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Why my independent GI practice started a GI fellowship program
In this video Naresh Gunaratnam, MD, discusses the gastroenterology fellowship program that Huron Gastroenterology developed with Trinity Health in Ann Arbor, Mich. Dr. Gunaratnam helped create the program because he and his colleagues felt that traditional fellowship programs don’t always provide information or guidance about non-academic career pathways in gastroenterology. Hear from Dr. Gunaratnam how the fellowship program at Huron Gastroenterology is training fellows to become excellent clinicians who care for patients in the community setting. He has no financial conflicts relative to the topics in this video.
In this video Naresh Gunaratnam, MD, discusses the gastroenterology fellowship program that Huron Gastroenterology developed with Trinity Health in Ann Arbor, Mich. Dr. Gunaratnam helped create the program because he and his colleagues felt that traditional fellowship programs don’t always provide information or guidance about non-academic career pathways in gastroenterology. Hear from Dr. Gunaratnam how the fellowship program at Huron Gastroenterology is training fellows to become excellent clinicians who care for patients in the community setting. He has no financial conflicts relative to the topics in this video.
In this video Naresh Gunaratnam, MD, discusses the gastroenterology fellowship program that Huron Gastroenterology developed with Trinity Health in Ann Arbor, Mich. Dr. Gunaratnam helped create the program because he and his colleagues felt that traditional fellowship programs don’t always provide information or guidance about non-academic career pathways in gastroenterology. Hear from Dr. Gunaratnam how the fellowship program at Huron Gastroenterology is training fellows to become excellent clinicians who care for patients in the community setting. He has no financial conflicts relative to the topics in this video.
Type of insurance linked to length of survival after lung surgery
The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.
Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.
Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.
“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.
A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.
In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).
At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).
“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.
“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.
“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.
The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.
The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.
The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.
The study was performed at a single center and cannot prove causation due to its retrospective nature.
Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.
*This article was updated on 4/13/2023.
The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.
Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.
Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.
“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.
A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.
In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).
At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).
“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.
“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.
“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.
The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.
The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.
The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.
The study was performed at a single center and cannot prove causation due to its retrospective nature.
Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.
*This article was updated on 4/13/2023.
The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.
Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.
Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.
“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.
A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.
In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).
At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).
“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.
“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.
“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.
The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.
The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.
The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.
The study was performed at a single center and cannot prove causation due to its retrospective nature.
Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.
*This article was updated on 4/13/2023.
FROM ELCC 2023
Outpatient costs top drug costs in some insured, working women with breast cancer
Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.
For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.
“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”
The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.
“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”
High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.
“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.
In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.
The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.
“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.
A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.
“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”
“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”
Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”
Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”
Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.
The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.
Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.
For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.
“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”
The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.
“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”
High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.
“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.
In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.
The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.
“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.
A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.
“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”
“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”
Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”
Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”
Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.
The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.
Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.
For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.
“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”
The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.
“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”
High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.
“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.
In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.
The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.
“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.
A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.
“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”
“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”
Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”
Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”
Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.
The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.
FROM JAMA NETWORK OPEN
Reforming prior authorization remains AGA’s top policy priority
Reforming prior authorization polices to reduce red tape for physicians and help patients get the care they need in a timely manner is the AGA’s number one policy priority as it impacts every gastroenterologist regardless of practice setting. We have seen an increase in prior authorization policies from every major insurer. The most recent prior authorization program to impact gastroenterologists was announced by UnitedHealthcare (UHC) in March for implementation on June 1, 2023 and will require prior authorization for most colonoscopy and upper GI endoscopy procedures with the exception of screening colonoscopy.1 This policy is a step back at a time when payers should be developing innovative policies in collaboration with health care providers to improve patient care.
UHC’s GI prior authorization policy
AGA met with UHC in March to discuss their plan to require prior authorization for most GI endoscopy procedures. We stressed how this change will cause care delays for high-risk individuals, deter patients from undergoing medically recommended procedures, exacerbate existing sociodemographic disparities in care and outcomes, and add unnecessary paperwork burden to physicians who have mounting rates of burnout.
Linda Lee, MD, medical director of endoscopy at Brigham and Women’s Hospital, Boston, recently spoke of the impact this policy will have on gastroenterologists and their patients. “We all know that requiring prior authorizations really only leads to more bureaucracy within the insurance company, as well as within each health care provider’s practice, because we need people to fill out these prior authorization forms, waste time trying to get through to their 1-800 number to speak with someone who has no clinical knowledge, then be told we need to speak with someone else who actually does have some medical knowledge about why these procedures are necessary.”
