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Biosimilars and patients: Discussions should address safety, cost, and anxiety about change
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
New state bill could protect docs prescribing abortion pills to out-of-state patients
California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.
State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.
“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.
Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.
As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.
“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.
“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.
Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.
Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.
California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.
It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.
“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.
“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”
A version of this article first appeared on Medscape.com.
California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.
State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.
“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.
Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.
As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.
“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.
“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.
Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.
Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.
California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.
It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.
“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.
“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”
A version of this article first appeared on Medscape.com.
California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.
State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.
“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.
Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.
As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.
“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.
“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.
Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.
Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.
California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.
It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.
“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.
“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”
A version of this article first appeared on Medscape.com.
Luxe vacations, private jets: Medical device maker, surgeon to pay $46 million penalty in kickback scheme
according to experts familiar with the federal Anti-Kickback Statute.
Historically, enforcement actions have primarily focused on the person or organization offering the perks – and not necessarily the physicians accepting it, Steven W. Ortquist, founder and principal of Arete Compliance Solutions, LLC, in Phoenix, told this news organization.
But that’s changing.
“In recent years, we are seeing a trend toward holding physicians and others on the receiving end of the inducement accountable as well,” said Mr. Ortquist, who is a past board member and president of the Health Care Compliance Association. He noted that authorities usually pursue the inducing company first before moving on to individual clinicians or practices.
The Department of Justice followed a similar pattern in a recently announced kickback settlement that ensnared an intraocular lens distributor, an ophthalmology equipment supplier, two CEOs, and a surgeon. Precision Lens must pay more than $43 million for offering high-end vacations and other expensive perks to surgeons who used its cataract products.
The verdict marks the end of a 6-week civil jury trial, where evidence emerged that Paul Ehlen, owner of Precision Lens and its parent company, Cameron-Ehlen Group, maintained a secret “slush fund” for paying kickbacks to ophthalmic surgeons. The inducement scheme netted the Minnesota-based company millions in sales and led to the submission of 64,575 false Medicare claims from 2006 to 2015, a violation of the Anti-Kickback Statute and the False Claims Act.
According to court documents, physicians received luxury travel and entertainment packages, including skiing, fishing, and golfing excursions at exclusive destinations, often traveling via private jet to attend Broadway musicals and major sporting events. Mr. Ehlen and company representatives also sold frequent flyer miles to physicians at a steep discount, allowing them to take personal and business trips below fair market value.
Federal authorities initially announced an investigation into the business practices of Precision Lens in 2017 after receiving a whistleblower complaint from Kipp Fesenmaier, a former executive at Sightpath Medical, an ophthalmology supplier and “corporate partner” of Precision Lens. Mr. Fesenmaier alleged that both companies were involved in an inducement scheme.
Sightpath Medical and its CEO, James Tiffany, agreed to a $12 million settlement to resolve the kickback allegations.
The Department of Justice subsequently investigated Jitendra Swarup, MD, an ophthalmologist and cataract surgeon who allegedly received “unlawful remuneration from Sightpath, Precision, and Ehlen” and filed false insurance claims. In addition to accepting expensive hunting and fishing trips from the medical device companies, Dr. Swarup was paid more than $100,000 per year for consulting services he did not fully render.
Dr. Swarup agreed to a nearly $3 million settlement and participation in a 3-year corporate integrity agreement with the Office of Inspector General. In exchange for compliance with such contracts, the OIG permits physicians to continue participating in Medicare, Medicaid, and other federal health care programs.
In a statement from attorneys, Precision Lens and Mr. Ehlen pledged to appeal the verdict and “defend ... our wholly appropriate actions” while remaining focused on their commitment to health care clinicians and manufacturers.
‘Endless’ opportunities for inducement
Unfortunately, opportunities for inducement are “endless,” experts say. Extravagant trips, dinners, and gifts can trigger a violation, but so can nearly anything of value.
Just last year, Biotronik reached a $12.95 million settlement amid allegations that company representatives wined and dined physicians to induce their use of its pacemakers and defibrillators. To date, no physicians have been charged.
But after a record-breaking number of whistleblower judgments last fiscal year totaling more than $2 billion, physicians should take note, Radha Bhatnagar, Esq, director of compliance at The CM Group, told the news organization.
“When manufacturers offer physicians kickbacks with the added element of fraudulent Medicare or Medicaid reimbursements, that is typically when manufacturers and individuals face civil and criminal liability,” said Ms. Bhatnagar, something the Department of Justice alluded to when announcing a settlement involving 15 Texas physicians last year.
In another case, Kingsley R. Chin, an orthopedic surgeon and designer of a spinal implant, was indicted in 2021 for paying millions of dollars in sham consulting fees to physicians who used his products. At least six surgeons who accepted money from Dr. Chin were later named in a civil case and ordered to pay $3.3 million in penalties.
Jason Montone, DO, an orthopedic surgeon who accepted the illicit payments, agreed to a plea deal with a reduced prison sentence, 1 year of supervised release, and a fine of $379,000.
Although Dr. Chin’s sentencing hasn’t been announced, violating kickback laws can result in a sentence of up to 10 years.
A version of this article originally appeared on Medscape.com.
according to experts familiar with the federal Anti-Kickback Statute.
Historically, enforcement actions have primarily focused on the person or organization offering the perks – and not necessarily the physicians accepting it, Steven W. Ortquist, founder and principal of Arete Compliance Solutions, LLC, in Phoenix, told this news organization.
But that’s changing.
“In recent years, we are seeing a trend toward holding physicians and others on the receiving end of the inducement accountable as well,” said Mr. Ortquist, who is a past board member and president of the Health Care Compliance Association. He noted that authorities usually pursue the inducing company first before moving on to individual clinicians or practices.
The Department of Justice followed a similar pattern in a recently announced kickback settlement that ensnared an intraocular lens distributor, an ophthalmology equipment supplier, two CEOs, and a surgeon. Precision Lens must pay more than $43 million for offering high-end vacations and other expensive perks to surgeons who used its cataract products.
The verdict marks the end of a 6-week civil jury trial, where evidence emerged that Paul Ehlen, owner of Precision Lens and its parent company, Cameron-Ehlen Group, maintained a secret “slush fund” for paying kickbacks to ophthalmic surgeons. The inducement scheme netted the Minnesota-based company millions in sales and led to the submission of 64,575 false Medicare claims from 2006 to 2015, a violation of the Anti-Kickback Statute and the False Claims Act.
According to court documents, physicians received luxury travel and entertainment packages, including skiing, fishing, and golfing excursions at exclusive destinations, often traveling via private jet to attend Broadway musicals and major sporting events. Mr. Ehlen and company representatives also sold frequent flyer miles to physicians at a steep discount, allowing them to take personal and business trips below fair market value.
Federal authorities initially announced an investigation into the business practices of Precision Lens in 2017 after receiving a whistleblower complaint from Kipp Fesenmaier, a former executive at Sightpath Medical, an ophthalmology supplier and “corporate partner” of Precision Lens. Mr. Fesenmaier alleged that both companies were involved in an inducement scheme.
Sightpath Medical and its CEO, James Tiffany, agreed to a $12 million settlement to resolve the kickback allegations.
The Department of Justice subsequently investigated Jitendra Swarup, MD, an ophthalmologist and cataract surgeon who allegedly received “unlawful remuneration from Sightpath, Precision, and Ehlen” and filed false insurance claims. In addition to accepting expensive hunting and fishing trips from the medical device companies, Dr. Swarup was paid more than $100,000 per year for consulting services he did not fully render.
Dr. Swarup agreed to a nearly $3 million settlement and participation in a 3-year corporate integrity agreement with the Office of Inspector General. In exchange for compliance with such contracts, the OIG permits physicians to continue participating in Medicare, Medicaid, and other federal health care programs.
In a statement from attorneys, Precision Lens and Mr. Ehlen pledged to appeal the verdict and “defend ... our wholly appropriate actions” while remaining focused on their commitment to health care clinicians and manufacturers.
‘Endless’ opportunities for inducement
Unfortunately, opportunities for inducement are “endless,” experts say. Extravagant trips, dinners, and gifts can trigger a violation, but so can nearly anything of value.
Just last year, Biotronik reached a $12.95 million settlement amid allegations that company representatives wined and dined physicians to induce their use of its pacemakers and defibrillators. To date, no physicians have been charged.
But after a record-breaking number of whistleblower judgments last fiscal year totaling more than $2 billion, physicians should take note, Radha Bhatnagar, Esq, director of compliance at The CM Group, told the news organization.
“When manufacturers offer physicians kickbacks with the added element of fraudulent Medicare or Medicaid reimbursements, that is typically when manufacturers and individuals face civil and criminal liability,” said Ms. Bhatnagar, something the Department of Justice alluded to when announcing a settlement involving 15 Texas physicians last year.
In another case, Kingsley R. Chin, an orthopedic surgeon and designer of a spinal implant, was indicted in 2021 for paying millions of dollars in sham consulting fees to physicians who used his products. At least six surgeons who accepted money from Dr. Chin were later named in a civil case and ordered to pay $3.3 million in penalties.
Jason Montone, DO, an orthopedic surgeon who accepted the illicit payments, agreed to a plea deal with a reduced prison sentence, 1 year of supervised release, and a fine of $379,000.
Although Dr. Chin’s sentencing hasn’t been announced, violating kickback laws can result in a sentence of up to 10 years.
A version of this article originally appeared on Medscape.com.
according to experts familiar with the federal Anti-Kickback Statute.
Historically, enforcement actions have primarily focused on the person or organization offering the perks – and not necessarily the physicians accepting it, Steven W. Ortquist, founder and principal of Arete Compliance Solutions, LLC, in Phoenix, told this news organization.
But that’s changing.
“In recent years, we are seeing a trend toward holding physicians and others on the receiving end of the inducement accountable as well,” said Mr. Ortquist, who is a past board member and president of the Health Care Compliance Association. He noted that authorities usually pursue the inducing company first before moving on to individual clinicians or practices.
The Department of Justice followed a similar pattern in a recently announced kickback settlement that ensnared an intraocular lens distributor, an ophthalmology equipment supplier, two CEOs, and a surgeon. Precision Lens must pay more than $43 million for offering high-end vacations and other expensive perks to surgeons who used its cataract products.
The verdict marks the end of a 6-week civil jury trial, where evidence emerged that Paul Ehlen, owner of Precision Lens and its parent company, Cameron-Ehlen Group, maintained a secret “slush fund” for paying kickbacks to ophthalmic surgeons. The inducement scheme netted the Minnesota-based company millions in sales and led to the submission of 64,575 false Medicare claims from 2006 to 2015, a violation of the Anti-Kickback Statute and the False Claims Act.
According to court documents, physicians received luxury travel and entertainment packages, including skiing, fishing, and golfing excursions at exclusive destinations, often traveling via private jet to attend Broadway musicals and major sporting events. Mr. Ehlen and company representatives also sold frequent flyer miles to physicians at a steep discount, allowing them to take personal and business trips below fair market value.
