June 7, 2012

Question: We understand CMS finalized the changes to the Medicare Conditions of Participation contained in its proposed rule issued back in October.  We also understand that these changes were intended to promote “flexibility” but note that, in the case of standing orders, CMS has implemented a number of requirements where there were none before.  Can you tell us about these changes?

Answer:

You are correct on all counts.  Final changes to the Medicare Conditions of Participation were published in the Federal Register on May 16.  The purpose of these revisions is to streamline and simplify CMS’s regulations.

That being said, CMS has now adopted a number of requirements related to standing orders, order sets, and protocols, where, as you said, there were none before.  In its Final Rules, CMS lays out the process it expects to be in place in order for a hospital to use pre-printed and electronic standing orders, order sets and protocols for patient orders.  This process includes the following steps:

(1)        establish that such orders and protocols have been reviewed and approved by the medical staff in consultation with the hospital’s nursing and pharmacy leadership;

(2)        demonstrate that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;

(3)        ensure that the periodic and regular review of such orders and protocols is conducted by the medical staff, in consultation with the hospital’s nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols; and

(4)        ensure that such orders and protocols are dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the patient’s care.

Seems simple enough, right?  But we know from experience that most hospitals have never had this type of formal review process in place and that oftentimes the documentation for the protocols that are carried out every day reside in a long forgotten three?ring binder on a shelf somewhere.  This means many hospitals will need to begin combing through those binders and desk drawers in order to catalog and review the various protocols in place at their facility.

So much for streamlining!

To learn more about the implications of CMS’s Final Rule, please join Horty Springer attorneys Charles Chulack and Ian Donaldson for a special audio conference on June 21, 2012, where they will discuss the new Medicare CoP revisions to the patient care requirements, including verbal orders, standing orders, patient restraints, and medication administration, and how these revisions will impact the patient care processes and policies in your hospital.