As part of the $32.5 billion budget that Massachusetts Governor Deval Patrick signed into law July 8, there are a few provisions of particular interest to the pharmaceutical and medical device industry. The law previously allowed companies to provide meals to Massachusetts healthcare practitioners (HCPs) only in an office/hospital setting and in connection with an informational presentation by the company. Now, companies may pay for or provide to Massachusetts HCPs "modest meals and refreshments" in connection with "non‑CME educational presentations 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." These events must occur in a venue and manner conducive to informational communication, and certain other conditions must be met. One of those conditions includes the filing of quarterly reports detailing where the activities occur, what products are discussed and the total amount expended (and per‑person amount) for the meals/refreshments provided to the attendees. What will constitute "modest" and be appropriate under this new paradigm will be left to the Massachusetts Department of Public Health to determine as part of its rulemaking authority.
The revisions to the law also make it easier for companies to provide technical training on the use of medical devices because companies may pay for reasonable expenses necessary for technical training without that payment having to be included as part of the original purchase or lease agreement for the device. Previously, the only way a manufacturer was permitted to provide reimbursement for training expenses in conjunction with training on a medical device was if reimbursement for the training expenses was expressly made a part of the device's sale or lease agreement.
Another welcome change is that the law makes clear pharmaceutical and medical device manufactures will not be required to disclose to the Massachusetts Department of Public Health the information they have already disclosed to a federal agency pursuant to federal law (e.g., to CMS under Sunshine) and that Massachusetts can obtain from the federal agency. This new law requires the Massachusetts Department of Public Health to make all disclosed data publicly available and easily searchable on its website not later than ninety (90) days following the receipt of the information disclosed from CMS.
Since the Pharmaceutical and Medical Device Manufacture Code of Conduct took effect in 2009, Massachusetts has been criticized for its restrictive approach, particularly with regard to treatment of meals. Hotel and restaurant associations argued that the Code, which required meals be provided onsite at the HPC's office or in a hospital, deprived them and the state of revenue. This revision should bring some relief while still preserving key portions of the Code, the purpose of which was to provide transparency and ensure that the relationships between industry and healthcare practitioners do not interfere with the independent judgment of HCPs.