Transcript Compliance Considerations: Joint Commission Revised

MS.01.01.01: A Corporate Lawyer’s Perspective
Presented by David L. Kyger
Smith Moore Leatherwood LLP
[email protected]
300 N. Greene Street, Suite 1400
Greensboro, NC 27401
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Question 1
• What are other names for MS.01.01.01?
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Answer 1
• MS.01 Cubed
• MS.01 Q? Not.
• MS “too many numbers”
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Question 2
• What is the most reassuring thing you’ve read or heard
concerning compliance with MS.01.01.01?
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Answer 2
• “Given the flexibility provided for in the revised standard,
a limited amount of revision is all that may be needed. In
some cases, no revisions may be required.”
– Frequently Asked Questions Regarding Standard
MS.01.01.01, The Joint Commission website
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Question 3
• What is the “flexibility” referred to in the previous
answer? Where does this added flexibility come from?
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EP 3
Every requirement set forth in Elements of Performance 12 through
36 must be in the medical staff bylaws. These requirements may
have associated details, some of which may be extensive; such
details may reside in the medical staff bylaws, rules and regulations,
or policies. The organized medical staff adopts what constitutes the
associated details, where they reside, and whether their adoption can
be delegated. Adoption of associated details that reside in medical
staff bylaws cannot be delegated. For those Elements of
Performance 12 through 36 that require a process, the medical staff
bylaws include at a minimum the basic steps, as determined by the
organized medical staff and approved by the governing body,
required for implementation of the requirement. The organized
medical staff submits its proposals to the governing body for action.
Proposals become effective only upon governing body approval.
(See the Leadership chapter for requirements regarding the
governing body’s authority and conflict management processes.)
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Answer 3
• Medical staff bylaws must contain “every requirement”
set forth in Elements of Performance 12 through 36, but
only a basic framework, not all the details. Use EP’s 12 36 as a checklist against existing medical staff bylaws.
• For EP’s that require a process, the medical staff bylaws
need only contain the basic steps required for
implementation.
• The details do not have to appear in the medical staff
bylaws.
• The details can be placed in freestanding policies, rules
or regulations.
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Question 4
• EP 3 says that the details may reside in the medical staff
bylaws, rules and regulations, or policies. Does it really
make a difference where the organized medical staff
(OMS) puts the details, as between the bylaws, the rules
and regulations, or the policies?
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Answer 4
• It can make a difference in the process for changing the
details, and, accordingly, in the ease or lack thereof
associated with amendments.
• Remember that the medical staff bylaws can only be
amended by the voting members of the OMS, so if the
details are in the bylaws a vote of OMS is required
• As between rules and regulations on the one hand and
policies on the other, assume that the OMS has
delegated to the Medical Executive Committee the
authority to change the details. Look at EP 9.
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EP 9
If the voting members of the organized medical staff
propose to adopt a rule, regulation, or policy, or an
amendment thereto, they first communicate the proposal
to the medical executive committee. If the medical
executive committee proposes to adopt a rule or
regulation, or an amendment thereto, it first
communicates the proposal to the medical staff; when it
adopts a policy or an amendment thereto, it
communicates this to the medical staff. This Element of
Performance applies only when the organized medical
staff, with the approval of the governing body, has
delegated authority over such rules, regulations, or
policies to the medical executive committee.
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Answer 4 (cont’d.)
• Thus, if the details are placed in the rules and
regulations, the MEC must give the OMS prior notice of
changes.
• In contrast, if the details are placed in policies, prior
notice is not required.
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Question 5A
• What’s the next most reassuring thing you’ve heard or
read about compliance with MS.01.01.01?
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Answer 5A
• “Do what makes sense, in good faith.”
– Representatives of The Joint Commission, speaking
at an AHLA webinar in September, 2010
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Question 5B
• Do you buy that?
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Answer 5B
• [This slide under construction.]
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Question 6
• From your standpoint as a corporate lawyer focused on
governance issues, what is the most troubling thing
about MS.01.01.01?
