Here Comes the Sun, Are You Prepared?, 10/18/2012), but with the final rule now implemented, providers should take a second look at it and reconsider its implications.
The Act requires applicable manufacturers of drugs, devices, biological, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (“CHIP”) to report payments or transfers of value provided to physicians or teaching hospitals. Additionally, applicable manufacturers and group purchasing organizations (“GPOs”) must annually report to CMS certain information regarding ownership or investment interests held by physicians (or their immediate family members).
The Act was proposed in December 2011 and CMS had expected to issue the final rule by the end of 2012. However, due to the overwhelming number of remarks received during the comments period from concerned providers, manufacturers, and GPOs, the Act took considerably more time to become final.
The final rule addresses some of the concerns raised through the comment period, but certainly not all. One of the biggest revisions is to exempt speaker fees for accredited and certified CME programs from the reporting requirements. There are several other exemptions from the reporting requirements, including, but not limited to:
- over-the-counter drugs and class I and II medical devices, such as elastic bandages and suture materials;
- incidental items worth less than $10, e.g., pens and note pads, as well as general food and drinks offered to all participants at conferences or large-scale events;
- gifts or payments valued at less than $10, unless the aggregate amount paid to the physician exceeds $100 annually; and
- educational materials and items intended for use by or with patients.
Additionally, the final rule makes numerous changes to definitions included in the proposed rule and adds several new terms.
The estimated costs, as stated by CMS, for the manufacturers and GPOs to comply with the Act is $269 million for the first year, with costs thereafter estimated to be $180 million. CMS estimates physicians will expend $250 during the first year for compliance, but many stakeholders have expressed the opinion that this is grossly underestimated.
The applicable manufacturers and group purchasing organizations are required to start collecting data on August 1, 2013. These data must be formalized in a report to CMS by March 31, 2014. The data are set to appear on a public website by September 30, 2014.
The final rule still creates a great deal of uncertainty. It is highly recommended that providers consider their existing relationships and revisit the Act when creating new ones. They should take time to review internal policies and examine all contacts for conflicts of interest.
Molly Nicol Lewis
McBrayer, McGinnis, Leslie & Kirkland, PLLC