Federal authorities initially announced an investigation into the business practices of Precision Lens in 2017 after receiving a whistleblower complaint from Kipp Fesenmaier, a former executive at Sightpath Medical, an ophthalmology supplier and “corporate partner” of Precision Lens. Mr. Fesenmaier alleged that both companies were involved in an inducement scheme.
Sightpath Medical and its CEO, James Tiffany, agreed to a $12 million settlement to resolve the kickback allegations.
The Department of Justice subsequently investigated Jitendra Swarup, MD, an ophthalmologist and cataract surgeon who allegedly received “unlawful remuneration from Sightpath, Precision, and Ehlen” and filed false insurance claims. In addition to accepting expensive hunting and fishing trips from the medical device companies, Dr. Swarup was paid more than $100,000 per year for consulting services he did not fully render.
Dr. Swarup agreed to a nearly $3 million settlement and participation in a 3-year corporate integrity agreement with the Office of Inspector General. In exchange for compliance with such contracts, the OIG permits physicians to continue participating in Medicare, Medicaid, and other federal health care programs.
In a statement from attorneys, Precision Lens and Mr. Ehlen pledged to appeal the verdict and “defend ... our wholly appropriate actions” while remaining focused on their commitment to health care clinicians and manufacturers.
‘Endless’ opportunities for inducement
Unfortunately, opportunities for inducement are “endless,” experts say. Extravagant trips, dinners, and gifts can trigger a violation, but so can nearly anything of value.
Just last year, Biotronik reached a $12.95 million settlement amid allegations that company representatives wined and dined physicians to induce their use of its pacemakers and defibrillators. To date, no physicians have been charged.
But after a record-breaking number of whistleblower judgments last fiscal year totaling more than $2 billion, physicians should take note, Radha Bhatnagar, Esq, director of compliance at The CM Group, told the news organization.
“When manufacturers offer physicians kickbacks with the added element of fraudulent Medicare or Medicaid reimbursements, that is typically when manufacturers and individuals face civil and criminal liability,” said Ms. Bhatnagar, something the Department of Justice alluded to when announcing a settlement involving 15 Texas physicians last year.
In another case, Kingsley R. Chin, an orthopedic surgeon and designer of a spinal implant, was indicted in 2021 for paying millions of dollars in sham consulting fees to physicians who used his products. At least six surgeons who accepted money from Dr. Chin were later named in a civil case and ordered to pay $3.3 million in penalties.
Jason Montone, DO, an orthopedic surgeon who accepted the illicit payments, agreed to a plea deal with a reduced prison sentence, 1 year of supervised release, and a fine of $379,000.
Although Dr. Chin’s sentencing hasn’t been announced, violating kickback laws can result in a sentence of up to 10 years.
A version of this article originally appeared on Medscape.com.
ED doc and group owe $13.5M after patient’s serious brain injury
according to a report in the Idaho Capital Sun.
The suit, which took nearly 5 years after filing to wend its way through the courts, stems from an incident that took place in the early morning of March 29, 2016. An Ada County resident peered into the family bathroom and discovered that her husband, Carl B. Stiefel, lay on the floor confused and vomiting and complaining of a severe headache. Recently, the man had experienced several of these same symptoms, plus sinus congestion, dizziness, and tinnitus.
As Mr. Stiefel’s confusion worsened, his wife called for an ambulance, which arrived at the local hospital emergency department (ED) at 4:12 AM. Within approximately 11 minutes, the patient was examined by a doctor and later underwent a cranial CT scan, which a second doctor said showed “no intracranial process.”
Mr. Stiefel’s condition improved somewhat, although his dizziness persisted, leaving him still unable to walk. At this point, his primary ED doctor admitted him to the hospital for “benign positional vertigo.” The doctor also joined colleagues in suggesting that the patient might well be a candidate for an MRI, just in case his condition failed to improve over the next few hours.
But the transfer from the ED to the main hospital reportedly took at least 3 hours, during which time Mr. Stiefel’s condition deteriorated. Once admitted, he was observed by a healthcare provider — the news report doesn’t indicate precisely who — to be “delirious without meaningful interaction.” At least 4 hours would pass before the patient was seen by still another doctor, as the plaintiffs later claimed.
The patient remained disoriented and restless as the day unfolded. The MRI contemplated earlier was finally ordered, but the scan wasn’t available for several hours, according to nursing notes cited by the plaintiffs in their lawsuit.
Finally, the scan was administered at about 5:50 PM, almost 12 hours since Mr. Stiefel had first arrived at the ED. It showed that he had a torn artery in his neck and was experiencing a stroke. This was, clearly, a very different diagnosis from the one that his admitting doctor had entered into his notes.
A surgeon operated to repair the arterial tear, but the patient’s condition continued to worsen. Over the next 3 weeks, Mr. Stiefel went from the hospital to a local rehab facility, and back to the hospital with bacterial meningitis. Ultimately, he was diagnosed with “an irreparable brain injury,” which ultimately left him disabled and unable to work.
At this point, he and his wife sued a broad range of defendants — a radiology group, individual healthcare providers employed by the hospital, the primary ED physician, and that doctor’s emergency medicine group. In the nearly 5 intervening years, each of the named defendants settled, except the ED doctor and the emergency medicine group.
The two remaining defendants vigorously contested the claims against them, denying “any and all allegations of responsibility and liability” and contending that the patient’s injuries resulted from unforeseen complications rather than the care that had been administered.
The Ada County jury disagreed, however. It found that the primary ED doctor — and by extension the group to which the doctor belonged — did in fact negligently and recklessly fail to meet the proper standard of care, leading directly to the patient’s life-altering injuries.
For this failure, the jury awarded the plaintiffs $13.5 million, well over the state’s current inflation-adjusted cap of $400,000. (To date, Idaho’s largest med-mal award is nearly $30 million, handed down more than 20 years ago.)
At press time, there was no word of an appeal.
Man sues dentist, ends up changing state medical malpractice law
In a surprise move, the Connecticut Supreme Court in mid-February reversed its own precedent regarding a 2005 law requiring certain pre-litigation steps be taken before state residents are permitted to file a medical malpractice claim, as a story in the Claims Journal reports.
In its 2011 review of that earlier law — passed to ensure that complainants had a reasonable basis for their claims — the high court went the legislature one better. It held that state courts had no “personal jurisdiction” in adjudicating malpractice claims in the absence of required supporting documents — specifically, a proper certificate and opinion letter from “a similar healthcare provider.”
For the past 12 years, this meant that any suit lacking the proper documents could not only be halted but dismissed with prejudice, meaning that such a case couldn’t be refiled.
That interpretation of the law was eventually challenged, however, by a Connecticut man who sued his dentist. Filed in 2018, the suit alleged that, during a root canal, the dentist had failed to properly diagnose and treat his patient’s dental abscess, which ultimately required surgery.
Complying with what he regarded as state law, the man attached a letter of opinion to his complaint, which testified to the merits of his claim. But, in a twist with significant consequences, the letter was written by an endodontist, not a general dentist. In response, the dentist’s attorneys submitted a motion to dismiss to the trial court, arguing that the plaintiff had breached the “similar provider” provision and that therefore the opinion letter was defective and the entire suit should be dismissed.
The trial court agreed — and the Connecticut Appellate Court went on to affirm the lower-court ruling. The case might have ended there, but the plaintiff appealed to the Connecticut Supreme Court, which agreed to review the appellate court finding.
In a 6-0 decision, the high court looked back on its 2011 interpretation of the med-mal statute, which in the intervening years had given rise to “a body of case law.” The problem with that body of law, the justices argued, was that it had “imposed substantially greater burdens on plaintiffs than the legislature intended” — and it did so “by allowing potentially curable, technical, pre-litigation defects to defeat otherwise meritorious malpractice actions, sometimes after several years of litigation.”
In short, said the justices, there was nothing in the original statute that required a court to dismiss a suit once it found a letter of opinion to be deficient. This was a “curable” defect, one that shouldn’t be allowed to derail an otherwise meritorious claim.
As for the case that prompted the high court’s latest review — that is, the Connecticut man’s suit against his dentist — the justices found that the appellate court had also erred when it tossed out the endodontist’s opinion letter. Technically, the dentist might not have been an endodontist, said the justices, but he had in fact practiced in the field during the course of a long career, so close enough.
The justices kicked the case back to the trial court, with instructions that it deny the defendant’s motion to dismiss.
Stakeholders divided over new awards cap
Last month, Iowa Gov. Kim Reynolds signed a bill into law that limits the amount of noneconomic damages a successful med-mal plaintiff can collect, explains a story posted on Radio Iowa, among other news sites.
Under the new law, the limit for suits involving hospitals is capped at $2 million — while those involving all other healthcare providers are capped at $1 million. Beginning in 2028, those caps will be adjusted annually for inflation by 2.1%.
“When mistakes happen, Iowans deserve compensation, but arbitrary multimillion-dollar awards do more than that,” said Gov. Reynolds. “They act as a tax on all Iowans by raising the cost of care. They drive medical clinics out of business and medical students out of state.”
The CEO of Knoxville Hospital and Clinics — a well-known regional provider — agreed, saying that the new law helped to make Iowa “a more attractive place to practice medicine.”
But most Democrats in the GOP-controlled legislature — and 16 Republicans — voted against the legislation. For her part, House Minority Leader Jennifer Konfrst said there was absolutely no evidence that states with caps fared any better with medical workforce shortages than states without caps.
A version of this article originally appeared on Medscape.com.
according to a report in the Idaho Capital Sun.
The suit, which took nearly 5 years after filing to wend its way through the courts, stems from an incident that took place in the early morning of March 29, 2016. An Ada County resident peered into the family bathroom and discovered that her husband, Carl B. Stiefel, lay on the floor confused and vomiting and complaining of a severe headache. Recently, the man had experienced several of these same symptoms, plus sinus congestion, dizziness, and tinnitus.
As Mr. Stiefel’s confusion worsened, his wife called for an ambulance, which arrived at the local hospital emergency department (ED) at 4:12 AM. Within approximately 11 minutes, the patient was examined by a doctor and later underwent a cranial CT scan, which a second doctor said showed “no intracranial process.”
Mr. Stiefel’s condition improved somewhat, although his dizziness persisted, leaving him still unable to walk. At this point, his primary ED doctor admitted him to the hospital for “benign positional vertigo.” The doctor also joined colleagues in suggesting that the patient might well be a candidate for an MRI, just in case his condition failed to improve over the next few hours.
But the transfer from the ED to the main hospital reportedly took at least 3 hours, during which time Mr. Stiefel’s condition deteriorated. Once admitted, he was observed by a healthcare provider — the news report doesn’t indicate precisely who — to be “delirious without meaningful interaction.” At least 4 hours would pass before the patient was seen by still another doctor, as the plaintiffs later claimed.
The patient remained disoriented and restless as the day unfolded. The MRI contemplated earlier was finally ordered, but the scan wasn’t available for several hours, according to nursing notes cited by the plaintiffs in their lawsuit.
