MS.1.20 : A Chance to Establish Neutral Peer Review

Although the newly adopted Joint Commission Standard MS.1.20 will compel hospitals and medical staffs to re-evaluate the provisions of the medical staff by-laws on a multitude of issues, I would like to focus just upon peer review issues from the physician’s perspective, i.e., the physician who is the “target” of the peer review investigation or process.

While some stakeholders in this process from all perspectives, i.e., hospitals, physicians, administrators, medical staff officers, reject the notion that sham peer review is a problem, there is nevertheless almost universal acknowledgment that the peer review process is a threatening process to physicians being investigated. True peer review is not designed as a threatening process; it is a process intended to correct behavior and improve the quality of care. Although summary suspension and other disciplinary acts at the later stages of the peer review process inevitably occur, and in many and even in perhaps the substantial majority of cases may be justified, disciplinary actions should be an unfortunate result of a process rather than the goal of a process.

However, since the disciplinary peer review process (as distinguished from typical morbidity and mortality conferences) is very secretive and is conducted without the participation and sometimes without the knowledge of the target physician, the perception of this process as being a secretive and punitive process is all to often supported by the facts. MS.1.20 provides the opportunity to improve this process from the physician perspective, without changing either the confidentiality of the process from the perspective of a third party or affecting the control or governance of the process by the hospital or medical staff. Confidentiality was never intended to exclude physician participation. After all, most of the gory details of the process are not only disclosed, but highlighted and emphasized, once a decision to impose adverse peer review is made. My suggestions are as follows:

1.         Knowledge and Representation on the Ad Hoc/Investigative Committee: Standard bylaws provide that an investigative committee is appointed or assigned to investigate complaints about physicians. Physicians are typically notified that this action has occurred, but we believe physicians should always be notified and should also have the opportunity to approve or appoint one member of the committee, without regard to the total number of members of the committee. The goal is not to achieve a voting balance of power or stalemate, but simply to assure the absence of secrecy and the presence of accountability.

2.         Physician Participation in the Investigated Process: Standard bylaws often provide that the physician is granted the opportunity to meet with the investigative committee and discuss the findings. However, once findings have been made, the participation of the physician is almost irrelevant. The opportunity for the committee to make a decision considering all perspectives has already been lost. Physician participation in the process must start at the inception of the process, as it would in lower level peer review not intended to result in disciplinary consequences. 

3.         Hearing Committee Representation: As with the investigative committee, a physician representative should be included on the hearing committee. This is again without regard to the numbers, because the goal of this safeguard is not to create minority voting power or stalemates, but simply to assure that the physician is represented where it counts, in the deliberative process. The current deliberative process is unapologetically skewed to favor the hospital and facilitate the outcome desired by the hospital. The hospital, or the medical staff executive officers appointed or elected with hospital support, select the hearing panel members, whom deliberate in private and often with the participation in advice of hospital counsel. It is not necessary that the physician being investigated have any control over this process; it is merely important that a physician representative bring openness and the light of day to the process.   

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Joint Commission Adopts New MS.1.20 Standards

Hospitals

Revisions to Standard MS.1.20 Approved

At its June meeting, the Joint Commission Board of Commissioners approved revisions to Standard MS.1.20, which addresses medical staff bylaws, rules and regulations, and policies.  These revisions were written with the intent of supporting and reinforcing a productive working relationship between the organized medical staff and the governing body – consistent with the requirements of the new Leadership Chapter – while minimizing disruptions to the hospital, including its medical staff.  All of the requirements in Standard MS.1.20 must be jointly approved by the organized medical staff (or the medical staff executive committee, if so delegated by the organized medical staff) and the governing body.

The main revisions to Standard MS.1.20 are as follows:

  • The Introduction was revised to include a discussion of the relationship between the organized medical staff and the medical staff executive committee, and the definitions of “process” and “procedural detail.”
  • A note was added referring the organization to Standard LD.2.40 for guidance on managing conflict that might arise concerning the medical staff bylaws, rules and regulations, and policies.
  • A note was added to explain the revised structure of the standard.
  • Lead-in sentences to groups of EPs were added to clearly delineate what must be in the medical staff bylaws, and what must be either in the bylaws, or in rules and regulations or policies.
  • Two new EPs were added to align the standard with the Centers for Medicare and Medicaid Services’ requirements regarding medical staff bylaws.
  • An EP was added to underscore the organized medical staff’s ability to propose medical staff bylaws, rules and regulations, and policies directly to the governing body.
  • A requirement was added that the medical staff bylaws must indicate the authority delegated to the medical staff executive committee by the organized medical staff to act on its behalf, and how that authority is delegated and removed.

The revised standard seeks to resolve several important issues.  First, it addresses situations in which a medical staff believes that its medical staff executive committee is not representing its views on issues of patient safety and quality of care.  The revised standard now states that the medical staff bylaws must indicate what authority the medical staff has delegated to the medical staff executive committee, and how that authority is delegated and removed.  Also, the revised standard now states that the medical staff has the ability to adopt medical staff bylaws, rules and regulations, and policies and propose them directly to the governing body, even if the subject matter had been delegated to the medical staff executive committee.  While the revised standard does not state what a medical staff should do if it does not agree with an action taken by its medical staff executive committee, the Introduction to the standard urges the medical staff to consider in advance what action it would take if such a situation occurred.

The revised standard also seeks to allow for an efficient process, for the hospital and its medical staff, for creating and maintaining medical staff bylaws, rules and regulations, and policies.  To do this, the standard indicates what must appear in the medical staff bylaws, and what must appear either in the bylaws, or in rules and regulations or policies.  The requirements in Elements of Performance (EPs) 9 through 33 must appear in the medical staff bylaws.  However, the procedural details associated with the processes listed in EPs 26 through 33 must appear either in the medical staff bylaws, or in rules and regulations or policies (see text of standard below).  The organized medical staff may, if it desires, delegate to its medical staff executive committee approval of the procedural details associated with the processes listed in EPs 26 through 33, when these procedural details are placed in rules and regulations or policies.

