Key Regulatory Updates and Compliance Deadlines for 2026

As we close out 2025, healthcare organizations face a complex regulatory landscape heading into the new year. Recent Federal Register publications and agency announcements have clarified several important compliance requirements, and in some cases, provided welcome relief from looming deadlines. Here’s what your organization needs to know to navigate 2026 successfully.

2025: EHR Certification Deadlines Shift Following Government Shutdown

Perhaps the most immediately relevant development for many organizations is the enforcement discretion announced by ASTP/ONC on November 24, 2025. Following the October-November government shutdown, the agency determined that the lapse in appropriations impacted the ability of healthcare entities to meet certain regulatory requirements.

The practical effect is straightforward; Health IT developers now have until March 1, 2026 to complete updates required under the HTI-1 Final Rule, for certification criteria that were originally scheduled to take effect January 1, 2026. For providers, the implications vary depending on their participation in quality programs.

Healthcare organizations participating in ACOs or other alternative payment models that require use of certified EHR technology for a full calendar year faced what was effectively a January 1, 2026 upgrade deadline. This two-month enforcement discretion window eliminates immediate pressure, allowing these providers to implement HTI-1 compliant systems through February without penalty.

For MIPS participants, the calculus is different. CMS regulations require use of 2026-certified technology for a minimum of 180 days, which translated to an unofficial mid-year upgrade deadline for most practices. Unless an organization was specifically planning to begin their attestation period in January or February 2026, this enforcement discretion will have minimal operational impact.

The separate attestation notice also extended the deadline for developer attestations from October 31, 2025 to January 1, 2026.

Key Resources:

• Certification Criteria Compliance Dates Enforcement Discretion Notice – Official ASTP/ONC notice on the March 1, 2026 extended deadline
• Attestations Condition and Maintenance of Certification Requirements Enforcement Discretion Notice – Official notice on developer attestation deadline extension
• ONC Health IT Certification Program – General certification program information

Outpatient Therapy Thresholds: The $2,480 Number to Remember

The August 2025 Federal Register correction to the CY 2026 Physician Fee Schedule proposed rule restored an inadvertently omitted section on outpatient therapy services. For organizations providing physical therapy, speech-language pathology, or occupational therapy services, the key number for 2026 is $2,480.

This figure represents the proposed KX modifier threshold for both the combined physical therapy and speech-language pathology category and for occupational therapy services separately. The threshold increased from $2,410 in 2025, reflecting the 2.7 percent Medicare Economic Index adjustment. When a beneficiary’s incurred expenses exceed this threshold, providers must append the KX modifier to attest that continued services are medically necessary and that supporting documentation exists in the medical record.

The medical review threshold remains unchanged at $3,000 and will stay at this level through 2027 before annual MEI adjustments begin in 2028.

Healthcare organizations should update their billing systems, staff training materials, and patient communication templates to reflect this new threshold before January 1.

Key Resources:

• CY 2026 PFS Proposed Rule Correction (Federal Register) – Full text of the correction document
• CY 2026 PFS Proposed Rule (Original) – Original July 2025 proposed rule
• CMS Therapy Services -CMS resource page for therapy services billing

Site of Service Migration: The Return of Outpatient-Focused Policy

The CY 2026 OPPS and ASC final rule, released November 21, 2025, signals a significant policy shift that will reshape where certain surgical procedures can be performed. CMS is returning to the approach initiated during the first Trump Administration, actively encouraging migration of procedures from inpatient hospital settings to lower-cost outpatient and ambulatory surgical center environments.

The most consequential change is the planned three-year elimination of the inpatient-only procedures list. Beginning in 2026, CMS will remove 285 procedures from this list, predominantly musculoskeletal procedures. This will have particular impact on orthopedic practices and the hospitals and ASCs that serve them.

Simultaneously, CMS is adding between 276 and 289 procedures to the ASC covered surgical procedures list, expanding the range of services that can be performed in these settings.

For context, this represents a reversal of the Biden Administration’s 2021 decision to reverse the first Trump Administration’s 2020 finalization of IPO list elimination. Healthcare organizations that adjusted their strategic planning after the 2021 reversal may need to re-calibrate once again.

The rule also strengthens hospital price transparency requirements beginning in 2026, continuing the regulatory focus on making healthcare costs more visible to patients.

Key Resources:

• CMS Press Release: CMS Empowers Patients, Boosts Transparency, Modernizing Hospital Payments – Official CMS announcement
• CY 2026 OPPS/ASC Final Rule Fact Sheet – Summary of key provisions
• Hospital Outpatient PPS – CMS OPPS resource page
• ASC Payment System – CMS ASC resource page
• Hospital Price Transparency – CMS price transparency requirements and resources

A New Chronic Care Model Emerges: Understanding ACCESS

CMS announced on December 1, 2025 the launch of the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a ten-year national demonstration program introducing what the agency calls an “outcome-aligned payment method” for chronic condition management.

The model establishes four clinical tracks: Early Cardio-Kidney-Metabolic (covering hypertension and obesity), Cardio-Kidney-Metabolic (diabetes and kidney disease), Musculoskeletal, and Behavioral Health (depression and anxiety). Participating providers will receive recurring payments tied to achieving defined clinical targets within these tracks, though CMS has not yet disclosed specific payment amounts.