Finally, the scan was administered at about 5:50 PM, almost 12 hours since Mr. Stiefel had first arrived at the ED. It showed that he had a torn artery in his neck and was experiencing a stroke. This was, clearly, a very different diagnosis from the one that his admitting doctor had entered into his notes.
A surgeon operated to repair the arterial tear, but the patient’s condition continued to worsen. Over the next 3 weeks, Mr. Stiefel went from the hospital to a local rehab facility, and back to the hospital with bacterial meningitis. Ultimately, he was diagnosed with “an irreparable brain injury,” which ultimately left him disabled and unable to work.
At this point, he and his wife sued a broad range of defendants — a radiology group, individual healthcare providers employed by the hospital, the primary ED physician, and that doctor’s emergency medicine group. In the nearly 5 intervening years, each of the named defendants settled, except the ED doctor and the emergency medicine group.
The two remaining defendants vigorously contested the claims against them, denying “any and all allegations of responsibility and liability” and contending that the patient’s injuries resulted from unforeseen complications rather than the care that had been administered.
The Ada County jury disagreed, however. It found that the primary ED doctor — and by extension the group to which the doctor belonged — did in fact negligently and recklessly fail to meet the proper standard of care, leading directly to the patient’s life-altering injuries.
For this failure, the jury awarded the plaintiffs $13.5 million, well over the state’s current inflation-adjusted cap of $400,000. (To date, Idaho’s largest med-mal award is nearly $30 million, handed down more than 20 years ago.)
At press time, there was no word of an appeal.
Man sues dentist, ends up changing state medical malpractice law
In a surprise move, the Connecticut Supreme Court in mid-February reversed its own precedent regarding a 2005 law requiring certain pre-litigation steps be taken before state residents are permitted to file a medical malpractice claim, as a story in the Claims Journal reports.
In its 2011 review of that earlier law — passed to ensure that complainants had a reasonable basis for their claims — the high court went the legislature one better. It held that state courts had no “personal jurisdiction” in adjudicating malpractice claims in the absence of required supporting documents — specifically, a proper certificate and opinion letter from “a similar healthcare provider.”
For the past 12 years, this meant that any suit lacking the proper documents could not only be halted but dismissed with prejudice, meaning that such a case couldn’t be refiled.
That interpretation of the law was eventually challenged, however, by a Connecticut man who sued his dentist. Filed in 2018, the suit alleged that, during a root canal, the dentist had failed to properly diagnose and treat his patient’s dental abscess, which ultimately required surgery.
Complying with what he regarded as state law, the man attached a letter of opinion to his complaint, which testified to the merits of his claim. But, in a twist with significant consequences, the letter was written by an endodontist, not a general dentist. In response, the dentist’s attorneys submitted a motion to dismiss to the trial court, arguing that the plaintiff had breached the “similar provider” provision and that therefore the opinion letter was defective and the entire suit should be dismissed.
The trial court agreed — and the Connecticut Appellate Court went on to affirm the lower-court ruling. The case might have ended there, but the plaintiff appealed to the Connecticut Supreme Court, which agreed to review the appellate court finding.
In a 6-0 decision, the high court looked back on its 2011 interpretation of the med-mal statute, which in the intervening years had given rise to “a body of case law.” The problem with that body of law, the justices argued, was that it had “imposed substantially greater burdens on plaintiffs than the legislature intended” — and it did so “by allowing potentially curable, technical, pre-litigation defects to defeat otherwise meritorious malpractice actions, sometimes after several years of litigation.”
In short, said the justices, there was nothing in the original statute that required a court to dismiss a suit once it found a letter of opinion to be deficient. This was a “curable” defect, one that shouldn’t be allowed to derail an otherwise meritorious claim.
As for the case that prompted the high court’s latest review — that is, the Connecticut man’s suit against his dentist — the justices found that the appellate court had also erred when it tossed out the endodontist’s opinion letter. Technically, the dentist might not have been an endodontist, said the justices, but he had in fact practiced in the field during the course of a long career, so close enough.
The justices kicked the case back to the trial court, with instructions that it deny the defendant’s motion to dismiss.
Stakeholders divided over new awards cap
Last month, Iowa Gov. Kim Reynolds signed a bill into law that limits the amount of noneconomic damages a successful med-mal plaintiff can collect, explains a story posted on Radio Iowa, among other news sites.
Under the new law, the limit for suits involving hospitals is capped at $2 million — while those involving all other healthcare providers are capped at $1 million. Beginning in 2028, those caps will be adjusted annually for inflation by 2.1%.
“When mistakes happen, Iowans deserve compensation, but arbitrary multimillion-dollar awards do more than that,” said Gov. Reynolds. “They act as a tax on all Iowans by raising the cost of care. They drive medical clinics out of business and medical students out of state.”
The CEO of Knoxville Hospital and Clinics — a well-known regional provider — agreed, saying that the new law helped to make Iowa “a more attractive place to practice medicine.”
But most Democrats in the GOP-controlled legislature — and 16 Republicans — voted against the legislation. For her part, House Minority Leader Jennifer Konfrst said there was absolutely no evidence that states with caps fared any better with medical workforce shortages than states without caps.
A version of this article originally appeared on Medscape.com.
according to a report in the Idaho Capital Sun.
The suit, which took nearly 5 years after filing to wend its way through the courts, stems from an incident that took place in the early morning of March 29, 2016. An Ada County resident peered into the family bathroom and discovered that her husband, Carl B. Stiefel, lay on the floor confused and vomiting and complaining of a severe headache. Recently, the man had experienced several of these same symptoms, plus sinus congestion, dizziness, and tinnitus.
As Mr. Stiefel’s confusion worsened, his wife called for an ambulance, which arrived at the local hospital emergency department (ED) at 4:12 AM. Within approximately 11 minutes, the patient was examined by a doctor and later underwent a cranial CT scan, which a second doctor said showed “no intracranial process.”
Mr. Stiefel’s condition improved somewhat, although his dizziness persisted, leaving him still unable to walk. At this point, his primary ED doctor admitted him to the hospital for “benign positional vertigo.” The doctor also joined colleagues in suggesting that the patient might well be a candidate for an MRI, just in case his condition failed to improve over the next few hours.
But the transfer from the ED to the main hospital reportedly took at least 3 hours, during which time Mr. Stiefel’s condition deteriorated. Once admitted, he was observed by a healthcare provider — the news report doesn’t indicate precisely who — to be “delirious without meaningful interaction.” At least 4 hours would pass before the patient was seen by still another doctor, as the plaintiffs later claimed.
The patient remained disoriented and restless as the day unfolded. The MRI contemplated earlier was finally ordered, but the scan wasn’t available for several hours, according to nursing notes cited by the plaintiffs in their lawsuit.
Finally, the scan was administered at about 5:50 PM, almost 12 hours since Mr. Stiefel had first arrived at the ED. It showed that he had a torn artery in his neck and was experiencing a stroke. This was, clearly, a very different diagnosis from the one that his admitting doctor had entered into his notes.
A surgeon operated to repair the arterial tear, but the patient’s condition continued to worsen. Over the next 3 weeks, Mr. Stiefel went from the hospital to a local rehab facility, and back to the hospital with bacterial meningitis. Ultimately, he was diagnosed with “an irreparable brain injury,” which ultimately left him disabled and unable to work.
At this point, he and his wife sued a broad range of defendants — a radiology group, individual healthcare providers employed by the hospital, the primary ED physician, and that doctor’s emergency medicine group. In the nearly 5 intervening years, each of the named defendants settled, except the ED doctor and the emergency medicine group.
The two remaining defendants vigorously contested the claims against them, denying “any and all allegations of responsibility and liability” and contending that the patient’s injuries resulted from unforeseen complications rather than the care that had been administered.
The Ada County jury disagreed, however. It found that the primary ED doctor — and by extension the group to which the doctor belonged — did in fact negligently and recklessly fail to meet the proper standard of care, leading directly to the patient’s life-altering injuries.
For this failure, the jury awarded the plaintiffs $13.5 million, well over the state’s current inflation-adjusted cap of $400,000. (To date, Idaho’s largest med-mal award is nearly $30 million, handed down more than 20 years ago.)
At press time, there was no word of an appeal.
Man sues dentist, ends up changing state medical malpractice law
In a surprise move, the Connecticut Supreme Court in mid-February reversed its own precedent regarding a 2005 law requiring certain pre-litigation steps be taken before state residents are permitted to file a medical malpractice claim, as a story in the Claims Journal reports.
In its 2011 review of that earlier law — passed to ensure that complainants had a reasonable basis for their claims — the high court went the legislature one better. It held that state courts had no “personal jurisdiction” in adjudicating malpractice claims in the absence of required supporting documents — specifically, a proper certificate and opinion letter from “a similar healthcare provider.”
For the past 12 years, this meant that any suit lacking the proper documents could not only be halted but dismissed with prejudice, meaning that such a case couldn’t be refiled.
That interpretation of the law was eventually challenged, however, by a Connecticut man who sued his dentist. Filed in 2018, the suit alleged that, during a root canal, the dentist had failed to properly diagnose and treat his patient’s dental abscess, which ultimately required surgery.
Complying with what he regarded as state law, the man attached a letter of opinion to his complaint, which testified to the merits of his claim. But, in a twist with significant consequences, the letter was written by an endodontist, not a general dentist. In response, the dentist’s attorneys submitted a motion to dismiss to the trial court, arguing that the plaintiff had breached the “similar provider” provision and that therefore the opinion letter was defective and the entire suit should be dismissed.
The trial court agreed — and the Connecticut Appellate Court went on to affirm the lower-court ruling. The case might have ended there, but the plaintiff appealed to the Connecticut Supreme Court, which agreed to review the appellate court finding.
In a 6-0 decision, the high court looked back on its 2011 interpretation of the med-mal statute, which in the intervening years had given rise to “a body of case law.” The problem with that body of law, the justices argued, was that it had “imposed substantially greater burdens on plaintiffs than the legislature intended” — and it did so “by allowing potentially curable, technical, pre-litigation defects to defeat otherwise meritorious malpractice actions, sometimes after several years of litigation.”
In short, said the justices, there was nothing in the original statute that required a court to dismiss a suit once it found a letter of opinion to be deficient. This was a “curable” defect, one that shouldn’t be allowed to derail an otherwise meritorious claim.
As for the case that prompted the high court’s latest review — that is, the Connecticut man’s suit against his dentist — the justices found that the appellate court had also erred when it tossed out the endodontist’s opinion letter. Technically, the dentist might not have been an endodontist, said the justices, but he had in fact practiced in the field during the course of a long career, so close enough.
The justices kicked the case back to the trial court, with instructions that it deny the defendant’s motion to dismiss.
Stakeholders divided over new awards cap
Last month, Iowa Gov. Kim Reynolds signed a bill into law that limits the amount of noneconomic damages a successful med-mal plaintiff can collect, explains a story posted on Radio Iowa, among other news sites.
