On November 21, 2012, the Massachusetts Public Health Council approved final amendments to 105 Mass. Code Regs. 970.000, the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law ("Massachusetts Marketing Code of Conduct"). These final amendments will implement changes to the Massachusetts Marketing Code of Conduct, Mass. Gen. Law ch. 111N, which were included in the fiscal year ("FY") 2013 Commonwealth budget, effective July 8, 2012. The Massachusetts Department of Public Health ("DPH") will file the amendments with the Secretary of the Commonwealth for final promulgation, which is scheduled to occur on December 7, 2012, at which time they will take effect. The final regulations can be found at http://www.mass.gov/dph/pharmamed.
Significantly, the final regulations adopt most of the September 19, 2012, emergency amendments, but with some substantive changes. Specifically, the key areas that have changed from the emergency regulations include federal preemption for annual reporting and the content of quarterly reports. Those areas that generally have remained the same from the emergency rules include modest meals, expenses related to training, and the requirement for annual fees. This Client Alert provides an overview of the final regulations. It also briefly discusses some key considerations for pharmaceutical and medical device manufacturers as they seek to implement the final regulations.
Overview of Final Regulations Regarding Provision of Meals and Implementation of Recent Statutory Changes
"Modest Meals and Refreshments"
The final regulations define the term "modest meals and refreshments" as "food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense." The DPH did not impose a specific dollar limit on meals, staying consistent with the definitions in the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America and the Code on Interactions with Healthcare Professionals developed by the Advanced Medical Technology Association. The final regulations and statute are both silent regarding the provision of alcoholic beverages. The DPH explained that "the legislature chose the term ‘modest meals and refreshments' rather than simply ‘modest meals.'"
Significantly, the final regulations maintain the quarterly reporting requirement from the amended statute. Therefore, no pharmaceutical or medical device manufacturing company may provide payment for modest meals and refreshments unless the company files quarterly reports detailing all non-continuing medical education ("non-CME") educational presentations at which such meals or refreshments are provided. This requirement will continue to exist even though the information will be included in the reports submitted under the Affordable Care Act (the relevant provisions known as the Physician Payments Sunshine Act) and also likely preempted if challenged.
The requirement for quarterly reports also includes a new catch-all provision, allowing the DPH to request reporting of additional information, as deemed necessary.
"Venue and Manner Conducive to Informational Communication"
The final regulations do not include additional guidance as to the meaning of a "venue and manner conducive to informational communication."
"Expenses Related to Training"
The final regulations include the specific language from the FY 2013 budget stating that "nothing in 105 CMR 970.000 shall prohibit the following … payment or reimbursement for the reasonable expenses, including travel and lodging related expenses necessary for technical training of health care practitioners on the use of a medical device…." Therefore, the payment of reasonable expenses necessary for technical training on the use of a medical device without a requirement for a pre-existing vendor purchase contract is permitted.
"Annual Fee and Federal Preemption"
The DPH codified the annual $2,000 registration fee by including this fee in a new section of the final regulations.
Significantly, the final regulations provide that no pharmaceutical and medical device manufacturing company is required to disclose information to the DPH that has been disclosed to the federal agency pursuant to the Affordable Care Act. However, as stated above, the quarterly reports associated with modest meals provided at non-CME events will continue to be required, as well as reports of information not covered under the Affordable Care Act.
The final regulations provide new compliance considerations for pharmaceutical and medical device manufacturers that operate in the Commonwealth of Massachusetts. However, the entire effect will remain unclear until the federal rules to the Affordable Care Act are promulgated, which is expected shortly. In the interim, companies should review current infrastructure and assess gaps that may exist that prevent compliance with the final regulations.