A California medical practice and its physician have agreed to pay more than $6.73 million to resolve allegations that they violated the False Claims Act by submitting false claims for medically unnecessary vascular interventional procedures performed on 20 Medicare beneficiaries.
The United States alleged that, from 2016 to 2024, the physician performed medically unnecessary dialysis access interventions, including angioplasty and stent procedures, on 18 patients, purportedly to treat stenosis in dialysis segments.
According to the allegations, the physician scheduled interventions on a routine basis without waiting for complications to arise and frequently repeated procedures every few days or weeks despite the lack of clinical benefit. One Medicare patient reportedly received approximately 42 stents in a dialysis segment between 2016 and 2023, including during a period when the physician informed the patient that dialysis was no longer needed.
The United States also alleged that, from 2019 to 2024, the physician performed medically unnecessary peripheral artery disease interventions, including stent and atherectomy procedures, on 17 patients, purportedly to treat stenosis in their legs.
The physician allegedly performed procedures on patients with only mild or no stenosis and minor symptoms. Although some patients reported pain in only one leg, the physician allegedly treated both legs and repeated procedures every few months. He also allegedly told patients that failure to undergo the procedures could result in amputation, despite there being little risk of amputation for mildly symptomatic peripheral artery disease. One Medicare patient reportedly underwent approximately 16 atherectomies between 2019 and 2023.
According to the allegations, the physician performed interventional procedures on vessels that did not qualify for treatment under accepted standards of medical practice, overstated the degree of stenosis, falsely documented patient symptoms and conservative therapy measures, and performed procedures in excess of accepted medical standards.
Under the settlement agreements, the physician will pay nearly $6.51 million to the United States and nearly $229,000 to the State of California.
Compliance Perspective
Issue
All medical services billed to Medicare, Medicaid, or other federal healthcare programs must be medically necessary and supported by appropriate clinical documentation. Medical necessity generally refers to services that are reasonable and required for the diagnosis or treatment of a patient’s illness, condition, or symptoms in accordance with accepted standards of medical practice. When services are performed or billed without sufficient medical necessity, or when documentation does not adequately support the services provided, the claims may be considered false or improper under the False Claims Act. Violations can result in significant financial penalties, repayment obligations, and potential exclusion from participation in federal healthcare programs.
Discussion Points
- Review and maintain policies and procedures related to medical necessity determinations, documentation standards, and billing practices for Medicare and other federal healthcare programs. Policies should clearly outline expectations for clinical justification prior to the performance of procedures, as well as requirements for complete and accurate medical record documentation that supports services billed. Operational procedures should also address oversight of service utilization to help ensure that care provided aligns with accepted standards of practice and documented patient needs. Collaboration with a compliance consultant for an independent review of billing and documentation practices may assist in identifying potential risk areas and reinforcing alignment with regulatory requirements.
- Provide education for appropriate staff on medical necessity requirements, documentation standards, and False Claims Act compliance. Training should emphasize the importance of ensuring that clinical documentation accurately reflects services provided and supports appropriate billing practices, particularly for skilled services requiring clear clinical justification. Med-Net Academy offers the courses Understanding and Using the Medicare Triple Check Process, which reviews the importance of accurate billing for skilled services, prevention of false claims, reduction of claim denials and adjustments, and alignment between clinical documentation and financial data, and Liability of Fraudulent Documentation, which addresses the risks associated with incomplete or inaccurate documentation, including regulatory penalties and enforcement actions, and reinforces the importance of maintaining complete and accurate medical records to support compliant billing practices.
- Conduct periodic audits of clinical documentation and billing records to confirm that billed services are supported by documented medical necessity and consistent with accepted standards of care. Reviews may include evaluation of procedure frequency, adequacy of clinical justification, and alignment between documented patient condition and services rendered. Periodic independent review or consultant-supported audits can provide an objective assessment of compliance practices, assist in identifying patterns of potential overutilization, and support timely corrective action where needed. Contact Med-Net Healthcare Consulting or info@mednetconcepts.com for more information.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*