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Answer 6
• MS.01.01.01 can put the governing body (e.g., the
hospital’s board of trustees) in a no-win situation.
• For example, suppose applicable law is amended, and
an amendment to medical staff bylaws, rules or
regulations is required in order to comply with the law as
amended. (EP 4 provides that the medical staff bylaws,
rules and regulations, and policies, the governing body
bylaws, and the hospital policies must be compatible
with each other and compliant with law.)
• If the organized medical staff (OMS) won’t agree to the
change, the governing body is stuck, because only the
OMS “adopts and amends” medical staff bylaws, subject
to governing body approval (under EP 2).
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Question 7
• What’s the big deal about the governing body being in
this situation?
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Answer 7
• Members of the governing body have fiduciary duties
(often articulated as a duty of care, a duty of loyalty, and
a duty of obedience) that, if breached, can result in
individual liability
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Question 8
• Doesn’t EP 11 offer some help to the governing body in
the hypothetical no-win situation you describe?
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EP 11
In cases of a documented need for an urgent amendment to rules and
regulations necessary to comply with law or regulation, there is a
process by which the medical executive committee, if delegated to do
so by the voting members of the organized medical staff, may
provisionally adopt and the governing body may provisionally approve
an urgent amendment without prior notification of the medical staff. In
such cases, the medical staff will be immediately notified by the
medical executive committee. The medical staff has the opportunity for
retrospective review of and comment on the provisional amendment. If
there is no conflict between the organized medical staff and the medical
executive committee, the provisional amendment stands. If there is
conflict over the provisional amendment, the process for resolving
conflict between the organized medical staff and the medical executive
committee is implemented. If necessary, a revised amendment is then
submitted to the governing body for action.
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Answer 8
• No. EP 11 allows for a process, where there is a need
for an “urgent amendment” to the organization’s “rules
and regulations,” in which the Medical Executive
Committee can speak for the OMS (if the OMS has
delegated that authority), and can provisionally adopt
rules and regulations that comply with the law as
amended, and, if it does so, the governing body may
provisionally approve an urgent amendment.
• Neither EP 11 nor any other EP allows unilateral action
by the governing body in amending the medical staff
bylaws, or the medical staff rules and regulations.
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Question 9
• What is the governing body’s “right path” in such cases?
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Answer 9
• According to The Joint Commission, the answer lies in
communication, collaboration and conflict resolution, by
and among the governing body, the Medical Executive
Committee, and the Organized Medical Staff.
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Standards For Corrective Action
Presented by:
Samuel O. Southern
Smith Moore Leatherwood LLP
434 Fayetteville Street, Suite 2800
Raleigh, NC 27601
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Standards For Corrective Action
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•
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Improving Quality of Care
Protecting Participants with Immunity and Confidentiality
Minimizing Claims (from both physician and patient)
Meeting Joint Commission Requirements
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Professional Review Actions
Focus: How Hospitals should undertake professional review actions
based on the competence or professional conduct of a physician
•Which conduct affects or could affect adversely the health or welfare of
a patient or patients, and
•Which conduct affects (or may affect) adversely the clinical privileges
of the physician
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Guidance For Effective Corrective Action
(1)
(2)
(3)
(4)
HCQIA -- provides IMMUNITY
Joint Commission – creates STANDARDS
Statutes – protect CONFIDENTIALITY
NC case law -- creates DUTY to monitor MDs
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Caught In The Cross-Fire
• Failure to follow controlling authority in (1) – (4) can put
hospitals in a cross-fire from three directions
– Patients
– Members of the Medical Staff
– Joint Commission
• Horns of the Dilemma
– Get sued by the patient, if you fail to take corrective
action against the bylaws
– Get sued by the MD, if you do take corrective action
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N.C. State Law: A Legal Duty To Monitor
And Oversee
State Law: Hospital has a duty to make a reasonable effort to monitor
and oversee the care being provided by physicians to hospital
patients
Bost v. Riley, 44 N.C. App. 638, 262 S.E.2d 291, cert. denied, 300 N.C.
