Practice Economics

A self-funded insurer does not have to share health data with a state’s all-payer database, according to a March 1 U.S. Supreme Court decision that could affect information-sharing reforms nationwide.

In a 6-2 opinion, the majority justices ruled that the Employee Retirement Income Security Act (ERISA) protects plaintiff Liberty Mutual from having to provide claims and member data to the Vermont Green Mountain Care Board. ERISA, which includes its own reporting, disclosure, and record-keeping provisions, has an express clause that invalidates Vermont’s reporting statute as applied to ERISA plans, Associate Justice Anthony Kennedy wrote in the opinion.

©jsmith/iStockphoto

“The state statute imposes duties that are inconsistent with the central design of ERISA, which is to provide a single uniform national scheme for the administration of ERISA plans without interference from laws of the several states even when those laws, to a large extent, impose parallel requirements,” Justice Kennedy wrote.

Associate Justice Ruth Bader-Ginsburg and Associate Justice Sonia Sotomayor dissented with the majority, insisting that Vermont’s database does not infringe on ERISA’s control to regulate self-funded plans. Seventeen other states have enacted similar database systems, which aim to “serve compelling interests,” Justice Ginsburg wrote, such as identifying effective reforms, driving down health care costs, evaluating utility of treatment options, and detecting discrimination in care provision.

“I would hold that Vermont’s effort to track health care services provided to its residents and the cost of those services does not impermissibly intrude on ERISA’s dominion over employee benefit plans,” Justice Ginsburg wrote in her dissent.

The case of Gobeille v. Liberty Mutual Insurance Company stems from a Vermont law that requires all health providers in the state to provide detailed data about their services for the development of an all-payer database. Liberty Mutual argued the law imposed a burden on the self-funded plan because it enforces sharing requirements on top of reporting and disclosure obligations already necessary for the federal Department of Labor. Vermont Green Mountain Care Board Chair Al Gobeille argued the insurer’s purported burdens are trivial because the insurer’s claims administrator already prepares the data required to the state for its non-ERISA operations in Vermont. The 2nd U.S. Circuit Court of Appeals sided with Liberty Mutual.

Liberty Mutual was “pleased,” with the Supreme Court ruling, spokesman John Cusolito said in an interview. He declined to comment further. Mr. Gobeille had not returned a request for comment at press time.

Medical associations expressed disappointment at the ruling.

“It is unfortunate that Vermont’s efforts to increase transparency of health insurance information has been thwarted. The U.S. Supreme Court determined today that a highly complex and confusing federal law can be used to keep the insurance payment process cloaked in mystery,” Dr. Steven J. Stack, president of the American Medical Association said in a statement. “The ruling stands in the way of reform efforts in Vermont and at least 18 other states aimed at providing important information to patients, health professionals and policymakers about health care options, outcomes and costs.”

The American Hospital Association concurred. “Self-insured plans cover a large, growing, and distinctive portion of the population,” AHA spokeswoman Marie Watteau said in a statement. “It is essential that they be included in all-payer databases if those databases are to realize their potential, and if America’s hospitals are to realize their goal of improving community health and controlling costs while providing the high-quality care for which they are known.”

Other medical associations previously weighed in on the case. In a friend-of-the-court brief to the U.S. Supreme Court, the AMA and the Vermont Medical Society said the Gobeille case presents a prime opportunity for the Supreme Court to reexamine ERISA and alleviate confusion between traditional state regulation of health care and exclusive federal regulation of employee benefit plans.

Seventeen states and the District of Columbia issued a joint brief in support of Vermont. A handful of insurers, including the Blue Cross and Blue Shield Association penned briefs in support of Liberty Mutual.

[email protected]

On Twitter @legal_med

A self-funded insurer does not have to share health data with a state’s all-payer database, according to a March 1 U.S. Supreme Court decision that could affect information-sharing reforms nationwide.

In a 6-2 opinion, the majority justices ruled that the Employee Retirement Income Security Act (ERISA) protects plaintiff Liberty Mutual from having to provide claims and member data to the Vermont Green Mountain Care Board. ERISA, which includes its own reporting, disclosure, and record-keeping provisions, has an express clause that invalidates Vermont’s reporting statute as applied to ERISA plans, Associate Justice Anthony Kennedy wrote in the opinion.

©jsmith/iStockphoto

“The state statute imposes duties that are inconsistent with the central design of ERISA, which is to provide a single uniform national scheme for the administration of ERISA plans without interference from laws of the several states even when those laws, to a large extent, impose parallel requirements,” Justice Kennedy wrote.

