2014 has been a big year for healthcare and continuing medical education (CME). Here are ten topics worth going back to that Policy and Medicine has covered over the past 12 months.
1) The year of disclosures
The Centers for Medicare and Medicaid Services (CMS) releases Medicare Part B data and payments from manufacturers to doctors as required under the Physician Payments Sunshine Act.
For an extensive article on all of our Open Payments coverage, view our Sunshine Act Resources. Also, one of the more notable stats from our look at the data was the fact that the Majority of Transactions in Open Payments Are Less Than $20.
2) No Huge Settlements in 2014
For a number of years, it seemed like drug company settlements would continue to rise every year. Fortunately, Johnson & Johnson’s $2.2 billion settlement reached last year (over conduct from the early 2000s) was the last >$1 billion payout. In 2014, there was plenty of action on the enforcement side, but over much smaller monetary figures.
Here are some of the notable articles we wrote on the enforcement side:
4) FDA Social Media Guidance
In 2014, FDA released two new guidances for companies looking to communicate online through social media, Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices and Presenting Risks and Benefits With Social Media’s Character Space Limitations
5) Expansive FDA Interpretations Struck Down in Court
6) OIG Activity
7) The Ever Changing Sunshine Act and CME issue
This past year saw CMS propose to change the Sunshine Act's specific CME exemption in July. This was met with hundreds of stakeholder comments arguing against such a change. CMS officially released their interpretation in their October Final Rule, seemingly maintaining the CME exemption through different sections of the Sunshine Act. In December, however, CMS released FAQs which muddled the water even more. Any changes to the Sunshine Act do not come into effect until 2016, with reporting not due until 2017, so we may have to wait out some more clarification from CMS.
Read about the new bill to exempt CME and journal reprints from the Sunshine Act.
8) GSK’s busy year:
9) FDA Biosimilar Guidance and Biosimilar Activity
The Affordable Care Act included an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" (biosimilar) to an FDA-approved biological product. 2014 has been a big year for biosimilars in the U.S.
Tune back in next year for extensive healthcare compliance coverage and Life Science Compliance Update, our new in-depth monthly publication starting in 2015!