Life Science Compliance Update

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June 06, 2014

Massachusetts Pharmaceutical and Device Code of Conduct: Companies Won’t Have to Report Payments Covered by Federal Sunshine Act; Gift Ban Still In Place

In 2009, the State of Massachusetts enacted the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC), which requires companies to report payments of more than $50 made to any healthcare practitioner. The law has provided a foreshadowing of the Federal Physician Payments Sunshine Act, which came into effect August of 2013. We have covered the release of Massachusetts' data from 2010, 2011, and, most recently, in 2012.

Massachusetts just released a Notice of Federal Preemption, which states that their "Department of Public Health may not require a pharmaceutical or medical device manufacturing company to disclose information that has been disclosed to a federal agency pursuant to federal law and that may be obtained by the department from such federal agency." Therefore, any payments disclosed to the Centers for Medicaid and Medicare Services (CMS) pursuant to the Sunshine need not be disclosed to the Department. The District of Columbia released a similar notice of Federal preemption a couple of weeks ago.

However, payments to practitioners that fall outside the federal mandate must continue to be disclosed. In Massachusetts, companies must track and report payments to nurse practitioners for example. Click here for our list of state transparency laws and their specific requirements.

Furthermore, Massachusetts' "Gift Ban" still remains in effect. The Federal Sunshine law merely requires disclosure of certain transfers of value.

While the original law strictly prohibited pharmaceutical and medical device companies from providing any meals of any value to health care practitioners outside a hospital or the practitioner's office, this section was amended in 2012. Such companies may now provide meals outside the office or hospital in a non-CME setting, as long as they are of "modest value," while in a setting conducive to informational communication. Massachusetts still prohibits meals in most settings:

  • Meals and refreshments provided as part of entertainment or a recreational event
  • Meals and refreshments provided without an informational presentation
  • Meals and refreshments provided to a health care practitioner's spouse or guest

Massachusetts' Code of Conduct also prohibits:

  • Entertainment or recreational items of any value, such as tickets to a sporting event or concert, or vacation trips
  • Payments of any kind, except as compensation for bona fide services
  • Grants, scholarships, subsidies or other items, in exchange for prescribing or disbursing prescription drugs, biologics or medical devices

Massachusetts notes: "Consistent with the regulation, the Department expects companies to continue to report all instances of non-compliance or be subject to a penalty (970.010) or enforcement action (970.011)."

They also state that a "guidance document regarding the new quarterly meal reports is being worked on, and will be released in the near future. Until that time, manufacturers should not take any action regarding the quarterly meal reports. Once guidance is released, it will be available in this location."

Thanks to Porzio Life Sciences for alerting us to this notice.

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