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CHICAGO – Accepting poor legal advice or inadvertently waiving the client-attorney privilege may result in tougher judicial scrutiny or have a direct impact the outcome of payment investigations, experts warned at a physicians’ legal issues conference held by the American Bar Association.

"While some audits are relatively minor, others can result in huge reimbursement demands or even more frightening things, including civil or criminal charges being made based on claims of fraud and abuse," said Michael E. Clark, chair of the American Bar Association’s Health Law Section. Legal advisers need to be able to guide physicians through the payment investigation process while protecting their rights.

Bad advice by a lawyer cannot be used as a court defense for a physician’s acts or oversights, health lawyer Eric C. Tostrud said. However, in some instances, poor legal advice can be used as a defense to a fraud claim.

"There are important nuances to the issue," said Mr. Tostrud, an attorney in Minneapolis. For example, a defense of "poor legal advice" depends on the accuracy and completeness of the information the doctor initially disclosed to the attorney as well as whether the physician was completely forthcoming. In addition, courts will review whether health providers disregarded one attorney’s advice for more self-seeking guidance from another lawyer.

The question of bad legal advice arose in the recent case of U.S. v. Tuomey Healthcare System, in which the South Carolina–based health system was accused of submitting Medicare claims that violated the Stark Law. This purported violation included reimbursement claims for services by physicians with whom Tuomey allegedly had financial relationships. As part of its defense, Tuomey said it had relied on attorneys to design and approve the physician contracts. But during the trial, the government presented evidence that Tuomey had dismissed adverse legal and expert opinions when entering into the contracts and had retained subsequent legal opinions that supported the arrangements. A federal jury found the system had violated Stark Law and the False Claims Act, and a federal judge in 2013 ordered Tuomey to pay $237 million in fines.

The attorney-client privilege is another complex concept that can land physicians – and their attorneys – in legal trouble. The privilege protects communications between an attorney and client that are made for the purpose of furnishing or obtaining professional legal advice or assistance. But physicians can waive the privilege by disclosing confidential information through conversations, paper documentation, or e-mails. Doctors who reveal details about such communications to colleagues thus relinquish the protection, Mr. Tostrud said.

"Doctors by their nature are very collaborative," he said in an interview. "They want to talk to other people and consult with others about issues and that includes the advice they might be getting from a lawyer. But the risk of doing that is that they will waive the privilege."

Also, not every communication from or to a lawyer is privileged. The privilege generally protects communications involving legal advice, but does not extend to underlying facts.

In the case of U.S. v. Halifax Hospital Medical Center, a federal court ruled that the Daytona Beach, Fla.–based hospital’s compliance "referral log" was not subject to the privilege even though it was prepared at the instruction of an attorney. The logs merely recorded facts and did not meet the purpose of the privilege. The court concluded also that hundreds of e-mails and other documents relating to Halifax’s compliance and audit activities were not protected. While an attorney may have been included in the e-mails, the lawyer was copied for business purposes, not for legal advice, the court said. Halifax in March agreed to pay the government $85 million to resolve False Claims Act and Stark Law violations.

"E-mail often becomes a lawyer’s nightmare because it’s permanent and clients and people generally tend to treat e-mail like a conversation," Mr. Tostrud said in an interview. "They are not thinking about the permanency of it and are not thinking of the long-term litigation consequences."

One privileged e-mail does not necessarily extend the privilege to an entire string of e-mails, he said. To be protected, each e-mail within a string must be for the purposes of legal advice.

Enlisting the help of an attorney early in an audit or payment investigation is essential, said Mr. Clark, who practices law in Houston. For instance, if it becomes necessary to retain specialized consultants to help review coding and documentation issues, an attorney can help structure a framework whereby the consultants report to the attorney, and the attorney then formulates advice to the physician client.

"Most physicians have a basic understanding about the attorney-client privilege and its scope, but don’t fully understand or appreciate how that legal protection can be lost inadvertently," Mr. Clark said. "Having an attorney on board early in the process of an audit or broader investigation is important to ensuring that the privilege is properly established and protected."

This article was updated Sept. 2, 2014.

[email protected]

On Twitter @legal_med

CHICAGO – Accepting poor legal advice or inadvertently waiving the client-attorney privilege may result in tougher judicial scrutiny or have a direct impact the outcome of payment investigations, experts warned at a physicians’ legal issues conference held by the American Bar Association.

"While some audits are relatively minor, others can result in huge reimbursement demands or even more frightening things, including civil or criminal charges being made based on claims of fraud and abuse," said Michael E. Clark, chair of the American Bar Association’s Health Law Section. Legal advisers need to be able to guide physicians through the payment investigation process while protecting their rights.

Bad advice by a lawyer cannot be used as a court defense for a physician’s acts or oversights, health lawyer Eric C. Tostrud said. However, in some instances, poor legal advice can be used as a defense to a fraud claim.

"There are important nuances to the issue," said Mr. Tostrud, an attorney in Minneapolis. For example, a defense of "poor legal advice" depends on the accuracy and completeness of the information the doctor initially disclosed to the attorney as well as whether the physician was completely forthcoming. In addition, courts will review whether health providers disregarded one attorney’s advice for more self-seeking guidance from another lawyer.

The question of bad legal advice arose in the recent case of U.S. v. Tuomey Healthcare System, in which the South Carolina–based health system was accused of submitting Medicare claims that violated the Stark Law. This purported violation included reimbursement claims for services by physicians with whom Tuomey allegedly had financial relationships. As part of its defense, Tuomey said it had relied on attorneys to design and approve the physician contracts. But during the trial, the government presented evidence that Tuomey had dismissed adverse legal and expert opinions when entering into the contracts and had retained subsequent legal opinions that supported the arrangements. A federal jury found the system had violated Stark Law and the False Claims Act, and a federal judge in 2013 ordered Tuomey to pay $237 million in fines.

The attorney-client privilege is another complex concept that can land physicians – and their attorneys – in legal trouble. The privilege protects communications between an attorney and client that are made for the purpose of furnishing or obtaining professional legal advice or assistance. But physicians can waive the privilege by disclosing confidential information through conversations, paper documentation, or e-mails. Doctors who reveal details about such communications to colleagues thus relinquish the protection, Mr. Tostrud said.

"Doctors by their nature are very collaborative," he said in an interview. "They want to talk to other people and consult with others about issues and that includes the advice they might be getting from a lawyer. But the risk of doing that is that they will waive the privilege."

Also, not every communication from or to a lawyer is privileged. The privilege generally protects communications involving legal advice, but does not extend to underlying facts.

