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Spray-dried fibrin sealant for surgical use approved by FDA
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.
The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.
Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.
The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”
The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.
VIDEO: Compliance plans, education can help physicians prevent Medicare fraud involvement
Medicare fraud and strategies to combat the crimes have become more intense as the program has grown in size and complexity, experts say.
As Medicare turns 50, Dr. Julie Taitsman, chief medical officer for the Department of Health & Human Services’ Office of Inspector General, discusses how doctors can avoid Medicare fraud. Dr. Taitsman shares common ways doctors and their billings come to the government’s attention and how doctors can fall prey to health fraud involvement.
In this exclusive video, Dr. Taitsman also discusses relevant health fraud laws that can impact physician practices and what doctors can expect of the OIG’s efforts to fight Medicare fraud in the future.
View the video interview on YouTube.
On Twitter @legal_med
Medicare fraud and strategies to combat the crimes have become more intense as the program has grown in size and complexity, experts say.
As Medicare turns 50, Dr. Julie Taitsman, chief medical officer for the Department of Health & Human Services’ Office of Inspector General, discusses how doctors can avoid Medicare fraud. Dr. Taitsman shares common ways doctors and their billings come to the government’s attention and how doctors can fall prey to health fraud involvement.
In this exclusive video, Dr. Taitsman also discusses relevant health fraud laws that can impact physician practices and what doctors can expect of the OIG’s efforts to fight Medicare fraud in the future.
View the video interview on YouTube.
On Twitter @legal_med
Medicare fraud and strategies to combat the crimes have become more intense as the program has grown in size and complexity, experts say.
As Medicare turns 50, Dr. Julie Taitsman, chief medical officer for the Department of Health & Human Services’ Office of Inspector General, discusses how doctors can avoid Medicare fraud. Dr. Taitsman shares common ways doctors and their billings come to the government’s attention and how doctors can fall prey to health fraud involvement.
In this exclusive video, Dr. Taitsman also discusses relevant health fraud laws that can impact physician practices and what doctors can expect of the OIG’s efforts to fight Medicare fraud in the future.
View the video interview on YouTube.
On Twitter @legal_med
Medicare at 50: Physicians struggle with antifraud regulations
For Dr. Carla L. Kakutani, it has become increasingly challenging to obtain durable medical equipment (DME) for her Medicare patients.
In addition to proving equipment is medically necessary, a 2013 rule requires physicians to document that a face-to-face encounter occurred between a patient and doctor or other health provider within 6 months of the DME order. (Enforcement of the rule has been delayed, but many physicians are currently complying with this policy.) Dr. Kakutani understands the added regulations are meant to prevent fraudulent billings, she said, but the heavy paperwork and additional red tape are burdensome.
“The problem is, [the process] turns into this back and forth between you, the equipment company, and Medicare,” said Dr. Kakutani, a family physician in Winters, Calif. “Meanwhile, the patient is waiting, and you’re being distracted from other things. The bad apples are making life rough for the rest of us.”
As Medicare turns 50 this year, Dr. Kakutani is not alone in her frustrations. In recent years, the U.S. Department of Health & Human Services has greatly expanded its efforts to combat Medicare fraud, and physicians across the country are feeling the effects.
The government’s primary antifraud tool is the Health Care Fraud Prevention and Enforcement Action Team (HEAT), created in 2009 to identify and investigate health fraud and abuse. CMS also works with an array of contractors to detect Medicare fraud, including comprehensive error rate testing (CERT) contractors, Medicare administrative contractors (MACs), Medicare drug integrity contractors (MEDICs), recovery audit program auditors (RACs), and zone program integrity contractors (ZPICs). In 2010, CMS launched the Fraud Prevention System (FPS), a predictive analytics technology that runs algorithms on all Medicare claims prior to payment. And in 2012, CMS created the Program Integrity Command Center that brings together investigators from Medicare, Medicaid, and the law enforcement community to develop predictive analytics that identify fraud and mobilize a rapid response.
Just how much Medicare fraud is happening at any given time is difficult to measure. In 2014, the federal government recouped $3 billion in Medicare- and Medicaid-related fraud settlements and judgments, according to an HHS analysis. In 2013 and 2012, the government recovered about $4 billion each year. And it’s nearly impossible to determine the volume of Medicare fraud committed by doctors, said Dr. Julie Taitsman, chief medical officer for the HHS Office of Inspector General.
“Getting at the actual amount of Medicare fraud in general, or Medicare fraud by physicians, is incredibly difficult,” Dr. Taitsman said in an interview. “We can tell you about the fraud we’ve identified, but we don’t know the total body of fraud.”
Dr. Taitsman stressed that all physicians play a major role in preventing health fraud and improving the quality of the Medicare system.
“Why it’s so important for physicians to practice with integrity – and we do believe that the vast majority of physicians practice with integrity – is because physicians control the bulk of care and services that [Medicare] patients receive,” Dr. Taitsman said. “That’s why it’s so important for physicians to be our partners in promoting high-quality care, promoting efficiency and compliance with the rules.”
But continually changing rules and guidelines make it difficult for many doctors to do just that, said Dr. James Szalados, an anesthesiologist and critical care physician based in Rochester, N.Y. Updates to payment rules, new OIG work plan targets, and growing documentation requirements can be overwhelming for practices.
“It’s not just the number of regulations, but it’s also the rate of change,” said Dr. Szalados, who is also an attorney. “For most doctors, it’s terrifying. They can’t keep up.”
Adhering to the latest regulations generally means hiring outside attorneys, consultants, and financial auditors who can help doctors self-police their practices, Dr. Szalados said.
Physicians also face Medicare fraud accusations from more directions than in the past, said Michael E. Clark, a Houston-based health law attorney and chair of the American Bar Association health law section. In addition to government claims, whistle-blower provisions under the False Claims Act allow individuals to file lawsuits alleging fraud and abuse on behalf of the government. If the government intervenes and the suit is successful, a whistle-blower can take home 15%-25% of money recovered. In 2014, the number of whistle-blower suits exceeded 700 for the second year in a row, according to the Department of Justice.
“A lot of people bringing these false claims actions are former or disgruntled employees or other doctors,” Mr. Clark said. “You might have a technical, regulatory type of theory, and yet it can be quickly changed into a fraud and abuse case.”
New laws have added to the challenge, Mr. Clark said. The Fraud Enforcement and Recovery Act (FERA), enacted in 2009, expands potential liability for false claims by applying the FCA to more entities and a larger range of transactions. The law also reduces the proof required to establish fault.
“FERA took away a lot of defenses that had been used successfully by defense counsel over the years on technical issues,” Mr. Clark said.
The antifraud climate has led many physicians to leave private practice or merge with hospitals or larger health systems, Dr. Szalados said. Other doctors have resorted to intentionally underbilling to avoid claim scrutiny, according to Dr. Robert A. Lee, who serves on the board of directors for the American Academy of Family Physicians . After a third-party compliance review, Dr. Lee’s private practice felt the best course of action was to bill more conservatively, he said.
“We kind of overdocument and undercode,” Dr. Lee said in an interview. “Of course that’s not fair to the physicians because they’re not billing for what they did do.”
On a more positive note, physicians are getting better at internal auditing and developing stronger compliance programs that address billing errors, said Alex T. Krouse, a health law attorney based in Mishawaka, Ind.
“I do think health care providers are getting more sophisticated and are really believing in the compliance-related function,” Mr. Krouse said in an interview. “That is helping and reducing the risk quite a bit.”
While antifraud enforcement will likely increase in the future, physicians that follow regulations and implement recommended protocols shouldn’t be too worried, Mr. Krouse added.
“If you’re a group, and you’re doing internal audits and you’ve got a compliance program in place, and you’re really working to have a compliant organization, the government’s aggressiveness and fraud detection is going to be minimal,” he said. “The aggressive tactics are really for those groups or organizations that have a blatant disregard for these processes.”
8 pro tips for avoiding fraud accusations
The possibility of coming under Medicare fraud scrutiny strikes fear in the heart of most physicians. Here’s what health law experts and federal officials recommend to stay in the clear:
• Designate a compliance officer. Assigning a specific employee to keep track of changing laws and regulations can help physicians remain compliant with antifraud regulations, said Mr. Krouse. The compliance officer should lead compliance efforts, inform staff of relevant rule changes, and take charge if billing practices come under government scrutiny.
• Retain a health law attorney. Seek the guidance of an experienced health law or Medicare fraud defense attorney should questions or billing problems arise, Mr. Clark recommended. Business or staff attorneys do not always have the needed expertise and can sometimes lead practices astray during critical times. Consider retaining a qualified, go-to health law attorney to answer questions and assist during crises.
• Develop a compliance program. Create strong compliance plans to address potential fraud, abuse, and billing issues, Dr. Taitsman advised. There is no one-size-fits all compliance plan, but the government offers suggested guidance about what plans should entail. No practice is too small to set up a compliance plan, she said.
• Perform internal audits. Internal audits should be a regular practice – annually or biennially – for all physicians, Mr. Krouse said. They can be completed by staff or a consultant.
• Send audit results to an attorney. If an internal audit is completed, the results should be conveyed first to an attorney, Mr. Clark said. Audit results shared directly with members of the medical practices are not privileged and could be communicated to the government. If an attorney shares audit results with physicians and practice leaders, the information is protected by the attorney-client privilege. The process limits the ability of staff members or disgruntled employees from sharing audit information or seeking whistle-blower claims.