To understand these requirements, the difference between “process” and “procedural detail” needs to be explained.  A process is a series of steps taken to accomplish a goal.  A procedural detail describes in detail how each step in the process is to be carried out.  For example, the process for credentialing licensed independent practitioners (see EP 26) can be stated in several steps such as collecting information on a physician, evaluating the information, and making a decision about the information.  That process will be contained in the medical staff bylaws.  The procedural details associated with this process might include who collects the information, how files are kept, what organizations need to be contacted to collect all the necessary information, etc.  For EPs 26 through 33, the medical staff decides whether such procedural details will be retained in the medical staff bylaws (which must be approved by the entire organized medical staff), or in rules and regulations or policies (whose approval may be delegated to the medical staff executive committee).

Revised Standard MS.1.20 becomes effective July 1, 2009.  The Joint Commission is allowing two years for the field to make any changes to medical staff bylaws that may be necessary to bring organizations into compliance with the revised standard.  In the meantime, the current version of Standard MS.1.20 will be in effect.

STANDARD MS.1.20

Effective July 1, 2009

Introduction for Standard MS.1.20 (CAH, HAP)

The (HAP: organized) medical staff and the governing body work together, reflecting clearly recognized roles, responsibilities, and accountabilities, to enhance the quality and safety of care, treatment, and services provided to patients.  To support this work, the (HAP: organized) medical staff creates a written set of documents that describes the organizational structure of the medical staff and the rules for its self-governance.  These documents are called medical staff bylaws.  The medical staff bylaws create a system of rights, responsibilities, and accountabilities between the (HAP: organized) medical staff and the governing body, and between the (HAP: organized) medical staff and the medical staff members.   

In addition to the medical staff bylaws, the (HAP: organized) medical staff may create other medical staff governance documents such as rules and regulations and policies. In doing so, the (HAP: organized) medical staff may recommend that the procedural details of those requirements listed in Elements of Performance 26-33 of this standard be retained in the medical staff bylaws, or in rules and regulations or policies, in accordance with applicable law and regulation. 

In developing its bylaws, the (HAP: organized) medical staff may include within the scope of responsibilities of the medical staff executive committee the authority to adopt, on the behalf of the entire (HAP: organized) medical staff, any procedural details associated with Elements of Performance 26-33 appearing in rules and regulations or policies.  The (HAP: organized) medical staff can also propose medical staff bylaws, rules and regulations, and policies, and amendments thereto, directly to the governing body.

When approval of procedural details associated with Elements of Performance 26-33 appearing in rules and regulations or policies is delegated to the medical staff executive committee, it is to represent to the governing body the organized medical staff’s views on issues of patient safety and quality of care.  The organized medical staff can take action to revise the authority it has delegated to the medical staff executive committee to act on its behalf.  The organized medical staff is urged to determine what steps it will take if it does not agree with an action taken by the medical staff executive committee.  Such steps might include a process that would allow the organized medical staff, at its discretion, to extract and consider an action by the medical staff executive committee prior to the action becoming effective.

To understand these requirements, the difference between “process” and “procedural detail” needs to be explained.  A process is a series of steps taken to accomplish a goal.  A procedural detail describes in detail how each step in the process is to be carried out.  For example, the process for credentialing licensed independent practitioners (see EP 26) can be stated in several steps such as collecting information on a physician, evaluating the information, and making a decision about the information.  That process will be contained in the medical staff bylaws.  The procedural details associated with this process might include who collects the information, how files are kept, what organizations need to be contacted to collect all the necessary information, etc.  For EPs 26 through 33, the medical staff decides whether such procedural details will be retained in the medical staff bylaws (which must be approved by the entire organized medical staff), or in rules and regulations or policies (whose approval may be delegated to the medical staff executive committee).

The significance of the medical staff bylaws cannot be overstated.  For this reason, the medical staff leaders should assure that all medical staff members understand the content and purpose of the bylaws, and the bylaws adoption and amendment processes.

Note: If conflicts regarding the medical staff bylaws, rules and regulations, or policies arise between the governing body and the (HAP: organized) medical staff, the organization’s conflict management process is implemented, as set forth in Standard LD.2.40.

Standard MS.1.20 (CAH, HAP)

Medical staff bylaws address self-governance and accountability to the governing body.

Note regarding Elements of Performance 9-33: All requirements appearing in Elements of Performance 9-33 must be in the medical staff bylaws.  These requirements may have associated procedural details.  Any procedural details associated with the requirements in Elements of Performance 9-25 must also be in the medical staff bylaws.  Any procedural details associated with Elements of Performance 26-33 must be either in the medical staff bylaws, or in rules and regulations or policies.  All requirements and procedural details addressed in the medical staff bylaws must be adopted and amended by the whole of the (HAP: organized) medical staff and approved by the governing body.  All procedural details addressed in rules and regulations or policies must be adopted and amended by either the whole of the medical staff or the medical staff executive committee, if so delegated by the (HAP: organized) medical staff, and approved by the governing body.

Elements of Performance for Standard MS.1.20

  1. (CAH, HAP) The (HAP: organized) medical staff develops medical staff bylaws, rules and regulations, and policies.
  2. (CAH, HAP) The (HAP: organized) medical staff adopts and amends, and the governing body approves, medical staff bylaws.
  3. (CAH, HAP) The (HAP: organized) medical staff, or the medical staff executive committee as delegated by the (HAP: organized) medical staff, adopts and amends, and the governing body approves, any rules and regulations and policies that address procedural details of the requirements in Elements of Performance 26-33.
  4. (HAP) Regardless of whether the medical staff executive committee is empowered to act on behalf of the organized medical staff, the organized medical staff as a whole has the ability to adopt medical staff bylaws, rules and regulations, and policies, and amendments thereto, and propose them directly to the governing body.

    Note: Please see the Introduction to this standard for further discussion of the organized medical staff’s relationship to the medical staff executive committee.
  5. (CAH, HAP) The governing body acts in accordance with those medical staff bylaws, rules and regulations, and policies that are adopted by the (HAP: organized) medical staff or, as delegated by the (HAP: organized) medical staff, the medical staff executive committee, and approved by the governing body.
  6. (HAP) The organized medical staff enforces the medical staff bylaws, rules and regulations, and policies.
  7. (HAP) The medical staff bylaws, rules and regulations, and policies and the governing body bylaws do not conflict.
  8. (CAH, HAP) The organized medical staff and its members comply with the medical staff bylaws, rules and regulations, and policies.
     

    The medical staff bylaws must include the requirements and any associated procedural details in Elements of Performance 9-25.

