The AMA has developed a free "toolkit" in PDF form to assist physicians with the CMS Open Payments Program (the "Sunshine Act").
The Sunshine Act was included as Section 6002 of the Patient Protection and Affordable Care Act. The final rule requires manufacturers of drugs, medical devices, and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value (typically $10 or more) given to physicians and teaching hospitals. CMS has been charged with implementing the Sunshine Act and has called it the Open Payments Program.
According to CMS, the idea is not to punish or create any new regulation prohibiting such payments. The Sunshine Act merely requires transparency, the federal agency states. Well I say, that is nonsense. The idea is to terrify physicians, who are already frightened, into refusing any kind of money from manufacturers — plain and simple. The Sunshine Act works like a tactic from a classic detective drama: put two suspects in different rooms and see if their stories match. If they don't, physicians could be in trouble. The only way to be certain, is to avoid any manufacturer's money; which is the true purpose of the Sunshine Act.
Stark Law and the Anti-Kickback Statute (AKS), together with the Civil Monetary Penalties Statute and the False Claims Act, continue to be the primary federal enforcement tools for preventing tainted referrals due to improper relationships. Trouble is, it is hard to find out whether or not relationships or payments have been made. The Sunshine Act attacks the problem from the manufacturer's end, and to make the terror complete, Zone Program Integrity Contractors (ZPICs) have been sending out letters on CMS letterhead to providers, asking for all contracts, of any kind, a provider may have with any other business.
As for the Sunshine Act, because the AKS is a criminal statute, and Stark Law does not require "intent," physicians are naturally worried about third-party reports of financial payments by manufacturers which could constitute a "relationship" for Stark Law purposes and a "kickback" under the AKS.
In sum, it will be important, that the physician self- reports match what manufactures are reporting. The AMA Sunshine Act reports page provides assistance for physicians just for this purpose. Physicians who wish to check up on what is being reported to CMS, can find guidance on when and how to object if a report is inaccurate, in three easy steps; assuming the CMS website is actually up and running, which at last check, it was not.
The process listed by the AMA is as follows:
Step 1: Complete CMS e-verification process today
CMS requires a two-phase registration process. In phase 1, which is now open, physicians complete CMS' e-verification process via the CMS Enterprise Portal (EIDM). Access detailed instructions at AMA Wire.
Step 2: Register with CMS' Open Payments system
(AMA Notes: The system is temporarily offline. Check back no later than Aug. 20, 2014, to determine if it is back online.)
Once physicians have completed Step 1 and gained access to EIDM, physicians can move onto phase two and register in CMS' Open Payments System via EIDM. Access detailed instructions at AMA Wire.
Step 3: Review and dispute data by Aug. 27
Physicians can request their individual report, review it, and flag disputes after completing Step 2. CMS has indicated that it will not resolve disputes, but errors can be reported to manufacturers through the Open Payments System or directly through Open Payments contacts listed on most manufacturer websites. Access detailed instructions at AMA Wire.
According to the AMA website, there is a very short fuse, particularly given the fact that the system is currently offline: "Physicians must initiate disputes by Aug. 27 to have potentially erroneous data flagged in the initial public release. Physicians can still initiate disputes on 2013 data until Dec. 31, 2014, but it will not be flagged in the public database until 2015."
**Editor's Note: After a few delays, CMS has extended the dispute deadline to Wed., Sept. 10.**