Alicia Gallegos

More than a third of medical malpractice lawsuits against hospitalists involve allegations of diagnostic errors, according to a study by national medical liability insurer The Doctors Company published online March 3.

Darrell Ranum, vice president for patient safety and risk management for The Doctors Company, and his colleagues, analyzed 464 claims against hospitalists in the insurer’s database that were closed from 2007 to 2014. The claims involved 2,100 hospitalists insured by The Doctors Company. More than a third of claims (36%) were diagnostic related; they included allegations of incorrect diagnosis, delayed diagnosis, or failure to diagnosis, the study found.

Conditions most commonly associated with incorrect or delayed diagnosis included intestinal disorders, such as obstruction, perforation, and vascular insufficiency (16%), cerebral artery occlusion and acute cerebral vascular accident (7%), acute myocardial infarction, and cardiac arrest (6%). Other conditions linked to diagnostic malpractice claims against hospitalists included sepsis and toxic shock syndrome (5%), pulmonary embolism (5%), spinal epidural abscess (4%), lung cancer (4%), viral and bacterial pneumonia (3%), subacute and acute endocarditis (3%), and aortic dissection or aneurysm (3%).

A surprising finding of the study is the number of uncommon diagnoses connected to frequent malpractice allegations, said Dr. John Nelson, medical director for the hospitalist practice at Overlake Hospital in Bellevue, Wash., and cofounder of the Society of Hospital Medicine. The connection between spinal epidural abscess and lawsuits for example, shows that such patient cases pose a greater legal risk than other conditions, he said.

“If every patient posed an equal risk of leading to a malpractice claim, you would expect the claims to mirror the frequency of illness,” Dr. Nelson said in an interview. “But they don’t. That suggests that [certain] diseases are riskier for hospitalists from a medical-legal perspective.”

Among the other claims, 31% related to improper treatment management, 11% claimed medication errors, and 5% alleged improper performance or delay in treatment or procedure.

The study also analyzed top factors that contributed to patient injury by hospitalists. Patient assessment issues, such as to failure establish a differential diagnosis, were the most common contributor at 35%. Communication breakdowns among providers, such as poor transfer of information between doctors and nurses, were the second-most-frequent contributor at 23%. Other factors were selection and management of therapy (16%), communication issues between health providers and patients/family members (12%), failure to obtain a consult or referral (12%), and patient factors (12%). (Claims could have more than one contributing factor.)

Claims arising from hospitalist care were likely to involve greater patient injury severity than other physician specialties, the study found.

The study underscores the importance of developing positive relationships with patients and strengthening communications between specialists, Dr. Nelson said.

“Build rapport with patients,” he said. “Communicate well. Make sure it’s safe if you’re gong to wait and see how things go [overnight] with a patient. If you’re not so sure, perhaps it’s better to act quickly.”

[email protected]

More than a third of medical malpractice lawsuits against hospitalists involve allegations of diagnostic errors, according to a study by national medical liability insurer The Doctors Company published online March 3.

Darrell Ranum, vice president for patient safety and risk management for The Doctors Company, and his colleagues, analyzed 464 claims against hospitalists in the insurer’s database that were closed from 2007 to 2014. The claims involved 2,100 hospitalists insured by The Doctors Company. More than a third of claims (36%) were diagnostic related; they included allegations of incorrect diagnosis, delayed diagnosis, or failure to diagnosis, the study found.

Conditions most commonly associated with incorrect or delayed diagnosis included intestinal disorders, such as obstruction, perforation, and vascular insufficiency (16%), cerebral artery occlusion and acute cerebral vascular accident (7%), acute myocardial infarction, and cardiac arrest (6%). Other conditions linked to diagnostic malpractice claims against hospitalists included sepsis and toxic shock syndrome (5%), pulmonary embolism (5%), spinal epidural abscess (4%), lung cancer (4%), viral and bacterial pneumonia (3%), subacute and acute endocarditis (3%), and aortic dissection or aneurysm (3%).

A surprising finding of the study is the number of uncommon diagnoses connected to frequent malpractice allegations, said Dr. John Nelson, medical director for the hospitalist practice at Overlake Hospital in Bellevue, Wash., and cofounder of the Society of Hospital Medicine. The connection between spinal epidural abscess and lawsuits for example, shows that such patient cases pose a greater legal risk than other conditions, he said.

“If every patient posed an equal risk of leading to a malpractice claim, you would expect the claims to mirror the frequency of illness,” Dr. Nelson said in an interview. “But they don’t. That suggests that [certain] diseases are riskier for hospitalists from a medical-legal perspective.”

Among the other claims, 31% related to improper treatment management, 11% claimed medication errors, and 5% alleged improper performance or delay in treatment or procedure.

The study also analyzed top factors that contributed to patient injury by hospitalists. Patient assessment issues, such as to failure establish a differential diagnosis, were the most common contributor at 35%. Communication breakdowns among providers, such as poor transfer of information between doctors and nurses, were the second-most-frequent contributor at 23%. Other factors were selection and management of therapy (16%), communication issues between health providers and patients/family members (12%), failure to obtain a consult or referral (12%), and patient factors (12%). (Claims could have more than one contributing factor.)

Claims arising from hospitalist care were likely to involve greater patient injury severity than other physician specialties, the study found.

The study underscores the importance of developing positive relationships with patients and strengthening communications between specialists, Dr. Nelson said.

“Build rapport with patients,” he said. “Communicate well. Make sure it’s safe if you’re gong to wait and see how things go [overnight] with a patient. If you’re not so sure, perhaps it’s better to act quickly.”

[email protected]

More than a third of medical malpractice lawsuits against hospitalists involve allegations of diagnostic errors, according to a study by national medical liability insurer The Doctors Company published online March 3.

Darrell Ranum, vice president for patient safety and risk management for The Doctors Company, and his colleagues, analyzed 464 claims against hospitalists in the insurer’s database that were closed from 2007 to 2014. The claims involved 2,100 hospitalists insured by The Doctors Company. More than a third of claims (36%) were diagnostic related; they included allegations of incorrect diagnosis, delayed diagnosis, or failure to diagnosis, the study found.

Conditions most commonly associated with incorrect or delayed diagnosis included intestinal disorders, such as obstruction, perforation, and vascular insufficiency (16%), cerebral artery occlusion and acute cerebral vascular accident (7%), acute myocardial infarction, and cardiac arrest (6%). Other conditions linked to diagnostic malpractice claims against hospitalists included sepsis and toxic shock syndrome (5%), pulmonary embolism (5%), spinal epidural abscess (4%), lung cancer (4%), viral and bacterial pneumonia (3%), subacute and acute endocarditis (3%), and aortic dissection or aneurysm (3%).