Associate Justice Ruth Bader-Ginsburg and Associate Justice Sonia Sotomayor dissented with the majority, insisting that Vermont’s database does not infringe on ERISA’s control to regulate self-funded plans. Seventeen other states have enacted similar database systems, which aim to “serve compelling interests,” Justice Ginsburg wrote, such as identifying effective reforms, driving down health care costs, evaluating utility of treatment options, and detecting discrimination in care provision.

“I would hold that Vermont’s effort to track health care services provided to its residents and the cost of those services does not impermissibly intrude on ERISA’s dominion over employee benefit plans,” Justice Ginsburg wrote in her dissent.

The case of Gobeille v. Liberty Mutual Insurance Company stems from a Vermont law that requires all health providers in the state to provide detailed data about their services for the development of an all-payer database. Liberty Mutual argued the law imposed a burden on the self-funded plan because it enforces sharing requirements on top of reporting and disclosure obligations already necessary for the federal Department of Labor. Vermont Green Mountain Care Board Chair Al Gobeille argued the insurer’s purported burdens are trivial because the insurer’s claims administrator already prepares the data required to the state for its non-ERISA operations in Vermont. The 2nd U.S. Circuit Court of Appeals sided with Liberty Mutual.

Liberty Mutual was “pleased,” with the Supreme Court ruling, spokesman John Cusolito said in an interview. He declined to comment further. Mr. Gobeille had not returned a request for comment at press time.

Medical associations expressed disappointment at the ruling.

“It is unfortunate that Vermont’s efforts to increase transparency of health insurance information has been thwarted. The U.S. Supreme Court determined today that a highly complex and confusing federal law can be used to keep the insurance payment process cloaked in mystery,” Dr. Steven J. Stack, president of the American Medical Association said in a statement. “The ruling stands in the way of reform efforts in Vermont and at least 18 other states aimed at providing important information to patients, health professionals and policymakers about health care options, outcomes and costs.”

The American Hospital Association concurred. “Self-insured plans cover a large, growing, and distinctive portion of the population,” AHA spokeswoman Marie Watteau said in a statement. “It is essential that they be included in all-payer databases if those databases are to realize their potential, and if America’s hospitals are to realize their goal of improving community health and controlling costs while providing the high-quality care for which they are known.”

Other medical associations previously weighed in on the case. In a friend-of-the-court brief to the U.S. Supreme Court, the AMA and the Vermont Medical Society said the Gobeille case presents a prime opportunity for the Supreme Court to reexamine ERISA and alleviate confusion between traditional state regulation of health care and exclusive federal regulation of employee benefit plans.

Seventeen states and the District of Columbia issued a joint brief in support of Vermont. A handful of insurers, including the Blue Cross and Blue Shield Association penned briefs in support of Liberty Mutual.

[email protected]

On Twitter @legal_med

A self-funded insurer does not have to share health data with a state’s all-payer database, according to a March 1 U.S. Supreme Court decision that could affect information-sharing reforms nationwide.

In a 6-2 opinion, the majority justices ruled that the Employee Retirement Income Security Act (ERISA) protects plaintiff Liberty Mutual from having to provide claims and member data to the Vermont Green Mountain Care Board. ERISA, which includes its own reporting, disclosure, and record-keeping provisions, has an express clause that invalidates Vermont’s reporting statute as applied to ERISA plans, Associate Justice Anthony Kennedy wrote in the opinion.

©jsmith/iStockphoto

“The state statute imposes duties that are inconsistent with the central design of ERISA, which is to provide a single uniform national scheme for the administration of ERISA plans without interference from laws of the several states even when those laws, to a large extent, impose parallel requirements,” Justice Kennedy wrote.

Associate Justice Ruth Bader-Ginsburg and Associate Justice Sonia Sotomayor dissented with the majority, insisting that Vermont’s database does not infringe on ERISA’s control to regulate self-funded plans. Seventeen other states have enacted similar database systems, which aim to “serve compelling interests,” Justice Ginsburg wrote, such as identifying effective reforms, driving down health care costs, evaluating utility of treatment options, and detecting discrimination in care provision.

“I would hold that Vermont’s effort to track health care services provided to its residents and the cost of those services does not impermissibly intrude on ERISA’s dominion over employee benefit plans,” Justice Ginsburg wrote in her dissent.

The case of Gobeille v. Liberty Mutual Insurance Company stems from a Vermont law that requires all health providers in the state to provide detailed data about their services for the development of an all-payer database. Liberty Mutual argued the law imposed a burden on the self-funded plan because it enforces sharing requirements on top of reporting and disclosure obligations already necessary for the federal Department of Labor. Vermont Green Mountain Care Board Chair Al Gobeille argued the insurer’s purported burdens are trivial because the insurer’s claims administrator already prepares the data required to the state for its non-ERISA operations in Vermont. The 2nd U.S. Circuit Court of Appeals sided with Liberty Mutual.

