The Centers for Medicare & Medicaid Services Are Tracking You — With The Help From Drug & Device Manufacturers

Posted by Donna Craig in Sep, 2013

The Centers for Medicare & Medicaid Services will be receiving information on financial arrangements physicians and teaching hospitals have with drug and device manufacturers as a result of the Open Payment Sunshine Rule.  Beginning in 2014 the information collected will be made publicly available on the CMS website.

The Sunshine Rules require drug and device manufacturers to report payments or transfer of value from the manufacturer to a physician or teaching hospital, and any physician ownership and investment interests in the manufacturer or group purchasing organizations.  Failure of a manufacturer to report these financial arrangements will result in civil monetary penalties.

Physicians are defined as doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors.  Any Physician who receives cash or cash equivalent, in-kind items or services, or stock or stock options, dividends, profits or return on investments by a  manufacturer or group purchasing organization will be reported to CMS.  Payments can be in the form of consulting fees, gifts, food, education, charitable contribution, honoraria, entertainment, travel, research, royalty or license, or compensation for faculty or speakers for CME programs.

Under the Sunshine Rules data collection began August 1, 2013, and the first reports to CMS are due on March 31, 2014, then quarterly thereafter. The information to be reported includes: name of the recipient (NPI & license of physician), form and nature of payment (cash, stock, etc.), and amount of payment, date of payment, the associated covered drug, device, biological or medical supply (if applicable), and the name of the entity that received payment, if not provided directly to covered recipients.

Once a report is filed with CMS, there will be a 45 day review period (with a 15 day extension) before it is made available to the public.  You will not be notified of the reports received unless you register with CMS. Registration can be done by going to http://go.cms.gov/openpayments.  If a manufacturer reports payment of $10,000 instead of the correct payment of $1,000, there is a dispute resolution process to resolve the discrepancy.  For physicians and teaching hospitals that have financial arrangements with manufacturers of drugs and devices, it is important that they know when a report is filed, to determine if it is accurate.  Accuracy is important as CMS will be reviewing data for compliance efforts to determine if there are conflicts of interest or if there are fraud & abuse issues.

To prepare for these reports physicians and teaching hospitals should:

• Become familiar with the information being collected and reported
• Keep good records of financial relationships with manufacturers
• Register with CMS so you can timely review manufacturer’s reports
• If reported information is not correct, work with the manufacturers to resolve the discrepancy.

Do you currently have a financial relationship with a drug and device manufacturer?   If so, now is the time prepare for data that will be reported about you.