A surprising finding of the study is the number of uncommon diagnoses connected to frequent malpractice allegations, said Dr. John Nelson, medical director for the hospitalist practice at Overlake Hospital in Bellevue, Wash., and cofounder of the Society of Hospital Medicine. The connection between spinal epidural abscess and lawsuits for example, shows that such patient cases pose a greater legal risk than other conditions, he said.

“If every patient posed an equal risk of leading to a malpractice claim, you would expect the claims to mirror the frequency of illness,” Dr. Nelson said in an interview. “But they don’t. That suggests that [certain] diseases are riskier for hospitalists from a medical-legal perspective.”

Among the other claims, 31% related to improper treatment management, 11% claimed medication errors, and 5% alleged improper performance or delay in treatment or procedure.

The study also analyzed top factors that contributed to patient injury by hospitalists. Patient assessment issues, such as to failure establish a differential diagnosis, were the most common contributor at 35%. Communication breakdowns among providers, such as poor transfer of information between doctors and nurses, were the second-most-frequent contributor at 23%. Other factors were selection and management of therapy (16%), communication issues between health providers and patients/family members (12%), failure to obtain a consult or referral (12%), and patient factors (12%). (Claims could have more than one contributing factor.)

Claims arising from hospitalist care were likely to involve greater patient injury severity than other physician specialties, the study found.

The study underscores the importance of developing positive relationships with patients and strengthening communications between specialists, Dr. Nelson said.

“Build rapport with patients,” he said. “Communicate well. Make sure it’s safe if you’re gong to wait and see how things go [overnight] with a patient. If you’re not so sure, perhaps it’s better to act quickly.”

[email protected]

AUSTIN,TEX. – There a lot of tough questions to answer when selling a medical practice during a government investigation, according to Morristown, N.J.–based health law attorney Glenn P. Prives.

How much information should potential buyers know about the case? Should the investigation be resolved before the sale? A wrong move in any direction may reduce sale profits or harm the investigation’s defense,

Mr. Prives said at an American Health Lawyers Association meeting.

Selling a practice in the midst of state or federal inquires has become more common in this era of increased government scrutiny, he said. Probes may include inquiries related to the False Claims Act, Stark Law, or Anti-Kickback Statute.

“Because of how hard the government is coming down on health care issues, more and more practices are finding themselves dealing with the government in an unfavorable light,” he said in an interview. “At the same time, you’ve got mass consolidation in the health care industry overall. Put those together, and it’s becoming more and more common” to sell a practice during an investigation.

“Just because the seller’s practice is under investigation does not mean it can’t be sold,” Mr. Prives said. “It requires extra effort and caution, but a deal is still possible.”

Be cautious about how much information about the investigation is disclosed to buyers, Mr. Prives warned. During the due diligence process, purchasers typically want to review the practice’s finances, leases, disciplinary complaints, malpractice history, and other pertinent information.

Be careful not to inadvertently waive the attorney-client privilege when divulging information to a potential buyer, Mr. Prives said. “Oftentimes, you’re dealing with health care laws that are vague and gray and broad. Physicians, like other health care providers, will engage health care attorneys to give them confidential advice on different structures. If [sellers] share that information with the buyer, and they have arguably lost the privilege, that advice may find its way into the government’s hands, which could be very damaging to the seller.”

Consider entering into a joint defense agreement, a contract that allows two parties conducting a transaction to freely share information about an investigation without waiving the attorney-client privilege. However, there is mixed case law about how effective joint defense agreements are in preserving the privilege, Mr. Prives said.

A better idea may be to limit disclosures to buyers to a “need to know” basis and provide more information only as the deal gets further along. Share enough information to keep the buyer engaged, but carefully frame issues to best position the practice in transaction negotiations, Mr. Prives advised.

There are pros and cons as to whether to resolve the investigation before closing the transaction, he said.

The selling physician may want to have the inquiry wrapped up before the sale is final to avoid the buyer’s involvement in the case. If the inquiry is ongoing, the buyer will likely want a large escrow or hold back in the purchase price, Mr. Prives said in an interview. In addition, the buyer may want to be part of discussions with the government about the case resolution.

“That can be a double-edged sword for the physician-seller,” he said. “Their objections are not necessarily aligned. The sellers are going to want to resolve the immediate issues and be done with it because they’re selling their business. The buyer cares less about the monetary payment to the government and is more concerned about what’s it’s going to have to do going forward to satisfy the government.”

On the other hand, the buyer may lose interest if kept waiting until the case is resolved.

“Many times when these investigations start, the sellers don’t know if they’ve done anything wrong or their exact role,” Mr. Prives said. “If a seller waits until the investigation is done, they may be waiting years, and a buyer is unlikely to be around for years. That’s the advantage for not waiting and doing the deal anyway.”

A wise move is to negotiate into the purchase agreement that the seller will take the lead in all government negotiations if the transaction closes before the investigation is complete, he added. Remember, however, that the deal will not likely close unless the buyer can approve or veto the final settlement. Ensure through buyer negotiations that such final confirmation is the only influence buyers can have on resolutions, he said.

“Basically, [conduct] everything until it’s about to be tied up with a nice bow, and then send that document over to the buyer for approval or disapproval,” he said. “That way the seller-physician will control the process, but satisfy that the buyer has final approval before everything is done.”

[email protected]

On Twitter@legal_med

AUSTIN,TEX. – There a lot of tough questions to answer when selling a medical practice during a government investigation, according to Morristown, N.J.–based health law attorney Glenn P. Prives.

How much information should potential buyers know about the case? Should the investigation be resolved before the sale? A wrong move in any direction may reduce sale profits or harm the investigation’s defense,

Mr. Prives said at an American Health Lawyers Association meeting.

Selling a practice in the midst of state or federal inquires has become more common in this era of increased government scrutiny, he said. Probes may include inquiries related to the False Claims Act, Stark Law, or Anti-Kickback Statute.

“Because of how hard the government is coming down on health care issues, more and more practices are finding themselves dealing with the government in an unfavorable light,” he said in an interview. “At the same time, you’ve got mass consolidation in the health care industry overall. Put those together, and it’s becoming more and more common” to sell a practice during an investigation.

“Just because the seller’s practice is under investigation does not mean it can’t be sold,” Mr. Prives said. “It requires extra effort and caution, but a deal is still possible.”

Be cautious about how much information about the investigation is disclosed to buyers, Mr. Prives warned. During the due diligence process, purchasers typically want to review the practice’s finances, leases, disciplinary complaints, malpractice history, and other pertinent information.