Liberty Mutual was “pleased,” with the Supreme Court ruling, spokesman John Cusolito said in an interview. He declined to comment further. Mr. Gobeille had not returned a request for comment at press time.

Medical associations expressed disappointment at the ruling.

“It is unfortunate that Vermont’s efforts to increase transparency of health insurance information has been thwarted. The U.S. Supreme Court determined today that a highly complex and confusing federal law can be used to keep the insurance payment process cloaked in mystery,” Dr. Steven J. Stack, president of the American Medical Association said in a statement. “The ruling stands in the way of reform efforts in Vermont and at least 18 other states aimed at providing important information to patients, health professionals and policymakers about health care options, outcomes and costs.”

The American Hospital Association concurred. “Self-insured plans cover a large, growing, and distinctive portion of the population,” AHA spokeswoman Marie Watteau said in a statement. “It is essential that they be included in all-payer databases if those databases are to realize their potential, and if America’s hospitals are to realize their goal of improving community health and controlling costs while providing the high-quality care for which they are known.”

Other medical associations previously weighed in on the case. In a friend-of-the-court brief to the U.S. Supreme Court, the AMA and the Vermont Medical Society said the Gobeille case presents a prime opportunity for the Supreme Court to reexamine ERISA and alleviate confusion between traditional state regulation of health care and exclusive federal regulation of employee benefit plans.

Seventeen states and the District of Columbia issued a joint brief in support of Vermont. A handful of insurers, including the Blue Cross and Blue Shield Association penned briefs in support of Liberty Mutual.

[email protected]

On Twitter @legal_med

We’re lost, but we’re making good time.
                                           -Yogi Berra

As Yogi Berra alludes, it is very easy to get caught up “in the flow” and continue to move along at a good pace, even when one does not know where he or she is ultimately headed. Similarly, in terms of medical malpractice, everyone seems to have an opinion on what should be done to improve the climate of medical malpractice for both providers and patients. Yet, there are many differences in opinions on how to solve these issues, and the “cure” for what “ails” in the system are many—with an undetermined endpoint.

Tort reform is often conjured as the communal fix; yet each state in the Union has its own medical malpractice tort laws, which begs the question of how an issue with so many different facets can be resolved. Additionally, the risk alone of medical malpractice continues to be an important area of concern to emergency physicians (EPs), not only because of the looming threat of malpractice litigation—both real and perceived—but also because of its influence on practice patterns, resource utilization, and patient care in the ED.^1,2

Physician Perception

Over the course of a career, an EP faces at least one claim, further perpetuating a common physician perception that the occurrence of a suit is not a condition of “if” but rather of “when.”³ This anxiety and fear among physicians in general are further provoked by the many headlines highlighting massive jury verdicts that dominate the news cycle.⁴ 

In addition, the EP’s work and practice are increasingly affected by the impositions of multiple nationally reported quality metrics, institutional throughput goals, and process-improvement efforts. Each of these in turn has the effect of increasing the pace of care and can challenge one’s real-time ability to recognize the dangers of inherent biases, to appreciate and act upon subtle clinical clues, and to rescue patient-experience misadventures. Accordingly, medical malpractice is a frequent topic of discussion for policy proposals among physicians and legislators.

Defensive Medicine and Tort Reform

As spending on health care in the United States topped $3 trillion, or 17.5% of the US gross domestic product in 2014, strategies for cost-containment have become a primary concern across all sectors of the health-care industry.^5,6 With defensive medicine proposed by some as a substantial driver of health-care costs, many physicians have focused on tort reform as an avenue to curb defensive testing. This has resulted in substantial policy shifts in a number of jurisdictions.^7,8 Some of the policy changes that have taken place over the past few decades have included state-imposed caps on medical malpractice awards and noneconomic damages, caps on attorney fees, and shortened statutes of limitations that require more timely filing of malpractice suits.

Defining Malpractice and Imposing Caps

In 2003, Texas changed its definition of the medical malpractice standard to “willful and wanton negligence”; in Georgia (2005) and South Carolina (2005) the definition was changed to “gross negligence.” Both of these revised definitions are essentially synonymous in a legal sense and are intended to protect physicians working in a high-risk, limited-information, high-intensity environment (eg, the ED) by raising the plaintiff’s responsibility to prove that the defendant physician was aware of the likelihood of serious injury but proceeded with “conscious indifference.”⁹