Under the new law, the limit for suits involving hospitals is capped at $2 million — while those involving all other healthcare providers are capped at $1 million. Beginning in 2028, those caps will be adjusted annually for inflation by 2.1%.
“When mistakes happen, Iowans deserve compensation, but arbitrary multimillion-dollar awards do more than that,” said Gov. Reynolds. “They act as a tax on all Iowans by raising the cost of care. They drive medical clinics out of business and medical students out of state.”
The CEO of Knoxville Hospital and Clinics — a well-known regional provider — agreed, saying that the new law helped to make Iowa “a more attractive place to practice medicine.”
But most Democrats in the GOP-controlled legislature — and 16 Republicans — voted against the legislation. For her part, House Minority Leader Jennifer Konfrst said there was absolutely no evidence that states with caps fared any better with medical workforce shortages than states without caps.
A version of this article originally appeared on Medscape.com.
The desk
Recently, Dr. Jeffrey Benabio (I don’t believe we’ve ever met), wrote an enjoyable commentary mourning the loss of letters – the wonderful paper-and-pen documents that were, for the vast majority of human history, the main method of long distance communication. Even today, he notes, there’s something special about a letter, with the time and human effort required to sit down and put pen to paper, seal it into an envelope, and entrust it to the post office.
In his piece, Dr. Benabio describes his work desk as “a small surface, perhaps just enough for the monitor and a mug ... it has no drawers. It is lean and immaculate, but it has no soul.”
With all due respect, I can’t do that. I need a desk to function. A REAL one.
I was 9 when I got my first desk, far more than a 4th-grader needed. My dad was an attorney and had an extra desk from a partner who’d retired. It was big and heavy and made of wood. It had three drawers on each side, one in the middle, and pull-outs on each side in case you needed even more writing space. I loved it. As the years went by I did homework, wrote short stories, and built models on it. I covered the pull-outs with stickers for starship controls, so on a whim I could jump to hyperspace. In 1984 a brand-new Apple Macintosh, with 128K of RAM showed up on it. I began using the computer to write college papers, but most of my work at the desk still involved books and handwriting.
My current home desk has been with me through college, medical school, residency, and fellowship, and it continues with me today.
At my office, though, is my main desk. Before 2013 I was in a small back office, with only room for a tiny three-drawer college desk.
But in 2013 I moved into my own office, for the first time in my career. Now it was time to bring in my real desk, waiting in storage since my Dad had retired.
This is my desk now. It’s huge. It’s heavy. My dad bought it when he started his law practice in 1968. It has eight drawers, and my Dad’s original leather blotter is on top. It came with his chrome and brass letter opener in the top drawer. It has space for my computer, writing pads, exam tools (for people who can’t get on the exam table across the hall), business cards, a few baubles from my kids, stapler, tape dispenser, pen cup, phone, coffee mug, and a million other things.
It takes up a lot of space, but I don’t mind. There’s a human comfort to it and the organized disorder on top of it.
Everyone practices medicine differently. What works for me isn’t going to work for another doctor, and definitely not for another specialty.
But here, the big desk is part of my personal style. Sitting there gets me into “doctor mode” each day. I hope the more casual surroundings make it comfortable for patients, too.
It’s part of the soul of my practice, and I wouldn’t have it any other way.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, Dr. Jeffrey Benabio (I don’t believe we’ve ever met), wrote an enjoyable commentary mourning the loss of letters – the wonderful paper-and-pen documents that were, for the vast majority of human history, the main method of long distance communication. Even today, he notes, there’s something special about a letter, with the time and human effort required to sit down and put pen to paper, seal it into an envelope, and entrust it to the post office.
In his piece, Dr. Benabio describes his work desk as “a small surface, perhaps just enough for the monitor and a mug ... it has no drawers. It is lean and immaculate, but it has no soul.”
With all due respect, I can’t do that. I need a desk to function. A REAL one.
I was 9 when I got my first desk, far more than a 4th-grader needed. My dad was an attorney and had an extra desk from a partner who’d retired. It was big and heavy and made of wood. It had three drawers on each side, one in the middle, and pull-outs on each side in case you needed even more writing space. I loved it. As the years went by I did homework, wrote short stories, and built models on it. I covered the pull-outs with stickers for starship controls, so on a whim I could jump to hyperspace. In 1984 a brand-new Apple Macintosh, with 128K of RAM showed up on it. I began using the computer to write college papers, but most of my work at the desk still involved books and handwriting.
My current home desk has been with me through college, medical school, residency, and fellowship, and it continues with me today.
At my office, though, is my main desk. Before 2013 I was in a small back office, with only room for a tiny three-drawer college desk.
But in 2013 I moved into my own office, for the first time in my career. Now it was time to bring in my real desk, waiting in storage since my Dad had retired.
This is my desk now. It’s huge. It’s heavy. My dad bought it when he started his law practice in 1968. It has eight drawers, and my Dad’s original leather blotter is on top. It came with his chrome and brass letter opener in the top drawer. It has space for my computer, writing pads, exam tools (for people who can’t get on the exam table across the hall), business cards, a few baubles from my kids, stapler, tape dispenser, pen cup, phone, coffee mug, and a million other things.
It takes up a lot of space, but I don’t mind. There’s a human comfort to it and the organized disorder on top of it.
Everyone practices medicine differently. What works for me isn’t going to work for another doctor, and definitely not for another specialty.
But here, the big desk is part of my personal style. Sitting there gets me into “doctor mode” each day. I hope the more casual surroundings make it comfortable for patients, too.
It’s part of the soul of my practice, and I wouldn’t have it any other way.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, Dr. Jeffrey Benabio (I don’t believe we’ve ever met), wrote an enjoyable commentary mourning the loss of letters – the wonderful paper-and-pen documents that were, for the vast majority of human history, the main method of long distance communication. Even today, he notes, there’s something special about a letter, with the time and human effort required to sit down and put pen to paper, seal it into an envelope, and entrust it to the post office.
In his piece, Dr. Benabio describes his work desk as “a small surface, perhaps just enough for the monitor and a mug ... it has no drawers. It is lean and immaculate, but it has no soul.”
With all due respect, I can’t do that. I need a desk to function. A REAL one.
I was 9 when I got my first desk, far more than a 4th-grader needed. My dad was an attorney and had an extra desk from a partner who’d retired. It was big and heavy and made of wood. It had three drawers on each side, one in the middle, and pull-outs on each side in case you needed even more writing space. I loved it. As the years went by I did homework, wrote short stories, and built models on it. I covered the pull-outs with stickers for starship controls, so on a whim I could jump to hyperspace. In 1984 a brand-new Apple Macintosh, with 128K of RAM showed up on it. I began using the computer to write college papers, but most of my work at the desk still involved books and handwriting.
My current home desk has been with me through college, medical school, residency, and fellowship, and it continues with me today.
At my office, though, is my main desk. Before 2013 I was in a small back office, with only room for a tiny three-drawer college desk.
But in 2013 I moved into my own office, for the first time in my career. Now it was time to bring in my real desk, waiting in storage since my Dad had retired.
This is my desk now. It’s huge. It’s heavy. My dad bought it when he started his law practice in 1968. It has eight drawers, and my Dad’s original leather blotter is on top. It came with his chrome and brass letter opener in the top drawer. It has space for my computer, writing pads, exam tools (for people who can’t get on the exam table across the hall), business cards, a few baubles from my kids, stapler, tape dispenser, pen cup, phone, coffee mug, and a million other things.
It takes up a lot of space, but I don’t mind. There’s a human comfort to it and the organized disorder on top of it.
Everyone practices medicine differently. What works for me isn’t going to work for another doctor, and definitely not for another specialty.
But here, the big desk is part of my personal style. Sitting there gets me into “doctor mode” each day. I hope the more casual surroundings make it comfortable for patients, too.
It’s part of the soul of my practice, and I wouldn’t have it any other way.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Dabigatran recalled over potential carcinogen
The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.
To date, Ascend Laboratories has not received any reports of adverse events related to this recall.
The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.
Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.
The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.
Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.
Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).
Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article originally appeared on Medscape.com.
The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.
To date, Ascend Laboratories has not received any reports of adverse events related to this recall.
The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.
Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.
The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.
Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.
Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).
Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article originally appeared on Medscape.com.
The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.
To date, Ascend Laboratories has not received any reports of adverse events related to this recall.
The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.
Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.
The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.
Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.
Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).
Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article originally appeared on Medscape.com.
Financial navigators saved about $2,500 per cancer patient
Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.
Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.
The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.
“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.
“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.
The study was published in JCO Oncology Practice.
The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.
The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.
A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.
The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.
Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).
With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).
Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).
“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”
The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.
Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.
The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.
“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.
“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.
The study was published in JCO Oncology Practice.
The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.
The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.
A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.
The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.
Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).
With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).
Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).
“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”
The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.
Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.
The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.
“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.
“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.
The study was published in JCO Oncology Practice.
The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.
The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.
A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.
The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.
Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).
With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).
Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).
“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”
The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JCO ONCOLOGY PRACTICE
Meet the JCOM Author with Dr. Barkoudah: Leading for High Reliability During the COVID-19 Pandemic
Meet the JCOM Author with Dr. Barkoudah: Residence Characteristics and Nursing Home Compare Quality Measures
Implementation of a Multidisciplinary Team–Based Clinical Care Pathway Is Associated With Increased Surgery Rates for Infective Endocarditis
From the University of Missouri School of Medicine, Columbia, MO (Haley Crosby); Department of Clinical Family and Community Medicine, University of Missouri, Columbia, MO (Dr. Pierce); and Department of Medicine, Divisions of Infectious Diseases and Pulmonary, Critical Care and Environmental Medicine, University of Missouri, Columbia, MO, and Divisions of Pulmonary and Critical Care Medicine and Infectious Diseases, University of Maryland Baltimore Washington Medical Center, Glen Burnie, MD (Dr. Regunath).
ABSTRACT
Objective: Multidisciplinary teams (MDTs) improve outcomes for patients with infective endocarditis (IE), but methods of implementation vary. In our academic medical center, we developed an MDT approach guided by a clinical care pathway and assessed outcomes of patients with IE.
Methods: We compared outcomes of patients with IE and indications for surgery between December 2018 and June 2020 with our prior published data for the period January to December 2016. MDT interventions involved recurring conferences with infectious diseases physicians in team meetings and promoting a clinical care pathway to guide providers on steps in management. Primary outcomes were surgery and in-hospital death.
Results: Prior to the intervention, 6 of 21 (28.6%) patients with indications for surgery underwent surgery or were transferred to higher centers for surgery, and 6 (28.6%) patients died. Post intervention, 17 of 31 (54.8%) patients underwent or were transferred for surgery, and 5 (16.1%) died. After adjusting for age and gender, the odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) compared with the pre-intervention period. The odds ratio for death among patients in the postintervention period was 0.40 (95% CI, 0.09-1.69; P = .21).
Conclusion: An MDT team approach using a clinical pathway was associated with an increased number of surgeries performed for IE and may lower rates of in-hospital mortality.
