CMS Releases Long-Awaited Details for Sunshine Act Compliance

by Jackson Walker
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The Physician Payment Sunshine Act (the "Act") was enacted as part of the Patient Protection and Affordable Care Act for the purpose of promoting transparency between the medical industry and health care providers. It requires "applicable manufacturers"1 of drugs, devices, biologicals, or medical supplies2 covered by Medicare, Medicaid or the Children's Health Insurance Program ("CHIP") to annually report payments or transfers of value provided directly to physicians or teaching hospitals (collectively, "Covered Recipients") or to third parties on behalf of Covered Recipients. In addition, applicable manufacturers and applicable group purchasing organizations ("GPOs") are required to annually report physician ownership or investment interests and the ownership or investment interests of immediate family members of a physician. The Centers for Medicare & Medicaid Services ("CMS") will collect this data, aggregate it, and publish it on a public website.

For CY2013, the first reporting year of the program, the data collection period was between August 1 and December 31.3 Late last week, almost four (4) years after passage of the Affordable Care Act, CMS finally posted long-awaited details for Sunshine Act program registration and data submission on its website, ("Program Registration" and "Data Submission and Attestation" tabs). According to CMS, on February 18 registration and data submission for applicable manufacturers and applicable GPOs will open with a two-phased approach for this first reporting year:

  • Phase 1 (February 18 through March 31) includes user registration in CMS' Enterprise Portal (the gateway to CMS' Enterprise Identity Management system (EIDM)) and submission of corporate profile information and aggregate 2013 payment data.
  • Phase 2 (begins in May and will extend for no fewer than 30 days) includes industry registration, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data.


According to CMS, both phases of data submission will be complete by August 1, and at that time healthcare providers and manufacturers will have an opportunity to review and correct inaccuracies.

Phase 1
The first step of Phase 1 requires applicable manufacturers and GPO's to register in the CMS Enterprise Portal and in EIDM. (Physicians and other affected providers themselves do not need to register or report.) An authorized official, meaning an executive-level officer who can legally represent the organization, must complete the EIDM registration and obtain a user ID. After registration is completed, the authorized official may delegate actual data submission responsibilities to authorized representatives.

The second step of Phase 1 is aggregate data submission. After registration has been completed, the authorized official or authorized representative will be directed to a webpage that will explain the requirements for Phase 1 data submission. The authorized official should download the data submission instruction document and the sample template available on that page.4

After completion, the authorized official or authorized representative(s) must submit the corporate profile information and aggregate 2013 payment data to CMS as instructed on the webpage and in the data submission instruction document.

When Phase 1 data has been submitted as instructed, the Open Payments Help Desk will reply directly to the submitter, confirming whether the submitted data meets all of the requirements. If information is missing or improperly formatted, CMS will provide additional instructions on how to correct the data submission.

Phase 2
As further evidence of the complexity of the process, CMS has not yet released detailed instructions for Phase 2 for CY2013. CMS only stated that beginning in May and continuing for no fewer than 30 days, applicable manufacturers and applicable GPOs with reportable data will need to register, submit detailed CY2013 payment data, and provide a legal attestation to the accuracy of such data.

1An "applicable manufacturer" is an entity that is either (i) engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply for sale or distribution in the United States, or in a territory, possession, or commonwealth of the United States; or (ii) under common ownership with such an entity, and which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply for sale or distribution in the United States, or in a territory, possession, or commonwealth of the United States.

2 For the purposes of the Act, drugs, devices, biologicals or medical supplies include any drugs, devices, biologicals, or medical supplies for which payment is available under Medicare, Medicaid or CHIP, either separately (such as through a fee schedule) or as part of a bundled payment (for example, under the hospital inpatient prospective payment system); provided that only those drugs and biologicals requiring a prescription to be dispensed are included, and only those devices (including medical supplies which are devices) requiring premarket approval by or premarket notification to the FDA are included.

3 Note that for CY2014 and each year thereafter, data collection occurs between January 1 and December 31.

4 These materials are not available on the Open Payments website, and are only accessible after CMS registration is completed.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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