User login
AUDIO: Firm policies prevent office discord
CHICAGO – Physicians can curb staff conflicts by enacting firm rules about appropriate employee conduct before such problems occur. Practical tips for promoting proper conduct were key themes of a session on office politics at the American Academy of Dermatology summer meeting.
In an interview after the session, presenter Dr. Seemal R. Desai of the University of Texas, Dallas, spoke about the significant impact that office politics can have on practices and patient care. He shared proactive strategies that doctors can employ to mitigate staff disagreements and reduce future issues.
While practices can face a host of varying situations, the same strong tenants can address most conflicts, Dr. Desai said. Listen and find out what approaches to office politics are most helpful. Dr. Desai had no relevant conflicts to disclose.
On Twitter @legal_med
CHICAGO – Physicians can curb staff conflicts by enacting firm rules about appropriate employee conduct before such problems occur. Practical tips for promoting proper conduct were key themes of a session on office politics at the American Academy of Dermatology summer meeting.
In an interview after the session, presenter Dr. Seemal R. Desai of the University of Texas, Dallas, spoke about the significant impact that office politics can have on practices and patient care. He shared proactive strategies that doctors can employ to mitigate staff disagreements and reduce future issues.
While practices can face a host of varying situations, the same strong tenants can address most conflicts, Dr. Desai said. Listen and find out what approaches to office politics are most helpful. Dr. Desai had no relevant conflicts to disclose.
On Twitter @legal_med
CHICAGO – Physicians can curb staff conflicts by enacting firm rules about appropriate employee conduct before such problems occur. Practical tips for promoting proper conduct were key themes of a session on office politics at the American Academy of Dermatology summer meeting.
In an interview after the session, presenter Dr. Seemal R. Desai of the University of Texas, Dallas, spoke about the significant impact that office politics can have on practices and patient care. He shared proactive strategies that doctors can employ to mitigate staff disagreements and reduce future issues.
While practices can face a host of varying situations, the same strong tenants can address most conflicts, Dr. Desai said. Listen and find out what approaches to office politics are most helpful. Dr. Desai had no relevant conflicts to disclose.
On Twitter @legal_med
EXPERT ANALYSIS FROM the aad summer academy 2014
Firm policies help address staff who behave badly
CHICAGO – Strong policies and open communication within a physician practice are key to resolving office conflicts and curtailing bad behavior by staff.
"Clear communication is essential," said Dr. Joseph S. Eastern, who practices dermatology and dermatologic surgery in Belleville, N.J. "Destructive political situations are often rooted in communication failure. Policies are also essential. Predictable conflicts can be prevented if policies have been agreed upon in advance; crises often result when there is no policy in place to address the issue in question."
Dr. Eastern and other presenters discussed common challenges that arise in staff environments during the recent American Academy of Dermatology summer meeting. Frequent challenges include employees who chronically leave early, staff members who abuse sick policies, and inappropriate interoffice relationships. Texting and Internet overuse are also growing burdens facing medical practices.
Firm policies that outline acceptable behavior by staff, and potential discipline for policy violations help tackle such difficult situations before they grow out of hand, presenters said.
"Every office should have a formal policy [that limits personal cell phone and Internet use during office hours]," Dr. Eastern said in an interview. "Mine is fairly straightforward: Using office time for personal texting and Web surfing is theft – pure and simple – theft of my time. I make this crystal clear. It is never permissible to steal any office property, least of all our most marketable commodity – office time."
In some circumstances, new rules may need to be drafted or old policies revised. For instance, in the case of employees who start dating. Smaller offices may not have specific policy language that addresses such relationships, said Dr. Seemal R. Desai of the University of Texas Southwestern Medical Center in Dallas and a dermatologist in private practice in Plano. Another challenge that may not be automatically outlined is staff members who constantly seek curbside consults with physicians to ask for personal medical advice. Both issues may lend themselves to consideration and institution of new standards.
Discuss problems or complaints early with employees in a nonconfrontational way, added Dr. Desai. This could mean a one-on-one chat with a staff member or a conversation with two employees who are in conflict.
"Approach the conversation with a really open attitude to try to hear the concerns," Dr. Desai said in an interview. "Not every situation that at first seems like a negative one, really ends up being that way."
Make sure staff are aware of policies and stick to them, Dr. Eastern notes. The worst way physicians can react to an issue is to ignore it. Ongoing office politics not only can cause tension among employees but also can reduce productivity and affect patient care.
"Sentiments and feelings and themes in an office-based setting can really translate a lot into how you practice," Dr. Desai said "and how successful you are on a daily basis."
On Twitter @legal_med
CHICAGO – Strong policies and open communication within a physician practice are key to resolving office conflicts and curtailing bad behavior by staff.
"Clear communication is essential," said Dr. Joseph S. Eastern, who practices dermatology and dermatologic surgery in Belleville, N.J. "Destructive political situations are often rooted in communication failure. Policies are also essential. Predictable conflicts can be prevented if policies have been agreed upon in advance; crises often result when there is no policy in place to address the issue in question."
Dr. Eastern and other presenters discussed common challenges that arise in staff environments during the recent American Academy of Dermatology summer meeting. Frequent challenges include employees who chronically leave early, staff members who abuse sick policies, and inappropriate interoffice relationships. Texting and Internet overuse are also growing burdens facing medical practices.
Firm policies that outline acceptable behavior by staff, and potential discipline for policy violations help tackle such difficult situations before they grow out of hand, presenters said.
"Every office should have a formal policy [that limits personal cell phone and Internet use during office hours]," Dr. Eastern said in an interview. "Mine is fairly straightforward: Using office time for personal texting and Web surfing is theft – pure and simple – theft of my time. I make this crystal clear. It is never permissible to steal any office property, least of all our most marketable commodity – office time."
In some circumstances, new rules may need to be drafted or old policies revised. For instance, in the case of employees who start dating. Smaller offices may not have specific policy language that addresses such relationships, said Dr. Seemal R. Desai of the University of Texas Southwestern Medical Center in Dallas and a dermatologist in private practice in Plano. Another challenge that may not be automatically outlined is staff members who constantly seek curbside consults with physicians to ask for personal medical advice. Both issues may lend themselves to consideration and institution of new standards.
Discuss problems or complaints early with employees in a nonconfrontational way, added Dr. Desai. This could mean a one-on-one chat with a staff member or a conversation with two employees who are in conflict.
"Approach the conversation with a really open attitude to try to hear the concerns," Dr. Desai said in an interview. "Not every situation that at first seems like a negative one, really ends up being that way."
Make sure staff are aware of policies and stick to them, Dr. Eastern notes. The worst way physicians can react to an issue is to ignore it. Ongoing office politics not only can cause tension among employees but also can reduce productivity and affect patient care.
"Sentiments and feelings and themes in an office-based setting can really translate a lot into how you practice," Dr. Desai said "and how successful you are on a daily basis."
On Twitter @legal_med
CHICAGO – Strong policies and open communication within a physician practice are key to resolving office conflicts and curtailing bad behavior by staff.
"Clear communication is essential," said Dr. Joseph S. Eastern, who practices dermatology and dermatologic surgery in Belleville, N.J. "Destructive political situations are often rooted in communication failure. Policies are also essential. Predictable conflicts can be prevented if policies have been agreed upon in advance; crises often result when there is no policy in place to address the issue in question."
Dr. Eastern and other presenters discussed common challenges that arise in staff environments during the recent American Academy of Dermatology summer meeting. Frequent challenges include employees who chronically leave early, staff members who abuse sick policies, and inappropriate interoffice relationships. Texting and Internet overuse are also growing burdens facing medical practices.
Firm policies that outline acceptable behavior by staff, and potential discipline for policy violations help tackle such difficult situations before they grow out of hand, presenters said.
