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From the Washington Office: Globals … again
Regular readers of this column may remember the March 2015 edition devoted to the topic of the CMS’s proposal to transition all 10-day and 90-day global codes to 0-day global codes in 2017 and 2018, respectively. As a result of a coordinated advocacy effort of the American College of Surgeons and a coalition of 24 other surgical and medical groups including the American Medical Association, the American Academy of Dermatology, and the American College of Cardiology, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) included a provision that required that the Centers for Medicare & Medicaid Services (CMS) instead collect data from a representative sample of providers to facilitate the accurate valuation of surgical services before proposing any changes to the global payment structure.
Fast forward to July 7, 2016, and the release of the 2017 Physician Fee Schedule (PFS) proposed rule. In that proposed rule, the CMS disregards the specific legislative language from Congress and proposes to collect data from all physicians who provide 10- and 90-day global services. This would obviously create yet another huge administrative burden AND also coincide with the time physicians and practices are engaged in efforts to implement the changes required by the new Quality Payment Program (QPP) mandated by MACRA. Specifically, if the proposed PFS rule is finalized, all surgeons would be required to submit data in 10-minute increments for all 10- and 90-day global code services.
Obviously, this is in direct conflict with the language in MACRA that directs the CMS to collect these data from a “representative sample” of practitioners.
Upon discovering the CMS’s plan in the proposed rule, the legislative team in ACS’s Division of Advocacy and Health Policy contacted the congressional sponsors of the original effort directed at the global codes, Rep. Larry Bucshon, MD, FACS (R-IN), and Rep. Ami Bera, MD (D-CA). Dr. Bucshon and Dr. Bera began circulating a letter, addressed to Health and Human Services Secretary Sylvia Burwell and CMS Acting Administrator Andrew Slavitt, urging the CMS to abandon the proposed policy outlined in the 2017 PFS proposed rule regarding the arduous data collection requirements for global codes.
In the week leading up to the summer congressional recess, the ACS sent the letter to all 435 offices in the House of Representatives urging other members to sign on to the letter. The ACS lobbyists and those from the coalition of groups previously involved in the efforts relative to global codes are currently engaged in individual follow-up with offices as well. The goal is to make a strong showing to the CMS with a large number of signatures from members of Congress in the hope that the CMS will modify the final rule in accordance with the legislative language found in MACRA.
This is where we need your help!
By the time you receive this issue of ACS Surgery News, all Fellows will have received an email requesting that they respond by contacting their individual members of Congress to urge them to sign on to the letter. This may be accomplished either by placing a call or by sending an email communication.
Those choosing to call may use the ACS Legislative Hotline at 877-996-4464. Follow the instructions to be connected to the office of your member of Congress. Once connected, please inform them that you are a constituent, and then deliver the following message:
“As a surgeon and a constituent, I urge Rep. _____ to join Rep Dr. Larry Bucshon and Rep. Dr. Ami Bera in supporting the bipartisan sign-on letter to the CMS in order to stop the administratively burdensome data entry changes proposed by the CMS relative to 10- and 90-day global codes.
“The proposed changes would mandate that all practitioners who perform global code services enter data in 10-minute intervals for every patient billed under global codes rather than adhering to the direction of Congress to obtain the necessary information from a ‘representative sample’ as was mandated in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).”
For those wishing further information on this matter or for those who would prefer to contact their representative by email, an ACTION Alert can be found on the SurgeonsVoice website (www.surgeonsvoice.com – click on the Take Action tab on the right side of the page). The alert addressing the global codes issue is at the top of the list and includes a fact sheet that outlines the issue and provides background information along with a link to facilitate transmittal of your message urging your representative to sign on to the Bucshon-Bera letter. Because Congress has adjourned for their summer recess and will not return until Sept. 6, 2016, we have ample time to gather the overwhelming support we need to initiate action precluding the inclusion of this flawed proposal in the final rule, which is expected to be released the first week of November 2016.
I respectfully request that ALL Fellows do their part and contact their member of Congress via one of the two methods provided. There can be no argument that the minimal time required to invest in our collective advocacy efforts relative to this matter pales in comparison to the time required to comply with the proposed CMS policy we seek to prevent being published in the final PFS rule.
Until next month …
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
Regular readers of this column may remember the March 2015 edition devoted to the topic of the CMS’s proposal to transition all 10-day and 90-day global codes to 0-day global codes in 2017 and 2018, respectively. As a result of a coordinated advocacy effort of the American College of Surgeons and a coalition of 24 other surgical and medical groups including the American Medical Association, the American Academy of Dermatology, and the American College of Cardiology, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) included a provision that required that the Centers for Medicare & Medicaid Services (CMS) instead collect data from a representative sample of providers to facilitate the accurate valuation of surgical services before proposing any changes to the global payment structure.
Fast forward to July 7, 2016, and the release of the 2017 Physician Fee Schedule (PFS) proposed rule. In that proposed rule, the CMS disregards the specific legislative language from Congress and proposes to collect data from all physicians who provide 10- and 90-day global services. This would obviously create yet another huge administrative burden AND also coincide with the time physicians and practices are engaged in efforts to implement the changes required by the new Quality Payment Program (QPP) mandated by MACRA. Specifically, if the proposed PFS rule is finalized, all surgeons would be required to submit data in 10-minute increments for all 10- and 90-day global code services.
Obviously, this is in direct conflict with the language in MACRA that directs the CMS to collect these data from a “representative sample” of practitioners.
Upon discovering the CMS’s plan in the proposed rule, the legislative team in ACS’s Division of Advocacy and Health Policy contacted the congressional sponsors of the original effort directed at the global codes, Rep. Larry Bucshon, MD, FACS (R-IN), and Rep. Ami Bera, MD (D-CA). Dr. Bucshon and Dr. Bera began circulating a letter, addressed to Health and Human Services Secretary Sylvia Burwell and CMS Acting Administrator Andrew Slavitt, urging the CMS to abandon the proposed policy outlined in the 2017 PFS proposed rule regarding the arduous data collection requirements for global codes.
In the week leading up to the summer congressional recess, the ACS sent the letter to all 435 offices in the House of Representatives urging other members to sign on to the letter. The ACS lobbyists and those from the coalition of groups previously involved in the efforts relative to global codes are currently engaged in individual follow-up with offices as well. The goal is to make a strong showing to the CMS with a large number of signatures from members of Congress in the hope that the CMS will modify the final rule in accordance with the legislative language found in MACRA.
This is where we need your help!
By the time you receive this issue of ACS Surgery News, all Fellows will have received an email requesting that they respond by contacting their individual members of Congress to urge them to sign on to the letter. This may be accomplished either by placing a call or by sending an email communication.
Those choosing to call may use the ACS Legislative Hotline at 877-996-4464. Follow the instructions to be connected to the office of your member of Congress. Once connected, please inform them that you are a constituent, and then deliver the following message:
“As a surgeon and a constituent, I urge Rep. _____ to join Rep Dr. Larry Bucshon and Rep. Dr. Ami Bera in supporting the bipartisan sign-on letter to the CMS in order to stop the administratively burdensome data entry changes proposed by the CMS relative to 10- and 90-day global codes.
“The proposed changes would mandate that all practitioners who perform global code services enter data in 10-minute intervals for every patient billed under global codes rather than adhering to the direction of Congress to obtain the necessary information from a ‘representative sample’ as was mandated in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).”
For those wishing further information on this matter or for those who would prefer to contact their representative by email, an ACTION Alert can be found on the SurgeonsVoice website (www.surgeonsvoice.com – click on the Take Action tab on the right side of the page). The alert addressing the global codes issue is at the top of the list and includes a fact sheet that outlines the issue and provides background information along with a link to facilitate transmittal of your message urging your representative to sign on to the Bucshon-Bera letter. Because Congress has adjourned for their summer recess and will not return until Sept. 6, 2016, we have ample time to gather the overwhelming support we need to initiate action precluding the inclusion of this flawed proposal in the final rule, which is expected to be released the first week of November 2016.
I respectfully request that ALL Fellows do their part and contact their member of Congress via one of the two methods provided. There can be no argument that the minimal time required to invest in our collective advocacy efforts relative to this matter pales in comparison to the time required to comply with the proposed CMS policy we seek to prevent being published in the final PFS rule.
Until next month …
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
Regular readers of this column may remember the March 2015 edition devoted to the topic of the CMS’s proposal to transition all 10-day and 90-day global codes to 0-day global codes in 2017 and 2018, respectively. As a result of a coordinated advocacy effort of the American College of Surgeons and a coalition of 24 other surgical and medical groups including the American Medical Association, the American Academy of Dermatology, and the American College of Cardiology, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) included a provision that required that the Centers for Medicare & Medicaid Services (CMS) instead collect data from a representative sample of providers to facilitate the accurate valuation of surgical services before proposing any changes to the global payment structure.
Fast forward to July 7, 2016, and the release of the 2017 Physician Fee Schedule (PFS) proposed rule. In that proposed rule, the CMS disregards the specific legislative language from Congress and proposes to collect data from all physicians who provide 10- and 90-day global services. This would obviously create yet another huge administrative burden AND also coincide with the time physicians and practices are engaged in efforts to implement the changes required by the new Quality Payment Program (QPP) mandated by MACRA. Specifically, if the proposed PFS rule is finalized, all surgeons would be required to submit data in 10-minute increments for all 10- and 90-day global code services.
Obviously, this is in direct conflict with the language in MACRA that directs the CMS to collect these data from a “representative sample” of practitioners.
Upon discovering the CMS’s plan in the proposed rule, the legislative team in ACS’s Division of Advocacy and Health Policy contacted the congressional sponsors of the original effort directed at the global codes, Rep. Larry Bucshon, MD, FACS (R-IN), and Rep. Ami Bera, MD (D-CA). Dr. Bucshon and Dr. Bera began circulating a letter, addressed to Health and Human Services Secretary Sylvia Burwell and CMS Acting Administrator Andrew Slavitt, urging the CMS to abandon the proposed policy outlined in the 2017 PFS proposed rule regarding the arduous data collection requirements for global codes.
In the week leading up to the summer congressional recess, the ACS sent the letter to all 435 offices in the House of Representatives urging other members to sign on to the letter. The ACS lobbyists and those from the coalition of groups previously involved in the efforts relative to global codes are currently engaged in individual follow-up with offices as well. The goal is to make a strong showing to the CMS with a large number of signatures from members of Congress in the hope that the CMS will modify the final rule in accordance with the legislative language found in MACRA.
This is where we need your help!
By the time you receive this issue of ACS Surgery News, all Fellows will have received an email requesting that they respond by contacting their individual members of Congress to urge them to sign on to the letter. This may be accomplished either by placing a call or by sending an email communication.
Those choosing to call may use the ACS Legislative Hotline at 877-996-4464. Follow the instructions to be connected to the office of your member of Congress. Once connected, please inform them that you are a constituent, and then deliver the following message:
“As a surgeon and a constituent, I urge Rep. _____ to join Rep Dr. Larry Bucshon and Rep. Dr. Ami Bera in supporting the bipartisan sign-on letter to the CMS in order to stop the administratively burdensome data entry changes proposed by the CMS relative to 10- and 90-day global codes.
“The proposed changes would mandate that all practitioners who perform global code services enter data in 10-minute intervals for every patient billed under global codes rather than adhering to the direction of Congress to obtain the necessary information from a ‘representative sample’ as was mandated in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).”
For those wishing further information on this matter or for those who would prefer to contact their representative by email, an ACTION Alert can be found on the SurgeonsVoice website (www.surgeonsvoice.com – click on the Take Action tab on the right side of the page). The alert addressing the global codes issue is at the top of the list and includes a fact sheet that outlines the issue and provides background information along with a link to facilitate transmittal of your message urging your representative to sign on to the Bucshon-Bera letter. Because Congress has adjourned for their summer recess and will not return until Sept. 6, 2016, we have ample time to gather the overwhelming support we need to initiate action precluding the inclusion of this flawed proposal in the final rule, which is expected to be released the first week of November 2016.