However, Dr. Lee stressed that “most importantly, this will lead to poorer patient care with delays in care as we are struggling to wade through the morass of prior authorization while patients are bleeding, not able to swallow, vomiting, and more while waiting for their insurance company to approve their potentially life-saving procedures.”
We were particularly troubled that UHC announced this policy during Colorectal Cancer Awareness Month, given the need to screen more Americans for colorectal cancer which remains the nation’s number two cancer killer. The UHC program would require a PA on surveillance colonoscopy for those patients who have previously had polyps removed and are at a higher risk for developing colorectal cancer.
“We know that patients with high-risk adenomas or advanced sessile serrated lesions have a higher risk of developing colorectal cancer and timely access to the necessary surveillance colonoscopy is critical,” said David Lieberman, MD, past president of the AGA and chair of the AGA Executive Committee on the Screening Continuum.
AGA plans to meet with UHC again to ask them to reconsider this policy, but we need your advocacy now to tell United how this will impact you and your patients.
How you can help stop UHC’s prior authorization program
Write to UHC: Tell UHC how this policy would impact you and your patients. Contact their CEO using our customizable letter2 that outlines the impact of United’s GI endoscopy prior authorization program on gastroenterologists and their patients available on the AGA Advocacy Action Center.
Use social media: Tag United (@UHC) on Twitter and tell them how this burdensome program will cause delays for high-risk individuals, deter patients from seeking treatment, and exacerbate existing disparities in care, all while saddling physicians with even more paperwork. Once you’ve tweeted, tag your colleagues and encourage them to get involved.
AGA is working to reform prior authorization
The AGA has supported federal legislation that would streamline prior authorization processes in Medicare Advantage (MA), the private insurance plans that contract with the Medicare program, given the explosion of these policies over the past several years. The Improving Seniors Timely Access to Care Act, bipartisan, bicameral legislation, would reduce prior authorization burdens by:
- Establishing an electronic prior authorization (ePA) program and require MA plans to adopt ePA capabilities.
- Requiring the Secretary of Health and Human Services to establish a list of items and services eligible for real-time decisions under an MA ePA program.
- Standardizing and streamlining the prior authorization process for routinely approved items and services.
- Ensuring prior authorization requests are reviewed by qualified medical personnel.
- Increasing transparency around MA prior authorization requirements and their use.
- Protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans.
The Centers for Medicare & Medicaid Services (CMS) has also recognized the impact that prior authorization is having on physician wellness and how it is contributing to physician burnout. The agency recently proposed implementing many of the provisions that are outlined in the legislation, and AGA has expressed our support for moving forward with many of their proposals.
Earlier this year, Shivan Mehta, MD, MPH, met with CMS administrator Chiquita Brooks-LaSure and Surgeon General Vivek Murthy, MD, MBA, to express AGA’s support for prior authorization reform and discussed how it impacts how patients with chronic conditions like inflammatory bowel disease maintain continuity of care. He also stressed how prior authorization further exacerbates health inequities since it creates an additional barrier to care when barriers already exist.
AGA is taking a multi-pronged approach to advocating for prior authorization reform and reducing paperwork through legislative advocacy, regulatory advocacy with the CMS, and payer advocacy. We can’t do this alone. Join our AGA Advocacy Center3 and get involved in our AGA Congressional Advocates Program.4The authors have no conflicts to declare.
References
1. UnitedHealthcare (2023 Mar 01) New requirements for gastroenterology services.
2. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Tell United to Stop New Prior Auth Requirements!
3. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Advocacy & Policy. Get Involved.
4. American Gastroenterological Association (n.d.) AGA Congressional Advocates Program.
Reforming prior authorization polices to reduce red tape for physicians and help patients get the care they need in a timely manner is the AGA’s number one policy priority as it impacts every gastroenterologist regardless of practice setting. We have seen an increase in prior authorization policies from every major insurer. The most recent prior authorization program to impact gastroenterologists was announced by UnitedHealthcare (UHC) in March for implementation on June 1, 2023 and will require prior authorization for most colonoscopy and upper GI endoscopy procedures with the exception of screening colonoscopy.1 This policy is a step back at a time when payers should be developing innovative policies in collaboration with health care providers to improve patient care.