"Every office should have a formal policy [that limits personal cell phone and Internet use during office hours]," Dr. Eastern said in an interview. "Mine is fairly straightforward: Using office time for personal texting and Web surfing is theft – pure and simple – theft of my time. I make this crystal clear. It is never permissible to steal any office property, least of all our most marketable commodity – office time."
In some circumstances, new rules may need to be drafted or old policies revised. For instance, in the case of employees who start dating. Smaller offices may not have specific policy language that addresses such relationships, said Dr. Seemal R. Desai of the University of Texas Southwestern Medical Center in Dallas and a dermatologist in private practice in Plano. Another challenge that may not be automatically outlined is staff members who constantly seek curbside consults with physicians to ask for personal medical advice. Both issues may lend themselves to consideration and institution of new standards.
Discuss problems or complaints early with employees in a nonconfrontational way, added Dr. Desai. This could mean a one-on-one chat with a staff member or a conversation with two employees who are in conflict.
"Approach the conversation with a really open attitude to try to hear the concerns," Dr. Desai said in an interview. "Not every situation that at first seems like a negative one, really ends up being that way."
Make sure staff are aware of policies and stick to them, Dr. Eastern notes. The worst way physicians can react to an issue is to ignore it. Ongoing office politics not only can cause tension among employees but also can reduce productivity and affect patient care.
"Sentiments and feelings and themes in an office-based setting can really translate a lot into how you practice," Dr. Desai said "and how successful you are on a daily basis."
On Twitter @legal_med
EXPERT ANALYSIS FROM THE AAD SUMMER ACADEMY 2014
Settling a malpractice suit is seldom a straightforward decision
Sometimes it makes sense to settle a malpractice lawsuit, but making that decision is seldom straightforward, according to legal experts.
Top reasons to settle a case include indefensible actions, inadequate malpractice insurance, and an expert review that concludes a failure to meet the standard of care, Joshua R. Cohen, a medical liability defense attorney practicing in New York, said in an interview.
A low insurance limit could lead to personal assets being tapped if a high trial verdict exceeds the physician’s insurance threshold. By settling early, doctors and their attorneys generally can negotiate a discounted payment, provide for quicker compensation to an injured patient and reduce ongoing defense costs, he said.
Settling also alleviates the time and burden of participating in a malpractice trial, said George F. Indest III, president and managing partner in a law firm specializing in health law in Orlando.
Settlement brings a resolution, "including relief from the worry and stress that such litigation carries with it, the imposition on the defendant’s time that depositions, hearings, and the trial might require, and the mental anxiety which the uncertainty causes," Mr. Indest said in an interview.
One distinct disadvantage of such financial agreements is that they must be reported to the National Practitioner Data Bank (NPDB), said Michael J. Sacopulos, founder and president of a consulting and liability risk management firm in Terre Haute, Ind. The reporting requirement means settlement details can arise during new employment, professional reviews or application for privileges.
"It is in many physicians’ minds, a stain that goes with them for the rest of their career," Mr. Sacopulos said in an interview.
Settlements also are reported to state licensure boards and state departments of insurance, which may lead to separate investigations against physicians based on the facts of the settlement, Mr. Indest said. Additionally, most medical staff bylaws require that physicians report settlements to the hospital and medical staff, which may result in peer-review actions.
For physicians who believe their case is strong and want to preserve their reputations, taking a case to trial may be the best option.
"For the most part, most malpractice cases fall into a gray area," Mr. Cohen said. "There could be some issues with the charting, but the medicine itself is defensible. The question is do you want to roll the dice as to what the jury is going to decide?"
To allow for that decision, ensure that contracts with insurance companies include a "consent to settle" clause. The clauses make certain that lawsuits are not settled without a doctor’s permission. Communication with attorneys and insurers throughout the lawsuit process is essential, Mr. Sacopulos said. Attorneys and insurers should make clear relevant case updates, potential success rates and possible loss values.
In a contraction accident case, a large corporation is affected, but with a doctor, it’s personal, Mr. Cohen said. Many equate malpractice with a violation of the Hippocratic Oath, "To do no harm." Doctors want their reputations defended when they believe they didn’t do anything wrong or if there was a complication that was not a result of malpractice. They want to go to trial.
Despite the strong emotions that come with a lawsuit, the decision about whether to settle or take a suit to trial should not be rushed, Mr. Sacopulos advised. "As the case goes on, more facts come out," he said. "The decision you make today as to what’s best for you may not be the best decision down the road. You need to continue to revisit (the situation) as the facts come out."
On Twitter @legal_med
Sometimes it makes sense to settle a malpractice lawsuit, but making that decision is seldom straightforward, according to legal experts.
Top reasons to settle a case include indefensible actions, inadequate malpractice insurance, and an expert review that concludes a failure to meet the standard of care, Joshua R. Cohen, a medical liability defense attorney practicing in New York, said in an interview.
A low insurance limit could lead to personal assets being tapped if a high trial verdict exceeds the physician’s insurance threshold. By settling early, doctors and their attorneys generally can negotiate a discounted payment, provide for quicker compensation to an injured patient and reduce ongoing defense costs, he said.
Settling also alleviates the time and burden of participating in a malpractice trial, said George F. Indest III, president and managing partner in a law firm specializing in health law in Orlando.
Settlement brings a resolution, "including relief from the worry and stress that such litigation carries with it, the imposition on the defendant’s time that depositions, hearings, and the trial might require, and the mental anxiety which the uncertainty causes," Mr. Indest said in an interview.
One distinct disadvantage of such financial agreements is that they must be reported to the National Practitioner Data Bank (NPDB), said Michael J. Sacopulos, founder and president of a consulting and liability risk management firm in Terre Haute, Ind. The reporting requirement means settlement details can arise during new employment, professional reviews or application for privileges.
"It is in many physicians’ minds, a stain that goes with them for the rest of their career," Mr. Sacopulos said in an interview.
Settlements also are reported to state licensure boards and state departments of insurance, which may lead to separate investigations against physicians based on the facts of the settlement, Mr. Indest said. Additionally, most medical staff bylaws require that physicians report settlements to the hospital and medical staff, which may result in peer-review actions.
For physicians who believe their case is strong and want to preserve their reputations, taking a case to trial may be the best option.
"For the most part, most malpractice cases fall into a gray area," Mr. Cohen said. "There could be some issues with the charting, but the medicine itself is defensible. The question is do you want to roll the dice as to what the jury is going to decide?"
To allow for that decision, ensure that contracts with insurance companies include a "consent to settle" clause. The clauses make certain that lawsuits are not settled without a doctor’s permission. Communication with attorneys and insurers throughout the lawsuit process is essential, Mr. Sacopulos said. Attorneys and insurers should make clear relevant case updates, potential success rates and possible loss values.
In a contraction accident case, a large corporation is affected, but with a doctor, it’s personal, Mr. Cohen said. Many equate malpractice with a violation of the Hippocratic Oath, "To do no harm." Doctors want their reputations defended when they believe they didn’t do anything wrong or if there was a complication that was not a result of malpractice. They want to go to trial.
Despite the strong emotions that come with a lawsuit, the decision about whether to settle or take a suit to trial should not be rushed, Mr. Sacopulos advised. "As the case goes on, more facts come out," he said. "The decision you make today as to what’s best for you may not be the best decision down the road. You need to continue to revisit (the situation) as the facts come out."
On Twitter @legal_med
Sometimes it makes sense to settle a malpractice lawsuit, but making that decision is seldom straightforward, according to legal experts.
Top reasons to settle a case include indefensible actions, inadequate malpractice insurance, and an expert review that concludes a failure to meet the standard of care, Joshua R. Cohen, a medical liability defense attorney practicing in New York, said in an interview.
A low insurance limit could lead to personal assets being tapped if a high trial verdict exceeds the physician’s insurance threshold. By settling early, doctors and their attorneys generally can negotiate a discounted payment, provide for quicker compensation to an injured patient and reduce ongoing defense costs, he said.