• Build a strong disclosure protocol. The government is usually more lenient with health providers who are forthcoming about billing mistakes, Dr. Szalados said. Disclosing potential health fraud or billing errors can save the stress, time, and money associated with a government-initiated investigation. Under the Affordable Care Act, providers must return overpayments within 60 days of identifying them. Failing to report overpayments can lead to liability under the False Claims Act.
• Address billing errors immediately. If overbilling errors or systemic mistakes are found, doctors must do more than simply repay the government, Mr. Krouse said. Practices also must change their billing practices and develop an improvement plan. Have a process in place for how billing and coding issues will be addressed in the present and in the future, he recommended.
• Formulate a correction plan. Should a practice come under Medicare fraud suspicion, physicians should immediately analyze past billings. Conduct a thorough internal investigation that includes the extent of the problem and the scope of its threat to the practice, Mr. Krouse added. Create a corrective action plan and outline it to the government. A strong corrective plan goes a long way in negotiating settlements with the government, he said.
Various online resources are available to help physicians prevent Medicare fraud including a roadmap from CMS and guidance for new physicians by the OIG.
On Twitter @legal_med
For Dr. Carla L. Kakutani, it has become increasingly challenging to obtain durable medical equipment (DME) for her Medicare patients.
In addition to proving equipment is medically necessary, a 2013 rule requires physicians to document that a face-to-face encounter occurred between a patient and doctor or other health provider within 6 months of the DME order. (Enforcement of the rule has been delayed, but many physicians are currently complying with this policy.) Dr. Kakutani understands the added regulations are meant to prevent fraudulent billings, she said, but the heavy paperwork and additional red tape are burdensome.
“The problem is, [the process] turns into this back and forth between you, the equipment company, and Medicare,” said Dr. Kakutani, a family physician in Winters, Calif. “Meanwhile, the patient is waiting, and you’re being distracted from other things. The bad apples are making life rough for the rest of us.”
As Medicare turns 50 this year, Dr. Kakutani is not alone in her frustrations. In recent years, the U.S. Department of Health & Human Services has greatly expanded its efforts to combat Medicare fraud, and physicians across the country are feeling the effects.
The government’s primary antifraud tool is the Health Care Fraud Prevention and Enforcement Action Team (HEAT), created in 2009 to identify and investigate health fraud and abuse. CMS also works with an array of contractors to detect Medicare fraud, including comprehensive error rate testing (CERT) contractors, Medicare administrative contractors (MACs), Medicare drug integrity contractors (MEDICs), recovery audit program auditors (RACs), and zone program integrity contractors (ZPICs). In 2010, CMS launched the Fraud Prevention System (FPS), a predictive analytics technology that runs algorithms on all Medicare claims prior to payment. And in 2012, CMS created the Program Integrity Command Center that brings together investigators from Medicare, Medicaid, and the law enforcement community to develop predictive analytics that identify fraud and mobilize a rapid response.
Just how much Medicare fraud is happening at any given time is difficult to measure. In 2014, the federal government recouped $3 billion in Medicare- and Medicaid-related fraud settlements and judgments, according to an HHS analysis. In 2013 and 2012, the government recovered about $4 billion each year. And it’s nearly impossible to determine the volume of Medicare fraud committed by doctors, said Dr. Julie Taitsman, chief medical officer for the HHS Office of Inspector General.
“Getting at the actual amount of Medicare fraud in general, or Medicare fraud by physicians, is incredibly difficult,” Dr. Taitsman said in an interview. “We can tell you about the fraud we’ve identified, but we don’t know the total body of fraud.”
Dr. Taitsman stressed that all physicians play a major role in preventing health fraud and improving the quality of the Medicare system.
“Why it’s so important for physicians to practice with integrity – and we do believe that the vast majority of physicians practice with integrity – is because physicians control the bulk of care and services that [Medicare] patients receive,” Dr. Taitsman said. “That’s why it’s so important for physicians to be our partners in promoting high-quality care, promoting efficiency and compliance with the rules.”
But continually changing rules and guidelines make it difficult for many doctors to do just that, said Dr. James Szalados, an anesthesiologist and critical care physician based in Rochester, N.Y. Updates to payment rules, new OIG work plan targets, and growing documentation requirements can be overwhelming for practices.
“It’s not just the number of regulations, but it’s also the rate of change,” said Dr. Szalados, who is also an attorney. “For most doctors, it’s terrifying. They can’t keep up.”
Adhering to the latest regulations generally means hiring outside attorneys, consultants, and financial auditors who can help doctors self-police their practices, Dr. Szalados said.
Physicians also face Medicare fraud accusations from more directions than in the past, said Michael E. Clark, a Houston-based health law attorney and chair of the American Bar Association health law section. In addition to government claims, whistle-blower provisions under the False Claims Act allow individuals to file lawsuits alleging fraud and abuse on behalf of the government. If the government intervenes and the suit is successful, a whistle-blower can take home 15%-25% of money recovered. In 2014, the number of whistle-blower suits exceeded 700 for the second year in a row, according to the Department of Justice.
“A lot of people bringing these false claims actions are former or disgruntled employees or other doctors,” Mr. Clark said. “You might have a technical, regulatory type of theory, and yet it can be quickly changed into a fraud and abuse case.”
New laws have added to the challenge, Mr. Clark said. The Fraud Enforcement and Recovery Act (FERA), enacted in 2009, expands potential liability for false claims by applying the FCA to more entities and a larger range of transactions. The law also reduces the proof required to establish fault.
“FERA took away a lot of defenses that had been used successfully by defense counsel over the years on technical issues,” Mr. Clark said.
The antifraud climate has led many physicians to leave private practice or merge with hospitals or larger health systems, Dr. Szalados said. Other doctors have resorted to intentionally underbilling to avoid claim scrutiny, according to Dr. Robert A. Lee, who serves on the board of directors for the American Academy of Family Physicians . After a third-party compliance review, Dr. Lee’s private practice felt the best course of action was to bill more conservatively, he said.
“We kind of overdocument and undercode,” Dr. Lee said in an interview. “Of course that’s not fair to the physicians because they’re not billing for what they did do.”
On a more positive note, physicians are getting better at internal auditing and developing stronger compliance programs that address billing errors, said Alex T. Krouse, a health law attorney based in Mishawaka, Ind.
“I do think health care providers are getting more sophisticated and are really believing in the compliance-related function,” Mr. Krouse said in an interview. “That is helping and reducing the risk quite a bit.”
While antifraud enforcement will likely increase in the future, physicians that follow regulations and implement recommended protocols shouldn’t be too worried, Mr. Krouse added.
“If you’re a group, and you’re doing internal audits and you’ve got a compliance program in place, and you’re really working to have a compliant organization, the government’s aggressiveness and fraud detection is going to be minimal,” he said. “The aggressive tactics are really for those groups or organizations that have a blatant disregard for these processes.”
8 pro tips for avoiding fraud accusations
The possibility of coming under Medicare fraud scrutiny strikes fear in the heart of most physicians. Here’s what health law experts and federal officials recommend to stay in the clear:
• Designate a compliance officer. Assigning a specific employee to keep track of changing laws and regulations can help physicians remain compliant with antifraud regulations, said Mr. Krouse. The compliance officer should lead compliance efforts, inform staff of relevant rule changes, and take charge if billing practices come under government scrutiny.
• Retain a health law attorney. Seek the guidance of an experienced health law or Medicare fraud defense attorney should questions or billing problems arise, Mr. Clark recommended. Business or staff attorneys do not always have the needed expertise and can sometimes lead practices astray during critical times. Consider retaining a qualified, go-to health law attorney to answer questions and assist during crises.
• Develop a compliance program. Create strong compliance plans to address potential fraud, abuse, and billing issues, Dr. Taitsman advised. There is no one-size-fits all compliance plan, but the government offers suggested guidance about what plans should entail. No practice is too small to set up a compliance plan, she said.
• Perform internal audits. Internal audits should be a regular practice – annually or biennially – for all physicians, Mr. Krouse said. They can be completed by staff or a consultant.
• Send audit results to an attorney. If an internal audit is completed, the results should be conveyed first to an attorney, Mr. Clark said. Audit results shared directly with members of the medical practices are not privileged and could be communicated to the government. If an attorney shares audit results with physicians and practice leaders, the information is protected by the attorney-client privilege. The process limits the ability of staff members or disgruntled employees from sharing audit information or seeking whistle-blower claims.
• Build a strong disclosure protocol. The government is usually more lenient with health providers who are forthcoming about billing mistakes, Dr. Szalados said. Disclosing potential health fraud or billing errors can save the stress, time, and money associated with a government-initiated investigation. Under the Affordable Care Act, providers must return overpayments within 60 days of identifying them. Failing to report overpayments can lead to liability under the False Claims Act.
• Address billing errors immediately. If overbilling errors or systemic mistakes are found, doctors must do more than simply repay the government, Mr. Krouse said. Practices also must change their billing practices and develop an improvement plan. Have a process in place for how billing and coding issues will be addressed in the present and in the future, he recommended.
• Formulate a correction plan. Should a practice come under Medicare fraud suspicion, physicians should immediately analyze past billings. Conduct a thorough internal investigation that includes the extent of the problem and the scope of its threat to the practice, Mr. Krouse added. Create a corrective action plan and outline it to the government. A strong corrective plan goes a long way in negotiating settlements with the government, he said.
Various online resources are available to help physicians prevent Medicare fraud including a roadmap from CMS and guidance for new physicians by the OIG.
On Twitter @legal_med
For Dr. Carla L. Kakutani, it has become increasingly challenging to obtain durable medical equipment (DME) for her Medicare patients.