Keywords: infective endocarditis, clinical pathway, quality improvement, multidisciplinary team, valve surgery.
Infective endocarditis (IE) is associated with significant morbidity and mortality.1 Rates of IE due to Staphylococcus aureus are increasing in the United States.2 Reported in-hospital mortality from IE ranges from 15% to 20%.3
Clinical pathways are defined as “structured, multidisciplinary plans of care used by health services to detail essential steps in the care of patients with a specific clinical problem.”12 In the modern era, these pathways are often developed and implemented via the electronic health record (EHR) system. Studies of clinical pathways generally demonstrate improvements in patient outcomes, quality of care, or resource utilization.13,14 Clinical pathways represent 1 possible approach to the implementation of a MDT in the care of patients with IE.15
In our earlier work, we used quality improvement principles in the design of an MDT approach to IE care at our institution.16 Despite having indications for surgery, 12 of 21 (57.1%) patients with IE did not undergo surgery, and we identified these missed opportunities for surgery as a leverage point for improvement of outcomes. With input from the various specialties and stakeholders, we developed a clinical pathway (algorithm) for the institutional management of IE that guides next steps in clinical care and their timelines, aiming to reduce by 50% (from 57.1% to 28.6%) the number of patients with IE who do not undergo surgery despite guideline indications for early surgical intervention. In this report, we describe the implementation of this clinical pathway as our MDT approach to the care of patients with IE at our institution.
Methods
The University of Missouri, Columbia, is a tertiary care academic health system with 5 hospitals and more than 60 clinic locations across central Missouri. In the spring of 2018, an MDT was developed, with support from administrative leaders, to improve the care of patients with IE at our institution. The work group prioritized one leverage point to improve IE outcomes, which was improving the number of surgeries performed on those IE patients who had guideline indications for surgery. A clinical pathway was developed around this leverage point (Figure 1). The pathway leveraged the 6 T’s (Table 1) to guide providers through the evaluation and management of IE.17 The pathway focused on improving adherence to standards of care and reduction in practice variation by defining indications for referrals and diagnostic interventions, helping to reduce delays in consultation and diagnosis. The pathway also clearly outlined the surgical indications and timing for patients with IE and provided the basis for decisions to proceed with surgery.
Starting in late 2018, in collaboration with cardiology and CTS teams, ID specialists socialized the clinical pathway to inpatient services that cared for patients with IE. Infectious diseases physicians also provided recurring conferences on the effectiveness of MDTs in IE management and participated in heart-valve team case discussions. Finally, in May 2019, an electronic version of the pathway was embedded in the EHR system using a Cerner PowerChart feature known as Care Pathways. The feature presents the user with algorithm questions in the EHR and provides recommendations, relevant orders, timelines, and other decision support in the clinical pathway. The feature is available to all providers in the health system.
To evaluate the effectiveness of our intervention, we recorded outcomes for patients with IE with surgical indications between December 2018 and June 2020 and compared them with our prior published data from January to December 2016. Cases of IE for the current study period were identified via retrospective chart review. Records from December 2018 to June 2020 were searched using International Statistical Classification of Diseases, Tenth Revision (ICD-10) discharge codes for IE (I33, I33.0, I33.9, I38, I39, M32.11). To select those patients with definitive IE and indications for surgery, the following criteria were applied: age ≥ 18 years; fulfilled modified Duke criteria for definite IE18; and met ≥ 1 American Heart Association (AHA)/Infection Diseases Society of America criteria for recommendation for surgery. Indications for surgery were ≥ 1 of the following: left-sided endocarditis caused by S aureus, fungal, or highly resistant organism; new heart block; annular or aortic abscess; persistent bacteremia or fever despite 5 days of appropriate antimicrobials; vegetation size ≥ 10 mm and evidence of embolic phenomena; recurrence of prosthetic valve infection; recurrent emboli and persistent vegetation despite antimicrobials; and increase in vegetation size despite antimicrobials.16
Age was treated as a categorical variable, using the age groups 18 to 44 years, 45 to 64 years, and 65 years and older. Gender was self-reported. Primary outcomes were surgery or transfer to a higher center for surgery and in-hospital death. Secondary outcomes included consults to teams involved in multidisciplinary care of patients with IE, including ID, cardiology, and CTS. Bivariate analyses were performed using Pearson χ2 tests. Odds ratios for surgery and death were calculated using a multivariate logistic regression model including age and gender covariates. Statistical significance was defined at α = 0.05, and statistical analysis was performed using Stata/IC v16.1 (StataCorp LLC). Our university institutional review board (IRB) reviewed the project (#2010858-QI) and determined that the project was quality-improvement activity, not human subject research, and therefore did not require additional IRB review.
Results
We identified 21 patients in the pre-intervention period and 31 patients in the postintervention period with definitive IE who had guideline indications for surgery. The postintervention cohort was older and had more male patients; this difference was not statistically significant. No differences were noted between the groups for race, gender, or intravenous (IV) drug use (Table 2). Chi-square tests of independence were performed to assess the relationship between age and our primary outcomes. There was a significant relationship between age and the likelihood of receiving or being transferred for surgery (59.3% vs 50% vs 7.7% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 [2, N = 52] = 9.67; P = .008), but not between age and mortality (14.8% vs 25.0% vs 30.8% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 = 1.48 [2, N = 52; P = .478]. The electronic version of the clinical pathway was activated and used in only 3 of the 31 patients in the postintervention period. Consultations to ID, cardiology, and CTS teams were compared between the study periods (Table 2). Although more consultations were seen in the postintervention period, differences were not statistically significant.
The unadjusted primary outcomes are shown in Table 2. More surgeries were performed per guideline indications, and fewer deaths were noted in the postintervention period than in the pre-intervention period, but the differences were not statistically significant (Table 2).
Because the postintervention period had more male patients and older patients, we evaluated the outcomes using a logistic regression model controlling for both age and gender. The odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) as compared with the pre-intervention period, and the odds ratio for death among patients in the postintervention period compared with the pre-intervention period was 0.40 (95% CI, 0.09-1.69; P = .21) (Figure 2).
Discussion
In our study, patients with IE with guideline indications for surgery had significantly higher rates of surgery in the postintervention period than in the pre-intervention period. The implementation of an MDT, recurring educational sessions, and efforts to implement and familiarize team members with the clinical pathway approach are the most likely reasons for this change. The increased rates of surgery in the postintervention period were the likely proximate cause of the 60% reduction in in-hospital mortality. This improvement in mortality, while not statistically significant, is very likely to be clinically significant and helps reinforce the value of the MDT intervention used.
Our findings are consistent with existing and mounting literature on the use of MDTs to improve outcomes for patients with IE, including 2 studies that noted an increased rate of surgery for patients with indications.8,19 Several other studies in both Europe and North America have found significant decreases in mortality,6-11,20,21 rates of complications,9 time to diagnosis and treatment,11 and length of stay9,20 for patients with IE managed with an MDT strategy. Although current AHA guidelines for care of patients with IE do suggest an MDT approach, the strategy for this approach is not well established.22 Only 1 study that has implemented a new MDT protocol for care of IE has been conducted in the United States.8
While effective MDTs certainly improve outcomes in patients with IE, there are reported differences in implementation of such an approach. With the MDT model as the core, various implementations included regular case conferences,10,11,19,21,23 formation of a consulting team,6,8 or establishment of a new protocol or algorithm for care.8,9,20 Our approach used a clinical pathway as a basis for improved communication among consulting services, education of learning providers via regular case conferences, and implementation of an electronic clinical care pathway to guide them step by step. Our pathway followed the institutionally standardized algorithm (Figure 1), using what we called the 6 T’s approach (Table 1), that guides providers to evaluate critical cases in a fast track.17
To the best of our knowledge, ours is the first report of an MDT that used an electronic clinical care pathway embedded within the EHR. The electronic version of our clinical pathway went live for only the second half of the postintervention study period, which is the most likely reason for its limited utilization. It is also possible that educational efforts in the first half of the intervention period were sufficient to familiarize providers with the care pathway such that the electronic version was seldom needed. We are exploring other possible ways of improving electronic pathway utilization, such as improving the feature usability and further systemwide educational efforts.
Our study has other limitations. Quasi-experimental before-and-after comparisons are subject to confounding from concurrent interventions. We had a substantial change in cardiothoracic faculty soon after the commencement of our efforts to form the MDT, and thus cannot rule out differences related to their comfort level in considering or offering surgery. We also cannot rule out a Hawthorne effect, where knowledge of the ongoing quality-improvement project changed provider behavior, making surgery more likely. We did not evaluate rates of right- versus left-sided endocarditis, which have been linked to mortality.24 Our study also was performed across a single academic institution, which may limit its generalizability. Finally, our study may not have been adequately powered to detect differences in mortality due to implementation of the MDT approach.
Conclusion
Our work suggests that an MDT for IE can be successfully designed and implemented with a clinical pathway using quality-improvement tools in centers where subspecialty services are available. Our approach was associated with a higher rate of surgery among patients with guideline indications for surgery and may reduce in-hospital mortality. An electronic clinical care pathway embedded in the EHR is feasible and may have a role in MDT implementation.
These data were also accepted as a poster at IDWeek 2022, Washington, DC. The poster abstract is published in an online supplement of Open Forum Infectious Diseases as an abstract publication.
Corresponding author: Haley Crosby; [email protected]
Disclosures: None reported.
1. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/cir.0000000000000296
2. Federspiel JJ, Stearns SC, Peppercorn AF, et al. Increasing US rates of endocarditis with Staphylococcus aureus: 1999-2008. Arch Intern Med. 2012;172(4):363-365. doi:10.1001/archinternmed.2011.1027
3. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(23):e521-e643. doi:10.1161/cir.0000000000000031
4. Chambers J, Sandoe J, Ray S, et al. The infective endocarditis team: recommendations from an international working group. Heart. 2014;100(7):524-527. doi:10.1136/heartjnl-2013-304354
5. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015;36(44):3075-3128. doi:10.1093/eurheartj/ehv319
6. Chirillo F, Scotton P, Rocco F, et al. Impact of a multidisciplinary management strategy on the outcome of patients with native valve infective endocarditis. Am J Cardiol. 2013;112(8):1171-1176. doi:10.1016/j.amjcard.2013.05.060
7. Botelho-Nevers E, Thuny F, Casalta JP, et al. Dramatic reduction in infective endocarditis-related mortality with a management-based approach. Arch Intern Med. 2009;169(14):1290-1298. doi:10.1001/archinternmed.2009.192
8. El-Dalati S, Cronin D, Riddell IV J, et al. The clinical impact of implementation of a multidisciplinary endocarditis team. Ann Thorac Surg. 2022;113(1):118-124.