I respectfully request that ALL Fellows do their part and contact their member of Congress via one of the two methods provided. There can be no argument that the minimal time required to invest in our collective advocacy efforts relative to this matter pales in comparison to the time required to comply with the proposed CMS policy we seek to prevent being published in the final PFS rule.
Until next month …
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
Law & Medicine: Disciplinary function of state medical boards
(This column is the first in a three-part series.)
Question: Which of the following statements about state medical boards is best?
A. They are made up exclusively of doctors.
B. Disciplinary actions are on the rise.
C. They investigate narrowly defined areas of clinical practice.
D. They usually end with physician suspension.
E. They are insufficiently vigilant, according to critics.
Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.
All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.
Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.1
State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.
There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.
In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.
On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.
However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.
For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.2 Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.
The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”
Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.3 In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.
The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.
For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.
Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”4
The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.5
To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.
For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.
In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.
The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.
To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.
Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.
Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.
All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.
Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.6
These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.
References
1. U.S. Medical Regulatory Trends and Actions, May 2014.
2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).
3. In Re Kindschi, 52 Wn.2d 8 (1958).
4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.
5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.
6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. 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].
(This column is the first in a three-part series.)
Question: Which of the following statements about state medical boards is best?
A. They are made up exclusively of doctors.
B. Disciplinary actions are on the rise.
C. They investigate narrowly defined areas of clinical practice.
D. They usually end with physician suspension.
E. They are insufficiently vigilant, according to critics.
Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.
All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.
Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.1
State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.
There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.
In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.
On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.
However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.
For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.2 Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.
The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”
Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.3 In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.
The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.
For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.
Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”4
The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.5
To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.
For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.
In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.
The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.
To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.
Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.
Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.
All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.
Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.6
These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.
References
1. U.S. Medical Regulatory Trends and Actions, May 2014.
2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).
3. In Re Kindschi, 52 Wn.2d 8 (1958).
4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.
5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.
6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. 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].
(This column is the first in a three-part series.)
Question: Which of the following statements about state medical boards is best?
A. They are made up exclusively of doctors.
B. Disciplinary actions are on the rise.
C. They investigate narrowly defined areas of clinical practice.
D. They usually end with physician suspension.
E. They are insufficiently vigilant, according to critics.
Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.
All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.
Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.1
State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.
There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.
In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.
On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.
However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.
For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.2 Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.
The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”
Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.3 In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.
The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.
For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.
Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”4
The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.5
To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.
For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.
In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.
The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.
To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.
Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.
Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.
All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.
Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.6
These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.
References
1. U.S. Medical Regulatory Trends and Actions, May 2014.
2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).
3. In Re Kindschi, 52 Wn.2d 8 (1958).
4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.
5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.
6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. 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].
Myth of the Month: Vaccinations in patients with Guillain-Barré syndrome
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
Blue and white light for seasonal affective disorder
Perhaps it’s the northern climate. Perhaps it’s that people at my office work a lot in the absence of office windows. But there are a lot of seasonal affective disorder lamps around me.
The one in my office turns on automatically (frequently in my absence), and the eerie blue light from my office floods the cubicles outside my door.
At a social gathering the other day, I related the story of my “moody blues office,” and somebody asked if the blue light for seasonal affective disorder was better than the white light. I did not know, so I did some reading.
It turns out that there is a retinal photoreceptor in the ganglion cells with a maximum sensitivity of 470-490 nm to blue light. These non-image–forming photoreceptors play a role in regulating the biological clock. Experiments have been conducted evaluating the impact of different wavelengths of light on symptoms of SAD.
In a study of people with subsyndromal SAD, investigators randomized 48 participants to bright white fluorescent light or narrow-band blue light (peak LED wavelength, 470 nm). Patients were exposed to the light for 20 minutes on 5 consecutive days. Standard scales measuring mood and fatigue were administered (BMC Psychiatry. 2016 Feb 18;16:27).
Investigators did not detect differences between the groups, and the authors concluded they had comparable efficacy.
Although the sample size is small, the data suggest that blue light is comparable to white light. I will start needing to pay attention if the folks in the cubicles outside my office are less depressed.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. Dr. Ebbert has no relevant financial disclosures about this article.
Perhaps it’s the northern climate. Perhaps it’s that people at my office work a lot in the absence of office windows. But there are a lot of seasonal affective disorder lamps around me.
The one in my office turns on automatically (frequently in my absence), and the eerie blue light from my office floods the cubicles outside my door.
At a social gathering the other day, I related the story of my “moody blues office,” and somebody asked if the blue light for seasonal affective disorder was better than the white light. I did not know, so I did some reading.
It turns out that there is a retinal photoreceptor in the ganglion cells with a maximum sensitivity of 470-490 nm to blue light. These non-image–forming photoreceptors play a role in regulating the biological clock. Experiments have been conducted evaluating the impact of different wavelengths of light on symptoms of SAD.
In a study of people with subsyndromal SAD, investigators randomized 48 participants to bright white fluorescent light or narrow-band blue light (peak LED wavelength, 470 nm). Patients were exposed to the light for 20 minutes on 5 consecutive days. Standard scales measuring mood and fatigue were administered (BMC Psychiatry. 2016 Feb 18;16:27).
Investigators did not detect differences between the groups, and the authors concluded they had comparable efficacy.
Although the sample size is small, the data suggest that blue light is comparable to white light. I will start needing to pay attention if the folks in the cubicles outside my office are less depressed.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. Dr. Ebbert has no relevant financial disclosures about this article.
Perhaps it’s the northern climate. Perhaps it’s that people at my office work a lot in the absence of office windows. But there are a lot of seasonal affective disorder lamps around me.
The one in my office turns on automatically (frequently in my absence), and the eerie blue light from my office floods the cubicles outside my door.
At a social gathering the other day, I related the story of my “moody blues office,” and somebody asked if the blue light for seasonal affective disorder was better than the white light. I did not know, so I did some reading.
It turns out that there is a retinal photoreceptor in the ganglion cells with a maximum sensitivity of 470-490 nm to blue light. These non-image–forming photoreceptors play a role in regulating the biological clock. Experiments have been conducted evaluating the impact of different wavelengths of light on symptoms of SAD.
In a study of people with subsyndromal SAD, investigators randomized 48 participants to bright white fluorescent light or narrow-band blue light (peak LED wavelength, 470 nm). Patients were exposed to the light for 20 minutes on 5 consecutive days. Standard scales measuring mood and fatigue were administered (BMC Psychiatry. 2016 Feb 18;16:27).
Investigators did not detect differences between the groups, and the authors concluded they had comparable efficacy.
Although the sample size is small, the data suggest that blue light is comparable to white light. I will start needing to pay attention if the folks in the cubicles outside my office are less depressed.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. Dr. Ebbert has no relevant financial disclosures about this article.
Don’t sell your practice short
I’ve written quite a lot over the past few years about the trend toward soloists and small groups selling their practices to hospitals, multispecialty groups, or larger practices. And I’ve made it fairly clear that I don’t think it’s a particularly good thing that the medical profession is going the way of the corner gas station and the mom-and-pop grocery store; it’s not good for physicians, patients, or private practice.
That said, if retirement looms with no individual buyers in sight, or your overhead is getting out of hand, selling to a larger entity is an option that you may need to consider. Too often, though, sellers are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions; and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than is an ordinary business and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 850 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
• Tangible Assets: equipment, cash, accounts receivable, and other property owned by the practice.
• Liabilities: accounts payable, outstanding loans, and anything else owed to others.
• Intangible Assets: sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal, you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place, and how well they pay, etc.), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again, there are many ways to estimate intangible asset value, and once again, you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular – but by no means the only – method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].
I’ve written quite a lot over the past few years about the trend toward soloists and small groups selling their practices to hospitals, multispecialty groups, or larger practices. And I’ve made it fairly clear that I don’t think it’s a particularly good thing that the medical profession is going the way of the corner gas station and the mom-and-pop grocery store; it’s not good for physicians, patients, or private practice.
That said, if retirement looms with no individual buyers in sight, or your overhead is getting out of hand, selling to a larger entity is an option that you may need to consider. Too often, though, sellers are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions; and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than is an ordinary business and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 850 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
• Tangible Assets: equipment, cash, accounts receivable, and other property owned by the practice.
• Liabilities: accounts payable, outstanding loans, and anything else owed to others.
• Intangible Assets: sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal, you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place, and how well they pay, etc.), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again, there are many ways to estimate intangible asset value, and once again, you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular – but by no means the only – method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].
I’ve written quite a lot over the past few years about the trend toward soloists and small groups selling their practices to hospitals, multispecialty groups, or larger practices. And I’ve made it fairly clear that I don’t think it’s a particularly good thing that the medical profession is going the way of the corner gas station and the mom-and-pop grocery store; it’s not good for physicians, patients, or private practice.
That said, if retirement looms with no individual buyers in sight, or your overhead is getting out of hand, selling to a larger entity is an option that you may need to consider. Too often, though, sellers are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions; and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than is an ordinary business and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 850 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
• Tangible Assets: equipment, cash, accounts receivable, and other property owned by the practice.
• Liabilities: accounts payable, outstanding loans, and anything else owed to others.
• Intangible Assets: sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal, you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place, and how well they pay, etc.), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again, there are many ways to estimate intangible asset value, and once again, you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular – but by no means the only – method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].
Tips for using EMRs effectively
All young physicians are adept at using electronic medical records. Do you agree? If so, you’d be wrong. It’s true that young, so-called “digital-native” physicians have more training and experience using EMRs, compared with those who trained in the days of paper charts. But young physicians are also inexperienced at caring for patients, and using a keyboard adds complexity to an already difficult task. Some struggle with the sheer volume of work that EMRs create, while others wrestle with the intrusive computer in the exam room. The former is a complex problem, and solving it involves improving both system and individual work flows. The latter is one I’ve had great success with when coaching inexperienced doctors.
One of my roles at Kaiser Permanente, San Diego, is to coach new physicians to help them perform at their best. In particular, we provide one-on-one help for physicians to optimize the quality of service they provide. More often than not, young physicians benefit from optimizing their work flow as much as from modifying their bedside manner.
Here are five common tips I share with them to improve their service while using EMRs:
• Preview coming attractions. High-quality interactions require that prep work be done before the visit begins. Before seeing your patient, review his or her record to learn about the medical history, particularly any recent important health issues. This is true even if the problem is not related to your specialty. This sends a strong signal to your patient that you know and care about him or her as a person.
• Connect with your patient first, then turn to HealthConnect (our version of the EPIC electronic record). For every patient, every visit, spend the first few minutes giving your undivided attention to them while in the room. Conversely, entering the room and logging on the computer immediately diminishes the quality of the experience for patients.
• Ask permission, not forgiveness. When you must use the EMR to review or to chart, ask permission first. Try something like, “This is important. Do you mind if I start typing some of this to be sure it is captured in your record?” I’ve never seen a patient object if you start typing. If they did, then the time isn’t right for you to go to the EMR, and it would best for you to address their concern first.
• Share the screen. Many patients love to see their chart. It’s like giving them a backstage pass. It’s also a great way to keep them engaged while you talk about their issues. Point things out to them and use it to engage in discussion. The better informed your patients are, the more likely they will evaluate you favorably, and the more likely they are to adhere to your advice.
• Complete diagnoses and write any prescriptions while in the room. This is a wonderful opportunity to engage with your patients on the risks and benefits of what you recommend, to review your specific instructions, and to allow them to see their diagnoses written out. Close with a printed copy of what just transpired. The act of giving something tangible makes the encounter feel complete, while also increasing patients’ retention of key information and their likelihood of following up as directed.