In addition to proving equipment is medically necessary, a 2013 rule requires physicians to document that a face-to-face encounter occurred between a patient and doctor or other health provider within 6 months of the DME order. (Enforcement of the rule has been delayed, but many physicians are currently complying with this policy.) Dr. Kakutani understands the added regulations are meant to prevent fraudulent billings, she said, but the heavy paperwork and additional red tape are burdensome.
“The problem is, [the process] turns into this back and forth between you, the equipment company, and Medicare,” said Dr. Kakutani, a family physician in Winters, Calif. “Meanwhile, the patient is waiting, and you’re being distracted from other things. The bad apples are making life rough for the rest of us.”
As Medicare turns 50 this year, Dr. Kakutani is not alone in her frustrations. In recent years, the U.S. Department of Health & Human Services has greatly expanded its efforts to combat Medicare fraud, and physicians across the country are feeling the effects.
The government’s primary antifraud tool is the Health Care Fraud Prevention and Enforcement Action Team (HEAT), created in 2009 to identify and investigate health fraud and abuse. CMS also works with an array of contractors to detect Medicare fraud, including comprehensive error rate testing (CERT) contractors, Medicare administrative contractors (MACs), Medicare drug integrity contractors (MEDICs), recovery audit program auditors (RACs), and zone program integrity contractors (ZPICs). In 2010, CMS launched the Fraud Prevention System (FPS), a predictive analytics technology that runs algorithms on all Medicare claims prior to payment. And in 2012, CMS created the Program Integrity Command Center that brings together investigators from Medicare, Medicaid, and the law enforcement community to develop predictive analytics that identify fraud and mobilize a rapid response.
Just how much Medicare fraud is happening at any given time is difficult to measure. In 2014, the federal government recouped $3 billion in Medicare- and Medicaid-related fraud settlements and judgments, according to an HHS analysis. In 2013 and 2012, the government recovered about $4 billion each year. And it’s nearly impossible to determine the volume of Medicare fraud committed by doctors, said Dr. Julie Taitsman, chief medical officer for the HHS Office of Inspector General.
“Getting at the actual amount of Medicare fraud in general, or Medicare fraud by physicians, is incredibly difficult,” Dr. Taitsman said in an interview. “We can tell you about the fraud we’ve identified, but we don’t know the total body of fraud.”
Dr. Taitsman stressed that all physicians play a major role in preventing health fraud and improving the quality of the Medicare system.
“Why it’s so important for physicians to practice with integrity – and we do believe that the vast majority of physicians practice with integrity – is because physicians control the bulk of care and services that [Medicare] patients receive,” Dr. Taitsman said. “That’s why it’s so important for physicians to be our partners in promoting high-quality care, promoting efficiency and compliance with the rules.”
But continually changing rules and guidelines make it difficult for many doctors to do just that, said Dr. James Szalados, an anesthesiologist and critical care physician based in Rochester, N.Y. Updates to payment rules, new OIG work plan targets, and growing documentation requirements can be overwhelming for practices.
“It’s not just the number of regulations, but it’s also the rate of change,” said Dr. Szalados, who is also an attorney. “For most doctors, it’s terrifying. They can’t keep up.”
Adhering to the latest regulations generally means hiring outside attorneys, consultants, and financial auditors who can help doctors self-police their practices, Dr. Szalados said.
Physicians also face Medicare fraud accusations from more directions than in the past, said Michael E. Clark, a Houston-based health law attorney and chair of the American Bar Association health law section. In addition to government claims, whistle-blower provisions under the False Claims Act allow individuals to file lawsuits alleging fraud and abuse on behalf of the government. If the government intervenes and the suit is successful, a whistle-blower can take home 15%-25% of money recovered. In 2014, the number of whistle-blower suits exceeded 700 for the second year in a row, according to the Department of Justice.
“A lot of people bringing these false claims actions are former or disgruntled employees or other doctors,” Mr. Clark said. “You might have a technical, regulatory type of theory, and yet it can be quickly changed into a fraud and abuse case.”
New laws have added to the challenge, Mr. Clark said. The Fraud Enforcement and Recovery Act (FERA), enacted in 2009, expands potential liability for false claims by applying the FCA to more entities and a larger range of transactions. The law also reduces the proof required to establish fault.
“FERA took away a lot of defenses that had been used successfully by defense counsel over the years on technical issues,” Mr. Clark said.
The antifraud climate has led many physicians to leave private practice or merge with hospitals or larger health systems, Dr. Szalados said. Other doctors have resorted to intentionally underbilling to avoid claim scrutiny, according to Dr. Robert A. Lee, who serves on the board of directors for the American Academy of Family Physicians . After a third-party compliance review, Dr. Lee’s private practice felt the best course of action was to bill more conservatively, he said.
“We kind of overdocument and undercode,” Dr. Lee said in an interview. “Of course that’s not fair to the physicians because they’re not billing for what they did do.”
On a more positive note, physicians are getting better at internal auditing and developing stronger compliance programs that address billing errors, said Alex T. Krouse, a health law attorney based in Mishawaka, Ind.
“I do think health care providers are getting more sophisticated and are really believing in the compliance-related function,” Mr. Krouse said in an interview. “That is helping and reducing the risk quite a bit.”
While antifraud enforcement will likely increase in the future, physicians that follow regulations and implement recommended protocols shouldn’t be too worried, Mr. Krouse added.
“If you’re a group, and you’re doing internal audits and you’ve got a compliance program in place, and you’re really working to have a compliant organization, the government’s aggressiveness and fraud detection is going to be minimal,” he said. “The aggressive tactics are really for those groups or organizations that have a blatant disregard for these processes.”
8 pro tips for avoiding fraud accusations
The possibility of coming under Medicare fraud scrutiny strikes fear in the heart of most physicians. Here’s what health law experts and federal officials recommend to stay in the clear:
• Designate a compliance officer. Assigning a specific employee to keep track of changing laws and regulations can help physicians remain compliant with antifraud regulations, said Mr. Krouse. The compliance officer should lead compliance efforts, inform staff of relevant rule changes, and take charge if billing practices come under government scrutiny.
• Retain a health law attorney. Seek the guidance of an experienced health law or Medicare fraud defense attorney should questions or billing problems arise, Mr. Clark recommended. Business or staff attorneys do not always have the needed expertise and can sometimes lead practices astray during critical times. Consider retaining a qualified, go-to health law attorney to answer questions and assist during crises.
• Develop a compliance program. Create strong compliance plans to address potential fraud, abuse, and billing issues, Dr. Taitsman advised. There is no one-size-fits all compliance plan, but the government offers suggested guidance about what plans should entail. No practice is too small to set up a compliance plan, she said.
• Perform internal audits. Internal audits should be a regular practice – annually or biennially – for all physicians, Mr. Krouse said. They can be completed by staff or a consultant.
• Send audit results to an attorney. If an internal audit is completed, the results should be conveyed first to an attorney, Mr. Clark said. Audit results shared directly with members of the medical practices are not privileged and could be communicated to the government. If an attorney shares audit results with physicians and practice leaders, the information is protected by the attorney-client privilege. The process limits the ability of staff members or disgruntled employees from sharing audit information or seeking whistle-blower claims.
• Build a strong disclosure protocol. The government is usually more lenient with health providers who are forthcoming about billing mistakes, Dr. Szalados said. Disclosing potential health fraud or billing errors can save the stress, time, and money associated with a government-initiated investigation. Under the Affordable Care Act, providers must return overpayments within 60 days of identifying them. Failing to report overpayments can lead to liability under the False Claims Act.
• Address billing errors immediately. If overbilling errors or systemic mistakes are found, doctors must do more than simply repay the government, Mr. Krouse said. Practices also must change their billing practices and develop an improvement plan. Have a process in place for how billing and coding issues will be addressed in the present and in the future, he recommended.
• Formulate a correction plan. Should a practice come under Medicare fraud suspicion, physicians should immediately analyze past billings. Conduct a thorough internal investigation that includes the extent of the problem and the scope of its threat to the practice, Mr. Krouse added. Create a corrective action plan and outline it to the government. A strong corrective plan goes a long way in negotiating settlements with the government, he said.
Various online resources are available to help physicians prevent Medicare fraud including a roadmap from CMS and guidance for new physicians by the OIG.
On Twitter @legal_med
New state litigation challenges physicians’ authority to regulate nonphysicians
The conflict between physicians and nonphysicians over how scope of practice should be regulated is heating up as a new antitrust challenge pits a medical board against a pain clinic.
The owners of Axcess Medical Clinic Inc. are suing the Mississippi State Board of Medical Licensure over a rule that requires pain clinics be owned by a hospital or licensed physician. The clinic claims the rule is anticompetitive and forced it to close, according to a lawsuit filed April 24 in U.S. District Court for the Southern District of Mississippi.
The lawsuit follows a February decision by the U.S. Supreme Court against a local dental board that attempted to stop nonprofessionals from providing teeth-whitening services. The Justices ruled the dental board had violated federal antitrust regulations because the board was not adequately supervised by the state. At the time, physician leaders worried the high court ruling could generate further lawsuits and alter state medical boards’ ability to regulate scope of practice.
The Mississippi case stems from a 2011 board rule that requires pain management clinics to be owned or operated by a hospital or licensed physician. The rule also requires that pain management clinics register with the board before doing business. Then-owner of Axcess Medical Clinic, Kenneth Charles Knight, requested that the clinic be grandfathered against complying with the rule because it opened in 2010, according to court records. The lawsuit claims the board failed to address the request, and Mr. Knight was forced to sell his ownership to a physician to salvage his investment. The physician later rescinded the purchase and the shares reverted back to Mr. Knight.