Settling also alleviates the time and burden of participating in a malpractice trial, said George F. Indest III, president and managing partner in a law firm specializing in health law in Orlando.
Settlement brings a resolution, "including relief from the worry and stress that such litigation carries with it, the imposition on the defendant’s time that depositions, hearings, and the trial might require, and the mental anxiety which the uncertainty causes," Mr. Indest said in an interview.
One distinct disadvantage of such financial agreements is that they must be reported to the National Practitioner Data Bank (NPDB), said Michael J. Sacopulos, founder and president of a consulting and liability risk management firm in Terre Haute, Ind. The reporting requirement means settlement details can arise during new employment, professional reviews or application for privileges.
"It is in many physicians’ minds, a stain that goes with them for the rest of their career," Mr. Sacopulos said in an interview.
Settlements also are reported to state licensure boards and state departments of insurance, which may lead to separate investigations against physicians based on the facts of the settlement, Mr. Indest said. Additionally, most medical staff bylaws require that physicians report settlements to the hospital and medical staff, which may result in peer-review actions.
For physicians who believe their case is strong and want to preserve their reputations, taking a case to trial may be the best option.
"For the most part, most malpractice cases fall into a gray area," Mr. Cohen said. "There could be some issues with the charting, but the medicine itself is defensible. The question is do you want to roll the dice as to what the jury is going to decide?"
To allow for that decision, ensure that contracts with insurance companies include a "consent to settle" clause. The clauses make certain that lawsuits are not settled without a doctor’s permission. Communication with attorneys and insurers throughout the lawsuit process is essential, Mr. Sacopulos said. Attorneys and insurers should make clear relevant case updates, potential success rates and possible loss values.
In a contraction accident case, a large corporation is affected, but with a doctor, it’s personal, Mr. Cohen said. Many equate malpractice with a violation of the Hippocratic Oath, "To do no harm." Doctors want their reputations defended when they believe they didn’t do anything wrong or if there was a complication that was not a result of malpractice. They want to go to trial.
Despite the strong emotions that come with a lawsuit, the decision about whether to settle or take a suit to trial should not be rushed, Mr. Sacopulos advised. "As the case goes on, more facts come out," he said. "The decision you make today as to what’s best for you may not be the best decision down the road. You need to continue to revisit (the situation) as the facts come out."
On Twitter @legal_med
Drug compounding law presents challenges, opportunities for physicians
Physicians can reduce liability and mitigate the risk of poor-quality drugs by taking advantage of a new federal law that tightens oversight on drug compounding facilities.
The ongoing implementation of the Compounding Quality Act (CQA) of 2013 follows a deadly 2012 meningitis outbreak linked to a steroid from a Framingham, Mass.–based drug compounder. The outbreak killed more than 60 people and sickened hundreds more.
"The whole tragedy from the meningitis outbreak was a wakeup call for policy makers, but also for physicians, who in a lot of cases weren’t always focused on whether the drugs they were administering or dispensing were compounded or not," Nathan A. Brown, a partner at Washington-based law firm, said in an interview. "As a result, there is a lot more awareness. Under the new law, there are now opportunities for doctors to ask more questions about the source of the drugs and whether they can be confident and have assurance of whether that drug is going to be of high quality."
The CQA is part of the Drug Quality and Security Act (DQSA) of 2013, which clarifies regulatory control over traditional drug compounding entities. The law also creates a new section under the federal Food, Drug and Cosmetic (FD&C) Act that allows compounders to voluntarily become "outsourcing facilities." As a registered outsourcing facility, compounders making sterile products can sell unlimited quantities of drugs on the Food and Drug Administration’s drug shortage list without a preexisting prescription and avoid new-drug approval requirements under the FD&C Act. However, they must undergo regular FDA inspections and follow the FDA’s Current Good Manufacturing Practice (cGMPs) regulations. Such facilities also must report adverse drug reactions to the FDA, compound under the supervision of only a licensed pharmacist or physician and use drugs from a bulk ingredients list only.
In a January letter, the FDA encouraged hospitals and other health care facility purchasers to use compounders registered as outsourcing facilities.
If facilities choose not to register, they may still be eligible to compound under 503A of the FD&C, which requires, among other rules, that they compound only for an identified, individual patient, based on the receipt of a valid prescription order. If compounders do not register as an outsourcing facility, nor are eligible under 503A, they must follow all of the requirements under the FD&C that are applicable to conventional manufacturers.
For physicians, the new law means the chance to better scrutinize where their drugs originate and to review whether compounders are using proper practices, legal experts said. This could include discussing possible FDA registration with outside compounders or, for hospital physicians, collaborating with administrators about the best source of compounded drugs. The FDA plans to publish registration and inspection data of outsourcing facilities on its website.
"Physicians should feel empowered to ask questions about the sources of their drugs because there’s more information available now, and it’s in their interest and their patients’ interest to make sure they fully understand the source of their drugs and potential risks," Mr. Brown said.
Doctors can also have a voice in what type of drug products compounders are allowed to work with. The FDA is currently accepting nominations for bulk drug substances that it should approve for compounding under 503A and 503B. Nominations for bulk drug substances are open until Sept. 30.
"Physicians and hospitals are going to be in the best position to really identify those types of drugs that are critical to have on hand in hospitals or office settings, and they should be monitoring the implementation process and commenting as appropriate, to make sure the drugs they need are still going to be available through outsourcing facilities or otherwise," Mr. Brown said.
Areas of uncertainty persist in the new law and its provisions. One unanswered question pertains to the purchasing of compounded products for office use, according to Christopher J. Topoleski, director of federal regulatory affairs for the American Society for Health-System Pharmacists during an American Health Lawyers Association webinar. This refers to drugs that physician practices or hospitals store for future use but that are not connected to a specific prescription. The DQSA does not specifically address the term "office use" or define what is acceptable.
"Many stakeholders have stated to the agency that office use is currently governed by state pharmacy laws," Mr. Topoleski said in an interview. "However, given the uncertainty of the FDA position, physicians who use entities that are not registered under 503B to supply office stock of compounded products may not be able to do so in the future."
How the DQSA might affect medical malpractice claims also is unclear. Plaintiffs’ attorneys could potentially use the law to assign greater blame against doctors in injury cases, Mr. Brown said.
"The concern for physicians is that with the growing awareness and concerns about compounding drugs, and the availability of a new federally-regulated source of compounded drugs, if there are tragic events that result from a compounded drug, (it’s possible) plaintiffs would look to doctors as a source of liability in that they should have been more mindful of the source of the drug," he said.
While some of the law’s edges need to be defined, doctors should not wait to research and determine the optimal base for their compounded drugs supply.
"Regardless of where the outsource falls under the law (503A vs, 503B) physicians, like any other purchaser, should carefully evaluate their practices and operations," Mr. Topoleski said.
On Twitter @ legal_med
Physicians can reduce liability and mitigate the risk of poor-quality drugs by taking advantage of a new federal law that tightens oversight on drug compounding facilities.
The ongoing implementation of the Compounding Quality Act (CQA) of 2013 follows a deadly 2012 meningitis outbreak linked to a steroid from a Framingham, Mass.–based drug compounder. The outbreak killed more than 60 people and sickened hundreds more.
"The whole tragedy from the meningitis outbreak was a wakeup call for policy makers, but also for physicians, who in a lot of cases weren’t always focused on whether the drugs they were administering or dispensing were compounded or not," Nathan A. Brown, a partner at Washington-based law firm, said in an interview. "As a result, there is a lot more awareness. Under the new law, there are now opportunities for doctors to ask more questions about the source of the drugs and whether they can be confident and have assurance of whether that drug is going to be of high quality."
