Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs

Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs

Malpractice Case: When Payment Should Not Be Part of the Issue

• If a physician doesn’t want to continue treating a patient or performing a procedure because the patient is uninsured or is otherwise unable to pay, the physician should provide sufficient notice to the patient to find another physician; not doing so can amount to abandonment.
• Because of anti-patient-dumping statutes and their “abandonment” corollary, issues about payment for emergency care carry risk.
• Physicians should work with their hospitals on financial arrangements in advance for emergency patients who might be unable to pay for care. Discussions about compensation should take place away from the patient’s care.

The Case

Certainly no one believes that a physician must work for nothing. But if somehow the issue of compensation becomes part of a dispute over a physician’s actions and judgment, the result can be inflammatory.

A 44-year-old man arrived at the emergency room via ambulance following chest pain radiating to the back, plus weakness, paleness, and profuse sweating. Family members reported that the patient smoked a half-pack of cigarettes daily and abused methamphetamine over several years. Also per the family, the patient had a heart attack 12-15 years earlier and two strokes, 16 and 19 years earlier. Dr I, an internist, admitted the patient for telemetry. A CT scan showed extensive aortic dissection from the root to the arch. An angiogram was planned for the next morning.

Dr CS, a cardiothoracic surgeon, saw the patient early in the afternoon of the next day. Dr CS reviewed the CT scan and planned a cardiac catheterization and, depending on the results, an ascending hemiarch replacement with possible right coronary bypass and other grafts.

Dr CS’s consultation expressed concern that the patient’s history of tobacco and methamphetamine use might have damaged the left anterior descending and circumflex arteries. Dr CS estimated an operative mortality of 10%-15%, with the risk of exacerbating the patient’s previous strokes.

After the patient’s catheterization the next morning, the cardiologist reported a markedly dilated aortic root and extensive dissection. The cardiologist noted that he discussed with Dr CS the plan for an aortic root replacement. Nursing entries following the patient’s return to the ICU from the catheterization lab noted: “Waiting for surgeon’s decision on what is to be done next; legs are cold on and off, BP on low side. No urine output, doctors are aware.”

According to the patient’s family, however, Dr CS (whose surgical group had an on-call contract with the hospital) refused to perform the procedure because the patient lacked insurance. The patient remained in the ICU and died in the early afternoon from a ruptured aorta.

The patient’s family sued Dr CS and the hospital for medical malpractice, intentional tort, and violation of the state and federal laws regarding emergency medical treatment. The complaint alleged that despite earlier consulting on the patient’s case, calling for the catheterization, and scheduling surgery, Dr CS withdrew from the patient’s care after improperly inquiring about the patient’s insurance status.

Further, the family’s complaint alleged, because Dr CS failed to provide sufficient notice to find another surgeon, his actions amounted to abandonment. During the workup of the litigation, the plaintiffs obtained supporting testimony from Dr I and an ICU nurse on comments that Dr CS allegedly made in the ICU regarding the patient’s lack of insurance.

In his own deposition, Dr CS testified that though he made specific (unsuccessful) requests to hospital administrators for monetary support for the surgical team needed for the difficult case, he denied telling anyone that he would not perform the surgery. He further testified that had he been told of the patient’s deteriorating condition, his partner could have performed surgery on the patient while Dr CS was in the OR with other scheduled patients.

All parties resolved the dispute without going to trial.

Because of anti-patient-dumping statutes and their “abandonment” corollary, discussions concerning payment for emergency care are fraught with risk. To avoid such peril, physicians should work with their hospitals on financial arrangements long before—and in a setting completely removed from any particular patient care.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. This article was originally titled “When Money Should Not Be Part of the Discussion.”

https://wb.md/2MfMaXs

Europe Stands Pat on Hypertension Guidelines

European blood pressure guidelines will stick with the 140/90 mm Hg diagnostic threshold and instead focus on improving control rates through initial two-drug antihypertensive combinations for most patients.

Topline release of new joint European Society of Cardiology (ESC)/European Society of Hypertension (ESH) blood pressure guidelines at the latter’s annual conference in Barcelona on Saturday is to be followed by full publication at the ESC meeting in August.

“There are many consistencies with the U.S. guideline, but there also is a slightly more conservative approach to the threshold and the target,” Bryan Williams, MD, of University College London and the guideline writing committee chair for the ESC, told MedPage Today.