In 2012, Mr. Knight divested his majority ownership to family physician Dr. Fitzhugh L. Neal Jr., according to court documents. The board approved the clinic’s registration, but later requested more information about the physician’s proof of ownership. According to the lawsuit, the board found the physician was practicing pain management without proper qualifications and did not renew its registration. The clinic temporarily closed, but reopened a month later with a new registration, court documents state. In 2013, the licensure board issued new education and certification requirements for physicians to practice pain management. The requirements forced Axcess Medical Clinic to permanently close, the lawsuit states.
Plaintiffs Mr. Knight and Dr. Neal claim the board violated state and federal antitrust regulations by engaging in anticompetitive activities that deprived patients of choice. The suit also alleges that the board is made up of market participants who are not adequately supervised by the state.
An attorney for Axcess Medical Clinic said he could not provide timely comment on the case.
Dr. H. Vann Craig, executive director for the Mississippi State Board of Medical Licensure declined to comment on details of the litigation, but defended the board’s general practices. He noted that he is not aware of any Federal Trade Commission interest in the case.
“Our process is we try to deal with physicians and make sure they’re qualified to be doing what they are doing,” he said in an interview.
The board, which will be represented by the Mississippi Attorney General’s office, has not yet issued a formal response to the lawsuit.
The vagueness of the Supreme Court’s decision opened the door for further legal challenges, according to Joshua Prober, senior vice president and general counsel for the American Osteopathic Association (AOA). The high court’s decision found North Carolina’s model for state licensing board regulation did not provide for sufficient state oversight of a board made up of market competitors, but the ruling does not provide clear guidance on what’s expected from state governments in structuring state licensing boards, he said.
“Instead, it said its inquiry would be ‘flexible and context dependent,’ which appears to invite challenges to structures used in other states,” he said. “Because antitrust litigation provides that a successful plaintiff can recover treble damages, there can be a generous payoff for a successful challenge.”
On Twitter @legal_med
The conflict between physicians and nonphysicians over how scope of practice should be regulated is heating up as a new antitrust challenge pits a medical board against a pain clinic.
The owners of Axcess Medical Clinic Inc. are suing the Mississippi State Board of Medical Licensure over a rule that requires pain clinics be owned by a hospital or licensed physician. The clinic claims the rule is anticompetitive and forced it to close, according to a lawsuit filed April 24 in U.S. District Court for the Southern District of Mississippi.
The lawsuit follows a February decision by the U.S. Supreme Court against a local dental board that attempted to stop nonprofessionals from providing teeth-whitening services. The Justices ruled the dental board had violated federal antitrust regulations because the board was not adequately supervised by the state. At the time, physician leaders worried the high court ruling could generate further lawsuits and alter state medical boards’ ability to regulate scope of practice.
The Mississippi case stems from a 2011 board rule that requires pain management clinics to be owned or operated by a hospital or licensed physician. The rule also requires that pain management clinics register with the board before doing business. Then-owner of Axcess Medical Clinic, Kenneth Charles Knight, requested that the clinic be grandfathered against complying with the rule because it opened in 2010, according to court records. The lawsuit claims the board failed to address the request, and Mr. Knight was forced to sell his ownership to a physician to salvage his investment. The physician later rescinded the purchase and the shares reverted back to Mr. Knight.
In 2012, Mr. Knight divested his majority ownership to family physician Dr. Fitzhugh L. Neal Jr., according to court documents. The board approved the clinic’s registration, but later requested more information about the physician’s proof of ownership. According to the lawsuit, the board found the physician was practicing pain management without proper qualifications and did not renew its registration. The clinic temporarily closed, but reopened a month later with a new registration, court documents state. In 2013, the licensure board issued new education and certification requirements for physicians to practice pain management. The requirements forced Axcess Medical Clinic to permanently close, the lawsuit states.
Plaintiffs Mr. Knight and Dr. Neal claim the board violated state and federal antitrust regulations by engaging in anticompetitive activities that deprived patients of choice. The suit also alleges that the board is made up of market participants who are not adequately supervised by the state.
An attorney for Axcess Medical Clinic said he could not provide timely comment on the case.
Dr. H. Vann Craig, executive director for the Mississippi State Board of Medical Licensure declined to comment on details of the litigation, but defended the board’s general practices. He noted that he is not aware of any Federal Trade Commission interest in the case.
“Our process is we try to deal with physicians and make sure they’re qualified to be doing what they are doing,” he said in an interview.
The board, which will be represented by the Mississippi Attorney General’s office, has not yet issued a formal response to the lawsuit.
The vagueness of the Supreme Court’s decision opened the door for further legal challenges, according to Joshua Prober, senior vice president and general counsel for the American Osteopathic Association (AOA). The high court’s decision found North Carolina’s model for state licensing board regulation did not provide for sufficient state oversight of a board made up of market competitors, but the ruling does not provide clear guidance on what’s expected from state governments in structuring state licensing boards, he said.
“Instead, it said its inquiry would be ‘flexible and context dependent,’ which appears to invite challenges to structures used in other states,” he said. “Because antitrust litigation provides that a successful plaintiff can recover treble damages, there can be a generous payoff for a successful challenge.”
On Twitter @legal_med
The conflict between physicians and nonphysicians over how scope of practice should be regulated is heating up as a new antitrust challenge pits a medical board against a pain clinic.
The owners of Axcess Medical Clinic Inc. are suing the Mississippi State Board of Medical Licensure over a rule that requires pain clinics be owned by a hospital or licensed physician. The clinic claims the rule is anticompetitive and forced it to close, according to a lawsuit filed April 24 in U.S. District Court for the Southern District of Mississippi.
The lawsuit follows a February decision by the U.S. Supreme Court against a local dental board that attempted to stop nonprofessionals from providing teeth-whitening services. The Justices ruled the dental board had violated federal antitrust regulations because the board was not adequately supervised by the state. At the time, physician leaders worried the high court ruling could generate further lawsuits and alter state medical boards’ ability to regulate scope of practice.
The Mississippi case stems from a 2011 board rule that requires pain management clinics to be owned or operated by a hospital or licensed physician. The rule also requires that pain management clinics register with the board before doing business. Then-owner of Axcess Medical Clinic, Kenneth Charles Knight, requested that the clinic be grandfathered against complying with the rule because it opened in 2010, according to court records. The lawsuit claims the board failed to address the request, and Mr. Knight was forced to sell his ownership to a physician to salvage his investment. The physician later rescinded the purchase and the shares reverted back to Mr. Knight.
In 2012, Mr. Knight divested his majority ownership to family physician Dr. Fitzhugh L. Neal Jr., according to court documents. The board approved the clinic’s registration, but later requested more information about the physician’s proof of ownership. According to the lawsuit, the board found the physician was practicing pain management without proper qualifications and did not renew its registration. The clinic temporarily closed, but reopened a month later with a new registration, court documents state. In 2013, the licensure board issued new education and certification requirements for physicians to practice pain management. The requirements forced Axcess Medical Clinic to permanently close, the lawsuit states.
Plaintiffs Mr. Knight and Dr. Neal claim the board violated state and federal antitrust regulations by engaging in anticompetitive activities that deprived patients of choice. The suit also alleges that the board is made up of market participants who are not adequately supervised by the state.
An attorney for Axcess Medical Clinic said he could not provide timely comment on the case.
Dr. H. Vann Craig, executive director for the Mississippi State Board of Medical Licensure declined to comment on details of the litigation, but defended the board’s general practices. He noted that he is not aware of any Federal Trade Commission interest in the case.
“Our process is we try to deal with physicians and make sure they’re qualified to be doing what they are doing,” he said in an interview.
The board, which will be represented by the Mississippi Attorney General’s office, has not yet issued a formal response to the lawsuit.
The vagueness of the Supreme Court’s decision opened the door for further legal challenges, according to Joshua Prober, senior vice president and general counsel for the American Osteopathic Association (AOA). The high court’s decision found North Carolina’s model for state licensing board regulation did not provide for sufficient state oversight of a board made up of market competitors, but the ruling does not provide clear guidance on what’s expected from state governments in structuring state licensing boards, he said.
“Instead, it said its inquiry would be ‘flexible and context dependent,’ which appears to invite challenges to structures used in other states,” he said. “Because antitrust litigation provides that a successful plaintiff can recover treble damages, there can be a generous payoff for a successful challenge.”
On Twitter @legal_med
FDA requests more data on antiseptics used in health care settings
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.
“Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.
Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.
“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”
The proposed rule is available at www.federalregister.gov. Public comments can be submitted until Oct. 27.
HIMSS15: Doctors can develop patient engagement platforms through strong partnerships
CHICAGO – For Margaret Mary Health in Batesville, Ind., partnerships were central to the formation of its community-wide patient portal.
In 2012, the hospital launched a portal that combines the records and information of multiple health providers in southeast Indiana and surrounding areas into a single system that patients can access. The approach departs from a standard portal model in which each physician practice has its own portal and patients must assess their health information from multiple sources, according to Dr. Jeffrey Hatcher, a Batesville ob.gyn and medical staff liaison for Margaret Mary Health.
“The whole goal of electronic records was to consolidate and centralize and streamline health care records,” Dr. Hatcher said in an interview. “In a lot of ways, what we’re doing is just building on that process. We’ve eliminated the need for all of those individual portals and connected the patients and their physicians to the health information exchange (HIE). Those practices feed the information through the HIE into the patient’s chart.”