  9. (CAH, HAP) The structure of the (HAP: organized) medical staff. 
  10. (CAH, HAP) The process for privileging licensed independent practitioners. 
  11. (CAH, HAP) Qualifications for appointment to the (HAP: organized) medical staff. 
  12. (HAP) Indications for automatic suspension of a practitioner’s medical staff membership or clinical privileges.
  13. (HAP) Indications for summary suspension of a practitioner’s medical staff membership or clinical privileges.
  14. (HAP) Indications for recommending termination or suspension of medical staff membership, and/or termination, suspension, or reduction of clinical privileges.
  15. (HAP) The composition of the fair hearing committee. (See also EP 32.)
  16. (CAH, HAP) The roles and responsibilities of each category of practitioner on the medical staff (active, courtesy, etc.). 
  17. (CAH, HAP) Requirements for performing medical histories and physical examinations. 
  18. (HAP) Those practitioners who are eligible to vote on the medical staff bylaws and their amendments.
  19. (HAP) A list of all the officer positions for the organized medical staff.
  20. (HAP) The medical staff executive committee’s function, size, and composition; the authority delegated to the medical staff executive committee by the organized medical staff to act on its behalf; and how such authority is delegated or removed.  (See also Standard MS.1.40.)
  21. (HAP) The process for selecting and removing the medical staff executive committee members.
  22. (HAP) That the medical staff executive committee includes physicians and may include other practitioners as determined by the organized medical staff.
  23. (HAP) That the medical staff executive committee acts on the behalf of the organized medical staff between meetings of the organized medical staff, within the scope of its responsibilities as defined by the organized medical staff.  (See also Standard MS.1.40.)
  24. (HAP) The process for adopting and amending the medical staff bylaws.
  25. (HAP) The process for adopting and amending medical staff rules and regulations, and policies.


    The medical staff bylaws must include the requirements in Elements of Performance 26-33.  The procedural details, if any, associated with Elements of Performance 26-33 must appear either in the medical staff bylaws, or in rules and regulations or policies (see Elements of Performance 1-4).

  26. (CAH, HAP) The process for credentialing licensed independent practitioners. 
  27. (HAP) The process for appointment to membership on the organized medical staff.
  28. (HAP) The process for selecting and removing the organized medical staff officers.

    Corrective Actions

  29. (HAP) The process for automatic suspension of a practitioner’s medical staff membership or clinical privileges.
  30. (HAP) The process for summary suspension of a practitioner’s medical staff membership or clinical privileges.
  31. (HAP) The process for recommending termination or suspension of medical staff membership and/or termination, suspension, or reduction of clinical privileges.

    Fair Hearing and Appeal

  32. (HAP) The fair hearing and appeal process (see also EP 15), which at a minimum shall include:

    - The process for scheduling hearings
    - The process for conducting hearings
    - The appeal process

    Qualifications and Roles and Responsibilities of the Department Chair

  33. (HAP) If departments of the organized medical staff exist, the qualifications and roles and responsibilities of the department chair, which shall include the following:

    Qualifications:
  • Certification by an appropriate specialty board or comparable competence affirmatively established through the credentialing process.

Roles and responsibilities:

  • Clinically related activities of the department.
  • Administratively related activities of the department, unless otherwise provided by the hospital.
  • Continuing surveillance of the professional performance of all individuals in the department who have delineated clinical privileges.
  • Recommending to the organized medical staff the criteria for clinical privileges that are relevant to the care provided in the department.
  • Recommending clinical privileges for each member of the department.
  • Assessing and recommending to the relevant hospital authority off-site sources for needed patient care, treatment, and services not provided by the department or the organization.
  • Integration of the department or service into the primary functions of the organization.
  • Coordination and integration of interdepartmental and intradepartmental services.
  • Development and implementation of policies and procedures that guide and support the provision of care, treatment, and services.
  • Recommendations for a sufficient number of qualified and competent persons to provide care, treatment, and services.
  • Determination of the qualifications and competence of department or service personnel who are not licensed independent practitioners and who provide patient care, treatment, and services.
  • Continuous assessment and improvement of the quality of care, treatment, and services.
  • Maintenance of quality control programs, as appropriate.
  • Orientation and continuing education of all persons in the department or service.
  • Recommending space and other resources needed by the department or service.

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Oklahoma Supreme Court Limits Peer Review Immunity

The Oklahoma Supreme Court has decided  the Oklahoma Peer Review statute (Professional Review Bodies - Protection From Liability Act) does not provide blanket immunity to peer review bodies in Oklahoma. The statute is only a defense to liability if the peer review body meets all of the requirements of the Act. In Smith v. Deaconess Hospital, a copy of which is attached at the link below, the Oklahoma Supreme Court overruled a trial court decision granting the hospital’s motion to dismiss and remanded the case for further proceedings. Among the significant shortcomings described by the Court, was the inability of Dr. Smith to cross examine the author of a peer review report of Dr. Smith’s cases and the failure to follow the bylaw procedures. The Oklahoma statute is reproduced in the text of the opinion, and it follows the structure of the requirements of the Health Care Quality Improvement Act, i.e., it establishes four similar conditions for qualified immunity and provides for specific procedural rights.

http://op.bna.com/hl.nsf/id/thyd-73qrnv/$File/Smith%20v%20Deaconess%20Hospital.htm

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Federal Courts Continue to Discourage Physician Antitrust Claims

Dr. John C. Perry and his practice, Teddy Bear Obstetrics & Gynecology, P.S., sued Kadlec Medical Center (which you may recall is the hospital that obtained a negligent credentialing judgment against Lakeview Medical Center in Louisiana for failing to provide credentialing information) and several members of the medical staff alleging that his credentials at Kadlec were improperly revoked as a result of a conspiracy by the defendants in restraint of trade in violation of Section 1 of the Sherman Act. 

The defendants filed a Motion to Dismiss under Federal Rule 12(b)(6), arguing that Dr. Perry failed to state a cause of action. The court reviewed the requirements for satisfactorily pleading an antitrust action in federal court and the general antitrust requirements, which are basically that the plaintiff adequately plead  facts indicating the existence of a conspiracy to restrain trade, or an attempted conspiracy, and harm to competition.

