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, Congress passed a laddered continuing resolution (CR) with new funding deadlines on March 1 and March 8, 2024, and CMS issued a final rule on interoperability and prior authorization. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On January 16, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Annual Update of the HHS Poverty Guidelines. This notice provides an update of HHS’s poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index.
- On January 18, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Federal Independent Dispute Resolution Operations; Reopening of Comment Period. This document reopens the comment period for the proposed rule entitled Federal Independent Dispute Resolution Operations that appeared in the November 3, 2023 issue of the Federal Register. The comment period for the proposed rule which closed on January 2, 2024, is reopened from 14 days after the date of its publication in the Federal Register.
- On January 18, 2024, the Agency for Toxic Substances and Disease Registry (ATSDR) released a notice entitled, Availability of Two Draft Toxicological Profiles. ATSDR announced the opening of a docket to obtain comments on drafts of two updated toxicological profiles: chloroform and chloroethane. This action is necessary as this is the opportunity for members of the public and organizations to submit comments on drafts of the profiles. The intended effect of this action is to ensure that the public can note any pertinent additional information or reports on studies about the health effects caused by exposure to the substances covered in these two profiles for review.
- On January 18, 2024, CMS released a rule entitled, Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, etc. on the Federally-Facilitated Exchanges, etc. This final rule will improve the electronic exchange of health care data and streamline processes related to prior authorization through new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). This final rule will also add new measures for eligible hospitals and critical access hospitals (CAHs) to report under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians to report under the Promoting Interoperability performance category of the MIPS. These policies, taken together, will reduce overall payer and provider burden and improve patient access to health information while continuing CMS’s drive toward interoperability in the health care market.
- On January 18, 2024, HHS released a notice entitled, Extension of Comment Period: Notice and Request for Comments on the Implications of Access and Benefit Sharing Commitments / Regimes and Other Proposed Commitments Being Considered under a World Health Organization Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response. This document extends the comment period for the Notice and Request for Comments on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a World Health Organization (WHO) Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response that appeared in the December 22, 2023 issue of the Federal Register. The comment period for the notice, which is due to close on January 22, 2024, is extended to January 31, 2024.
Event Notices
January 22, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
January 24, 2024: The National Institutes of Health (NIH) announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.
January 24, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council Stillbirth Working Group . This is a virtual meeting open to the public.
January 25, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). This is a hybrid meeting open to the public.
January 29, 2024: NIH announced a meeting of the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee. This is a virtual meeting open to the public.
January 29, 2024: NIH announced a meeting of the Interagency Coordinating Committee on the Validation of Alternative Methods entitled “Implementing Computational Approaches for Regulatory Safety Assessments.” This is a virtual meeting open to the public.
January 29, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This is a hybrid meeting open to the public.
February 1, 2024: CMS announced a virtual meeting of the Advisory Panel on Outreach and Education (APOE). This meeting is open to the public.
February 2, 2024: The Food and Drug Administration (FDA) announced a meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. This meeting is open to the public.
February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
February 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.
February 14, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.
February 16, 2024: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
February 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). This is a hybrid meeting open to the public.
February 27, 2024: SAMHSA announced a meeting of SAMSHA’s Center for Mental Health Services National Advisory Council. This is a hybrid meeting open to the public.
February 28-29, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics that is open to the public.
March 13, 2024: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
II. Hearings & Markups
Senate
- On January 18, 2024, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Addressing Long COVID: Advancing Research and Improving Patient Care. Witnesses present included Angela Meriquez Vázquez, M.S.W., Long COVID Patient, Los Angeles, CA; Rachel Beale, M.B.A., Long COVID Patient, Southampton County, VA; Nicole Heim, Parent of Long COVID Patient, Winchester, VA; Michelle Harkins, M.D., Professor of Medicine, University of New Mexico, Albuquerque, NM; Ziyad Al-Aly, M.D., Clinical Epidemiologist, Washington University in St. Louis, St. Louis, MO; Charisse Madlock-Brown, Ph.D., Associate Professor of Health Informatics, University of Iowa, Iowa City, IA; and Tiffany Walker, M.D., Assistant Professor, Emory University School of Medicine, Atlanta, GA.
III. Reports, Studies, & Analyses
- On January 16, 2024, the Government Accountability Office (GAO) released a report entitled, Public Health Preparedness: HHS Emergency Agency Needs to Strengthen Workforce Planning. GAO assessed the Administration for Strategic Preparedness and Response’s (ASPR) workforce capabilities and provided several recommendations to improve and address issues of emergency responses. The report notes that ASPR workforce doubled from roughly 1,000 to 2,000 individuals from 2019 to 2022 due to the COVID-19 pandemic. However, much of this staff was contractors, rather than in-house, permanent staff. The report recommends that ASPR do the following: (1) establish goals and performance measures to use for its in-house hiring office; (2) create specific recruitment strategies to meet its hiring needs; (3) identify areas of improvement and implement assessment and development plans; and (4) conduct a workforce assessment to assess the skills and competencies needed to achieve agency-wide goals.