Margaret Mary began efforts to design its portal in early 2011. The hospital partnered with NoMoreClipboard, a company that offers patient engagement tools to health providers, and HealthBridge, a nonprofit corporation that supports health information technology adoption and health information exchange (HIE). The timing was perfect, Dr. Hatcher said, because NoMoreClipboard and Indiana Health Information Technology Inc. (IHIT) had just received a joint $1.5 million grant from the Office of the National Coordinator for Health Information Technology (ONC) to develop, deploy, and pilot test solutions that enable patients to access electronic health information exchange data.
Despite a knowledgeable design team, the road to Margaret Mary’s united provider portal was strewn with bumps and obstacles, Dr. Hatcher said at the annual meeting of the Healthcare Information and Management Systems Society (HIMSS). Developers encountered skepticism from some health providers and received push back from electronic health record (EHR) vendors.
The vendors’ “excitement to participate and help us develop this was not as great because it basically took the place of their product,” Dr. Hatcher said in an interview. “It’s a really slow process to get them to cooperate. They’re just not willing to move things along at a pace that’s rapid enough.”
Dr. Hatcher’s team worked to gain the trust of each participant. One key was ensuring that each provider was comfortable with what medical information would be released and when, and what type of sensitive information should be withheld and for how long, he said. Portal developers also had to create policies for the system and take into account the various data access rules of patients’ home states – including Indiana, Ohio, and Kentucky.
There were privacy issues as well. While the hospital serves a regional population of 70,000, it is situated in the rural community of Batesville, a town of 7,000. Residents in the small community historically have passed down identical first and last names for several generations leading to four or five people in the community with the same name, according to a case study on the project by NoMoreClipboard.
To address the situation, development experts created standards-based policies to securely match consumers with their data, and once authenticated, transport those data into patients’ personal health record.
Since the portal launched in 2012, 18,000 patients have accepted their access codes and about 5,000 patient have used the portal, Dr. Hatcher said. Because the portal links to HealthBridge, patients are able to get data from across the continuum of care, whether or not they receive the care at Margaret Mary. HealthBridge serves southwest Ohio, southeast Indiana and northern Kentucky. Additionally, several Cincinnati hospitals have authorized sharing their HIE data with Margaret Mary patients who use the portal.
No hard numbers on the portal’s impact yet exist, but providers have noted an increase in productivity and a rise in patient satisfaction, Dr. Hatcher said.
“When you look at the care perspective, it’s changed the dynamics of the conversations we’re having,” he said. “When patients get data, we can point them to trusted websites and they can come in prepared. The follow-up appointment becomes more of a discussion and not a lab review. Now you’re spending [more] time planning care.”
Dr. Hatcher encourages other physicians and health systems to participate in such patient engagement efforts, especially as Stage 3 of meaningful use approaches. The Centers for Medicare & Medicaid Services has proposed that all physicians and hospitals meet Stage 3 meaningful use requirements beginning in 2018. The proposed rule also calls for 25% of patients to access their data, although it allows for third-party providers to access a patient’s account as a means of satisfying the requirement.
“As we begin this heath care–sharing process, it’s really important to have patients in a position where they’re more educated about the process that’s going on with them,” Dr. Hatcher said in an interview. “The more you educate your patients, the more it helps them embrace what you’re trying to do. It’ll be hard to meet the upcoming meaningful use measures if you don’t have patients engaged in their health care plan.”
Health providers interested in creating a similar patient portal should review what other health systems have done in the past and build on their ideas, Dr. Hatcher added.
“You’ve got to have the enthusiasm of your medical staff,” he said. “You’ve got to have the support of your organization, and you have to have a vision. Know what you want before you start. If you do that, then you’re well on your way.”
On Twitter @legal_med
CHICAGO – For Margaret Mary Health in Batesville, Ind., partnerships were central to the formation of its community-wide patient portal.
In 2012, the hospital launched a portal that combines the records and information of multiple health providers in southeast Indiana and surrounding areas into a single system that patients can access. The approach departs from a standard portal model in which each physician practice has its own portal and patients must assess their health information from multiple sources, according to Dr. Jeffrey Hatcher, a Batesville ob.gyn and medical staff liaison for Margaret Mary Health.
“The whole goal of electronic records was to consolidate and centralize and streamline health care records,” Dr. Hatcher said in an interview. “In a lot of ways, what we’re doing is just building on that process. We’ve eliminated the need for all of those individual portals and connected the patients and their physicians to the health information exchange (HIE). Those practices feed the information through the HIE into the patient’s chart.”
Margaret Mary began efforts to design its portal in early 2011. The hospital partnered with NoMoreClipboard, a company that offers patient engagement tools to health providers, and HealthBridge, a nonprofit corporation that supports health information technology adoption and health information exchange (HIE). The timing was perfect, Dr. Hatcher said, because NoMoreClipboard and Indiana Health Information Technology Inc. (IHIT) had just received a joint $1.5 million grant from the Office of the National Coordinator for Health Information Technology (ONC) to develop, deploy, and pilot test solutions that enable patients to access electronic health information exchange data.
Despite a knowledgeable design team, the road to Margaret Mary’s united provider portal was strewn with bumps and obstacles, Dr. Hatcher said at the annual meeting of the Healthcare Information and Management Systems Society (HIMSS). Developers encountered skepticism from some health providers and received push back from electronic health record (EHR) vendors.
The vendors’ “excitement to participate and help us develop this was not as great because it basically took the place of their product,” Dr. Hatcher said in an interview. “It’s a really slow process to get them to cooperate. They’re just not willing to move things along at a pace that’s rapid enough.”
Dr. Hatcher’s team worked to gain the trust of each participant. One key was ensuring that each provider was comfortable with what medical information would be released and when, and what type of sensitive information should be withheld and for how long, he said. Portal developers also had to create policies for the system and take into account the various data access rules of patients’ home states – including Indiana, Ohio, and Kentucky.
There were privacy issues as well. While the hospital serves a regional population of 70,000, it is situated in the rural community of Batesville, a town of 7,000. Residents in the small community historically have passed down identical first and last names for several generations leading to four or five people in the community with the same name, according to a case study on the project by NoMoreClipboard.
To address the situation, development experts created standards-based policies to securely match consumers with their data, and once authenticated, transport those data into patients’ personal health record.
Since the portal launched in 2012, 18,000 patients have accepted their access codes and about 5,000 patient have used the portal, Dr. Hatcher said. Because the portal links to HealthBridge, patients are able to get data from across the continuum of care, whether or not they receive the care at Margaret Mary. HealthBridge serves southwest Ohio, southeast Indiana and northern Kentucky. Additionally, several Cincinnati hospitals have authorized sharing their HIE data with Margaret Mary patients who use the portal.
No hard numbers on the portal’s impact yet exist, but providers have noted an increase in productivity and a rise in patient satisfaction, Dr. Hatcher said.
“When you look at the care perspective, it’s changed the dynamics of the conversations we’re having,” he said. “When patients get data, we can point them to trusted websites and they can come in prepared. The follow-up appointment becomes more of a discussion and not a lab review. Now you’re spending [more] time planning care.”
Dr. Hatcher encourages other physicians and health systems to participate in such patient engagement efforts, especially as Stage 3 of meaningful use approaches. The Centers for Medicare & Medicaid Services has proposed that all physicians and hospitals meet Stage 3 meaningful use requirements beginning in 2018. The proposed rule also calls for 25% of patients to access their data, although it allows for third-party providers to access a patient’s account as a means of satisfying the requirement.
“As we begin this heath care–sharing process, it’s really important to have patients in a position where they’re more educated about the process that’s going on with them,” Dr. Hatcher said in an interview. “The more you educate your patients, the more it helps them embrace what you’re trying to do. It’ll be hard to meet the upcoming meaningful use measures if you don’t have patients engaged in their health care plan.”
Health providers interested in creating a similar patient portal should review what other health systems have done in the past and build on their ideas, Dr. Hatcher added.
“You’ve got to have the enthusiasm of your medical staff,” he said. “You’ve got to have the support of your organization, and you have to have a vision. Know what you want before you start. If you do that, then you’re well on your way.”
On Twitter @legal_med
CHICAGO – For Margaret Mary Health in Batesville, Ind., partnerships were central to the formation of its community-wide patient portal.
In 2012, the hospital launched a portal that combines the records and information of multiple health providers in southeast Indiana and surrounding areas into a single system that patients can access. The approach departs from a standard portal model in which each physician practice has its own portal and patients must assess their health information from multiple sources, according to Dr. Jeffrey Hatcher, a Batesville ob.gyn and medical staff liaison for Margaret Mary Health.
“The whole goal of electronic records was to consolidate and centralize and streamline health care records,” Dr. Hatcher said in an interview. “In a lot of ways, what we’re doing is just building on that process. We’ve eliminated the need for all of those individual portals and connected the patients and their physicians to the health information exchange (HIE). Those practices feed the information through the HIE into the patient’s chart.”
Margaret Mary began efforts to design its portal in early 2011. The hospital partnered with NoMoreClipboard, a company that offers patient engagement tools to health providers, and HealthBridge, a nonprofit corporation that supports health information technology adoption and health information exchange (HIE). The timing was perfect, Dr. Hatcher said, because NoMoreClipboard and Indiana Health Information Technology Inc. (IHIT) had just received a joint $1.5 million grant from the Office of the National Coordinator for Health Information Technology (ONC) to develop, deploy, and pilot test solutions that enable patients to access electronic health information exchange data.
Despite a knowledgeable design team, the road to Margaret Mary’s united provider portal was strewn with bumps and obstacles, Dr. Hatcher said at the annual meeting of the Healthcare Information and Management Systems Society (HIMSS). Developers encountered skepticism from some health providers and received push back from electronic health record (EHR) vendors.
