As the health care industry prepares for data collection beginning August 1, 2013, in accordance with the federal sunshine provisions in Section 6002 of the Affordable Care Act and its implementing regulations, industry must also plan ahead for reporting the data collected. Data collection and reporting are inextricably linked, as manufacturers must track reporting requirements in order to collect the necessary information in the format required by the Centers for Medicare and Medicaid Services (“CMS”).

In February 2013, CMS issued a Final Rule implementing the sunshine provisions, which require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare or a State plan under Medicaid or CHIP to report annually to the Secretary certain payments or other transfers of value to physicians and teaching hospitals. The Final Rule requires applicable manufacturers and applicable group purchasing organizations (“GPOs”) to begin collecting the required data on August 1, 2013 and to report the data to CMS by March 31, 2014, with data submission to be completed electronically in the form required by CMS.

Since issuing the Final Rule, CMS has established a website with applicable resources: The Official Website for the National Physician Payment Transparency Program: OPEN PAYMENTS. There, CMS has posted a link to separate templates for reporting: (1) General Payments (Non-Research); (2) Physician Ownership; and 3) Research. The data templates provide detailed information about the data to be collected including the data element name, format, allowable values, required versus optional fields, and other associated rules intended to aid the applicable manufacturers and applicable GPOs as they prepare for and participate in data collection. The reporting templates are subject to revision, but any changes will be provided at least 90 days in advance of data collection in order to provide adequate time for relevant systems changes by applicable manufacturers and applicable GPOs. Applicable manufacturers and applicable GPOs should utilize these templates to support complete, accurate and timely reporting by March 31, 2014.

Posted by David Sclar

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