UHC’s GI prior authorization policy
AGA met with UHC in March to discuss their plan to require prior authorization for most GI endoscopy procedures. We stressed how this change will cause care delays for high-risk individuals, deter patients from undergoing medically recommended procedures, exacerbate existing sociodemographic disparities in care and outcomes, and add unnecessary paperwork burden to physicians who have mounting rates of burnout.
Linda Lee, MD, medical director of endoscopy at Brigham and Women’s Hospital, Boston, recently spoke of the impact this policy will have on gastroenterologists and their patients. “We all know that requiring prior authorizations really only leads to more bureaucracy within the insurance company, as well as within each health care provider’s practice, because we need people to fill out these prior authorization forms, waste time trying to get through to their 1-800 number to speak with someone who has no clinical knowledge, then be told we need to speak with someone else who actually does have some medical knowledge about why these procedures are necessary.”
However, Dr. Lee stressed that “most importantly, this will lead to poorer patient care with delays in care as we are struggling to wade through the morass of prior authorization while patients are bleeding, not able to swallow, vomiting, and more while waiting for their insurance company to approve their potentially life-saving procedures.”
We were particularly troubled that UHC announced this policy during Colorectal Cancer Awareness Month, given the need to screen more Americans for colorectal cancer which remains the nation’s number two cancer killer. The UHC program would require a PA on surveillance colonoscopy for those patients who have previously had polyps removed and are at a higher risk for developing colorectal cancer.
“We know that patients with high-risk adenomas or advanced sessile serrated lesions have a higher risk of developing colorectal cancer and timely access to the necessary surveillance colonoscopy is critical,” said David Lieberman, MD, past president of the AGA and chair of the AGA Executive Committee on the Screening Continuum.
AGA plans to meet with UHC again to ask them to reconsider this policy, but we need your advocacy now to tell United how this will impact you and your patients.
How you can help stop UHC’s prior authorization program
Write to UHC: Tell UHC how this policy would impact you and your patients. Contact their CEO using our customizable letter2 that outlines the impact of United’s GI endoscopy prior authorization program on gastroenterologists and their patients available on the AGA Advocacy Action Center.
Use social media: Tag United (@UHC) on Twitter and tell them how this burdensome program will cause delays for high-risk individuals, deter patients from seeking treatment, and exacerbate existing disparities in care, all while saddling physicians with even more paperwork. Once you’ve tweeted, tag your colleagues and encourage them to get involved.
AGA is working to reform prior authorization
The AGA has supported federal legislation that would streamline prior authorization processes in Medicare Advantage (MA), the private insurance plans that contract with the Medicare program, given the explosion of these policies over the past several years. The Improving Seniors Timely Access to Care Act, bipartisan, bicameral legislation, would reduce prior authorization burdens by:
- Establishing an electronic prior authorization (ePA) program and require MA plans to adopt ePA capabilities.
- Requiring the Secretary of Health and Human Services to establish a list of items and services eligible for real-time decisions under an MA ePA program.
- Standardizing and streamlining the prior authorization process for routinely approved items and services.
- Ensuring prior authorization requests are reviewed by qualified medical personnel.
- Increasing transparency around MA prior authorization requirements and their use.
- Protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans.
The Centers for Medicare & Medicaid Services (CMS) has also recognized the impact that prior authorization is having on physician wellness and how it is contributing to physician burnout. The agency recently proposed implementing many of the provisions that are outlined in the legislation, and AGA has expressed our support for moving forward with many of their proposals.
Earlier this year, Shivan Mehta, MD, MPH, met with CMS administrator Chiquita Brooks-LaSure and Surgeon General Vivek Murthy, MD, MBA, to express AGA’s support for prior authorization reform and discussed how it impacts how patients with chronic conditions like inflammatory bowel disease maintain continuity of care. He also stressed how prior authorization further exacerbates health inequities since it creates an additional barrier to care when barriers already exist.
AGA is taking a multi-pronged approach to advocating for prior authorization reform and reducing paperwork through legislative advocacy, regulatory advocacy with the CMS, and payer advocacy. We can’t do this alone. Join our AGA Advocacy Center3 and get involved in our AGA Congressional Advocates Program.4The authors have no conflicts to declare.
