Life Science Compliance Update

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September 21, 2012

Massachusetts Pharmaceutical and Medical Device Manufactures Code of Conduct: Proposed Emergency Regulations to Allow for Meals at Corporate Educational Events

Davios Rest

The Massachusetts Public Health Council passed the first round for emergency regulations to allow companies to provide modest meals for healthcare providers for product education. 

As we noted back in July, Massachusetts finally passed a partial repeal of their 2008 Pharmaceutical and Medical Device Manufacturer Code of Conduct as part of their 2013 $32.5 Billion Dollar State Budget.  In signing the legislation, Massachusetts Governor Deval Patrick noted that the change will “afford health care providers some flexibility to be educated on new clinically relevant products and allow them to stay informed on advancements and medical devices that benefit patients and lower our health care costs,” Patrick wrote in a letter to life sciences industry organizations.” 

The changes include allowing for payment of expenses for medical device training, “modest meals” for non-CMEpresentations at locations beyond hospitals, medical offices and training sites.  “The new exception applies only to presentations occurring in a ‘venue and manner conducive to informational communication.’”  The revisions also eliminated state reporting for physicians that duplicates federal Sunshine Act reporting, and added quarterly reports for the non-CME events by manufactures.  

Consequently, yesterday, the Boston Globe reported that the Massachusetts Public Health Council approved emergency regulations pertaining to the definition of “modest meals” under the code.  A presentationto the Public Health Council by the Massachusetts Bureau of Healthcare Safety & Quality sets forth the proposed definition of “modest meals:” 

Modest Meals and Refreshments, 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. 

In addition to this definition, the new emergency regulations specify the following: 

  • Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals to health care practitioners in the health care practitioner’s office or hospital setting in connection with informational or educational meetings or presentations.     
  • Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals and refreshments to health care practitioners outside of the health care practitioner’s office or hospital setting for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and manner conducive to informational communication.  For the purposes of 105 CMR 970.006(3), “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices

No pharmaceutical or medical device manufacturing company may provide or provide payment for such meals and refreshments permitted under 105 CMR 970.006(3) unless such pharmaceutical or medical device manufacturing company files quarterly reports detailing all non-CME educational presentations at which such meals or refreshments are provided.  Reports shall include: 

  • the location of the non-CME presentation;
  • a description of any pharmaceutical products, medical devices or other products discussed at such presentation; 
  • the total amount expended on such presentation; and
  • an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation. 

The emergency regulations included several other modifications: 

  • Each pharmaceutical and medical device manufacturing company must report all incidents of non-compliance with the Code to the Office of the Attorney General in a format specified by the Department.
  • Each pharmaceutical and medical device manufacturing company must register with the Department annually and must pay the annual registration fee established by the Department. 

According to the presentation, the Public Health Council, the revised regulations “are consistent with nationally-recognized standards included in industry codes of conduct (e.g., PhRMA, AdvaMed, and the American Medical Association).”  They also said that such regulations: 

  • promote educational and training opportunities
  • implement the legislative intent to balance consumer protection, the legitimate interests of pharmaceutical and medical device manufacturers, and promoting the education of health professionals.
  • include a definition of modest meals and refreshments that does not include a specific dollar limit, but rather is “similar to what a HCP might have purchased when dining at his or her own expense,” as judged by local standards.
  • We also propose that this regulation be filed on an emergency basis. 

The Council gave an anticipated timeline for implementation as follows: 

  • The regulation was presented for a vote to adopt the proposed emergency regulation on September 19, 2012.  The regulation will be filed as an emergency regulation with the Secretary of the Commonwealth and the regulation becomes effective upon filing.
  •  A public hearing will be held on October 19, 2012 at 10am, in the Public Health Council Room. DPH will also be accepting written comment. All of the feedback will be considered to determine if additional changes to the regulations will be proposed. 
  • Regulation will be voted on by PHC at its November 14 meeting and filed with Secretary of the Commonwealth. The final regulation will be effective upon publication on December 7, 2012

The public health council should be applauded for taking a reasonable approach in defining modest meals. 

It is important that physicians and others who work with industry to produce live saving medications and products participate in the public hearing and provide written testimony to the Department of Public Health for the October 19th public hearing.  

Davio's the resturant picture featured at the top of the story and other local restaurant owners were instrumental in passing this law earlier this year, and in this and future articles we will give honor to those small businessmen who stood up for their rights as Americans, so that our healthcare providers stay up to date.

 

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