In the case of U.S. v. Halifax Hospital Medical Center, a federal court ruled that the Daytona Beach, Fla.–based hospital’s compliance "referral log" was not subject to the privilege even though it was prepared at the instruction of an attorney. The logs merely recorded facts and did not meet the purpose of the privilege. The court concluded also that hundreds of e-mails and other documents relating to Halifax’s compliance and audit activities were not protected. While an attorney may have been included in the e-mails, the lawyer was copied for business purposes, not for legal advice, the court said. Halifax in March agreed to pay the government $85 million to resolve False Claims Act and Stark Law violations.

"E-mail often becomes a lawyer’s nightmare because it’s permanent and clients and people generally tend to treat e-mail like a conversation," Mr. Tostrud said in an interview. "They are not thinking about the permanency of it and are not thinking of the long-term litigation consequences."

One privileged e-mail does not necessarily extend the privilege to an entire string of e-mails, he said. To be protected, each e-mail within a string must be for the purposes of legal advice.

Enlisting the help of an attorney early in an audit or payment investigation is essential, said Mr. Clark, who practices law in Houston. For instance, if it becomes necessary to retain specialized consultants to help review coding and documentation issues, an attorney can help structure a framework whereby the consultants report to the attorney, and the attorney then formulates advice to the physician client.

"Most physicians have a basic understanding about the attorney-client privilege and its scope, but don’t fully understand or appreciate how that legal protection can be lost inadvertently," Mr. Clark said. "Having an attorney on board early in the process of an audit or broader investigation is important to ensuring that the privilege is properly established and protected."

This article was updated Sept. 2, 2014.

[email protected]

On Twitter @legal_med

CHICAGO – Accepting poor legal advice or inadvertently waiving the client-attorney privilege may result in tougher judicial scrutiny or have a direct impact the outcome of payment investigations, experts warned at a physicians’ legal issues conference held by the American Bar Association.

"While some audits are relatively minor, others can result in huge reimbursement demands or even more frightening things, including civil or criminal charges being made based on claims of fraud and abuse," said Michael E. Clark, chair of the American Bar Association’s Health Law Section. Legal advisers need to be able to guide physicians through the payment investigation process while protecting their rights.

Bad advice by a lawyer cannot be used as a court defense for a physician’s acts or oversights, health lawyer Eric C. Tostrud said. However, in some instances, poor legal advice can be used as a defense to a fraud claim.

"There are important nuances to the issue," said Mr. Tostrud, an attorney in Minneapolis. For example, a defense of "poor legal advice" depends on the accuracy and completeness of the information the doctor initially disclosed to the attorney as well as whether the physician was completely forthcoming. In addition, courts will review whether health providers disregarded one attorney’s advice for more self-seeking guidance from another lawyer.

The question of bad legal advice arose in the recent case of U.S. v. Tuomey Healthcare System, in which the South Carolina–based health system was accused of submitting Medicare claims that violated the Stark Law. This purported violation included reimbursement claims for services by physicians with whom Tuomey allegedly had financial relationships. As part of its defense, Tuomey said it had relied on attorneys to design and approve the physician contracts. But during the trial, the government presented evidence that Tuomey had dismissed adverse legal and expert opinions when entering into the contracts and had retained subsequent legal opinions that supported the arrangements. A federal jury found the system had violated Stark Law and the False Claims Act, and a federal judge in 2013 ordered Tuomey to pay $237 million in fines.

The attorney-client privilege is another complex concept that can land physicians – and their attorneys – in legal trouble. The privilege protects communications between an attorney and client that are made for the purpose of furnishing or obtaining professional legal advice or assistance. But physicians can waive the privilege by disclosing confidential information through conversations, paper documentation, or e-mails. Doctors who reveal details about such communications to colleagues thus relinquish the protection, Mr. Tostrud said.

"Doctors by their nature are very collaborative," he said in an interview. "They want to talk to other people and consult with others about issues and that includes the advice they might be getting from a lawyer. But the risk of doing that is that they will waive the privilege."

Also, not every communication from or to a lawyer is privileged. The privilege generally protects communications involving legal advice, but does not extend to underlying facts.

In the case of U.S. v. Halifax Hospital Medical Center, a federal court ruled that the Daytona Beach, Fla.–based hospital’s compliance "referral log" was not subject to the privilege even though it was prepared at the instruction of an attorney. The logs merely recorded facts and did not meet the purpose of the privilege. The court concluded also that hundreds of e-mails and other documents relating to Halifax’s compliance and audit activities were not protected. While an attorney may have been included in the e-mails, the lawyer was copied for business purposes, not for legal advice, the court said. Halifax in March agreed to pay the government $85 million to resolve False Claims Act and Stark Law violations.

"E-mail often becomes a lawyer’s nightmare because it’s permanent and clients and people generally tend to treat e-mail like a conversation," Mr. Tostrud said in an interview. "They are not thinking about the permanency of it and are not thinking of the long-term litigation consequences."

One privileged e-mail does not necessarily extend the privilege to an entire string of e-mails, he said. To be protected, each e-mail within a string must be for the purposes of legal advice.

Enlisting the help of an attorney early in an audit or payment investigation is essential, said Mr. Clark, who practices law in Houston. For instance, if it becomes necessary to retain specialized consultants to help review coding and documentation issues, an attorney can help structure a framework whereby the consultants report to the attorney, and the attorney then formulates advice to the physician client.

"Most physicians have a basic understanding about the attorney-client privilege and its scope, but don’t fully understand or appreciate how that legal protection can be lost inadvertently," Mr. Clark said. "Having an attorney on board early in the process of an audit or broader investigation is important to ensuring that the privilege is properly established and protected."

This article was updated Sept. 2, 2014.

[email protected]

On Twitter @legal_med

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

BOSTON – Central lymph node dissection may not be necessary in patients with small parathyroid carcinomas, results of a data review suggest.

Among 405 U.S. patients treated in the last two decades for parathyroid carcinomas, disease-specific mortality and degree of local tumor invasion did not differ depending on nodal involvement, reported Dr. Kun-Tai Hsu, an associate research specialist in the surgery department at the University of Wisconsin, Madison.

Patients with tumors greater than 3 cm in diameter and distal metastasis had worse disease-specific mortality, and larger tumors were significantly more likely to be associated with positive lymph nodes, Dr. Hsu reported at the annual meeting of the American Association of Endocrine Surgeons.

The findings raise the question of whether central lymph node dissection is necessary for all patients with parathyroid carcinomas, but "our conclusions may not translate directly into definitive recommendations," said Dr. Hsu, who advised further study of whether patients with tumors larger than 3 cm may benefit from lymph node dissection.

Parathyroid carcinomas are rare cancers, accounting for 0.005% of all malignancies and less than 1% of primary hyperparathyroidism. The current standard of therapy is en bloc removal of the parathyroid tumor and ipsilateral lobectomy, isthmusectomy, and central lymph node dissection.

Over at least 5 years of follow-up, neither tumor size nor lymph node status was significantly predictive of outcomes in an earlier retrospective study of 286 patients treated in the 1980s and 1990s.

