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Jan 1, 2026·Healthcare Finance News

UnitedHealthcare has delayed its planned policy limiting coverage for remote physiologic monitoring (RPM) to heart failure and hypertensive disorders of pregnancy, which was initially set to begin in January 2026. This controversial decision has drawn criticism for contradicting existing scientific evidence that supports the benefits of RPM for various conditions, such as anxiety, COPD, diabetes, and obstructive sleep apnea. Health experts warn that restricting coverage may hinder advancements in managing cardiovascular diseases and might negatively impact patient care. As RPM adoption grows—particularly within Medicare—healthcare professionals must closely monitor these developments to advocate for effective technologies that improve patient outcomes.

Dec 31, 2025·Fierce Healthcare

In late 2025, various organizations began launching artificial intelligence (AI) certification programs to standardize practices in healthcare, reflecting an industry shift towards establishing ethical and technical benchmarks. This development follows the discontinuation of the Coalition for Health AI's proposed nationwide AI assurance labs, highlighting the ongoing regulatory void in health AI. President Trump's executive order aims to create a national framework for AI, though details remain vague, suggesting a preference for voluntary compliance over stringent regulation. The initiatives by the Utilization Review Accreditation Commission and the Consumer Technology Association represent significant steps toward ensuring accountability in AI applications in clinical care.

Dec 29, 2025·CMS Newsroom

The Centers for Medicare & Medicaid Services (CMS) has unveiled a $50 billion investment via the Rural Health Transformation Program to enhance healthcare access and services in rural areas nationwide, starting in 2026. This initiative will provide states with substantial funding, averaging $200 million, to modernize healthcare facilities and technology while expanding services such as preventive and behavioral health. Health and Human Services Secretary Robert F. Kennedy Jr. underscored the initiative's aim to ensure equitable access to quality care for the over 60 million Americans in rural communities. The program indicates a strategic commitment to address longstanding disparities in rural healthcare delivery and strengthen the workforce, potentially setting a new standard for healthcare access in underserved areas.

Dec 26, 2025·Becker's ASC

Recent federal policy changes are significantly impacting Ambulatory Surgical Centers (ASCs), particularly concerning the Affordable Care Act's enhanced tax subsidies, which could expire soon and affect over 20 million Americans reliant on ACA marketplace plans. The Centers for Medicare & Medicaid Services (CMS) announced a 2.6% payment increase for ASCs, alongside phasing out the inpatient-only list and streamlining outpatient payments. However, the ASC Quality Reporting Program will not implement several proposed metrics, including COVID-19 vaccination reporting, which raises questions about quality oversight in these settings. These developments underscore the ongoing shifts in healthcare policy that professionals must navigate, as they may influence operational funding and patient care strategies.

Dec 26, 2025·justice.gov

Gary Cox, CEO of Power Mobility Doctor Rx, LLC, was sentenced to 15 years in prison and ordered to pay over $452 million in restitution for orchestrating a fraudulent scheme that scammed Medicare and federal health programs out of more than $1 billion. His operation involved generating false doctors' orders for unnecessary medical items through an internet platform, exploiting vulnerable patients via deceptive advertisements and offshore call centers. This case highlights the ongoing challenges in regulating telemedicine and medical equipment practices, emphasizing the critical need for enhanced oversight and protection against fraudulent activities within healthcare technology systems. The significant financial penalties serve as a warning to others in the industry about the consequences of engaging in similar fraudulent schemes.

Dec 22, 2025·HHS

The U.S. Department of Health and Human Services has proposed the HTI-5 Rule to streamline health IT certification, enhance patient data access, and promote AI interoperability, aligning with President Trump’s Executive Order 14192. This rule aims to cut regulatory burdens for health IT developers by eliminating over 50% of the current certification criteria, potentially saving $1.53 billion and 1.4 million compliance hours in its first year. These changes are significant as they encourage innovation in healthcare technology while facilitating seamless electronic health information exchange. Such regulatory updates could transform the health IT landscape, emphasizing efficiency and improved patient care.

