Conditions of Participation

June 18, 2020

Posted on by hortyspringer
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QUESTION:        Does our Utilization Review Committee have to be a Medical Staff committee, or can it be a Hospital committee?

ANSWER:           In our experience, some hospitals do have a utilization review committee set up as a Medical Staff committee, but many do not.  There is no explicit regulatory requirement or accreditation standard obligating a hospital to have a Medical Staff utilization review committee.  For example, the Centers for Medicare & Medicaid Services (“CMS”) Conditions of Participation for Hospitals require hospitals to have a utilization review plan and a utilization review committee.  The committee, per the Conditions of Participation, has to be a “staff committee of the institution” with at least two physicians as members.  The requirement can be satisfied by “a group outside the institution” such as one established by local medical societies.  CMS includes the utilization review requirements in the Conditions of Participation in a separate section from the medical staff requirements.  The Medical Staff sections of the Conditions of Participation do not even mention utilization review.  Even though the Conditions of Participation note that a utilization review committee has to be a “staff committee,”  this is different from a “medical staff committee.” CMS knows how to signify when something falls under the purview of the medical staff and the fact that CMS left out “medical staff” when describing the requirements for the utilization review committee is significant.  Furthermore, the Conditions of Participation state that the committee has to be a committee of the “institution,” which signifies “hospital” as opposed to Medical Staff.  The fact that the utilization review committee requirement can be satisfied by a “group outside the institution” (that would not be a medical staff committee) also demonstrates that it does not need a medical staff committee.  Keep in mind that if you decide to have the utilization review committee as a hospital committee, we recommend that you confirm that your state does not require that the committee be a medical staff committee.

That being said, we are aware of at least one client who received feedback from the CMS Survey & Certification Group, Division of Acute Care Services that the utilization review committee “must be a committee or subcommittee of the medical staff.”  Nonetheless, this feedback, as noted above, is not consistent with the Conditions of Participation and we are not aware of CMS citing any hospital for having a Hospital utilization review committee.  It is also not consistent with current practice of many hospitals whose utilization review committees are multi-disciplinary hospital committees with membership comprised of both practitioners and administrative personnel such as directors of coordinated care, billing staff, and internal audit staff.

May 30, 2019

Posted on by hortyspringer

QUESTION:        We have some advanced practice nurses and physician’s assistants who are lobbying to become members of the Medical Staff.  Some physicians support the idea, but others aren’t so sure.  What are you seeing out there?

ANSWER:             In our experience, most Medical Staffs are composed of physicians, dentists, oral surgeons and, increasingly, podiatrists.  In some states, it is required that others be appointed to the staff, such as psychologists in Ohio.  State laws still vary. For example, in Pennsylvania, a hospital wanting to include podiatrists must seek an exception from the Department of Health, but it is readily granted.

As CMS has amended the Conditions of Participation and Interpretive Guidelines in recent years, the door has been opened:

§482.22(a) Standard: Eligibility and Process for Appointment to Medical Staff

The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope-of-practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body.

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Interpretive Guidelines §482.22(a) The hospital’s governing body has the responsibility, consistent with State law, including scope-of-practice laws, to determine which types/categories of physicians and, if it so chooses, non-physician practitioners or other licensed healthcare professionals (collectively referred to in this guidance as “practitioners”) may be privileged to provide care to hospital patients.  All practitioners who require privileges in order to furnish care to hospital patients must be evaluated under the hospital’s medical staff privileging system before the hospital’s governing body may grant them privileges.  All practitioners granted medical staff privileges must function under the bylaws, regulations and rules of the hospital’s medical staff.  The privileges granted to an individual practitioner must be consistent with State scope-of-practice laws.

CMS provided the following statement in 2014:

For Information Only – Not Required/Not to be Cited

CMS expects that all practitioners granted privileges are also appointed as members of the medical staff.  However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only physician practitioners, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for those specific categories of non-physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law.  (79 FR 27114-27115, May 12, 2014)

Today, it is becoming more common for a category to be added to the Bylaws for Advanced Practice Clinicians, and APCs may serve on committees with vote.

