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.

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Photo of Sukrti Thonse Sukrti Thonse

Associate, Corporate and Healthcare

Sukrti supports the firm’s representation of clients in corporate transactions and in legal matters related to the healthcare sector, with experience across all stages of the corporate life cycle.

Her work includes the formation of corporate entities, including capitalization…

Associate, Corporate and Healthcare

Sukrti supports the firm’s representation of clients in corporate transactions and in legal matters related to the healthcare sector, with experience across all stages of the corporate life cycle.

Her work includes the formation of corporate entities, including capitalization structures, fundraising, financing, strategic issues, and negotiations with investors. She provides support related to merger and acquisition transactions, venture capital financings, public offerings, regulatory due diligence reviews, private equity investments, regulatory disclosures in securities filings, and transactions involving FDA-regulated entities. She also assists clients with issues related to corporate governance and day-to-day business operations.

Sukrti has developed expertise related to HIPAA compliance and other healthcare privacy issues. She provides guidance on regulatory frameworks, including those associated with FDA regulations, the Anti-Kickback Statute, Stark Law, and other healthcare compliance concerns.

Contact information:

sthonse@greenbaumlaw.com | 732.476.2480 | vCard

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

Photo of James A. Robertson James A. Robertson

Partner and Chair, Healthcare

Jim’s healthcare practice is reflective of his significant expertise across a wide range of legal disciplines, enabling him to effectively counsel clients on a myriad of healthcare regulatory, corporate and litigation matters. He represents a diverse array of healthcare…

Partner and Chair, Healthcare

Jim’s healthcare practice is reflective of his significant expertise across a wide range of legal disciplines, enabling him to effectively counsel clients on a myriad of healthcare regulatory, corporate and litigation matters. He represents a diverse array of healthcare industry clients including for-profit and not-for-profit healthcare and hospital systems, academic medical centers, nursing homes, home health agencies, medical device manufacturers, pharmaceutical companies, integrated delivery networks, physicians and physician practice groups, and healthcare private equity funds.

Jim provides comprehensive representation in connection with all types of healthcare transactions, including corporate mergers and acquisitions, joint ventures, and divestitures. He assists clients with the structuring and creation of clinically integrated networks (CINs), organized delivery systems (ODSs), accountable care organizations (ACOs), multiple employer welfare arrangements (MEWAs), and health insurance companies. He oversees the establishment and purchase/sale of individual physician and group practices, ambulatory surgery centers, nursing homes, and assisted living facilities. He structures and negotiates compensation arrangements with physicians in connection with employment and exclusive contracting arrangements, medical directorships, physician recruitment initiatives, hospital department management, office and equipment leases, and management services arrangements. He also negotiates managed care agreements and risk-sharing arrangements with payors and represents healthcare clients in payor litigation.

On the regulatory and compliance fronts, Jim regularly provides guidance on issues related to fraud and abuse laws, including the federal Anti-Kickback Statute and Stark Law, the New Jersey Codey Law, the certificate of need statute and Community Healthcare Asset Protection Act (CHAPA), as well as other regulatory compliance issues associated with healthcare transactions and physician-integration arrangements. He develops, implements, and maintains corporate compliance programs for hospitals and other providers in the healthcare industry and is well-versed in the compliance issues associated with, and the implementation of requirements under, the Health Insurance Portability and Accountability Act (HIPAA), the Emergency Medical Treatment and Labor Act (EMTALA), and the Affordable Care Act (ACA).

In the area of information privacy and data security, Jim advises healthcare clients on issues arising under HIPAA and the Health Information Technology for Economic and Clinical Health Act (HITECH). This includes the drafting and negotiation of HIPAA compliant business associate agreements with third party vendors, drafting and assisting in the enforcement of privacy and security policies within client organizations, and providing guidance on record retention requirements and the physical or electronic storage of medical records. In addition, he represents healthcare clients in investigating, reporting, and remediating information breaches and the liability such breaches create under various information privacy and security laws.

Jim assists clients in seeking advisory opinions from federal and state regulatory agencies, and regularly represents healthcare entities in Medicare, Medicaid, charity care, graduate medical education (GME) and disproportionate share hospital (DSH) reimbursement matters before state administrative agencies and the federal Provider Reimbursement Review Board. His work also encompasses internal audits and investigations, responding to government inquiries, investigations, subpoenas and search warrants, and providing advice in connection with voluntary self-disclosures and corporate integrity agreements (CIAs).

Jim is a resource for addressing medical staff matters, providing counsel on fair hearing requirements and designing state-of-the-art medical staff bylaws. He also provides guidance in connection with strategic initiatives on system affiliations including the establishment of outpatient health care offices, diagnostic imaging facilities and ambulatory surgery centers.

Contact information:

jrobertson@greenbaumlaw.com | 973.577.1784 | vCard | LinkedIn

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