The CQA is part of the Drug Quality and Security Act (DQSA) of 2013, which clarifies regulatory control over traditional drug compounding entities. The law also creates a new section under the federal Food, Drug and Cosmetic (FD&C) Act that allows compounders to voluntarily become "outsourcing facilities." As a registered outsourcing facility, compounders making sterile products can sell unlimited quantities of drugs on the Food and Drug Administration’s drug shortage list without a preexisting prescription and avoid new-drug approval requirements under the FD&C Act. However, they must undergo regular FDA inspections and follow the FDA’s Current Good Manufacturing Practice (cGMPs) regulations. Such facilities also must report adverse drug reactions to the FDA, compound under the supervision of only a licensed pharmacist or physician and use drugs from a bulk ingredients list only.
In a January letter, the FDA encouraged hospitals and other health care facility purchasers to use compounders registered as outsourcing facilities.
If facilities choose not to register, they may still be eligible to compound under 503A of the FD&C, which requires, among other rules, that they compound only for an identified, individual patient, based on the receipt of a valid prescription order. If compounders do not register as an outsourcing facility, nor are eligible under 503A, they must follow all of the requirements under the FD&C that are applicable to conventional manufacturers.
For physicians, the new law means the chance to better scrutinize where their drugs originate and to review whether compounders are using proper practices, legal experts said. This could include discussing possible FDA registration with outside compounders or, for hospital physicians, collaborating with administrators about the best source of compounded drugs. The FDA plans to publish registration and inspection data of outsourcing facilities on its website.
"Physicians should feel empowered to ask questions about the sources of their drugs because there’s more information available now, and it’s in their interest and their patients’ interest to make sure they fully understand the source of their drugs and potential risks," Mr. Brown said.
Doctors can also have a voice in what type of drug products compounders are allowed to work with. The FDA is currently accepting nominations for bulk drug substances that it should approve for compounding under 503A and 503B. Nominations for bulk drug substances are open until Sept. 30.
"Physicians and hospitals are going to be in the best position to really identify those types of drugs that are critical to have on hand in hospitals or office settings, and they should be monitoring the implementation process and commenting as appropriate, to make sure the drugs they need are still going to be available through outsourcing facilities or otherwise," Mr. Brown said.
Areas of uncertainty persist in the new law and its provisions. One unanswered question pertains to the purchasing of compounded products for office use, according to Christopher J. Topoleski, director of federal regulatory affairs for the American Society for Health-System Pharmacists during an American Health Lawyers Association webinar. This refers to drugs that physician practices or hospitals store for future use but that are not connected to a specific prescription. The DQSA does not specifically address the term "office use" or define what is acceptable.
"Many stakeholders have stated to the agency that office use is currently governed by state pharmacy laws," Mr. Topoleski said in an interview. "However, given the uncertainty of the FDA position, physicians who use entities that are not registered under 503B to supply office stock of compounded products may not be able to do so in the future."
How the DQSA might affect medical malpractice claims also is unclear. Plaintiffs’ attorneys could potentially use the law to assign greater blame against doctors in injury cases, Mr. Brown said.
"The concern for physicians is that with the growing awareness and concerns about compounding drugs, and the availability of a new federally-regulated source of compounded drugs, if there are tragic events that result from a compounded drug, (it’s possible) plaintiffs would look to doctors as a source of liability in that they should have been more mindful of the source of the drug," he said.
While some of the law’s edges need to be defined, doctors should not wait to research and determine the optimal base for their compounded drugs supply.
"Regardless of where the outsource falls under the law (503A vs, 503B) physicians, like any other purchaser, should carefully evaluate their practices and operations," Mr. Topoleski said.
On Twitter @ legal_med
Physicians can reduce liability and mitigate the risk of poor-quality drugs by taking advantage of a new federal law that tightens oversight on drug compounding facilities.
The ongoing implementation of the Compounding Quality Act (CQA) of 2013 follows a deadly 2012 meningitis outbreak linked to a steroid from a Framingham, Mass.–based drug compounder. The outbreak killed more than 60 people and sickened hundreds more.
"The whole tragedy from the meningitis outbreak was a wakeup call for policy makers, but also for physicians, who in a lot of cases weren’t always focused on whether the drugs they were administering or dispensing were compounded or not," Nathan A. Brown, a partner at Washington-based law firm, said in an interview. "As a result, there is a lot more awareness. Under the new law, there are now opportunities for doctors to ask more questions about the source of the drugs and whether they can be confident and have assurance of whether that drug is going to be of high quality."
The CQA is part of the Drug Quality and Security Act (DQSA) of 2013, which clarifies regulatory control over traditional drug compounding entities. The law also creates a new section under the federal Food, Drug and Cosmetic (FD&C) Act that allows compounders to voluntarily become "outsourcing facilities." As a registered outsourcing facility, compounders making sterile products can sell unlimited quantities of drugs on the Food and Drug Administration’s drug shortage list without a preexisting prescription and avoid new-drug approval requirements under the FD&C Act. However, they must undergo regular FDA inspections and follow the FDA’s Current Good Manufacturing Practice (cGMPs) regulations. Such facilities also must report adverse drug reactions to the FDA, compound under the supervision of only a licensed pharmacist or physician and use drugs from a bulk ingredients list only.
In a January letter, the FDA encouraged hospitals and other health care facility purchasers to use compounders registered as outsourcing facilities.
If facilities choose not to register, they may still be eligible to compound under 503A of the FD&C, which requires, among other rules, that they compound only for an identified, individual patient, based on the receipt of a valid prescription order. If compounders do not register as an outsourcing facility, nor are eligible under 503A, they must follow all of the requirements under the FD&C that are applicable to conventional manufacturers.
For physicians, the new law means the chance to better scrutinize where their drugs originate and to review whether compounders are using proper practices, legal experts said. This could include discussing possible FDA registration with outside compounders or, for hospital physicians, collaborating with administrators about the best source of compounded drugs. The FDA plans to publish registration and inspection data of outsourcing facilities on its website.
"Physicians should feel empowered to ask questions about the sources of their drugs because there’s more information available now, and it’s in their interest and their patients’ interest to make sure they fully understand the source of their drugs and potential risks," Mr. Brown said.
Doctors can also have a voice in what type of drug products compounders are allowed to work with. The FDA is currently accepting nominations for bulk drug substances that it should approve for compounding under 503A and 503B. Nominations for bulk drug substances are open until Sept. 30.
"Physicians and hospitals are going to be in the best position to really identify those types of drugs that are critical to have on hand in hospitals or office settings, and they should be monitoring the implementation process and commenting as appropriate, to make sure the drugs they need are still going to be available through outsourcing facilities or otherwise," Mr. Brown said.
Areas of uncertainty persist in the new law and its provisions. One unanswered question pertains to the purchasing of compounded products for office use, according to Christopher J. Topoleski, director of federal regulatory affairs for the American Society for Health-System Pharmacists during an American Health Lawyers Association webinar. This refers to drugs that physician practices or hospitals store for future use but that are not connected to a specific prescription. The DQSA does not specifically address the term "office use" or define what is acceptable.
"Many stakeholders have stated to the agency that office use is currently governed by state pharmacy laws," Mr. Topoleski said in an interview. "However, given the uncertainty of the FDA position, physicians who use entities that are not registered under 503B to supply office stock of compounded products may not be able to do so in the future."
How the DQSA might affect medical malpractice claims also is unclear. Plaintiffs’ attorneys could potentially use the law to assign greater blame against doctors in injury cases, Mr. Brown said.
"The concern for physicians is that with the growing awareness and concerns about compounding drugs, and the availability of a new federally-regulated source of compounded drugs, if there are tragic events that result from a compounded drug, (it’s possible) plaintiffs would look to doctors as a source of liability in that they should have been more mindful of the source of the drug," he said.
While some of the law’s edges need to be defined, doctors should not wait to research and determine the optimal base for their compounded drugs supply.
