STark Law

MedPro Systems and SAP Concur collaborate to help businesses capture and monitor expenses made to Healthcare Providers (HCPs). Leverage seamless and Comprehensive Stark Law Compliance with StarkLawID.

What is Stark Law?

First enacted by Congress in 1989, Section 1877 of the Social Security Act (referred to as the, ‘Physician Self-Referral Law’ or more commonly, ‘Stark Law’) was implemented to protect Medicare and other beneficiaries from costs associated with physician referrals for clinical laboratory services with which they had a direct financial relationship with. As part of the Omnibus Reconciliation Act of 1993, Stark Law was further expanded (Section 1903) to prohibit all referrals to ‘Designated Health Services (DHS)’ payable by Medicare with which the physician (or an immediate family member) has a financial relationship, unless an exception applies.

Since then, the Centers for Medicare & Medicaid Services (CMS) have published a number of rules and regulations interpreting the Stark Law statute, defining covered DHS entities and petalites for non-compliance.

The Importance of Complying with Stark Law

Regulatory compliance requires adherence to numerous laws, regulations and ethical codes that govern the healthcare industry. In general, these are in place to ensure that healthcare entities and professionals operate within a framework that prioritizes patient safety, data confidentiality and upholds the integrity of medical practices.

Federal fraud and abuse laws include the Physician Self-Referral Law [42 U.S.C. § 1395nn], commonly referred to as the Stark law, which prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. 

Stark Law requires transparency reporting to demonstrate the monetary connections made by medical device manufacturers and pharmaceutical companies to physicians and teaching hospitals. These mandated reporting requirements are intended to provide a policy goal of preventing inappropriate financial influence on education, research and patient clinical decision-making.

The federal entities overseeing the enforcement of Stark Law include: the Department of Justice (DOJ), the Centers for Medicare and Medicaid Services(CMS) and the Department of Health and Human Services Office of Inspector General (HHS OIG). At its core, it is designed to eliminate any potential conflict of interest that could cloud medical judgment. By ensuring that healthcare decisions are solely guided by patients’ best interests, devoid of any financial incentives for physicians, it upholds the ethical standards and transparency crucial to healthcare services. 

Under the Stark Law, any HCP, healthcare system, or hospital covered by the statute faces strict liability for violations. They can be found at fault for breaches, irrespective of intent or awareness. In other words, merely demonstrating an improper referral suffices to establish liability, regardless of whether the HCP was aware of potential financial or familial conflicts.

Violation of the Stark Law may require the HCP to refund all payments for the improper amounts collected; to pay up to $15,000 per improper referral; and to be excluded from all federal healthcare programs.

Applicable DHS Entities Covered Under Stark Law

  • Clinical laboratory services
  • Physical therapy services
  • Occupational therapy services
  • Outpatient speech-language pathology services
  • Radiology and certain other imaging services
  • Radiation therapy services and supplies
  • Durable medical equipment and supplies
  • Parenteral and enteral nutrients, equipment and supplies
  • Prosthetics, orthotics and prosthetic devices and supplies
  • Home health services
  • Outpatient prescription drugs
  • Inpatient and outpatient hospital services

What Healthcare Organizations Need to Know

There is an exception in Stark Law which allows DHS entities to provide non-monetary compensation to Healthcare Professionals (HCPs) up to an aggregate amount each year (adjusted annually for inflation).

For the calendar year of 2025, if the aggregate amount goes above $519, the DHS provider will face penalties for violating Stark Law including but not limited to civil penalties per violation, exclusion from the Medicare and a denial of refund from Medicare.

It is up to the DHS provider to track and record non-monetary compensation expenses and any errors or overages are expected to be reported to CMS using the Self-Referral Disclosure Protocol. To Learn more about Stark Law regulations, please visit the CMS website: https://www.cms.gov/.

How MedPro Systems Can Help

The MedPro Concur Connect suite offers DHS entities a comprehensive approach for monitoring non-monetary compensation to HCPs to streamline Stark Law compliance.

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MedPro Concur Connect – Expense

Enables Sales Representatives to access MedPro data directly within Concur Expense to capture key HCP identifiers in real time, empowering accurate matching and reporting.