The element of harming competition has been a problem for many physicians alleging antitrust violations,  because the general rule is that the antitrust laws are intended to protect competition and not competitors. In order to proceed, the court indicated that Dr. Perry had to reasonably plead some actual harm to competition, such as price increase or at least the absence of price decreases in the OB-GYN field, a decrease in the availability of sufficient OB-GYNs in the market adversely impacting  patient access, or a decrease in quality. The court concluded that Dr. Perry had not adequately plead any of those facts and that the presence of other physicians in the market ,and in fact other physicians within Dr. Perry's practice,  belied any market impact or injury. 

The court concluded that "Factual allegations which plaintiffs say they could plea in an amended complaint are not enough to raise the right to relief above the speculative level. Not enough factual matter is alleged which, if taken as true, suggests there was any injury to competition beyond the impact on Dr. Perry. The plaintiffs have not plead enough facts in their complaint, nor have they proposed to plead enough facts in an amended complaint to reach a reasonable expectation that discovery will reveal evidence of injury to competition". The opinion in the case of John C. Perry, M.D. and Teddy Bear Obstetrics & Gynecology, P.S. v. Thomas M. Rado, M.D., et al., is available at the following link:

http://www.healthlawyers.org/email/pg/070529antitrust/Perry_v_Rado.pdf

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Peer Review Updates and Semmelweis Meeting Presentation

Curtsinger v. HCA, Inc.

Dr. Curtsinger's case illustrates one of the traps for the unwary in medical staff privileging cases. Dr. Curtsinger was summarily suspended, but was reinstated upon agreeing to a leave of absence to fulfill certain conditions for reinstatement. Upon completion of those conditions, Dr. Curtsinger requested return from his leave of absence; the hospital agreed to the return but imposed additional conditions which, according to the Court opinion, would have waived certain of Dr. Curtsinger's due process rights under the existing bylaws. This case illustrates the unanticipated consequences of what can happen when physicians voluntarily take themselves out of the due process protections of the medical staff bylaws, which commonly occurs in connection with leaves of absence. Typical medical staff bylaws require hospital approval for the return from a leave of absence but do not include denials of applications to return from leaves of absence as adverse peer review decisions subject to the fair hearing procedures of the bylaws.

Dr. Curtsinger's complaint against the hospital was dismissed on the basis of hospital immunity pursuant to the Health Care Quality Improvement Act (HCQIA). The Court concluded that the hospital had met all four standards for immunity under the HCQIA:

1.     Dr. Curtsinger's behavior was disruptive and disruptive behavior can affect patient care, so there could be a reasonable belief that the action was taken in the furtherance of quality healthcare;

2.     The hospital conducted a reasonable investigation;

3.     The hospital provided adequate due process, i.e., notice and hearing rights, and the Court rejected Dr. Curtsinger's contention that there should have been two separate notices and two separate hearings for the initial summary suspension and the subsequent denial for return from the leave of absence; and

4.     The action was taken in the reasonable belief that it was warranted because the evidence submitted by the hospital was not "so obviously mistaken or inadequate to make reliance upon them unreasonable".

The case also contained an interesting procedural decision regarding discovery of peer review records. The Court concluded that Dr. Curtsinger was entitled to discovery regarding issues of malice or bad faith regarding the peer review process but not entitled to discovery regarding other substantive issues. The distinction was concocted by the court based on the presumption language of HCQIA, which shifts the burden of proof to the physician. Since the physician bears the burden of disproving all HCQIA elements, I cannot see the distinction between the burden of proof regarding bad faith issues and the burden of proof regarding the other medical issues. Hospitals choose to disclose whatever peer review records they wish to disclose to the physician to make the case, but withhold the rest.

The opinion is available at: http://www.tsc.slate.tn.us./opinions/tca/pdf/072/curtsingerjopn.


Braswell v. HaywoodRegionalMedicalCenter

Dr. Braswell's case involved a different issue but his breach of contract claim was still dismissed pursuant to the immunity provisions of HCQIA. Dr. Braswell claimed the peer review actions instituted against him were retaliation for protected free speech under the First Amendment. Dr. Braswell was a general surgeon at a hospital in North Carolina and a member of a hospital committee recruiting additional general surgeons into the area.  The hospital agreed to recruit and subsidize the general surgeon for Dr. Braswell's practice and for another practice in the community. Dr. Braswell wrote to the physician being recruited for the other practice and, using the information supplied to the recruiting committee, advised the other surgeon being recruited that he was concerned that there would be insufficient patient volume to support two surgeons. The other recruited surgeons subsequently chose to accept the position at a different hospital.

Shortly thereafter, Dr. Braswell's peer review problems started. There was not sufficient factual information in the case to examine whether the cases and outcomes involved in the peer review process were in any way similar to the cases and the outcomes experienced by Dr. Braswell prior to the recruiting issue.

With regard to the free speech argument, the Court concluded that Dr. Braswell was not a public employee and therefore not entitled to protection under the First Amendment, because Dr. Braswell was an independent contractor/medical staff member and not an employee of the hospital. 

The Court also dismissed Dr. Braswell's breach of contract claim on the basis of HCQIA immunity. Since it dismissed the complaint, the Court did not discuss whether the bylaws constituted a contract under North Carolina law.

One interesting aspect of the HCQIA immunity was the fact that the hearing committee for Dr. Braswell's medical staff hearing concluded that the hospital had not satisfactorily documented its investigation, despite the fact that there may have been serious quality issues. The Court's opinion presumes that these actions were in violation of the bylaws but also concludes that the due process was fair under the circumstances, therefore allowing Dr. Braswell the protection of the "good enough" clause.

The opinion is available at: http://op.bna.com/hl.nsf/r?open=psts-72rpj6.

Semmelweis National Meeting

Mike Cassidy presented to the Semmelweis Society at its National Meeting in Washington, DC on the topic, “Protecting Yourself in Peer Review; What the Bylaws Should Say and What You Shouldn’t.”  

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Physician Protect Thyself

My last MedLaw Blog post described four rules for making the peer review process fair. Here are four rules physicians should follow to protect themselves regardless of the peer review process.

1.         Recognize peer review when it is happening to you. There is no doubt that peer review is occurring when you get a letter proposing adverse peer review actions. The more problematic cases are the peer review processes that begin with collegial counseling or intervention.

There are two types of collegial intervention, but both can be traps. The first is the meaning discussion with a well-meaning colleague who serves on the relevant peer review committee. Since most colleagues desire to avoid conflict among themselves, it is sometimes difficult to identify these conversations as actual peer review. However, these conversations can show up later as recorded attempts to correct perceived misconduct.