Be careful not to inadvertently waive the attorney-client privilege when divulging information to a potential buyer, Mr. Prives said. “Oftentimes, you’re dealing with health care laws that are vague and gray and broad. Physicians, like other health care providers, will engage health care attorneys to give them confidential advice on different structures. If [sellers] share that information with the buyer, and they have arguably lost the privilege, that advice may find its way into the government’s hands, which could be very damaging to the seller.”

Consider entering into a joint defense agreement, a contract that allows two parties conducting a transaction to freely share information about an investigation without waiving the attorney-client privilege. However, there is mixed case law about how effective joint defense agreements are in preserving the privilege, Mr. Prives said.

A better idea may be to limit disclosures to buyers to a “need to know” basis and provide more information only as the deal gets further along. Share enough information to keep the buyer engaged, but carefully frame issues to best position the practice in transaction negotiations, Mr. Prives advised.

There are pros and cons as to whether to resolve the investigation before closing the transaction, he said.

The selling physician may want to have the inquiry wrapped up before the sale is final to avoid the buyer’s involvement in the case. If the inquiry is ongoing, the buyer will likely want a large escrow or hold back in the purchase price, Mr. Prives said in an interview. In addition, the buyer may want to be part of discussions with the government about the case resolution.

“That can be a double-edged sword for the physician-seller,” he said. “Their objections are not necessarily aligned. The sellers are going to want to resolve the immediate issues and be done with it because they’re selling their business. The buyer cares less about the monetary payment to the government and is more concerned about what’s it’s going to have to do going forward to satisfy the government.”

On the other hand, the buyer may lose interest if kept waiting until the case is resolved.

“Many times when these investigations start, the sellers don’t know if they’ve done anything wrong or their exact role,” Mr. Prives said. “If a seller waits until the investigation is done, they may be waiting years, and a buyer is unlikely to be around for years. That’s the advantage for not waiting and doing the deal anyway.”

A wise move is to negotiate into the purchase agreement that the seller will take the lead in all government negotiations if the transaction closes before the investigation is complete, he added. Remember, however, that the deal will not likely close unless the buyer can approve or veto the final settlement. Ensure through buyer negotiations that such final confirmation is the only influence buyers can have on resolutions, he said.

“Basically, [conduct] everything until it’s about to be tied up with a nice bow, and then send that document over to the buyer for approval or disapproval,” he said. “That way the seller-physician will control the process, but satisfy that the buyer has final approval before everything is done.”

[email protected]

On Twitter@legal_med

AUSTIN,TEX. – There a lot of tough questions to answer when selling a medical practice during a government investigation, according to Morristown, N.J.–based health law attorney Glenn P. Prives.

How much information should potential buyers know about the case? Should the investigation be resolved before the sale? A wrong move in any direction may reduce sale profits or harm the investigation’s defense,

Mr. Prives said at an American Health Lawyers Association meeting.

Selling a practice in the midst of state or federal inquires has become more common in this era of increased government scrutiny, he said. Probes may include inquiries related to the False Claims Act, Stark Law, or Anti-Kickback Statute.

“Because of how hard the government is coming down on health care issues, more and more practices are finding themselves dealing with the government in an unfavorable light,” he said in an interview. “At the same time, you’ve got mass consolidation in the health care industry overall. Put those together, and it’s becoming more and more common” to sell a practice during an investigation.

“Just because the seller’s practice is under investigation does not mean it can’t be sold,” Mr. Prives said. “It requires extra effort and caution, but a deal is still possible.”

Be cautious about how much information about the investigation is disclosed to buyers, Mr. Prives warned. During the due diligence process, purchasers typically want to review the practice’s finances, leases, disciplinary complaints, malpractice history, and other pertinent information.

Be careful not to inadvertently waive the attorney-client privilege when divulging information to a potential buyer, Mr. Prives said. “Oftentimes, you’re dealing with health care laws that are vague and gray and broad. Physicians, like other health care providers, will engage health care attorneys to give them confidential advice on different structures. If [sellers] share that information with the buyer, and they have arguably lost the privilege, that advice may find its way into the government’s hands, which could be very damaging to the seller.”

Consider entering into a joint defense agreement, a contract that allows two parties conducting a transaction to freely share information about an investigation without waiving the attorney-client privilege. However, there is mixed case law about how effective joint defense agreements are in preserving the privilege, Mr. Prives said.

A better idea may be to limit disclosures to buyers to a “need to know” basis and provide more information only as the deal gets further along. Share enough information to keep the buyer engaged, but carefully frame issues to best position the practice in transaction negotiations, Mr. Prives advised.

There are pros and cons as to whether to resolve the investigation before closing the transaction, he said.

The selling physician may want to have the inquiry wrapped up before the sale is final to avoid the buyer’s involvement in the case. If the inquiry is ongoing, the buyer will likely want a large escrow or hold back in the purchase price, Mr. Prives said in an interview. In addition, the buyer may want to be part of discussions with the government about the case resolution.

“That can be a double-edged sword for the physician-seller,” he said. “Their objections are not necessarily aligned. The sellers are going to want to resolve the immediate issues and be done with it because they’re selling their business. The buyer cares less about the monetary payment to the government and is more concerned about what’s it’s going to have to do going forward to satisfy the government.”

On the other hand, the buyer may lose interest if kept waiting until the case is resolved.

“Many times when these investigations start, the sellers don’t know if they’ve done anything wrong or their exact role,” Mr. Prives said. “If a seller waits until the investigation is done, they may be waiting years, and a buyer is unlikely to be around for years. That’s the advantage for not waiting and doing the deal anyway.”

A wise move is to negotiate into the purchase agreement that the seller will take the lead in all government negotiations if the transaction closes before the investigation is complete, he added. Remember, however, that the deal will not likely close unless the buyer can approve or veto the final settlement. Ensure through buyer negotiations that such final confirmation is the only influence buyers can have on resolutions, he said.

“Basically, [conduct] everything until it’s about to be tied up with a nice bow, and then send that document over to the buyer for approval or disapproval,” he said. “That way the seller-physician will control the process, but satisfy that the buyer has final approval before everything is done.”

[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

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

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

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

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

Government investigators recovered nearly $755 million in criminal and civil health fraud actions in 2015, according to new figures from the Health & Human Services Office of Inspector General (OIG).

The recoveries were made by Medicaid Fraud Control Units that operate in every state and consist of nearly 2,000 staff members.

This interactive OIG map shows the distribution of recoveries by state.

[email protected]

On Twitter @legal_med

Government investigators recovered nearly $755 million in criminal and civil health fraud actions in 2015, according to new figures from the Health & Human Services Office of Inspector General (OIG).

The recoveries were made by Medicaid Fraud Control Units that operate in every state and consist of nearly 2,000 staff members.

