Significant Changes in Compliance and Payment for Off-Campus Outpatient Departments

Section 6225 of the Consolidated Appropriations Act, 2026, introduces significant changes in compliance and payment protocols for off-campus outpatient departments. On July 7, 2026, the Centers for Medicare & Medicaid Services (CMS) unveiled a proposed regulation to align current rules with these new statutory requirements, inviting public feedback until August 31, 2026.

Starting January 1, 2028, any off-campus outpatient department not meeting two critical conditions—compliance with attestation mandates and possessing a distinct National Provider Identifier (NPI)—will be ineligible for payments under the Outpatient Prospective Payment System (OPPS). The proposed regulation seeks to amend the provider-based rule in 42 CFR 413.65, clarifying the attestation process and related compliance expectations.

A key aspect of the proposal includes defining "off-campus outpatient department" similarly to the statutory language. Specifically, this includes facilities not located on the main hospital campus or beyond 250 yards from a remote hospital location. Those within 250 yards of remote sites will not need to adhere to new attestation or NPI stipulations, a distinction impacting multicampus hospital operations.

For existing departments, initial attestations are required by December 31, 2027. Submissions made within two years before January 1, 2028, will satisfy the new requirements, even if the provider-based status hasn't yet been assigned. New departments must submit their attestations two years before service provision, with further attestations needed every five years—a frequency CMS plans to address in future regulations.

Providers must sign attestations using an official identified in the Provider Enrollment, Chain, and Ownership System (PECOS), submitting these via a CMS-standardized electronic platform still in development. CMS aims to create a uniform attestation template, although current templates will be accepted until the new version is ready. Documentation highlighting compliance with 42 CFR 413.65’s various requirements, such as structural and clinical integration, is necessary, but not all must accompany the initial attestation unless specifically requested.

CMS also seeks input on potentially allowing departments with a pre-2026 provider-based status to verify ongoing compliance through a letter, instead of the initial attestation. Compliance verification will involve CMS and MAC approvals if attestations show adherence to the specified requirements. Should an attestation fail to meet these, CMS will issue a denial, with any such decisions open to appeal via typical administrative channels.

From January 1, 2028, OPPS payments will require off-campus outpatient departments to have a unique NPI, separate from their main facility, an inclusion that must be part of their provider-based status attestation. The impending regulations require preparatory actions by hospitals aiming to comply by the outlined deadlines. Stakeholders are encouraged to engage in the comment process, which remains open until the end of August 2026.