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Sunshine Act Compliance Efforts Continue to Chug Along

Reg Pulse

In my previous blog entry, I noted the Physician Payment Sunshine Act (“Sunshine Act”) has a lot of moving parts and compliance — is without doubt — a complex undertaking. As the March 31st reporting deadline looms large, we have seen that complexity manifest itself in the communications coming out of the Centers for Medicare and Medicaid Services (“CMS”).

The most recent big announcement is that CMS has split the registration and data submission into two parts. Phase 1, which is occurring now, requires applicable manufacturers to register and submit corporate profile and “aggregate 2013 payment data” by March 31, 2014.1 Phase 2, which starts in May and will last at least 30 days, requires submission of detailed payment data and attestation to the data’s accuracy.

The phased approach has engendered a lot of questions, especially around what CMS meant by “aggregate 2013 payment data.” CMS has clarified things by noting that aggregate payment data is required in three areas: general payments, research payments and ownership or investment interests.2 For general and research payments made between August 1 and December 31, 2013, the data to be submitted is: the total aggregate value of payments or transfers of value, the total number of payments or transfers of value made and the total number of covered recipients. For ownership or investment interests, CMS wants only the total number of physician owners, investors or their immediate family members.

This change in direction has applicable manufacturers struggling to shift gears, but as I noted before: Don’t panic. It is unlikely that this will be the last directional change as CMS has yet to clarify a number of points, especially with regards to foreign applicable manufacturers.

Finally, we saw the first evidence of industry behaviors changing as the result of the Sunshine Act. According to ProPublica, some large pharmaceutical manufacturers have reduced payments to health professionals for promotional speeches.3 While ProPublica tracked the decline in spending since 2011, I am not sure the correlation between the drop and the Sunshine Act has been clearly established.

I’d like to hear from you about any challenges you have faced in complying with the Sunshine Act and whether or not you believe that the decline in spending on promotional talks is attributable to the Sunshine Act? Please take a moment to share your thoughts regarding this issue.

Seth Whitelaw, Director, Deloitte & Touche LLP

1 See CMS.gov, Program registration, https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Program-Registration.html
2 See CMS.gov, Data submission and attestation, https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Data-Submission-and-Attestation.html
3 See Charles Orstein, et. al, As full disclosure nears, doctors’ pay for drug talks, ProPublica (March 3, 2014), http://www.propublica.org/article/as-full-disclosure-nears-doctors-pay-for-drug-talks-plummets

As used in this document, “Deloitte” means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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