It seems, however, that such efforts have been not been entirely effective in reigning in costs of care, decreasing insurance costs, and limiting defensive medicine, particularly in the ED.⁹ A study by Paik et a^l10 on the effect of caps on malpractice claims and payouts found that in states with caps, both claims and payouts were effectively reduced, with a large impact on payout per physician and a drop in claims for those cases with larger payouts. While stricter caps had larger effects, the authors did not examine the impact of caps on “defensive medicine.”¹⁰ Furthermore, many physicians, health systems, and patient advocacy groups have been exploring and implementing alternative models of claim resolution outside of the legal process.¹¹

Alternative Compensation Models

In the state legislatures of Georgia and Florida, alternative patient-compensation models are currently under proposal. Both models are designed to eliminate the current medical tort system and replace it with an administrative system to compensate patients for medical errors that have caused them harm.¹² These proposals are similar to the existing Birth-Related Neurological Injury Compensation Programs (BRNICP) in effect in both Florida and Virginia. The BRNICP in each of these states serves as an administrative system to provide monetary compensation to patients who have clearly suffered only birth-related medical injuries, thus keeping this type of liability out of the court system.

Program Structure
Compensation programs such as the BRNICP in Florida and Virginia would replace traditional tort law. In this system, physicians would pay annually into a compensation fund (as do the physicians in Virginia and Florida), with amounts prorated to liability risk based on practice specialty. A patient harmed by a claimed medical injury that was allegedly caused by the proximate treatment rendered, would apply to the patient compensation system via a designated patient advocate. The advocate would initiate the claim process on behalf of the patient, after which the claim would be reviewed by a panel of medical experts in the appropriate field. If the panel finds the injury was preventable or avoidable, the case would then proceed to a compensation committee to render payment to the injured individual.  

This compensation model not only eliminates the need for legal counsel for the patient, but also the need for medical malpractice liability insurance and defense counsel for the physician. Unlike traditional tort law, this alternate process encourages a system of transparency that supports appropriate disclosure of medical error rather than delaying late discovery of error and increased angst both for the patient and the physician.

Potential Benefits
One would anticipate that an alternate compensation model such as the BRNCIP that eliminates the fear of a lawsuit (ie, if patients no longer sued physicians for medical malpractice) would have a significant impact on defensive medicine and its associated costs. A study conducted by Emory University concluded that as much as $7 billion in the state of Georgia could be saved each year if such a program was enacted.¹³ In addition to the financial benefits, the care of all patients would improve through increased efficiency and better appropriation of finite resources. Moreover, patients harmed in a medical mishap would have a more direct, expedited, and less expensive mechanism of compensation compared to traditional tort systems.

The alternate compensation model would also benefit patients by negating the need for legal counsel. In the current tort system, many cases go unaddressed either because the patient does not have the means to hire counsel or the case seems too inconsequential for a lawyer to accept it. The compensation system would improve access for patients with valid claims, from egregious high impact errors to the lower impact errors, which are still significant.

There are also public health benefits to the alternate compensation model, including advances in patient safety as a result of the transparency of medical error and addressing medical mishaps in a timelier manner, providing an opportunity to improve knowledge and system gaps closer to real-time events. No longer would a patient have to forge an adversarial offensive on a physician. The panel of experts, who becomes the peer of the physician, can fairly assess the conditions of the case and bring forth an impartial recommendation to either reimburse or not reimburse the patient.

By eliminating the punitive nature of tort law upon the physician, and because this system compensates through a state-based compensation program, there is no indelible report made naming the physician to the National Practitioner Data Bank. Further, if a provider is identified as a significant risk to the public, the panel of medical experts can report that physician to the state licensing board immediately, which would prove more effective and efficient than the traditional method of data collection and referral currently in place in most states.

Challenges
Challenges to these bills include resistance from those who may be adversely affected by such legislation—mainly medical malpractice trial lawyers (both plaintiff and defendant) and medical malpractice insurance companies.

Conclusion

In consideration of innovative solutions to medical malpractice reform, the efforts in the states of Georgia and Florida clearly think outside the box. Neither of these proposed solutions is currently operational, but certainly if they become state statutes, they will create a very interesting environment to observe while the effects of such systems play out. The operations of the birth-related injury funds have been successful in states that have already implemented such programs. In the meantime, pending such changes in policy and legislation, EPs can mitigate malpractice risk by maintaining board certification and specialty training requirements, and by employing the following:

     Follow the basic principles for every patient. Vital signs are vital for a reason, and all abnormal data must be accounted for;

     Maintain open communication with patients—a paramount component in reducing the risk of a malpractice allegation;

     Ensure that all members of the care team engender an environment that is focused on patient safety, including open      communication with nursing staff and technical support;

     Be aware of inherent biases in medical decision-making, which helps to maintain mindfulness in the routine practice of      emergency medicine (EM);

     Make sure departmental policies and procedures are designed to identify and address all late resulting laboratory results,      radiology reading discrepancies and culture results in a timely and uniform manner; and

     Provide clear and concise at-home care instructions to patients—prior to discharge—and in a manner the patient can      understand.