As more young physicians join us in the workforce, we know that it doesn’t matter much if you grew up with Facebook and Snapchat; using EMRs effectively is a learned skill that all of us can improve upon.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
All young physicians are adept at using electronic medical records. Do you agree? If so, you’d be wrong. It’s true that young, so-called “digital-native” physicians have more training and experience using EMRs, compared with those who trained in the days of paper charts. But young physicians are also inexperienced at caring for patients, and using a keyboard adds complexity to an already difficult task. Some struggle with the sheer volume of work that EMRs create, while others wrestle with the intrusive computer in the exam room. The former is a complex problem, and solving it involves improving both system and individual work flows. The latter is one I’ve had great success with when coaching inexperienced doctors.
One of my roles at Kaiser Permanente, San Diego, is to coach new physicians to help them perform at their best. In particular, we provide one-on-one help for physicians to optimize the quality of service they provide. More often than not, young physicians benefit from optimizing their work flow as much as from modifying their bedside manner.
Here are five common tips I share with them to improve their service while using EMRs:
• Preview coming attractions. High-quality interactions require that prep work be done before the visit begins. Before seeing your patient, review his or her record to learn about the medical history, particularly any recent important health issues. This is true even if the problem is not related to your specialty. This sends a strong signal to your patient that you know and care about him or her as a person.
• Connect with your patient first, then turn to HealthConnect (our version of the EPIC electronic record). For every patient, every visit, spend the first few minutes giving your undivided attention to them while in the room. Conversely, entering the room and logging on the computer immediately diminishes the quality of the experience for patients.
• Ask permission, not forgiveness. When you must use the EMR to review or to chart, ask permission first. Try something like, “This is important. Do you mind if I start typing some of this to be sure it is captured in your record?” I’ve never seen a patient object if you start typing. If they did, then the time isn’t right for you to go to the EMR, and it would best for you to address their concern first.
• Share the screen. Many patients love to see their chart. It’s like giving them a backstage pass. It’s also a great way to keep them engaged while you talk about their issues. Point things out to them and use it to engage in discussion. The better informed your patients are, the more likely they will evaluate you favorably, and the more likely they are to adhere to your advice.
• Complete diagnoses and write any prescriptions while in the room. This is a wonderful opportunity to engage with your patients on the risks and benefits of what you recommend, to review your specific instructions, and to allow them to see their diagnoses written out. Close with a printed copy of what just transpired. The act of giving something tangible makes the encounter feel complete, while also increasing patients’ retention of key information and their likelihood of following up as directed.
As more young physicians join us in the workforce, we know that it doesn’t matter much if you grew up with Facebook and Snapchat; using EMRs effectively is a learned skill that all of us can improve upon.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
All young physicians are adept at using electronic medical records. Do you agree? If so, you’d be wrong. It’s true that young, so-called “digital-native” physicians have more training and experience using EMRs, compared with those who trained in the days of paper charts. But young physicians are also inexperienced at caring for patients, and using a keyboard adds complexity to an already difficult task. Some struggle with the sheer volume of work that EMRs create, while others wrestle with the intrusive computer in the exam room. The former is a complex problem, and solving it involves improving both system and individual work flows. The latter is one I’ve had great success with when coaching inexperienced doctors.
One of my roles at Kaiser Permanente, San Diego, is to coach new physicians to help them perform at their best. In particular, we provide one-on-one help for physicians to optimize the quality of service they provide. More often than not, young physicians benefit from optimizing their work flow as much as from modifying their bedside manner.
Here are five common tips I share with them to improve their service while using EMRs:
• Preview coming attractions. High-quality interactions require that prep work be done before the visit begins. Before seeing your patient, review his or her record to learn about the medical history, particularly any recent important health issues. This is true even if the problem is not related to your specialty. This sends a strong signal to your patient that you know and care about him or her as a person.
• Connect with your patient first, then turn to HealthConnect (our version of the EPIC electronic record). For every patient, every visit, spend the first few minutes giving your undivided attention to them while in the room. Conversely, entering the room and logging on the computer immediately diminishes the quality of the experience for patients.
• Ask permission, not forgiveness. When you must use the EMR to review or to chart, ask permission first. Try something like, “This is important. Do you mind if I start typing some of this to be sure it is captured in your record?” I’ve never seen a patient object if you start typing. If they did, then the time isn’t right for you to go to the EMR, and it would best for you to address their concern first.
• Share the screen. Many patients love to see their chart. It’s like giving them a backstage pass. It’s also a great way to keep them engaged while you talk about their issues. Point things out to them and use it to engage in discussion. The better informed your patients are, the more likely they will evaluate you favorably, and the more likely they are to adhere to your advice.
• Complete diagnoses and write any prescriptions while in the room. This is a wonderful opportunity to engage with your patients on the risks and benefits of what you recommend, to review your specific instructions, and to allow them to see their diagnoses written out. Close with a printed copy of what just transpired. The act of giving something tangible makes the encounter feel complete, while also increasing patients’ retention of key information and their likelihood of following up as directed.
As more young physicians join us in the workforce, we know that it doesn’t matter much if you grew up with Facebook and Snapchat; using EMRs effectively is a learned skill that all of us can improve upon.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
The role of lymphadenectomy in endometrial cancer, Part 1
Endometrial cancer is the most common gynecologic malignancy in the United States. Fortunately, most endometrial cancers present at an early stage with excellent overall survival – approximately 85% – in clinical stage I disease. Since 1988, the International Federation of Gynecology and Obstetrics (FIGO) staging of endometrial cancer has required surgical staging reflecting increasing data on the prognostic significance of lymph node metastasis and the treatment implications for node positive cancers.
Indeed, lymph nodes represent the most common location for extrauterine spread in endometrial cancer. The lymphatic drainage from the uterus is to both the pelvic and the para-aortic lymph nodes. Lymphatic channels from the uterus can drain directly from the fundus via the infundibulopelvic ligament to the aortic lymph node chain, thereby bypassing the pelvic lymph nodes. As a result, there is a 2%-3% risk of isolated aortic metastasis with negative pelvic lymph nodes.
The extent of lymph node evaluation required for staging is debatable. The National Comprehensive Cancer Network (NCCN) guidelines recommend complete hysterectomy with bilateral salpingo-oophorectomy and additional procedures based on preoperative and intraoperative findings. During surgery, the surgeon should evaluate all peritoneal surfaces and the retroperitoneal lymphatic chains for abnormalities. All suspicious lymph nodes should be removed, but the extent of lymphadenectomy should be based on the NCCN guidelines.1 The NCCN offers the option for use of sentinel lymph node evaluation with adherence to specific staging algorithms for this technology.
Proponents of lymphadenectomy cite the need for accurate staging to guide adjuvant therapies, to provide prognostic information, and to eradicate metastatic lymph nodes with possible therapeutic benefit. However, criticisms of lymphadenectomy include a lack of randomized studies demonstrating a therapeutic benefit and the morbidity of lymphedema with its corresponding quality of life and cost implications. As a result, practices regarding lymph node evaluation vary widely.
There is conflicting data on whether there is a therapeutic benefit to performing lymphadenectomy. Retrospective studies have shown a benefit, but this was not seen in two prospective trials. There appears to be clear benefit for debulking of clinically enlarged nodal metastasis,2,3 and likely benefit to resection of microscopic metastasis, particularly with combined pelvic and aortic lymphadenectomy in high-risk endometrial cancers.4,5,6,7,8
The ASTEC trial by Kitchener et al and an Italian collaborative trial by Benedetti et al, however, both evaluated the role of lymph node dissection in predominantly low-risk endometrial cancer and found no benefit.9,10 Both studies documented no difference in overall survival, but increased morbidity with lymphadenectomy. No prospective trials have evaluated the role of lymphadenectomy in high-risk endometrial cancers.
Universal use of complete lymphadenectomy in all patients with endometrial cancer would subject a large percent of low risk patients to undo surgical risk. The two most commonly utilized strategies are risk factor based lymphadenectomy and sentinel lymph node evaluation.
Tumors are considered low risk if they are less than 2cm in size, grade 1 or 2, and superficially invasive (less than 50% myometrial invasion).11 The risk of lymph node metastasis in these patients was exceedingly low with no lymph node metastasis detect in more than 400 women who prospectively underwent this evaluation, thus lymphadenectomy can be safely avoided. Utilizing risk factor based lymphadenectomy does require the availability of reliable frozen section pathology evaluation, which may be a limitation for some institutions.
A key argument against routine use of systematic lymphadenectomy is the concern for postoperative complications and lymphedema. The estimated incidence of lymphedema following lymphadenectomy is 20%-30%.12 However, there are challenges in studying lymphedema that likely limit our understanding of the true incidence. The ASTEC trial and Italian cooperative trial have demonstrated that there is an eight-fold increased risk of lymphedema in women who undergo lymphadenectomy, compared with those who do not.13 The development of lymphedema requires ongoing treatment with associated costs of care. Thus, the selective lymphadenectomy or sentinel nodes have the ability to reduce healthcare costs.14 Sentinel lymph nodes will be covered in Part Two of this article.
References
1. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80.
2. Gynecol Oncol. 2005 Dec;99(3):689-95.
3. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):664-72.
4. Gynecol Oncol. 1995 Jan;56(1):29-33.
5. J Clin Oncol. 2005 Jun 1;23(16):3668-75.
6. Lancet. 2010 Apr 3;375(9721):1165-72.
7. Gynecol Oncol. 1998 Dec;71(3):340-3.
8. Cancer. 2006 Oct 15;107(8):1823-30.
9. Lancet. 2009 Jan 10;373(9658):125-36.
10. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
11. Gynecol Oncol. 2008 Apr;109(1):11-8.
12. Obstet Gynecol. 2014 Aug;124(2 Pt 1):307-15.
13. Cochrane Database Syst Rev. 2015 Sep 21;(9):CD007585.
14. Gynecol Oncol. 2014 Dec;135(3):518-24.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Endometrial cancer is the most common gynecologic malignancy in the United States. Fortunately, most endometrial cancers present at an early stage with excellent overall survival – approximately 85% – in clinical stage I disease. Since 1988, the International Federation of Gynecology and Obstetrics (FIGO) staging of endometrial cancer has required surgical staging reflecting increasing data on the prognostic significance of lymph node metastasis and the treatment implications for node positive cancers.
Indeed, lymph nodes represent the most common location for extrauterine spread in endometrial cancer. The lymphatic drainage from the uterus is to both the pelvic and the para-aortic lymph nodes. Lymphatic channels from the uterus can drain directly from the fundus via the infundibulopelvic ligament to the aortic lymph node chain, thereby bypassing the pelvic lymph nodes. As a result, there is a 2%-3% risk of isolated aortic metastasis with negative pelvic lymph nodes.
The extent of lymph node evaluation required for staging is debatable. The National Comprehensive Cancer Network (NCCN) guidelines recommend complete hysterectomy with bilateral salpingo-oophorectomy and additional procedures based on preoperative and intraoperative findings. During surgery, the surgeon should evaluate all peritoneal surfaces and the retroperitoneal lymphatic chains for abnormalities. All suspicious lymph nodes should be removed, but the extent of lymphadenectomy should be based on the NCCN guidelines.1 The NCCN offers the option for use of sentinel lymph node evaluation with adherence to specific staging algorithms for this technology.
Proponents of lymphadenectomy cite the need for accurate staging to guide adjuvant therapies, to provide prognostic information, and to eradicate metastatic lymph nodes with possible therapeutic benefit. However, criticisms of lymphadenectomy include a lack of randomized studies demonstrating a therapeutic benefit and the morbidity of lymphedema with its corresponding quality of life and cost implications. As a result, practices regarding lymph node evaluation vary widely.
There is conflicting data on whether there is a therapeutic benefit to performing lymphadenectomy. Retrospective studies have shown a benefit, but this was not seen in two prospective trials. There appears to be clear benefit for debulking of clinically enlarged nodal metastasis,2,3 and likely benefit to resection of microscopic metastasis, particularly with combined pelvic and aortic lymphadenectomy in high-risk endometrial cancers.4,5,6,7,8
The ASTEC trial by Kitchener et al and an Italian collaborative trial by Benedetti et al, however, both evaluated the role of lymph node dissection in predominantly low-risk endometrial cancer and found no benefit.9,10 Both studies documented no difference in overall survival, but increased morbidity with lymphadenectomy. No prospective trials have evaluated the role of lymphadenectomy in high-risk endometrial cancers.