In addition, a 2006 study using data from the Surveillance, Epidemiology and End Results (SEER) database showed a significant increase in the incidence of this malignancy from 1988 through 2003. The authors identified younger age, female sex, more recent diagnosis, and absence of distant metastases as favorable prognostic factors (Cancer 2007;109:1736-41).

What the previous studies could not answer, however, was whether lymph node metastases were associated with worse disease-specific mortality and whether central lymph node dissection might improve survival in patients with parathyroid carcinomas, Dr. Hsu noted.

He and his colleagues queried SEER for disease-specific survival outcomes and lymph-node status of all patients treated in the United States for parathyroid carcinomas from 1988 through 2010.

They identified 212 female and 193 male patients. Among all patients, 112 (27.7%) had tumors 3 cm or greater, and 12 (3%) had positive lymph nodes. Median follow-up was 68 months.

In a multivariate analysis of disease-specific mortality predictors adjusted for sex and age only, tumors 3 cm or greater and the presence of metastasis were predictive of worse survival, with respective hazard ratios of 5.35 (P = .01) and 45.1 (P less than .01).

Similarly, an analysis adjusted for sex, age, and year of diagnosis showed that tumor size but not age or sex significantly predicted lymph node metastasis (HR, 19.48; P = .02)

A comparison of outcomes between patients with and without lymph node examinations found no differences in disease-specific mortality by sex, age, year of diagnosis, tumor size, local invasion, or metastasis. Significant predictors of disease-specific mortality in this analysis included surgery type (parathyroidectomy, en bloc excision, or debulking), the use of radiation, and white race.

Dr. Hsu noted that the study was limited by its retrospective design, lack of information on other significant clinical variables, lack of detailed follow-up data, and the possibility of misclassification or miscoding of cases.

He acknowledged that uncertainty about the diagnosis is a drawback to SEER-based studies, but that given the rarity of the disease, SEER data are the most reliable source of information.

The study was supported by the Wisconsin Surgical Outcomes Research Program. Dr. Hsu reported having no relevant disclosures. Study coauthor Dr. Rebecca Sippel is a member of this publication’s editorial advisory board.

BOSTON – Central lymph node dissection may not be necessary in patients with small parathyroid carcinomas, results of a data review suggest.

Among 405 U.S. patients treated in the last two decades for parathyroid carcinomas, disease-specific mortality and degree of local tumor invasion did not differ depending on nodal involvement, reported Dr. Kun-Tai Hsu, an associate research specialist in the surgery department at the University of Wisconsin, Madison.

Patients with tumors greater than 3 cm in diameter and distal metastasis had worse disease-specific mortality, and larger tumors were significantly more likely to be associated with positive lymph nodes, Dr. Hsu reported at the annual meeting of the American Association of Endocrine Surgeons.

The findings raise the question of whether central lymph node dissection is necessary for all patients with parathyroid carcinomas, but "our conclusions may not translate directly into definitive recommendations," said Dr. Hsu, who advised further study of whether patients with tumors larger than 3 cm may benefit from lymph node dissection.

Parathyroid carcinomas are rare cancers, accounting for 0.005% of all malignancies and less than 1% of primary hyperparathyroidism. The current standard of therapy is en bloc removal of the parathyroid tumor and ipsilateral lobectomy, isthmusectomy, and central lymph node dissection.

Over at least 5 years of follow-up, neither tumor size nor lymph node status was significantly predictive of outcomes in an earlier retrospective study of 286 patients treated in the 1980s and 1990s.

In addition, a 2006 study using data from the Surveillance, Epidemiology and End Results (SEER) database showed a significant increase in the incidence of this malignancy from 1988 through 2003. The authors identified younger age, female sex, more recent diagnosis, and absence of distant metastases as favorable prognostic factors (Cancer 2007;109:1736-41).

What the previous studies could not answer, however, was whether lymph node metastases were associated with worse disease-specific mortality and whether central lymph node dissection might improve survival in patients with parathyroid carcinomas, Dr. Hsu noted.

He and his colleagues queried SEER for disease-specific survival outcomes and lymph-node status of all patients treated in the United States for parathyroid carcinomas from 1988 through 2010.

They identified 212 female and 193 male patients. Among all patients, 112 (27.7%) had tumors 3 cm or greater, and 12 (3%) had positive lymph nodes. Median follow-up was 68 months.

In a multivariate analysis of disease-specific mortality predictors adjusted for sex and age only, tumors 3 cm or greater and the presence of metastasis were predictive of worse survival, with respective hazard ratios of 5.35 (P = .01) and 45.1 (P less than .01).

Similarly, an analysis adjusted for sex, age, and year of diagnosis showed that tumor size but not age or sex significantly predicted lymph node metastasis (HR, 19.48; P = .02)

A comparison of outcomes between patients with and without lymph node examinations found no differences in disease-specific mortality by sex, age, year of diagnosis, tumor size, local invasion, or metastasis. Significant predictors of disease-specific mortality in this analysis included surgery type (parathyroidectomy, en bloc excision, or debulking), the use of radiation, and white race.

Dr. Hsu noted that the study was limited by its retrospective design, lack of information on other significant clinical variables, lack of detailed follow-up data, and the possibility of misclassification or miscoding of cases.

He acknowledged that uncertainty about the diagnosis is a drawback to SEER-based studies, but that given the rarity of the disease, SEER data are the most reliable source of information.

The study was supported by the Wisconsin Surgical Outcomes Research Program. Dr. Hsu reported having no relevant disclosures. Study coauthor Dr. Rebecca Sippel is a member of this publication’s editorial advisory board.

BOSTON – Central lymph node dissection may not be necessary in patients with small parathyroid carcinomas, results of a data review suggest.

Among 405 U.S. patients treated in the last two decades for parathyroid carcinomas, disease-specific mortality and degree of local tumor invasion did not differ depending on nodal involvement, reported Dr. Kun-Tai Hsu, an associate research specialist in the surgery department at the University of Wisconsin, Madison.

Patients with tumors greater than 3 cm in diameter and distal metastasis had worse disease-specific mortality, and larger tumors were significantly more likely to be associated with positive lymph nodes, Dr. Hsu reported at the annual meeting of the American Association of Endocrine Surgeons.

The findings raise the question of whether central lymph node dissection is necessary for all patients with parathyroid carcinomas, but "our conclusions may not translate directly into definitive recommendations," said Dr. Hsu, who advised further study of whether patients with tumors larger than 3 cm may benefit from lymph node dissection.

Parathyroid carcinomas are rare cancers, accounting for 0.005% of all malignancies and less than 1% of primary hyperparathyroidism. The current standard of therapy is en bloc removal of the parathyroid tumor and ipsilateral lobectomy, isthmusectomy, and central lymph node dissection.