"Regardless of where the outsource falls under the law (503A vs, 503B) physicians, like any other purchaser, should carefully evaluate their practices and operations," Mr. Topoleski said.
On Twitter @ legal_med
Social media can help, harm liability cases
Physicians should be mindful of how social media can affect a medical malpractice case for better or worse and take steps to avoid legal dangers.
As a case proceeds through the legal process, social media "can be used to take the pulse of the parties, to discover public information that can be used in [cross examinations], and to explore themes for trials," said John E. Hall Jr., an Atlanta-based medical liability defense attorney, at the American Conference Institute’s obstetric malpractice claims forum in Philadelphia.
Plaintiffs’ and defense attorneys both turn toward social media use by patients and physicians to search for ways to build their respective cases. For the defense, this could mean reviewing a patient’s Facebook or Twitter account for information that contradicts their alleged injury claim. For instance, a patient who alleges a serious leg injury may be posting pictures of recent running activities.
On the other hand, plaintiffs may search social media for evidence about physicians’ activities around the time the alleged malpractice occurred. For example, by arguing a doctor’s late-night posts suggest the doctor had little sleep and was less than attentive during the patient’s visit, said Adam J. Davis, a Cleveland-based medical liability defense attorney. He was a copresenter at the obstetric claims conference.
"The courts are viewing electronically stored information, such as Facebook profiles, no differently than a person’s photo album at home or a journal that relates to the care in question, all of which have been discoverable in litigation," Mr. Davis said in an interview. Judges "are treating electronically stored information in much the same way they treat real, [tangible] evidence. Once that information is out there in a public forum, it’s fair game."
To prevent social media postings from being used against them in court, physicians should considering making their personal accounts private, Mr. Davis said. They should also be wary about what information they are posting or forwarding on public websites or on their practice’s social media accounts.
Deleting or changing a social media posting because it may arise during a malpractice case is a bad idea. Data residing in social media sites is subject to the same "duty to preserve" as other types of electronically stored information, Mr. Davis said. The duty to preserve is triggered when a party reasonably foresees the information may be relevant to issues in litigation. Deleting Facebook posts or other social media texts could result in sanctions for physicians or a spoliation of evidence claim.
If physicians believe a medical malpractice lawsuit may be forthcoming, it might be helpful to monitor the social media landscape and review what is being said about their care or practices, legal experts add. Physicians can search mainstream media, blogger websites, online reviews or tweets for their names or facilities. Such information could help them be more prepared if a suit is filed and help them direct their attorneys to relevant online comments.
"Monitoring [social media] pre-, during, and post trial can give a variety of information from the opinion of the case in the community, the predispositions witnesses may have, and compliance with court directives and rules," Mr. Hall said in an interview.
However, doctors should leave to attorneys the searching of jurors on social media, especially during trial. Contacting jurors during trial – even accidently – can lead to serious legal consequences for physicians, such as a mistrial.
"The best practice is for doctors not to be checking on jurors during trial – leave that to counsel," Mr. Davis said. "It’s too risky for the physician. A physician’s inadvertent communication with a juror over social media – say they accidently send a friend request – that’s considered communication, and it could result in a mistrial or the [excusing] of the juror or the start a new trial."
On Twitter @legal_med
Physicians should be mindful of how social media can affect a medical malpractice case for better or worse and take steps to avoid legal dangers.
As a case proceeds through the legal process, social media "can be used to take the pulse of the parties, to discover public information that can be used in [cross examinations], and to explore themes for trials," said John E. Hall Jr., an Atlanta-based medical liability defense attorney, at the American Conference Institute’s obstetric malpractice claims forum in Philadelphia.
Plaintiffs’ and defense attorneys both turn toward social media use by patients and physicians to search for ways to build their respective cases. For the defense, this could mean reviewing a patient’s Facebook or Twitter account for information that contradicts their alleged injury claim. For instance, a patient who alleges a serious leg injury may be posting pictures of recent running activities.
On the other hand, plaintiffs may search social media for evidence about physicians’ activities around the time the alleged malpractice occurred. For example, by arguing a doctor’s late-night posts suggest the doctor had little sleep and was less than attentive during the patient’s visit, said Adam J. Davis, a Cleveland-based medical liability defense attorney. He was a copresenter at the obstetric claims conference.
"The courts are viewing electronically stored information, such as Facebook profiles, no differently than a person’s photo album at home or a journal that relates to the care in question, all of which have been discoverable in litigation," Mr. Davis said in an interview. Judges "are treating electronically stored information in much the same way they treat real, [tangible] evidence. Once that information is out there in a public forum, it’s fair game."
To prevent social media postings from being used against them in court, physicians should considering making their personal accounts private, Mr. Davis said. They should also be wary about what information they are posting or forwarding on public websites or on their practice’s social media accounts.
Deleting or changing a social media posting because it may arise during a malpractice case is a bad idea. Data residing in social media sites is subject to the same "duty to preserve" as other types of electronically stored information, Mr. Davis said. The duty to preserve is triggered when a party reasonably foresees the information may be relevant to issues in litigation. Deleting Facebook posts or other social media texts could result in sanctions for physicians or a spoliation of evidence claim.
If physicians believe a medical malpractice lawsuit may be forthcoming, it might be helpful to monitor the social media landscape and review what is being said about their care or practices, legal experts add. Physicians can search mainstream media, blogger websites, online reviews or tweets for their names or facilities. Such information could help them be more prepared if a suit is filed and help them direct their attorneys to relevant online comments.
"Monitoring [social media] pre-, during, and post trial can give a variety of information from the opinion of the case in the community, the predispositions witnesses may have, and compliance with court directives and rules," Mr. Hall said in an interview.
However, doctors should leave to attorneys the searching of jurors on social media, especially during trial. Contacting jurors during trial – even accidently – can lead to serious legal consequences for physicians, such as a mistrial.
"The best practice is for doctors not to be checking on jurors during trial – leave that to counsel," Mr. Davis said. "It’s too risky for the physician. A physician’s inadvertent communication with a juror over social media – say they accidently send a friend request – that’s considered communication, and it could result in a mistrial or the [excusing] of the juror or the start a new trial."
On Twitter @legal_med
Physicians should be mindful of how social media can affect a medical malpractice case for better or worse and take steps to avoid legal dangers.
As a case proceeds through the legal process, social media "can be used to take the pulse of the parties, to discover public information that can be used in [cross examinations], and to explore themes for trials," said John E. Hall Jr., an Atlanta-based medical liability defense attorney, at the American Conference Institute’s obstetric malpractice claims forum in Philadelphia.
Plaintiffs’ and defense attorneys both turn toward social media use by patients and physicians to search for ways to build their respective cases. For the defense, this could mean reviewing a patient’s Facebook or Twitter account for information that contradicts their alleged injury claim. For instance, a patient who alleges a serious leg injury may be posting pictures of recent running activities.
On the other hand, plaintiffs may search social media for evidence about physicians’ activities around the time the alleged malpractice occurred. For example, by arguing a doctor’s late-night posts suggest the doctor had little sleep and was less than attentive during the patient’s visit, said Adam J. Davis, a Cleveland-based medical liability defense attorney. He was a copresenter at the obstetric claims conference.
"The courts are viewing electronically stored information, such as Facebook profiles, no differently than a person’s photo album at home or a journal that relates to the care in question, all of which have been discoverable in litigation," Mr. Davis said in an interview. Judges "are treating electronically stored information in much the same way they treat real, [tangible] evidence. Once that information is out there in a public forum, it’s fair game."
To prevent social media postings from being used against them in court, physicians should considering making their personal accounts private, Mr. Davis said. They should also be wary about what information they are posting or forwarding on public websites or on their practice’s social media accounts.