Universal use of complete lymphadenectomy in all patients with endometrial cancer would subject a large percent of low risk patients to undo surgical risk. The two most commonly utilized strategies are risk factor based lymphadenectomy and sentinel lymph node evaluation.
Tumors are considered low risk if they are less than 2cm in size, grade 1 or 2, and superficially invasive (less than 50% myometrial invasion).11 The risk of lymph node metastasis in these patients was exceedingly low with no lymph node metastasis detect in more than 400 women who prospectively underwent this evaluation, thus lymphadenectomy can be safely avoided. Utilizing risk factor based lymphadenectomy does require the availability of reliable frozen section pathology evaluation, which may be a limitation for some institutions.
A key argument against routine use of systematic lymphadenectomy is the concern for postoperative complications and lymphedema. The estimated incidence of lymphedema following lymphadenectomy is 20%-30%.12 However, there are challenges in studying lymphedema that likely limit our understanding of the true incidence. The ASTEC trial and Italian cooperative trial have demonstrated that there is an eight-fold increased risk of lymphedema in women who undergo lymphadenectomy, compared with those who do not.13 The development of lymphedema requires ongoing treatment with associated costs of care. Thus, the selective lymphadenectomy or sentinel nodes have the ability to reduce healthcare costs.14 Sentinel lymph nodes will be covered in Part Two of this article.
References
1. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80.
2. Gynecol Oncol. 2005 Dec;99(3):689-95.
3. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):664-72.
4. Gynecol Oncol. 1995 Jan;56(1):29-33.
5. J Clin Oncol. 2005 Jun 1;23(16):3668-75.
6. Lancet. 2010 Apr 3;375(9721):1165-72.
7. Gynecol Oncol. 1998 Dec;71(3):340-3.
8. Cancer. 2006 Oct 15;107(8):1823-30.
9. Lancet. 2009 Jan 10;373(9658):125-36.
10. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
11. Gynecol Oncol. 2008 Apr;109(1):11-8.
12. Obstet Gynecol. 2014 Aug;124(2 Pt 1):307-15.
13. Cochrane Database Syst Rev. 2015 Sep 21;(9):CD007585.
14. Gynecol Oncol. 2014 Dec;135(3):518-24.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Endometrial cancer is the most common gynecologic malignancy in the United States. Fortunately, most endometrial cancers present at an early stage with excellent overall survival – approximately 85% – in clinical stage I disease. Since 1988, the International Federation of Gynecology and Obstetrics (FIGO) staging of endometrial cancer has required surgical staging reflecting increasing data on the prognostic significance of lymph node metastasis and the treatment implications for node positive cancers.
Indeed, lymph nodes represent the most common location for extrauterine spread in endometrial cancer. The lymphatic drainage from the uterus is to both the pelvic and the para-aortic lymph nodes. Lymphatic channels from the uterus can drain directly from the fundus via the infundibulopelvic ligament to the aortic lymph node chain, thereby bypassing the pelvic lymph nodes. As a result, there is a 2%-3% risk of isolated aortic metastasis with negative pelvic lymph nodes.
The extent of lymph node evaluation required for staging is debatable. The National Comprehensive Cancer Network (NCCN) guidelines recommend complete hysterectomy with bilateral salpingo-oophorectomy and additional procedures based on preoperative and intraoperative findings. During surgery, the surgeon should evaluate all peritoneal surfaces and the retroperitoneal lymphatic chains for abnormalities. All suspicious lymph nodes should be removed, but the extent of lymphadenectomy should be based on the NCCN guidelines.1 The NCCN offers the option for use of sentinel lymph node evaluation with adherence to specific staging algorithms for this technology.
Proponents of lymphadenectomy cite the need for accurate staging to guide adjuvant therapies, to provide prognostic information, and to eradicate metastatic lymph nodes with possible therapeutic benefit. However, criticisms of lymphadenectomy include a lack of randomized studies demonstrating a therapeutic benefit and the morbidity of lymphedema with its corresponding quality of life and cost implications. As a result, practices regarding lymph node evaluation vary widely.
There is conflicting data on whether there is a therapeutic benefit to performing lymphadenectomy. Retrospective studies have shown a benefit, but this was not seen in two prospective trials. There appears to be clear benefit for debulking of clinically enlarged nodal metastasis,2,3 and likely benefit to resection of microscopic metastasis, particularly with combined pelvic and aortic lymphadenectomy in high-risk endometrial cancers.4,5,6,7,8
The ASTEC trial by Kitchener et al and an Italian collaborative trial by Benedetti et al, however, both evaluated the role of lymph node dissection in predominantly low-risk endometrial cancer and found no benefit.9,10 Both studies documented no difference in overall survival, but increased morbidity with lymphadenectomy. No prospective trials have evaluated the role of lymphadenectomy in high-risk endometrial cancers.
Universal use of complete lymphadenectomy in all patients with endometrial cancer would subject a large percent of low risk patients to undo surgical risk. The two most commonly utilized strategies are risk factor based lymphadenectomy and sentinel lymph node evaluation.
Tumors are considered low risk if they are less than 2cm in size, grade 1 or 2, and superficially invasive (less than 50% myometrial invasion).11 The risk of lymph node metastasis in these patients was exceedingly low with no lymph node metastasis detect in more than 400 women who prospectively underwent this evaluation, thus lymphadenectomy can be safely avoided. Utilizing risk factor based lymphadenectomy does require the availability of reliable frozen section pathology evaluation, which may be a limitation for some institutions.
A key argument against routine use of systematic lymphadenectomy is the concern for postoperative complications and lymphedema. The estimated incidence of lymphedema following lymphadenectomy is 20%-30%.12 However, there are challenges in studying lymphedema that likely limit our understanding of the true incidence. The ASTEC trial and Italian cooperative trial have demonstrated that there is an eight-fold increased risk of lymphedema in women who undergo lymphadenectomy, compared with those who do not.13 The development of lymphedema requires ongoing treatment with associated costs of care. Thus, the selective lymphadenectomy or sentinel nodes have the ability to reduce healthcare costs.14 Sentinel lymph nodes will be covered in Part Two of this article.
References
1. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80.
2. Gynecol Oncol. 2005 Dec;99(3):689-95.
3. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):664-72.
4. Gynecol Oncol. 1995 Jan;56(1):29-33.
5. J Clin Oncol. 2005 Jun 1;23(16):3668-75.
6. Lancet. 2010 Apr 3;375(9721):1165-72.
7. Gynecol Oncol. 1998 Dec;71(3):340-3.
8. Cancer. 2006 Oct 15;107(8):1823-30.
9. Lancet. 2009 Jan 10;373(9658):125-36.
10. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
11. Gynecol Oncol. 2008 Apr;109(1):11-8.
12. Obstet Gynecol. 2014 Aug;124(2 Pt 1):307-15.
13. Cochrane Database Syst Rev. 2015 Sep 21;(9):CD007585.
14. Gynecol Oncol. 2014 Dec;135(3):518-24.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Clark is a fellow in the division of gynecologic oncology, department of obstetrics and gynecology at the university. They reported having no financial disclosures relevant to this column. Email them at [email protected].
Update on vitamin E
Available in the diet through fresh vegetables (particularly green leafy vegetables), vegetable oils, grains, nuts, seeds, corn, soy, whole wheat flour, margarine, and in some meat and dairy products, vitamin E, or tocopherol, is the primary lipid-soluble antioxidant found in human skin (via sebum), membranes, plasma, and tissues that protects cells from oxidative stress.1-4 Vitamin E is often used to treat minor burns, surgical scars, and other wounds, although the Food and Drug Administration has not approved its use for skin conditions.
In 1938, Karrer, Fritzsche, Ringier, and Salomon became the first to synthesize alpha-tocopherol,5,6 the main biologically active form of vitamin E.7 In the 1940s, vitamin E was labeled a “chain-breaking” antioxidant for its role in hindering the chain reaction induced by free radicals, and it is known to protect cutaneous cell membranes from peroxidation.8 Most topical formulations contain synthetic laboratory-made alpha-tocopherol or one of its many esters or ethers. As an ingredient in skin care agents, significant evidence has been amassed to suggest that topically applied vitamin E confers photoprotective activity against erythema, edema, sun burn cell formation, and other indicators of acute UV-induced damage as well as responses to chronic UVA and UVB exposure, including skin wrinkling and skin cancer.2,9-14 This column will focus on the topical applications of vitamin E.
Topical uses and findings
The lipophilic nature of vitamin E makes it suitable for topical application and percutaneous absorption through the skin.9,15 Vitamin E is generally used in 1%-5% concentrations alpha-tocopherol or tocopherol acetate in over-the-counter products.16 When topically applied, vitamin E has been shown to hydrate the stratum corneum (SC) and improve water-binding capacity.16 It is also considered an effective ingredient for imparting skin protection and treating atopic dermatitis (AD).2
In 2005, Ekanayake-Mudiyanselage et al. studied whether one application of an alpha-tocopherol–enriched rinse-off product could effectively lead to deposition of alpha-tocopherol on the SC in 13 volunteers. The researchers found that the alpha-tocopherol product raised alpha-tocopherol levels in surface lipids, which remained consistent for at least 24 hours, whereas such levels were reduced in the alpha-tocopherol–free vehicle control group. The alpha-tocopherol rinse-off product also significantly inhibited photo-oxidation of squalene.7
A 2009 6-month study in healthy human volunteers with actinic keratoses demonstrated that while topically applied dl-alpha-tocopherol, of which cutaneous levels were significantly increased at the end of the study, did not significantly change already present lesions, alterations in polyamine metabolism revealed that squamous cell carcinogenesis potential was significantly diminished.17
Patrizi et al., in a 2015 randomized, controlled, double-blind, single center study, assessed the safety and efficacy of MD2011001 cream (a nonsteroidal topical cream including vitamin E, epigallocatechin gallate and grape seed procyanidins) versus placebo, in 44 patients with mild to moderate AD in the perioral/periocular area and/or the neck. The researchers noted a significantly more rapid reduction in affected surface area with the test formulation, compared with placebo; the product was found to be well tolerated and safe as well as effective for mild to moderate AD.18
Also that year, Ruiz-Tovar et al. performed a prospective randomized clinical trial in 60 patients, showing that topical vitamin E ointment reduced postoperative pain.19
The vitamin C, vitamin E, ferulic acid combination
Vitamin E is perceived to be more effective when used in combination with other antioxidant ingredients. Some data suggest a cumulative benefit derived from using oral and topical antioxidant products in combination, including vitamins C and E in particular.20-22 Because vitamin C can restore oxidized vitamin E, combining the antioxidants is a stabilizing factor in topical formulations.23,24 Further, ferulic acid has been shown to stabilize both vitamins, with the topical combination yielding photoprotective effects against UVB exposure, including the significant reduction in thymine dimer formation.9,24,25
A small study of nine patients conducted by Murray et al. in 2008 found that a stable topical preparation of 15% l-ascorbic acid, 1% alpha-tocopherol, and 0.5% ferulic acid protected human skin in vivo from UV-induced damage, specifically erythema and apoptosis. The formulation also suppressed p53 activation and limited thymine dimer mutations, which are associated with skin cancer.26
Waibel et al. conducted a double-blind, prospective, single-center, randomized split-face trial in 2015 to study whether laser-assisted delivery of vitamins C and E and ferulic acid after fractional ablative laser procedures to treat photodamage could enhance wound healing. Fifteen healthy men and women (aged 30-55 years) were treated with the combination formulation on one side of the face and vehicle on the other side within 2 minutes of receiving fractional ablative CO2 laser surgery. They also received daily treatments and evaluations during days 1 through 7 of healing. Edema was found to be diminished on the sides treated with the antioxidant combination, compared with vehicle on day 7, and erythema, on days 3 and 5.27
Other vitamin E combinations
In 2014, Farris et al. found vitamin E to be a key ingredient, along with resveratrol and baicalin, in a nighttime antioxidant formulation that netted a statistically significant improvement in skin rejuvenation, specifically ameliorating fine lines and wrinkles, skin firmness, skin elasticity, skin laxity, hyperpigmentation, radiance, and skin roughness over 3 months, compared with baseline.28
Pereira et al. reported in 2014 that they found that the topical application of polymeric bioadhesive films containing aloe vera and vitamin E acetate appear to be an effective approach to burn treatment.29
A 2015 randomized, controlled, double-blind prospective study in 30 healthy volunteers also indicated that an SPF 30 sunscreen supplemented with an antioxidant combination containing grape seed extract, vitamin E, coenzyme Q10, and vitamin C effectively protected skin against infrared A radiation damage, unlike the use of the SPF 30 product without the antioxidant cocktail.30
Conclusion
Combining vitamin E with other antioxidants appears to enhance its bioactivity and, likely, that of the other interacting antioxidants. The potential therapeutic benefits of vitamin E in preventing and treating skin cancer and photoaging remain an important focus of research. As an ingredient in topical anti-aging skin care preparations, vitamin E displays emollient properties, and is stable, easy to formulate, and relatively inexpensive, making it a popular additive. More controlled trials are necessary to fully clarify the role of vitamin E in treating various dermatoses.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
References
1. J Mol Med (Berl). 1995 Jan;73(1):7-17.
2. Dermatol Surg. 2005 Jul;31(7 Pt 2):805-13.
3. J Cosmet Dermatol. 2004 Jul;3(3):149-55.
4. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:87-91.