This interactive OIG map shows the distribution of recoveries by state.

[email protected]

On Twitter @legal_med

Government investigators recovered nearly $755 million in criminal and civil health fraud actions in 2015, according to new figures from the Health & Human Services Office of Inspector General (OIG).

The recoveries were made by Medicaid Fraud Control Units that operate in every state and consist of nearly 2,000 staff members.

This interactive OIG map shows the distribution of recoveries by state.

[email protected]

On Twitter @legal_med

The fate of several high-profile health care cases remains uncertain after the death of U.S. Supreme Court Justice Antonin Scalia.

The eight remaining justices will hear oral arguments on and weigh in on a range of cases this term. Justice Scalia’s death however, means the possibility of a tie vote in some cases, which could lead to conflicting case law across states.

“Most Supreme Court decisions are not decided on a 5-to-4 split, so presumably regular business will continue as to most of the cases they are deciding,” said Timothy S. Jost, health law professor at Washington and Lee University in Lexington, Va. “However, for some of the most important cases in health care – like the abortion decision or the contraceptive decision – it was likely there was going to be a 5-to-4 split. Of those cases, the justices can either hold them over or vote, in which case there [could] be a 4-to-4 split.”

If the court divides equally on a case, the lower court’s decision is affirmed. But the case would not have a Supreme Court precedent, meaning the lower ruling would apply only in the circuit court’s jurisdiction, said Eric J. Segall, a professor of law at Georgia State University, Atlanta.

In Whole Woman’s Health v. Cole, also known as Whole Woman’s Health v. Hellerstedt, for instance, a split would uphold an appellate decision that allowed abortion restrictions in Texas to go forward. In that case, the state is battling health providers over a mandate that abortion providers must have admitting privileges at a hospital within 30 miles and that abortion clinics must meet the same requirements as those of ambulatory surgical centers (ASCs). The 5th U.S. Circuit Court of Appeals ruled that the regulations do not impose an undue burden on a patient’s right to get an abortion.

“If a 5-4 [Supreme Court decision] upheld those restrictions, that would be national law for the whole country, and it would be a huge deal,” Mr. Segall said in an interview. “If it’s a 4-4 tie, than in Texas and two other states, the Texas decision would still be good law, but it would have no effect outside that circuit.”

In the case of Zubik v. Burwell however, a split vote would mean nationwide differences in how the Affordable Care Act’s contraceptive mandate is applied, said Ilya Shapiro, a senior fellow in constitutional studies at the Cato Institute. The Zubik case centers on whether the ACA contraceptive-coverage mandate and its “accommodation” violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuits.

Because of the conflicting lower court opinions, if the Zubik case were decided 4-4, “the regulation [would be] in place in parts of the country and not in others,” Mr. Shapiro said in an interview. “That seems untenable. Cases like that especially, the court would likely delay the arguments that are currently scheduled until the next term.”

Justices can decide whether to vote or rehear cases that were already heard with Justice Scalia in attendance, but are not yet decided. They can also dismiss or wait to address cases next term. Decisions that were made with Justice Scalia’s vote, but were not yet published, will be void, Mr. Shapiro said. As for Justice Scalia’s replacement, Mr. Shapiro noted that even if President Obama makes a nomination and it is confirmed by the Senate, it would be too late to consider cases this term.

Mr. Segall stressed that it’s too early to tell how Justice Scalia’s death will impact ongoing and future cases and the court as a whole.

“We don’t really have a precedent for this,” he said. “We’ve had vacancies before, but we’ve never had a vacancy in an election year where [the Court comprised] four conservative Republicans and four liberal Democrats. I think we should all step back. There are so many imponderables.”

Supreme Court analysts predict the eight justices will announce their decisions – or lack thereof – during the last week of June.

Justice Scalia was known as the high court’s most vocal conservative and was the longest-serving current justice on the court, hearing cases for 29 years.

What’s on the docket?

The Supreme Court is set to decide a number of significant health law cases this term. Here are some of the most pressing ones and the issues at stake.

Zubik v. Burwell

Argument date: March 23, 2016

The court will decide whether an accommodation under the ACA contraceptive mandate violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs, when the government has not proved that this compulsion is the least restrictive means of advancing a compelling interest. The accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities such as churches. The plaintiffs argue the process serves as a trigger that enables contraceptive use and makes the groups complicit. The government argues the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share employers’ religious beliefs.

Whole Woman’s Health v. Cole

Argument date: March 2, 2016

Justices will weigh whether two Texas regulations place an undue burden on a woman’s right to access an abortion. The regulations mandate that abortion providers have admitting privileges at a hospital within 30 miles of an abortion clinic in order to provide the service, and that all abortion clinics meet the same requirements as those of ambulatory surgical centers (ASCs). The plaintiffs, who are clinics and doctors, argue that both restrictions are unnecessary and limit access to abortion services. The Texas Department of State Health Services states the restrictions are reasonable and effective measures that raise the standard of care for abortion patients and ensure health and safety. The case is sometimes cited as Whole Woman’s Health v. Hellerstedt.

Universal Health Services v. United States ex rel. Escobar

Argument date: To be determined

In question is whether the legal theory used by the federal government to bring False Claims Act (FCA) lawsuits is valid. The case centers on a patient who died after receiving care by Universal Health Services Inc. (UHS) in Lawrence, Mass. The patient’s parents sued UHS under both the federal and state False Claims Act laws alleging that UHS providers were improperly licensed and made fraudulent government claims. The Supreme Court will answer whether the implied certification test for determining when claims “sufficiently plead falsity” under the FCA is constitutional and if so, if the relevant statute needs to explicitly state the conditions of payment with which the defendant allegedly failed to comply. Physician associations are concerned that a ruling for the plaintiff will expand the FCA’s reach and increase false claim lawsuits against health providers.

Gobeille v. Liberty Mutual Insurance Company

Argument date: Dec. 2, 2015

The Supreme Court will decide whether a self-funded insurer must share certain information, such as claims and member data, with Vermont’s all-payer database. The state argues the information is needed to improve the cost and effectiveness of health care and that an adverse ruling would chill reform efforts in other states with similar databases. Liberty Mutual, which maintains a self-insured health plan for its employees, argues that the Employee Retirement Income Security Act of 1973 (ERISA) preempts state statutes that provide for “all payer” health care databases, and that it does not have to supply the information. Analysts say the case will ultimately decide to what extent federal law can facilitate the centralized management of health care.

[email protected]

On Twitter @legal_med

The fate of several high-profile health care cases remains uncertain after the death of U.S. Supreme Court Justice Antonin Scalia.

