Joseph Potashnik & Associates PC healthcare attorneys assist independent clinical laboratories and physician-owned laboratories with complex regulatory and legal issues including:

• Clinical Laboratory Improvement Amendments (CLIA) certification and compliance
• Compliance with the Stark law and federal Anti-Kickback Statute
• HIPAA compliance
• FDA compliance
• Medicaid and Medicare participation issues
• RAC, ZPIC, MAC, Medicare, Medicaid or private payor auditsand appeals
• Marketing and labeling
• State licensure
• Clinical research contracts and institutional review board (IRB) compliance

Clinical Laboratory Compliance Attorneys

Clinical laboratories are subject to numerous federal regulations. OIG’s Compliance Guidance for Clinical Laboratories outlines and clarifies the risk areas clinical laboratories face and suggests the steps all clinical laboratories should take as part of their compliance programs to make sure that their billing practices are in accordance with the requirements.

The main risk areas faced by clinical laboratories as outlined by the OIG include:

Medical Necessity– According to the Lab Guidance, clinical labs must take specific affirmative steps to make sure that physicians only order medically necessary tests. For example, labs should modify their requisition forms to collect the correct information. Medical codes submitted by the physicians should be verified for accuracy. Also, labs should include provisions in their compliance plans for the proper use of the Advance Beneficiary Notices and test utilization monitoring.

Billing–clinical laboratories must ensure that the codes such as CPT, HCPCS, and ICD-9-CM, which are used to bill are appropriately used and fully describe the service that was ordered and performed. Labs are not allowed to bill for both calculations and the tests that are performed to derive such calculations.

Reliance on standing orders– clinical laboratories may permit the use of standing orders but according to the OIG, these orders must be monitored. They should have a fixed term of validity and must be renewed when expire.

Fraud Alert Compliance– the OIG demands that clinical laboratories must review and follow government-issued fraud alerts

Marketing Practices– clinical labs’ compliance plans must include policies ensuring that the labs’ marketing is honest and non-deceptive.

Prices charged to Physicians – laboratories must take steps to prevent issues that may arise with the prices they charge physicians, such as providing inducement to gain a physician’s business. An example would be charging prices below fair market value.

Clinical Laboratories Audit Lawyers

We assist independent laboratories and physician-owned laboratories in Medicare and Medicaid audits, investigations and appeals. We have extensive experience handling Medicare and Medicaid audits and appeals utilizing top-notch experts and winning legal strategies. Clinical laboratories and physician-owned laboratories have unique issues affecting them; the attorneys work hand in hand with their clients to come up with the best strategy for an audit defense.

The appeals strategies we use have helped reduce the financial burden faced by clinical laboratories. We work hard to mount a strong defense mechanism to help our clients face challenges with confidence.

Health care’s Supply Chain and Purchasing Lawyer

Our healthcare attorneys have knowledge and experience in counseling clinical laboratories regarding supply chain and purchasing activities. We understand the regulatory environment affecting the supply chain operations. Our attorneys help clients with matters involving the purchasing of laboratory equipment, devices, and services.