5. Am J Clin Nutr. 1987 Jul;46(1 Suppl):183-6.
6. Nutr Rev. 2012 Sep;70(9):483-90.
7. Skin Pharmacol Physiol. 2005 Jan-Feb;18(1):20-6.
8. Ann Nutr Metab. 2012;61(3):207-12.
9. J Am Acad Dermatol. 2003 Jun;48(6):866-74.
10. Plast Reconstr Surg. 1997 Sep;100(4):973-80.
11. Acta Derm Venereol. 1996 Jul;76(4):264-8.
12. J Invest Dermatol. 1995 Apr;104(4):484-8.
13. Photodermatol Photoimmunol Photomed. 1990 Apr;7(2):56-62.
14. Photodermatol. 1989 Oct;6(5):228-33.
15. Drug Metab Rev. 2000 Aug-Nov;32(3-4):413-20.
16. Clin Dermatol. 2009 Sep-Oct;27(5):469-74.
17. Cancer Prev Res (Phila). 2009 Apr;2(4):394-400.
18. J Dermatolog Treat. 2015 Dec 10:1-5. [Epub ahead of print].
19. Int J Colorectal Dis. 2016 Jul;31(7):1371-2.
20. Skin Pharmacol Appl Skin Physiol. 15:307;2002.
21. Biofactors. 2003;18(1-4):289-97.
22. J Drugs Dermatol. 2008 Jul;7(7 Suppl):s2-6.
23. Can J Physiol Pharmacol. 1993 Sep;71(9):725-31.
24. PLoS One. 2013 May 14;8(5):e63809.
25. J Invest Dermatol. 2005 Oct;125(4):826-32.
26. J Am Acad Dermatol. 2008 Sep;59(3):418-25.
27. Lasers Surg Med. 2016 Mar;48(3):238-44.
28. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
Available in the diet through fresh vegetables (particularly green leafy vegetables), vegetable oils, grains, nuts, seeds, corn, soy, whole wheat flour, margarine, and in some meat and dairy products, vitamin E, or tocopherol, is the primary lipid-soluble antioxidant found in human skin (via sebum), membranes, plasma, and tissues that protects cells from oxidative stress.1-4 Vitamin E is often used to treat minor burns, surgical scars, and other wounds, although the Food and Drug Administration has not approved its use for skin conditions.
In 1938, Karrer, Fritzsche, Ringier, and Salomon became the first to synthesize alpha-tocopherol,5,6 the main biologically active form of vitamin E.7 In the 1940s, vitamin E was labeled a “chain-breaking” antioxidant for its role in hindering the chain reaction induced by free radicals, and it is known to protect cutaneous cell membranes from peroxidation.8 Most topical formulations contain synthetic laboratory-made alpha-tocopherol or one of its many esters or ethers. As an ingredient in skin care agents, significant evidence has been amassed to suggest that topically applied vitamin E confers photoprotective activity against erythema, edema, sun burn cell formation, and other indicators of acute UV-induced damage as well as responses to chronic UVA and UVB exposure, including skin wrinkling and skin cancer.2,9-14 This column will focus on the topical applications of vitamin E.
Topical uses and findings
The lipophilic nature of vitamin E makes it suitable for topical application and percutaneous absorption through the skin.9,15 Vitamin E is generally used in 1%-5% concentrations alpha-tocopherol or tocopherol acetate in over-the-counter products.16 When topically applied, vitamin E has been shown to hydrate the stratum corneum (SC) and improve water-binding capacity.16 It is also considered an effective ingredient for imparting skin protection and treating atopic dermatitis (AD).2
In 2005, Ekanayake-Mudiyanselage et al. studied whether one application of an alpha-tocopherol–enriched rinse-off product could effectively lead to deposition of alpha-tocopherol on the SC in 13 volunteers. The researchers found that the alpha-tocopherol product raised alpha-tocopherol levels in surface lipids, which remained consistent for at least 24 hours, whereas such levels were reduced in the alpha-tocopherol–free vehicle control group. The alpha-tocopherol rinse-off product also significantly inhibited photo-oxidation of squalene.7
A 2009 6-month study in healthy human volunteers with actinic keratoses demonstrated that while topically applied dl-alpha-tocopherol, of which cutaneous levels were significantly increased at the end of the study, did not significantly change already present lesions, alterations in polyamine metabolism revealed that squamous cell carcinogenesis potential was significantly diminished.17
Patrizi et al., in a 2015 randomized, controlled, double-blind, single center study, assessed the safety and efficacy of MD2011001 cream (a nonsteroidal topical cream including vitamin E, epigallocatechin gallate and grape seed procyanidins) versus placebo, in 44 patients with mild to moderate AD in the perioral/periocular area and/or the neck. The researchers noted a significantly more rapid reduction in affected surface area with the test formulation, compared with placebo; the product was found to be well tolerated and safe as well as effective for mild to moderate AD.18
Also that year, Ruiz-Tovar et al. performed a prospective randomized clinical trial in 60 patients, showing that topical vitamin E ointment reduced postoperative pain.19
The vitamin C, vitamin E, ferulic acid combination
Vitamin E is perceived to be more effective when used in combination with other antioxidant ingredients. Some data suggest a cumulative benefit derived from using oral and topical antioxidant products in combination, including vitamins C and E in particular.20-22 Because vitamin C can restore oxidized vitamin E, combining the antioxidants is a stabilizing factor in topical formulations.23,24 Further, ferulic acid has been shown to stabilize both vitamins, with the topical combination yielding photoprotective effects against UVB exposure, including the significant reduction in thymine dimer formation.9,24,25
A small study of nine patients conducted by Murray et al. in 2008 found that a stable topical preparation of 15% l-ascorbic acid, 1% alpha-tocopherol, and 0.5% ferulic acid protected human skin in vivo from UV-induced damage, specifically erythema and apoptosis. The formulation also suppressed p53 activation and limited thymine dimer mutations, which are associated with skin cancer.26
Waibel et al. conducted a double-blind, prospective, single-center, randomized split-face trial in 2015 to study whether laser-assisted delivery of vitamins C and E and ferulic acid after fractional ablative laser procedures to treat photodamage could enhance wound healing. Fifteen healthy men and women (aged 30-55 years) were treated with the combination formulation on one side of the face and vehicle on the other side within 2 minutes of receiving fractional ablative CO2 laser surgery. They also received daily treatments and evaluations during days 1 through 7 of healing. Edema was found to be diminished on the sides treated with the antioxidant combination, compared with vehicle on day 7, and erythema, on days 3 and 5.27
Other vitamin E combinations
In 2014, Farris et al. found vitamin E to be a key ingredient, along with resveratrol and baicalin, in a nighttime antioxidant formulation that netted a statistically significant improvement in skin rejuvenation, specifically ameliorating fine lines and wrinkles, skin firmness, skin elasticity, skin laxity, hyperpigmentation, radiance, and skin roughness over 3 months, compared with baseline.28
Pereira et al. reported in 2014 that they found that the topical application of polymeric bioadhesive films containing aloe vera and vitamin E acetate appear to be an effective approach to burn treatment.29
A 2015 randomized, controlled, double-blind prospective study in 30 healthy volunteers also indicated that an SPF 30 sunscreen supplemented with an antioxidant combination containing grape seed extract, vitamin E, coenzyme Q10, and vitamin C effectively protected skin against infrared A radiation damage, unlike the use of the SPF 30 product without the antioxidant cocktail.30
Conclusion
Combining vitamin E with other antioxidants appears to enhance its bioactivity and, likely, that of the other interacting antioxidants. The potential therapeutic benefits of vitamin E in preventing and treating skin cancer and photoaging remain an important focus of research. As an ingredient in topical anti-aging skin care preparations, vitamin E displays emollient properties, and is stable, easy to formulate, and relatively inexpensive, making it a popular additive. More controlled trials are necessary to fully clarify the role of vitamin E in treating various dermatoses.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
References
1. J Mol Med (Berl). 1995 Jan;73(1):7-17.
2. Dermatol Surg. 2005 Jul;31(7 Pt 2):805-13.
3. J Cosmet Dermatol. 2004 Jul;3(3):149-55.
4. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:87-91.
5. Am J Clin Nutr. 1987 Jul;46(1 Suppl):183-6.
6. Nutr Rev. 2012 Sep;70(9):483-90.
7. Skin Pharmacol Physiol. 2005 Jan-Feb;18(1):20-6.
8. Ann Nutr Metab. 2012;61(3):207-12.
9. J Am Acad Dermatol. 2003 Jun;48(6):866-74.
10. Plast Reconstr Surg. 1997 Sep;100(4):973-80.
11. Acta Derm Venereol. 1996 Jul;76(4):264-8.
12. J Invest Dermatol. 1995 Apr;104(4):484-8.
13. Photodermatol Photoimmunol Photomed. 1990 Apr;7(2):56-62.
14. Photodermatol. 1989 Oct;6(5):228-33.
15. Drug Metab Rev. 2000 Aug-Nov;32(3-4):413-20.
16. Clin Dermatol. 2009 Sep-Oct;27(5):469-74.
17. Cancer Prev Res (Phila). 2009 Apr;2(4):394-400.
18. J Dermatolog Treat. 2015 Dec 10:1-5. [Epub ahead of print].
19. Int J Colorectal Dis. 2016 Jul;31(7):1371-2.
20. Skin Pharmacol Appl Skin Physiol. 15:307;2002.
21. Biofactors. 2003;18(1-4):289-97.
22. J Drugs Dermatol. 2008 Jul;7(7 Suppl):s2-6.
23. Can J Physiol Pharmacol. 1993 Sep;71(9):725-31.
24. PLoS One. 2013 May 14;8(5):e63809.
25. J Invest Dermatol. 2005 Oct;125(4):826-32.
26. J Am Acad Dermatol. 2008 Sep;59(3):418-25.
27. Lasers Surg Med. 2016 Mar;48(3):238-44.
28. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
Available in the diet through fresh vegetables (particularly green leafy vegetables), vegetable oils, grains, nuts, seeds, corn, soy, whole wheat flour, margarine, and in some meat and dairy products, vitamin E, or tocopherol, is the primary lipid-soluble antioxidant found in human skin (via sebum), membranes, plasma, and tissues that protects cells from oxidative stress.1-4 Vitamin E is often used to treat minor burns, surgical scars, and other wounds, although the Food and Drug Administration has not approved its use for skin conditions.