Over at least 5 years of follow-up, neither tumor size nor lymph node status was significantly predictive of outcomes in an earlier retrospective study of 286 patients treated in the 1980s and 1990s.

In addition, a 2006 study using data from the Surveillance, Epidemiology and End Results (SEER) database showed a significant increase in the incidence of this malignancy from 1988 through 2003. The authors identified younger age, female sex, more recent diagnosis, and absence of distant metastases as favorable prognostic factors (Cancer 2007;109:1736-41).

What the previous studies could not answer, however, was whether lymph node metastases were associated with worse disease-specific mortality and whether central lymph node dissection might improve survival in patients with parathyroid carcinomas, Dr. Hsu noted.

He and his colleagues queried SEER for disease-specific survival outcomes and lymph-node status of all patients treated in the United States for parathyroid carcinomas from 1988 through 2010.

They identified 212 female and 193 male patients. Among all patients, 112 (27.7%) had tumors 3 cm or greater, and 12 (3%) had positive lymph nodes. Median follow-up was 68 months.

In a multivariate analysis of disease-specific mortality predictors adjusted for sex and age only, tumors 3 cm or greater and the presence of metastasis were predictive of worse survival, with respective hazard ratios of 5.35 (P = .01) and 45.1 (P less than .01).

Similarly, an analysis adjusted for sex, age, and year of diagnosis showed that tumor size but not age or sex significantly predicted lymph node metastasis (HR, 19.48; P = .02)

A comparison of outcomes between patients with and without lymph node examinations found no differences in disease-specific mortality by sex, age, year of diagnosis, tumor size, local invasion, or metastasis. Significant predictors of disease-specific mortality in this analysis included surgery type (parathyroidectomy, en bloc excision, or debulking), the use of radiation, and white race.

Dr. Hsu noted that the study was limited by its retrospective design, lack of information on other significant clinical variables, lack of detailed follow-up data, and the possibility of misclassification or miscoding of cases.

He acknowledged that uncertainty about the diagnosis is a drawback to SEER-based studies, but that given the rarity of the disease, SEER data are the most reliable source of information.

The study was supported by the Wisconsin Surgical Outcomes Research Program. Dr. Hsu reported having no relevant disclosures. Study coauthor Dr. Rebecca Sippel is a member of this publication’s editorial advisory board.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

Less than 4 months after the Florida Supreme Court struck down the state’s wrongful death noneconomic damages cap, the fate of the state’s personal injury medical malpractice award limit may also be in jeopardy.

The state’s highest court heard oral arguments in June regarding Myles et al. v. Weingrad, an injury malpractice case that focuses on whether Florida’s $500,000 medical malpractice noneconomic damages cap can be applied retroactively. However, after the court in March ruled that the state’s wrongful death cap was unconstitutional, the plaintiffs in Weingrad now argue the injury limit should be thrown out on constitutional grounds.

The personal injury malpractice cap is indeed in danger of being overturned, said Jeff Scott, general counsel for the Florida Medical Association. The FMA is not directly involved in the case.

"Given the track record of the (Florida) Supreme Court, one would have to conclude the likelihood of a favorable opinion is slim," Mr. Scott said in an interview.

The case stems from leg surgery performed on Kimberly Ann Miles by Aventura, Fla.–based surgeon Dr. Daniel Weingrad. Ms. Miles claimed the surgery to remove residual melanoma was unnecessary and resulted in ongoing pain. A jury awarded Ms. Miles and her husband $1.5 million in noneconomic damages and $16,000 in economic damages.

Dr. Weingrad requested that the trial court reduce the noneconomic damages award to $500,000 in accordance with the state’s cap, enacted in 2003. The plaintiffs argued the statute was implemented after the alleged negligence occurred and should not apply. An appeals court ruled in favor of Dr. Weingrad, and the plaintiffs appealed to the Florida Supreme Court.

Before Florida Supreme Court justices heard the case however, they reviewed McCall v. United States in which they overturned the state’s $1 million wrongful death damages cap. The award limit violated plaintiffs’ equal protection rights, judges said. In the months following the decision, plaintiffs’ attorneys have tried to get the injury award limit struck down by citing language in McCall, said Dinah S. Stein, a malpractice defense attorney who represents Dr. Weingrad.

"The plaintiffs’ bar has become fired up about" the McCall ruling, she said. "It’s our job to explain to the courts it’s not as far reaching as the plaintiffs’ bar would like them to think. (McCall) is limited. It doesn’t apply here; it’s prospective only and only applies to per-claim caps."

In Weingrad, the state Supreme Court has the option of ruling on the injury cap’s constitutionality or deciding only whether the limit can be applied retroactively. Other state courts faced with cap retroactivity questions have declined to immediately address constitutional issues. The Missouri Supreme Court for instance, in 2010 ruled that the state’s noneconomic damages cap in medical malpractices cases could not be applied retroactively in Klotz v. St. Anthonys Medical Center.

"The Supreme Court’s opinion was very limited, and they never addressed the overriding issues of the general constitutionality of caps," said J. Thaddeus Eckenrode, a malpractice defense attorney who represented the defendant in the Missouri case. "To that extent, it was surprising, although I think many people thought the court would rule against the use of the caps. All the court held was that in this particular case, since the plaintiff’s cause of action accrued before the new cap law went into effect, that law could not be applied to his case."

However, the same court held in 2012 that Missouri’s noneconomic damages cap violated a plaintiff’s right to a jury trial and overturned the award limit. Other noneconomic damages caps have faced similar challenges recently. The Georgia Supreme Court in 2010 found unconstitutional the state’s $350,000 cap. A proposed ballot measure in California aims to quadruple that state’s $250,000 cap.

Significant conflicts among court precedents exist across the country about the constitutionality of lawsuit award limits, Mr. Eckenrode said.

"Nearly any state’s highest court can find support for their decision to either uphold or throw out caps," he said in an e-mail. "As you examine the notion of caps around the country, you’ll find a relatively even split of states with caps in place and states that have thrown them out. It seems to be a political hotbed issue and, depending on the philosophical leaning of any state’s legislature and/or Supreme Court, one can take a pretty educated guess as to what the immediate future holds for caps in a given state."

[email protected]

On Twitter @legal_med

Less than 4 months after the Florida Supreme Court struck down the state’s wrongful death noneconomic damages cap, the fate of the state’s personal injury medical malpractice award limit may also be in jeopardy.

The state’s highest court heard oral arguments in June regarding Myles et al. v. Weingrad, an injury malpractice case that focuses on whether Florida’s $500,000 medical malpractice noneconomic damages cap can be applied retroactively. However, after the court in March ruled that the state’s wrongful death cap was unconstitutional, the plaintiffs in Weingrad now argue the injury limit should be thrown out on constitutional grounds.

