I recently had the pleasure of taking a break from my normal day job to shadow a validation review. Given that my everyday tasks don’t really overlap with the review process, I was excited to get the chance to observe our reviewers in action. I regularly interact with product development, so I have a general understanding of how our standards are developed/revised, but this was a great opportunity to see our standards come to life, for lack of better words.

In June the President signed the VA MISSION Act into law which overhauled the Veterans Community Care Program. If you aren’t familiar, the community care program allows veterans to access private care outside of traditional U.S. Department of Veterans Affairs (VA) facilities. It was created in 2014 in response to the very public PR nightmare concerning extensive wait times and other instances of negligence.

The Senate Judiciary Committee advanced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, S. 974, out of committee on June 14. The main purpose of this bill is to make it easier for generic and biosimilar developers to obtain confidential information from branded drug manufacturers. The bipartisan bill was first introduced in April 2017 but stalled due to strong lobbying efforts from brand-name pharma against the measure. Some members of the GOP have also expressed concern that the bill would lead to unfounded lawsuits against drug companies.

If you’ve been keeping up with Congress and the Trump Administration over the last month or so, then you know that drugs have been pushed to the forefront of just about everything healthcare related. On May 11, The Department of Health and Human Services (HHS) released their drug pricing blueprint, American Patients First, which coincided with a speech from the President about the ridiculously high cost of pharmaceuticals and what his administration plans to do about it.

I did want to make sure that everyone who wasn’t already aware knows I updated the compendium of accreditation citations. 

Due to heavy media coverage back in February, you may be aware of CMS’ latest effort to expand access to affordable coverage through the expansion of short-term health plans. CMS unveiled their Notice of Proposed Rulemaking on this effort entitled, “Short-Term, Limited-Duration Insurance” in the Federal Register on February 21. If you are a policy wonk like myself then you’ve been anticipating the release of this rule for a few months now following the President’s October 2017 executive order which essentially all but mandated it.

You may have read that the Chronic Care Act, which has been praised by industry groups and telemedicine providers for paving the way for greater use of telemedicine, was included in the most recent Congressional budget.