The eight remaining justices will hear oral arguments on and weigh in on a range of cases this term. Justice Scalia’s death however, means the possibility of a tie vote in some cases, which could lead to conflicting case law across states.

“Most Supreme Court decisions are not decided on a 5-to-4 split, so presumably regular business will continue as to most of the cases they are deciding,” said Timothy S. Jost, health law professor at Washington and Lee University in Lexington, Va. “However, for some of the most important cases in health care – like the abortion decision or the contraceptive decision – it was likely there was going to be a 5-to-4 split. Of those cases, the justices can either hold them over or vote, in which case there [could] be a 4-to-4 split.”

If the court divides equally on a case, the lower court’s decision is affirmed. But the case would not have a Supreme Court precedent, meaning the lower ruling would apply only in the circuit court’s jurisdiction, said Eric J. Segall, a professor of law at Georgia State University, Atlanta.

In Whole Woman’s Health v. Cole, also known as Whole Woman’s Health v. Hellerstedt, for instance, a split would uphold an appellate decision that allowed abortion restrictions in Texas to go forward. In that case, the state is battling health providers over a mandate that abortion providers must have admitting privileges at a hospital within 30 miles and that abortion clinics must meet the same requirements as those of ambulatory surgical centers (ASCs). The 5th U.S. Circuit Court of Appeals ruled that the regulations do not impose an undue burden on a patient’s right to get an abortion.

“If a 5-4 [Supreme Court decision] upheld those restrictions, that would be national law for the whole country, and it would be a huge deal,” Mr. Segall said in an interview. “If it’s a 4-4 tie, than in Texas and two other states, the Texas decision would still be good law, but it would have no effect outside that circuit.”

In the case of Zubik v. Burwell however, a split vote would mean nationwide differences in how the Affordable Care Act’s contraceptive mandate is applied, said Ilya Shapiro, a senior fellow in constitutional studies at the Cato Institute. The Zubik case centers on whether the ACA contraceptive-coverage mandate and its “accommodation” violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuits.

Because of the conflicting lower court opinions, if the Zubik case were decided 4-4, “the regulation [would be] in place in parts of the country and not in others,” Mr. Shapiro said in an interview. “That seems untenable. Cases like that especially, the court would likely delay the arguments that are currently scheduled until the next term.”

Justices can decide whether to vote or rehear cases that were already heard with Justice Scalia in attendance, but are not yet decided. They can also dismiss or wait to address cases next term. Decisions that were made with Justice Scalia’s vote, but were not yet published, will be void, Mr. Shapiro said. As for Justice Scalia’s replacement, Mr. Shapiro noted that even if President Obama makes a nomination and it is confirmed by the Senate, it would be too late to consider cases this term.

Mr. Segall stressed that it’s too early to tell how Justice Scalia’s death will impact ongoing and future cases and the court as a whole.

“We don’t really have a precedent for this,” he said. “We’ve had vacancies before, but we’ve never had a vacancy in an election year where [the Court comprised] four conservative Republicans and four liberal Democrats. I think we should all step back. There are so many imponderables.”

Supreme Court analysts predict the eight justices will announce their decisions – or lack thereof – during the last week of June.

Justice Scalia was known as the high court’s most vocal conservative and was the longest-serving current justice on the court, hearing cases for 29 years.

What’s on the docket?

The Supreme Court is set to decide a number of significant health law cases this term. Here are some of the most pressing ones and the issues at stake.

Zubik v. Burwell

Argument date: March 23, 2016

The court will decide whether an accommodation under the ACA contraceptive mandate violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs, when the government has not proved that this compulsion is the least restrictive means of advancing a compelling interest. The accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities such as churches. The plaintiffs argue the process serves as a trigger that enables contraceptive use and makes the groups complicit. The government argues the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share employers’ religious beliefs.

Whole Woman’s Health v. Cole

Argument date: March 2, 2016

Justices will weigh whether two Texas regulations place an undue burden on a woman’s right to access an abortion. The regulations mandate that abortion providers have admitting privileges at a hospital within 30 miles of an abortion clinic in order to provide the service, and that all abortion clinics meet the same requirements as those of ambulatory surgical centers (ASCs). The plaintiffs, who are clinics and doctors, argue that both restrictions are unnecessary and limit access to abortion services. The Texas Department of State Health Services states the restrictions are reasonable and effective measures that raise the standard of care for abortion patients and ensure health and safety. The case is sometimes cited as Whole Woman’s Health v. Hellerstedt.

Universal Health Services v. United States ex rel. Escobar

Argument date: To be determined

In question is whether the legal theory used by the federal government to bring False Claims Act (FCA) lawsuits is valid. The case centers on a patient who died after receiving care by Universal Health Services Inc. (UHS) in Lawrence, Mass. The patient’s parents sued UHS under both the federal and state False Claims Act laws alleging that UHS providers were improperly licensed and made fraudulent government claims. The Supreme Court will answer whether the implied certification test for determining when claims “sufficiently plead falsity” under the FCA is constitutional and if so, if the relevant statute needs to explicitly state the conditions of payment with which the defendant allegedly failed to comply. Physician associations are concerned that a ruling for the plaintiff will expand the FCA’s reach and increase false claim lawsuits against health providers.

Gobeille v. Liberty Mutual Insurance Company

Argument date: Dec. 2, 2015

The Supreme Court will decide whether a self-funded insurer must share certain information, such as claims and member data, with Vermont’s all-payer database. The state argues the information is needed to improve the cost and effectiveness of health care and that an adverse ruling would chill reform efforts in other states with similar databases. Liberty Mutual, which maintains a self-insured health plan for its employees, argues that the Employee Retirement Income Security Act of 1973 (ERISA) preempts state statutes that provide for “all payer” health care databases, and that it does not have to supply the information. Analysts say the case will ultimately decide to what extent federal law can facilitate the centralized management of health care.

[email protected]

On Twitter @legal_med

The fate of several high-profile health care cases remains uncertain after the death of U.S. Supreme Court Justice Antonin Scalia.

The eight remaining justices will hear oral arguments on and weigh in on a range of cases this term. Justice Scalia’s death however, means the possibility of a tie vote in some cases, which could lead to conflicting case law across states.

“Most Supreme Court decisions are not decided on a 5-to-4 split, so presumably regular business will continue as to most of the cases they are deciding,” said Timothy S. Jost, health law professor at Washington and Lee University in Lexington, Va. “However, for some of the most important cases in health care – like the abortion decision or the contraceptive decision – it was likely there was going to be a 5-to-4 split. Of those cases, the justices can either hold them over or vote, in which case there [could] be a 4-to-4 split.”