What distinguishes ACCESS from other alternative payment models is its consent structure. Unlike ACO participation, which requires only provider agreement, ACCESS requires consent from both the individual patient and the provider. This makes the model functionally more similar to chronic care management or remote patient monitoring billing codes—voluntary add-on services with outcome-based payment variability rather than a comprehensive payment methodology transformation.

Applications will begin January 1, 2026, with the first participant cohort scheduled to begin July 1, 2026. However, as of this writing, CMS has not released the actual application or detailed payment specifications.

Medicare ACOs may find themselves particularly well-positioned for ACCESS participation given their existing care management infrastructure and focus on chronic condition populations. Health technology companies meeting CMS requirements, including Medicare provider enrollment and designated physician clinical director oversight, are also eligible.

Key Resources:

• ACCESS Model Overview – Official CMS Innovation Center model page
• ACCESS Model Technical FAQs – Detailed questions and answers about model requirements
• CMS Innovation Center – Information on all CMS demonstration models and alternative payment programs
• MobiHealthNews Coverage: CMS unveils ACCESS model to expand digital care for Medicare patients – Industry analysis of the announcement

HHS Releases AI Strategy

On December 4, 2025, the U.S. Department of Health and Human Services released its AI Strategy outlining how the department will integrate artificial intelligence across internal operations, research, and public health functions. The strategy was issued to comply with the Trump Administration’s AI Action Plan and related Executive Orders.

The strategy is organized around five pillars: ensuring governance and risk management; designing infrastructure and platforms for user needs; promoting workforce development and burden reduction; fostering health research and reproducibility; and enabling care and public health delivery modernization.

It’s important to note that this strategy applies to HHS internal operations and workforce, not to the healthcare delivery system that HHS regulates. However, HHS has indicated the strategy “paves the way for engagement with private sector stakeholders to co-create solutions,” suggesting potential future regulatory or collaborative initiatives affecting providers and health IT vendors.

Key Resources:

• HHS Press Release: HHS Unveils AI Strategy to Transform Agency Operations – Official announcement
• HHS Artificial Intelligence Strategy (PDF) – Full 21-page strategy document

MIPS Quality Measure Corrections Worth Noting

The Federal Register correction addressed several technical errors in the original proposed rule that MIPS participants should be aware of. Most significantly, the number of quality measures undergoing proposed substantive changes was corrected from 42 to 32—a meaningful difference for organizations tracking measure specifications.

Additionally, quality measure Q144 (Oncology: Medical and Radiation: Plan of Care for Pain) was restored to the Advancing Cancer Care MVP under the Radiation Oncology Clinical Grouping after being inadvertently omitted. Organizations participating in this MVP should ensure their quality reporting workflows account for this measure.

The improvement activities list for the Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP was also corrected, which may affect activity selection for relevant specialties.

Finally, a technical correction to the RVU Budget Neutrality Adjustment factor—from 1.0045 to 1.0055—will flow through to conversion factor calculations for both qualifying APM and non-qualifying APM participants.

Key Resources:

• Quality Payment Program – Official QPP portal for MIPS and APM information
• QPP Resource Library – Measure specifications, guides, and tools
• MIPS Value Pathways (MVPs) – Information on MVP participation
• CMS PFS Federal Regulation Notices – Access to proposed and final rules and public use files
• Medicare Physician Fee Schedule Look-Up Tool – Search for specific procedure payments

The ACA Subsidy Question Mark

While not a direct compliance requirement, healthcare organizations should monitor ongoing congressional activity around enhanced ACA premium tax credits. Senate Minority Leader Chuck Schumer announced a December 11 vote on a three-year extension of these enhanced credits, though the measure is not expected to pass.

The House is developing alternative legislation, and bipartisan compromise efforts continue, but passage of any extension before year-end remains unlikely. If the enhanced subsidies expire, Congressional Budget Office projections suggest approximately 2 million fewer individuals will be covered through ACA individual market plans in 2026.

For healthcare organizations, this translates to potential shifts in payer mix and coverage status for portions of their patient populations.

Planning for the Year Ahead

The regulatory landscape for 2026 presents both challenges and opportunities. The enforcement discretion on EHR certification requirements provides breathing room for organizations still completing HTI-1 implementations. The expansion of ASC-eligible procedures and phase-out of the inpatient-only list creates new service delivery options for surgical specialties. The ACCESS Model offers a new chronic care revenue opportunity for organizations positioned to meet its requirements.

At the same time, organizations must ensure their therapy billing reflects updated thresholds, their MIPS reporting accounts for corrected measure specifications, and their strategic planning incorporates potential coverage shifts from ACA subsidy changes.

The common thread across these developments is the importance of staying current with regulatory detail. Proposed rules receive corrections. Enforcement dates shift. New programs launch with applications not yet available. In this environment, proactive monitoring and flexible implementation planning remain essential competencies for healthcare compliance teams.

This article is intended for informational purposes only and does not constitute legal or compliance advice. Organizations should consult with qualified professionals regarding their specific regulatory obligations. Links to external websites are provided for reference; content at these URLs may change over time.