Physician Payments Sunshine Act: Issues To Watch For As You Submit Phase 2 Data

 Pharmaceutical and device manufacturers must submit detailed data on payments to physicians and teaching hospitals to comply with the Sunshine Act by June 30, 2014.

Click here for a comprehensive overview of companies’ Phase 2 responsibilities. There are just about two weeks left in the process, and companies should not wait until the last minute to go through the Open Payments system. We surveyed companies that are currently working through the process in order to see if there were any common issues that other companies can avoid.

The main issues related to the system are small technical fixes that can nonetheless make for a difficult submission process. We encourage companies to start the process sooner rather than later. Here are some tips in bullet points that we’ve heard:

• The Centers for Medicare and Medicaid Services (CMS) is likely inundated with calls, and we’ve heard users say that CMS may not have the answer you need if you get through.
• Make sure you remember those secret password questions, as passwords expire every 60 days, and anyone that hasn’t logged in since Phase 1 registration will need to reset their password.
• Companies must include doctors’ MIDDLE INITIAL. 
• Every physician companies’ submission requires a taxonomy code. This was a big surprise to many, as most companies filled out taxonomy only for individuals with an NPI. Options include matching corporate specialties for non-NPI individuals to the taxonomy cross walk or defaulting to 208D00000X (Physician/Undefined Physician type)
• As of very recently, the “test upload” button does not work.
• Double check your submission files that were developed earlier have been updated to reflect your new Registration ID.
• Watch out for special characters, most fields don’t accept characters outside of letters and numbers.
• Make sure that if a principal investigator (PI) is also the covered recipient you duplicate their information in the PI fields as well as the covered recipient fields.
• Make sure your NDC codes are 10 digits without hyphens or 12 with hyphens.
• Beware of field validations and field lengths, make sure those zip codes are all 5 or 9 digits in total. Nine digit zip codes need a hyphen.
• Once your data validation issues are resolved, make sure to click the “final” submission so CMS  can perform the match/merge process.
• Make sure the new registration IDs are in both places in the reports
• Make sure the company name is exactly as it was registered during Phase  2 registration, not Phase 1
• Make sure all dollar values are xxxx.xx
• Make sure the file headers read exactly as in the spec, including all capitalizations
• Country is US or United States, not USA

We also heard issues regarding the nominations of “Attesters” and Submitters.” In one case, CMS had sent reminder emails to clients asking them to “accept” their nominations as Attester and Submitter within 5 days. The email stated:

“This is a reminder to accept or reject your nomination for a user role(s) in the Open Payments system for the following entity:

– Entity registration ID: 

– Entity name: 

– Nomination ID: 

– Role nominated in the Entity:  Submitter

– List of role(s) in the entity:  Submitter

You have five business days remaining to accept or reject your nomination for this role. You will receive a final reminder to accept or reject the nomination a day before the 10th day. If no action is taken, your nomination will be deactivated after the 10th business day.”

However, when the user attempted to accept their role, Open Payments notified them that an error occurred: “Error: Nominee already exists with the same Role.” When users emailed CMS, they were told to have “an Authorized Official or Officer call in to proceed.”

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Obviously, CMS is receiving tons of inquiries from submitters over their Phase 2 reports and may be delayed in getting back to questions. Most of these issues we’ve raised are workable, but companies need to set aside the time and resources to deal with setbacks if they arise.

A special thank you to Polaris and G&M Health LLC for insights regarding the Phase 2 process.