerce held a markup entitled, Full Committee Markup on 15 Bills. Legislation considered during the markup included: R. 824, the Telehealth Benefit Expansion for Workers Act of 2023 (Rep. Walberg (R-MI)); H.R. 3226, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023 (Rep. Eshoo (D-CA)); H.R. 3838, the Preventing Maternal Deaths Reauthorization Act of 2023 (Rep. Burgess (R-TX)); H.R. 3843, the Action for Dental Health Act of 2023 (Rep. Kelly (D-IL)); H.R. 3884, the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 (Rep. Burgess (R-TX)); H.R. 3821, the Firefighter Cancer Registry Reauthorization Act of 2023 (Rep. Pascrell (D-NJ)); H.R. 3391, the Gabriella Miller Kids First Research Act 2.0 (Rep. Wexton (D-VA)); H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act (Rep. Hudson (R-NC)); H.R. 4420, the Preparedness and Response Reauthorization Act (Rep. Hudson (R-NC)); H.R. 4529, the Public Health Guidance Transparency and Accountability Act of 2023 (Rep. Rodgers (R-WA)); H.R. 4381, the Public Health Emergency Congressional Review Act (Rep. Murphy (R-NC)); H.R. 3813, the CDC Leadership Accountability Act of 2023 (Rep. Guthrie (R-KY)); H.R. 3836, the Medicaid Primary Care Improvement Act (Rep. Crenshaw (R-TX)); H.R. 4531, the Support for Patients and Communities Reauthorization Act (Rep. Guthrie (R-KY)); and H.R. 3887, the Children’s Hospital GME Support Reauthorization Act of 2023 (Rep. Crenshaw (R-TX))
- On July 19, 2023, the Senate Committee on the Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights held a hearing entitled, Trends in Vertical Merger Enforcement. Witnesses present included: Charlotte Slaiman, Competition Policy Director, Public Knowledge; Nancy Rose, Charles P. Kindleberger Professor of Applied Economics, Massachusetts Institute of Technology (MIT); and Makan Delrahim, Partner, Latham & Watkins LLP, Former Assistant Attorney General, Department of Justice (DOJ) Antitrust Division.
- On July 20, 2023, the Senate Committee on Finance Subcommittee on Health held a hearing entitled, The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System. Witnesses present included: LaQuayia Goldring, Patient; Molly McCarthy, Vice Chair & Region 6 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network (OPTN); Matthew Wadsworth, President And CEO, Life Connection of Ohio; Dr. Raymond Lynch, Professor Of Surgery and Director Of Transplantation Quality And Outcomes, Penn State Health Milton S. Hershey Medical Center; and Donna Cryer, Founder And CEO, Global Liver Institute.
- On July 20, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an executive session entitled, 2333, Pandemic and All-Hazards Preparedness and Response Act. The Committee considered S. 2333, the Pandemic and All-Hazards Preparedness and Response Act.
III. Reports, Studies & Analyses
- On July 17, 2023, Alston & Bird published an advisory entitled, Health Care Advisory: Provider Relief Fund Reconsideration Requests Nixed by Debt Limit Deal. The Health Resources and Services Administration (HRSA) announced that payments to health care providers under the Provider Relief Fund (PRF) have ended and there will be no reconsideration payments. This announcement came after President Biden signed into law the Fiscal Responsibility Act of 2023 (FRA), which rescinded various unobligated funds that Congress authorized during the COVID-19 public health emergency (PHE). That funding included the Public Health and Social Services Emergency Fund, which financed the PRF program. The advisory explained that HRSA was reviewing Phase 4 and ARP Rural reconsideration requests prior to the recission, with some providers anticipating millions of dollars in additional payments due to inaccurate HRSA calculations and reviews of original Phase 4 and ARP Rural payment applications. The advisory concludes by highlighting that reporting and auditing requirements continue for previously distributed PRF and ARP Rural payments.
- On July 18, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, HRSA Made COVID-19 Uninsured Program Payments to Providers on Behalf of Individuals Who Had Health Insurance Coverage and for Services Unrelated to COVID-19. During the COVID-19 pandemic, HRSA was selected to provide day-to-day oversight and management of the COVID-19 Uninsured Program (UIP). HRSA entered into an agreement with a contractor to administer the UIP, which allowed providers to enroll and submit claims for reimbursement of COVID-19 testing and treatment made to uninsured patients. OIG conducted an audit to determine whether claims for COVID-19 testing and treatment services reimbursed through the UIP complied with federal requirements. OIG found that HRSA made payments that did not comply with federal requirements, with improper payments found for 58 out of 300 sampled patients. The sample showed $294,294 in improper payments. OIG then estimated that nearly $784 million of $4.2 billion (or 19 percent) in UIP payments made to providers during the audit period for approximately 3.7 million of 19.2 million patients were improper. OIG recommended that HRSA recover the funds deemed to be improper from the audit and then develop a process by which to identify and recover other improper payments distributed through the UIP.
