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, the House E&C Oversight Subcommittee held a hearing on the 340B Program and HHS expanded the new Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program to ten new states.
I. Regulations, Notices & Guidance
- On June 3, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Agency Forms Undergoing Paperwork Reduction Act Review. In accordance with the Paperwork Reduction Act of 1995, CDC submitted the information collection request titled National Center for Chronic Disease Prevention and Health Promotion: Work Plans, Progress Monitoring, and Evaluation Reporting (NCCDPHP WPPMER) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a Proposed Data Collection Submitted for Public Comment and Recommendations notice on December 1, 2023, to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
- On June 4, 2024, the Food and Drug Administration (FDA) released a notice entitled, Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability. This draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs FDA to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The draft guidance is intended to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.
- On June 4, 2024, FDA released a notice entitled, Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability. The draft guidance document and Bioresearch Monitoring (BIMO) Technical Conformance Guide provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by FDA’s Center for Biologics Evaluation and Research (CBER) in the planning of, and by FDA’s Office of Regulatory Affairs (ORA) in the conduct of, BIMO inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by CBER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of BLA and NDA content for the planning and conduct of CBER BIMO inspections, using the electronic Common Technical Document.
- On June 6, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs: Application by the Community Health Accreditation Partner (CHAP) Inc. for Continued Approval of its Hospice Accreditation Program. This notice acknowledges the receipt of an application from Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
- On June 6, 2024, FDA released a notice entitled, Advisory Committee; Arthritis Advisory Committee; Renewal FDA is announcing the renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until April 5, 2026.
- On June 6, 2024, FDA released a notice entitled, Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory; Renewal. FDA is announcing the renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee by the Commissioner. The Commissioner has determined that it is in the public interest to renew the Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the March 23, 2026.
- On June 6, 2024, FDA released a notice entitled, Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing. The Director of the Center for Drug Evaluation and Research (Center Director) at FDA is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director’s proposal and offers Vanda an opportunity to request a hearing on the matter.
- On June 6, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Privacy Act; Implementation. In accordance with subsections (j)(2) and (k)(2) of the Privacy Act of 1974, as amended, HHS is proposing to exempt a new system of records maintained by the National Institutes of Health (NIH), System No. 09-25-0224, “NIH Police Records,” from certain requirements of the act. The new system of records will cover criminal and non-criminal law enforcement investigatory material maintained by the NIH Division of Police, a component of NIH which performs criminal law enforcement as its principal function. According to the agency, the exemptions are necessary and appropriate to protect the integrity of law enforcement proceedings and records compiled in the course of NIH Division of Police activities, prevent disclosure of investigative techniques, and protect the identity of confidential sources involved in those activities. Elsewhere in the Federal Register, HHS/NIH has published a System of Records Notice (SORN) for System No. 09-25-0224 for public notice and comment which describes the new system of records in more detail.
- On June 7, 2024, CDC released a notice entitled, Notice of Award of a Sole-Source Cooperative Agreement to Fund Mali Ministry of Health. CDC announced an award, of approximately $600,000 with an expected total funding of approximately $3,000,000 over a 5-year period, to the Mali Ministry of Health. This award will strengthen Mali’s health system capacities to prevent, detect, and respond to infectious disease outbreaks and other public health emergencies.
Event Notices
June 10, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee. This is a virtual meeting open to the public.
June 13, 2014: HHS announced a meeting of the National Vaccine Advisory Committee. This is a hybrid meeting open to the public.
June 20, 2024: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a virtual meeting open to the public.
June 26, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
June 26, 2024: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
June 26-28, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
June 28-29, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a hybrid meeting open to the public.
July 1-2, 2024: HHS announced a meeting of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting open to the public.
July 9, 2024: AHRQ announced a meeting of a Special Emphasis Panel on Evaluation and Coordinating Center for the AHRQ/PCORI Learning Health System Embedded Scientist Training and Research Centers (U18).
July 11-12, 2024: FDA announced a meeting entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. This is a hybrid meeting open to the public.
July 25, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This meeting is open to the public.
II. Hearings & Markups
- On June 3, 2024, the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations held a hearing entitled Oversight of the 340B Drug Pricing Program. Witnesses present included: Anthony DiGiorgio, D.O., MHA, Neurosurgeon, University of California San Francisco (UCSF) Health; Sue Veer, President and Chief Executive Officer (CEO), Carolina Health Center; William (Bill) Smith, PhD, Senior Fellow and Director of Pioneer Life Sciences Initiative, Pioneer Institute; and Matthew Perry, President and CEO, Genesis Healthcare System.
