Provider-based attestation compliance for off-campus hospital outpatient departments (HOPD) remains a high-risk Medicare issue for hospitals, particularly for off-campus clinics and recently acquired physician practices.
Provider-based status allows hospitals to bill under the Hospital Outpatient Prospective Payment System (OPPS) at more favorable rates designed to cover higher hospital overhead, and allow the ability to utilize the 340B drug program at these locations. The Consolidated Appropriations Act of 2026 formally requires attestation of compliance with complex regulations and significantly penalizes noncompliance.
Hospitals need to start preparing a compliance framework to review their provider-based compliance and to outline how it will meet the new attestation requirements. The underlying regulations that need to be reviewed under 42 CFR § 413.65 are not changing, so hospitals shouldn’t wait until Centers for Medicare & Medicaid Services (CMS) issues new implementation instructions to start their review.
CMS hasn’t required hospitals to submit attestations to confirm compliance with the regulations under 42 CFR § 413.65 for over 20 years. Attestations were voluntary yet beneficial in reducing financial risk of being out of compliance. Other than the voluntary attestation process, hospitals needed to act in good faith that the regulations were being followed.
With the passage of The Consolidated Appropriations Act on February 3, 2026, hospitals must be aware of the new requirements on the attestation process for HOPDs and act accordingly or lose the status.
Here’s what you need to know about the Consolidated Appropriations Act of 2026 as it relates to provider-based attestation compliance.
Provider-based attestation is the hospital’s formal representation to CMS that a clinic, department, or facility qualifies as a department of the hospital, rather than a freestanding entity. When a location meets provider-based requirements, the hospital may bill Medicare under the OPPS, including a facility fee.
Through the attestation process, hospitals must maintain documentation of the basis for its attestations and make that documentation available to CMS and to CMS contractors upon request.
The attestation process will extend to all hospitals that operate an off-campus provider-based department located more than 250 yards from the hospital. While not specified, Critical Access Hospitals (CAH) should be ready to follow the same process. While CAH are not reimbursed under OPPS, their ability to bill as part of the hospital and receive cost-based reimbursement is subject to the same regulations under 42 CFR § 413.65.
From a compliance perspective, the greatest risk is misalignment between the attestation and actual operations. CMS is expected to focus on ownership and control, clinical and financial integration, public awareness, and Emergency Medical Treatment and Labor Act (EMTALA) compliance when applicable. Changes in staffing models, management agreements, branding, billing, workflows, or cost reporting can quietly undermine provider-based status over time.
Potential noncompliance of all provider-based regulations can lead to overpayment issues and fraud, waste and abuse issues, and the ability to enroll a location into the 340B program.
CMS audits typically relate to one or more of these items.
CMS audits often rely heavily on staff interviews and operational validation. When operational reality contradicts the attestation, hospitals may face retroactive repayment of facility fees, reclassification of the site, and corrective action requirements.
Net revenue will be reduced to site-neutrality levels. Reductions can be significant given that HOPD reimbursement can be 1.5–3x higher than standard non-hospital outpatient reimbursement.
Hospitals should treat provider-based status as a living compliance obligation, not a one-time designation. Periodic assessments, alignment between operations and billing, and leadership-level risk review are essential to mitigating audit exposure and start now because mitigation efforts can take time.
Provider-based attestation is not about checking a box for reimbursement. It’s about demonstrating, every day, that a location truly functions as part of the hospital.
If CMS audited tomorrow, your operations—not your paperwork—would decide the outcome. That’s the standard hospitals should be prepared to meet.
The provider-based attestation process is time-consuming and complex to navigate. To learn more about provider-based attestation and how it can help your organization in meeting these requirements, contact your firm professional.
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