The vendors’ “excitement to participate and help us develop this was not as great because it basically took the place of their product,” Dr. Hatcher said in an interview. “It’s a really slow process to get them to cooperate. They’re just not willing to move things along at a pace that’s rapid enough.”
Dr. Hatcher’s team worked to gain the trust of each participant. One key was ensuring that each provider was comfortable with what medical information would be released and when, and what type of sensitive information should be withheld and for how long, he said. Portal developers also had to create policies for the system and take into account the various data access rules of patients’ home states – including Indiana, Ohio, and Kentucky.
There were privacy issues as well. While the hospital serves a regional population of 70,000, it is situated in the rural community of Batesville, a town of 7,000. Residents in the small community historically have passed down identical first and last names for several generations leading to four or five people in the community with the same name, according to a case study on the project by NoMoreClipboard.
To address the situation, development experts created standards-based policies to securely match consumers with their data, and once authenticated, transport those data into patients’ personal health record.
Since the portal launched in 2012, 18,000 patients have accepted their access codes and about 5,000 patient have used the portal, Dr. Hatcher said. Because the portal links to HealthBridge, patients are able to get data from across the continuum of care, whether or not they receive the care at Margaret Mary. HealthBridge serves southwest Ohio, southeast Indiana and northern Kentucky. Additionally, several Cincinnati hospitals have authorized sharing their HIE data with Margaret Mary patients who use the portal.
No hard numbers on the portal’s impact yet exist, but providers have noted an increase in productivity and a rise in patient satisfaction, Dr. Hatcher said.
“When you look at the care perspective, it’s changed the dynamics of the conversations we’re having,” he said. “When patients get data, we can point them to trusted websites and they can come in prepared. The follow-up appointment becomes more of a discussion and not a lab review. Now you’re spending [more] time planning care.”
Dr. Hatcher encourages other physicians and health systems to participate in such patient engagement efforts, especially as Stage 3 of meaningful use approaches. The Centers for Medicare & Medicaid Services has proposed that all physicians and hospitals meet Stage 3 meaningful use requirements beginning in 2018. The proposed rule also calls for 25% of patients to access their data, although it allows for third-party providers to access a patient’s account as a means of satisfying the requirement.
“As we begin this heath care–sharing process, it’s really important to have patients in a position where they’re more educated about the process that’s going on with them,” Dr. Hatcher said in an interview. “The more you educate your patients, the more it helps them embrace what you’re trying to do. It’ll be hard to meet the upcoming meaningful use measures if you don’t have patients engaged in their health care plan.”
Health providers interested in creating a similar patient portal should review what other health systems have done in the past and build on their ideas, Dr. Hatcher added.
“You’ve got to have the enthusiasm of your medical staff,” he said. “You’ve got to have the support of your organization, and you have to have a vision. Know what you want before you start. If you do that, then you’re well on your way.”
On Twitter @legal_med
AT HIMSS15
ELCC: Urine tumor DNA shows high testing promise
GENEVA – Blood sampling provides a less invasive alternative to tumor biopsy for collecting cancer DNA for mutation testing, but retrieving tumor DNA from a patient’s urine is least invasive of all.
In an early phase of clinical investigation, researchers assessed the feasibility of using urine to collect cell-free tumor DNA to detect mutations in 34 patients with advanced non–small cell lung cancer. The results suggested that testing circulating tumor (ct) DNA isolated from patients’ urine was sensitive compared with testing DNA from biopsied specimens of the primary tumor, and it was able to flag tumor changes early, before clinically-identifiable effects appeared, Dr. Hatim Husain said at the European Lung Cancer Conference.
He used ctDNA isolated from patients’ urine to test for the presence of three different resistance mutations within the epidermal growth factor receptor (EGFR) gene. Genetic testing of biopsy specimens showed 10 patients carried the T790M mutation, 18 carried an exon 19 deletion, and eight carried an exon 21 L858R mutation. Of these 36 mutations in 34 patients, testing ctDNA isolated from urine identified 35 as positive, a 97% overall concordance rate.
In addition, testing with ctDNA from urine also picked up three additional T790M mutations not seen in the three corresponding tumor-biopsy specimens, but in patients with high clinical suspicion for carrying an EGFR mutation, Dr. Husain reported.
Further evidence for the utility of urinary ctDNA came from following 22 patients on treatment with erlotinib (Tarceva) and monitored for their acquisition of an EGFR-gene mutation making the tumor erlotinib resistant. Dr. Husain and his associates ran a DNA test every 3-6 weeks and tracked the time until patients developed radiographic progression. Using urinary ctDNA, they found four patients who developed EGFR mutations 29-111 days before clinical progression of the tumor became radiographically apparent.
The ctDNA that ends up in a patient’s urine starts out circulating in the blood; urine works as the main elimination route. Urine ctDNA is more concentrated than in blood, and ctDNA remains stable in urine at ambient temperature for 2 weeks, said Dr. Husain, an oncology researcher at the University of California San Diego, La Jolla.
“These interim results suggest that use of urinary ctDNA has potential to detect EGFR T790M status in a higher number of study subjects and may make some patients eligible for therapy who would by tissue biopsy be falsely classified as negative,” Dr. Husain said in a written statement. “Detecting the emergence of EGFR T790M mutations before progression has the potential to enable physicians to better align therapeutic selection and inform early therapeutic decision making,” he said.
Testing ctDNA in patients’ urine is a “novel way to do noninvasive testing,” said Dr. Egbert F. Smit, professor of pulmonary medicine at VU University Medical Center in Amsterdam and the meeting’s designated discussant for Dr. Husain’s report. “It’s attractive for collecting ctDNA because you get a high concentration, and it has potential for a high level of sensitivity. It may have potential for showing how a tumor reacts to treatment. The method seems robust, but we still need data on reproducibility and cost effectiveness,” Dr. Smit cautioned.
On Twitter @mitchelzoler
GENEVA – Blood sampling provides a less invasive alternative to tumor biopsy for collecting cancer DNA for mutation testing, but retrieving tumor DNA from a patient’s urine is least invasive of all.
In an early phase of clinical investigation, researchers assessed the feasibility of using urine to collect cell-free tumor DNA to detect mutations in 34 patients with advanced non–small cell lung cancer. The results suggested that testing circulating tumor (ct) DNA isolated from patients’ urine was sensitive compared with testing DNA from biopsied specimens of the primary tumor, and it was able to flag tumor changes early, before clinically-identifiable effects appeared, Dr. Hatim Husain said at the European Lung Cancer Conference.
He used ctDNA isolated from patients’ urine to test for the presence of three different resistance mutations within the epidermal growth factor receptor (EGFR) gene. Genetic testing of biopsy specimens showed 10 patients carried the T790M mutation, 18 carried an exon 19 deletion, and eight carried an exon 21 L858R mutation. Of these 36 mutations in 34 patients, testing ctDNA isolated from urine identified 35 as positive, a 97% overall concordance rate.
In addition, testing with ctDNA from urine also picked up three additional T790M mutations not seen in the three corresponding tumor-biopsy specimens, but in patients with high clinical suspicion for carrying an EGFR mutation, Dr. Husain reported.
Further evidence for the utility of urinary ctDNA came from following 22 patients on treatment with erlotinib (Tarceva) and monitored for their acquisition of an EGFR-gene mutation making the tumor erlotinib resistant. Dr. Husain and his associates ran a DNA test every 3-6 weeks and tracked the time until patients developed radiographic progression. Using urinary ctDNA, they found four patients who developed EGFR mutations 29-111 days before clinical progression of the tumor became radiographically apparent.
The ctDNA that ends up in a patient’s urine starts out circulating in the blood; urine works as the main elimination route. Urine ctDNA is more concentrated than in blood, and ctDNA remains stable in urine at ambient temperature for 2 weeks, said Dr. Husain, an oncology researcher at the University of California San Diego, La Jolla.
“These interim results suggest that use of urinary ctDNA has potential to detect EGFR T790M status in a higher number of study subjects and may make some patients eligible for therapy who would by tissue biopsy be falsely classified as negative,” Dr. Husain said in a written statement. “Detecting the emergence of EGFR T790M mutations before progression has the potential to enable physicians to better align therapeutic selection and inform early therapeutic decision making,” he said.
Testing ctDNA in patients’ urine is a “novel way to do noninvasive testing,” said Dr. Egbert F. Smit, professor of pulmonary medicine at VU University Medical Center in Amsterdam and the meeting’s designated discussant for Dr. Husain’s report. “It’s attractive for collecting ctDNA because you get a high concentration, and it has potential for a high level of sensitivity. It may have potential for showing how a tumor reacts to treatment. The method seems robust, but we still need data on reproducibility and cost effectiveness,” Dr. Smit cautioned.
On Twitter @mitchelzoler
GENEVA – Blood sampling provides a less invasive alternative to tumor biopsy for collecting cancer DNA for mutation testing, but retrieving tumor DNA from a patient’s urine is least invasive of all.
In an early phase of clinical investigation, researchers assessed the feasibility of using urine to collect cell-free tumor DNA to detect mutations in 34 patients with advanced non–small cell lung cancer. The results suggested that testing circulating tumor (ct) DNA isolated from patients’ urine was sensitive compared with testing DNA from biopsied specimens of the primary tumor, and it was able to flag tumor changes early, before clinically-identifiable effects appeared, Dr. Hatim Husain said at the European Lung Cancer Conference.
He used ctDNA isolated from patients’ urine to test for the presence of three different resistance mutations within the epidermal growth factor receptor (EGFR) gene. Genetic testing of biopsy specimens showed 10 patients carried the T790M mutation, 18 carried an exon 19 deletion, and eight carried an exon 21 L858R mutation. Of these 36 mutations in 34 patients, testing ctDNA isolated from urine identified 35 as positive, a 97% overall concordance rate.