If the court divides equally on a case, the lower court’s decision is affirmed. But the case would not have a Supreme Court precedent, meaning the lower ruling would apply only in the circuit court’s jurisdiction, said Eric J. Segall, a professor of law at Georgia State University, Atlanta.

In Whole Woman’s Health v. Cole, also known as Whole Woman’s Health v. Hellerstedt, for instance, a split would uphold an appellate decision that allowed abortion restrictions in Texas to go forward. In that case, the state is battling health providers over a mandate that abortion providers must have admitting privileges at a hospital within 30 miles and that abortion clinics must meet the same requirements as those of ambulatory surgical centers (ASCs). The 5th U.S. Circuit Court of Appeals ruled that the regulations do not impose an undue burden on a patient’s right to get an abortion.

“If a 5-4 [Supreme Court decision] upheld those restrictions, that would be national law for the whole country, and it would be a huge deal,” Mr. Segall said in an interview. “If it’s a 4-4 tie, than in Texas and two other states, the Texas decision would still be good law, but it would have no effect outside that circuit.”

In the case of Zubik v. Burwell however, a split vote would mean nationwide differences in how the Affordable Care Act’s contraceptive mandate is applied, said Ilya Shapiro, a senior fellow in constitutional studies at the Cato Institute. The Zubik case centers on whether the ACA contraceptive-coverage mandate and its “accommodation” violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuits.

Because of the conflicting lower court opinions, if the Zubik case were decided 4-4, “the regulation [would be] in place in parts of the country and not in others,” Mr. Shapiro said in an interview. “That seems untenable. Cases like that especially, the court would likely delay the arguments that are currently scheduled until the next term.”

Justices can decide whether to vote or rehear cases that were already heard with Justice Scalia in attendance, but are not yet decided. They can also dismiss or wait to address cases next term. Decisions that were made with Justice Scalia’s vote, but were not yet published, will be void, Mr. Shapiro said. As for Justice Scalia’s replacement, Mr. Shapiro noted that even if President Obama makes a nomination and it is confirmed by the Senate, it would be too late to consider cases this term.

Mr. Segall stressed that it’s too early to tell how Justice Scalia’s death will impact ongoing and future cases and the court as a whole.

“We don’t really have a precedent for this,” he said. “We’ve had vacancies before, but we’ve never had a vacancy in an election year where [the Court comprised] four conservative Republicans and four liberal Democrats. I think we should all step back. There are so many imponderables.”

Supreme Court analysts predict the eight justices will announce their decisions – or lack thereof – during the last week of June.

Justice Scalia was known as the high court’s most vocal conservative and was the longest-serving current justice on the court, hearing cases for 29 years.

What’s on the docket?

The Supreme Court is set to decide a number of significant health law cases this term. Here are some of the most pressing ones and the issues at stake.

Zubik v. Burwell

Argument date: March 23, 2016

The court will decide whether an accommodation under the ACA contraceptive mandate violates the Religious Freedom Restoration Act by forcing religious nonprofits to act in violation of their beliefs, when the government has not proved that this compulsion is the least restrictive means of advancing a compelling interest. The accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities such as churches. The plaintiffs argue the process serves as a trigger that enables contraceptive use and makes the groups complicit. The government argues the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share employers’ religious beliefs.

Whole Woman’s Health v. Cole

Argument date: March 2, 2016

Justices will weigh whether two Texas regulations place an undue burden on a woman’s right to access an abortion. The regulations mandate that abortion providers have admitting privileges at a hospital within 30 miles of an abortion clinic in order to provide the service, and that all abortion clinics meet the same requirements as those of ambulatory surgical centers (ASCs). The plaintiffs, who are clinics and doctors, argue that both restrictions are unnecessary and limit access to abortion services. The Texas Department of State Health Services states the restrictions are reasonable and effective measures that raise the standard of care for abortion patients and ensure health and safety. The case is sometimes cited as Whole Woman’s Health v. Hellerstedt.

Universal Health Services v. United States ex rel. Escobar

Argument date: To be determined

In question is whether the legal theory used by the federal government to bring False Claims Act (FCA) lawsuits is valid. The case centers on a patient who died after receiving care by Universal Health Services Inc. (UHS) in Lawrence, Mass. The patient’s parents sued UHS under both the federal and state False Claims Act laws alleging that UHS providers were improperly licensed and made fraudulent government claims. The Supreme Court will answer whether the implied certification test for determining when claims “sufficiently plead falsity” under the FCA is constitutional and if so, if the relevant statute needs to explicitly state the conditions of payment with which the defendant allegedly failed to comply. Physician associations are concerned that a ruling for the plaintiff will expand the FCA’s reach and increase false claim lawsuits against health providers.

Gobeille v. Liberty Mutual Insurance Company

Argument date: Dec. 2, 2015

The Supreme Court will decide whether a self-funded insurer must share certain information, such as claims and member data, with Vermont’s all-payer database. The state argues the information is needed to improve the cost and effectiveness of health care and that an adverse ruling would chill reform efforts in other states with similar databases. Liberty Mutual, which maintains a self-insured health plan for its employees, argues that the Employee Retirement Income Security Act of 1973 (ERISA) preempts state statutes that provide for “all payer” health care databases, and that it does not have to supply the information. Analysts say the case will ultimately decide to what extent federal law can facilitate the centralized management of health care.

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AUSTIN, TEX. – Physicians could face more reportable actions to the National Practitioner Data Bank (NPDB) under changes to the data bank’s guidebook.

In its last update of the guidebook, the Health Resources and Services Administration (HRSA) expanded its definition of “investigation” and now interprets the term “expansively” and will not be limited by how hospital bylaws define an investigation.

Data bank officials will review a health care entity’s bylaws and other documents for assistance in determining whether an investigation has started or is ongoing, but they retain “the ultimate authority to determine whether an investigation exists,” according to the guidebook.

The change is significant because it means more reviews by health care entities could be considered investigations by the data bank, regardless of how hospitals regard the assessment, Michael A. Cassidy said at the meeting, which was held by the American Health Lawyers Association.

Investigations alone are not reportable to the data bank, but actions taken by doctors during investigations are. This includes:

• Resignation of clinical privileges.

• Failure to renew clinical privileges.

• Lapse of license.

• Leave of absence.

• Relinquishment of panel membership.

The guidebook notes that a routine, formal peer review process under which a health care entity evaluates, against defined measures, privilege-specific competence of all practitioners is not considered an investigation by the NPDB. However, a formal, “targeted process used when issues related to a specific practitioner’s professional competence or conduct are identified” is considered an investigation for purposes of reporting to the NPDB.

The catch for doctors is that their awareness of an investigation is immaterial, said Mr. Cassidy, a Pittsburgh-based health law attorney. In the past, a doctor’s awareness of an investigation was a prerequisite for filing a report with the data bank.

