New CMS Phase 2 Guidelines

By Ben Carmel

Manufacturers Finally Receive Long Awaited Phase 2 Reporting Guidelines from CMS Providing Limited Data Testing Options

Phase 2 Open Payments submission guidelines and timelines were issued last week by CMS as manufacturers try to get through final reporting hurdles over the coming weeks. The new guidelines come on the heels of CMS guidance earlier this month where it updated its reporting template requirements for Phase 2.

While CMS is allowing data to be tested prior to submission up until June 30th, manufacturers will still need to meet an intense three week schedule — from June 9th thru June 30th – to capture, gather and verify information to meet disclosure deadlines in this second phase.

As previously announced, authorized officials will now be able to delegate reporting-related duties to a maximum of 10 users per entity (which includes the authorized official) across 3 roles. These include:

1. Officer Role, who must be an officer and can manage the users in the other roles
2. Submitter Role, who need not be an officer and would be responsible for submitting data in Open Payments
3. Attester Role, who must be an officer and would be responsible for attesting to the Open Payments data

The guidelines add that the same user may fill multiple roles, provided that they meet the requirements of the role.

The key focus for manufacturers over these next several weeks as Phase 2 gets into full swing should be to absolutely take advantage of the data testing option that CMS is offering. Rigorous testing internally over the coming weeks followed by final data spot checks prior to report submissions should be examined around categories where common errors take place, including:

  • Use of nature of payment values that correspond to common understandings of the nature description, but which do not correspond with federal Sunshine’s definition of the term (e.g., honoraria payments)
  • Incorrect state and state license formatting
  • Incorrect allocation of meal expenses
  • Attribution of spend to the wrong HCP due to similarities in name
    • A simple analysis might include reviewing all recipients by specialty and investigating those with specialties not commonly interacted with in the course of a company’s business

By utilizing the Phase 2 testing option as a catalyst for implementing a thorough due diligence process for data authentication and validation, life sciences organizations can potentially mitigate some of the cases of initial report rejections they experienced in Phase 1.