References
1. UnitedHealthcare (2023 Mar 01) New requirements for gastroenterology services.
2. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Tell United to Stop New Prior Auth Requirements!
3. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Advocacy & Policy. Get Involved.
4. American Gastroenterological Association (n.d.) AGA Congressional Advocates Program.
Reforming prior authorization polices to reduce red tape for physicians and help patients get the care they need in a timely manner is the AGA’s number one policy priority as it impacts every gastroenterologist regardless of practice setting. We have seen an increase in prior authorization policies from every major insurer. The most recent prior authorization program to impact gastroenterologists was announced by UnitedHealthcare (UHC) in March for implementation on June 1, 2023 and will require prior authorization for most colonoscopy and upper GI endoscopy procedures with the exception of screening colonoscopy.1 This policy is a step back at a time when payers should be developing innovative policies in collaboration with health care providers to improve patient care.
UHC’s GI prior authorization policy
AGA met with UHC in March to discuss their plan to require prior authorization for most GI endoscopy procedures. We stressed how this change will cause care delays for high-risk individuals, deter patients from undergoing medically recommended procedures, exacerbate existing sociodemographic disparities in care and outcomes, and add unnecessary paperwork burden to physicians who have mounting rates of burnout.
Linda Lee, MD, medical director of endoscopy at Brigham and Women’s Hospital, Boston, recently spoke of the impact this policy will have on gastroenterologists and their patients. “We all know that requiring prior authorizations really only leads to more bureaucracy within the insurance company, as well as within each health care provider’s practice, because we need people to fill out these prior authorization forms, waste time trying to get through to their 1-800 number to speak with someone who has no clinical knowledge, then be told we need to speak with someone else who actually does have some medical knowledge about why these procedures are necessary.”
However, Dr. Lee stressed that “most importantly, this will lead to poorer patient care with delays in care as we are struggling to wade through the morass of prior authorization while patients are bleeding, not able to swallow, vomiting, and more while waiting for their insurance company to approve their potentially life-saving procedures.”
We were particularly troubled that UHC announced this policy during Colorectal Cancer Awareness Month, given the need to screen more Americans for colorectal cancer which remains the nation’s number two cancer killer. The UHC program would require a PA on surveillance colonoscopy for those patients who have previously had polyps removed and are at a higher risk for developing colorectal cancer.
“We know that patients with high-risk adenomas or advanced sessile serrated lesions have a higher risk of developing colorectal cancer and timely access to the necessary surveillance colonoscopy is critical,” said David Lieberman, MD, past president of the AGA and chair of the AGA Executive Committee on the Screening Continuum.
AGA plans to meet with UHC again to ask them to reconsider this policy, but we need your advocacy now to tell United how this will impact you and your patients.
How you can help stop UHC’s prior authorization program
Write to UHC: Tell UHC how this policy would impact you and your patients. Contact their CEO using our customizable letter2 that outlines the impact of United’s GI endoscopy prior authorization program on gastroenterologists and their patients available on the AGA Advocacy Action Center.
Use social media: Tag United (@UHC) on Twitter and tell them how this burdensome program will cause delays for high-risk individuals, deter patients from seeking treatment, and exacerbate existing disparities in care, all while saddling physicians with even more paperwork. Once you’ve tweeted, tag your colleagues and encourage them to get involved.
AGA is working to reform prior authorization
The AGA has supported federal legislation that would streamline prior authorization processes in Medicare Advantage (MA), the private insurance plans that contract with the Medicare program, given the explosion of these policies over the past several years. The Improving Seniors Timely Access to Care Act, bipartisan, bicameral legislation, would reduce prior authorization burdens by:
- Establishing an electronic prior authorization (ePA) program and require MA plans to adopt ePA capabilities.
- Requiring the Secretary of Health and Human Services to establish a list of items and services eligible for real-time decisions under an MA ePA program.
- Standardizing and streamlining the prior authorization process for routinely approved items and services.
- Ensuring prior authorization requests are reviewed by qualified medical personnel.
- Increasing transparency around MA prior authorization requirements and their use.
- Protecting beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans.
The Centers for Medicare & Medicaid Services (CMS) has also recognized the impact that prior authorization is having on physician wellness and how it is contributing to physician burnout. The agency recently proposed implementing many of the provisions that are outlined in the legislation, and AGA has expressed our support for moving forward with many of their proposals.
