Amendments allow for more relaxed rules regarding the provision of modest meals and refreshments for educational interactions, require new quarterly reporting, provide a sunset date on certain provisions in anticipation of federal reporting requirements, and establish a new mandated disclosure provision to instances of noncompliance.
On September 19, 2012, the Massachusetts Department of Public Health (Department) released the amended implementing regulation 105 C.M.R. 970.000, which captures changes to the Massachusetts Pharmaceutical and Device Manufacturers Conduct, Massachusetts General Law Chapter 111N, that were approved as part of the FY 2013 budget earlier this summer. The amended regulation 105 C.M.R. 970.000, commonly referred to as the "Gift Ban" law (Gift Ban), went into effect on September 19. It has several notable provisions, including one that mandates disclosure of instances of noncompliance with the regulation. While most of the provisions in the Department's amended regulation do not differ from the amendments to Massachusetts General Law Chapter 111N, the Department has included some additional amendments such as the sunset date and disclosure requirements.
Amended Regulation 105 C.M.R. 970.000
The amended Gift Ban now does the following:
- Such meals and refreshments occur in a venue and manner conducive to informational communication
- Such educational presentations are not used to promote off-label uses of prescription drugs or medical devices
- Pharmaceutical or medical device manufacturers comply with the new quarterly reporting requirement described below
This expands the current law significantly from only allowing meals within a healthcare practitioner's office or a hospital setting to include other venues such as a restaurant.
- Location of the non-CME presentation
- Description of any products discussed at the non-CME presentation
- Total amount expended for the non-CME presentation, including the amount expended per participant—factoring in meals, refreshments, and other items of economic value provided
These significant amendments to the Gift Ban help to eliminate redundancies that would have existed after the implementation of federal transparency reporting requirements under Section 6002 of the Patient Protection and Affordable Care Act, known broadly as the U.S. Sunshine Act. CMS issued its proposed rule to implement requirements under the U.S. Sunshine Act in December 2011. As of yet, no final rule has been released. Until CMS issues the final rule, companies will continue to report required data to the Department. In a prepared statement delivered at a recent roundtable discussion held by the Special Committee on Aging, Senator Herb Kohl (D-WI) noted that "Secretary Sebelius and CMS tell us that the rule will be finalized by the end of ."
The Department issued a notice of public hearing on the amendments to 105 C.M.R. 970.000 to be held on October 19, 2012, at 10 a.m. in the Public Health Council Room, Second Floor, Department of Public Health located at 250 Washington Street, Boston, Massachusetts.
Please visit our Transparency Compliance Resource Center here for relevant documents related to transparency.
If you have any questions or would like more information on any of the issues discussed in this LawFlash, please contact Kathleen McDermott (202.739.5458; firstname.lastname@example.org) or any of the following members of our Transparency Compliance team:
*Morgan Lewis’s Director of Healthcare Compliance is a non-attorney professional working to assist clients in developing and implementing practical and sustainable global compliant business practices.
. View our July 11, 2012, LawFlash, "Massachusetts Adopts Revisions to Health Care Practitioner 'Gift Ban' Law," available here, and our July 20, 2012, LawFlash, "Massachusetts Amends Anti-Kickback Law," available here.