Print
Email
Print Edition Stories
MHT managing editor Rodney Brown on NECN: 22 tech companies give back to community
How is the economic crisis affecting tech companies?
Industry spokesmen intend to voice concerns at a state hearing today on controversial new guidelines meant to prevent medical device and pharmaceutical companies from unduly influencing doctors and other health care providers.
The guidelines are part of legislation passed last August. The law calls for the Massachusetts Department of Public Health (DPH) to establish a code governing how medical manufacturing companies interact with doctors. This code, for instance, requires any payment or gift of $50 and over to a doctor to be reported to the DPH, which in turn would list it on the state’s website. The first of two hearings is being held this morning at the DPH in Boston.
Robert Coughlin, president and CEO of the Cambridge-based Massachusetts Biotechnology Council, is expected to testify at the morning hearing. These are the strictest industry rules in the country, Coughlin claimed. They will have a “chilling effect” on the state’s biotech and medical device industry in an already bad economic time, he said.
“There are a number of areas that are of concern to us,” said Thomas Sommer, president of the Massachusetts Medical Device Industry Council, and another expected attendee. “We’re committed to complying with this now that it’s law,” he said. “But we’d like to use the comment period to push for changes that make sense.”
Among the provisions MassMEDIC takes issue with is the July 1 compliance date, which may not give companies time to prepare for all the reporting requirements. Another point of contention is around the disclosure requirement. Not only must all medical manufacturers make an annual disclosure of any fee paid out exceeding $50 in value, and its recipient, they must also pay the DPH a $2,000 disclosure fee each year.
Sommer noted the $2,000 fee might be a “burden” for startup companies that haven’t made it to the markeplace so far.
However, the crafting of the guidelines within the Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Care is still ongoing, and there is a “fair and open and well-considered” public comment process under way, said John Jacob, a spokesman for the Mass. DPH. The ultimate goal of these rules is to reform health care in the state. As part of that, the law’s intent is to drive out as many “inefficiencies and hidden costs” as possible, said Jacob.
The second hearing is scheduled for Jan. 12 at UMass Medical School in Worcester.
DPH transparency guidelines at a glance
• Establishes a marketing code of conduct for medical device and pharma companies
• Bans recreation, entertainment, and complimentary gifts
• Limits meals provided to doctors, their hospitals or offices
• Payments of $50 or more to doctors must be reported and made public
• Charges annual disclosure fee of $2,000
• Subject to public comment until January 19
• Assess penalties of up to $5,000 per violation
• Will go into effect in July
RSS Feeds
Comments
Please Login/Register to post comments.
No comments have been added or approved.