The second and more obvious collegial intervention is an actual meeting with somebody that is less of a colleague and more of a peer review officer. Even though these interventions are clearly peer review, physicians often perceive these somewhat informed meetings as officious intrusions and either disregard the meetings or respond inappropriately.

It is important to recognize that both of these interventions can have future consequences if they are not recognized as harbingers of precursors to potential peer review problems.

2.         Request access to peer review records. Whenever physicians are advised that someone perceives a problem with their performance or their conduct, that physician should request a copy of the complaint or record precipitating the peer review contact, even if the hospital insists upon maintaining anonymity at that point. It is important to know how many complaints there may have been and what those complaints say. It is also important that physicians create a record of this process, preferably a record that includes at least neutral and perhaps partial witnesses. Third-party witnesses are important to prevent later distortions of the facts.

3.         Resist the urge to counterattack. Most accomplished individuals, and doctors include themselves in this category, resent disparaging comments about their conduct or competence. Resist the urge to be overly defensive. Threatening whistleblower disclosures and accusing the other physicians involved in the peer review process of competitive conspiracies and jealousies polarizes the peer review process. The other physicians resent the attacks just as much the target physician resents the intrusion. The precipitous counter attack rarely reads the mutually acceptable results.

4.         Retain experienced counsel. It is amazing that physicians who seek a medical consult at the first sign of a medical problem outside the scope of their particular sub-specialty nevertheless believe they can represent themselves in the peer review process or of that counsel is not necessary until the end of the process, when the physician as legal-patient now requires emergency surgery. Seeking experienced counsel is not an indication of lack intelligence; the issue is not intelligence, but training, experience and detached analysis.

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Bylaws Can Protect Against Sham Peer Review

Sham peer review is created and perpetuated by secrecy. Charles Mackay wrote in “Eternal Justice”:

“But the sunshine aye shall light the sky,

As round and round we run;

And the truth shall ever come uppermost,

And justice shall be done.”

Physicians do not need voluminous due process protections in medical staff bylaws in order to protect their interests; they merely need the opportunity to assure that the truth will come out. Here are four suggestions to let the truth be told.

1.         Notice. Physicians should receive notice and/or copies of all complaints filed against them, whether they are mere incident reports or formal complaints requesting investigation by the medical staff. Notice provide the physicians an opportunity to respond to the complaint at the time it was made, rather than allowing them to accumulate until a more serious dispute arises. Hospitals respond that effective peer review requires confidentiality and immunity. However, the confidentiality provisions were never intended to allow anonymous complaints; they were intended to prevent third parties from discovering peer review documents as part of a tort or malpractice complaint. Those people submitting valid complaints are protected by the immunity provisions of state peer review laws, so confidentiality should not be an issue.

Hospitals defended their position by arguing that they are concerned about retaliation. Retaliation should not be permitted. Retaliation should be punishable by suspension, which may or may not be reportable to the Data Bank. Once physicians understand that they cannot retaliate against hospital employees who are just trying to do their job, retaliation should not be an issue.

Physicians should receive notice of ongoing investigations. There is nothing worst than being on the “watch list” or being on “double secret probation” in an environment in which incident reports and case review are being invited.

2.         Cross examination of witnesses. All individuals who submit reports should be included within the definition of the term “witnesses” and their reports should not be accepted as true or relied upon by the medical staff hearing committee unless the physician has had the opportunity to cross examine those individuals about those complaints. Cross examination does need to be integration under harsh lights; it is simply intended to give the physician the right to question and point out errors, inconsistencies and inaccuracies in written complaints. The immunity provisions of the state peer review laws should protect those witnesses from good faith disclosures.

3.         Premature suspensions: Clinical privileges should not be suspended unless the physician has had the opportunity to respond or to explain the situation which has thought to be the problem. Medical staff bylaws should allow suspension in those situations in which patient’s safety is an immediate and significant concern. When deciding whether patient’s safety gets protected or the physician’s right to practice gets protected, obviously the hospitals must come down on the side of patient safety. However, except in those situations, which exception will always give the hospital the most leverage or upper hand in these proceedings, suspension should not be imposed before the physician has had the opportunity to defend himself.

4.         Participation in the hearing panel: The due process procedures of the medical staff peer hearing process should allow the physician to appoint a member of the hearing panel. The hospital may retain the right to appoint the majority of the members; this safeguard is not intended to deadlock the process. It is merely intended to bring the light of day into the deliberations.

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District Court Holds Hospital Liable for Breach of Bylaws/Contract and Peer Review Violations

The United States District Court for the District of Iowa held that Mercy Medical Center-Sioux City was not immune from liability under the Federal Health Care Quality Improvement Act. The Court entered summary judgment to the estate of Dr. Horst G. Blume on the basis of Mercy’s breach of contract and awarded damages to Dr. Blume in the amount of $146,000.

The District Court found that Mercy was not immune under the Federal Health Care Quality Improvement Act (HCQIA) because it breached its bylaws by never providing Dr. Blume the hearing to which he was entitled under the bylaws and that it failed to conduct a reasonable investigation as required by one of the elements of the HCQIA. The key facts regarding the failure to conduct a reasonable investigation were that Dr. Blume was never provided access to incident reports allegedly supporting the hospital’s action, that there was no reasonable effort by the hospital to obtain any facts in contrast to those incident reports, and that Dr. Blume was not given a meaningful opportunity to rebut those charges.

The hospital asserted in its defense that the HCQIA merely required a procedure which was fair to the physician under the circumstances. The Court acknowledged the existence of that language, but concluded it was not applicable to the present case.

In granting summary judgment on breach of contract issues, the Iowa Court followed the majority position with regard to medical staff bylaws, finding that the medical staff bylaws constituted a contract between the hospital and the individual members of the medical staff.

The full text of the case is available at http://op.bna.com/hl.nsf/r?Open=psts-6zpr5q.

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Physican Cases: Antitrust, Restrictive Covenant & Credentialing

RESTRICTIVE COVENANT UNENFORCEABLE

BY SURVIVING SPOUSE 

The Virginia Supreme Court ruled that a medical practice corporation, ownership of which had transferred from the deceased sole physician shareholder to his spouse and which was converted to a business corporation by state law, could not enforce a restrictive covenant because it could not practice medicine and had no enforceable interest. This same result could apply in Pennsylvania because it has the same combination of corporate practice of medicine and professional corporation laws. The Virginia case is Parikh v. Family Care Center and the case is available at: http://op.bna.com/hl.nsf/id/psts-6z2sn8/$File/parkikh.pdf. Although liquidated damages would prejudice your injunction rights, liquidated damages would be an effective resolution for this problem.

