The Fox Group has extensive experience helping hospitals evaluate provider-based compliance, Medicare enrollment, and the operational requirements affecting off-campus hospital outpatient departments. That experience makes one point clear: even narrowly written regulatory requirements can create significant documentation, oversight, and implementation obligations.
Executive Summary – Key Takeaways
- Begin off-campus HOPD compliance reviews well before attestation.
- Brief requirements create extensive operational and documentation obligations.
- Separate NPIs require coordinated enrollment, billing, and systems changes.
- Audit-ready evidence must support every compliance determination.
Table of contents
- New Attestation and NPI Requirements for Off-Campus HOPDs
- Requirements for both On and Off-Campus Outpatient Departments
- Additional Requirements for Off-Campus Hospital Outpatient Departments
- Documentation of Compliance with the Requirements for Off-Campus Outpatient Department
- Download the Expanded Off-Campus HOPD Compliance Checklist
- Begin Reviewing Off-Campus HOPD Compliance Now
- Off-Campus HOPD Compliance: Frequently Asked Questions
New Attestation and NPI Requirements for Off-Campus HOPDs
Hospitals that currently operate, or are planning to open, provider-based off-campus hospital outpatient departments should begin evaluating their compliance now.
These new requirements for off-campus departments are courtesy of Section 6225 of the Consolidated Appropriations Act of 2026.
The provider-based requirements of this section are brief, but they imply a great deal of effort on the part of hospitals that currently operate, or are planning to open, provider-based off-campus hospital outpatient departments:
- Hospitals must submit a provider-based attestation that they are in compliance with the provisions of 42 CFR 413.65.
- Hospitals must have applied for and be using a distinct National Provider Identifier for each off-campus hospital outpatient department that is providing services to Medicare patients.
For additional guidance, see our articles on provider-based attestation readiness for off-campus HOPDs and off-campus HOPD NPI requirements.
Another month (or week) and another issue for hospital compliance professionals to put on their to-do list.
Here is a detailed look at the requirements in 42 CFR 413.65 that you can use as a checklist to review your current compliance or prepare for an initial attestation. In this list, the term “hospital” also includes critical access hospitals.
Requirements for both On and Off-Campus Outpatient Departments
Here is a practical checklist hospitals can use to evaluate whether their off-campus hospital outpatient departments meet key provider-based requirements. Review each item based on current operations and available documentation. A “yes” response should be supported by records that can be produced during an attestation review, remote audit, or site visit.
|
Compliance Requirement |
Review Status |
|---|---|
|
Licensure |
|
|
Is the HOPD listed on the hospital’s state license? |
◻ Yes |
|
If state law does not permit that, is the HOPD licensed under another applicable healthcare organization category? |
◻ Yes |
|
If required by the state, is the HOPD operating under a separate state license? |
◻ Yes |
|
Has any state cost review commission or other applicable state agency determined that the HOPD is not part of the hospital? |
◻ Yes |
|
Integration of Clinical Services |
|
|
Does the professional staff of the HOPD have clinical privileges at the hospital? |
◻ Yes |
|
Is the HOPD integrated into the same monitoring and oversight processes as other hospital clinical departments? |
◻ Yes |
|
Does the medical director of the HOPD report to the hospital’s chief medical officer? |
◻ Yes |
|
Is the HOPD medical director subject to the same requirements for frequency, intensity, and accountability as other clinical service medical directors? |
◻ Yes |
|
Are hospital medical staff committees responsible for quality assurance, utilization review, and other medical staff functions also responsible for those activities in the HOPD? |
◻ Yes |
|
Are HOPD patient medical records incorporated into, or cross-referenced with, the hospital’s patient medical records? |
◻ Yes |
|
Are HOPD patients able to access all other hospital inpatient and outpatient services at the main provider hospital without barriers? |
◻ Yes |
|
Financial Integration |
|
|
Are the financial operations of the HOPD fully integrated with the hospital? |
◻ Yes |
|
Are the HOPD’s income and expenses incorporated into the hospital’s financial systems and reporting? |
◻ Yes |
|
Is the HOPD listed in the hospital’s chart of accounts as a separate cost center? |
◻ Yes |
|
Is the HOPD’s financial status identifiable in the hospital’s trial balance? |
◻ Yes |
|
Public Awareness |
|
|
Is the HOPD held out to the public and to payers as part of the hospital? |
◻ Yes |
|
Are HOPD patients made aware that they are receiving services in a setting which is part of the hospital and will be billed accordingly? |
◻ Yes |
HOPDs generally must be included on the hospital’s state-issued license unless state licensing regulations do not permit such facilities to be part of a hospital’s licensed facilities. Where required, the hospital must operate the HOPD under a separate state license. If a state cost review commission or other applicable agency determines that the HOPD is not part of the hospital, CMS will determine that the department does not have provider-based status.