194, 269 S.E.2d 621 (1980)
Blanton v. Moses Cone Hosp., 319 NC 372, 354 S.E.2d 455 (1957)
The Supreme Court, Webb, J., held in Blanton that:
1) Hospital owed duty of care to patient to ascertain that doctor, who
was not agent of hospital, was qualified to perform operation
2) Hospital had duty to monitor and supervise physician's overall
performance in hospital on ongoing basis
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How Do Hospitals Comply With The Legal
Duty?
• How does a hospital "monitor and oversee" physician
care? Through its Medical Staff by
– Credentialing
– Recredentialing
– Performance Improvement
– Peer Review
– Corrective Action/Professional Review Action
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HCQIA Immunity
• Health Care Quality Improvement Act. 42 U.S.C. §
11111
– Provides immunity from damages for those who
participate in professional review actions, so long as
they conduct the professional review within the safe
harbor of HCQIA
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Insuring HCQIA Immunity From Damages
• If a professional review action meets all the standards
specified in section 11112(a) of HCQIA, no person shall
not be liable in damages under any law
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Exceptions
• Statutory immunity may be lost if
– Violation of civil rights
– Knowingly provide false information
– Failure to comply with reporting requirements of
HCQIA
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Navigating The Safe Harbor Of HCQIA
• What must a hospital do to bring itself within the safe harbor of
HCQIA?
• 42 U.S.C. § 11112(a).For purposes of immunity, a professional
review action must be taken
(1) in the reasonable belief that the action was in the furtherance
of quality health care
(2) after a reasonable effort to obtain the facts of the matter
(3) after adequate notice and hearing procedures are afforded to
the physician involved
(4) in the reasonable belief that the action was warranted by the
facts known after such reasonable effort to obtain facts and
after meeting the requirement of paragraph (3)
• Summary: Adhere to (1)-(4) and immunity attaches to the
proceedings
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Presumption Of Compliance With
Standards
• A professional review action shall be presumed to have
met the preceding standards necessary for immunity
unless the presumption is rebutted by a preponderance
of the evidence
• The Statute puts the B/P on the person/entity who seeks
to attack the recommendations sought to be enforced
• The lesson here: The law does not place the B/P on the
Hospital (although the Hospital, through bylaws, hearing
plan, etc. can place the burden on itself)
• B/P is NOT on the hospital to show clinical deficiencies,
disruptive behavior or anything else
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Burden Of Proof: Check The Bylaws
• Many hearings turn on the question of who has the B/P
• Bylaws usually answer the question
Example #1: B/P is on hospital to prove by a
preponderance of the evidence
Example #2: B/P is on practitioner to prove by clear
and convincing evidence that the hospital's decision was
arbitrary, unreasonable, or not supported by the
evidence
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Notice And Hearing Requirements
• A health care entity is deemed to have met the adequate
notice and hearing requirement of HCQIA if the following
conditions are met or waived
– The physician has been given notice stating:
• that a professional review action has been
proposed
• the reasons for the proposed action
• the physician has the right to request a hearing
• the physician's rights at the hearing
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Additional Notice When A Hearing Is
Requested
• If a hearing is requested, the physician must be given
additional notice stating
– the place, time, and date, of the hearing, which date
shall not be less than 30 days after the date of the
notice
– a list of the witnesses (if any) expected to testify at the
hearing on behalf of the professional review body
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Practitioner Rights At The Hearing
• An impartial “decider” is:
– a mutually acceptable" arbitrator
– a hearing officer appointed by the entity
– a panel not in "direct economic competition”
• Representation by an attorney
• To have a record made of the proceedings (but must pay for his/her
own copy)
• To call, examine, and cross-examine witnesses
• To present evidence determined to be relevant by the hearing
officer, regardless of its admissibility in a court of law
• To submit a written statement at the close of the hearing
• To receive the written recommendation of the panel, including a
statement of the basis for the recommendations
• To receive a written decision of the health care entity, including a
statement of the basis for the decision
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Exceptions To “Trial Before Punishment”
• If suspension/restriction of clinical privileges is less than
14 days, during which an investigation is being
conducted, OR
• In the case of summary suspension, where the failure to
act "may result in an imminent danger to the health of
any individual"
– Practitioner may be suspended, with hearing to come
later
– Immunity is preserved for participants
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Joint Commission Overview
• MS is responsible for the ongoing evaluation of the
competency of practitioners who are privileged
• MS must maintain bylaws that define its responsibilities
for the oversight of care, treatment and services
• MS primary responsibility is to provide oversight of care
provided by practitioners with privileges
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MS Bylaws As A Contract
• Maintained by the Medical Staff
• Must be approved by governing body
• Joint Commission
– Bylaws create a “system of rights and responsibilities”
between MS and the governing body
– Bylaws creates a “system of rights and
responsibilities” between the MS and its members
– Bylaws are contractual:
• Virmani v. Presbyterian, 127 NC App 71, 448 SE
2d 284 (1997)
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Joint Commission – Other Governing
Documents
• MS may create them, including policies, procedures,
rules and regs, fair hearing plan, etc.