Join Barbara Blackmond and Josh Hodges for the next Grand Rounds audio conference on June 4, “Q&A on Advanced Practice Clinicians,” where they will discuss practical issues, including credentialing, privileging, peer review, collaborative practice in states allowing independent practice for some APCs, the role in emergency call, hearing rights and emerging issues, such as the role of APCs in admission, discharge, and  consults.

 

April 4, 2019

Posted on by hortyspringer

QUESTION:        Do the Medicare Conditions of Participation place any requirements on the use of standing orders?

 

ANSWER:            Yes, they do.  The Centers for Medicare & Medicaid Services (“CMS”) have established multiple requirements for compliant use of standing orders in the hospital setting.  For example, each standing order must be reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership prior to use.  CMS emphasizes that this should be a “multi-disciplinary collaborative effort.”  Crucially, each standing order must have clearly identified specific criteria that govern when it will be executed.  CMS is very clear:  “Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.”

Note that there is some ambiguity in the term “standing order,” and CMS recognizes this.  Consequently, it is possible that some of your pre-printed and electronic order sets could fall outside the scope of this regulation.

As part of your compliance efforts, we recommend periodically reviewing your policies on standing orders, order sets, and protocols for patient orders to ensure compliance with the Conditions of Participation and with state law.  We also recommend periodic compliance audits of medical records to verify that your policies are being implemented appropriately.

March 22, 2018

Posted on by hortyspringer

QUESTION:        A patient is asking the hospital staff to allow him to use medical marijuana that he obtained in compliance with state law.  Should we let him?

ANSWER:            This is a tough question especially in light of the recent, increased, legal acceptance on a state level of both medical and recreational marijuana.  The patient in the question is claiming that he obtained the medical marijuana in compliance with state law.  In such a situation, you should ask yourself a number of questions.  First, does your state law protect facilities or staff that permit medical marijuana use?  For example, Maine law states that hospitals and staff members will not be liable for facilitating the use of medical marijuana by certified, admitted patients, as long as the marijuana is not smoked or vaped.  Second, does your state law require a hospital to accommodate a patient’s use of medical marijuana?  Minnesota has a law on the books that says, in part, “no [health care] facility shall unreasonably limit a patient’s access to or use of medical cannabis to the extent that use is authorized by the patient.”

Even if the answer to these first two questions is “yes,” you have to ask yourself if you are willing to accept the legal risk under federal law.  Marijuana is a Schedule 1 controlled substance under the federal Controlled Substance Act.  Regardless of state laws to the contrary, it is still a violation of federal law to manufacture, possess or prescribe marijuana for either medical or recreational purposes.  The Medicare Conditions of Participation (“COPs”) for hospitals state “drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.”  The COPs do not anticipate that Schedule 1 controlled substances will be stored or distributed in hospitals.  The applicable regulations and the Interpretive Guidelines to the COPs only refer to Schedule 2-5 substances.

Some hospitals have accepted the risk and permit patients to bring their own medical marijuana into the hospital for administration.  At least one of those hospitals has put the following safeguards in place:

  • Hospital staff (such as nurses and pharmacists) are not permitted to assist with dispensing or administering medical marijuana. The drug must be self-administered.
  • The hospital is required to verify that the patient is registered with the state’s medical marijuana program.
  • The hospital must provide a safe for the storage of medical marijuana in the patient’s room. Hospital employees do not access the safe or handle the medical marijuana at any time.
  • The medical marijuana must be in liquid or capsule form, and must have been provided by an in-state dispensary.

That being said, such safeguards do not protect you from CMS disapproval or sanctions.  Although it is a fascinating topic with numerous legal issues to consider, the fact is that marijuana continues to be a Schedule 1 drug under federal law.  Consequently, there is risk that CMS could take action based on the COPs.

