Midweek Update

Yesterday, AHIP, Blue Cross and several other organizations released a set of guiding principles to encourage the federal government to take steps toward solving the problem of surprise billing that typically occur in the course of emergency care.

STAT offers a report on FDA Administrator's recent talk about reducing insulin prices.

Insulins are biologic drugs, meaning they’re made from living cells. But they haven’t been regulated the same way. Neither have copycat or generic insulins, known as follow-on insulins, been regulated the same way as most copycat biologic drugs, known as biosimilars. 

That’s set to change in 2020, when insulins will be regulated as biologics, and, thus, the copycats will be regulated the same way as biosimilars. 

That transition was written into the 2009 Affordable Care Act, and Gottlieb expects it will lead to more competition and lower prices for patients. “This is a watershed moment for insulin products,” Gottlieb said Tuesday, about the 2020 transition.

The FDA released guidance about how it intends to implement this change.  Congress is expected to consider surprise billing and drug pricing legislation next year,

The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, announced another settlement yesterday.  The settlement, which includes a $111,400 payment from and a compliance plan obligation on Pagosa Springs (CO) Medical Center ("PSMC").

The settlement resolves a complaint alleging that a former PSMC employee continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ electronic protected health information (ePHI), after separation of employment. OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a HIPAA required business associate agreement in place.