HHS' Office of Inspector General released its General Compliance Program Guidance on Nov. 6, providing an overview on Stark law and physician referrals.
Here's what physicians and ASCs need to know:
1. Stark law prohibits physicians from making referrals for Medicare-payable health services to entities that the physician or an immediate family member has a financial relationship with, unless an exception applies. These financial relationships include ownership, investment interests and compensation relationships.
2. The designated health services include the following:
- Clinical laboratory services
- Physical therapy, occupational therapy and outpatient speech-language pathology services
- Radiology and 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
3. Stark law is implicated when the following six elements are present:
- A physician
- A referral made by the physician
- The referral is for a designated health service
- The service is payable by Medicare
- The service is to an entity
- The entity is one with which the physician or immediate family member has a financial relationship with. This includes physician organizations that the referring physician has an interest in.
4. CMS emphasizes that all providers who offer designated health services keep track and review the financial relationships with referring physicians. Because Stark law is a strict-liability statute, proof of intent is not required.
5. CMS has a voluntary self-referral disclosure protocol that allows providers to self-disclose actual or potential violations.