The HRSA’s stance is that “physicians’ awareness of the investigation doesn’t have any impact on whether it’s an investigation or not,” Mr. Cassidy said in an interview. “From a physician standpoint, they want to be aware all the time whether an investigation has started. If they don’t find out an investigation has started until after they get a decision, it’s too late to forestall any of the reporting consequences.”

In addition, the NPDB considers an investigation ongoing until the health care entity takes a final action or formally closes the investigation. Formal closure is not defined, but written notice to the doctor would likely be the best evidence, according to Mr. Cassidy.

Changing medical staff bylaws to include doctors early in the process could help mitigate future investigation woes, he advised.

“It is not enough simply to provide that the doctor will be advised when an investigation starts because that triggers the reporting requirements, and places the parties in an adversarial position,” he said. “The bylaws should require notification to the physician whenever a complaint is made so that the physician can defend himself before it becomes an investigation.”

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – Physicians could face more reportable actions to the National Practitioner Data Bank (NPDB) under changes to the data bank’s guidebook.

In its last update of the guidebook, the Health Resources and Services Administration (HRSA) expanded its definition of “investigation” and now interprets the term “expansively” and will not be limited by how hospital bylaws define an investigation.

Data bank officials will review a health care entity’s bylaws and other documents for assistance in determining whether an investigation has started or is ongoing, but they retain “the ultimate authority to determine whether an investigation exists,” according to the guidebook.

The change is significant because it means more reviews by health care entities could be considered investigations by the data bank, regardless of how hospitals regard the assessment, Michael A. Cassidy said at the meeting, which was held by the American Health Lawyers Association.

Investigations alone are not reportable to the data bank, but actions taken by doctors during investigations are. This includes:

• Resignation of clinical privileges.

• Failure to renew clinical privileges.

• Lapse of license.

• Leave of absence.

• Relinquishment of panel membership.

The guidebook notes that a routine, formal peer review process under which a health care entity evaluates, against defined measures, privilege-specific competence of all practitioners is not considered an investigation by the NPDB. However, a formal, “targeted process used when issues related to a specific practitioner’s professional competence or conduct are identified” is considered an investigation for purposes of reporting to the NPDB.

The catch for doctors is that their awareness of an investigation is immaterial, said Mr. Cassidy, a Pittsburgh-based health law attorney. In the past, a doctor’s awareness of an investigation was a prerequisite for filing a report with the data bank.

The HRSA’s stance is that “physicians’ awareness of the investigation doesn’t have any impact on whether it’s an investigation or not,” Mr. Cassidy said in an interview. “From a physician standpoint, they want to be aware all the time whether an investigation has started. If they don’t find out an investigation has started until after they get a decision, it’s too late to forestall any of the reporting consequences.”

In addition, the NPDB considers an investigation ongoing until the health care entity takes a final action or formally closes the investigation. Formal closure is not defined, but written notice to the doctor would likely be the best evidence, according to Mr. Cassidy.

Changing medical staff bylaws to include doctors early in the process could help mitigate future investigation woes, he advised.

“It is not enough simply to provide that the doctor will be advised when an investigation starts because that triggers the reporting requirements, and places the parties in an adversarial position,” he said. “The bylaws should require notification to the physician whenever a complaint is made so that the physician can defend himself before it becomes an investigation.”

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – Physicians could face more reportable actions to the National Practitioner Data Bank (NPDB) under changes to the data bank’s guidebook.

In its last update of the guidebook, the Health Resources and Services Administration (HRSA) expanded its definition of “investigation” and now interprets the term “expansively” and will not be limited by how hospital bylaws define an investigation.

Data bank officials will review a health care entity’s bylaws and other documents for assistance in determining whether an investigation has started or is ongoing, but they retain “the ultimate authority to determine whether an investigation exists,” according to the guidebook.

The change is significant because it means more reviews by health care entities could be considered investigations by the data bank, regardless of how hospitals regard the assessment, Michael A. Cassidy said at the meeting, which was held by the American Health Lawyers Association.

Investigations alone are not reportable to the data bank, but actions taken by doctors during investigations are. This includes:

• Resignation of clinical privileges.

• Failure to renew clinical privileges.

• Lapse of license.

• Leave of absence.

• Relinquishment of panel membership.

The guidebook notes that a routine, formal peer review process under which a health care entity evaluates, against defined measures, privilege-specific competence of all practitioners is not considered an investigation by the NPDB. However, a formal, “targeted process used when issues related to a specific practitioner’s professional competence or conduct are identified” is considered an investigation for purposes of reporting to the NPDB.

The catch for doctors is that their awareness of an investigation is immaterial, said Mr. Cassidy, a Pittsburgh-based health law attorney. In the past, a doctor’s awareness of an investigation was a prerequisite for filing a report with the data bank.

The HRSA’s stance is that “physicians’ awareness of the investigation doesn’t have any impact on whether it’s an investigation or not,” Mr. Cassidy said in an interview. “From a physician standpoint, they want to be aware all the time whether an investigation has started. If they don’t find out an investigation has started until after they get a decision, it’s too late to forestall any of the reporting consequences.”

In addition, the NPDB considers an investigation ongoing until the health care entity takes a final action or formally closes the investigation. Formal closure is not defined, but written notice to the doctor would likely be the best evidence, according to Mr. Cassidy.

Changing medical staff bylaws to include doctors early in the process could help mitigate future investigation woes, he advised.

“It is not enough simply to provide that the doctor will be advised when an investigation starts because that triggers the reporting requirements, and places the parties in an adversarial position,” he said. “The bylaws should require notification to the physician whenever a complaint is made so that the physician can defend himself before it becomes an investigation.”

[email protected]

On Twitter @legal_med

There is finally some clarity about how to report and return Medicare overpayments, under a final rule released by the Centers for Medicare & Medicaid Services Feb. 11.

The final regulation clarifies that health providers have identified an overpayment when they “have or should have, through the exercise of reasonable diligence, determined [they have] received an overpayment and quantified the amount of the overpayment.”

Overpayments must be reported and returned only if identified within 6 years of the date the payment was received – down from the 10 years included in the proposed rule released in 2012. Physician organizations and other health care stakeholders had criticized the proposal, calling the 10-year time frame unreasonable and burdensome.

The revised definition of identification makes more sense for physicians, particularly that identification exists when providers have quantified the amount of the overpayment, said Scot T. Hasselman, a Washington health law attorney. In many cases, it takes time to decipher how much money is owed after discovering a potential overpayment, he said in an interview.

“This all goes to: When does the clock begin ticking for the 60 days?” he said. “The language in the final rule provides for a standard that is easier to apply.