RADIOLOGIST DENIED ANTI-TRUST RELIEF

DESPITE PROVING CONSPIRACY

Dr. Saskia V. W. Hilton failed to demonstrate that “competition in the market for pediatric radiology services” was injured despite producing evidence that would have supported finding of an anti-competitive conduct by this hospital and its existing pediatric radiologist. The classic position is that the law protects competition not competitors.

See: http://op.bna.com/hl.nsf/id/psts-6z8qrp/$File/hilton.pdf 

CALIFORNIA PHYSICIAN NOT DAMAGED

BY BOARD CERTIFICATION REQUIREMENT

A California physician lost his medical staff privileges when he failed to meet the hospital’s new board certification requirements was found not to be entitled to pursue an action in court for damages relating to the termination of his clinical privileges because the court rule that the decision of the hospital, under California law, was a quasi legislative act of general application, in the form of the adoption of minimum qualification standards for clinical privileges, which did not create an individual cause of action. See: Tran vs. MissionHospitalRegionalMedicalCenter at:

http://op.bna.com/hl.nsf/id/thyd-9prg/$File/Tran%20v%20Mission%20Hospital.pdf

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California Court Ruling Waiving Administrative Exhaustion of Remedies Doctrine Somewhat Misleading

A California court recently concluded that exhaustion of administrative remedies was not required as a condition precedent to reinstatement of a physician. The summary description of this holding is somewhat misleading, because it is commonly accepted that physicians must exhaust their administrative remedies, i.e., the medical staff peer review hearing process, before pursuing either civil or equitable remedies. The California holding would apparently contradict that.

However, the California case involves peculiar circumstances. The physician was both a member of medical staff of the hospital and an employee of the hospital. The hospital summarily suspended the physician’s clinical privileges and terminated the physician’s employment. During an extended period of legal posturing, the parties were unable to agree upon a medical staff peer review process, due to technicalities in the due process procedures which gave both sides an arguable position about the appointment of a hearing officer.

During that period, the physician petitioned for an injunction reinstating her employment. The court cited an earlier California case holding that there must be a “pre-termination” hearing with respect to the employment if continued employment presented no immediate danger to patients. The court reasoned that since the physician’s clinical privileges were already summarily suspended and the physician could, therefore, not pose any risk to patients, the physician was, therefore, entitled to a pre-termination hearing with respect to the termination of her employment. Since the pre-termination hearing had not been held, the court ordered reinstatement of the petitioner’s employment and the hospital placed the physician on paid administrative leave. 

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Joint Commission: Disruptive Physicians

A comment by  Al Tobias www.medicalaw.net indicates the problem with the new proposed standars for disruptive physicians. There are no standards. This is an open invitation for hospitals to impose new peer review issues on physicians with the support of the Joint Commission.

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JOINT COMMISSION PROPOSES STANDARDS FOR DISRUPTIVE PHYSICIANS

JOINT COMMISSION PROPOSES STANDARDS FOR DISRUPTIVE PHYSICIANS

The Joint Commission (which has always been the informal name for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and which will now be its formal name) has proposed disruptive behavior standards for Joint Commission accreditation, which it intends to apply in early 2007.

The new standard, LD.3.15, will state: “As a critical component of the culture of safety, leaders set expectations for behavior among those who work in the organization.” The new elements of performance will be as follows:

1.         The leaders develop a code of conduct that applies to everyone who works in the organization.

2.         The code of conduct defines desirable and disruptive behavior.

3.         All who work in the organization are educated about both desirable and disruptive behaviors.

4.         The leaders develop processes for managing disruptive behavior.

5.         Leaders identify the rules of individual leadership groups in managing disruptive behavior.

6.         The organized medical staff manages disruptive behavior exhibited by physicians or individuals who are granted clinical privileges.

7.         Leaders establish a fair hearing process for those who exhibit disruptive behavior.

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Pennsylvania U.S. District Court Rejects Hospital Claim for Attorneys Fees Arising From Credentialing Dispute

“The U. S. District Court for the Middle District of Pennsylvania ruled that Lewistown Hospital was not entitled to recover the legal costs incurred fighting the allegations of Dr. Alan D. Gordon under the Sherman Act because the hospital could not show the claims brought by the ophthalmologist were frivolous or unreasonable, or brought in bad faith.” BNA Health Care Daily, October 18, 2006.

The Health Care Quality Improvement Act (HCQIA), § 11113, provides as follows:

“In any suit brought against the defendant, to the extent that a defendant has met the standards set forth under § 11112 (A) of this title and the defendant substantially prevails, the court shall, at the conclusion of the action, award to a substantially prevailing party defending against any such claim the cost of the suit attributable to such claim, including a reasonable attorneys’ fees, if the claim, or the claimant’s conduct or the litigation of the claim, was frivolous, unreasonable, without foundation, or in bad faith. For the purposes of this section, a defendant shall not be considered to have substantially prevailed when the plaintiff obtains an award for damages or permanent injunctive or declaratory relief.”

Lewistown Hospital had alleged that Dr. Gordon was either frivolous or unreasonable and acted in bad faith. Dr. Gordon argued that, in order to prevail, Lewistown must prove that he was both frivolous and that he acted in bad faith. The court rejected that argument, interpreting the statutory conditions in the disjunctive manner based upon the presence of the word "or".

However, the court also concluded that feelings of hostility or revenge do not demonstrate bad faith and are not uncommon in adversarial proceedings stating “to find bad faith on the existence of such feelings alone, absent some indication that those feelings fuel litigation, believed to be baseless, just for the sake of litigation, would seem to award attorneys’ fees in almost every case.” The court opined that, in order to show bad faith, the plaintiff would have had to knowingly proceed when the claim was “baseless, known to be baseless, and motivated by improper purpose.”

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Ohio State Appellate Court Apparently Endorses Bad Faith Peer Review

Cowett v. TCH Pediatrics Inc. seems to endorse bad faith peer review, but a closer examination of the opinion should reveal a significant distinction between bad faith peer review and peer review involving legitimate peer review concerns in situations which also include bad faith motivations among the peer review entities.