Part 2 will discuss each of these recommendations in detail and will consider recent trends in medical malpractice as they relate to EM, explore areas of risk, and discuss strategies to reduce medical malpractice risk in the ED.

We’re lost, but we’re making good time.
                                           -Yogi Berra

As Yogi Berra alludes, it is very easy to get caught up “in the flow” and continue to move along at a good pace, even when one does not know where he or she is ultimately headed. Similarly, in terms of medical malpractice, everyone seems to have an opinion on what should be done to improve the climate of medical malpractice for both providers and patients. Yet, there are many differences in opinions on how to solve these issues, and the “cure” for what “ails” in the system are many—with an undetermined endpoint.

Tort reform is often conjured as the communal fix; yet each state in the Union has its own medical malpractice tort laws, which begs the question of how an issue with so many different facets can be resolved. Additionally, the risk alone of medical malpractice continues to be an important area of concern to emergency physicians (EPs), not only because of the looming threat of malpractice litigation—both real and perceived—but also because of its influence on practice patterns, resource utilization, and patient care in the ED.^1,2

Physician Perception

Over the course of a career, an EP faces at least one claim, further perpetuating a common physician perception that the occurrence of a suit is not a condition of “if” but rather of “when.”³ This anxiety and fear among physicians in general are further provoked by the many headlines highlighting massive jury verdicts that dominate the news cycle.⁴ 

In addition, the EP’s work and practice are increasingly affected by the impositions of multiple nationally reported quality metrics, institutional throughput goals, and process-improvement efforts. Each of these in turn has the effect of increasing the pace of care and can challenge one’s real-time ability to recognize the dangers of inherent biases, to appreciate and act upon subtle clinical clues, and to rescue patient-experience misadventures. Accordingly, medical malpractice is a frequent topic of discussion for policy proposals among physicians and legislators.

Defensive Medicine and Tort Reform

As spending on health care in the United States topped $3 trillion, or 17.5% of the US gross domestic product in 2014, strategies for cost-containment have become a primary concern across all sectors of the health-care industry.^5,6 With defensive medicine proposed by some as a substantial driver of health-care costs, many physicians have focused on tort reform as an avenue to curb defensive testing. This has resulted in substantial policy shifts in a number of jurisdictions.^7,8 Some of the policy changes that have taken place over the past few decades have included state-imposed caps on medical malpractice awards and noneconomic damages, caps on attorney fees, and shortened statutes of limitations that require more timely filing of malpractice suits.

Defining Malpractice and Imposing Caps

In 2003, Texas changed its definition of the medical malpractice standard to “willful and wanton negligence”; in Georgia (2005) and South Carolina (2005) the definition was changed to “gross negligence.” Both of these revised definitions are essentially synonymous in a legal sense and are intended to protect physicians working in a high-risk, limited-information, high-intensity environment (eg, the ED) by raising the plaintiff’s responsibility to prove that the defendant physician was aware of the likelihood of serious injury but proceeded with “conscious indifference.”⁹

It seems, however, that such efforts have been not been entirely effective in reigning in costs of care, decreasing insurance costs, and limiting defensive medicine, particularly in the ED.⁹ A study by Paik et a^l10 on the effect of caps on malpractice claims and payouts found that in states with caps, both claims and payouts were effectively reduced, with a large impact on payout per physician and a drop in claims for those cases with larger payouts. While stricter caps had larger effects, the authors did not examine the impact of caps on “defensive medicine.”¹⁰ Furthermore, many physicians, health systems, and patient advocacy groups have been exploring and implementing alternative models of claim resolution outside of the legal process.¹¹

Alternative Compensation Models

In the state legislatures of Georgia and Florida, alternative patient-compensation models are currently under proposal. Both models are designed to eliminate the current medical tort system and replace it with an administrative system to compensate patients for medical errors that have caused them harm.¹² These proposals are similar to the existing Birth-Related Neurological Injury Compensation Programs (BRNICP) in effect in both Florida and Virginia. The BRNICP in each of these states serves as an administrative system to provide monetary compensation to patients who have clearly suffered only birth-related medical injuries, thus keeping this type of liability out of the court system.

Program Structure
Compensation programs such as the BRNICP in Florida and Virginia would replace traditional tort law. In this system, physicians would pay annually into a compensation fund (as do the physicians in Virginia and Florida), with amounts prorated to liability risk based on practice specialty. A patient harmed by a claimed medical injury that was allegedly caused by the proximate treatment rendered, would apply to the patient compensation system via a designated patient advocate. The advocate would initiate the claim process on behalf of the patient, after which the claim would be reviewed by a panel of medical experts in the appropriate field. If the panel finds the injury was preventable or avoidable, the case would then proceed to a compensation committee to render payment to the injured individual.  