9. Carrasco-Chinchilla F, Sánchez-Espín G, Ruiz-Morales J, et al. Influence of a multidisciplinary alert strategy on mortality due to left-sided infective endocarditis. Rev Esp Cardiol (Engl Ed). 2014;67(5):380-386. doi:10.1016/j.rec.2013.09.010
10. Issa N, Dijos M, Greib C, et al. Impact of an endocarditis team in the management of 357 infective endocarditis [abstract]. Open Forum Infect Dis. 2016;3(suppl 1):S201. doi:10.1093/ofid/ofw172.825
11. Kaura A, Byrne J, Fife A, et al. Inception of the ‘endocarditis team’ is associated with improved survival in patients with infective endocarditis who are managed medically: findings from a before-and-after study. Open Heart. 2017;4(2):e000699. doi:10.1136/openhrt-2017-000699
12. Rotter T, Kinsman L, James E, et al. Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst Rev. 2010;(3):Cd006632. doi:10.1002/14651858.CD006632.pub2
13. Neame MT, Chacko J, Surace AE, et al. A systematic review of the effects of implementing clinical pathways supported by health information technologies. J Am Med Inform Assoc. 2019;26(4):356-363. doi:10.1093/jamia/ocy176
14. Trimarchi L, Caruso R, Magon G, et al. Clinical pathways and patient-related outcomes in hospital-based settings: a systematic review and meta-analysis of randomized controlled trials. Acta Biomed. 2021;92(1):e2021093. doi:10.23750/abm.v92i1.10639
15. Gibbons EF, Huang G, Aldea G, et al. A multidisciplinary pathway for the diagnosis and treatment of infectious endocarditis. Crit Pathw Cardiol. 2020;19(4):187-194. doi:10.1097/hpc.0000000000000224
16. Regunath H, Vasudevan A, Vyas K, et al. A quality improvement initiative: developing a multi-disciplinary team for infective endocarditis. Mo Med. 2019;116(4):291-296.
17. Regunath H, Whitt SP. Multidisciplinary service delivery for the endocarditis patient. In: Infective Endocarditis: A Multidisciplinary Approach. 1st ed. Kilic A, ed. Academic Press; 2022.
18. Durack DT, Lukes AS, Bright DK. New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings. Duke Endocarditis Service. Am J Med. 1994;96(3):200-209. doi:10.1016/0002-9343(94)90143-0
19. Tan C, Hansen MS, Cohen G, et al. Case conferences for infective endocarditis: a quality improvement initiative. PLoS One. 2018;13(10):e0205528. doi:10.1371/journal.pone.0205528
20. Ruch Y, Mazzucotelli JP, Lefebvre F, et al. Impact of setting up an “endocarditis team” on the management of infective endocarditis. Open Forum Infect Dis. 2019;6(9):ofz308. doi:10.1093/ofid/ofz308
21. Camou F, Dijos M, Barandon L, et al. Management of infective endocarditis and multidisciplinary approach. Med Mal Infect. 2019;49(1):17-22. doi:10.1016/j.medmal.2018.06.007
22. Pettersson GB, Hussain ST. Current AATS guidelines on surgical treatment of infective endocarditis. Ann Cardiothorac Surg. 2019;8(6):630-644. doi:10.21037/acs.2019.10.05
23. Mestres CA, Paré JC, Miró JM. Organization and functioning of a multidisciplinary team for the diagnosis and treatment of infective endocarditis: a 30-year perspective (1985-2014). Rev Esp Cardiol (Engl Ed). 2015;68(5):363-368. doi:10.1016/j.rec.2014.10.006
24. Stavi V, Brandstaetter E, Sagy I, et al. Comparison of clinical characteristics and prognosis in patients with right- and left-sided infective endocarditis. Rambam Maimonides Med J. 2019;10(1):e00003. doi:10.5041/rmmj.10338
From the University of Missouri School of Medicine, Columbia, MO (Haley Crosby); Department of Clinical Family and Community Medicine, University of Missouri, Columbia, MO (Dr. Pierce); and Department of Medicine, Divisions of Infectious Diseases and Pulmonary, Critical Care and Environmental Medicine, University of Missouri, Columbia, MO, and Divisions of Pulmonary and Critical Care Medicine and Infectious Diseases, University of Maryland Baltimore Washington Medical Center, Glen Burnie, MD (Dr. Regunath).
ABSTRACT
Objective: Multidisciplinary teams (MDTs) improve outcomes for patients with infective endocarditis (IE), but methods of implementation vary. In our academic medical center, we developed an MDT approach guided by a clinical care pathway and assessed outcomes of patients with IE.
Methods: We compared outcomes of patients with IE and indications for surgery between December 2018 and June 2020 with our prior published data for the period January to December 2016. MDT interventions involved recurring conferences with infectious diseases physicians in team meetings and promoting a clinical care pathway to guide providers on steps in management. Primary outcomes were surgery and in-hospital death.
Results: Prior to the intervention, 6 of 21 (28.6%) patients with indications for surgery underwent surgery or were transferred to higher centers for surgery, and 6 (28.6%) patients died. Post intervention, 17 of 31 (54.8%) patients underwent or were transferred for surgery, and 5 (16.1%) died. After adjusting for age and gender, the odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) compared with the pre-intervention period. The odds ratio for death among patients in the postintervention period was 0.40 (95% CI, 0.09-1.69; P = .21).
Conclusion: An MDT team approach using a clinical pathway was associated with an increased number of surgeries performed for IE and may lower rates of in-hospital mortality.
Keywords: infective endocarditis, clinical pathway, quality improvement, multidisciplinary team, valve surgery.
Infective endocarditis (IE) is associated with significant morbidity and mortality.1 Rates of IE due to Staphylococcus aureus are increasing in the United States.2 Reported in-hospital mortality from IE ranges from 15% to 20%.3
Clinical pathways are defined as “structured, multidisciplinary plans of care used by health services to detail essential steps in the care of patients with a specific clinical problem.”12 In the modern era, these pathways are often developed and implemented via the electronic health record (EHR) system. Studies of clinical pathways generally demonstrate improvements in patient outcomes, quality of care, or resource utilization.13,14 Clinical pathways represent 1 possible approach to the implementation of a MDT in the care of patients with IE.15
In our earlier work, we used quality improvement principles in the design of an MDT approach to IE care at our institution.16 Despite having indications for surgery, 12 of 21 (57.1%) patients with IE did not undergo surgery, and we identified these missed opportunities for surgery as a leverage point for improvement of outcomes. With input from the various specialties and stakeholders, we developed a clinical pathway (algorithm) for the institutional management of IE that guides next steps in clinical care and their timelines, aiming to reduce by 50% (from 57.1% to 28.6%) the number of patients with IE who do not undergo surgery despite guideline indications for early surgical intervention. In this report, we describe the implementation of this clinical pathway as our MDT approach to the care of patients with IE at our institution.
Methods
The University of Missouri, Columbia, is a tertiary care academic health system with 5 hospitals and more than 60 clinic locations across central Missouri. In the spring of 2018, an MDT was developed, with support from administrative leaders, to improve the care of patients with IE at our institution. The work group prioritized one leverage point to improve IE outcomes, which was improving the number of surgeries performed on those IE patients who had guideline indications for surgery. A clinical pathway was developed around this leverage point (Figure 1). The pathway leveraged the 6 T’s (Table 1) to guide providers through the evaluation and management of IE.17 The pathway focused on improving adherence to standards of care and reduction in practice variation by defining indications for referrals and diagnostic interventions, helping to reduce delays in consultation and diagnosis. The pathway also clearly outlined the surgical indications and timing for patients with IE and provided the basis for decisions to proceed with surgery.
Starting in late 2018, in collaboration with cardiology and CTS teams, ID specialists socialized the clinical pathway to inpatient services that cared for patients with IE. Infectious diseases physicians also provided recurring conferences on the effectiveness of MDTs in IE management and participated in heart-valve team case discussions. Finally, in May 2019, an electronic version of the pathway was embedded in the EHR system using a Cerner PowerChart feature known as Care Pathways. The feature presents the user with algorithm questions in the EHR and provides recommendations, relevant orders, timelines, and other decision support in the clinical pathway. The feature is available to all providers in the health system.
To evaluate the effectiveness of our intervention, we recorded outcomes for patients with IE with surgical indications between December 2018 and June 2020 and compared them with our prior published data from January to December 2016. Cases of IE for the current study period were identified via retrospective chart review. Records from December 2018 to June 2020 were searched using International Statistical Classification of Diseases, Tenth Revision (ICD-10) discharge codes for IE (I33, I33.0, I33.9, I38, I39, M32.11). To select those patients with definitive IE and indications for surgery, the following criteria were applied: age ≥ 18 years; fulfilled modified Duke criteria for definite IE18; and met ≥ 1 American Heart Association (AHA)/Infection Diseases Society of America criteria for recommendation for surgery. Indications for surgery were ≥ 1 of the following: left-sided endocarditis caused by S aureus, fungal, or highly resistant organism; new heart block; annular or aortic abscess; persistent bacteremia or fever despite 5 days of appropriate antimicrobials; vegetation size ≥ 10 mm and evidence of embolic phenomena; recurrence of prosthetic valve infection; recurrent emboli and persistent vegetation despite antimicrobials; and increase in vegetation size despite antimicrobials.16
Age was treated as a categorical variable, using the age groups 18 to 44 years, 45 to 64 years, and 65 years and older. Gender was self-reported. Primary outcomes were surgery or transfer to a higher center for surgery and in-hospital death. Secondary outcomes included consults to teams involved in multidisciplinary care of patients with IE, including ID, cardiology, and CTS. Bivariate analyses were performed using Pearson χ2 tests. Odds ratios for surgery and death were calculated using a multivariate logistic regression model including age and gender covariates. Statistical significance was defined at α = 0.05, and statistical analysis was performed using Stata/IC v16.1 (StataCorp LLC). Our university institutional review board (IRB) reviewed the project (#2010858-QI) and determined that the project was quality-improvement activity, not human subject research, and therefore did not require additional IRB review.
Results
We identified 21 patients in the pre-intervention period and 31 patients in the postintervention period with definitive IE who had guideline indications for surgery. The postintervention cohort was older and had more male patients; this difference was not statistically significant. No differences were noted between the groups for race, gender, or intravenous (IV) drug use (Table 2). Chi-square tests of independence were performed to assess the relationship between age and our primary outcomes. There was a significant relationship between age and the likelihood of receiving or being transferred for surgery (59.3% vs 50% vs 7.7% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 [2, N = 52] = 9.67; P = .008), but not between age and mortality (14.8% vs 25.0% vs 30.8% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 = 1.48 [2, N = 52; P = .478]. The electronic version of the clinical pathway was activated and used in only 3 of the 31 patients in the postintervention period. Consultations to ID, cardiology, and CTS teams were compared between the study periods (Table 2). Although more consultations were seen in the postintervention period, differences were not statistically significant.
The unadjusted primary outcomes are shown in Table 2. More surgeries were performed per guideline indications, and fewer deaths were noted in the postintervention period than in the pre-intervention period, but the differences were not statistically significant (Table 2).
Because the postintervention period had more male patients and older patients, we evaluated the outcomes using a logistic regression model controlling for both age and gender. The odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) as compared with the pre-intervention period, and the odds ratio for death among patients in the postintervention period compared with the pre-intervention period was 0.40 (95% CI, 0.09-1.69; P = .21) (Figure 2).