In addition, testing with ctDNA from urine also picked up three additional T790M mutations not seen in the three corresponding tumor-biopsy specimens, but in patients with high clinical suspicion for carrying an EGFR mutation, Dr. Husain reported.
Further evidence for the utility of urinary ctDNA came from following 22 patients on treatment with erlotinib (Tarceva) and monitored for their acquisition of an EGFR-gene mutation making the tumor erlotinib resistant. Dr. Husain and his associates ran a DNA test every 3-6 weeks and tracked the time until patients developed radiographic progression. Using urinary ctDNA, they found four patients who developed EGFR mutations 29-111 days before clinical progression of the tumor became radiographically apparent.
The ctDNA that ends up in a patient’s urine starts out circulating in the blood; urine works as the main elimination route. Urine ctDNA is more concentrated than in blood, and ctDNA remains stable in urine at ambient temperature for 2 weeks, said Dr. Husain, an oncology researcher at the University of California San Diego, La Jolla.
“These interim results suggest that use of urinary ctDNA has potential to detect EGFR T790M status in a higher number of study subjects and may make some patients eligible for therapy who would by tissue biopsy be falsely classified as negative,” Dr. Husain said in a written statement. “Detecting the emergence of EGFR T790M mutations before progression has the potential to enable physicians to better align therapeutic selection and inform early therapeutic decision making,” he said.
Testing ctDNA in patients’ urine is a “novel way to do noninvasive testing,” said Dr. Egbert F. Smit, professor of pulmonary medicine at VU University Medical Center in Amsterdam and the meeting’s designated discussant for Dr. Husain’s report. “It’s attractive for collecting ctDNA because you get a high concentration, and it has potential for a high level of sensitivity. It may have potential for showing how a tumor reacts to treatment. The method seems robust, but we still need data on reproducibility and cost effectiveness,” Dr. Smit cautioned.
On Twitter @mitchelzoler
AT ELCC 2015
Key clinical point: Urine showed potential as a fully noninvasive source for circulating tumor DNA with high testing concordance compared with tumor-biopsy DNA in initial clinical experience with 34 lung cancer patients.
Major finding: Urine circulating tumor DNA had overall concordance of 97% compared with tumor-biopsy DNA for detecting treatment-altering mutations.
Data source: Single-center study of 34 patients with advanced non-small cell lung cancer.
Disclosures: The study was sponsored by Trovagene, the company developing the tests used in the study. Several coauthors on the study are Trovagene employees. Dr. Husain had no personal disclosures.
Biomarker correlates with pancreatic cancer severity
HOUSTON – A circulating biomarker has the potential to identify metastatic pancreatic cancer and may be able to predict prognosis, investigators said.
Levels of a gene encoding for the gap-junction beta 3 (GJB3) protein were highly elevated in both pancreatic cancer cell lines and in blood samples from patients with pancreatic ductal adenocarcinoma (PDAC), but the gene was undetectable in blood samples from patients without cancer, reported Dr. Raoud Marayati from the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill.
An analysis of gene expression in tumors from patients with PDAC also showed that patients with tumors expressing higher levels of GJB3 had significantly worse overall survival rates.
“GJB3 is highly expressed in blood samples from patients with metastatic versus local pancreatic cancer. GJB3 is a potential circulating biomarker for metastatic pancreatic cancer,” Dr. Marayati said at the annual Society of Surgical Oncology Cancer Symposium.
Markers lacking
PDAC is a highly aggressive cancer with a propensity for early invasion and metastasis. More than half of all patients (53%) have metastatic disease at the time of diagnosis, and 5-year survival for these patients is only 2.3%, according to the Surveillance, Epidemiology, and End Results (SEER) cancer statistics review for 2014, she noted.
The only currently available clinical biomarker for PDAC, carbohydrate antigen 19-9 (CA 19-9), generally correlates with treatment response and disease recurrence but has low sensitivity and specificity, Dr. Marayati said.
Circulating tumor cells (CTCs) – cells shed from the primary tumor into circulation – hold promise for better detection of cancer, but CTCs from pancreatic tumors have proven to be extremely difficult to isolate and count, she added.
To see whether they could identify circulating biomarkers of metastatic PDAC, Dr. Marayati and colleagues working in the laboratory of Dr. Jen Jen Yeh at the university first identified 76 genes that are differentially overexpressed in metastatic PDAC tumors, compared with localized primary tumors and with normal tissues.
The investigators looked for expression of the genes in 11 pancreatic cancer cell lines and in blood samples from 20 patients with pancreatic cancer and four without cancer. As noted, one gene, GJB3, was highly expressed in all of the cell-line samples but could not be detected in white blood cells from patients without PDAC.
To validate GJB3 as a potential cancer marker, the authors looked at expression levels in circulating tumor cells and found that, among the patients with cancer, expression levels of GBJ3 were significantly higher in those with metastatic disease, compared with localized disease (P = .016).
“That would suggest that GJB3 is a potential circulating biomarker specifically for metastatic pancreatic cancer patients,” Dr. Marayati said.
The investigators hypothesized that GJB3 may play a role in the biology of pancreatic cancer metastasis. To test this idea, they looked at resected tumors from 131 patients with primary pancreatic cancer and found that high tumor expression of GJB3 was associated with worse survival. Median overall survival among 32 patients with low levels of gene expression in their tumors was 24 months, compared with 15 months for 99 patients with high levels of GJB3 expression (P = .031).
The investigators plan to further validate the marker by testing it with larger samples from both patients with pancreatic cancer and controls.
The study funding source was not disclosed. Dr. Marayati reported having no disclosures.
HOUSTON – A circulating biomarker has the potential to identify metastatic pancreatic cancer and may be able to predict prognosis, investigators said.
Levels of a gene encoding for the gap-junction beta 3 (GJB3) protein were highly elevated in both pancreatic cancer cell lines and in blood samples from patients with pancreatic ductal adenocarcinoma (PDAC), but the gene was undetectable in blood samples from patients without cancer, reported Dr. Raoud Marayati from the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill.
An analysis of gene expression in tumors from patients with PDAC also showed that patients with tumors expressing higher levels of GJB3 had significantly worse overall survival rates.
“GJB3 is highly expressed in blood samples from patients with metastatic versus local pancreatic cancer. GJB3 is a potential circulating biomarker for metastatic pancreatic cancer,” Dr. Marayati said at the annual Society of Surgical Oncology Cancer Symposium.
Markers lacking
PDAC is a highly aggressive cancer with a propensity for early invasion and metastasis. More than half of all patients (53%) have metastatic disease at the time of diagnosis, and 5-year survival for these patients is only 2.3%, according to the Surveillance, Epidemiology, and End Results (SEER) cancer statistics review for 2014, she noted.
The only currently available clinical biomarker for PDAC, carbohydrate antigen 19-9 (CA 19-9), generally correlates with treatment response and disease recurrence but has low sensitivity and specificity, Dr. Marayati said.
Circulating tumor cells (CTCs) – cells shed from the primary tumor into circulation – hold promise for better detection of cancer, but CTCs from pancreatic tumors have proven to be extremely difficult to isolate and count, she added.
To see whether they could identify circulating biomarkers of metastatic PDAC, Dr. Marayati and colleagues working in the laboratory of Dr. Jen Jen Yeh at the university first identified 76 genes that are differentially overexpressed in metastatic PDAC tumors, compared with localized primary tumors and with normal tissues.
The investigators looked for expression of the genes in 11 pancreatic cancer cell lines and in blood samples from 20 patients with pancreatic cancer and four without cancer. As noted, one gene, GJB3, was highly expressed in all of the cell-line samples but could not be detected in white blood cells from patients without PDAC.
To validate GJB3 as a potential cancer marker, the authors looked at expression levels in circulating tumor cells and found that, among the patients with cancer, expression levels of GBJ3 were significantly higher in those with metastatic disease, compared with localized disease (P = .016).
“That would suggest that GJB3 is a potential circulating biomarker specifically for metastatic pancreatic cancer patients,” Dr. Marayati said.
The investigators hypothesized that GJB3 may play a role in the biology of pancreatic cancer metastasis. To test this idea, they looked at resected tumors from 131 patients with primary pancreatic cancer and found that high tumor expression of GJB3 was associated with worse survival. Median overall survival among 32 patients with low levels of gene expression in their tumors was 24 months, compared with 15 months for 99 patients with high levels of GJB3 expression (P = .031).
The investigators plan to further validate the marker by testing it with larger samples from both patients with pancreatic cancer and controls.
The study funding source was not disclosed. Dr. Marayati reported having no disclosures.
HOUSTON – A circulating biomarker has the potential to identify metastatic pancreatic cancer and may be able to predict prognosis, investigators said.
Levels of a gene encoding for the gap-junction beta 3 (GJB3) protein were highly elevated in both pancreatic cancer cell lines and in blood samples from patients with pancreatic ductal adenocarcinoma (PDAC), but the gene was undetectable in blood samples from patients without cancer, reported Dr. Raoud Marayati from the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill.
An analysis of gene expression in tumors from patients with PDAC also showed that patients with tumors expressing higher levels of GJB3 had significantly worse overall survival rates.
“GJB3 is highly expressed in blood samples from patients with metastatic versus local pancreatic cancer. GJB3 is a potential circulating biomarker for metastatic pancreatic cancer,” Dr. Marayati said at the annual Society of Surgical Oncology Cancer Symposium.