This compensation model not only eliminates the need for legal counsel for the patient, but also the need for medical malpractice liability insurance and defense counsel for the physician. Unlike traditional tort law, this alternate process encourages a system of transparency that supports appropriate disclosure of medical error rather than delaying late discovery of error and increased angst both for the patient and the physician.

Potential Benefits
One would anticipate that an alternate compensation model such as the BRNCIP that eliminates the fear of a lawsuit (ie, if patients no longer sued physicians for medical malpractice) would have a significant impact on defensive medicine and its associated costs. A study conducted by Emory University concluded that as much as $7 billion in the state of Georgia could be saved each year if such a program was enacted.¹³ In addition to the financial benefits, the care of all patients would improve through increased efficiency and better appropriation of finite resources. Moreover, patients harmed in a medical mishap would have a more direct, expedited, and less expensive mechanism of compensation compared to traditional tort systems.

The alternate compensation model would also benefit patients by negating the need for legal counsel. In the current tort system, many cases go unaddressed either because the patient does not have the means to hire counsel or the case seems too inconsequential for a lawyer to accept it. The compensation system would improve access for patients with valid claims, from egregious high impact errors to the lower impact errors, which are still significant.

There are also public health benefits to the alternate compensation model, including advances in patient safety as a result of the transparency of medical error and addressing medical mishaps in a timelier manner, providing an opportunity to improve knowledge and system gaps closer to real-time events. No longer would a patient have to forge an adversarial offensive on a physician. The panel of experts, who becomes the peer of the physician, can fairly assess the conditions of the case and bring forth an impartial recommendation to either reimburse or not reimburse the patient.

By eliminating the punitive nature of tort law upon the physician, and because this system compensates through a state-based compensation program, there is no indelible report made naming the physician to the National Practitioner Data Bank. Further, if a provider is identified as a significant risk to the public, the panel of medical experts can report that physician to the state licensing board immediately, which would prove more effective and efficient than the traditional method of data collection and referral currently in place in most states.

Challenges
Challenges to these bills include resistance from those who may be adversely affected by such legislation—mainly medical malpractice trial lawyers (both plaintiff and defendant) and medical malpractice insurance companies.

Conclusion

In consideration of innovative solutions to medical malpractice reform, the efforts in the states of Georgia and Florida clearly think outside the box. Neither of these proposed solutions is currently operational, but certainly if they become state statutes, they will create a very interesting environment to observe while the effects of such systems play out. The operations of the birth-related injury funds have been successful in states that have already implemented such programs. In the meantime, pending such changes in policy and legislation, EPs can mitigate malpractice risk by maintaining board certification and specialty training requirements, and by employing the following:

     Follow the basic principles for every patient. Vital signs are vital for a reason, and all abnormal data must be accounted for;

     Maintain open communication with patients—a paramount component in reducing the risk of a malpractice allegation;

     Ensure that all members of the care team engender an environment that is focused on patient safety, including open      communication with nursing staff and technical support;

     Be aware of inherent biases in medical decision-making, which helps to maintain mindfulness in the routine practice of      emergency medicine (EM);

     Make sure departmental policies and procedures are designed to identify and address all late resulting laboratory results,      radiology reading discrepancies and culture results in a timely and uniform manner; and

     Provide clear and concise at-home care instructions to patients—prior to discharge—and in a manner the patient can      understand.

Part 2 will discuss each of these recommendations in detail and will consider recent trends in medical malpractice as they relate to EM, explore areas of risk, and discuss strategies to reduce medical malpractice risk in the ED.

We’re lost, but we’re making good time.
                                           -Yogi Berra

As Yogi Berra alludes, it is very easy to get caught up “in the flow” and continue to move along at a good pace, even when one does not know where he or she is ultimately headed. Similarly, in terms of medical malpractice, everyone seems to have an opinion on what should be done to improve the climate of medical malpractice for both providers and patients. Yet, there are many differences in opinions on how to solve these issues, and the “cure” for what “ails” in the system are many—with an undetermined endpoint.