After following the fair hearing procedures provided by the By-Laws of the parties (which included TCH Pediatrics Inc, Forum Health, Western Reserve Care System, and Tod’s Children’s Hospital), Dr. Cowett was terminated from the medical staff and then sued the parties, asserting numerous claims which were not specified in the appellate opinion addressing only the issue of HCQIA immunity at the summary judgment level. The Appellate Court granted summary judgment on behalf of the Defendants based upon the immunity provided by the federal Health Care Quality Improvement Act (HCQIA). Dr. Cowett asserted that immunity should not be available because the peer review process was conducted in bad faith, and the Opinion implies that evidence regarding the existence of bad faith was at least potentially present. However, the Court concluded that:

“Dr. Cowett believes Forum should not be immune from suit pursuant to HCQIA because it acted in bad faith when determining that his privileges should be revoked. However, the only relevant issues under HCQIA are with regard to the objective reasonableness of the hospital’s actions, not whether those actions were taken in good faith. No reasonable fact finder could conclude that Dr. Cowett could overcome the presumption that Forum’s actions were reasonable. Accordingly, the judgment of the trial court is affirmed.”

Therefore, the Court concluded that, since there was evidence upon which a reasonable conclusion could be founded justifying the peer review actions taken by the hospital as having been based upon the reasonable belief that they were in the furtherance of quality health care, evidence that the hospital had potentially bad faith motives was irrelevant.

This case appears to miss the focus of the Health Care Quality Improvement Act. In HCQIA, there are four standards for immunity. The Cowett case focuses on the first, i.e., whether there was a reasonable belief that the action was in furtherance of quality health care. Using this standard, any bad faith peer review can be justified so long the peer review entity is able to identify events which can be objectively classified as legitimate patient care concerns. However, there is another standard in HCQIA which requires a “reasonable belief that the action was warranted by the facts.” This can only be a relative standard, a subjective standard, because there cannot be a reasonable belief that one physician should be subjected to peer review for causing a certain event if other physicians are causing the same events and are not subject to peer review, assuming, of course, that the peer review entities are equally aware of both circumstances and choose to act in one but not in the other.

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Poliner Award Reduced to $22 Million on Remittitur

A federal district court in Texas has ruled that Dr. Poliner can either accept a reduced damages award of $22 million or face a new trial. The U.S. District Court for the Northern District of Texas granted a motion by Presbyterian Hospital Dallas (Texas Health Systems) and Dr. James Knochel to reduce the damage award for Dr. Poliner from $366 million to $22.5 million. This process is a legal procedure known as “remittitur,” which process allows a judge to reduce a jury award if the court believes the amount to be excessive and unsupported by the facts. This new decision was handed down on September 18, 2006. It was available on the BNA Health Care Daily health law news service at http://op.bna.com/hl.nsf/?Open=psts-6tutrcon

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Poliner: A Texas-Sized Credentialing Verdict for Physicians

Click here to read Mike Cassidy's article published in Health Lawyers News, September 2006.

Copyright 2006 American Health Lawyers Association, Washington, D.C. Reprint permission granted.  Further reprint requests should be directed to American Health Lawyers Association 1025 Connecticut Avenue, NW, Suite 600 Washington, DC 20036, (202) 833-1100.  For more information on Health Lawyers content, visit us at www.healthlawyers.org.

 

 

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United States Distrcit Court in Pennsylvania Concludes HCQIA Does Not Immunize Defamatory Statements

A health law news service recently reported a United States District Court holding that a physician whose privileges were summarily suspended and ultimately terminated by a Pennsylvania hospital could not prevail on antitrust or breach of contract claims asserted against the hospital based upon the federal and state peer review immunity statutes. Although it is accurate to state that Bakare v. Pinnale Health Hospitals, Inc. dismissed the antitrust and breach of contract claims, the article overlooked what I believe to be the most significant aspect of the decision, which was that neither the federal Health Care Quality Improvement Act (HCQIA) nor the Pennsylvania Peer Review Protection Act immunized defamatory statements which, although made by physicians involved in the peer review process, were not made as part of the peer review process.

It is also important to realize that this decision was made based upon a motion for summary judgment. The Court did not conclude that defamatory statements had been made nor that the defendants were liable for the defamatory statements; the Court only dismissed the defendants’ motion for summary judgment of certain defamation claims. The impact of the dismissal is that the Court concluded there was sufficient evidence to allow the issues to be presented to a jury with respect to the defamation occurring outside the peer review process, stating as follows:

“Finally, claims relating to Dr. Moore’s statements in the operating room lounge and Dr. Bakare’s moonlighting contract does not arise out of the peer review process and, therefore, are not covered under HCQIA immunity.”

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JCAHO Issues Revised Propsed Medical Staff Bylaws Standards (M.S. 1.20)

JCAHO MS.1.20 (i.e. the proposed medical staff by-laws standards to be adopted by the Joint Commission for the Accreditation of Healthcare Organizations) has been generating significant controversy since amendments were first proposed in January of 2004, which amendments would have required approval of both the medical staff and the hospital governing board to adopt and amend the medical staff by-laws. Enforcement of these accreditation standards would prohibit unilateral amendment of medical staff by-laws by a hospital or its governing board, which created significant controversy among hospitals and their governing board because of the perceived “veto” power and granted to the medical staff. Although medical staff leadership welcomed this approach, said leadership has never felt nearly as threatened about this standard as the hospitals have because medical staff leadership have never expected unilateral amendment opportunities.

The latest iteration of MS.1.20 was recently posted on the JCAHO website (http://www.jointcommission.org/Standards/FieldReviews/fr_ms120.htm). The proposed standards are available for review and comment through October 27, 2006. Significant among the performance standards are the following:

“A.2. Medical staff by-laws are adopted and amended by the medical staff and approved by the governing body.”

“A.4. The governing body acts in accordance with the medical staff by-laws, rules and regulations, and policies that are adopted by the medical staff and approved by the governing body.”

A.7. to A.11. The medical staff by-laws or rules and regulations and policies adopted by the organized medical staff and approved by the governing body delineate the structure of the medical staff, both practitioners who are eligible for membership in the organized medical staff, most practitioners who are eligible to vote on the medical staff by-laws and their amendments, and the organized medical staff officers and the methods for their selection and removal.