Additional Requirements for Off-Campus Hospital Outpatient Departments
Off-campus outpatient departments also several other requirements that apply to their organization and operations.
|
Compliance Requirement |
Review Status |
|---|---|
|
Hospitals must exercise control over off-campus outpatient departments in several ways. |
|
|
Is the business entity that constitutes the OCHOPD 100% owned by the hospital? |
◻ Yes |
|
Is the OCOHPD subject to common bylaws requirements and operating decisions of the hospital governing body? |
◻ Yes |
|
Does the hospital have final responsibility for administrative decisions, final approval for contracts with outside parties, final approval for personnel actions, final responsibility for personnel policies (such as fringe benefits or code of conduct), and final approval for medical staff appointments in the OCOHPD? |
◻ Yes |
|
Administration and Supervision requirements for off-campus outpatient departments. |
|
|
Is the OCHOPD under direct supervision of the hospital? |
◻ Yes |
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Is the OCHOPD operated under the same monitoring and oversight by the hospital as any other department of the hospital? |
◻ Yes |
|
Does the director or manager of the OCHOPD report to a manager at the hospital, and have the same accountability and responsibility as other hospital directors or managers? |
◻ Yes |
|
Is the director or manager of the OCHPD accountable to the governing body in the same way as other hospital directors or managers? |
◻ Yes |
|
Are administrative functions—including billing, records, human resources, payroll, employee benefits, salary structure, and purchasing—furnished by the hospital to the OCHOPD? |
◻ Yes |
|
If any administrative functions are contracted to an outside source, does the hospital monitor the applicable contracts? |
◻ Yes |
|
Location |
|
|
Is the OCHOPD within a 35-mile radius of the hospital, or does it meet other conditions related to disproportionate share compensation and overlap of patient population with the hospital? (See the regulations for several exceptions.) |
◻ Yes |
|
Public Awareness |
|
|
Does the OCHPD furnish a notice to Medicare beneficiaries prior to rendering services explaining the additional financial responsibility the beneficiary may incur by receiving services in the OCHPD, including the amount, if known? |
◻ Yes |
|
National Provider Identifier (NPI) |
|
|
Effective not later than December 31, 2027: has the OCHPD applied for, received and begun using an NPI for the OCHPD location? |
◻ Yes |
The 35-mile radius is not the only pathway for satisfying the provider-based location requirement. Under 42 CFR § 413.65(e)(3), certain facilities may qualify based on factors such as the hospital’s disproportionate share status, integration with the main provider and overlapping patient populations, limited operating history, qualifying children’s hospital neonatal intensive care arrangements, or rural health clinic status. In all cases, the facility and main provider must be located in the same state or, where permitted under both states’ laws, in adjacent states.
Documentation of Compliance with the Requirements for Off-Campus Outpatient Department
Naturally, simply answering questions in the affirmative is not enough. The law revising the Social Security Act to address the separate NPI and attestation requirements also directs the Secretary of Health and Human Services (HHS) to establish a process for attestations, as well as remote audits or site visits of the attestation requirements.