Tort reform is often conjured as the communal fix; yet each state in the Union has its own medical malpractice tort laws, which begs the question of how an issue with so many different facets can be resolved. Additionally, the risk alone of medical malpractice continues to be an important area of concern to emergency physicians (EPs), not only because of the looming threat of malpractice litigation—both real and perceived—but also because of its influence on practice patterns, resource utilization, and patient care in the ED.^1,2

Physician Perception

Over the course of a career, an EP faces at least one claim, further perpetuating a common physician perception that the occurrence of a suit is not a condition of “if” but rather of “when.”³ This anxiety and fear among physicians in general are further provoked by the many headlines highlighting massive jury verdicts that dominate the news cycle.⁴ 

In addition, the EP’s work and practice are increasingly affected by the impositions of multiple nationally reported quality metrics, institutional throughput goals, and process-improvement efforts. Each of these in turn has the effect of increasing the pace of care and can challenge one’s real-time ability to recognize the dangers of inherent biases, to appreciate and act upon subtle clinical clues, and to rescue patient-experience misadventures. Accordingly, medical malpractice is a frequent topic of discussion for policy proposals among physicians and legislators.

Defensive Medicine and Tort Reform

As spending on health care in the United States topped $3 trillion, or 17.5% of the US gross domestic product in 2014, strategies for cost-containment have become a primary concern across all sectors of the health-care industry.^5,6 With defensive medicine proposed by some as a substantial driver of health-care costs, many physicians have focused on tort reform as an avenue to curb defensive testing. This has resulted in substantial policy shifts in a number of jurisdictions.^7,8 Some of the policy changes that have taken place over the past few decades have included state-imposed caps on medical malpractice awards and noneconomic damages, caps on attorney fees, and shortened statutes of limitations that require more timely filing of malpractice suits.

Defining Malpractice and Imposing Caps

In 2003, Texas changed its definition of the medical malpractice standard to “willful and wanton negligence”; in Georgia (2005) and South Carolina (2005) the definition was changed to “gross negligence.” Both of these revised definitions are essentially synonymous in a legal sense and are intended to protect physicians working in a high-risk, limited-information, high-intensity environment (eg, the ED) by raising the plaintiff’s responsibility to prove that the defendant physician was aware of the likelihood of serious injury but proceeded with “conscious indifference.”⁹

It seems, however, that such efforts have been not been entirely effective in reigning in costs of care, decreasing insurance costs, and limiting defensive medicine, particularly in the ED.⁹ A study by Paik et a^l10 on the effect of caps on malpractice claims and payouts found that in states with caps, both claims and payouts were effectively reduced, with a large impact on payout per physician and a drop in claims for those cases with larger payouts. While stricter caps had larger effects, the authors did not examine the impact of caps on “defensive medicine.”¹⁰ Furthermore, many physicians, health systems, and patient advocacy groups have been exploring and implementing alternative models of claim resolution outside of the legal process.¹¹

Alternative Compensation Models

In the state legislatures of Georgia and Florida, alternative patient-compensation models are currently under proposal. Both models are designed to eliminate the current medical tort system and replace it with an administrative system to compensate patients for medical errors that have caused them harm.¹² These proposals are similar to the existing Birth-Related Neurological Injury Compensation Programs (BRNICP) in effect in both Florida and Virginia. The BRNICP in each of these states serves as an administrative system to provide monetary compensation to patients who have clearly suffered only birth-related medical injuries, thus keeping this type of liability out of the court system.

Program Structure
Compensation programs such as the BRNICP in Florida and Virginia would replace traditional tort law. In this system, physicians would pay annually into a compensation fund (as do the physicians in Virginia and Florida), with amounts prorated to liability risk based on practice specialty. A patient harmed by a claimed medical injury that was allegedly caused by the proximate treatment rendered, would apply to the patient compensation system via a designated patient advocate. The advocate would initiate the claim process on behalf of the patient, after which the claim would be reviewed by a panel of medical experts in the appropriate field. If the panel finds the injury was preventable or avoidable, the case would then proceed to a compensation committee to render payment to the injured individual.  

This compensation model not only eliminates the need for legal counsel for the patient, but also the need for medical malpractice liability insurance and defense counsel for the physician. Unlike traditional tort law, this alternate process encourages a system of transparency that supports appropriate disclosure of medical error rather than delaying late discovery of error and increased angst both for the patient and the physician.

Potential Benefits
One would anticipate that an alternate compensation model such as the BRNCIP that eliminates the fear of a lawsuit (ie, if patients no longer sued physicians for medical malpractice) would have a significant impact on defensive medicine and its associated costs. A study conducted by Emory University concluded that as much as $7 billion in the state of Georgia could be saved each year if such a program was enacted.¹³ In addition to the financial benefits, the care of all patients would improve through increased efficiency and better appropriation of finite resources. Moreover, patients harmed in a medical mishap would have a more direct, expedited, and less expensive mechanism of compensation compared to traditional tort systems.

