Top Policy and Medicine Stories of 2014

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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.

Medicare Part B: Medicare Payment Data Released: Journalists Create National and Regional Searchable Databases, Often with Little Context for Payments

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:

DaVita Dialysis had the biggest settlement we covered, $350 million

Novartis Kickback Case Allowed To Continue

 

3) Whistleblowers 

2014 saw whistleblowers come from a variety of departments, including paralegals and high-ranking regulatory officers

 

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

FDA Combination Product Classification Again Struck Down By D.C. Court

Ivy Sports Medicine v. Burwell, et al.: FDA May Not “Short-Circuit” the Process For Reclassifying Medical Devices, Rules Federal Appeals Court

US v. Caronia, One Year Later

FDA warning letters are inadmissible, says Arkansas Supreme Court

 

6) OIG Activity

Kickback Alert: Pharmaceutical Manufacturer Copayment Coupons and Medicare Part D

OIG Releases Special Fraud Alert: Laboratory Payments to Referring Physicians

OIG 2015 Work Plan

 

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:

Trouble in China

GSK’s New Sales Approach- Is it Working?

GSK Enters $105 Million State Consumer Protection Law Settlement; Agrees To Strict Compliance Provisions

 

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. 

 

10) ACCME Bans Corporate Logos 

 Tune back in next year for extensive healthcare compliance coverage and Life Science Compliance Update, our new in-depth monthly publication starting in 2015!

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