Deleting or changing a social media posting because it may arise during a malpractice case is a bad idea. Data residing in social media sites is subject to the same "duty to preserve" as other types of electronically stored information, Mr. Davis said. The duty to preserve is triggered when a party reasonably foresees the information may be relevant to issues in litigation. Deleting Facebook posts or other social media texts could result in sanctions for physicians or a spoliation of evidence claim.
If physicians believe a medical malpractice lawsuit may be forthcoming, it might be helpful to monitor the social media landscape and review what is being said about their care or practices, legal experts add. Physicians can search mainstream media, blogger websites, online reviews or tweets for their names or facilities. Such information could help them be more prepared if a suit is filed and help them direct their attorneys to relevant online comments.
"Monitoring [social media] pre-, during, and post trial can give a variety of information from the opinion of the case in the community, the predispositions witnesses may have, and compliance with court directives and rules," Mr. Hall said in an interview.
However, doctors should leave to attorneys the searching of jurors on social media, especially during trial. Contacting jurors during trial – even accidently – can lead to serious legal consequences for physicians, such as a mistrial.
"The best practice is for doctors not to be checking on jurors during trial – leave that to counsel," Mr. Davis said. "It’s too risky for the physician. A physician’s inadvertent communication with a juror over social media – say they accidently send a friend request – that’s considered communication, and it could result in a mistrial or the [excusing] of the juror or the start a new trial."
On Twitter @legal_med
Federation issues revised draft of telemedicine compact
The Federation of State Medical Boards has released an updated draft of a proposed interstate compact that would expand the practice of telemedicine by streamlining physician licensure. The revised text includes new requirements for physicians who wish to participate in an expedited process for gaining multiple state licenses.
Under the draft, interested physicians would need to complete a background check including biometric data (fingerprints or other) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
Additional new draft language alters specialty certification requirements of the compact to clarify that those with time-unlimited certification are eligible to participate in the compact.
"The goal of the compact is to ensure that qualified physicians are able to practice medicine in a safe and accountable manner, and that the strongest health care consumer protections are maintained," Dr. Humayun J. Chaudhry, FSMB president and CEO, said in a statement. "The revised compact helps ensure that as the practice of telemedicine continues to expand, patient protection remains a top priority. We look forward to sharing the revised compact with state medical boards across the country and look forward to working with them to achieve implementation."
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight, according to the proposed compact.
The interstate compact system is expected to significantly reduce barriers to the process of gaining licensure in multiple states, while helping to facilitate licensure portability and telemedicine. The state boards of medicine intend to present the final compact draft to state legislators for their consideration in 2015 legislative sessions.
On Twitter @legal_med
The Federation of State Medical Boards has released an updated draft of a proposed interstate compact that would expand the practice of telemedicine by streamlining physician licensure. The revised text includes new requirements for physicians who wish to participate in an expedited process for gaining multiple state licenses.
Under the draft, interested physicians would need to complete a background check including biometric data (fingerprints or other) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
Additional new draft language alters specialty certification requirements of the compact to clarify that those with time-unlimited certification are eligible to participate in the compact.
"The goal of the compact is to ensure that qualified physicians are able to practice medicine in a safe and accountable manner, and that the strongest health care consumer protections are maintained," Dr. Humayun J. Chaudhry, FSMB president and CEO, said in a statement. "The revised compact helps ensure that as the practice of telemedicine continues to expand, patient protection remains a top priority. We look forward to sharing the revised compact with state medical boards across the country and look forward to working with them to achieve implementation."
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight, according to the proposed compact.
The interstate compact system is expected to significantly reduce barriers to the process of gaining licensure in multiple states, while helping to facilitate licensure portability and telemedicine. The state boards of medicine intend to present the final compact draft to state legislators for their consideration in 2015 legislative sessions.
On Twitter @legal_med
The Federation of State Medical Boards has released an updated draft of a proposed interstate compact that would expand the practice of telemedicine by streamlining physician licensure. The revised text includes new requirements for physicians who wish to participate in an expedited process for gaining multiple state licenses.
Under the draft, interested physicians would need to complete a background check including biometric data (fingerprints or other) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
Additional new draft language alters specialty certification requirements of the compact to clarify that those with time-unlimited certification are eligible to participate in the compact.
"The goal of the compact is to ensure that qualified physicians are able to practice medicine in a safe and accountable manner, and that the strongest health care consumer protections are maintained," Dr. Humayun J. Chaudhry, FSMB president and CEO, said in a statement. "The revised compact helps ensure that as the practice of telemedicine continues to expand, patient protection remains a top priority. We look forward to sharing the revised compact with state medical boards across the country and look forward to working with them to achieve implementation."
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight, according to the proposed compact.
The interstate compact system is expected to significantly reduce barriers to the process of gaining licensure in multiple states, while helping to facilitate licensure portability and telemedicine. The state boards of medicine intend to present the final compact draft to state legislators for their consideration in 2015 legislative sessions.
On Twitter @legal_med
Shoulder dystocia malpractice claims becoming more common
As ob.gyns. face a growing number of shoulder dystocia cases, also escalating are medical malpractice lawsuits that claim physicians are to blame for related injuries.
"Because there is an increasing incidence of obesity in the United States, as well as women entering pregnancy at high risk or already having diabetes, the risks of dystocia are rising," said Dr. Robert H. Debbs, director of the Pennsylvania Hospital Maternal Fetal Medicine, Philadelphia. "The trends appear to be suits now being filed not for failing to perform C [cesarean] sections, but for how the dystocia was handled; i.e., was it anticipated? Were the proper maneuvers done? Is there evidence of excessive force used? And was the ‘team’ responsive to the situation?"
Adding to legal risks is the difficulty of predicting shoulder dystocia, noted Dr. Debbs. A 2012 study in Archives of Gynecology and Obstetrics that analyzed 234 shoulder dystocia cases found only mode of delivery and birth weight were independent risk factors of the condition. The U.K. researchers concluded that exact birth weight and delivery mode is difficult to foretell, and therefore, occurrence of shoulder dystocia is highly unpredictable (Arch. Gynecol. Obstet. 2012;285:291-5).
"It’s clear that we are neither able to predict with accuracy, nor prevent dystocia accurately in that most cases occur in normal-weight babies, and only 25% of patients have risk factors," said Dr. Debbs, who recently spoke on the subject at the American Conference Institute obstetric claims forum in Philadelphia. "Performing elective cesarean sections for suspected large babies has not reduced significantly the number of dystocias, and we would have to perform close to 300 cesarean-sections to prevent one permanent nerve injury to a child, a number that places women at risk of future pregnancy complications in addition to morbidity and even mortality from surgery," according to Dr. Debbs.
Despite the literature, many plaintiffs’ attorneys argue the mere presence of a brachial plexus injury in a newborn indicates the physician pulled too hard or in the wrong direction, said Dr. Michael G. Ross, chair of the obstetrics and gynecology department for Harbor-UCLA Medical Center, Torrance, Calif.
"That’s simply not true," he said in an interview. "It’s the forces of the contraction, the forces of maternal pushing. It’s the baby’s movement down the birth canal," that causes the injuries.
To avoid litigation, ob.gyns. should be aware of American Congress of Obstetricians and Gynecologists guidelines pertaining to shoulder dystocia and ensure that the risks of dystocia and brachial plexus injuries are discussed with patients, Dr. Ross said.
Additionally, physicians and health care team members should attend a dystocia drill every 1-2 years and make sure their institution has designated appropriate staff to respond during dystocia events, Dr. Debbs said. Documentation of dystocia incidents and conversations with families after the fact also are crucial.
"Always sit down with patient and family and discuss what happened and how it was remedied in detail," he said. "Many lawsuits are filed after families feel no one spoke with them and explained things."
As ob.gyns. face a growing number of shoulder dystocia cases, also escalating are medical malpractice lawsuits that claim physicians are to blame for related injuries.