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MedPro Concur Connect – Export

Expense data is exported to MedPro via automated Concur Attendee Detail Extract (ADE) files, securely delivered via MedPo hosted FTP.

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MedPro Data Matching, Tracking and Report Creation

After Export, MedPro automatically loads the ADE files and matches HCP against the MedProID database to aggregate spend . Stark customers will be given access to MedPro Compliance Reporting ID to view our Stark Law Analytics report. This report will track unique physicians and the current aggregate spend against them across your organization.

MedPro’s reports and dashboards enable you to stay ahead of potential overages and compliant with Stark law, avoiding fines or penalties. Find activity trends with HCPs and your own sales representatives to accurately and efficiently manage expenditures and reporting.

CUSTOMER CASE STUDY

Streamlined Stark Law Compliance

How MedPro Systems offers DHS entities a comprehensive approach for monitoring and reporting non-monetary compensation to HCPs using MedPro’s expense capture integrations and Stark Law solutions.   

  • “MedPro Systems is one of the easiest vendors to work with and the customer service and responsiveness is second to none. The ease and confidence of these reports with the data makes all the difference.” 
Pharma lab

To help support their 19 million patients, the largest, full-service specialty laboratory in the United States utilizes SAP Concur Expense to track HCP engagements for their 140 sales representatives and external vendors. 

As a Clinical laboratory services provider, identified by CMS as a DHS organization, they are required to report on their HCP non-monetary spend to CMS to comply with Stark Law. 

MedPro Systems’ award-winning expense platform integrations paired with our MedPro Compliance Reporting ID (MCR), enabled the US leader in specialty laboratory services to automate their Healthcare Professional (HCP) expense capture to track aggregated non-monetary spend across their organization, ensuring Stark Law compliance. 

 With a rapidly growing sales team, this clinical laboratory relied on their expense capture platform to manually enter HCP data—names, taxonomy codes, NPI numbers, and more. As their sales organization expanded, this specialty laboratory depended on this process to manually capture HCP data—including names, taxonomy codes and NPI numbers. 

They also needed to reduce the manual burden on the compliance team, allowing them to focus on broader priorities—without requiring additional headcount or resources. With a manual process for generating Stark Law expense reports the compliance team spent nearly an hour per sales rep, forcing them to limit which individuals they could audit.  Lacking a consolidated view of total spend across the organization, they faced heightened compliance risk and spent valuable time resolving duplicate records and data errors. Meanwhile, the sales team had no automated way to track their non-monetary HCP spend to date, leaving them unaware of how close they were to reaching Stark Law thresholds. 

MedPro Systems collaborated closely with this customer to identify risk areas and develop a proactive roadmap to address their pain points. 

First, MedPro implemented MedPro Concur Connect (MPCC) Expense, providing access to the industry-leading MedProID database directly within SAP Concur Expense. This gave the sales team the ability to quick search and select accurate HCP details – eliminating the need for manual entry and improving data quality at the point of capture. 

Next, MPCC Export was implemented, automating Attendee Detail Extract (ADE) files from SAP Concur Expense into MCR – MedPro’s comprehensive Stark Law tracking and reporting module. 

MedPro’s Stark Law solution enabled detailed organization-wide aggregated reporting  capabilities by matching the ADE reports to the MedProID database and aggregating non-monetary spend per HCP.  Monthly reports—both at the admin and individual sales rep level—are sent to the compliance team and relevant field reps, ensuring full visibility into spend activity before CMS Stark Law thresholds are exceeded. 

Reports include visual indicators to highlight how close each HCP is to the annual limit, proactively flagging potential compliance risks before they become issues. 

MedPro’s comprehensive and automated approach allowed a compliance team of just eight people to confidently oversee more than 140 sales reps—without the need to hire additional resources. 

What once took hours now happens automatically. Manual report building has been eliminated, saving valuable time and reducing the risk of human error. 

With clear, actionable reports delivered monthly, sales reps can now proactively monitor their own spend, and the compliance team has a reliable, aggregated view of HCP interactions—ensuring the organization stays ahead of Stark Law limits. 

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