Earlier this year, Shivan Mehta, MD, MPH, met with CMS administrator Chiquita Brooks-LaSure and Surgeon General Vivek Murthy, MD, MBA, to express AGA’s support for prior authorization reform and discussed how it impacts how patients with chronic conditions like inflammatory bowel disease maintain continuity of care. He also stressed how prior authorization further exacerbates health inequities since it creates an additional barrier to care when barriers already exist.
AGA is taking a multi-pronged approach to advocating for prior authorization reform and reducing paperwork through legislative advocacy, regulatory advocacy with the CMS, and payer advocacy. We can’t do this alone. Join our AGA Advocacy Center3 and get involved in our AGA Congressional Advocates Program.4The authors have no conflicts to declare.
References
1. UnitedHealthcare (2023 Mar 01) New requirements for gastroenterology services.
2. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Tell United to Stop New Prior Auth Requirements!
3. American Gastroenterological Association (n.d.) AGA Advocacy Action Center. Advocacy & Policy. Get Involved.
4. American Gastroenterological Association (n.d.) AGA Congressional Advocates Program.
Malpractice risks for docs who oversee NPs or PAs
Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.
Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.
Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.
“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.
In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
Yet more states are removing supervision requirements
With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.
“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”
*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.
In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”
As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.
The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.
The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.
However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.
Court cases in which supervising physician was found liable
There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.
Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.
“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.
A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.
When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.
The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.
Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.
The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.
When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.
The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
Different standards for expert witnesses
In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.
These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.
Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
Supervision pointers from a physician
Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.
Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.
“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
Collaborating with autonomous NPs
Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.
At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”
The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
Conclusion
Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.
Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.
*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.
A version of this article first appeared on Medscape.com.
Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.
Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.
Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.
“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.
In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
Yet more states are removing supervision requirements
With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.
“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”
*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.
In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”
As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.
The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.
The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.
However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.
Court cases in which supervising physician was found liable
There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.
Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.
“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.
A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.
When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.
The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.
Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.
The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.
When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.
The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
Different standards for expert witnesses
In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.
These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.
Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
Supervision pointers from a physician
Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.
Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.
“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
Collaborating with autonomous NPs
Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.
At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”
The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
Conclusion
Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.
Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.
*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.
A version of this article first appeared on Medscape.com.
Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.
Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.
Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.
“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.
In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
Yet more states are removing supervision requirements
With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.
“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”
*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.
In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”
As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.
The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.
The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.
However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.
Court cases in which supervising physician was found liable
There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.
Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.
“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.
A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.
When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.
The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.
Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.
The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.
When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.
The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
Different standards for expert witnesses
In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.
These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.
Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
Supervision pointers from a physician
Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.
Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.
“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
Collaborating with autonomous NPs
Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.
At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”
The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
Conclusion
Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.
Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.
*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.
A version of this article first appeared on Medscape.com.
The end of the telemedicine era?
I started taking care of Jim, a 68-year-old man with metastatic renal cell carcinoma back in the fall of 2018. Jim lived far from our clinic in the rural western Sierra Mountains and had a hard time getting to Santa Monica, but needed ongoing pain and symptom management, as well as follow-up visits with oncology and discussions with our teams about preparing for the end of life.
Luckily for Jim, the Centers for Medicare & Medicaid Services had relaxed the rules around telehealth because of the public health emergency, and we were easily able to provide telemedicine visits throughout the pandemic ensuring that Jim retained access to the care team that had managed his cancer for several years at that point. This would not have been possible without the use of telemedicine – at least not without great effort and expense by Jim to make frequent trips to our Santa Monica clinic.
So, you can imagine my apprehension when I received an email the other day from our billing department, informing billing providers like myself that “telehealth visits are still covered through the end of the year.” While this initially seemed like reassuring news, it immediately begged the question – what happens at the end of the year? What will care look like for patients like Jim who live at a significant distance from their providers?
The end of the COVID-19 public health emergency on May 11 has prompted states to reevaluate the future of telehealth for Medicaid and Medicare recipients. Most states plan to make some telehealth services permanent, particularly in rural areas. While other telehealth services have been extended through Dec. 31, 2024, under the Consolidated Appropriations Act of 2023.