Discussion
In our study, patients with IE with guideline indications for surgery had significantly higher rates of surgery in the postintervention period than in the pre-intervention period. The implementation of an MDT, recurring educational sessions, and efforts to implement and familiarize team members with the clinical pathway approach are the most likely reasons for this change. The increased rates of surgery in the postintervention period were the likely proximate cause of the 60% reduction in in-hospital mortality. This improvement in mortality, while not statistically significant, is very likely to be clinically significant and helps reinforce the value of the MDT intervention used.
Our findings are consistent with existing and mounting literature on the use of MDTs to improve outcomes for patients with IE, including 2 studies that noted an increased rate of surgery for patients with indications.8,19 Several other studies in both Europe and North America have found significant decreases in mortality,6-11,20,21 rates of complications,9 time to diagnosis and treatment,11 and length of stay9,20 for patients with IE managed with an MDT strategy. Although current AHA guidelines for care of patients with IE do suggest an MDT approach, the strategy for this approach is not well established.22 Only 1 study that has implemented a new MDT protocol for care of IE has been conducted in the United States.8
While effective MDTs certainly improve outcomes in patients with IE, there are reported differences in implementation of such an approach. With the MDT model as the core, various implementations included regular case conferences,10,11,19,21,23 formation of a consulting team,6,8 or establishment of a new protocol or algorithm for care.8,9,20 Our approach used a clinical pathway as a basis for improved communication among consulting services, education of learning providers via regular case conferences, and implementation of an electronic clinical care pathway to guide them step by step. Our pathway followed the institutionally standardized algorithm (Figure 1), using what we called the 6 T’s approach (Table 1), that guides providers to evaluate critical cases in a fast track.17
To the best of our knowledge, ours is the first report of an MDT that used an electronic clinical care pathway embedded within the EHR. The electronic version of our clinical pathway went live for only the second half of the postintervention study period, which is the most likely reason for its limited utilization. It is also possible that educational efforts in the first half of the intervention period were sufficient to familiarize providers with the care pathway such that the electronic version was seldom needed. We are exploring other possible ways of improving electronic pathway utilization, such as improving the feature usability and further systemwide educational efforts.
Our study has other limitations. Quasi-experimental before-and-after comparisons are subject to confounding from concurrent interventions. We had a substantial change in cardiothoracic faculty soon after the commencement of our efforts to form the MDT, and thus cannot rule out differences related to their comfort level in considering or offering surgery. We also cannot rule out a Hawthorne effect, where knowledge of the ongoing quality-improvement project changed provider behavior, making surgery more likely. We did not evaluate rates of right- versus left-sided endocarditis, which have been linked to mortality.24 Our study also was performed across a single academic institution, which may limit its generalizability. Finally, our study may not have been adequately powered to detect differences in mortality due to implementation of the MDT approach.
Conclusion
Our work suggests that an MDT for IE can be successfully designed and implemented with a clinical pathway using quality-improvement tools in centers where subspecialty services are available. Our approach was associated with a higher rate of surgery among patients with guideline indications for surgery and may reduce in-hospital mortality. An electronic clinical care pathway embedded in the EHR is feasible and may have a role in MDT implementation.
These data were also accepted as a poster at IDWeek 2022, Washington, DC. The poster abstract is published in an online supplement of Open Forum Infectious Diseases as an abstract publication.
Corresponding author: Haley Crosby; [email protected]
Disclosures: None reported.
From the University of Missouri School of Medicine, Columbia, MO (Haley Crosby); Department of Clinical Family and Community Medicine, University of Missouri, Columbia, MO (Dr. Pierce); and Department of Medicine, Divisions of Infectious Diseases and Pulmonary, Critical Care and Environmental Medicine, University of Missouri, Columbia, MO, and Divisions of Pulmonary and Critical Care Medicine and Infectious Diseases, University of Maryland Baltimore Washington Medical Center, Glen Burnie, MD (Dr. Regunath).
ABSTRACT
Objective: Multidisciplinary teams (MDTs) improve outcomes for patients with infective endocarditis (IE), but methods of implementation vary. In our academic medical center, we developed an MDT approach guided by a clinical care pathway and assessed outcomes of patients with IE.
Methods: We compared outcomes of patients with IE and indications for surgery between December 2018 and June 2020 with our prior published data for the period January to December 2016. MDT interventions involved recurring conferences with infectious diseases physicians in team meetings and promoting a clinical care pathway to guide providers on steps in management. Primary outcomes were surgery and in-hospital death.
Results: Prior to the intervention, 6 of 21 (28.6%) patients with indications for surgery underwent surgery or were transferred to higher centers for surgery, and 6 (28.6%) patients died. Post intervention, 17 of 31 (54.8%) patients underwent or were transferred for surgery, and 5 (16.1%) died. After adjusting for age and gender, the odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) compared with the pre-intervention period. The odds ratio for death among patients in the postintervention period was 0.40 (95% CI, 0.09-1.69; P = .21).
Conclusion: An MDT team approach using a clinical pathway was associated with an increased number of surgeries performed for IE and may lower rates of in-hospital mortality.
Keywords: infective endocarditis, clinical pathway, quality improvement, multidisciplinary team, valve surgery.
Infective endocarditis (IE) is associated with significant morbidity and mortality.1 Rates of IE due to Staphylococcus aureus are increasing in the United States.2 Reported in-hospital mortality from IE ranges from 15% to 20%.3
Clinical pathways are defined as “structured, multidisciplinary plans of care used by health services to detail essential steps in the care of patients with a specific clinical problem.”12 In the modern era, these pathways are often developed and implemented via the electronic health record (EHR) system. Studies of clinical pathways generally demonstrate improvements in patient outcomes, quality of care, or resource utilization.13,14 Clinical pathways represent 1 possible approach to the implementation of a MDT in the care of patients with IE.15
In our earlier work, we used quality improvement principles in the design of an MDT approach to IE care at our institution.16 Despite having indications for surgery, 12 of 21 (57.1%) patients with IE did not undergo surgery, and we identified these missed opportunities for surgery as a leverage point for improvement of outcomes. With input from the various specialties and stakeholders, we developed a clinical pathway (algorithm) for the institutional management of IE that guides next steps in clinical care and their timelines, aiming to reduce by 50% (from 57.1% to 28.6%) the number of patients with IE who do not undergo surgery despite guideline indications for early surgical intervention. In this report, we describe the implementation of this clinical pathway as our MDT approach to the care of patients with IE at our institution.
Methods
The University of Missouri, Columbia, is a tertiary care academic health system with 5 hospitals and more than 60 clinic locations across central Missouri. In the spring of 2018, an MDT was developed, with support from administrative leaders, to improve the care of patients with IE at our institution. The work group prioritized one leverage point to improve IE outcomes, which was improving the number of surgeries performed on those IE patients who had guideline indications for surgery. A clinical pathway was developed around this leverage point (Figure 1). The pathway leveraged the 6 T’s (Table 1) to guide providers through the evaluation and management of IE.17 The pathway focused on improving adherence to standards of care and reduction in practice variation by defining indications for referrals and diagnostic interventions, helping to reduce delays in consultation and diagnosis. The pathway also clearly outlined the surgical indications and timing for patients with IE and provided the basis for decisions to proceed with surgery.
Starting in late 2018, in collaboration with cardiology and CTS teams, ID specialists socialized the clinical pathway to inpatient services that cared for patients with IE. Infectious diseases physicians also provided recurring conferences on the effectiveness of MDTs in IE management and participated in heart-valve team case discussions. Finally, in May 2019, an electronic version of the pathway was embedded in the EHR system using a Cerner PowerChart feature known as Care Pathways. The feature presents the user with algorithm questions in the EHR and provides recommendations, relevant orders, timelines, and other decision support in the clinical pathway. The feature is available to all providers in the health system.
To evaluate the effectiveness of our intervention, we recorded outcomes for patients with IE with surgical indications between December 2018 and June 2020 and compared them with our prior published data from January to December 2016. Cases of IE for the current study period were identified via retrospective chart review. Records from December 2018 to June 2020 were searched using International Statistical Classification of Diseases, Tenth Revision (ICD-10) discharge codes for IE (I33, I33.0, I33.9, I38, I39, M32.11). To select those patients with definitive IE and indications for surgery, the following criteria were applied: age ≥ 18 years; fulfilled modified Duke criteria for definite IE18; and met ≥ 1 American Heart Association (AHA)/Infection Diseases Society of America criteria for recommendation for surgery. Indications for surgery were ≥ 1 of the following: left-sided endocarditis caused by S aureus, fungal, or highly resistant organism; new heart block; annular or aortic abscess; persistent bacteremia or fever despite 5 days of appropriate antimicrobials; vegetation size ≥ 10 mm and evidence of embolic phenomena; recurrence of prosthetic valve infection; recurrent emboli and persistent vegetation despite antimicrobials; and increase in vegetation size despite antimicrobials.16
Age was treated as a categorical variable, using the age groups 18 to 44 years, 45 to 64 years, and 65 years and older. Gender was self-reported. Primary outcomes were surgery or transfer to a higher center for surgery and in-hospital death. Secondary outcomes included consults to teams involved in multidisciplinary care of patients with IE, including ID, cardiology, and CTS. Bivariate analyses were performed using Pearson χ2 tests. Odds ratios for surgery and death were calculated using a multivariate logistic regression model including age and gender covariates. Statistical significance was defined at α = 0.05, and statistical analysis was performed using Stata/IC v16.1 (StataCorp LLC). Our university institutional review board (IRB) reviewed the project (#2010858-QI) and determined that the project was quality-improvement activity, not human subject research, and therefore did not require additional IRB review.
Results
We identified 21 patients in the pre-intervention period and 31 patients in the postintervention period with definitive IE who had guideline indications for surgery. The postintervention cohort was older and had more male patients; this difference was not statistically significant. No differences were noted between the groups for race, gender, or intravenous (IV) drug use (Table 2). Chi-square tests of independence were performed to assess the relationship between age and our primary outcomes. There was a significant relationship between age and the likelihood of receiving or being transferred for surgery (59.3% vs 50% vs 7.7% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 [2, N = 52] = 9.67; P = .008), but not between age and mortality (14.8% vs 25.0% vs 30.8% for 18-44 y, 45-64 y, and ≥ 65 y, respectively; χ2 = 1.48 [2, N = 52; P = .478]. The electronic version of the clinical pathway was activated and used in only 3 of the 31 patients in the postintervention period. Consultations to ID, cardiology, and CTS teams were compared between the study periods (Table 2). Although more consultations were seen in the postintervention period, differences were not statistically significant.
The unadjusted primary outcomes are shown in Table 2. More surgeries were performed per guideline indications, and fewer deaths were noted in the postintervention period than in the pre-intervention period, but the differences were not statistically significant (Table 2).