The alternate compensation model would also benefit patients by negating the need for legal counsel. In the current tort system, many cases go unaddressed either because the patient does not have the means to hire counsel or the case seems too inconsequential for a lawyer to accept it. The compensation system would improve access for patients with valid claims, from egregious high impact errors to the lower impact errors, which are still significant.

There are also public health benefits to the alternate compensation model, including advances in patient safety as a result of the transparency of medical error and addressing medical mishaps in a timelier manner, providing an opportunity to improve knowledge and system gaps closer to real-time events. No longer would a patient have to forge an adversarial offensive on a physician. The panel of experts, who becomes the peer of the physician, can fairly assess the conditions of the case and bring forth an impartial recommendation to either reimburse or not reimburse the patient.

By eliminating the punitive nature of tort law upon the physician, and because this system compensates through a state-based compensation program, there is no indelible report made naming the physician to the National Practitioner Data Bank. Further, if a provider is identified as a significant risk to the public, the panel of medical experts can report that physician to the state licensing board immediately, which would prove more effective and efficient than the traditional method of data collection and referral currently in place in most states.

Challenges
Challenges to these bills include resistance from those who may be adversely affected by such legislation—mainly medical malpractice trial lawyers (both plaintiff and defendant) and medical malpractice insurance companies.

Conclusion

In consideration of innovative solutions to medical malpractice reform, the efforts in the states of Georgia and Florida clearly think outside the box. Neither of these proposed solutions is currently operational, but certainly if they become state statutes, they will create a very interesting environment to observe while the effects of such systems play out. The operations of the birth-related injury funds have been successful in states that have already implemented such programs. In the meantime, pending such changes in policy and legislation, EPs can mitigate malpractice risk by maintaining board certification and specialty training requirements, and by employing the following:

     Follow the basic principles for every patient. Vital signs are vital for a reason, and all abnormal data must be accounted for;

     Maintain open communication with patients—a paramount component in reducing the risk of a malpractice allegation;

     Ensure that all members of the care team engender an environment that is focused on patient safety, including open      communication with nursing staff and technical support;

     Be aware of inherent biases in medical decision-making, which helps to maintain mindfulness in the routine practice of      emergency medicine (EM);

     Make sure departmental policies and procedures are designed to identify and address all late resulting laboratory results,      radiology reading discrepancies and culture results in a timely and uniform manner; and

     Provide clear and concise at-home care instructions to patients—prior to discharge—and in a manner the patient can      understand.

Part 2 will discuss each of these recommendations in detail and will consider recent trends in medical malpractice as they relate to EM, explore areas of risk, and discuss strategies to reduce medical malpractice risk in the ED.

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

AUSTIN, TEX. – As use of mid-level providers grows, legal risks for practices also can rise.

In this video interview at an American Health Lawyers Association conference, attorney Alex T. Krouse discusses common liability dangers that arise when working with physician assistants and nurse practitioners. Mr. Krouse also speaks about frequent billing errors that can happen within provider teams and breaks down the difference between physician supervision and physician collaboration.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – As use of mid-level providers grows, legal risks for practices also can rise.

In this video interview at an American Health Lawyers Association conference, attorney Alex T. Krouse discusses common liability dangers that arise when working with physician assistants and nurse practitioners. Mr. Krouse also speaks about frequent billing errors that can happen within provider teams and breaks down the difference between physician supervision and physician collaboration.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – As use of mid-level providers grows, legal risks for practices also can rise.

In this video interview at an American Health Lawyers Association conference, attorney Alex T. Krouse discusses common liability dangers that arise when working with physician assistants and nurse practitioners. Mr. Krouse also speaks about frequent billing errors that can happen within provider teams and breaks down the difference between physician supervision and physician collaboration.

[email protected]

On Twitter @legal_med

WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.

Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.

The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.

The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.

Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.

“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”

He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.

The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.

He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.

“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”

As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.

In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.

“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”

[email protected]

WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.

Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.

The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.

The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.

Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.

“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”

He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.

The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.

He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.

“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”

As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.

In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.

“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”

[email protected]

WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.

Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.

The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.

The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.

Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.

“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”

He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.

The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.

He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.

“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”

As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.

In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.

“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”

[email protected]

Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.

Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.

FDA photo by Michael J. Ermarth

“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”

Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.

The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).

“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.

Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.

Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.

“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”

On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.

“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”

Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.

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On Twitter @legal_med

Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.

Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.

FDA photo by Michael J. Ermarth

“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”

Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.

The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).

“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.

Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.

Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.

“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”

On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.

“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”

Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.

[email protected]

On Twitter @legal_med

Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.

Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.

FDA photo by Michael J. Ermarth

“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”

Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.

The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).

“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.

Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.

Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.

“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”

On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.

“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”

Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.

[email protected]

On Twitter @legal_med