In 1938, Karrer, Fritzsche, Ringier, and Salomon became the first to synthesize alpha-tocopherol,5,6 the main biologically active form of vitamin E.7 In the 1940s, vitamin E was labeled a “chain-breaking” antioxidant for its role in hindering the chain reaction induced by free radicals, and it is known to protect cutaneous cell membranes from peroxidation.8 Most topical formulations contain synthetic laboratory-made alpha-tocopherol or one of its many esters or ethers. As an ingredient in skin care agents, significant evidence has been amassed to suggest that topically applied vitamin E confers photoprotective activity against erythema, edema, sun burn cell formation, and other indicators of acute UV-induced damage as well as responses to chronic UVA and UVB exposure, including skin wrinkling and skin cancer.2,9-14 This column will focus on the topical applications of vitamin E.
Topical uses and findings
The lipophilic nature of vitamin E makes it suitable for topical application and percutaneous absorption through the skin.9,15 Vitamin E is generally used in 1%-5% concentrations alpha-tocopherol or tocopherol acetate in over-the-counter products.16 When topically applied, vitamin E has been shown to hydrate the stratum corneum (SC) and improve water-binding capacity.16 It is also considered an effective ingredient for imparting skin protection and treating atopic dermatitis (AD).2
In 2005, Ekanayake-Mudiyanselage et al. studied whether one application of an alpha-tocopherol–enriched rinse-off product could effectively lead to deposition of alpha-tocopherol on the SC in 13 volunteers. The researchers found that the alpha-tocopherol product raised alpha-tocopherol levels in surface lipids, which remained consistent for at least 24 hours, whereas such levels were reduced in the alpha-tocopherol–free vehicle control group. The alpha-tocopherol rinse-off product also significantly inhibited photo-oxidation of squalene.7
A 2009 6-month study in healthy human volunteers with actinic keratoses demonstrated that while topically applied dl-alpha-tocopherol, of which cutaneous levels were significantly increased at the end of the study, did not significantly change already present lesions, alterations in polyamine metabolism revealed that squamous cell carcinogenesis potential was significantly diminished.17
Patrizi et al., in a 2015 randomized, controlled, double-blind, single center study, assessed the safety and efficacy of MD2011001 cream (a nonsteroidal topical cream including vitamin E, epigallocatechin gallate and grape seed procyanidins) versus placebo, in 44 patients with mild to moderate AD in the perioral/periocular area and/or the neck. The researchers noted a significantly more rapid reduction in affected surface area with the test formulation, compared with placebo; the product was found to be well tolerated and safe as well as effective for mild to moderate AD.18
Also that year, Ruiz-Tovar et al. performed a prospective randomized clinical trial in 60 patients, showing that topical vitamin E ointment reduced postoperative pain.19
The vitamin C, vitamin E, ferulic acid combination
Vitamin E is perceived to be more effective when used in combination with other antioxidant ingredients. Some data suggest a cumulative benefit derived from using oral and topical antioxidant products in combination, including vitamins C and E in particular.20-22 Because vitamin C can restore oxidized vitamin E, combining the antioxidants is a stabilizing factor in topical formulations.23,24 Further, ferulic acid has been shown to stabilize both vitamins, with the topical combination yielding photoprotective effects against UVB exposure, including the significant reduction in thymine dimer formation.9,24,25
A small study of nine patients conducted by Murray et al. in 2008 found that a stable topical preparation of 15% l-ascorbic acid, 1% alpha-tocopherol, and 0.5% ferulic acid protected human skin in vivo from UV-induced damage, specifically erythema and apoptosis. The formulation also suppressed p53 activation and limited thymine dimer mutations, which are associated with skin cancer.26
Waibel et al. conducted a double-blind, prospective, single-center, randomized split-face trial in 2015 to study whether laser-assisted delivery of vitamins C and E and ferulic acid after fractional ablative laser procedures to treat photodamage could enhance wound healing. Fifteen healthy men and women (aged 30-55 years) were treated with the combination formulation on one side of the face and vehicle on the other side within 2 minutes of receiving fractional ablative CO2 laser surgery. They also received daily treatments and evaluations during days 1 through 7 of healing. Edema was found to be diminished on the sides treated with the antioxidant combination, compared with vehicle on day 7, and erythema, on days 3 and 5.27
Other vitamin E combinations
In 2014, Farris et al. found vitamin E to be a key ingredient, along with resveratrol and baicalin, in a nighttime antioxidant formulation that netted a statistically significant improvement in skin rejuvenation, specifically ameliorating fine lines and wrinkles, skin firmness, skin elasticity, skin laxity, hyperpigmentation, radiance, and skin roughness over 3 months, compared with baseline.28
Pereira et al. reported in 2014 that they found that the topical application of polymeric bioadhesive films containing aloe vera and vitamin E acetate appear to be an effective approach to burn treatment.29
A 2015 randomized, controlled, double-blind prospective study in 30 healthy volunteers also indicated that an SPF 30 sunscreen supplemented with an antioxidant combination containing grape seed extract, vitamin E, coenzyme Q10, and vitamin C effectively protected skin against infrared A radiation damage, unlike the use of the SPF 30 product without the antioxidant cocktail.30
Conclusion
Combining vitamin E with other antioxidants appears to enhance its bioactivity and, likely, that of the other interacting antioxidants. The potential therapeutic benefits of vitamin E in preventing and treating skin cancer and photoaging remain an important focus of research. As an ingredient in topical anti-aging skin care preparations, vitamin E displays emollient properties, and is stable, easy to formulate, and relatively inexpensive, making it a popular additive. More controlled trials are necessary to fully clarify the role of vitamin E in treating various dermatoses.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
References
1. J Mol Med (Berl). 1995 Jan;73(1):7-17.
2. Dermatol Surg. 2005 Jul;31(7 Pt 2):805-13.
3. J Cosmet Dermatol. 2004 Jul;3(3):149-55.
4. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:87-91.
5. Am J Clin Nutr. 1987 Jul;46(1 Suppl):183-6.
6. Nutr Rev. 2012 Sep;70(9):483-90.
7. Skin Pharmacol Physiol. 2005 Jan-Feb;18(1):20-6.
8. Ann Nutr Metab. 2012;61(3):207-12.
9. J Am Acad Dermatol. 2003 Jun;48(6):866-74.
10. Plast Reconstr Surg. 1997 Sep;100(4):973-80.
11. Acta Derm Venereol. 1996 Jul;76(4):264-8.
12. J Invest Dermatol. 1995 Apr;104(4):484-8.
13. Photodermatol Photoimmunol Photomed. 1990 Apr;7(2):56-62.
14. Photodermatol. 1989 Oct;6(5):228-33.
15. Drug Metab Rev. 2000 Aug-Nov;32(3-4):413-20.
16. Clin Dermatol. 2009 Sep-Oct;27(5):469-74.
17. Cancer Prev Res (Phila). 2009 Apr;2(4):394-400.
18. J Dermatolog Treat. 2015 Dec 10:1-5. [Epub ahead of print].
19. Int J Colorectal Dis. 2016 Jul;31(7):1371-2.
20. Skin Pharmacol Appl Skin Physiol. 15:307;2002.
21. Biofactors. 2003;18(1-4):289-97.
22. J Drugs Dermatol. 2008 Jul;7(7 Suppl):s2-6.
23. Can J Physiol Pharmacol. 1993 Sep;71(9):725-31.
24. PLoS One. 2013 May 14;8(5):e63809.
25. J Invest Dermatol. 2005 Oct;125(4):826-32.
26. J Am Acad Dermatol. 2008 Sep;59(3):418-25.
27. Lasers Surg Med. 2016 Mar;48(3):238-44.
28. J Drugs Dermatol. 2014 Dec;13(12):1467-72.
• Copiously available through the diet, this main lipid-soluble antioxidant in human skin is used to treat some dermatoses but is not approved by the Food and Drug Administration for skin conditions.
• Its lipophilic nature renders it suitable for topical application and percutaneous absorption.
• Topical uses include skin hydration and treatment of atopic dermatitis.
• It is thought to be most effective when used with other antioxidant ingredients, particularly vitamin C and ferulic acid, with the combination yielding photoprotective activity.
After-hours texting and professional boundaries
Recently, I was out on a Friday night with a friend who is a resident in another program. I hadn’t seen her in a very long time because of our hectic schedules. Around 10 p.m., she received a text from her attending asking her if she had left the scripts ready for the patient who was leaving on Monday.
Much has been written about professional boundaries and bosses texting their employees. For most jobs, a boss texting after hours over nonurgent matters is completely out of line. But in the medical field, there are no limits. People say, “Oh well, it’s the physician life.” Well maybe if we had more professional boundaries, our quality of life would be better. Maybe there wouldn’t be such a huge rate of burnout.
I encourage physicians to remember to contact your resident and coworkers during business hours. If the matter is not placing patients in danger, it can wait till the next morning. Nobody wants to pick up his phone in the middle of dinner to deal with patient care–related expectations that can be addressed the next business day.
Receiving a text brings all the stress of work back in the middle of our time off in which we are trying to take care of ourselves and the rest of our lives. It adds unnecessary stress to the overall high stress level and undermines our attempt to have a social life and meet a friend. A quick Internet search shows many blogs, journals, and different websites discussing this issue, but the voices of doctors and other health care providers are strangely silent on this topic.
I consider emails a more professional way of communicating than a text. I check my email often during a 24-hour period, and when I do, I’m ready for any potential information I might receive. I do not get notifications on my phone from my work email. But like my friend, I can’t avoid texts. We should have the opportunity to use our right to disconnect.
Some may argue, “Put your phone on silent if you don’t want to deal with it.” But not only do I use my phone for my life outside of work (as a resident, I make an effort to have one), but I want to be available for my peers and juniors when they are in the hospital. I want to be a resident my coworkers can text when they have a question and appreciate my advice. That is a decision I have made about the type of resident I want to be, and I am comfortable with it. Now if they text me asking a question that can wait till business hours the following day, they are crossing boundaries.
It might seem like a gray line. Somebody – maybe residency programs or our professional organizations – should address this so we have clear guidelines to protect our off-work time. Doesn’t our culture need to change the “physician life” so that we don’t bring our work responsibilities out for dinner on a Friday night? If the issue doesn’t need to be resolved quickly, it should be a given that texting is inappropriate.
Dr. Serrano is a PGY3 psychiatry resident at the Einstein Medical Center in Philadelphia.
Recently, I was out on a Friday night with a friend who is a resident in another program. I hadn’t seen her in a very long time because of our hectic schedules. Around 10 p.m., she received a text from her attending asking her if she had left the scripts ready for the patient who was leaving on Monday.
Much has been written about professional boundaries and bosses texting their employees. For most jobs, a boss texting after hours over nonurgent matters is completely out of line. But in the medical field, there are no limits. People say, “Oh well, it’s the physician life.” Well maybe if we had more professional boundaries, our quality of life would be better. Maybe there wouldn’t be such a huge rate of burnout.
I encourage physicians to remember to contact your resident and coworkers during business hours. If the matter is not placing patients in danger, it can wait till the next morning. Nobody wants to pick up his phone in the middle of dinner to deal with patient care–related expectations that can be addressed the next business day.
Receiving a text brings all the stress of work back in the middle of our time off in which we are trying to take care of ourselves and the rest of our lives. It adds unnecessary stress to the overall high stress level and undermines our attempt to have a social life and meet a friend. A quick Internet search shows many blogs, journals, and different websites discussing this issue, but the voices of doctors and other health care providers are strangely silent on this topic.
I consider emails a more professional way of communicating than a text. I check my email often during a 24-hour period, and when I do, I’m ready for any potential information I might receive. I do not get notifications on my phone from my work email. But like my friend, I can’t avoid texts. We should have the opportunity to use our right to disconnect.