But still, We can now see very ill patients in their own homes without imposing an undue burden on them to come in for yet another office visit. Prior to the public health emergency, our embedded palliative care program would see patients only when they were in the oncology clinic so as to not burden them with having to travel to yet another clinic. This made our palliative providers less efficient since patients were being seen by multiple providers in the same space, which led to some time spent waiting around. It also frequently tied up our clinic exam rooms for long periods of time, delaying care for patients sitting in the waiting room.
Telehealth changed that virtually overnight. With the widespread availability of smartphones and tablets, patients could stay at home and speak more comfortably in their own surroundings – especially about the difficult topics we tend to dig into in palliative care – such as fears, suffering, grief, loss, legacy, regret, trauma, gratitude, dying – without the impersonal, aseptic environment of a clinic. We could visit with their family/caregivers, kids, and their pets. We could tour their living space and see how they were managing from a functional standpoint. We could get to know aspects of our patients’ lives that we’d never have seen in the clinic that could help us understand their goals and values better and help care for them more fully.
The benefit to the institution was also measurable. We could see our patients faster – the time from referral to consult dropped dramatically because patients could be scheduled for next-day virtual visits instead of having to wait for them to come back to an oncology visit. We could do quick symptom-focused visits that prior to telehealth would have been conducted by phone without the ability to perform at the very least an observational physical exam of the patient, which is important when prescribing medications to medically frail populations.
If telemedicine goes, how will it affect outpatient palliative care?
If that goes away, I do not know what will happen to outpatient palliative care. I can tell you we will be much less efficient in terms of when we see patients. There will probably be a higher clinic burden to patients, as well as higher financial toxicity to patients (Parking in the structure attached to my office building is $22 per day). And, what about the uncaptured costs associated with transportation for those whose illness prevents them from driving themselves? This can range from Uber costs to the time cost for a patient’s family member to take off work and arrange for childcare in order to drive the patient to a clinic for a visit.
In February, I received emails from the Drug Enforcement Agency suggesting that they, too, may roll back providers’ ability to prescribe controlled substances to patients who are mainly receiving telehealth services. While I understand and fully support the need to curb inappropriate overprescribing of controlled medications, I am concerned about the unintended consequences to cancer patients who live at a remote distance from their oncologists and palliative care providers. I remain hopeful that DEA will consider a carveout exception for those patients who have cancer, are receiving palliative care services, or are deemed to be at the end of life, much like the chronic opioid guidelines developed by the Centers for Disease Control and Prevention have done.
Telemedicine in essential care
Back to Jim. Using telehealth and electronic prescribing, our oncology and palliative care programs were able to keep Jim comfortable and at home through the end of his life. He did not have to travel 3 hours each way to get care. He did not have to spend money on parking and gas, and his daughter did not have to take days off work and arrange for a babysitter in order to drive him to our clinic. We partnered with a local pharmacy that was willing to special order medications for Jim when his pain became worse and he required a long-acting opioid. We partnered with a local home health company that kept a close eye on Jim and let us know when he seemed to be declining further, prompting discussions about transitioning to hospice.
I’m proud of the fact that our group helped Jim stay in comfortable surroundings and out of the clinic and hospital over the last 6 months of his life, but that would never have happened without the safe and thoughtful use of telehealth by our team.
Ironically, because of a public health emergency, we were able to provide efficient and high-quality palliative care at the right time, to the right person, in the right place, satisfying CMS goals to provide better care for patients and whole populations at lower costs.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I started taking care of Jim, a 68-year-old man with metastatic renal cell carcinoma back in the fall of 2018. Jim lived far from our clinic in the rural western Sierra Mountains and had a hard time getting to Santa Monica, but needed ongoing pain and symptom management, as well as follow-up visits with oncology and discussions with our teams about preparing for the end of life.
Luckily for Jim, the Centers for Medicare & Medicaid Services had relaxed the rules around telehealth because of the public health emergency, and we were easily able to provide telemedicine visits throughout the pandemic ensuring that Jim retained access to the care team that had managed his cancer for several years at that point. This would not have been possible without the use of telemedicine – at least not without great effort and expense by Jim to make frequent trips to our Santa Monica clinic.
So, you can imagine my apprehension when I received an email the other day from our billing department, informing billing providers like myself that “telehealth visits are still covered through the end of the year.” While this initially seemed like reassuring news, it immediately begged the question – what happens at the end of the year? What will care look like for patients like Jim who live at a significant distance from their providers?