The personal injury malpractice cap is indeed in danger of being overturned, said Jeff Scott, general counsel for the Florida Medical Association. The FMA is not directly involved in the case.

"Given the track record of the (Florida) Supreme Court, one would have to conclude the likelihood of a favorable opinion is slim," Mr. Scott said in an interview.

The case stems from leg surgery performed on Kimberly Ann Miles by Aventura, Fla.–based surgeon Dr. Daniel Weingrad. Ms. Miles claimed the surgery to remove residual melanoma was unnecessary and resulted in ongoing pain. A jury awarded Ms. Miles and her husband $1.5 million in noneconomic damages and $16,000 in economic damages.

Dr. Weingrad requested that the trial court reduce the noneconomic damages award to $500,000 in accordance with the state’s cap, enacted in 2003. The plaintiffs argued the statute was implemented after the alleged negligence occurred and should not apply. An appeals court ruled in favor of Dr. Weingrad, and the plaintiffs appealed to the Florida Supreme Court.

Before Florida Supreme Court justices heard the case however, they reviewed McCall v. United States in which they overturned the state’s $1 million wrongful death damages cap. The award limit violated plaintiffs’ equal protection rights, judges said. In the months following the decision, plaintiffs’ attorneys have tried to get the injury award limit struck down by citing language in McCall, said Dinah S. Stein, a malpractice defense attorney who represents Dr. Weingrad.

"The plaintiffs’ bar has become fired up about" the McCall ruling, she said. "It’s our job to explain to the courts it’s not as far reaching as the plaintiffs’ bar would like them to think. (McCall) is limited. It doesn’t apply here; it’s prospective only and only applies to per-claim caps."

In Weingrad, the state Supreme Court has the option of ruling on the injury cap’s constitutionality or deciding only whether the limit can be applied retroactively. Other state courts faced with cap retroactivity questions have declined to immediately address constitutional issues. The Missouri Supreme Court for instance, in 2010 ruled that the state’s noneconomic damages cap in medical malpractices cases could not be applied retroactively in Klotz v. St. Anthonys Medical Center.

"The Supreme Court’s opinion was very limited, and they never addressed the overriding issues of the general constitutionality of caps," said J. Thaddeus Eckenrode, a malpractice defense attorney who represented the defendant in the Missouri case. "To that extent, it was surprising, although I think many people thought the court would rule against the use of the caps. All the court held was that in this particular case, since the plaintiff’s cause of action accrued before the new cap law went into effect, that law could not be applied to his case."

However, the same court held in 2012 that Missouri’s noneconomic damages cap violated a plaintiff’s right to a jury trial and overturned the award limit. Other noneconomic damages caps have faced similar challenges recently. The Georgia Supreme Court in 2010 found unconstitutional the state’s $350,000 cap. A proposed ballot measure in California aims to quadruple that state’s $250,000 cap.

Significant conflicts among court precedents exist across the country about the constitutionality of lawsuit award limits, Mr. Eckenrode said.

"Nearly any state’s highest court can find support for their decision to either uphold or throw out caps," he said in an e-mail. "As you examine the notion of caps around the country, you’ll find a relatively even split of states with caps in place and states that have thrown them out. It seems to be a political hotbed issue and, depending on the philosophical leaning of any state’s legislature and/or Supreme Court, one can take a pretty educated guess as to what the immediate future holds for caps in a given state."

[email protected]

On Twitter @legal_med

Less than 4 months after the Florida Supreme Court struck down the state’s wrongful death noneconomic damages cap, the fate of the state’s personal injury medical malpractice award limit may also be in jeopardy.

The state’s highest court heard oral arguments in June regarding Myles et al. v. Weingrad, an injury malpractice case that focuses on whether Florida’s $500,000 medical malpractice noneconomic damages cap can be applied retroactively. However, after the court in March ruled that the state’s wrongful death cap was unconstitutional, the plaintiffs in Weingrad now argue the injury limit should be thrown out on constitutional grounds.

The personal injury malpractice cap is indeed in danger of being overturned, said Jeff Scott, general counsel for the Florida Medical Association. The FMA is not directly involved in the case.

"Given the track record of the (Florida) Supreme Court, one would have to conclude the likelihood of a favorable opinion is slim," Mr. Scott said in an interview.

The case stems from leg surgery performed on Kimberly Ann Miles by Aventura, Fla.–based surgeon Dr. Daniel Weingrad. Ms. Miles claimed the surgery to remove residual melanoma was unnecessary and resulted in ongoing pain. A jury awarded Ms. Miles and her husband $1.5 million in noneconomic damages and $16,000 in economic damages.

Dr. Weingrad requested that the trial court reduce the noneconomic damages award to $500,000 in accordance with the state’s cap, enacted in 2003. The plaintiffs argued the statute was implemented after the alleged negligence occurred and should not apply. An appeals court ruled in favor of Dr. Weingrad, and the plaintiffs appealed to the Florida Supreme Court.

Before Florida Supreme Court justices heard the case however, they reviewed McCall v. United States in which they overturned the state’s $1 million wrongful death damages cap. The award limit violated plaintiffs’ equal protection rights, judges said. In the months following the decision, plaintiffs’ attorneys have tried to get the injury award limit struck down by citing language in McCall, said Dinah S. Stein, a malpractice defense attorney who represents Dr. Weingrad.

"The plaintiffs’ bar has become fired up about" the McCall ruling, she said. "It’s our job to explain to the courts it’s not as far reaching as the plaintiffs’ bar would like them to think. (McCall) is limited. It doesn’t apply here; it’s prospective only and only applies to per-claim caps."

In Weingrad, the state Supreme Court has the option of ruling on the injury cap’s constitutionality or deciding only whether the limit can be applied retroactively. Other state courts faced with cap retroactivity questions have declined to immediately address constitutional issues. The Missouri Supreme Court for instance, in 2010 ruled that the state’s noneconomic damages cap in medical malpractices cases could not be applied retroactively in Klotz v. St. Anthonys Medical Center.

"The Supreme Court’s opinion was very limited, and they never addressed the overriding issues of the general constitutionality of caps," said J. Thaddeus Eckenrode, a malpractice defense attorney who represented the defendant in the Missouri case. "To that extent, it was surprising, although I think many people thought the court would rule against the use of the caps. All the court held was that in this particular case, since the plaintiff’s cause of action accrued before the new cap law went into effect, that law could not be applied to his case."

However, the same court held in 2012 that Missouri’s noneconomic damages cap violated a plaintiff’s right to a jury trial and overturned the award limit. Other noneconomic damages caps have faced similar challenges recently. The Georgia Supreme Court in 2010 found unconstitutional the state’s $350,000 cap. A proposed ballot measure in California aims to quadruple that state’s $250,000 cap.

Significant conflicts among court precedents exist across the country about the constitutionality of lawsuit award limits, Mr. Eckenrode said.