• But the requirements of the Elements of Performance
("EPs") for MS.01.01.01 “must be retained in the MS
bylaws.”
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Joint Commission: Elements Of Performance For MS
01.01.01 Which Are Related To Corrective Action
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•
•
•
•
•
•
•
EP 28
– Indications for automatic suspension of a practitioner's MS membership or clinical privileges
EP 29
– Indications for summary suspension of a practitioner's MS membership or clinical privileges
EP 30
– Indications for recommending termination or suspension of medical staff membership, and/or
termination, suspension, or reduction of clinical privileges
EP 31
– The process for automatic suspension of a practitioner's medical staff membership or clinical
privileges
EP 32
– The process for summary suspension of a practitioner's medical staff membership or clinical
privileges
EP 33
– The process for recommending termination or suspension of medical staff membership,
and/or termination, suspension, or reduction of clinical privileges
EP 34
– The fair hearing and appeal process, which at a minimum shall include
• The process for scheduling hearings and appeals
• The process for conducting hearings and appeals
EP 35
– The composition of the fair hearing committee
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MS Standard 10.01.01 Corrective Action
• There are mechanisms including a fair hearing and
appeal process for addressing adverse decisions
regarding reappointment, denial, reduction, suspension,
or revocation of privileges that may relate to quality of
care, treatment, and services issues
• Designed to allow the practitioner the opportunity to:
– Defend himself/herself before an impartial panel
– Appeal any adverse decision to the GB
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Elements Of Performance (EPS) For
MS 10.01.01
• Provide a fair process that may differ for members and
non-members of the MS
• Provide a mechanism to schedule a hearing
• Identify procedures for the hearing to follow
• Identify the composition of the hearing panel, with
provision for impartial peers
• Provide a mechanism for appeal to the governing body
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MS 06.01.09 – Notice To Practitioner Of
Adverse Action
• Adverse decision to be communicated to practitioner
within the time required by the MS bylaws
• If denial, reason for denial
• If adverse, decision must be disseminated as required by
hospital and bylaws
• The process of disseminating outcome has been
approved by the MS
• The hospital makes the practitioner aware of due
process and, if applicable, the option to implement the
fair hearing plan
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MS 11.01.01 – Practitioner Health Issues
• The MS implements a process to identify and manage
matters of individual health for licensed independent
practitioners which is separate from actions taken for
disciplinary purposes
• Duty to provided education regarding impairing
conditions
• Goal is to optimize professional functioning consistent
with protection of the Patient
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Conclusion And Summary
• Bylaw provisions should comply with Joint Commission
requirements relating to fair hearing and corrective action
• Bylaw provisions should comply with the minimum standards of
HCQIA, but not more
• Bylaw provisions should comply with state and federal law so as to
insure confidentiality
• Document, document, document throughout the course of a
corrective action
Result: Improve the quality of care, maintain confidentiality of
privileged documents, protect your institution and those
who participate in the process by guaranteeing HCQIA
immunity from civil action damages
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