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New Compliance Requirements for Off-Campus Hospital Outpatient Departments – Next Steps for Hospitals and Health Systems

By Sukrti Thonse & James A. Robertson on March 30, 2026
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One of the most immediate developments affecting hospitals is a new compliance requirement for off-campus hospital outpatient departments (OPDs) enacted through the FY2026 federal appropriations bill.

Beginning January 1, 2028, hospitals must obtain a unique National Provider Identifier (NPI) for each of its off-campus outpatient departments. Hospitals will also be required to attest that each off-campus facility meets Medicare’s provider-based requirements. Failure to comply with these requirements may render the department ineligible for Medicare reimbursement.

Increased Scrutiny of Provider-Based Departments

The new statutory requirement builds on earlier site-neutral payment reforms and expands the Centers for Medicare & Medicaid Services’ (CMS) oversight of provider-based departments (PBDs). Historically, hospitals could bill certain off-campus facilities under the Outpatient Prospective Payment System (OPPS) if they met CMS provider-based criteria. This often resulted in higher reimbursement than services billed by freestanding physician offices.

Under the new provisions, CMS is expected to increase scrutiny of whether off-campus departments truly satisfy provider-based requirements under 42 C.F.R. § 413.65, including standards related to clinical integration, financial control, and public awareness of hospital affiliation.

Hospitals may face both prospective payment denials and potential recoupment of past payments if CMS determines that a department is improperly billing under OPPS.

Broader Site-Neutral Payment Trends

The new requirements are widely viewed as part of a broader federal push toward site-neutral payment policies. For example, CMS has already taken steps to expand site-neutral payments to certain drug administration services, and to begin phasing out the Medicare inpatient-only list. Increased transparency into off-campus billing patterns may further accelerate site-neutral payment reforms in future rulemaking.

Extension of Key Provider Programs

At the same time, the FY2026 appropriations package extends several provider-favorable programs, including:

  • Medicare telehealth waivers through 2027
  • The hospital-at-home program through fiscal year 2030
  • Supplemental payments for low-volume and Medicare-dependent hospitals
  • Add-on payments for ambulance services

Implications for Hospitals and Healthcare Stakeholders

Viewed collectively, these developments signal a continued federal shift toward greater transparency, tighter compliance oversight, and expanded site-neutral payment policies across care settings. Hospitals and health systems should begin evaluating their off-campus outpatient department structures well in advance of the January 1, 2028, compliance deadline, including confirming whether each location satisfies Medicare’s provider-based requirements under the federal regulations, and preparing for the operational implications of obtaining separate NPIs.

At the same time, stakeholders should closely monitor future regulatory and legislative activity and related appropriations measures that may further accelerate payment reform, increase scrutiny of hospital-affiliated outpatient operations, and reshape reimbursement dynamics across the healthcare system.

Proactive compliance planning and strategic review of outpatient facility structures may help providers mitigate financial exposure and adapt to the evolving federal policy landscape.

Photo of Sukrti Thonse Sukrti Thonse

Associate, Corporate and Healthcare

Sukrti supports clients across a broad range of corporate and regulatory matters, advising at all stages of the business lifecycle with a strong concentration in healthcare and healthcare-adjacent industries. She regularly counsels physicians, medispas, multi-state provider groups, hospitals, and…

Associate, Corporate and Healthcare

Sukrti supports clients across a broad range of corporate and regulatory matters, advising at all stages of the business lifecycle with a strong concentration in healthcare and healthcare-adjacent industries. She regularly counsels physicians, medispas, multi-state provider groups, hospitals, and private equity sponsors on compliant corporate structuring, operational strategy, and growth initiatives. She provides guidance to healthcare start-ups, physician practices, and hospital systems on day-to-day operational, regulatory, and strategic matters, and assists clients in navigating complex and novel regulatory issues in highly regulated, multi-jurisdictional environments, including multi-state regulatory compliance and expansion.

In her corporate practice, Sukrti assists with the formation and capitalization of business structures and prepares key documents for fundraising, financing, and investor negotiations. She provides support on M&A transactions and in the structuring and implementation of Management Services Organization-Professional Corporation (MSO–PC) and Friendly PC models, ensuring compliance with Corporate Practice of Medicine (CPOM) doctrines, fee-splitting laws, and state ownership restrictions. Her work frequently involves advising on management services arrangements, equity structuring, rollover investments, and platform acquisitions involving physician-owned entities and private equity-backed healthcare companies.