Markers lacking
PDAC is a highly aggressive cancer with a propensity for early invasion and metastasis. More than half of all patients (53%) have metastatic disease at the time of diagnosis, and 5-year survival for these patients is only 2.3%, according to the Surveillance, Epidemiology, and End Results (SEER) cancer statistics review for 2014, she noted.
The only currently available clinical biomarker for PDAC, carbohydrate antigen 19-9 (CA 19-9), generally correlates with treatment response and disease recurrence but has low sensitivity and specificity, Dr. Marayati said.
Circulating tumor cells (CTCs) – cells shed from the primary tumor into circulation – hold promise for better detection of cancer, but CTCs from pancreatic tumors have proven to be extremely difficult to isolate and count, she added.
To see whether they could identify circulating biomarkers of metastatic PDAC, Dr. Marayati and colleagues working in the laboratory of Dr. Jen Jen Yeh at the university first identified 76 genes that are differentially overexpressed in metastatic PDAC tumors, compared with localized primary tumors and with normal tissues.
The investigators looked for expression of the genes in 11 pancreatic cancer cell lines and in blood samples from 20 patients with pancreatic cancer and four without cancer. As noted, one gene, GJB3, was highly expressed in all of the cell-line samples but could not be detected in white blood cells from patients without PDAC.
To validate GJB3 as a potential cancer marker, the authors looked at expression levels in circulating tumor cells and found that, among the patients with cancer, expression levels of GBJ3 were significantly higher in those with metastatic disease, compared with localized disease (P = .016).
“That would suggest that GJB3 is a potential circulating biomarker specifically for metastatic pancreatic cancer patients,” Dr. Marayati said.
The investigators hypothesized that GJB3 may play a role in the biology of pancreatic cancer metastasis. To test this idea, they looked at resected tumors from 131 patients with primary pancreatic cancer and found that high tumor expression of GJB3 was associated with worse survival. Median overall survival among 32 patients with low levels of gene expression in their tumors was 24 months, compared with 15 months for 99 patients with high levels of GJB3 expression (P = .031).
The investigators plan to further validate the marker by testing it with larger samples from both patients with pancreatic cancer and controls.
The study funding source was not disclosed. Dr. Marayati reported having no disclosures.
AT SSO 2015
Key clinical point: GJB3 may be a serum marker for metastatic pancreatic ductal adenocarcinoma.
Major finding: GJB3 was expressed at significantly higher levels in patients with metastatic vs. localized PDAC.
Data source: Gene expression analyses involving patient tumor samples and 11 pancreatic cancer cell lines.
Disclosures: The study funding source was not disclosed. Dr. Marayati reported having no disclosures.
Cesarean intervention reduces rates in low-risk pregnancies
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Audits of indications for cesarean delivery and feedback for health professionals can reduce the rate of cesarean deliveries, especially in low-risk pregnancies.
Major finding: A multifaceted intervention resulted in an overall 10% reduction in the rate of cesarean deliveries.
Data source: A cluster-randomized controlled trial in 32 Quebec hospitals, involving a total of 184,952 women.
Disclosures: The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
Implantable filter doesn’t cut rate of recurrent PE
Implanting a retrievable filter in the inferior vena cava did not reduce the rate of recurrent pulmonary embolism or mortality in high-risk patients, according to a report published online April 28 in JAMA.
In recent years, there has been a sharp increase in the use of these devices as an add-on to anticoagulant therapy among patients hospitalized for acute PE associated with lower-limb deep or superficial vein thrombosis. Several clinical guidelines advocate this strategy, though others do not, citing the paucity of reliable data concerning both risks and benefits.
The findings in this study “do not support the use of this type of filter in patients who can be treated with anticoagulation alone,” and clinical guidelines recommending this approach should be reexamined, Dr. Patrick Mismetti of the University Hospital of Saint-Etienne, France, and his associates said.
They performed a randomized, open-label clinical study at 17 French medical centers to compare anticoagulation alone against anticoagulation plus implanting a filter to be retrieved 3 months later.
The study participants were 399 adults enrolled during a 6-year period who were deemed at high risk for recurrent PE because of advanced age, active cancer, chronic cardiac or respiratory insufficiency, ischemic stroke with leg paralysis, DVT that was bilateral or affected the iliocaval segment, or signs of right ventricular dysfunction or myocardial injury.
The primary efficacy outcome, recurrent PE within 3 months of hospitalization, developed in 6 of 200 patients assigned to receive an implantable filter (3%) and 3 of the 199 assigned to the control group (1.5%). All but one of these episodes of recurrent PE were fatal. One additional PE developed in each study group between 3 and 6 months. There were no differences between patients who received an inferior vena cava filter and those who did not in the incidence of DVT, major bleeding, or death from any cause at 3 or 6 months, the investigators said (JAMA 2015 April 28 [doi:10.1001/jama.2015.3780]).
Besides failing to prevent recurrent PE, the filter implantation caused access site hematomas in five patients, and the filter itself caused thrombosis formation in three. One patient developed cardiac arrest during the procedure. In addition, retrieval of the device failed in 11 patients because of mechanical problems.
Implanting a retrievable filter in the inferior vena cava did not reduce the rate of recurrent pulmonary embolism or mortality in high-risk patients, according to a report published online April 28 in JAMA.
In recent years, there has been a sharp increase in the use of these devices as an add-on to anticoagulant therapy among patients hospitalized for acute PE associated with lower-limb deep or superficial vein thrombosis. Several clinical guidelines advocate this strategy, though others do not, citing the paucity of reliable data concerning both risks and benefits.
The findings in this study “do not support the use of this type of filter in patients who can be treated with anticoagulation alone,” and clinical guidelines recommending this approach should be reexamined, Dr. Patrick Mismetti of the University Hospital of Saint-Etienne, France, and his associates said.
They performed a randomized, open-label clinical study at 17 French medical centers to compare anticoagulation alone against anticoagulation plus implanting a filter to be retrieved 3 months later.
The study participants were 399 adults enrolled during a 6-year period who were deemed at high risk for recurrent PE because of advanced age, active cancer, chronic cardiac or respiratory insufficiency, ischemic stroke with leg paralysis, DVT that was bilateral or affected the iliocaval segment, or signs of right ventricular dysfunction or myocardial injury.
The primary efficacy outcome, recurrent PE within 3 months of hospitalization, developed in 6 of 200 patients assigned to receive an implantable filter (3%) and 3 of the 199 assigned to the control group (1.5%). All but one of these episodes of recurrent PE were fatal. One additional PE developed in each study group between 3 and 6 months. There were no differences between patients who received an inferior vena cava filter and those who did not in the incidence of DVT, major bleeding, or death from any cause at 3 or 6 months, the investigators said (JAMA 2015 April 28 [doi:10.1001/jama.2015.3780]).
Besides failing to prevent recurrent PE, the filter implantation caused access site hematomas in five patients, and the filter itself caused thrombosis formation in three. One patient developed cardiac arrest during the procedure. In addition, retrieval of the device failed in 11 patients because of mechanical problems.
Implanting a retrievable filter in the inferior vena cava did not reduce the rate of recurrent pulmonary embolism or mortality in high-risk patients, according to a report published online April 28 in JAMA.
In recent years, there has been a sharp increase in the use of these devices as an add-on to anticoagulant therapy among patients hospitalized for acute PE associated with lower-limb deep or superficial vein thrombosis. Several clinical guidelines advocate this strategy, though others do not, citing the paucity of reliable data concerning both risks and benefits.
The findings in this study “do not support the use of this type of filter in patients who can be treated with anticoagulation alone,” and clinical guidelines recommending this approach should be reexamined, Dr. Patrick Mismetti of the University Hospital of Saint-Etienne, France, and his associates said.
They performed a randomized, open-label clinical study at 17 French medical centers to compare anticoagulation alone against anticoagulation plus implanting a filter to be retrieved 3 months later.
The study participants were 399 adults enrolled during a 6-year period who were deemed at high risk for recurrent PE because of advanced age, active cancer, chronic cardiac or respiratory insufficiency, ischemic stroke with leg paralysis, DVT that was bilateral or affected the iliocaval segment, or signs of right ventricular dysfunction or myocardial injury.
The primary efficacy outcome, recurrent PE within 3 months of hospitalization, developed in 6 of 200 patients assigned to receive an implantable filter (3%) and 3 of the 199 assigned to the control group (1.5%). All but one of these episodes of recurrent PE were fatal. One additional PE developed in each study group between 3 and 6 months. There were no differences between patients who received an inferior vena cava filter and those who did not in the incidence of DVT, major bleeding, or death from any cause at 3 or 6 months, the investigators said (JAMA 2015 April 28 [doi:10.1001/jama.2015.3780]).
Besides failing to prevent recurrent PE, the filter implantation caused access site hematomas in five patients, and the filter itself caused thrombosis formation in three. One patient developed cardiac arrest during the procedure. In addition, retrieval of the device failed in 11 patients because of mechanical problems.
FROM JAMA
Key clinical point: Use of a retrievable filter implanted in the inferior vena cava did not reduce the rate of recurrent pulmonary embolism.
Major finding: The primary efficacy outcome, recurrent PE within 3 months of hospitalization, developed in 6 of 200 patients assigned to receive an implantable filter (3%) and 3 of 199 assigned to the control group (1.5%).
Data source: An open-label randomized trial involving 399 adults hospitalized in France for acute PE.
Disclosures: This study was sponsored by the University Hospital of Saint-Etienne and supported by the French Department of Health, Fondation de l’Avenir, and Fondation de France. Vena cava filters were provided free of charge by ALN Implants Chirurgicaux. Dr. Mismetti and his associates reported ties to numerous industry sources.