"Because there is an increasing incidence of obesity in the United States, as well as women entering pregnancy at high risk or already having diabetes, the risks of dystocia are rising," said Dr. Robert H. Debbs, director of the Pennsylvania Hospital Maternal Fetal Medicine, Philadelphia. "The trends appear to be suits now being filed not for failing to perform C [cesarean] sections, but for how the dystocia was handled; i.e., was it anticipated? Were the proper maneuvers done? Is there evidence of excessive force used? And was the ‘team’ responsive to the situation?"
Adding to legal risks is the difficulty of predicting shoulder dystocia, noted Dr. Debbs. A 2012 study in Archives of Gynecology and Obstetrics that analyzed 234 shoulder dystocia cases found only mode of delivery and birth weight were independent risk factors of the condition. The U.K. researchers concluded that exact birth weight and delivery mode is difficult to foretell, and therefore, occurrence of shoulder dystocia is highly unpredictable (Arch. Gynecol. Obstet. 2012;285:291-5).
"It’s clear that we are neither able to predict with accuracy, nor prevent dystocia accurately in that most cases occur in normal-weight babies, and only 25% of patients have risk factors," said Dr. Debbs, who recently spoke on the subject at the American Conference Institute obstetric claims forum in Philadelphia. "Performing elective cesarean sections for suspected large babies has not reduced significantly the number of dystocias, and we would have to perform close to 300 cesarean-sections to prevent one permanent nerve injury to a child, a number that places women at risk of future pregnancy complications in addition to morbidity and even mortality from surgery," according to Dr. Debbs.
Despite the literature, many plaintiffs’ attorneys argue the mere presence of a brachial plexus injury in a newborn indicates the physician pulled too hard or in the wrong direction, said Dr. Michael G. Ross, chair of the obstetrics and gynecology department for Harbor-UCLA Medical Center, Torrance, Calif.
"That’s simply not true," he said in an interview. "It’s the forces of the contraction, the forces of maternal pushing. It’s the baby’s movement down the birth canal," that causes the injuries.
To avoid litigation, ob.gyns. should be aware of American Congress of Obstetricians and Gynecologists guidelines pertaining to shoulder dystocia and ensure that the risks of dystocia and brachial plexus injuries are discussed with patients, Dr. Ross said.
Additionally, physicians and health care team members should attend a dystocia drill every 1-2 years and make sure their institution has designated appropriate staff to respond during dystocia events, Dr. Debbs said. Documentation of dystocia incidents and conversations with families after the fact also are crucial.
"Always sit down with patient and family and discuss what happened and how it was remedied in detail," he said. "Many lawsuits are filed after families feel no one spoke with them and explained things."
As ob.gyns. face a growing number of shoulder dystocia cases, also escalating are medical malpractice lawsuits that claim physicians are to blame for related injuries.
"Because there is an increasing incidence of obesity in the United States, as well as women entering pregnancy at high risk or already having diabetes, the risks of dystocia are rising," said Dr. Robert H. Debbs, director of the Pennsylvania Hospital Maternal Fetal Medicine, Philadelphia. "The trends appear to be suits now being filed not for failing to perform C [cesarean] sections, but for how the dystocia was handled; i.e., was it anticipated? Were the proper maneuvers done? Is there evidence of excessive force used? And was the ‘team’ responsive to the situation?"
Adding to legal risks is the difficulty of predicting shoulder dystocia, noted Dr. Debbs. A 2012 study in Archives of Gynecology and Obstetrics that analyzed 234 shoulder dystocia cases found only mode of delivery and birth weight were independent risk factors of the condition. The U.K. researchers concluded that exact birth weight and delivery mode is difficult to foretell, and therefore, occurrence of shoulder dystocia is highly unpredictable (Arch. Gynecol. Obstet. 2012;285:291-5).
"It’s clear that we are neither able to predict with accuracy, nor prevent dystocia accurately in that most cases occur in normal-weight babies, and only 25% of patients have risk factors," said Dr. Debbs, who recently spoke on the subject at the American Conference Institute obstetric claims forum in Philadelphia. "Performing elective cesarean sections for suspected large babies has not reduced significantly the number of dystocias, and we would have to perform close to 300 cesarean-sections to prevent one permanent nerve injury to a child, a number that places women at risk of future pregnancy complications in addition to morbidity and even mortality from surgery," according to Dr. Debbs.
Despite the literature, many plaintiffs’ attorneys argue the mere presence of a brachial plexus injury in a newborn indicates the physician pulled too hard or in the wrong direction, said Dr. Michael G. Ross, chair of the obstetrics and gynecology department for Harbor-UCLA Medical Center, Torrance, Calif.
"That’s simply not true," he said in an interview. "It’s the forces of the contraction, the forces of maternal pushing. It’s the baby’s movement down the birth canal," that causes the injuries.
To avoid litigation, ob.gyns. should be aware of American Congress of Obstetricians and Gynecologists guidelines pertaining to shoulder dystocia and ensure that the risks of dystocia and brachial plexus injuries are discussed with patients, Dr. Ross said.
Additionally, physicians and health care team members should attend a dystocia drill every 1-2 years and make sure their institution has designated appropriate staff to respond during dystocia events, Dr. Debbs said. Documentation of dystocia incidents and conversations with families after the fact also are crucial.
"Always sit down with patient and family and discuss what happened and how it was remedied in detail," he said. "Many lawsuits are filed after families feel no one spoke with them and explained things."
Judges reveal secrets to successful malpractice trials
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
Judges reveal secrets to successful malpractice trials
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
Proactive efforts can mitigate Open Payments disputes
Early communication with pharmaceutical companies about the requirements of the Physician Payment Sunshine Act and better education on its provisions will prevent data disputes and reduce reporting surprises for doctors.
"A lot of physicians don’t realize how broad [the law] is," Stefanie A. Doebler, special counsel for Covington & Burling health care and food and drug practice groups in Washington, said in an interview. "Virtually everything [doctors] get from a manufacturer going forward is going to be reported. They need to be aware. They need to ask questions."
The federal Sunshine Act, adopted as part of the Affordable Care Act, requires manufacturers of drugs, devices, and biologics who participate in federal health care programs to report payments and items of value provided to physicians and teaching hospitals. The information must be made publicly available on a searchable federal database starting in September.
The federal government now calls the program Open Payments.
A 45-day review and dispute period for physicians began July 14. During this period, doctors can register with the Centers for Medicaid & Medicare Services’s Enterprise Portal, review data reported about them, and, if desired, initiate disputes with applicable manufacturers. Drug and device makers will then have an additional 15 days from then – ending Sept. 11 – to submit updated information to CMS.
Physicians need to make time to register and review their information now, Ms. Doebler said in an interview.
"They really need to be on top of reviewing their data," she said. "It’s kind of a pain in the neck for doctors, but they want to review it now and not once it goes public. Once it goes public, it’s there until the data is refreshed 6 months from now. They want to catch it now."
Physicians appear to be unclear on some areas of the law, Robert Ciolek, senior corporate counsel for Bristol-Myers Squibb, said during an American Bar Association webinar. For example, confusion often surfaces about whether the cost of lunches provided during educational programs are reportable.
"Frequently, the best opportunity [manufacturers] have is to do a lunch program where they can sit with a hospital staff and put together an educational program that talks either about a disease area or about a manufacturer’s product," Mr. Ciolek said. "The issue that always arises is, ‘What about the meal? Is it going to be reportable?’ We’ve seen time and time again, where doctors simply don’t understand the rule."
If a doctor consumes a meal in such a setting, the cost of the physician’s meal is reportable, Mr. Ciolek said. However, the cost of meals provided to office staff or other health care team members is not reportable. If physicians do not want their lunch costs reported, but still want to attend the program, they should not eat the meal, he said.