Dec 22, 2025·AHA

The Centers for Medicare & Medicaid Services (CMS) has launched the Office of Rural Health Transformation to improve healthcare delivery in rural communities. This initiative aims to tackle the unique challenges faced by rural hospitals and providers, addressing critical gaps in access to quality care, particularly in behavioral health services. The widespread interest from all 50 states underscores the urgency of enhancing rural healthcare infrastructure. The office's focus on innovative strategies is expected to significantly impact health outcomes for residents in these underserved areas.

Dec 21, 2025·cms.gov

The Trump Administration, alongside CMS and other departments, is proposing significant updates to health care price transparency rules aimed at making pricing clearer and more actionable for consumers. These revisions build on the 2020 Transparency in Coverage rules by addressing complexities in data presentation, ultimately enhancing usability for patients and stakeholders. Key improvements include reorganizing in-network rate files, reducing reporting frequency, and expanding out-of-network pricing information. The implications for healthcare professionals involve a more informed patient base that can make better choices, potentially leading to increased competition and affordability in the health care system.

Dec 17, 2025·FDA

The U.S. Food and Drug Administration (FDA) has announced a policy change allowing real-world evidence (RWE) to be used in drug and medical device applications without the need for identifiable patient data. This shift, initially focused on medical devices, aims to enhance the review process by utilizing large datasets while protecting patient privacy, addressing past limitations that slowed RWE integration. Since 2016, RWE has been included in various drug applications but has seen stagnation in device approvals, indicating a need for updated regulatory frameworks. This new guidance represents a significant step forward, potentially increasing the volume and diversity of data used in regulatory decisions for healthcare professionals.

Dec 15, 2025·MobiHealthNews

President Trump's executive order aims to create a cohesive national AI policy framework to prevent regulatory fragmentation across the U.S., which poses challenges for healthcare startups and innovation. By establishing an "AI Litigation Task Force," the order seeks to identify and challenge state laws that conflict with federal regulations and may embed ideological biases in AI models. The U.S. Secretary of Commerce will review existing state laws and compile burdensome regulations, with funding incentives for states aligning with national goals. This initiative underscores the need for uniformity in AI regulations, which could significantly impact the development and deployment of AI technologies in healthcare.

Dec 12, 2025·aha.org

recent efforts to reform healthcare affordability in the U.S. Two Senate bills aimed at this issue have failed to pass, revealing deep divisions in Congress over effective solutions for rising costs. Simultaneously, the Centers for Medicare & Medicaid Services (CMS) has issued guidance on Medicaid reforms, emphasizing its role in shaping federal health policies. Additionally, Aetna's upcoming inpatient payment policy—tying reimbursement to patient severity—may influence how healthcare providers allocate resources and manage care, underscoring the ongoing evolution of healthcare reimbursement models.

Dec 12, 2025·AMA

The One Big Beautiful Bill Act of 2025 (OBBBA), effective in 2026, presents substantial shifts in healthcare policy, including ending fiscal incentives for Medicaid expansion and increasing costs for Affordable Care Act (ACA) marketplace enrollees. The bill could displace 10 million people from health insurance by 2034, with another 14 million at risk of losing coverage if ACA tax credits are not renewed. Key provisions such as more frequent Medicaid eligibility checks, work requirements for enrollees, and shortened ACA enrollment windows are designed to cut federal health program funding but could significantly hinder access to care. Healthcare professionals must prepare for the anticipated challenges in patient coverage and the broader implications for healthcare delivery.

Dec 10, 2025·MedTech Dive

The FDA has announced a new pathway for digital health devices, enabling them to access Medicare payment options without the usual premarket authorization and investigational requirements. This initiative, developed in collaboration with CMS, is part of the ACCESS program, which seeks to provide stable funding for healthcare sites managing chronic conditions in exchange for achieving specific health outcomes. By facilitating real-world data collection, this policy aims to support the integration of technology into chronic care management, ultimately improving patient outcomes and transforming healthcare delivery models. The accompanying TEMPO pilot further aids manufacturers in navigating regulatory hurdles, encouraging innovation in digital health solutions.

Dec 9, 2025·Healthcare IT News

The FDA has launched the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO) to enhance the management of chronic diseases through the use of digital health technologies. This initiative promotes a risk-based regulatory approach, focusing on improving health outcomes for various conditions, including cardio-kidney-metabolic and behavioral health issues. Collaborating with the CMS Innovation Center, TEMPO aims to facilitate access to integrated healthcare solutions and will involve manufacturers collecting real-world data to evaluate the effectiveness of their tools. This pilot underscores the necessity for regulatory frameworks to evolve alongside digital health innovations, ultimately impacting patient care and outcomes in chronic disease management.