April 27, 2017

Posted on by hortyspringer

QUESTION:        Our hospital policies allow almost anyone to order outpatient services, regardless of whether they are a member of the Medical Staff or not.  Is this a problem?

ANSWER:            This poses compliance issues under the Medicare Conditions of Participation (“CoPs”).  The CoPs only allow outpatient services to be ordered by practitioners who meet certain conditions.  The ordering practitioner must be (1) responsible for the patient, (2) licensed in the state where he or she provides care to the patient, (3) acting within his or her scope of practice under state law, and (4) authorized by state law and policies adopted by the Medical Staff (with approval from the governing body) to order the applicable outpatient services.

Your Medical Staff policies can reflect a determination as to whether practitioners who are not on your Medical Staff are permitted to order outpatient services.  However, these policies must address how you will verify that the referring/ordering practitioner meets the requirements in the CoPs.  You will need to keep documentation to show that you have complied with the CoPs (e.g., documents showing that you checked the ordering practitioner’s license).

If you permit allied health professionals not affiliated with your hospital to order outpatient services, you may have to do a significant amount of work.  Be sure to check their scope of practice to make sure they are permitted to order the service in question.  In addition, be sure to follow the laws of your own state!

You may decide that certain orders should be permitted only by individuals with specific hospital privileges.  The Interpretive Guidelines give the example of requiring practitioners to have hospital privileges before they can place an order for outpatient chemotherapy services.  If you do this, be sure to delineate these terms clearly in your policies.

February 23, 2017

Posted on by hortyspringer

QUESTION:        One of our busiest general surgeons is chronically late in dictating her operative reports.  She often does not dictate the complete operative report until days or weeks later.  We are concerned about patient care and compliance with accreditation standards.  And we are expending unnecessary resources sending constant reminders. We think our rules and regulations are clear.  What can we do?

ANSWER:            You are correct that a surgeon’s failure to timely complete an operative report has patient care and compliance implications.  It is difficult to imagine how an accurate operative report can be dictated days or weeks after the procedure, especially when the surgeon has a busy practice.  That is why the issue of operative reports is addressed both in the Conditions of Participation and the Joint Commission Standards.

According to §482.51(b)(6) of the Conditions of Participation: “An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon.”  Joint Commission RC.02.01.03 Element of Performance 5 requires: “An operative or other high-risk procedure report is written or dictated upon completion of the operative or other high-risk procedure and before the patient is transferred to the next level of care.” There is an exception to this requirement when an operative progress note is written immediately after the procedure, in which case the full report can be written or dictated within a time frame defined by the hospital.

In dealing with your particular situation, we recommend, as a first step, that you gather information about the surgeon’s non-compliance with your standards, including any reminder letters that have been sent within the last year.  Share this with the Leadership Council (typically the Chief Medical Officer, the Chief of Staff, the Chair of the Credentials Committee and the Chair of the Peer Review Committee) and the Chair of the Department of Surgery.  Then invite the surgeon to meet with the Leadership Council.

In advance of the meeting, the Leadership Council can outline a proposed Performance Improvement Plan, including specific expectations and consequences.  For example, the Performance Improvement Plan may provide:

You acknowledge and agree that an operative progress note must be entered into the medical record immediately after surgery and before the patient is transferred to the next level of care.  This progress note must include the following:  the names of the physician(s) and physician assistants, procedure performed, findings, estimated blood loss, specimens removed, and post?operative diagnosis.

You acknowledge and agree that a complete operative report must be dictated within 24 hours of the surgery/procedure.

You may want to consider a course on medical record documentation and mentoring sessions to further help the surgeon correct the underlying issues.

Some medical staffs have had success in gaining compliance with medical record requirements by imposing fines for non-compliance. Other medical staffs use the concept of automatic relinquishment.  Both approaches can be progressive with each subsequent incident of non?compliance leading to higher fines and/or longer periods of relinquishment of appointment and privileges.