December 15, 2016 Legislation



Not every one got what they wanted but the 21st Century Cures Act was passed by a huge majority of both parties.  The drug industry wanted but did not get a provision that would have exempted them from reporting payments to physician for CME events.  This was a law due to Ocare. A major portion of the bill is address to off label uses of meds.  HHS will be required to collect real world information and not just clinical trial information.  One knows this is a good thing since Public Citizen is against it. The bill gives billions of dollars for cancer and Alzheimer research (about 30% less than requested) to the NIH who will fund medical schools.  The FDA will get about $500 million to hire more staff and speed up the agency.  States would get money for the opium epidemic.  The funding must be annually and comes from preventive health care fund.  Another provision will stop data blocking in EHRs. Interoperability will be king, hopefully. The poor hair growth people were left out as Medicaid will no longer fund drugs to restore hair. The Senate easily passed the bill as well with the likes of Sanders and Warren part of the five that opposed it.  Obama has signed it.

The OIG has issued final rules for anti kickback safe harbors.  The OIG can now penalize if providers do not give access to requested records.  Cost sharing is now OK for pharmacies with some needy beneficiaries as well as cost sharing for emergency ambulance services of state or municipality owned providers.  Some hospital coupons or rebates are also OK now. 

In an interesting twist the Senate Subcommittee on Finance wants hospitals to curtail the practice of surgeons overseeing two simultaneous surgeries.  This committee has no medical knowledge nor any power over hospitals to put this into motion but the practice is probably one that can not be billed for.  At the same time the Mayo Clinic came out with a scientific study that shows overlapping surgeries are safe as long as the main parts of the surgery do not occur at the same time. 

The VA ha given all advance practitioner nurses full privileges within the scope of their licenses except for nurse anesthetists.  The MD anesthesiologists had a great union.  

CMS has issued a ruling that dialysis units may no longer game the system by paying for their Medicaid patients to get real insurance so they can get more money.          Top


DISCLAIMER: Although this article is updated periodically, it reflects the author's point of view at the time of publication. Nothing in this article constitutes legal advice. Readers should consult with their own legal counsel before acting on any of the information presented.