The end of the COVID-19 public health emergency on May 11 has prompted states to reevaluate the future of telehealth for Medicaid and Medicare recipients. Most states plan to make some telehealth services permanent, particularly in rural areas. While other telehealth services have been extended through Dec. 31, 2024, under the Consolidated Appropriations Act of 2023.
But still, We can now see very ill patients in their own homes without imposing an undue burden on them to come in for yet another office visit. Prior to the public health emergency, our embedded palliative care program would see patients only when they were in the oncology clinic so as to not burden them with having to travel to yet another clinic. This made our palliative providers less efficient since patients were being seen by multiple providers in the same space, which led to some time spent waiting around. It also frequently tied up our clinic exam rooms for long periods of time, delaying care for patients sitting in the waiting room.
Telehealth changed that virtually overnight. With the widespread availability of smartphones and tablets, patients could stay at home and speak more comfortably in their own surroundings – especially about the difficult topics we tend to dig into in palliative care – such as fears, suffering, grief, loss, legacy, regret, trauma, gratitude, dying – without the impersonal, aseptic environment of a clinic. We could visit with their family/caregivers, kids, and their pets. We could tour their living space and see how they were managing from a functional standpoint. We could get to know aspects of our patients’ lives that we’d never have seen in the clinic that could help us understand their goals and values better and help care for them more fully.
The benefit to the institution was also measurable. We could see our patients faster – the time from referral to consult dropped dramatically because patients could be scheduled for next-day virtual visits instead of having to wait for them to come back to an oncology visit. We could do quick symptom-focused visits that prior to telehealth would have been conducted by phone without the ability to perform at the very least an observational physical exam of the patient, which is important when prescribing medications to medically frail populations.
If telemedicine goes, how will it affect outpatient palliative care?
If that goes away, I do not know what will happen to outpatient palliative care. I can tell you we will be much less efficient in terms of when we see patients. There will probably be a higher clinic burden to patients, as well as higher financial toxicity to patients (Parking in the structure attached to my office building is $22 per day). And, what about the uncaptured costs associated with transportation for those whose illness prevents them from driving themselves? This can range from Uber costs to the time cost for a patient’s family member to take off work and arrange for childcare in order to drive the patient to a clinic for a visit.
In February, I received emails from the Drug Enforcement Agency suggesting that they, too, may roll back providers’ ability to prescribe controlled substances to patients who are mainly receiving telehealth services. While I understand and fully support the need to curb inappropriate overprescribing of controlled medications, I am concerned about the unintended consequences to cancer patients who live at a remote distance from their oncologists and palliative care providers. I remain hopeful that DEA will consider a carveout exception for those patients who have cancer, are receiving palliative care services, or are deemed to be at the end of life, much like the chronic opioid guidelines developed by the Centers for Disease Control and Prevention have done.
Telemedicine in essential care
Back to Jim. Using telehealth and electronic prescribing, our oncology and palliative care programs were able to keep Jim comfortable and at home through the end of his life. He did not have to travel 3 hours each way to get care. He did not have to spend money on parking and gas, and his daughter did not have to take days off work and arrange for a babysitter in order to drive him to our clinic. We partnered with a local pharmacy that was willing to special order medications for Jim when his pain became worse and he required a long-acting opioid. We partnered with a local home health company that kept a close eye on Jim and let us know when he seemed to be declining further, prompting discussions about transitioning to hospice.
I’m proud of the fact that our group helped Jim stay in comfortable surroundings and out of the clinic and hospital over the last 6 months of his life, but that would never have happened without the safe and thoughtful use of telehealth by our team.
Ironically, because of a public health emergency, we were able to provide efficient and high-quality palliative care at the right time, to the right person, in the right place, satisfying CMS goals to provide better care for patients and whole populations at lower costs.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I started taking care of Jim, a 68-year-old man with metastatic renal cell carcinoma back in the fall of 2018. Jim lived far from our clinic in the rural western Sierra Mountains and had a hard time getting to Santa Monica, but needed ongoing pain and symptom management, as well as follow-up visits with oncology and discussions with our teams about preparing for the end of life.
Luckily for Jim, the Centers for Medicare & Medicaid Services had relaxed the rules around telehealth because of the public health emergency, and we were easily able to provide telemedicine visits throughout the pandemic ensuring that Jim retained access to the care team that had managed his cancer for several years at that point. This would not have been possible without the use of telemedicine – at least not without great effort and expense by Jim to make frequent trips to our Santa Monica clinic.