Some may argue, “Put your phone on silent if you don’t want to deal with it.” But not only do I use my phone for my life outside of work (as a resident, I make an effort to have one), but I want to be available for my peers and juniors when they are in the hospital. I want to be a resident my coworkers can text when they have a question and appreciate my advice. That is a decision I have made about the type of resident I want to be, and I am comfortable with it. Now if they text me asking a question that can wait till business hours the following day, they are crossing boundaries.
It might seem like a gray line. Somebody – maybe residency programs or our professional organizations – should address this so we have clear guidelines to protect our off-work time. Doesn’t our culture need to change the “physician life” so that we don’t bring our work responsibilities out for dinner on a Friday night? If the issue doesn’t need to be resolved quickly, it should be a given that texting is inappropriate.
Dr. Serrano is a PGY3 psychiatry resident at the Einstein Medical Center in Philadelphia.
Recently, I was out on a Friday night with a friend who is a resident in another program. I hadn’t seen her in a very long time because of our hectic schedules. Around 10 p.m., she received a text from her attending asking her if she had left the scripts ready for the patient who was leaving on Monday.
Much has been written about professional boundaries and bosses texting their employees. For most jobs, a boss texting after hours over nonurgent matters is completely out of line. But in the medical field, there are no limits. People say, “Oh well, it’s the physician life.” Well maybe if we had more professional boundaries, our quality of life would be better. Maybe there wouldn’t be such a huge rate of burnout.
I encourage physicians to remember to contact your resident and coworkers during business hours. If the matter is not placing patients in danger, it can wait till the next morning. Nobody wants to pick up his phone in the middle of dinner to deal with patient care–related expectations that can be addressed the next business day.
Receiving a text brings all the stress of work back in the middle of our time off in which we are trying to take care of ourselves and the rest of our lives. It adds unnecessary stress to the overall high stress level and undermines our attempt to have a social life and meet a friend. A quick Internet search shows many blogs, journals, and different websites discussing this issue, but the voices of doctors and other health care providers are strangely silent on this topic.
I consider emails a more professional way of communicating than a text. I check my email often during a 24-hour period, and when I do, I’m ready for any potential information I might receive. I do not get notifications on my phone from my work email. But like my friend, I can’t avoid texts. We should have the opportunity to use our right to disconnect.
Some may argue, “Put your phone on silent if you don’t want to deal with it.” But not only do I use my phone for my life outside of work (as a resident, I make an effort to have one), but I want to be available for my peers and juniors when they are in the hospital. I want to be a resident my coworkers can text when they have a question and appreciate my advice. That is a decision I have made about the type of resident I want to be, and I am comfortable with it. Now if they text me asking a question that can wait till business hours the following day, they are crossing boundaries.
It might seem like a gray line. Somebody – maybe residency programs or our professional organizations – should address this so we have clear guidelines to protect our off-work time. Doesn’t our culture need to change the “physician life” so that we don’t bring our work responsibilities out for dinner on a Friday night? If the issue doesn’t need to be resolved quickly, it should be a given that texting is inappropriate.
Dr. Serrano is a PGY3 psychiatry resident at the Einstein Medical Center in Philadelphia.
One More Comment on Expanding the Scope of Practice for VA Advanced Practice Nurses
You may have heard that the VA has proposed to amend its regulations to permit advanced practice registered nurses (APRNs) to wield full practice authority. For several years, there have been rumors of the change, but there also was uncertainty until Under Secretary for Health David J. Shulkin, MD, announced the proposed rule May 29, 2016.1 When the commentary period ended July 25, 2016, an incredible 212,242 people had commented on the proposed rule.
The function of the regulatory process during this period of open comment in the Federal Register is to inform the drafting of the final rule, meaning that this proposal is a long way from becoming law.2 If nothing else, it will take months for the VA to take stock of the responses. That makes this an optimal time to figure out why the issues involved have generated such intense controversy and to invite you, our readers, to share your thoughtful opinions.
The rule is written in the usual bureaucratic language, but the plain meaning is APRNs would be able to practice without physician supervision. If you’re not familiar with how much advanced practice nursing has grown, this ruling can come as a pleasant surprise or an unpleasant shock, depending on your perspective. And although advanced practice nursing may be a new development in the VA, it is in no way a novel one for American health care. Clearly, APRNs will play a greater role in health care at the VA, but the nature of that role remains contentious, and, it cannot be emphasized enough, undecided.
Advanced practice registered nurses who provide health care with full practice authority already are the standard in other branches of federal service, including the DoD and IHS. Many veterans are therefore used to having a nurse practitioner (NP) as their primary care provider and seeing other types of APRNs in specialty care in the clinic and the hospital. As of 2015, 18 states and the District of Columbia granted APRNs full scope of practice. The other states have various and variable forms of reduced and restricted practice that in some manner involve physician supervision, reflecting the debate that now engages the VA.3
I read many of the comments on the proposed rule. A majority of the responses are formulaic comments promoted by organizations on each side of the issue. The opinions of those for and against the proposal express genuine and principled concerns about patient safety and access, while less admirable postings reflect vainglory and turf battles.4 Prestigious organizations came down on each side of the debate and along relatively predictable discipline lines: The American Medical Association (AMA) took the con stance on the specific proposal, and the Institute of Medicine took the pro position on the more general issues of APRNs having full scope of practice as early as 2011.5,6
Many of the objections to the rule are focused on one of the 4 recognized APRN roles: the certified registered nurse anesthetist (CRNA). The volume and vehemence of the comments along with other considerations persuaded Dr. Shulkin and his advisors to exclude CRNAs from the current policy change. For that reason and my lack of expertise in the area, I will not discuss CRNAs and instead focus my discussion on the other 3 roles that will be granted full authority: certified NPs, certified nurse specialists, and certified nurse midwives.
We are all familiar with continuing education presentations beginning with a conflict of interest statement, so here is mine: I am a board-certified physician (MD) and educator of medical students and medical residents. But I also have trained and supervised—when the latter was required—APRNs in the VA. What I have learned from these experiences is not revelatory but is relevant. There are good doctors and bad, just as there are outstanding and poor APRNs. For both, the distinction between those who competently provide safe, high-quality, compassionate care and those who do not is based not on a degree, but on the ability to recognize one’s limitations and seek outside consultation when necessary.
After decades in clinical education, only 2 types of trainees (of any profession) worry me—the ones who don’t know that they don’t know and the ones who won’t ask for help. It is sheer hubris to think APRNs will not need the consultation of physicians and, even in some cases, their supervision, or that they can “replace doctors” especially given the VA population of older patients with more mental health comorbidities and a higher prevalence of medical illnesses.7 Equally arrogant is to not recognize that superior physicians also routinely need to consult their colleagues, specialists, and other experts in order to provide the best care to patients. The scientific and informatics base on which clinical medicine must rest in the 21st century does not give any practitioner the luxury of self-sufficient knowledge.
We also must keep in mind that the proposed rule will increase the authority of the APRN and his or her accountability. Like physicians and other VA-licensed independent practitioners (LIPs), APRNs will be subject to the same rigorous credentialing and privileging that includes scrutiny of education and training, qualifications, and licensure before being granted full scope of practice. Where final responsibility for decisions once stopped with the physician, APRNs could now be the captain of the ship in many circumstances, sharing with physicians and other LIPs the discipline of peer review and the risk of tort claims.
In my July editorial, I talked about the physician shortage in the VA, a microcosm of national patient demand exceeding doctor supply. Two of the biggest lacunae are in the most critical areas for the VA cohort: primary care and mental health.8 The empirical work supporting the model of the National Council of State Boards of Nursing Consensus strongly suggests that APRNs can improve access and wait times while upholding the quality of patient-centered care.9 To deny this evidence exists or is solid research, as some opponents have, brings more heat than light to the debate. But it does not answer what the relationship between physicians and APRNs in the VA will or should be, hence, the thousands upon thousands of comments on the proposal.
The AMA and other physician professional societies have many valid points expressed in a plethora of recent articles in print and on the Internet. As they rightly point out, health care is best delivered in teams, teams that physicians are often, but not always, in the optimal position to lead. Both physicians and APRNs are educated and trained, but that professional identity formation is different. Those differences should be seen as complementary skill sets. Any attempt in this brief space to characterize those differences and their relationship would risk my being perceived as invidious. What is clear is that the logical corollary of approving the proposed rule is to pass a similar regulation that provides greater incentives for physicians, especially those in family medicine, general internal medicine, and psychiatry, to work at the VA. Then and only then will veterans have the best of both health care worlds.
1. U.S. Department of Veterans Affairs. VA proposes to grant full practice authority to advanced practice registered nurses [news release]. U.S. Department of Veterans Affairs website. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2793. Published May 29, 2016. Accessed July 13, 2016.
2. State practice environment. American Association of Nurse Practitioners website. https://www.aanp.org/legislation-regulation/state-legislation/state-practice-environment. Accessed July 13, 2016.
3. AP44-Proposed Rule-Advanced Practice Registered Nurses. Regulations.gov website https://www.regulations.gov/docket?D=VA-2016-VHA-0011. Accessed July 13, 2016.
4. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
5. Permut SR. AMA statement on VA proposed rule on advance practice nurses [news release]. American Medical Association website. http://www.ama-assn.org/ama/pub/news/news/2016/2016-05-25-va-rule-advanced-practice-nurses.page. Published May 25, 2016. Accessed July 13, 2016.
6. Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011;14(6):293-298.
7. Department of Veterans Affairs Office of Inspector General, Office of Healthcare Inspection. OIG determination of Veterans Health Administration’s occupational staffing shortages. Report no. 15-00430-103. http://www.va.gov/oig/pubs/VAOIG-15-00430-103.pdf. Published January 30, 2015. Accessed July 13, 2016.
8. APRN Consensus Work Group and the National Council of State Boards of Nursing Advisory Committee. Consensus Model for APRN regulation: licensure, accreditation, certification & education. https://www.ncsbn.org/Consensus_Model_for_APRN_Regulation_July_2008.pdf. Published July 7, 2008. Accessed July 13, 2016.
You may have heard that the VA has proposed to amend its regulations to permit advanced practice registered nurses (APRNs) to wield full practice authority. For several years, there have been rumors of the change, but there also was uncertainty until Under Secretary for Health David J. Shulkin, MD, announced the proposed rule May 29, 2016.1 When the commentary period ended July 25, 2016, an incredible 212,242 people had commented on the proposed rule.
The function of the regulatory process during this period of open comment in the Federal Register is to inform the drafting of the final rule, meaning that this proposal is a long way from becoming law.2 If nothing else, it will take months for the VA to take stock of the responses. That makes this an optimal time to figure out why the issues involved have generated such intense controversy and to invite you, our readers, to share your thoughtful opinions.
The rule is written in the usual bureaucratic language, but the plain meaning is APRNs would be able to practice without physician supervision. If you’re not familiar with how much advanced practice nursing has grown, this ruling can come as a pleasant surprise or an unpleasant shock, depending on your perspective. And although advanced practice nursing may be a new development in the VA, it is in no way a novel one for American health care. Clearly, APRNs will play a greater role in health care at the VA, but the nature of that role remains contentious, and, it cannot be emphasized enough, undecided.
