Stark Group Practice Definition (42 CFR 411.352)

42 CFR 411.352 defines "group practice" for Stark purposes. Failure to qualify means the in-office ancillary services exception is unavailable and the practice loses several other exception pathways.

Required elements:

• Single legal entity operated primarily to provide medical care.
• Members: at least two physicians.
• Range of services: each physician must furnish substantially the full range of patient care services to the group's patients, and members must furnish substantially all of their patient care services through the group.
• Income and expense distribution: agreed in advance and not based directly on volume or value of DHS referrals by individual physicians, with limited carve-outs (productivity bonuses tied to personally performed services and certain profit shares).
• Unified business: centralized decision-making, consolidated billing, accounting, and financial reporting.
• Substantially all test: at least 75% of the total patient care services of the group members are furnished through the group, billed under the group's billing number, and treated as the group's receipts.

CMS's annual Physician Self-Referral Disclosure Protocol settlements include many practices that thought they qualified as a group practice but failed one structural test — for example, compensation tied to individually generated DHS, decentralized billing, or member physicians retaining separate practices.