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From Health Law Daily, June 2, 2014

New system for reporting physician payments, ownership, and investment interests

By Harold M. Bishop, JD

On June 5, 2014, CMS will publish notice of a new system of records (SOR) titled, “Open Payments,” System No. 09-70-0507, which requires applicable manufacturers and Group Purchasing Organizations (GPOs) to report: (1) payments and other transfers of value to covered physician recipients; and (2) certain ownership or investment interests held by physicians and their immediate family members in such manufacturers and GPOs. The payments and transfers of value to covered physician recipients are defined at 42 C.F.R. Sec. 403.902.

The new Open Payments SOR implements section 6002 of the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148) (ACA), which added section 1128G to the Social Security Act. Under the provisions of section 1128G, CMS is required to publish the data submitted by the applicable manufacturers or GPOs on a public website. The published data must be downloadable, easily searchable, and aggregated. CMS must also make annual reports to Congress and each state summarizing the reported data.

Terminology. The term “applicable manufacturer” means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States. The term “applicable GPO” means a GPO that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States (Soc. Sec. Act Sec. 1128G(e)).

Review of information. Covered physician recipients and physicians who are owners or investors are entitled to (1) a 45-day review period to review data submitted about them and submit corrections prior to the data becoming available to the public, and (2) an opportunity to dispute the accuracy of such information. Applicable manufacturers and GPOs will receive a notification that the information is disputed. If a dispute is resolved or if errors or omissions are discovered, the applicable manufacturer or applicable GPO is required to submit corrected data to CMS. Upon receipt, CMS will notify the affected covered physician recipient or the physician who is an owner or investor that the additional information has been submitted and is available for review. CMS will update the website at least once annually with corrected information.

Information. The SOR will contain information about the following individuals: (1) physicians and authorized representatives of physicians and teaching hospitals and, (2) any applicable manufacturers and applicable GPO system users. The categories of records in the SOR will be as follows:

  • Applicable manufacturers or GPOs. Records may include profile information (first and last name, business contact information, and job title) for the company and users interacting with the Open Payments system on the applicable manufacturers or GPOs’ behalf.

  • Physicians. Records may include the physician’s name, specialty, business address, business phone number, National Provider Identifier (NPI) number, state license numbers, types and descriptions as to the nature and form of payments received from applicable manufacturers or GPOs, amounts of payments, natures and context of payments, and dates of payments.

  • Payments. With regard to payments made for a covered drug, device, biological, or medical supply, the records must include the name of that covered drug, device, biological, or medical supply.

  • Physicians who hold certain ownership/investment interests in applicable manufacturers and GPOs, or who have immediate family members who hold such interests. The records will include the dollar amount invested, the value and terms of such ownership or investment, and information pertaining to any payment or other transfer of value provided to a physician holding such an ownership interest.

  • Teaching hospitals. Records include profile information for users interfacing with the SOR on the hospitals behalf, including first and last name, business contact information, and job title.

Use of the information. CMS may use information from this new SOR to: (1) support regulatory, reimbursement, and policy functions performed by CMS contractors, consultants, or grantees; (2) assist federal agencies and their fiscal agents in performing the statutory functions; (3) assist applicable manufacturers or GPOs with the statutory reporting requirements; (4) comply with the requirements of Soc. Sec. Act sec. 1128G, and publish the information submitted on a public website; (5) support research and program evaluation activities; (6) support litigation involving the agency; (7) assist with fraud, waste, and abuse detection and prevention activities; (8) assist agencies, entities, contractors, or persons tasked with the response and remedial efforts in the event of a breach of information, and (9) assist the Department of Homeland Security cyber security personnel.

Comments on the SOR may be submitted within 30 days of the June 5 publication date. CMS’ Center for Program Integrity (CPI) may publish an amended SOR Notice based on comments received.

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