Advanced practice registered nurses who provide health care with full practice authority already are the standard in other branches of federal service, including the DoD and IHS. Many veterans are therefore used to having a nurse practitioner (NP) as their primary care provider and seeing other types of APRNs in specialty care in the clinic and the hospital. As of 2015, 18 states and the District of Columbia granted APRNs full scope of practice. The other states have various and variable forms of reduced and restricted practice that in some manner involve physician supervision, reflecting the debate that now engages the VA.3
I read many of the comments on the proposed rule. A majority of the responses are formulaic comments promoted by organizations on each side of the issue. The opinions of those for and against the proposal express genuine and principled concerns about patient safety and access, while less admirable postings reflect vainglory and turf battles.4 Prestigious organizations came down on each side of the debate and along relatively predictable discipline lines: The American Medical Association (AMA) took the con stance on the specific proposal, and the Institute of Medicine took the pro position on the more general issues of APRNs having full scope of practice as early as 2011.5,6
Many of the objections to the rule are focused on one of the 4 recognized APRN roles: the certified registered nurse anesthetist (CRNA). The volume and vehemence of the comments along with other considerations persuaded Dr. Shulkin and his advisors to exclude CRNAs from the current policy change. For that reason and my lack of expertise in the area, I will not discuss CRNAs and instead focus my discussion on the other 3 roles that will be granted full authority: certified NPs, certified nurse specialists, and certified nurse midwives.
We are all familiar with continuing education presentations beginning with a conflict of interest statement, so here is mine: I am a board-certified physician (MD) and educator of medical students and medical residents. But I also have trained and supervised—when the latter was required—APRNs in the VA. What I have learned from these experiences is not revelatory but is relevant. There are good doctors and bad, just as there are outstanding and poor APRNs. For both, the distinction between those who competently provide safe, high-quality, compassionate care and those who do not is based not on a degree, but on the ability to recognize one’s limitations and seek outside consultation when necessary.
After decades in clinical education, only 2 types of trainees (of any profession) worry me—the ones who don’t know that they don’t know and the ones who won’t ask for help. It is sheer hubris to think APRNs will not need the consultation of physicians and, even in some cases, their supervision, or that they can “replace doctors” especially given the VA population of older patients with more mental health comorbidities and a higher prevalence of medical illnesses.7 Equally arrogant is to not recognize that superior physicians also routinely need to consult their colleagues, specialists, and other experts in order to provide the best care to patients. The scientific and informatics base on which clinical medicine must rest in the 21st century does not give any practitioner the luxury of self-sufficient knowledge.
We also must keep in mind that the proposed rule will increase the authority of the APRN and his or her accountability. Like physicians and other VA-licensed independent practitioners (LIPs), APRNs will be subject to the same rigorous credentialing and privileging that includes scrutiny of education and training, qualifications, and licensure before being granted full scope of practice. Where final responsibility for decisions once stopped with the physician, APRNs could now be the captain of the ship in many circumstances, sharing with physicians and other LIPs the discipline of peer review and the risk of tort claims.
In my July editorial, I talked about the physician shortage in the VA, a microcosm of national patient demand exceeding doctor supply. Two of the biggest lacunae are in the most critical areas for the VA cohort: primary care and mental health.8 The empirical work supporting the model of the National Council of State Boards of Nursing Consensus strongly suggests that APRNs can improve access and wait times while upholding the quality of patient-centered care.9 To deny this evidence exists or is solid research, as some opponents have, brings more heat than light to the debate. But it does not answer what the relationship between physicians and APRNs in the VA will or should be, hence, the thousands upon thousands of comments on the proposal.
The AMA and other physician professional societies have many valid points expressed in a plethora of recent articles in print and on the Internet. As they rightly point out, health care is best delivered in teams, teams that physicians are often, but not always, in the optimal position to lead. Both physicians and APRNs are educated and trained, but that professional identity formation is different. Those differences should be seen as complementary skill sets. Any attempt in this brief space to characterize those differences and their relationship would risk my being perceived as invidious. What is clear is that the logical corollary of approving the proposed rule is to pass a similar regulation that provides greater incentives for physicians, especially those in family medicine, general internal medicine, and psychiatry, to work at the VA. Then and only then will veterans have the best of both health care worlds.
You may have heard that the VA has proposed to amend its regulations to permit advanced practice registered nurses (APRNs) to wield full practice authority. For several years, there have been rumors of the change, but there also was uncertainty until Under Secretary for Health David J. Shulkin, MD, announced the proposed rule May 29, 2016.1 When the commentary period ended July 25, 2016, an incredible 212,242 people had commented on the proposed rule.
The function of the regulatory process during this period of open comment in the Federal Register is to inform the drafting of the final rule, meaning that this proposal is a long way from becoming law.2 If nothing else, it will take months for the VA to take stock of the responses. That makes this an optimal time to figure out why the issues involved have generated such intense controversy and to invite you, our readers, to share your thoughtful opinions.
The rule is written in the usual bureaucratic language, but the plain meaning is APRNs would be able to practice without physician supervision. If you’re not familiar with how much advanced practice nursing has grown, this ruling can come as a pleasant surprise or an unpleasant shock, depending on your perspective. And although advanced practice nursing may be a new development in the VA, it is in no way a novel one for American health care. Clearly, APRNs will play a greater role in health care at the VA, but the nature of that role remains contentious, and, it cannot be emphasized enough, undecided.
Advanced practice registered nurses who provide health care with full practice authority already are the standard in other branches of federal service, including the DoD and IHS. Many veterans are therefore used to having a nurse practitioner (NP) as their primary care provider and seeing other types of APRNs in specialty care in the clinic and the hospital. As of 2015, 18 states and the District of Columbia granted APRNs full scope of practice. The other states have various and variable forms of reduced and restricted practice that in some manner involve physician supervision, reflecting the debate that now engages the VA.3
I read many of the comments on the proposed rule. A majority of the responses are formulaic comments promoted by organizations on each side of the issue. The opinions of those for and against the proposal express genuine and principled concerns about patient safety and access, while less admirable postings reflect vainglory and turf battles.4 Prestigious organizations came down on each side of the debate and along relatively predictable discipline lines: The American Medical Association (AMA) took the con stance on the specific proposal, and the Institute of Medicine took the pro position on the more general issues of APRNs having full scope of practice as early as 2011.5,6
Many of the objections to the rule are focused on one of the 4 recognized APRN roles: the certified registered nurse anesthetist (CRNA). The volume and vehemence of the comments along with other considerations persuaded Dr. Shulkin and his advisors to exclude CRNAs from the current policy change. For that reason and my lack of expertise in the area, I will not discuss CRNAs and instead focus my discussion on the other 3 roles that will be granted full authority: certified NPs, certified nurse specialists, and certified nurse midwives.
We are all familiar with continuing education presentations beginning with a conflict of interest statement, so here is mine: I am a board-certified physician (MD) and educator of medical students and medical residents. But I also have trained and supervised—when the latter was required—APRNs in the VA. What I have learned from these experiences is not revelatory but is relevant. There are good doctors and bad, just as there are outstanding and poor APRNs. For both, the distinction between those who competently provide safe, high-quality, compassionate care and those who do not is based not on a degree, but on the ability to recognize one’s limitations and seek outside consultation when necessary.
After decades in clinical education, only 2 types of trainees (of any profession) worry me—the ones who don’t know that they don’t know and the ones who won’t ask for help. It is sheer hubris to think APRNs will not need the consultation of physicians and, even in some cases, their supervision, or that they can “replace doctors” especially given the VA population of older patients with more mental health comorbidities and a higher prevalence of medical illnesses.7 Equally arrogant is to not recognize that superior physicians also routinely need to consult their colleagues, specialists, and other experts in order to provide the best care to patients. The scientific and informatics base on which clinical medicine must rest in the 21st century does not give any practitioner the luxury of self-sufficient knowledge.
We also must keep in mind that the proposed rule will increase the authority of the APRN and his or her accountability. Like physicians and other VA-licensed independent practitioners (LIPs), APRNs will be subject to the same rigorous credentialing and privileging that includes scrutiny of education and training, qualifications, and licensure before being granted full scope of practice. Where final responsibility for decisions once stopped with the physician, APRNs could now be the captain of the ship in many circumstances, sharing with physicians and other LIPs the discipline of peer review and the risk of tort claims.
In my July editorial, I talked about the physician shortage in the VA, a microcosm of national patient demand exceeding doctor supply. Two of the biggest lacunae are in the most critical areas for the VA cohort: primary care and mental health.8 The empirical work supporting the model of the National Council of State Boards of Nursing Consensus strongly suggests that APRNs can improve access and wait times while upholding the quality of patient-centered care.9 To deny this evidence exists or is solid research, as some opponents have, brings more heat than light to the debate. But it does not answer what the relationship between physicians and APRNs in the VA will or should be, hence, the thousands upon thousands of comments on the proposal.
The AMA and other physician professional societies have many valid points expressed in a plethora of recent articles in print and on the Internet. As they rightly point out, health care is best delivered in teams, teams that physicians are often, but not always, in the optimal position to lead. Both physicians and APRNs are educated and trained, but that professional identity formation is different. Those differences should be seen as complementary skill sets. Any attempt in this brief space to characterize those differences and their relationship would risk my being perceived as invidious. What is clear is that the logical corollary of approving the proposed rule is to pass a similar regulation that provides greater incentives for physicians, especially those in family medicine, general internal medicine, and psychiatry, to work at the VA. Then and only then will veterans have the best of both health care worlds.
1. U.S. Department of Veterans Affairs. VA proposes to grant full practice authority to advanced practice registered nurses [news release]. U.S. Department of Veterans Affairs website. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2793. Published May 29, 2016. Accessed July 13, 2016.
2. State practice environment. American Association of Nurse Practitioners website. https://www.aanp.org/legislation-regulation/state-legislation/state-practice-environment. Accessed July 13, 2016.
3. AP44-Proposed Rule-Advanced Practice Registered Nurses. Regulations.gov website https://www.regulations.gov/docket?D=VA-2016-VHA-0011. Accessed July 13, 2016.
4. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
5. Permut SR. AMA statement on VA proposed rule on advance practice nurses [news release]. American Medical Association website. http://www.ama-assn.org/ama/pub/news/news/2016/2016-05-25-va-rule-advanced-practice-nurses.page. Published May 25, 2016. Accessed July 13, 2016.
6. Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011;14(6):293-298.
7. Department of Veterans Affairs Office of Inspector General, Office of Healthcare Inspection. OIG determination of Veterans Health Administration’s occupational staffing shortages. Report no. 15-00430-103. http://www.va.gov/oig/pubs/VAOIG-15-00430-103.pdf. Published January 30, 2015. Accessed July 13, 2016.
8. APRN Consensus Work Group and the National Council of State Boards of Nursing Advisory Committee. Consensus Model for APRN regulation: licensure, accreditation, certification & education. https://www.ncsbn.org/Consensus_Model_for_APRN_Regulation_July_2008.pdf. Published July 7, 2008. Accessed July 13, 2016.
1. U.S. Department of Veterans Affairs. VA proposes to grant full practice authority to advanced practice registered nurses [news release]. U.S. Department of Veterans Affairs website. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2793. Published May 29, 2016. Accessed July 13, 2016.
2. State practice environment. American Association of Nurse Practitioners website. https://www.aanp.org/legislation-regulation/state-legislation/state-practice-environment. Accessed July 13, 2016.
3. AP44-Proposed Rule-Advanced Practice Registered Nurses. Regulations.gov website https://www.regulations.gov/docket?D=VA-2016-VHA-0011. Accessed July 13, 2016.
4. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.
5. Permut SR. AMA statement on VA proposed rule on advance practice nurses [news release]. American Medical Association website. http://www.ama-assn.org/ama/pub/news/news/2016/2016-05-25-va-rule-advanced-practice-nurses.page. Published May 25, 2016. Accessed July 13, 2016.
6. Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011;14(6):293-298.
7. Department of Veterans Affairs Office of Inspector General, Office of Healthcare Inspection. OIG determination of Veterans Health Administration’s occupational staffing shortages. Report no. 15-00430-103. http://www.va.gov/oig/pubs/VAOIG-15-00430-103.pdf. Published January 30, 2015. Accessed July 13, 2016.
8. APRN Consensus Work Group and the National Council of State Boards of Nursing Advisory Committee. Consensus Model for APRN regulation: licensure, accreditation, certification & education. https://www.ncsbn.org/Consensus_Model_for_APRN_Regulation_July_2008.pdf. Published July 7, 2008. Accessed July 13, 2016.