"Nearly any state’s highest court can find support for their decision to either uphold or throw out caps," he said in an e-mail. "As you examine the notion of caps around the country, you’ll find a relatively even split of states with caps in place and states that have thrown them out. It seems to be a political hotbed issue and, depending on the philosophical leaning of any state’s legislature and/or Supreme Court, one can take a pretty educated guess as to what the immediate future holds for caps in a given state."

[email protected]

On Twitter @legal_med

GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.

"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.

In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.

The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."

The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.

To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.

Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."

Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.

The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.

Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.

[email protected]

GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.

"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.

In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.

The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."

The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.

To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.

Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."

Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.

The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.

Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.

[email protected]

GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.

"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.

In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.

The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."

The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.

To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.

Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."

Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.

The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.

Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.

[email protected]

CHICAGO – Legal pitfalls lie along the path of transitioning from an independent practice to hospital employment, an accountable care organization, a medical home, or a merger to build a multispecialty group practice, legal experts warned at a physicians’ legal issues conference held by the American Bar Association.

"As a seller, you need to know what you’re getting into when you’re selling" your practice, said Hal Katz, an attorney in Austin, Tex. "Due diligence for you is just as important as it is for the buyer. The business structure you move into is going to be something you’re going to have to live with for the long term. You want to make sure it’s a good fit."

At the due-diligence stage, doctors partnering with another entity should ensure that they review a number of critical records from the other organization, such as corporate records, financial information, payer contracts, and real estate information, he said. Additionally, physician sellers should be aware of any litigation against their future partner and be knowledgeable about their affiliated entities and financial relationships.

Financial troubles or issues with federal regulation compliance are possible red flags for physician sellers. Examples include overpayments, repayments, audits, investigations, subpoenas or corporate integrity agreements.

Medicare providers changing ownership must inform federal authorities. A change of ownership (CHOW) generally happens when a Medicare provider is being purchased or leased by another entity. The CHOW results in the transfer of the former owner’s Medicare identification number and provider agreement to the new owner.

Adequately valuing the practice is another essential – albeit complex – process for physician sellers, Clinton Flome said at the ABA conference.

"Understanding price, understanding value, and most importantly understanding what physicians’ compensation is going to be going forward," are crucial, said Mr. Flome, senior manager at VMG Health in Dallas, a business valuation company. Knowing those criteria is "going to determine whether you have available" funds.

The three primary practice valuation methods include income, asset, and market approaches. The income approach examines historical financial and production information to estimate the future level of cash flows, Mr. Flome said. The asset approach takes into consideration the cost of replicating a comparable asset, security, or service with the same level of utility. The market approach estimates value by comparing the value of similar assets, securities, or services traded in a free and open market and the subject asset, security, or service.

"Everybody (should) be on the same page as to what the transaction is going to look like," Mr. Flome said. "Is this a 100% asset transaction or are you looking at some other alternatives?"

[email protected]

On Twitter @legal_med

CHICAGO – Legal pitfalls lie along the path of transitioning from an independent practice to hospital employment, an accountable care organization, a medical home, or a merger to build a multispecialty group practice, legal experts warned at a physicians’ legal issues conference held by the American Bar Association.

"As a seller, you need to know what you’re getting into when you’re selling" your practice, said Hal Katz, an attorney in Austin, Tex. "Due diligence for you is just as important as it is for the buyer. The business structure you move into is going to be something you’re going to have to live with for the long term. You want to make sure it’s a good fit."

At the due-diligence stage, doctors partnering with another entity should ensure that they review a number of critical records from the other organization, such as corporate records, financial information, payer contracts, and real estate information, he said. Additionally, physician sellers should be aware of any litigation against their future partner and be knowledgeable about their affiliated entities and financial relationships.

Financial troubles or issues with federal regulation compliance are possible red flags for physician sellers. Examples include overpayments, repayments, audits, investigations, subpoenas or corporate integrity agreements.

Medicare providers changing ownership must inform federal authorities. A change of ownership (CHOW) generally happens when a Medicare provider is being purchased or leased by another entity. The CHOW results in the transfer of the former owner’s Medicare identification number and provider agreement to the new owner.

Adequately valuing the practice is another essential – albeit complex – process for physician sellers, Clinton Flome said at the ABA conference.

"Understanding price, understanding value, and most importantly understanding what physicians’ compensation is going to be going forward," are crucial, said Mr. Flome, senior manager at VMG Health in Dallas, a business valuation company. Knowing those criteria is "going to determine whether you have available" funds.

The three primary practice valuation methods include income, asset, and market approaches. The income approach examines historical financial and production information to estimate the future level of cash flows, Mr. Flome said. The asset approach takes into consideration the cost of replicating a comparable asset, security, or service with the same level of utility. The market approach estimates value by comparing the value of similar assets, securities, or services traded in a free and open market and the subject asset, security, or service.

"Everybody (should) be on the same page as to what the transaction is going to look like," Mr. Flome said. "Is this a 100% asset transaction or are you looking at some other alternatives?"

[email protected]

On Twitter @legal_med

CHICAGO – Legal pitfalls lie along the path of transitioning from an independent practice to hospital employment, an accountable care organization, a medical home, or a merger to build a multispecialty group practice, legal experts warned at a physicians’ legal issues conference held by the American Bar Association.

"As a seller, you need to know what you’re getting into when you’re selling" your practice, said Hal Katz, an attorney in Austin, Tex. "Due diligence for you is just as important as it is for the buyer. The business structure you move into is going to be something you’re going to have to live with for the long term. You want to make sure it’s a good fit."

At the due-diligence stage, doctors partnering with another entity should ensure that they review a number of critical records from the other organization, such as corporate records, financial information, payer contracts, and real estate information, he said. Additionally, physician sellers should be aware of any litigation against their future partner and be knowledgeable about their affiliated entities and financial relationships.

Financial troubles or issues with federal regulation compliance are possible red flags for physician sellers. Examples include overpayments, repayments, audits, investigations, subpoenas or corporate integrity agreements.

Medicare providers changing ownership must inform federal authorities. A change of ownership (CHOW) generally happens when a Medicare provider is being purchased or leased by another entity. The CHOW results in the transfer of the former owner’s Medicare identification number and provider agreement to the new owner.

Adequately valuing the practice is another essential – albeit complex – process for physician sellers, Clinton Flome said at the ABA conference.

"Understanding price, understanding value, and most importantly understanding what physicians’ compensation is going to be going forward," are crucial, said Mr. Flome, senior manager at VMG Health in Dallas, a business valuation company. Knowing those criteria is "going to determine whether you have available" funds.

The three primary practice valuation methods include income, asset, and market approaches. The income approach examines historical financial and production information to estimate the future level of cash flows, Mr. Flome said. The asset approach takes into consideration the cost of replicating a comparable asset, security, or service with the same level of utility. The market approach estimates value by comparing the value of similar assets, securities, or services traded in a free and open market and the subject asset, security, or service.

