Reporting Deadline For Medical Device And Drug Companies Approaches
Here's a list of additional state requirements:
- Authored by: Mark DuVal
- Published on: September 1, 2010
Please be reminded that October 1, 2010 is the reporting deadline for medical device and drug companies filing 2009 marketing disclosures in Vermont (e.g. disclosures include things like CME grants, consulting fees, clinical expenditures, etc.). The deadline is approaching quickly. Failure to report in Vermont carries a fine of $10,000 per violation. A $500 filing fee and compliance declaration for Vermont were due July 1, 2010.
Device and drug companies, additional state requirements:
2009 marketing disclosures, annual compliance declaration and $2,000 filing fee were due by July 1, 2010.
Failure to report in Massachusetts carries a fine of $5,000 per violation.
There is debate as to whether or not this law applies to device companies.
Each company must make their annual declaration of compliance available on their website (no specific due date) along with a toll-free telephone number where a copy the company’s compliance program and written declaration of compliance may be obtained.
Failure to comply carries a fine of $2,500 per violation.
Annual compliance declaration was due by June 1, 2010.
Companies must have a code of conduct, a compliance program, and provide training and auditing on their code and compliance program.
Failure to comply carries a fine up to $5,000.
Drug companies, additional state requirements:
2009 marketing disclosures and $2,500 filing fee were due by July 1, 2010.
Failure to report in D.C. carries a fine of $1,000.
2009 marketing disclosures and $1,500 filing fee were due by July 1, 2010.
Failure to report in Maine carries a fine of $1,000.
2009 marketing disclosures were due by May 1, 2010.
Failure to report in Minnesota carries a fine of up to $10,000 per violation.
2009 marketing disclosures were due by April 1, 2010.
Failure to report in West Virginia carries an undefined fine.
Upcoming federal requirements (disclosures for 2012 due in March 2013):
Disclosure of financial ties between physicians and companies was universally mandated as part of the Patient Protection and Affordable Care Act of 2010 passed earlier this year.
The Physician Payments Sunshine Provision ("Sunshine Provision") was included in this Act.The Sunshine Provision requires companies to begin reporting "transfers of value" made in 2012 greater than $10 (or $100 in aggregate per year) no later than March 31, 2013. An example of a "transfer of value" is a meal provided to a physician.