Dec 9, 2025·Healthcare IT News

A coalition of telehealth stakeholders, led by ATA Action, is pressing the federal Office of Management and Budget (OMB) and the Drug Enforcement Administration (DEA) to extend pandemic-era telemedicine flexibilities that enable virtual prescriptions for controlled substances. These measures have been pivotal in ensuring uninterrupted patient care, especially for those with mental and behavioral health needs, but they are set to expire soon. Without the extension, patients and providers risk facing significant disruptions in care continuity. The ongoing debate highlights the necessity of balancing patient access with safeguards against misuse as healthcare technology evolves.

Dec 9, 2025·Fast Company

President Donald Trump has announced an executive order aimed at establishing federal regulations for artificial intelligence (AI), preventing individual states from creating their own rules. This initiative, part of a broader deregulation agenda, seeks to maintain the U.S. competitive edge in AI by standardizing regulations and could penalize states with existing laws by withholding federal funding. While proponents argue it streamlines compliance for tech companies, critics, including some state leaders, warn that it undermines local protections against issues such as data privacy and online censorship. As AI technology rapidly advances, this move highlights the tension between federal oversight and state-level governance, posing significant implications for healthcare technology regulation and innovation.

Dec 3, 2025·MobiHealthNews

The Center for Medicare and Medicaid Services (CMS) has unveiled the ACCESS model, aimed at improving digital care for Medicare patients with chronic conditions such as obesity and depression. Set to launch on July 1, 2026, this initiative will impact two-thirds of Medicare recipients and shifts towards a results-oriented payment structure, incentivizing clinicians to incorporate digital tools in patient care. The ACCESS model outlines four clinical tracks and its Outcome-Aligned Payments will reward organizations based on their ability to achieve significant health outcomes. This approach is expected to enhance the delivery of integrated, technology-driven services across various formats, thereby reshaping care delivery for chronic diseases.

Dec 3, 2025·BankInfoSecurity

The Senate Committee on Appropriations has proposed a draft bill that significantly cuts funding for federal cybersecurity and IT modernization programs, reducing allocations for the Office of the National Cyber Director and the Technology Modernization Fund. The bill allocates just $20 million for the National Cyber Director and $5 million for the Technology Modernization Fund, a drastic decline from previous proposals, raising alarms about the federal capacity to address outdated technology systems. This funding shift favors decentralized agency responsibilities over coordinated modernization efforts, which could hinder cross-agency cybersecurity and IT improvements. For healthcare professionals, this underscores a concerning trend that may limit federal support for critical IT infrastructure essential for maintaining secure and efficient healthcare systems.

Dec 2, 2025·Home Health Care News

The U.S. House of Representatives has passed the bipartisan Hospital Inpatient Services Modernization Act, extending the Acute Hospital Care at Home (AHCaH) program for five years, crucial for providing hospital-level care at home. With over 330 hospitals in 37 states currently participating, this extension seeks to eliminate regulatory uncertainty that has previously hindered the sector and discouraged involvement from organizations. Healthcare professionals see this long-term stability as vital for enabling investments in hospital-at-home services, ultimately enhancing patient care. The bill's approval has garnered support from notable healthcare associations, emphasizing the significant role of telehealth in modern healthcare delivery.

Dec 2, 2025·AHA

The American Hospital Association, in conjunction with the Maine Hospital Association and four safety-net health systems, has launched a lawsuit against the 340B Rebate Model Pilot Program set to begin on January 1, 2026. The plaintiffs argue that its implementation would impose severe financial and operational challenges for 340B hospitals, threatening their already precarious margins while providing vital care to underserved populations. Additionally, the lawsuit alleges that the Department of Health and Human Services bypassed necessary transparency and stakeholder consultation, raising concerns about the long-term viability of these institutions and their ability to deliver essential services to their communities. This legal challenge highlights the critical intersection of healthcare policy, financial sustainability, and patient care, urging professionals to consider the broader implications of such regulatory changes.