- On January 16, 2024, the Kaiser Family Foundation (KFF) released a brief entitled, States Obtain Special Waivers to Help Unwinding Efforts. The brief found that as states navigate the unwinding of continuous enrollment provisions and complete redeterminations for Medicaid enrollees, they encounter challenges such as staffing shortages and outdated systems. Over 14 million individuals were disenrolled during the continuous enrollment unwinding, with 71 percent due to procedural reasons. To assist states in complying with federal renewal requirements, CMS identified strategies including temporary waivers under the Social Security Act. According to the report, as of January 12, 2023, CMS approved 392 waivers for 49 states and the District of Columbia. These waivers help increase ex parte renewals, support enrollees in completing renewal forms, update enrollee contact information, and facilitate reenrollment for individuals disenrolled for procedural reasons. A recent concern over Medicaid coverage loss for children led to the extension of these waivers through the end of 2024. States vary in their use of these waivers, and ongoing efforts to improve renewal processes and reduce procedural disenrollments may lead to the extension or permanent adoption of some waiver options.
IV. Other Health Policy News
- On January 17, 2024, CMS issued a final rule entitled, the CMS Interoperability and Prior Authorization Final Rule. Beginning in 2026, the rule requires that payers under CMS jurisdiction, except for Qualified Health Plans (QHPs) on the Federally Facilitated Exchanges (FFEs), must send prior authorization decisions to providers within 72 hours when urgent and within seven days when standard. If payers deny a request, they must provide a specific reason. Beginning in 2027, payers must implement a Prior Authorization application programming interface (API) to help streamline prior authorization requests, promote interoperability, and reduce administration burdens. Payers must also implement a Provider Access API and expand their Patient Access API in 2027. The final rule specifies that CMS will use enforcement discretion for the Health Insurance Portability and Accountability Act of 1996 (HIPAA) X12 278 prior authorization standard, promoting flexibility and efficiency for covered entities. The text of the final rule is available here.
- On January 18, 2024, Congress passed a continuing resolution (CR), preventing a partial government shutdown. H.R.2872, the Further Additional Continuing Appropriations and Other Extensions Act, 2024, continues the laddered funding approach from the previous CR, H.R.6363, the Further Continuing Appropriations and Other Extensions Act, 2024, with certain agency appropriations set to now expire on March 1 (rather than January 19) and others, including funding for HHS, on March 8 (rather than February 2). Funding for public health extenders, including funding for community health centers, the National Health Service Corps and Teaching Health Center Graduate Medical Education, were included in the CR, and are funded through March 8. Notably, the CR does not address the 3.4 percent cut to the Medicare Physician Fee Schedule that went into effect on January 1, 2024. Congress will now continue to negotiate fiscal year 2024 appropriations bills. The text of the CR is available here.
- On January 18, 2024, CMS introduced a new Center for Medicare and Medicaid Innovation model called the Innovation in Behavioral Health (IBH) Model. The objective of this model is to enhance the quality of care, access, and outcomes for individuals with mental health conditions and substance use disorders in Medicaid and Medicare. Under the IBH Model, community-based behavioral health practices will form interprofessional care teams comprising behavioral and physical health providers, along with community-based supports. The model aligns with the Biden Administration’s mental health strategy and aims to implement the HHS Roadmap for Behavioral Health integration. Through this approach, individuals will experience integrated services that bridge the gaps between physical and behavioral health, promoting a "no wrong door" approach to care. The IBH Model also seeks to reduce overall program expenditures while improving care quality and outcomes. This initiative responds to the significant impact of behavioral health conditions on Medicare and Medicaid populations, addressing challenges such as high out-of-pocket costs, limited access to quality behavioral health treatment, and fragmented care systems. The IBH Model is set to launch in Fall 2024, operating for eight years in up to eight states, with a Notice of Funding Opportunity expected in Spring 2024. A fact sheet with more information is available here.
- On January 19, 2024, HHS, through the Indian Health Service (IHS), awarded $55 million in funding to 15 tribes and tribal organizations as part of the Small Ambulatory Program. This competitive program aims to invest in the construction, expansion, or modernization of small ambulatory health care facilities. HHS Secretary Xavier Becerra emphasized the importance of providing tribal partners with access to culturally appropriate and quality health care, including preventive services for chronic diseases. The IHS Small Ambulatory Program, ongoing since 2001, has supported over 79 projects, totaling more than $178 million. The program focuses on expanding access to outpatient services, offering new and enhanced services, and upgrading outdated facilities within tribally operated health care facilities, which predominantly provide ambulatory services and play a crucial role in preventing chronic diseases. The IHS Office of Environmental Health and Engineering supports these efforts by ensuring functional, well-maintained health care facilities and providing technical and financial assistance to tribes. A press release with more information is available here.
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