2023 Board Resources

standard is required for civil monetary assessments and the False Claims Act. 24 When Stark Law violations are discovered, the DHS entity may refund the claims or inform CMS of the violation through the Voluntary Self-Referral Disclosure Protocol (SRDP). 25 In the SRDP, CMS may reduce the amount owed in consideration of the following factors: (a) The nature and extent of the improper or illegal practice; (b) The timeliness of self-disclosure; (c) The cooperation in providing additional information related to the disclosure; (d) Other factors as the Secretary deems appropriate. 2.3 Statutory and Regulatory Exceptions . (a) General Exceptions . 26 These exceptions permit payment for referrals otherwise prohibited: (i) Physician services; (ii) In-office ancillary services; (iii) Services furnished by a health plan or its contractors or subcontractors to health plan enrollees; (iv) Academic medical centers; (v) Implants furnished by an ambulatory surgical center; (vi) EPO and other dialysis-related drugs;

(vii) Preventive screening tests, immunizations, and vaccines; (viii) Eyeglasses and contact lenses following cataract surgery; and (ix) Intra-family rural referrals;

Ownership Exceptions . 27 The following exceptions designate ownership

(b)

and investment interests that do not constitute a prohibited financial relationship: (i) Publically-traded securities; (ii) Mutual funds;

(iii) Interests in rural providers, hospitals in Puerto Rico, and certain physician-owned hospitals

(c) Compensation Exceptions . 28 The following exceptions designate compensation arrangements that do not constitute a prohibited financial relationship:

24 “Comparison of the Anti-Kickback Statute and Stark Law,” Office of Inspector General: U.S. Department of Health and Human Services , available at https://oig.hhs.gov/compliance/provider-compliance- training/files/starkandakscharthandout508.pdf (last accessed August 16, 2017). 25 “CMS Voluntary Self-Referral Disclosure Protocol (Revised March 27, 2017),” U.S. Centers for Medicare and Medicaid Services , available at https://www.cms.gov/Medicare/Fraud-and- Abuse/PhysicianSelfReferral/Downloads/CMS-Voluntary-Self-Referral-Disclosure-Protocol-Original.pdf (last accessed August 16, 2017).

26 42 C.F.R. § 411.355. 27 42 C.F.R. § 411.356. 28 42 C.F.R. § 411.357.