HHS Transparency

• Physician Self-Referral Exceptions. Adds requirements for rural hospitals to qualify for the rural provider exception to the prohibition on certain physician self-referrals due to ownership or investment. Beginning not later than 9/23/11, only hospitals with physician ownership or investment and a provider agreement in operation on 12/31/10 and that meet numerous specified requirements are exempt from the prohibition on self-referral. Limits such hospitals from expanding their facilities, with a process for appeal. Places requirements on the physician-hospital relationship. (PPACA §§ 6001, 10601)
• Reporting of Physician Ownership/Investment Interests. Manufacturers of drugs, biologicals, medical devices and supplies must file public reports with HHS on payments or value transfers to physicians and/or physician ownership interests. Effective 3/31/13. (PPACA § 6002)
• Disclosure Requirements. Disclosure requirements for certain, previously exempt, in-office ancillary imaging services under the prohibition on physician self-referral (Stark). Effective 1/1/10. (PPACA § 6003)
• Rx Drug Sample Transparency. Drug manufacturers and distributors must report to HHS the drug samples requested and distributed and the identity of the requesting practitioner. Effective 4/1/12. (PPACA § 6004)
• PBM Transparency Requirements. For purposes of Medicare Part D and plans offered through state Exchanges, PBMs must report to HHS, at a time and in a manner to be specified by HHS, the generic dispensing rate payments by pharmacy type, aggregate amounts and types of rebates, discounts or price concessions based on patient utilization negotiated and passed on to plan sponsors, the total number of prescriptions dispensed and the aggregate difference between the amount the plan pays the PBM and the PBM pays the pharmacies. HHS must keep the information confidential except for specified purposes. Effective on date of enactment (requires HHS regulation). (PPACA § 6005)