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Provider-Based Attestation and NPI Requirements for Off-Campus HOPDs

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Published April 6th, 2026
Detected April 7th, 2026
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Summary

The Consolidated Appropriations Act of 2026 requires hospitals with off-campus HOPDs to submit provider-based attestations and obtain separate NPIs by January 1, 2028. Non-compliant off-campus HOPDs will lose Medicare payment eligibility and potentially 340B drug pricing access.

What changed

The Consolidated Appropriations Act of 2026 (enacted February 3, 2026) adds two new requirements for off-campus HOPDs effective January 1, 2028. First, hospitals must submit provider-based attestations for each off-campus HOPD evidencing compliance with 42 C.F.R. § 413.65, even if previously exempt under the Balanced Budget Act of 2015 site neutrality rules. Second, hospitals must obtain and bill under a separate NPI for each off-campus HOPD. These requirements apply to sites located more than 250 yards from the main hospital campus or remote hospital locations.

Hospitals should immediately inventory all off-campus HOPD sites, assess compliance with 42 C.F.R. § 413.65 requirements, and prepare attestations using the existing framework while awaiting CMS rulemaking. The compliance deadline of January 1, 2028 is firm—HOPDs failing both attestation and NPI requirements will be ineligible for Medicare payments and may lose access to 340B pricing, creating significant revenue and access risks.

What to do next

  1. Inventory all off-campus HOPD sites to identify locations more than 250 yards from the main campus or remote hospital locations
  2. Assess each off-campus HOPD's compliance with 42 C.F.R. § 413.65 provider-based requirements
  3. Prepare and submit provider-based attestations between January 1, 2026 and January 1, 2028, and obtain separate NPIs for each off-campus HOPD

Penalties

Loss of Medicare payment eligibility for non-compliant off-campus HOPDs; potential loss of 340B drug pricing access

Source document (simplified)

April 6, 2026

Off-Campus HOPDs: Prepare Now for Mandatory Provider-Based Attestations

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Summary — **** Off-campus hospital outpatient departments (HOPDs) must submit provider-based attestations evidencing compliance with the Medicare provider-based regulations and obtain a separate NPI for each off-campus HOPD. HOPDs that fail to take these steps are not eligible for Medicare payments, beginning January 1, 2028.

The Consolidated Appropriations Act of 2026 (the “Act”), enacted on February 3, 2026, included two new requirements for HOPDs:

  1. Beginning January 1, 2028, hospitals must have submitted a provider-based attestation dated on or after January 1, 2026 for each off-campus HOPD evidencing compliance with the Medicare provider-based regulations at 42 C.F.R. § 413.65. This requirement applies even if the hospital previously submitted a voluntary provider-based attestation prior to January 1, 2026. Additionally, the statute requires that hospitals routinely submit provider-based attestations on a go-forward basis for their off-campus HOPDs on a cadence to be developed by CMS in the future.
  2. Beginning January 1, 2028, hospitals are required to obtain and bill under a separate NPI for each off-campus HOPD. Off-campus HOPDs that do not comply with both #1 and #2 are not eligible for Medicare payments, even if the HOPD was “grandfathered” under the site neutrality rules that were previously passed as part of the Balanced Budget Act of 2015. In addition to the significant reimbursement implications, failure to satisfy these new requirements may also potentially jeopardize the off-campus HOPD’s access to 340B pricing.

As a refresher, “off-campus HOPD” means any site located more than 250 yards from the main hospital campus or more than 250 yards from a remote location of the hospital. A “remote location of a hospital” is a facility that furnishes inpatient hospital services under the name, ownership, and financial and administrative control of the main hospital.

A provider-based attestation is a formal representation to CMS that the HOPD qualifies as a department of the hospital, i.e., that it meets the requirements set forth in 42 C.F.R. § 413.65. Provider-based attestations have historically been voluntary since 2002, and while some health systems previously submitted voluntary attestations, many have not. The preparation of provider-based attestations is an administratively tedious and time-consuming process, often involving significant back-and-forth exchanges of information with the applicable Medicare Administrative Contractor (MAC) before the MAC (and ultimately CMS) is willing to reach a determination as to whether the site meets the provider-based requirements.

The Act requires CMS to establish rules regarding the new provider-based attestation process, which have not yet been released. In the meantime, the Act permits hospitals to submit attestations under the existing framework set forth in 42 C.F.R. § 413.65(b)(3). Understandably, some providers may wish to hold off on submitting attestations until the new CMS rules are released in case the new rules streamline the prior process. We recommend that these providers nevertheless take steps now to assess their current compliance by conducting an inventory of their off-campus HOPD sites and evaluating each site’s compliance with the provider-based requirements at 42 C.F.R. § 413.65 so they are ready to move forward with the attestations when the new CMS rules are released.

Key Takeaways

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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Williams Mullen
2026

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CFR references

42 CFR 413.65 42 CFR 413.65(b)(3)

Named provisions

Provider-Based Attestation Requirements Separate NPI Requirements Site Neutrality Grandfathering Elimination

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
CMS
Published
April 6th, 2026
Compliance deadline
January 1st, 2028 (634 days)
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Consolidated Appropriations Act, 2026

Who this affects

Applies to
Healthcare providers Hospitals
Industry sector
6211 Healthcare Providers 6221 Hospitals & Health Systems
Activity scope
Medicare Billing Provider-Based Attestation 340B Drug Pricing
Threshold
Off-campus HOPDs defined as sites located more than 250 yards from the main hospital campus or more than 250 yards from a remote location of the hospital
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Compliance frameworks
GxP
Topics
Medicare Hospital Outpatient Departments Provider-Based Attestations

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