Follow the 4 Golden Rules for Standing Orders Under Hospital CoP Requirements

Is your hospital complying with the rules that the Centers for Medicare & Medicaid Services (CMS) has established for standing orders? If you feel less than confident answering “yes” to this question, you’re not alone – but your noncompliance could seriously hurt your bottom line.

If your hospital accepts Medicare and Medicaid patients, then your payments are on the line, warns Sue Dill Calloway, RN, MSN, JD, in her educational session, “Crack the Code to CMS & Joint Commission Hospital CoP Requirements for Order Sets, Protocols, Preprinted Orders, and Standing Orders.” Your reimbursement could be in jeopardy if your hospital isn’t in compliance with CMS’ hospital Conditions of Participation (CoP) for standing orders, order sets, protocols, and pre-printed orders.

Standing Orders, Order Sets, Protocols – What’s the Difference?

Problem: Protocols, standing orders, and order sets are “the most ubiquitous tools in modern healthcare, used to create predictable routines and outcomes in clinical care,” explained Dirk Stanley, MD, MPH in a recent posting in his blog “DirkMD – CMIO Perspective.” But when attempting to actually define and differentiate between a protocol and a standing order, “there is a curious paucity of information” in regulations, he noted.

A protocol requires the patient to meet certain clinical criteria, but there must be an order to initiate the protocol, according to a 2018 Joint Commission Medication Management Update presentation by Jeannell Mansur, R.Ph., PharmD, FASHP, FSMSO, CJCP.

A standing order, on the other hand, is an order that may be initiated without an initial order if the patient meets certain criteria. And an order set is a list of individually selectable interventions or orders that the practitioner may choose from.

In 2011, CMS issued guidance that allowed hospitals to utilize standing orders, Stanley noted. And now, CMS has incorporated standing orders, protocols, and order sets into the hospital CoP.

Know the 4 Rules for Standing Orders

According to the CMS CoP (in a section referred to as “Tag 457”), hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital:

  1. Establishes that the medical staff and the hospital’s nursing and pharmacy leadership have reviewed and approved such orders and protocols;
  2. Demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;
  3. Ensures that the medical staff and the nursing and pharmacy conduct periodic and regular reviews of such orders and protocols to determine their continuing usefulness and safety; and
  4. Ensures that the ordering practitioner or another practitioner responsible for the patient’s care dates, times, and authenticates such orders promptly in the patient’s medical record.


Under tag 457, you’ll notice that CMS offers no standard definition of standing orders – instead, CMS states that standing orders include pre-printed orders, electronic standing orders, order sets, and protocols, Calloway points out. Adding to the confusion is that CMS’ regulations don’t consider all pre-printed and electronic order sets as standing orders.

Example: A doctor or qualified practitioner picks from an order set menu. Nurses or other non-practitioner staff cannot initiate the treatment choices. In this case, the menus are not standing orders covered by this regulation, Calloway notes. Menu options don’t create an order set subject to the CMS regulations, because the physician has the choice not to use this menu and could create orders from scratch or modify it.

Meet the Minimum Requirements

Bottom line: However your hospital chooses to implement standing orders, make sure you’re meeting CMS’ minimum four requirements in the CoP.

Make sure your medical staff reviews and approves all protocols, Calloway stresses. Show that the orders and protocols are consistent with nationally recognized and evidence-based guidelines. Also, make sure there’s periodic review of the standing orders, and ensure that the practitioner dates, times, and authenticates the standing orders.

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1 Comment

  1. I have a question in reference to order sets that I am hoping you can help me with. In our Nursery, the Nurse is expected to initiate an order set based on the baby, example less than 35 weeks gestation or hypoglycemic newborn. The are actually admit orders with treatments, labs, meds etc…She is expected to initiate the order set on her own without any discussion with the physician based on her own assessment and information about the pregnancy and delivery. The Physician has not even seen the baby as if yet in this circumstance and may see them until the next day. Question, can the nurse initiate an order set without the physician evening seeing the patient or instructing the nurse which order set to use?

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