The 6-year time frame is also more reasonable and will save practices money by limiting their audit obligations, Mr. Hasselman noted.

The final rule also allows the 60-day deadline for returning overpayments to be suspended if a provider requests an extended repayment schedule. In the past, “people could be in a real pickle if they didn’t have the money to return,” Mr. Hasselman said. “This [provision] is important, especially for smaller [practices] and physicians who may not have big credit lines or the cash flow of an institutional provider.”

The final rule also clarifies how to report overpayments. Providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or another appropriate process to satisfy the obligation to report and return overpayments, the rule states. If a provider has reported a self-identified overpayment using the self-referral disclosure protocol managed by CMS or the self-disclosure protocol managed by the HHS Office of Inspector General (OIG), the provider is considered to be in compliance with the rule.

But the final rule is not entirely positive, according to Houston-based health law attorney Michael E. Clark. Many health providers had requested clarification about the level of resources small providers are expected to devote to investigating potential overpayments. Commenters suggested CMS allow for more defined overpayment responses based on provider size and resources. The agency did not do so, saying that providers, “large and small have a duty to ensure claims are accurate and appropriate and to report and return overpayments they have received.”

Refusing to allow scalable responses is unfortunate for practices that do not have the ability to react to overpayments as robustly as larger chains, Mr. Clark said.

“The agency was unwilling to go that far,” Mr. Clark said. “They’re not going to give a lesser standard for smaller providers. They’re going to look at the facts and circumstances. It gives [CMS] subjectivity, whereas doctors would rather have more clarification and objectivity.”

[email protected]

On Twitter @legal_med

There is finally some clarity about how to report and return Medicare overpayments, under a final rule released by the Centers for Medicare & Medicaid Services Feb. 11.

The final regulation clarifies that health providers have identified an overpayment when they “have or should have, through the exercise of reasonable diligence, determined [they have] received an overpayment and quantified the amount of the overpayment.”

Overpayments must be reported and returned only if identified within 6 years of the date the payment was received – down from the 10 years included in the proposed rule released in 2012. Physician organizations and other health care stakeholders had criticized the proposal, calling the 10-year time frame unreasonable and burdensome.

The revised definition of identification makes more sense for physicians, particularly that identification exists when providers have quantified the amount of the overpayment, said Scot T. Hasselman, a Washington health law attorney. In many cases, it takes time to decipher how much money is owed after discovering a potential overpayment, he said in an interview.

“This all goes to: When does the clock begin ticking for the 60 days?” he said. “The language in the final rule provides for a standard that is easier to apply.

The 6-year time frame is also more reasonable and will save practices money by limiting their audit obligations, Mr. Hasselman noted.

The final rule also allows the 60-day deadline for returning overpayments to be suspended if a provider requests an extended repayment schedule. In the past, “people could be in a real pickle if they didn’t have the money to return,” Mr. Hasselman said. “This [provision] is important, especially for smaller [practices] and physicians who may not have big credit lines or the cash flow of an institutional provider.”

The final rule also clarifies how to report overpayments. Providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or another appropriate process to satisfy the obligation to report and return overpayments, the rule states. If a provider has reported a self-identified overpayment using the self-referral disclosure protocol managed by CMS or the self-disclosure protocol managed by the HHS Office of Inspector General (OIG), the provider is considered to be in compliance with the rule.

But the final rule is not entirely positive, according to Houston-based health law attorney Michael E. Clark. Many health providers had requested clarification about the level of resources small providers are expected to devote to investigating potential overpayments. Commenters suggested CMS allow for more defined overpayment responses based on provider size and resources. The agency did not do so, saying that providers, “large and small have a duty to ensure claims are accurate and appropriate and to report and return overpayments they have received.”

Refusing to allow scalable responses is unfortunate for practices that do not have the ability to react to overpayments as robustly as larger chains, Mr. Clark said.

“The agency was unwilling to go that far,” Mr. Clark said. “They’re not going to give a lesser standard for smaller providers. They’re going to look at the facts and circumstances. It gives [CMS] subjectivity, whereas doctors would rather have more clarification and objectivity.”

[email protected]

On Twitter @legal_med

There is finally some clarity about how to report and return Medicare overpayments, under a final rule released by the Centers for Medicare & Medicaid Services Feb. 11.

The final regulation clarifies that health providers have identified an overpayment when they “have or should have, through the exercise of reasonable diligence, determined [they have] received an overpayment and quantified the amount of the overpayment.”

Overpayments must be reported and returned only if identified within 6 years of the date the payment was received – down from the 10 years included in the proposed rule released in 2012. Physician organizations and other health care stakeholders had criticized the proposal, calling the 10-year time frame unreasonable and burdensome.

The revised definition of identification makes more sense for physicians, particularly that identification exists when providers have quantified the amount of the overpayment, said Scot T. Hasselman, a Washington health law attorney. In many cases, it takes time to decipher how much money is owed after discovering a potential overpayment, he said in an interview.

“This all goes to: When does the clock begin ticking for the 60 days?” he said. “The language in the final rule provides for a standard that is easier to apply.

The 6-year time frame is also more reasonable and will save practices money by limiting their audit obligations, Mr. Hasselman noted.

The final rule also allows the 60-day deadline for returning overpayments to be suspended if a provider requests an extended repayment schedule. In the past, “people could be in a real pickle if they didn’t have the money to return,” Mr. Hasselman said. “This [provision] is important, especially for smaller [practices] and physicians who may not have big credit lines or the cash flow of an institutional provider.”

The final rule also clarifies how to report overpayments. Providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or another appropriate process to satisfy the obligation to report and return overpayments, the rule states. If a provider has reported a self-identified overpayment using the self-referral disclosure protocol managed by CMS or the self-disclosure protocol managed by the HHS Office of Inspector General (OIG), the provider is considered to be in compliance with the rule.

But the final rule is not entirely positive, according to Houston-based health law attorney Michael E. Clark. Many health providers had requested clarification about the level of resources small providers are expected to devote to investigating potential overpayments. Commenters suggested CMS allow for more defined overpayment responses based on provider size and resources. The agency did not do so, saying that providers, “large and small have a duty to ensure claims are accurate and appropriate and to report and return overpayments they have received.”

Refusing to allow scalable responses is unfortunate for practices that do not have the ability to react to overpayments as robustly as larger chains, Mr. Clark said.

“The agency was unwilling to go that far,” Mr. Clark said. “They’re not going to give a lesser standard for smaller providers. They’re going to look at the facts and circumstances. It gives [CMS] subjectivity, whereas doctors would rather have more clarification and objectivity.”

[email protected]

On Twitter @legal_med