Because the postintervention period had more male patients and older patients, we evaluated the outcomes using a logistic regression model controlling for both age and gender. The odds of surgery or transfer for surgery for patients in the postintervention period were 4.88 (95% CI, 1.20-19.79; P = .027) as compared with the pre-intervention period, and the odds ratio for death among patients in the postintervention period compared with the pre-intervention period was 0.40 (95% CI, 0.09-1.69; P = .21) (Figure 2).
Discussion
In our study, patients with IE with guideline indications for surgery had significantly higher rates of surgery in the postintervention period than in the pre-intervention period. The implementation of an MDT, recurring educational sessions, and efforts to implement and familiarize team members with the clinical pathway approach are the most likely reasons for this change. The increased rates of surgery in the postintervention period were the likely proximate cause of the 60% reduction in in-hospital mortality. This improvement in mortality, while not statistically significant, is very likely to be clinically significant and helps reinforce the value of the MDT intervention used.
Our findings are consistent with existing and mounting literature on the use of MDTs to improve outcomes for patients with IE, including 2 studies that noted an increased rate of surgery for patients with indications.8,19 Several other studies in both Europe and North America have found significant decreases in mortality,6-11,20,21 rates of complications,9 time to diagnosis and treatment,11 and length of stay9,20 for patients with IE managed with an MDT strategy. Although current AHA guidelines for care of patients with IE do suggest an MDT approach, the strategy for this approach is not well established.22 Only 1 study that has implemented a new MDT protocol for care of IE has been conducted in the United States.8
While effective MDTs certainly improve outcomes in patients with IE, there are reported differences in implementation of such an approach. With the MDT model as the core, various implementations included regular case conferences,10,11,19,21,23 formation of a consulting team,6,8 or establishment of a new protocol or algorithm for care.8,9,20 Our approach used a clinical pathway as a basis for improved communication among consulting services, education of learning providers via regular case conferences, and implementation of an electronic clinical care pathway to guide them step by step. Our pathway followed the institutionally standardized algorithm (Figure 1), using what we called the 6 T’s approach (Table 1), that guides providers to evaluate critical cases in a fast track.17
To the best of our knowledge, ours is the first report of an MDT that used an electronic clinical care pathway embedded within the EHR. The electronic version of our clinical pathway went live for only the second half of the postintervention study period, which is the most likely reason for its limited utilization. It is also possible that educational efforts in the first half of the intervention period were sufficient to familiarize providers with the care pathway such that the electronic version was seldom needed. We are exploring other possible ways of improving electronic pathway utilization, such as improving the feature usability and further systemwide educational efforts.
Our study has other limitations. Quasi-experimental before-and-after comparisons are subject to confounding from concurrent interventions. We had a substantial change in cardiothoracic faculty soon after the commencement of our efforts to form the MDT, and thus cannot rule out differences related to their comfort level in considering or offering surgery. We also cannot rule out a Hawthorne effect, where knowledge of the ongoing quality-improvement project changed provider behavior, making surgery more likely. We did not evaluate rates of right- versus left-sided endocarditis, which have been linked to mortality.24 Our study also was performed across a single academic institution, which may limit its generalizability. Finally, our study may not have been adequately powered to detect differences in mortality due to implementation of the MDT approach.
Conclusion
Our work suggests that an MDT for IE can be successfully designed and implemented with a clinical pathway using quality-improvement tools in centers where subspecialty services are available. Our approach was associated with a higher rate of surgery among patients with guideline indications for surgery and may reduce in-hospital mortality. An electronic clinical care pathway embedded in the EHR is feasible and may have a role in MDT implementation.
These data were also accepted as a poster at IDWeek 2022, Washington, DC. The poster abstract is published in an online supplement of Open Forum Infectious Diseases as an abstract publication.
Corresponding author: Haley Crosby; [email protected]
Disclosures: None reported.
1. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/cir.0000000000000296
2. Federspiel JJ, Stearns SC, Peppercorn AF, et al. Increasing US rates of endocarditis with Staphylococcus aureus: 1999-2008. Arch Intern Med. 2012;172(4):363-365. doi:10.1001/archinternmed.2011.1027
3. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(23):e521-e643. doi:10.1161/cir.0000000000000031
4. Chambers J, Sandoe J, Ray S, et al. The infective endocarditis team: recommendations from an international working group. Heart. 2014;100(7):524-527. doi:10.1136/heartjnl-2013-304354
5. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015;36(44):3075-3128. doi:10.1093/eurheartj/ehv319
6. Chirillo F, Scotton P, Rocco F, et al. Impact of a multidisciplinary management strategy on the outcome of patients with native valve infective endocarditis. Am J Cardiol. 2013;112(8):1171-1176. doi:10.1016/j.amjcard.2013.05.060
7. Botelho-Nevers E, Thuny F, Casalta JP, et al. Dramatic reduction in infective endocarditis-related mortality with a management-based approach. Arch Intern Med. 2009;169(14):1290-1298. doi:10.1001/archinternmed.2009.192
8. El-Dalati S, Cronin D, Riddell IV J, et al. The clinical impact of implementation of a multidisciplinary endocarditis team. Ann Thorac Surg. 2022;113(1):118-124.
9. Carrasco-Chinchilla F, Sánchez-Espín G, Ruiz-Morales J, et al. Influence of a multidisciplinary alert strategy on mortality due to left-sided infective endocarditis. Rev Esp Cardiol (Engl Ed). 2014;67(5):380-386. doi:10.1016/j.rec.2013.09.010
10. Issa N, Dijos M, Greib C, et al. Impact of an endocarditis team in the management of 357 infective endocarditis [abstract]. Open Forum Infect Dis. 2016;3(suppl 1):S201. doi:10.1093/ofid/ofw172.825
11. Kaura A, Byrne J, Fife A, et al. Inception of the ‘endocarditis team’ is associated with improved survival in patients with infective endocarditis who are managed medically: findings from a before-and-after study. Open Heart. 2017;4(2):e000699. doi:10.1136/openhrt-2017-000699
12. Rotter T, Kinsman L, James E, et al. Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst Rev. 2010;(3):Cd006632. doi:10.1002/14651858.CD006632.pub2
13. Neame MT, Chacko J, Surace AE, et al. A systematic review of the effects of implementing clinical pathways supported by health information technologies. J Am Med Inform Assoc. 2019;26(4):356-363. doi:10.1093/jamia/ocy176
14. Trimarchi L, Caruso R, Magon G, et al. Clinical pathways and patient-related outcomes in hospital-based settings: a systematic review and meta-analysis of randomized controlled trials. Acta Biomed. 2021;92(1):e2021093. doi:10.23750/abm.v92i1.10639
15. Gibbons EF, Huang G, Aldea G, et al. A multidisciplinary pathway for the diagnosis and treatment of infectious endocarditis. Crit Pathw Cardiol. 2020;19(4):187-194. doi:10.1097/hpc.0000000000000224
16. Regunath H, Vasudevan A, Vyas K, et al. A quality improvement initiative: developing a multi-disciplinary team for infective endocarditis. Mo Med. 2019;116(4):291-296.
17. Regunath H, Whitt SP. Multidisciplinary service delivery for the endocarditis patient. In: Infective Endocarditis: A Multidisciplinary Approach. 1st ed. Kilic A, ed. Academic Press; 2022.
18. Durack DT, Lukes AS, Bright DK. New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings. Duke Endocarditis Service. Am J Med. 1994;96(3):200-209. doi:10.1016/0002-9343(94)90143-0
19. Tan C, Hansen MS, Cohen G, et al. Case conferences for infective endocarditis: a quality improvement initiative. PLoS One. 2018;13(10):e0205528. doi:10.1371/journal.pone.0205528
20. Ruch Y, Mazzucotelli JP, Lefebvre F, et al. Impact of setting up an “endocarditis team” on the management of infective endocarditis. Open Forum Infect Dis. 2019;6(9):ofz308. doi:10.1093/ofid/ofz308
21. Camou F, Dijos M, Barandon L, et al. Management of infective endocarditis and multidisciplinary approach. Med Mal Infect. 2019;49(1):17-22. doi:10.1016/j.medmal.2018.06.007
22. Pettersson GB, Hussain ST. Current AATS guidelines on surgical treatment of infective endocarditis. Ann Cardiothorac Surg. 2019;8(6):630-644. doi:10.21037/acs.2019.10.05
23. Mestres CA, Paré JC, Miró JM. Organization and functioning of a multidisciplinary team for the diagnosis and treatment of infective endocarditis: a 30-year perspective (1985-2014). Rev Esp Cardiol (Engl Ed). 2015;68(5):363-368. doi:10.1016/j.rec.2014.10.006
24. Stavi V, Brandstaetter E, Sagy I, et al. Comparison of clinical characteristics and prognosis in patients with right- and left-sided infective endocarditis. Rambam Maimonides Med J. 2019;10(1):e00003. doi:10.5041/rmmj.10338
1. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/cir.0000000000000296
2. Federspiel JJ, Stearns SC, Peppercorn AF, et al. Increasing US rates of endocarditis with Staphylococcus aureus: 1999-2008. Arch Intern Med. 2012;172(4):363-365. doi:10.1001/archinternmed.2011.1027
3. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(23):e521-e643. doi:10.1161/cir.0000000000000031
4. Chambers J, Sandoe J, Ray S, et al. The infective endocarditis team: recommendations from an international working group. Heart. 2014;100(7):524-527. doi:10.1136/heartjnl-2013-304354
5. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015;36(44):3075-3128. doi:10.1093/eurheartj/ehv319
6. Chirillo F, Scotton P, Rocco F, et al. Impact of a multidisciplinary management strategy on the outcome of patients with native valve infective endocarditis. Am J Cardiol. 2013;112(8):1171-1176. doi:10.1016/j.amjcard.2013.05.060
7. Botelho-Nevers E, Thuny F, Casalta JP, et al. Dramatic reduction in infective endocarditis-related mortality with a management-based approach. Arch Intern Med. 2009;169(14):1290-1298. doi:10.1001/archinternmed.2009.192
8. El-Dalati S, Cronin D, Riddell IV J, et al. The clinical impact of implementation of a multidisciplinary endocarditis team. Ann Thorac Surg. 2022;113(1):118-124.
9. Carrasco-Chinchilla F, Sánchez-Espín G, Ruiz-Morales J, et al. Influence of a multidisciplinary alert strategy on mortality due to left-sided infective endocarditis. Rev Esp Cardiol (Engl Ed). 2014;67(5):380-386. doi:10.1016/j.rec.2013.09.010
10. Issa N, Dijos M, Greib C, et al. Impact of an endocarditis team in the management of 357 infective endocarditis [abstract]. Open Forum Infect Dis. 2016;3(suppl 1):S201. doi:10.1093/ofid/ofw172.825
11. Kaura A, Byrne J, Fife A, et al. Inception of the ‘endocarditis team’ is associated with improved survival in patients with infective endocarditis who are managed medically: findings from a before-and-after study. Open Heart. 2017;4(2):e000699. doi:10.1136/openhrt-2017-000699
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