- On July 19, 2023, HHS OIG published a report entitled, High Rates of Prior Authorization Denials by Some Plans and Limited State Oversight Raise Concerns About Access to Care in Medicaid Managed Care. HHS believes that Medicaid managed care organizations (MCOs) play an increasingly important role in ensuring that individuals with Medicaid have access to medically necessary, covered services. OIG conducted this review due to reports in recent years that some MCOs inappropriately delayed or denied care for thousands of people enrolled in Medicaid, including patients who needed treatment for cancer and cardiac conditions, elderly patients, and patients with disabilities who needed in-home care and medical devices. OIG selected a sample of seven MCO parent companies, which operate 115 MCOs across 37 states and enroll a total of 29.8 million people. OIG collected data from the selected parent companies about prior authorization denials and related appeals for each MCO they operated. OIG found that the MCOs included in the review denied one out of every eight requests for the prior authorization of services in 2019, with 12 of the 115 MCOs having denial rates exceeding 25 percent. Additionally, OIG found that most state Medicaid agencies reported that they did not routinely review whether MCOs in their state were issuing appropriate denials of prior authorization requests. Further, OIG found that only a small number of Medicaid patients appealed their prior authorization denials. After review, OIG is recommending that CMS require states to review the appropriateness of a sample of MCO prior authorization denials regularly and collect data on MCO prior authorization decisions. OIG also recommended that CMS work with states on actions to identify and remedy inappropriate prior authorization denials by MCOs.
- On July 19, 2023, the Kaiser Family Foundation (KFF) published a report entitled, Medicare Households Spend More on Health Care Than Other Households. KFF conducted this analysis to assess the financial burden health care spending places on households where all members are covered by Medicare, relative to households where no members are covered under Medicare. Following its analysis, KFF found that Medicare households shouldered two times the health care spending burden of non-Medicare households during 2021. In terms of household spending, health-related expenses accounted for 15 percent of total spending for Medicare households and only seven percent for non-Medicare households. In line with the higher health care spending burden among Medicare households compared to non-Medicare households, 32 percent of Medicare households spent 20 percent or more of their total household spending on health-related expenses compared to just seven percent of non-Medicare households. KFF concluded that the relatively high burden of health care costs on Medicare households should inform policy debate over the level of cost-sharing and premiums in Medicare.
IV. Other Health Policy News
- On July 19, 2023, SAMHSA announced awards in five grant programs devoted to combating multiple facets of substance misuse and the nation’s overdose epidemic. The grant awards total up to $47.8 million. The Medication-Assisted Treatment-Prescription Drug and Opioid Addiction (MAT-PDOA) Grant Program, which helps expand or enhance access to Medications for Opioid Use Disorder (MOUD), distributed 21 awards totaling up to $18.4 million. The Emergency Department Alternatives to Opioids Demonstration Program, which develops and implements alternatives to opioids for pain management in hospitals and emergency department (ED) settings, distributed 15 awards totaling up to $7.4 million. Other programs distributing funding include the Sober Truth on Preventing Underage Drinking Act (STOP Act) program, the Adult Reentry Program, and the State Pilot Grant Program for Treatment for Pregnant and Postpartum Women. More information on this funding announcement can be found here.
- On July 20, 2023, the HHS Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) warned hospitals and telehealth providers about the privacy and security risks related to the use of online tracking technologies when they are integrated into their websites or mobile apps that may be impermissibly disclosing consumers’ sensitive personal health data to third parties. OCR and FTC sent a joint letter to approximately 130 hospital systems and telehealth providers to emphasize the risks and concerns about the use of technologies, such as the Meta/Facebook pixel and Google Analytics, that can track a user’s online activities. OCR has stepped up enforcement actions recently as it has confirmed active investigations nationwide to ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The announcement reminds hospitals and telehealth providers that companies not covered by HIPAA still have a responsibility to protect against the unauthorized disclosure of personal health information (PHI)—even when a third party developed their website or mobile app. More information on this announcement can be found here.
- On July 20, 2023, CMS approved Medicaid state plan amendments from California and Kentucky to implement community-based mobile crisis intervention teams for the provision of Medicaid services. Mobile crisis intervention teams aim to provide rapid response, individual assessment, and crisis de-escalation by trained behavioral health professionals and paraprofessionals. The multidisciplinary team provides screening and assessment; stabilization and de-escalation; and coordination with and referrals to health, social, and other services, as needed. With California and Kentucky joining, there are now six states that have expanded access to community-based mental health and substance use crisis care through the American Rescue Plan (ARP). The state plan amendments add mobile crisis response crisis planning; facilitation of a warm handoff; referrals to ongoing supports; and follow up check-ins for individuals experiencing a mental health or SUD crisis. These expanded crisis intervention service programs are intended to ensure that behavioral health professionals are the first point of contact for individuals in crisis. More information on these approvals can be found here.
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