I've yet to see a driverless car, but I bet that it's headed to the funeral of some hospital.
Dr. Bob, the group’s compliance officer, has HIPAA on his mind almost all the time, that is, when he’s not thinking about coding or Stark or the federal Anti-Kickback Statute.
Earlier this month, the FDA approved the first 3-D printed drug product, Spritam, developed by Aprecia Pharmaceuticals.
The layering process of 3-D printing allows Apecia to tightly package active ingredients in precise dosages.
A far more complex use of that technology is certainly not far behind. One that will open the door to mechanized compounding of drugs at patient-by-patient, individualized dosages: a customized 3-D printed pill for Mr. Smith and a different one for Ms. Jones.
For compounding pharmacists, the expansion of the use of 3-D printing technology will mean even more demand, whether on a small scale of production (i.e., a local pharmacy) or on a large one (e.g., a centralized facility filling hundreds of thousands or millions of prescriptions for individualized medications).
At the small scale end of this continuum, the move from large scale drug manufacturing to individualized drug compounding via 3-D printing is the equivalent of the morphing of the million dollar printing press into the laser printer or ink jet in your home office. It’s the dematerialization and democratization of drug manufacturing.
For physicians in states that either allow them to own interests in pharmacies or to dispense pharmaceuticals from their practices, the technology opens new doors to patient care and to profit.
Underlying all of this, for physicians and pharmacists alike, is the opportunity to do new types of deals with unique structures. That requires a new way of thinking. It also requires careful compliance with a host of regulatory issues, from the federal Anti-Kickback Statute to Stark to the Federal Food, Drug, and Cosmetic Act.
But those are just the problems on the route to outcomes that will be profitable for patients and profitable for providers.
Comment or contact me if you’d like to discuss this post.
Mark F. Weiss
Google’s driverless cars have logged over 100,000 miles without incident. I don’t know how many car drivers will want to give up the control, but I’d bet that large trucking companies are doing the calculations.