Hospitals should therefore create and retain all documentation supporting their compliance with the attestation requirements. This should include:
|
Documentation Requirement. |
Documentation Status |
|---|---|
|
An inventory of all off-campus locations, including documentation of distance and location, and confirmation each remote location’s provider-based and Medicare enrollment status. |
◻ Available |
|
Classification of each service location and service line as excepted or non-excepted where applicable. |
◻ Available |
|
Validation of claims reporting; correct NPI’s, service facility addresses, modifiers, revenue codes, and payer-specific requirements. |
◻ Available |
|
Copies of signage, patient notices, registration scripts, estimates, and billing explanations. |
◻ Available |
|
Evidence of clinical, financial, administrative, and medical record integration with the main provider, plus oversight by the governing body. |
◻ Available |
|
Documentation of any relocation, ownership, service expansion, or operational changes that could affect status. |
◻ Available |
Attestations can be submitted as early as January 1, 2026. It is never too early to begin preparing and verifying compliance. Every hospital operating an off-campus hospital provider based outpatient department has a lot at stake to get this right!
Download the Expanded Off-Campus HOPD Compliance Checklist
This downloadable version of the “Core Off-Campus HOPD Compliance Checklist” expands the on-page checklist into a fillable working document for reviewing an individual off-campus HOPD. It includes location-specific identification fields, space to document evidence and corrective actions, and a summary section for tracking follow-up.
Unlike the simplified checklist shown in the article, the downloadable version is designed for practical use by compliance, reimbursement, enrollment, and operational teams. It can be completed separately for each off-campus HOPD and retained with the organization’s supporting compliance records.
Use the fillable PDF to document review status, supporting evidence, corrective actions, and follow-up responsibilities.
Begin Reviewing Off-Campus HOPD Compliance Now
Attestations and be submitted as early as January 1, 2027, but hospitals should not wait until then to begin preparing. Reviewing each off-campus HOPD against the provider-based requirements, confirming the correct NPI is in use, and assembling supporting documentation will take time, particularly where multiple departments, service lines, or operational changes are involved.
Hospitals that identify gaps now will have more time to correct them before attestation, remote audit, or site-visit activity begins. The downloadable checklist below combines the requirements in this article into one working document that compliance teams can use to organize their review and document follow-up actions.
Off-Campus HOPD Compliance: Frequently Asked Questions
An off-campus HOPD review should cover general provider-based requirements and the additional conditions applicable to off-campus locations.
The general requirements include licensure, clinical integration, financial integration, public awareness, and hospital outpatient department obligations. Off-campus locations must also satisfy requirements involving hospital ownership and control, administration and supervision, geographic location, beneficiary notices, and any applicable management arrangements.
Yes. Hospitals should assess each off-campus HOPD separately because compliance depends on department-specific operations, records, and circumstances.
CMS’s proposed attestation process calls for identifying each department by information such as its NPI, provider number, address, and applicable status date. A separate working checklist for each location will make deficiencies and supporting evidence easier to track. For submission considerations, see our related article on provider-based attestation readiness.
No. A completed checklist is a readiness tool, not a CMS determination or a substitute for the required attestation.
Hospitals must maintain documentation supporting the basis for their compliance representations. CMS or its contractors may request that evidence during attestation review, validation, audit, or other oversight activities. A checked “Yes” box is therefore meaningful only when current records and actual operations support the response.
A “No” or “Needs Review” response should become a documented remediation item before the hospital attests to compliance.
The hospital should determine whether the issue is an operational deficiency, missing documentation, or both. It should then assign responsibility, identify corrective action, establish a completion date, and retain evidence of resolution. Issues affecting enrollment, claims, ownership, governance, or patient notices may require coordination across several departments.
No. The 35-mile radius is one pathway, but 42 CFR § 413.65(e)(3) provides limited alternatives.
Other pathways address certain hospitals with qualifying disproportionate-share characteristics, facilities demonstrating substantial integration and overlapping patient populations, newly operating facilities, specified neonatal intensive care arrangements, and qualifying rural health clinics. The facility and main provider must also be in the same state or, where both states permit it, adjacent states.
Hospitals should repeat the review whenever a material operational change occurs and before any required subsequent attestation.
Relevant changes may include relocation, ownership changes, new management contracts, service expansion, governance changes, or altered clinical and financial integration. CMS has proposed requiring subsequent attestations at an interval it will specify, not exceeding five years, but the final cadence has not yet been established.