So, you can imagine my apprehension when I received an email the other day from our billing department, informing billing providers like myself that “telehealth visits are still covered through the end of the year.” While this initially seemed like reassuring news, it immediately begged the question – what happens at the end of the year? What will care look like for patients like Jim who live at a significant distance from their providers?
The end of the COVID-19 public health emergency on May 11 has prompted states to reevaluate the future of telehealth for Medicaid and Medicare recipients. Most states plan to make some telehealth services permanent, particularly in rural areas. While other telehealth services have been extended through Dec. 31, 2024, under the Consolidated Appropriations Act of 2023.
But still, We can now see very ill patients in their own homes without imposing an undue burden on them to come in for yet another office visit. Prior to the public health emergency, our embedded palliative care program would see patients only when they were in the oncology clinic so as to not burden them with having to travel to yet another clinic. This made our palliative providers less efficient since patients were being seen by multiple providers in the same space, which led to some time spent waiting around. It also frequently tied up our clinic exam rooms for long periods of time, delaying care for patients sitting in the waiting room.
Telehealth changed that virtually overnight. With the widespread availability of smartphones and tablets, patients could stay at home and speak more comfortably in their own surroundings – especially about the difficult topics we tend to dig into in palliative care – such as fears, suffering, grief, loss, legacy, regret, trauma, gratitude, dying – without the impersonal, aseptic environment of a clinic. We could visit with their family/caregivers, kids, and their pets. We could tour their living space and see how they were managing from a functional standpoint. We could get to know aspects of our patients’ lives that we’d never have seen in the clinic that could help us understand their goals and values better and help care for them more fully.
The benefit to the institution was also measurable. We could see our patients faster – the time from referral to consult dropped dramatically because patients could be scheduled for next-day virtual visits instead of having to wait for them to come back to an oncology visit. We could do quick symptom-focused visits that prior to telehealth would have been conducted by phone without the ability to perform at the very least an observational physical exam of the patient, which is important when prescribing medications to medically frail populations.
If telemedicine goes, how will it affect outpatient palliative care?
If that goes away, I do not know what will happen to outpatient palliative care. I can tell you we will be much less efficient in terms of when we see patients. There will probably be a higher clinic burden to patients, as well as higher financial toxicity to patients (Parking in the structure attached to my office building is $22 per day). And, what about the uncaptured costs associated with transportation for those whose illness prevents them from driving themselves? This can range from Uber costs to the time cost for a patient’s family member to take off work and arrange for childcare in order to drive the patient to a clinic for a visit.
In February, I received emails from the Drug Enforcement Agency suggesting that they, too, may roll back providers’ ability to prescribe controlled substances to patients who are mainly receiving telehealth services. While I understand and fully support the need to curb inappropriate overprescribing of controlled medications, I am concerned about the unintended consequences to cancer patients who live at a remote distance from their oncologists and palliative care providers. I remain hopeful that DEA will consider a carveout exception for those patients who have cancer, are receiving palliative care services, or are deemed to be at the end of life, much like the chronic opioid guidelines developed by the Centers for Disease Control and Prevention have done.
Telemedicine in essential care
Back to Jim. Using telehealth and electronic prescribing, our oncology and palliative care programs were able to keep Jim comfortable and at home through the end of his life. He did not have to travel 3 hours each way to get care. He did not have to spend money on parking and gas, and his daughter did not have to take days off work and arrange for a babysitter in order to drive him to our clinic. We partnered with a local pharmacy that was willing to special order medications for Jim when his pain became worse and he required a long-acting opioid. We partnered with a local home health company that kept a close eye on Jim and let us know when he seemed to be declining further, prompting discussions about transitioning to hospice.
I’m proud of the fact that our group helped Jim stay in comfortable surroundings and out of the clinic and hospital over the last 6 months of his life, but that would never have happened without the safe and thoughtful use of telehealth by our team.
Ironically, because of a public health emergency, we were able to provide efficient and high-quality palliative care at the right time, to the right person, in the right place, satisfying CMS goals to provide better care for patients and whole populations at lower costs.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
Meet the JCOM Author with Dr. Barkoudah: A Multidisciplinary Team–Based Clinical Care Pathway for Infective Endocarditis
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.
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.