"Everybody (should) be on the same page as to what the transaction is going to look like," Mr. Flome said. "Is this a 100% asset transaction or are you looking at some other alternatives?"

[email protected]

On Twitter @legal_med

DALLAS – Emergency departments have substantially improved their readiness to receive pediatric patients since a 2009 multispecialty call to action was triggered by documented major deficiencies in preparedness, the results of a comprehensive new survey indicate.

"We’ve seen significant improvement in all ED patient volume classes in terms of median pediatric readiness scores. The data are pretty exciting. It says we’re moving in the right direction," Dr. Marianne Gausche-Hill said in presenting the survey findings at the annual meeting of the Society for Academic Emergency Medicine.

The key outcome measure in the national survey was a weighted ED pediatric readiness score based upon the extent to which an ED was compliant with the major recommendations of the 2009 joint American Academy of Pediatrics/American College of Emergency Physicians/Emergency Nurses Association guidelines for the care of children in EDs (Pediatrics 2009;124:1233-44.

The guidelines lay out in concrete terms what ED pediatric readiness entails in terms of specialized equipment, medications, policies and protocols, safety issues, staff, and professional education.

Lack of recommended equipment needed to handle pediatric emergencies, such as laryngeal mask airways for children, was a major problem identified in the first survey. Indeed, at that time only 6% of EDs had all the recommended equipment and supplies. In contrast, the new survey showed that today EDs have a median of 91% of all recommended equipment; in higher-volume EDs that figure rises to virtually 100%, according to Dr. Gausche-Hill.

Overall, the median ED pediatric readiness score in the new survey was 69 on a 0-100 scale, up sharply from a median of 55 in an earlier nationwide survey, conducted in 2003 and published in 2007, for which Dr. Gausche-Hill also was the lead author (Pediatrics 2007;120:1229-37).

A test score of 55 gets a big red F in any classroom not grading on the curve. So this disappointing performance was an impetus for the 2009 joint guidelines, of which Dr. Gausche-Hill was a lead coauthor. The guidelines were endorsed by nearly two dozen organizations, including the American Academy of Family Physicians and the American College of Surgeons.

A theme emphasized in the joint guidelines is that all EDs need to be prepared to meet the unique needs of pediatric patients; 90% of all ED visits by patients under age 15 are to nonchildren’s hospitals, and roughly one-third of these visits are to EDs in rural and remote areas, which generally scored poorly in the initial national survey.

Another impetus for issuing the guidelines was recognition that pediatric ED visits are increasing even as the number of EDs nationwide is declining, worsening overcrowding, explained Dr. Gausche-Hill, professor of emergency medicine at the University of California, Los Angeles, and director of emergency medical services at Harbor-UCLA Medical Center.

She and her coinvestigators in the large coalition known as the National Pediatric Readiness Project sent the survey to more than 5,000 U.S. EDs. The response rate was an impressive 83%, despite the fact that the 55-question survey addressed 189 items and took a full hour to complete. Dr. Gausche-Hill attributed this remarkable response rate to on-site advocates’ passion for improved ED pediatric preparedness. Another factor: survey respondents received immediate feedback about how their hospital’s ED score compared with the average score of other hospitals with similar patient volume, as well as information about the top three things their hospital needs to do to reach a preparedness score of at least 80, which is the coalition’s short-term goal.

In analyzing the ED scores, the single most effective way most hospitals can improve their ED pediatric readiness score is for the hospital ED medical director to appoint a physician and/or a nurse pediatric emergency care coordinator. Hospitals with a coordinator scored higher, and the 42% of hospitals with both a physician and a nurse pediatric emergency care coordinator scored highest of all. Hospitals with at least one pediatric emergency care coordinator were more than fivefold more likely to have a quality improvement plan in place for ED pediatric patients, as recommended in a 2006 Institute of Medicine report that described the nation’s ED pediatric readiness as uneven.

In the new survey, 82% of EDs reported one or more barriers to compliance with the pediatric readiness guidelines. These barriers will be the focus of future quality improvement initiatives.

What’s next? Dr. Gausche-Hill said the coalition is reaching out to health care corporate groups in an effort to convince them to make changes in their hospitals.

"We’ve seen the Hospital Corporation of America make a huge initiative and change their average readiness score from 66 to 91 in the intervention hospitals. Also, Kaiser Permanente has initiated a readiness initiative," she said.

The plan is to keep the survey’s internet portal open so that hospitals can enter updated data and show continuous quality improvement. In addition, the coalition’s website – www.pediatricreadiness.org – includes tools to improve readiness.

Dr. Gausche-Hill reported having no financial conflicts regarding this project.

[email protected]

DALLAS – Emergency departments have substantially improved their readiness to receive pediatric patients since a 2009 multispecialty call to action was triggered by documented major deficiencies in preparedness, the results of a comprehensive new survey indicate.

"We’ve seen significant improvement in all ED patient volume classes in terms of median pediatric readiness scores. The data are pretty exciting. It says we’re moving in the right direction," Dr. Marianne Gausche-Hill said in presenting the survey findings at the annual meeting of the Society for Academic Emergency Medicine.

The key outcome measure in the national survey was a weighted ED pediatric readiness score based upon the extent to which an ED was compliant with the major recommendations of the 2009 joint American Academy of Pediatrics/American College of Emergency Physicians/Emergency Nurses Association guidelines for the care of children in EDs (Pediatrics 2009;124:1233-44.

The guidelines lay out in concrete terms what ED pediatric readiness entails in terms of specialized equipment, medications, policies and protocols, safety issues, staff, and professional education.

Lack of recommended equipment needed to handle pediatric emergencies, such as laryngeal mask airways for children, was a major problem identified in the first survey. Indeed, at that time only 6% of EDs had all the recommended equipment and supplies. In contrast, the new survey showed that today EDs have a median of 91% of all recommended equipment; in higher-volume EDs that figure rises to virtually 100%, according to Dr. Gausche-Hill.

Overall, the median ED pediatric readiness score in the new survey was 69 on a 0-100 scale, up sharply from a median of 55 in an earlier nationwide survey, conducted in 2003 and published in 2007, for which Dr. Gausche-Hill also was the lead author (Pediatrics 2007;120:1229-37).

A test score of 55 gets a big red F in any classroom not grading on the curve. So this disappointing performance was an impetus for the 2009 joint guidelines, of which Dr. Gausche-Hill was a lead coauthor. The guidelines were endorsed by nearly two dozen organizations, including the American Academy of Family Physicians and the American College of Surgeons.