Sukrti also has significant experience in physician and provider contracting, including drafting and negotiating employment agreements, independent contractor arrangements, professional services agreements, and compensation models (including wRVU-based structures), with careful attention to regulatory compliance and commercial reasonableness. Her practice includes coordinating regulatory due diligence and assisting with disclosure requirements, including for entities operating in FDA-regulated sectors.  She regularly structures and negotiates compensation arrangements with physicians in connection with employment and exclusive contracting arrangements, medical directorships, physician recruitment initiatives, office and equipment leases, and other key operational documents that support healthcare delivery and scalable platform growth.

She has developed particular strength in healthcare privacy and HIPAA compliance and works closely with firm partners to advise on federal and state regulatory frameworks. Sukrti regularly conducts multi-state regulatory analyses, including 50-state surveys addressing licensure, supervision, telehealth, reimbursement, and scope of practice considerations, enabling clients to expand across jurisdictions while mitigating regulatory risk.

Results may vary depending on your particular facts and legal circumstances.

Contact information:

sthonse@greenbaumlaw.com | 732.476.2480 | vCard

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.

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Photo of James A. Robertson James A. Robertson

Partner and Practice Leader, Healthcare

Jim serves as trusted counsel to the entire healthcare sector. His practice spans the full spectrum of legal, regulatory, and corporate challenges facing healthcare entities.

With a deep technical command of reimbursement and payer strategy, Jim regularly represents…

Partner and Practice Leader, Healthcare

Jim serves as trusted counsel to the entire healthcare sector. His practice spans the full spectrum of legal, regulatory, and corporate challenges facing healthcare entities.

With a deep technical command of reimbursement and payer strategy, Jim regularly represents hospital systems and providers in high-stakes Medicare, Medicaid, and charity care subsidy matters. He possesses particular expertise in navigating disproportionate share hospital (DSH) and graduate medical education (GME) issues before state agencies and the federal Provider Reimbursement Review Board (PRRB). Jim further ensures the long-term sustainability of provider-payer relationships by negotiating complex Medicare Advantage and Managed Medicaid risk-sharing arrangements.

In the transactional arena, Jim provides comprehensive representation for mergers, acquisitions, joint ventures, and divestitures. He serves a diverse array of industry leaders, including for-profit and nonprofit hospital systems, academic medical centers, pharmaceutical companies, integrated delivery networks (IDNs), physician practices, and healthcare private equity funds. Jim is instrumental in the structural development of Clinically Integrated Networks (CINs), Accountable Care Organizations (ACOs), and Multiple Employer Welfare Arrangements (MEWAs), frequently securing necessary certifications from the New Jersey Department of Banking and Insurance (DOBI). His work encompasses the establishment and sale of individual and group practices, ambulatory surgery centers, nursing homes, and assisted living facilities, as well as the negotiation of executive contracts, recruitment initiatives, medical directorships, hospital department management, and office or equipment leases.

To mitigate operational risk, Jim guides clients through the development of robust corporate compliance programs and manages internal audits, government inquiries, and voluntary self-disclosures. His counsel ensures that provider arrangements satisfy the Stark Law, the federal Anti-Kickback Statute (AKS), and New Jersey’s Codey Law. He assists clients in seeking advisory opinions, obtaining Certificates of Need, and securing transaction approvals from the New Jersey Department of Health and the Attorney General under the Community Healthcare Asset Protection Act (CHAPA). His counsel ensures compliance with the Corporate Practice of Medicine (CPOM) doctrine and federal mandates including HIPAA, HITECH, the ACA, and Emergency Medical Treatment and Labor Act (EMTALA)—from drafting Business Associate Agreements (BAAs) to managing medical record retention and the physical or electronic storage of medical records.

Jim’s advocacy extends to medical staff matters, where he designs state-of-the-art bylaws and provides guidance on fair hearing requirements and strategic initiatives. Finally, he represents healthcare entities in business-critical litigation, including provider-payor disputes, restrictive covenant matters, and medical staff privileging hearings. By combining this granular knowledge of reimbursement and regulatory compliance with a veteran litigator’s perspective, Jim provides the strategic foresight necessary to navigate the administrative and operational hurdles of the modern healthcare landscape.

Results may vary depending on your particular facts and legal circumstances.

Contact information:

jrobertson@greenbaumlaw.com | 973.577.1784 | vCard | LinkedIn

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Healthcare Perspectives
  • Organization:
    Greenbaum, Rowe, Smith & Davis LLP
  • Article: View Original Source

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