Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The amendments relax Massachusetts’ strict ban on gifts from pharmaceutical and medical device manufacturers to healthcare practitioners. Most significantly, pharmaceutical and device manufacturers now may:
- pay for “reasonable expenses” necessary to train healthcare practitioners to use medical devices
- provide or pay for modest meals and refreshments associated with educating healthcare practitioners during non-CME presentations
Consistent with the prior law, manufacturers must report any permitted payments to the state. Specifically, the amendments require manufacturers to file quarterly reports detailing all non-CME educational presentations and the value of items provided to healthcare practitioners at such presentations. Manufacturers are still responsible for submitting yearly reports to the Massachusetts Department of Public Health (DPH).
Duplicative Disclosures Eliminated
The amendments do, however, provide some relief for manufacturers by eliminating duplicative disclosures. Manufacturers are not required to disclose to DPH information already disclosed to a federal agency pursuant to federal law. Most notably, this includes disclosures made under the Physician Sunshine Act (recently upheld under the Patient Protection and Affordable Care Act), which requires manufacturers to submit to the Centers for Medicare and Medicaid Services (CMS) an annual report of transfers of value over $10 provided to physicians. Where manufacturers report information to CMS, they will not be required to disclose the same information to DPH.
Increased Flexibility for Training and Education These amendments represent a significant change to the Massachusetts gift ban, which was considered one of the strictest in the nation. Manufacturers now have increased flexibility both in the ways in which they provide training and education to Massachusetts healthcare practitioners (e.g., not segregating Massachusetts physicians from physicians of other states for programming), and in the timing of these programs (e.g., training physicians prior to signing a contract to purchase a device). It is important to note, however, that even with this change most of the restrictions of the original law remain in place. Therefore, manufacturers should continue to monitor their relationships with Massachusetts healthcare practitioners and ensure they comply with the remaining requirements of the law.