These accreditation guidelines will also be interesting when viewed in relation to the issue of whether medical staff by-laws create enforceable contracts, because of the standards which are applied. Even in those states which have decided that medical staff by-laws in and of themselves do not create contracts with medical staff members, the general opinion has been the adoption of medical staff by-laws nevertheless creates an obligation or requiring the hospital to act in accordance with the by-laws, regulations and policies which it has adopted.

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Adverse Peer Review Report To National Practitioner Data Bank Voided By District Court

An adverse peer review report to the National Practitioner Data Bank is a threat frequently used by hospitals to leverage physicians into otherwise unacceptable peer review compromises. Once the report has been made to the Data Bank, the alleged adverse peer review of action is public knowledge and significantly jeopardizes physicians’ continued practice opportunities. Although the Data Bank allows physicians to submit a dispute and has a process to contest the report filed by the hospital, that process is cumbersome and does not provide much recourse for physicians who disagree with the ultimate decision by the Secretary of Health and Human Services.

The United States District Court for the District of Nebraska has provided a breath of fresh air and potential recourse to this process. In Costa v. Leavitt (2006 U.S. Dist. LEXIS 51675), the District Court ordered the Secretary of Health and Human Services “to remove the National Practitioner Data Bank the adverse action report filed on April 6, 2005, by Gothenburg Memorial Hospital.” In this case, the hospital was in the process of denying a physician’s application for reappointment, with the credentials committee making an adverse recommendation what the by-laws requiring approval of that recommendation before final action, when the physician withdrew his application for reappointment. The hospital submitted a report which stated:

“Dr. Costa’s competence and professionalism are under review at the Gothenburg Memorial Hospital at the time he withdrew his medical staff application for reappointment and surrendered his privileges. The medical staff had concerns regarding recent obstetrical cases in which Dr. Costa was the primary physician, as well as concerns regarding his professionalism to nursing and administrative staff. Dr. Costa surrendered his privileges one and one-half hours after the medical staff unanimously voted to reject his application for reappointment and prior to that recommendation being forwarded to the board of directors for further action.”

The physician disputed this report with the National Practitioner Data Bank, utilizing the dispute mechanism provided by the regulations. The Secretary of the Department of Health and Human Services ultimately determined that the hospital report was accurate. The District Court concluded that the evidence did not support the Secretary’s determination and ordered the Secretary to remove that report.

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COMPARATIVE PEER REVIEW RECORDS MADE AVAILABLE BY COURT ORDER

In a recent discovery order of The United States District Court, the Southern District of Texas confirms the relevance and discoverability of patient records in credentialing disputes involving comparative peer review, i.e., the peer review disputes where the penalties imposed one physician are dissimilar or unequal to those imposed on others. 

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ECONOMIC CREDENTIALING POLICIES COULD VIOLATE FRAUD AND ABUSE RULES

ARKANSAS SUPREME COURT RULES ECONOMIC CREDENTIALING POLICIES COULD VIOLATE FRAUD AND ABUSE RULES IN BAPTIST HEALTH CASE

The Arkansas Supreme Court affirmed a state appellate court ruling issuing a temporary injunction prohibiting Baptist Health, enjoining the hospital from enforcing its economic credentialing policies. The basis of this injunction is that the Baptist Health economic credentialing policy, which would prohibit physicians from owning financial interest in competitive facilities from maintaining Medical Staff membership and clinical privileges at Baptist Health, is the following;

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Credentialing Developments

Credentialing Developments: U.S. Supreme Court Refuses To Review Hearing Officer Authority Ruling; Ohio Court Of Appeals Allows Discovery Of Peer Review Records Under Prior Law

Hearing Officer Authority

In California, a Medical Staff Hearing Officer terminated a Medical Staff Hearing on the grounds the physician was “repeatedly disruptive, disdainful of the Hearing Officer's authority, and flagrantly violated the rules pertaining to discovery and documentary exhibits.” This ruling allows the ruling by a California State Court that the termination did not violate the physician's due process rights to stand. Meleikowsky v. Tenet Healthsystem, U.S. No. 05-638.

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U.S. District Court Denies Fair Hearing Based Upon Exclusive Contract

In Bocobo v. Radiology Consultants of South Jersey, et al, a federal district court granted summary judgment to the radiology group and hospital defendants on eleven counts including the denial of a medical staff hearing. The radiologist was employed by the radiology group and the exclusive contract between the hospital and the group provided that medical staff membership and clinical privileges were coterminous, and that the physician was not entiltled to a medical staff fair hearing if the termination resulted from termination of employment by the mecial group. 2005 U.S. Dist.LEXIS 29321.

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Medical Staff Bylaws and Policies Are Contracts But No Due Process Rights Triggered by Exclusive Contract

In Naples Community Hospital v.Desmond Hussy,M.D., a Florida state court held that the Medical Staff By-Laws, and the Hospital policies enacted by the Board pursuant to those By-Laws, constitute a contract between the Hospital and the individual members of the Medical Staff. However, this did not entitle a physician to a due process hearing following the denial of his application for Medical Staff membership and clinical privileges. This physician's privileges had expired. During the term of the physician's prior privileges, the Hospital had entered into an exclusive contract, granting a different physician the exclusive right to practice those privileges at the Hospital. Although the Hospital allowed the physician with the existing privileges to continue to practice those privileges until the natural expiration thereof, his application for renewal was denied. The court held that the physician was not entitled to a due process hearing because the By-Laws provided for a due process hearing only if the privileges were terminated for professional cause, but not if they were not renewed as a business decision of the Hospital.

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JCAHO Proposes New Medical Staff Credentialing Standards

JCAHO has posted a field review notice regarding hospital Medical Staff credentialing in privileging standards. The proposed standards would establish additional evidence based processes for the determining the competence of practitioners. See the JCAHO website link for the field review.

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10 Biggest Mistakes Physicians Make In The Credentialing Process

Physicians often ignore crucial early warning signs in the credentialing process. Physicians also sometimes ignore the fact that the credentialing process is a structured legal process which can trap the unwary and penalize the careless. Here are 10 mistakes physicians make during the process, along with advice on how to prevent them.

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Patient Safety And Quality Improvement Act Of 2005

President Bush signed the Patient Safety and Quality Improvement Act of 2005 on July 29, 2005, describing the legislation as “a critical step towards our goals insuring top quality, patient-driven healthcare for all Americans.”

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