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SUNY Downstate Emergency Medicine Doc Charged With $1.5M Fraud
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
FDA Approves First Engineered Cell Therapy for a Solid Tumor
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.
FDA Expands Darzalex Faspro Indication in Myeloma
Approval followed priority review and was based on efficacy and safety findings from the open-label PERSEUS trial involving 709 patients under age 70 years who were randomized to receive bortezomib, lenalidomide, and dexamethasone alone or in combination with daratumumab and hyaluronidase-fihj, according to the FDA.
Compared with bortezomib, lenalidomide, and dexamethasone alone, the addition of daratumumab and hyaluronidase-fihj resulted in a 60% reduction in the risk for disease progression or death (hazard ratio, 0.40). Median progression-free survival was not reached in either group.
Adverse reactions occurring in ≥ 20% of patients were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
The recommended dosage for this indication is 1800 mg daratumumab and 30,000 units hyaluronidase, according to the full prescribing information.
Daratumumab and hyaluronidase-fihj, which was first approved in 2020, has a range of other indications in multiple myeloma.
A version of this article first appeared on Medscape.com.
Approval followed priority review and was based on efficacy and safety findings from the open-label PERSEUS trial involving 709 patients under age 70 years who were randomized to receive bortezomib, lenalidomide, and dexamethasone alone or in combination with daratumumab and hyaluronidase-fihj, according to the FDA.
Compared with bortezomib, lenalidomide, and dexamethasone alone, the addition of daratumumab and hyaluronidase-fihj resulted in a 60% reduction in the risk for disease progression or death (hazard ratio, 0.40). Median progression-free survival was not reached in either group.
Adverse reactions occurring in ≥ 20% of patients were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
The recommended dosage for this indication is 1800 mg daratumumab and 30,000 units hyaluronidase, according to the full prescribing information.
Daratumumab and hyaluronidase-fihj, which was first approved in 2020, has a range of other indications in multiple myeloma.
A version of this article first appeared on Medscape.com.
Approval followed priority review and was based on efficacy and safety findings from the open-label PERSEUS trial involving 709 patients under age 70 years who were randomized to receive bortezomib, lenalidomide, and dexamethasone alone or in combination with daratumumab and hyaluronidase-fihj, according to the FDA.
Compared with bortezomib, lenalidomide, and dexamethasone alone, the addition of daratumumab and hyaluronidase-fihj resulted in a 60% reduction in the risk for disease progression or death (hazard ratio, 0.40). Median progression-free survival was not reached in either group.
Adverse reactions occurring in ≥ 20% of patients were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
The recommended dosage for this indication is 1800 mg daratumumab and 30,000 units hyaluronidase, according to the full prescribing information.
Daratumumab and hyaluronidase-fihj, which was first approved in 2020, has a range of other indications in multiple myeloma.
A version of this article first appeared on Medscape.com.
The Last 30 Days: How Oncologists’ Choices Affect End-of-Life Cancer Care
TOPLINE:
Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.
METHODOLOGY:
- Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
- A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
- Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
- The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
- Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.
TAKEAWAY:
- Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
- Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
- Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
- No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).
IN PRACTICE:
“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.
SOURCE:
The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.
LIMITATIONS:
The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.
METHODOLOGY:
- Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
- A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
- Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
- The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
- Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.
TAKEAWAY:
- Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
- Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
- Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
- No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).
IN PRACTICE:
“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.
SOURCE:
The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.
LIMITATIONS:
The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.
METHODOLOGY:
- Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
- A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
- Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
- The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
- Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.
TAKEAWAY:
- Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
- Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
- Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
- No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).
IN PRACTICE:
“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.
SOURCE:
The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.
LIMITATIONS:
The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Insurers’ Rules and AI for Preauthorization: ‘Ethically Nuts,’ Says Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City.
There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.
I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.
Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. or somebody saying, this is the standard of care and this is what ought to happen.
We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine.
We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.
We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.
If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review?
Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.
Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.
This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.
There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.
This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.
I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.
Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.
A version of this article first appeared on Medscape.com.
Elevate Your Career: AGA Women in GI Regional Workshops Await
As a woman in a dynamic and ever-changing profession, balancing life as a powerhouse physician or scientist is no easy feat. AGA recognizes the challenges you face and is committed to addressing them directly at the AGA Women in GI Regional Workshops. The program has been expanded to six workshops in 2024.
. Participate in candid discussions regarding the challenges you face as a woman navigating the 21st century healthcare environment. Derive inspiration from your community and cultivate meaningful connections that will carry you beyond the workshop.
You may choose to join us in person or virtually, whatever fits into your busy schedule. We are also pleased to offer grants of $300 to support travel and registration fees for trainee and early career women. Additional details for the Maria Leo-Lieber Travel Award may be found in your confirmation email.
Register today for the final three workshops.
Rocky Mountain West
Saturday, Sept. 8
Colorado Springs, Colorado
Deadline to apply for a travel grant: Aug. 23
Deadline to register: Aug. 30
Southwest
Saturday, Sept. 14
Houston, Texas
Deadline to apply for a travel grant: Aug. 30
Deadline to register: Sept. 6
Southeast
Saturday, Nov. 2
Coral Gables, Florida
Deadline to apply for a travel grant: Oct. 8
Deadline to register: Oct. 25
This program is supported by Janssen.
As a woman in a dynamic and ever-changing profession, balancing life as a powerhouse physician or scientist is no easy feat. AGA recognizes the challenges you face and is committed to addressing them directly at the AGA Women in GI Regional Workshops. The program has been expanded to six workshops in 2024.
