• Physician Payment Sunshine Act Final Rules

    The Final Rule on the Physician Payment Sunshine Act was published last week. 284 pages, including the helpful Preamble. The law was designed to create a public website for all “payments and transfers of value” to “covered recipients” (physicians & teaching hospitals) by “applicable manufacturers” (generally, drug and device companies selling a prescribed product covered by Medicare). The theory is that transparency might mitigate potential financial conflicts of interest in Medicare. Any payment or transfer of value over $10 will be reported, as will smaller payments that aggregate over $100 per year.

    Some highlights to the Final Rule:

    • Data collection begins August 1, 2013, with the first report due to HHS on March 31, 2014. The law (s.6002 of the ACA) wanted data collection to start on January 1, 2012 with the first full year report on March 31, 2013. These rules are twenty months late in the data collection process.
    • The law defined “physicians” as defined in s.1861(r) of the SSA, which excludes many categories of mid-level practitioners with limited prescribing authority, such as physician assistants. The Final Rule was sympathetic with the need to cover all prescribers, but felt constrained by the text of the statute. One alternative not explored would be to attribute these payments to the physician associated with these mid-level practitioners.
    • The Preamble extensively discussed how to identify physicians to enable aggregation of data from various manufacturers by physician. The National Physician Identifier will be used, where available.
    • All reporting is done by “applicable manufacturers,” not physicians or teaching hospitals. Reporting can be on a consolidated basis within corporate groups, and the Final Rule contains elaborate provisions to prevent transfers from being unreported through corporate affiliates, including offshore firms.
    • If a company meets the definition of an “applicable manufacturer,” it must report all payments to covered persons (physicians and teaching hospitals), not just payments relating to a covered drug or device. Firms who meet a de minimum standard (10% of revenues in covered products) need only report payments related to covered products.

    This should be a rich data set for researchers, available on the CMS website at some point in 2014.

    I’ll post more on the Final Rules as I work my way through them.

    @koutterson

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