III. Reports, Studies, & Analyses
- On May 31, 2024, the RAND Corporation released a research article entitled, Ransomware Attacks, ED Visits and Inpatient Admissions in Targeted and Nearby Hospitals. This analysis of ransomware attacks on hospitals in California from 2014 to 2020 examined the effects of emergency department (ED) visits and inpatient admissions in both targeted and neighboring hospitals. According to the article, ransomware attacks on hospitals have surged in recent years, particularly during the COVID-19 pandemic, with over 370 incidents reported between 2016 and 2021. These cyberattacks, which involve hackers encrypting hospital networks and demanding payment for restoration, can severely disrupt healthcare services. Evidence suggests significant impacts, such as a 15 percent increase in emergency department visits at nearby facilities following an attack. The study found that hospitals targeted by ransomware attacks showed a temporary decrease in ED visits and inpatient admissions, while hospitals not targeted showed a temporary increase in the ED visits and inpatient admissions. Researchers acknowledged potential limitations of their analysis, including the lack of post-2020 data.
- On June 3, 2024, the Government Accountability Office (GAO) released a report entitled, Veterans Health Care: Opportunities Exist to Improve Assessment of Network Adequacy for Mental Health. The report found that the Department of Veterans Affairs (VA) needs to improve its assessment of network adequacy for mental health care within its Community Care Networks (CCNs). These networks, managed by two contractors, provide care to veterans outside VA facilities. The VA uses two primary network adequacy standards to measure how long veterans should wait for or travel to appointments. However, the GAO found that the VA’s assessment methodology excludes certain claims, such as when veterans choose specific providers or appointment times, potentially leading to an incomplete and misleading evaluation of network adequacy. This gap poses a risk to fully assessing whether CCNs meet veterans' mental health care needs.
- According to the report, the VA lacks comprehensive information on factors contributing to scheduling challenges, such as difficulties in finding community providers. The report asserts that without systematically capturing reasons for scheduling delays, the VA cannot accurately determine if an insufficient number of providers is affecting access to community care. Consequently, the GAO recommended that the VA reassess its methodology for calculating specialty care network adequacy and systematically capture reasons for community care appointment scheduling challenges. The VA has agreed with these recommendations in principle.
IV. Other Health Policy News
- On June 3, 2024, HHS announced a $15 million investment over four years through the Health Resources and Services Administration (HRSA) to address maternal health needs and disparities in rural communities. This funding, allocated under the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program, aims to improve maternal health care in rural areas and in the Delta region, covering states like Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee. HRSA’s initiative includes almost $4 million per awardee over four years for the Rural MOMS Program to enhance access to maternal care through a coordinated network of rural hospitals, medical centers, and clinics. Additionally, the new Delta Region Maternal Care Coordination Program will receive up to $7 million over four years to improve health care services before, during, and after pregnancy in the Delta region, addressing high rates of maternal morbidity and mortality. These investments are part of the broader Biden-Harris Administration strategy to tackle maternal health disparities, which also includes previous allocations such as $105 million for the Healthy Start program and $65 million to health centers to improve maternal health outcomes. A press release with more information is available here.
- On June 4, 2024, HHS announced expansion of the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program to ten new states. HHS, through CMS and the SAMHSA, announced that Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island, and Vermont have successfully developed the necessary infrastructure and programs to meet CCBHC standards. CCBHCs provide comprehensive care coordination and evidence-based practices, ensuring 24/7 crisis services and routine outpatient care within ten business days. This expansion aligns with President Biden’s national strategy to transform the behavioral health system and addresses the mental health and addiction crises by offering sustainable funding through Medicaid. The addition of these ten states brings the total to eighteen states participating in the CCBHC Medicaid Demonstration Program, which aims to improve access to equitable, quality care for those with serious mental health and substance use needs. A press release with more information is available here.
- On June 5, 2024 Senate Finance Committee Chair Ron Wyden (D-OR) released a statement announcing that he was urging HHS to immediately mandate key cybersecurity practices on systemically important healthcare companies. In his letter to HHS, Wyden specifically noted that HHS does not require use of multi-factor authentication (MFA) and other cybersecurity best practices leaving medical centers and patient medical information exposed to criminals for weeks. In his letter, Senator Wyden recommended HHS take the following four steps:
- “HHS should require minimum, mandatory technical cybersecurity standards for systemically important entities (SIEs), including clearinghouses and large health system.”
- “HHS should require SIEs to meet resiliency requirements, so they are able to get back up and running quickly if they are infected with ransomware. SIEs must be capable of rebuilding their information technology infrastructure from scratch and within 48-72 hours.”
- “HHS should conduct periodic cybersecurity audits of covered entities and business associates as part of the audits required by Section 13411 of the HITECH Act.”
- “HHS should provide technical assistance on cybersecurity to health care providers . . . particularly those with low resources.”
- Earlier this year, HHS announced a series of voluntary standards, but following the Change Healthcare disruption, the Administration indicated they would be reviewing mandatory options and further action is expected at any time.
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