Open Payments requirements should be discussed by companies and physicians and/or noted before or at the time of transfers of value, said Carolyn M. Bruguera, vice president of consulting services and general counsel for R-Squared Services & Solutions, a consulting and software firm.
For instance, language regarding the law should be included in contracts, referenced on sign-in sheets for group meals, or stated orally during meetings.
Many large manufacturers and industry trade groups have developed websites and brochures to help educate physicians about reporting obligations, she added.
"These are also good tools for avoiding disputes and misunderstandings, but in some cases, manufacturers may need to be more proactive about getting the information to the covered recipients," she said. "Greater coordination with, for example, physician groups, such as specialty societies, might be helpful in this regard."
Another crucial step for doctors is explaining to patients their relationships with pharmaceutical companies and device manufacturers and ensuring patients understand why these interactions are useful, Ms. Doebler said. Once the value transfers go public, some mainstream media likely will paint all transfers of value among companies and doctors in a negative light, she said.
"It’s incumbent on doctors to explain to patients that there are valuable reasons" behind transactions with companies, she said. "It’s helpful for physicians to be able to explain why these relationships are important."
On Twitter @legal_med
Early communication with pharmaceutical companies about the requirements of the Physician Payment Sunshine Act and better education on its provisions will prevent data disputes and reduce reporting surprises for doctors.
"A lot of physicians don’t realize how broad [the law] is," Stefanie A. Doebler, special counsel for Covington & Burling health care and food and drug practice groups in Washington, said in an interview. "Virtually everything [doctors] get from a manufacturer going forward is going to be reported. They need to be aware. They need to ask questions."
The federal Sunshine Act, adopted as part of the Affordable Care Act, requires manufacturers of drugs, devices, and biologics who participate in federal health care programs to report payments and items of value provided to physicians and teaching hospitals. The information must be made publicly available on a searchable federal database starting in September.
The federal government now calls the program Open Payments.
A 45-day review and dispute period for physicians began July 14. During this period, doctors can register with the Centers for Medicaid & Medicare Services’s Enterprise Portal, review data reported about them, and, if desired, initiate disputes with applicable manufacturers. Drug and device makers will then have an additional 15 days from then – ending Sept. 11 – to submit updated information to CMS.
Physicians need to make time to register and review their information now, Ms. Doebler said in an interview.
"They really need to be on top of reviewing their data," she said. "It’s kind of a pain in the neck for doctors, but they want to review it now and not once it goes public. Once it goes public, it’s there until the data is refreshed 6 months from now. They want to catch it now."
Physicians appear to be unclear on some areas of the law, Robert Ciolek, senior corporate counsel for Bristol-Myers Squibb, said during an American Bar Association webinar. For example, confusion often surfaces about whether the cost of lunches provided during educational programs are reportable.
"Frequently, the best opportunity [manufacturers] have is to do a lunch program where they can sit with a hospital staff and put together an educational program that talks either about a disease area or about a manufacturer’s product," Mr. Ciolek said. "The issue that always arises is, ‘What about the meal? Is it going to be reportable?’ We’ve seen time and time again, where doctors simply don’t understand the rule."
If a doctor consumes a meal in such a setting, the cost of the physician’s meal is reportable, Mr. Ciolek said. However, the cost of meals provided to office staff or other health care team members is not reportable. If physicians do not want their lunch costs reported, but still want to attend the program, they should not eat the meal, he said.
Open Payments requirements should be discussed by companies and physicians and/or noted before or at the time of transfers of value, said Carolyn M. Bruguera, vice president of consulting services and general counsel for R-Squared Services & Solutions, a consulting and software firm.
For instance, language regarding the law should be included in contracts, referenced on sign-in sheets for group meals, or stated orally during meetings.
Many large manufacturers and industry trade groups have developed websites and brochures to help educate physicians about reporting obligations, she added.
"These are also good tools for avoiding disputes and misunderstandings, but in some cases, manufacturers may need to be more proactive about getting the information to the covered recipients," she said. "Greater coordination with, for example, physician groups, such as specialty societies, might be helpful in this regard."
Another crucial step for doctors is explaining to patients their relationships with pharmaceutical companies and device manufacturers and ensuring patients understand why these interactions are useful, Ms. Doebler said. Once the value transfers go public, some mainstream media likely will paint all transfers of value among companies and doctors in a negative light, she said.
"It’s incumbent on doctors to explain to patients that there are valuable reasons" behind transactions with companies, she said. "It’s helpful for physicians to be able to explain why these relationships are important."
On Twitter @legal_med
Early communication with pharmaceutical companies about the requirements of the Physician Payment Sunshine Act and better education on its provisions will prevent data disputes and reduce reporting surprises for doctors.
"A lot of physicians don’t realize how broad [the law] is," Stefanie A. Doebler, special counsel for Covington & Burling health care and food and drug practice groups in Washington, said in an interview. "Virtually everything [doctors] get from a manufacturer going forward is going to be reported. They need to be aware. They need to ask questions."
The federal Sunshine Act, adopted as part of the Affordable Care Act, requires manufacturers of drugs, devices, and biologics who participate in federal health care programs to report payments and items of value provided to physicians and teaching hospitals. The information must be made publicly available on a searchable federal database starting in September.
The federal government now calls the program Open Payments.
A 45-day review and dispute period for physicians began July 14. During this period, doctors can register with the Centers for Medicaid & Medicare Services’s Enterprise Portal, review data reported about them, and, if desired, initiate disputes with applicable manufacturers. Drug and device makers will then have an additional 15 days from then – ending Sept. 11 – to submit updated information to CMS.
Physicians need to make time to register and review their information now, Ms. Doebler said in an interview.
"They really need to be on top of reviewing their data," she said. "It’s kind of a pain in the neck for doctors, but they want to review it now and not once it goes public. Once it goes public, it’s there until the data is refreshed 6 months from now. They want to catch it now."
Physicians appear to be unclear on some areas of the law, Robert Ciolek, senior corporate counsel for Bristol-Myers Squibb, said during an American Bar Association webinar. For example, confusion often surfaces about whether the cost of lunches provided during educational programs are reportable.
"Frequently, the best opportunity [manufacturers] have is to do a lunch program where they can sit with a hospital staff and put together an educational program that talks either about a disease area or about a manufacturer’s product," Mr. Ciolek said. "The issue that always arises is, ‘What about the meal? Is it going to be reportable?’ We’ve seen time and time again, where doctors simply don’t understand the rule."
If a doctor consumes a meal in such a setting, the cost of the physician’s meal is reportable, Mr. Ciolek said. However, the cost of meals provided to office staff or other health care team members is not reportable. If physicians do not want their lunch costs reported, but still want to attend the program, they should not eat the meal, he said.
Open Payments requirements should be discussed by companies and physicians and/or noted before or at the time of transfers of value, said Carolyn M. Bruguera, vice president of consulting services and general counsel for R-Squared Services & Solutions, a consulting and software firm.
For instance, language regarding the law should be included in contracts, referenced on sign-in sheets for group meals, or stated orally during meetings.
Many large manufacturers and industry trade groups have developed websites and brochures to help educate physicians about reporting obligations, she added.
"These are also good tools for avoiding disputes and misunderstandings, but in some cases, manufacturers may need to be more proactive about getting the information to the covered recipients," she said. "Greater coordination with, for example, physician groups, such as specialty societies, might be helpful in this regard."
Another crucial step for doctors is explaining to patients their relationships with pharmaceutical companies and device manufacturers and ensuring patients understand why these interactions are useful, Ms. Doebler said. Once the value transfers go public, some mainstream media likely will paint all transfers of value among companies and doctors in a negative light, she said.
"It’s incumbent on doctors to explain to patients that there are valuable reasons" behind transactions with companies, she said. "It’s helpful for physicians to be able to explain why these relationships are important."
On Twitter @legal_med