A theme emphasized in the joint guidelines is that all EDs need to be prepared to meet the unique needs of pediatric patients; 90% of all ED visits by patients under age 15 are to nonchildren’s hospitals, and roughly one-third of these visits are to EDs in rural and remote areas, which generally scored poorly in the initial national survey.

Another impetus for issuing the guidelines was recognition that pediatric ED visits are increasing even as the number of EDs nationwide is declining, worsening overcrowding, explained Dr. Gausche-Hill, professor of emergency medicine at the University of California, Los Angeles, and director of emergency medical services at Harbor-UCLA Medical Center.

She and her coinvestigators in the large coalition known as the National Pediatric Readiness Project sent the survey to more than 5,000 U.S. EDs. The response rate was an impressive 83%, despite the fact that the 55-question survey addressed 189 items and took a full hour to complete. Dr. Gausche-Hill attributed this remarkable response rate to on-site advocates’ passion for improved ED pediatric preparedness. Another factor: survey respondents received immediate feedback about how their hospital’s ED score compared with the average score of other hospitals with similar patient volume, as well as information about the top three things their hospital needs to do to reach a preparedness score of at least 80, which is the coalition’s short-term goal.

In analyzing the ED scores, the single most effective way most hospitals can improve their ED pediatric readiness score is for the hospital ED medical director to appoint a physician and/or a nurse pediatric emergency care coordinator. Hospitals with a coordinator scored higher, and the 42% of hospitals with both a physician and a nurse pediatric emergency care coordinator scored highest of all. Hospitals with at least one pediatric emergency care coordinator were more than fivefold more likely to have a quality improvement plan in place for ED pediatric patients, as recommended in a 2006 Institute of Medicine report that described the nation’s ED pediatric readiness as uneven.

In the new survey, 82% of EDs reported one or more barriers to compliance with the pediatric readiness guidelines. These barriers will be the focus of future quality improvement initiatives.

What’s next? Dr. Gausche-Hill said the coalition is reaching out to health care corporate groups in an effort to convince them to make changes in their hospitals.

"We’ve seen the Hospital Corporation of America make a huge initiative and change their average readiness score from 66 to 91 in the intervention hospitals. Also, Kaiser Permanente has initiated a readiness initiative," she said.

The plan is to keep the survey’s internet portal open so that hospitals can enter updated data and show continuous quality improvement. In addition, the coalition’s website – www.pediatricreadiness.org – includes tools to improve readiness.

Dr. Gausche-Hill reported having no financial conflicts regarding this project.

[email protected]

DALLAS – Emergency departments have substantially improved their readiness to receive pediatric patients since a 2009 multispecialty call to action was triggered by documented major deficiencies in preparedness, the results of a comprehensive new survey indicate.

"We’ve seen significant improvement in all ED patient volume classes in terms of median pediatric readiness scores. The data are pretty exciting. It says we’re moving in the right direction," Dr. Marianne Gausche-Hill said in presenting the survey findings at the annual meeting of the Society for Academic Emergency Medicine.

The key outcome measure in the national survey was a weighted ED pediatric readiness score based upon the extent to which an ED was compliant with the major recommendations of the 2009 joint American Academy of Pediatrics/American College of Emergency Physicians/Emergency Nurses Association guidelines for the care of children in EDs (Pediatrics 2009;124:1233-44.

The guidelines lay out in concrete terms what ED pediatric readiness entails in terms of specialized equipment, medications, policies and protocols, safety issues, staff, and professional education.

Lack of recommended equipment needed to handle pediatric emergencies, such as laryngeal mask airways for children, was a major problem identified in the first survey. Indeed, at that time only 6% of EDs had all the recommended equipment and supplies. In contrast, the new survey showed that today EDs have a median of 91% of all recommended equipment; in higher-volume EDs that figure rises to virtually 100%, according to Dr. Gausche-Hill.

Overall, the median ED pediatric readiness score in the new survey was 69 on a 0-100 scale, up sharply from a median of 55 in an earlier nationwide survey, conducted in 2003 and published in 2007, for which Dr. Gausche-Hill also was the lead author (Pediatrics 2007;120:1229-37).

A test score of 55 gets a big red F in any classroom not grading on the curve. So this disappointing performance was an impetus for the 2009 joint guidelines, of which Dr. Gausche-Hill was a lead coauthor. The guidelines were endorsed by nearly two dozen organizations, including the American Academy of Family Physicians and the American College of Surgeons.

A theme emphasized in the joint guidelines is that all EDs need to be prepared to meet the unique needs of pediatric patients; 90% of all ED visits by patients under age 15 are to nonchildren’s hospitals, and roughly one-third of these visits are to EDs in rural and remote areas, which generally scored poorly in the initial national survey.

Another impetus for issuing the guidelines was recognition that pediatric ED visits are increasing even as the number of EDs nationwide is declining, worsening overcrowding, explained Dr. Gausche-Hill, professor of emergency medicine at the University of California, Los Angeles, and director of emergency medical services at Harbor-UCLA Medical Center.

She and her coinvestigators in the large coalition known as the National Pediatric Readiness Project sent the survey to more than 5,000 U.S. EDs. The response rate was an impressive 83%, despite the fact that the 55-question survey addressed 189 items and took a full hour to complete. Dr. Gausche-Hill attributed this remarkable response rate to on-site advocates’ passion for improved ED pediatric preparedness. Another factor: survey respondents received immediate feedback about how their hospital’s ED score compared with the average score of other hospitals with similar patient volume, as well as information about the top three things their hospital needs to do to reach a preparedness score of at least 80, which is the coalition’s short-term goal.

In analyzing the ED scores, the single most effective way most hospitals can improve their ED pediatric readiness score is for the hospital ED medical director to appoint a physician and/or a nurse pediatric emergency care coordinator. Hospitals with a coordinator scored higher, and the 42% of hospitals with both a physician and a nurse pediatric emergency care coordinator scored highest of all. Hospitals with at least one pediatric emergency care coordinator were more than fivefold more likely to have a quality improvement plan in place for ED pediatric patients, as recommended in a 2006 Institute of Medicine report that described the nation’s ED pediatric readiness as uneven.

In the new survey, 82% of EDs reported one or more barriers to compliance with the pediatric readiness guidelines. These barriers will be the focus of future quality improvement initiatives.

What’s next? Dr. Gausche-Hill said the coalition is reaching out to health care corporate groups in an effort to convince them to make changes in their hospitals.

"We’ve seen the Hospital Corporation of America make a huge initiative and change their average readiness score from 66 to 91 in the intervention hospitals. Also, Kaiser Permanente has initiated a readiness initiative," she said.

The plan is to keep the survey’s internet portal open so that hospitals can enter updated data and show continuous quality improvement. In addition, the coalition’s website – www.pediatricreadiness.org – includes tools to improve readiness.

Dr. Gausche-Hill reported having no financial conflicts regarding this project.

[email protected]

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.