. Participate in candid discussions regarding the challenges you face as a woman navigating the 21st century healthcare environment. Derive inspiration from your community and cultivate meaningful connections that will carry you beyond the workshop.
You may choose to join us in person or virtually, whatever fits into your busy schedule. We are also pleased to offer grants of $300 to support travel and registration fees for trainee and early career women. Additional details for the Maria Leo-Lieber Travel Award may be found in your confirmation email.
Register today for the final three workshops.
Rocky Mountain West
Saturday, Sept. 8
Colorado Springs, Colorado
Deadline to apply for a travel grant: Aug. 23
Deadline to register: Aug. 30
Southwest
Saturday, Sept. 14
Houston, Texas
Deadline to apply for a travel grant: Aug. 30
Deadline to register: Sept. 6
Southeast
Saturday, Nov. 2
Coral Gables, Florida
Deadline to apply for a travel grant: Oct. 8
Deadline to register: Oct. 25
This program is supported by Janssen.
As a woman in a dynamic and ever-changing profession, balancing life as a powerhouse physician or scientist is no easy feat. AGA recognizes the challenges you face and is committed to addressing them directly at the AGA Women in GI Regional Workshops. The program has been expanded to six workshops in 2024.
. Participate in candid discussions regarding the challenges you face as a woman navigating the 21st century healthcare environment. Derive inspiration from your community and cultivate meaningful connections that will carry you beyond the workshop.
You may choose to join us in person or virtually, whatever fits into your busy schedule. We are also pleased to offer grants of $300 to support travel and registration fees for trainee and early career women. Additional details for the Maria Leo-Lieber Travel Award may be found in your confirmation email.
Register today for the final three workshops.
Rocky Mountain West
Saturday, Sept. 8
Colorado Springs, Colorado
Deadline to apply for a travel grant: Aug. 23
Deadline to register: Aug. 30
Southwest
Saturday, Sept. 14
Houston, Texas
Deadline to apply for a travel grant: Aug. 30
Deadline to register: Sept. 6
Southeast
Saturday, Nov. 2
Coral Gables, Florida
Deadline to apply for a travel grant: Oct. 8
Deadline to register: Oct. 25
This program is supported by Janssen.
How To Navigate Your First Job
In a special episode live from Digestive Disease Week® (DDW) 2024, host Dr. Matthew Whitson talks with returning guest Dr. Janice Jou. Dr. Jou is a transplant hematologist at the Portland VA and currently serves as professor of medicine and fellowship program director at Oregon Health & Science University. Don’t miss her insight as she shares advice all about what she wishes she knew when going into her first job in gastroenterology. Dr. Jou also answers questions from the audience on topics including “when to say no” and the importance of encouraging emotional transparency with fellows and faculty.
Catch up with past episodes and subscribe wherever you listen to podcasts. You can also listen by clicking on the episode name below.
- Episode 5: Janice Jou: Live from #DDW2024 with tips for your first job
- Episode 4: Loren Rabinowitz and Rachel Issaka: Building research collaborations
- Episode 3: Andy Tau: How to treat GI emergencies
- Episode 2: Laurel Fisher and Asma Khapra: Advancing and advocating for women in GI
- Episode 1: Barbara Jung: Unpacking mentorship with AGA’s president
In a special episode live from Digestive Disease Week® (DDW) 2024, host Dr. Matthew Whitson talks with returning guest Dr. Janice Jou. Dr. Jou is a transplant hematologist at the Portland VA and currently serves as professor of medicine and fellowship program director at Oregon Health & Science University. Don’t miss her insight as she shares advice all about what she wishes she knew when going into her first job in gastroenterology. Dr. Jou also answers questions from the audience on topics including “when to say no” and the importance of encouraging emotional transparency with fellows and faculty.
Catch up with past episodes and subscribe wherever you listen to podcasts. You can also listen by clicking on the episode name below.
- Episode 5: Janice Jou: Live from #DDW2024 with tips for your first job
- Episode 4: Loren Rabinowitz and Rachel Issaka: Building research collaborations
- Episode 3: Andy Tau: How to treat GI emergencies
- Episode 2: Laurel Fisher and Asma Khapra: Advancing and advocating for women in GI
- Episode 1: Barbara Jung: Unpacking mentorship with AGA’s president
In a special episode live from Digestive Disease Week® (DDW) 2024, host Dr. Matthew Whitson talks with returning guest Dr. Janice Jou. Dr. Jou is a transplant hematologist at the Portland VA and currently serves as professor of medicine and fellowship program director at Oregon Health & Science University. Don’t miss her insight as she shares advice all about what she wishes she knew when going into her first job in gastroenterology. Dr. Jou also answers questions from the audience on topics including “when to say no” and the importance of encouraging emotional transparency with fellows and faculty.
Catch up with past episodes and subscribe wherever you listen to podcasts. You can also listen by clicking on the episode name below.
- Episode 5: Janice Jou: Live from #DDW2024 with tips for your first job
- Episode 4: Loren Rabinowitz and Rachel Issaka: Building research collaborations
- Episode 3: Andy Tau: How to treat GI emergencies
- Episode 2: Laurel Fisher and Asma Khapra: Advancing and advocating for women in GI
- Episode 1: Barbara Jung: Unpacking mentorship with AGA’s president
FDA Calls AstraZeneca’s NSCLC Trial Design Into Question
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
Retirement Planning for Gastroenterologists
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Navigating as a GI Locum: My Path and Guide to This Alternative Practice Model
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.