The 2017 American College of Cardiology (ACC)/American Heart Association (AHA) guidelinerevised the diagnostic thresholds to 130/80 mm Hg for stage 1 hypertension — what the ESC calls high-normal — and 140/90 mm Hg for stage 2, with pharmacologic treatment for stage 2 and high-risk stage 1.

“Their suggestions are reasonable and pragmatic,” commented William White, MD, a past president of the American Society of Hypertension. “There’s been some criticism of the ACC/AHA 2017 guidelines for a couple of reasons — that it was based so much on one study, SPRINT, and that SPRINT’s population was not below [age] 60 in general and all had risk.”

The European guideline writers shied away from “medicalizing” the 130-140 mm Hg systolic group, Williams said.

Rather, “we still strongly believe that the most important objective is to get all our patients who are treated below 140 systolic. That should be the first target. When you have lower targets, people try to get below that number in the worried well. Let’s try to get everyone below 140.”

The ESC/ESH recommendations included a range for pharmacologic treatment aims from under 140 to 130 mm Hg, with consideration of going below 130 mm Hg for those who tolerate it well, but not below 120 mm Hg.

For people over age 65, the target was below 140 to 130 mm Hg, but not any lower.

“That’s a big change, because in the past the target was 150 to 140 in those over 65,” Williams noted. “The blood pressure targets are more aggressive, but we’re talking about mobile, fit, non-frail elderly.” For the frail elderly and those in residential facilities, there’s not much evidence, so clinicians have to use their judgment, he added.

The American College of Physicians and American College of Family Physicians guidelinesfrom 2017 controversially recommended a 150 mm Hg systolic threshold for diagnosis and treatment of average and lower-risk adults age 60 and older.

“The Europeans have a nice kind of medium here,” White noted.

For treatment, the ESC/ESH guideline aimed to cut clinical inertia that contributes to poor control rates.

“One of the objectives was to simplify treatment recommendations, and we’ve done that,” Williams said. “We know what optimal treatment should be for most people. Why don’t we normalize the concept that the patient should be treated with two drugs as initial therapy? Most guidelines get around to saying that, but don’t say it directly enough. Start with two drugs — we’ve made that completely clear.”

While those just above the treatment threshold or the frail elderly would be exceptions, the emphasis for two-antihypertensive combination therapy for most patients was on single pill combinations, if at a cost acceptable to the healthcare system.

White cautioned, though: “But for somebody who is 140/90 I don’t even know that even I would consider starting two drugs, because I think there are a lot of people who demonstrate really substantial reductions with one drug and they would probably get symptomatically low if you started them on two drugs. That is not a one size fits all.”

Other aspects of the European guidelines to be discussed in more detail with the full release in August are an emphasis on statin therapy for many more hypertensive patients than currently receive them, based on their total cardiovascular risk, blood pressure in pregnancy, hypertension emergencies, resistant hypertension, atrial fibrillation, and anticoagulation, and a stronger recommendation for home and ambulatory blood pressure monitoring.

https://bit.ly/2JDBL9F

FDA OKs chemo-free therapy for chronic, relapsed leukemia

The FDA on Friday approved a fixed-duration chemotherapy-free regimen for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients, with or without 17p deletion, the agency announced.

The phase III MURANO trial that led to the approval randomized 389 patients 1:1 to treatment with rituximab (Rituxan) plus either venetoclax (Venclexta) or bendamustine. After a nearly 2-year follow-up, the rate of progression-free survival (PFS) was 84.9% in venetoclax/rituximab compared with 36.3% for bendamustine/rituximab (HR for progression or death 0.17, 95% CI 0.11-0.25, P<0.001).

And the 2-year PFS advantage with the venetoclax combination was seen regardless of chromosome 17p deletion status (with, 81.5% versus 27.8%; without, 85.9% versus 41.0%).

“The approval of the combination of Venclexta plus rituximab for patients with relapsed/refractory CLL or SLL validates the results seen in the phase III trial, including the significant improvement in progression-free survival over a standard of care comparator arm,” said lead MURANO investigator John Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia, in a statement. “Progression-free survival is considered a gold standard for demonstrating clinical benefit in oncology.”

The fixed-duration treatment regimen allows patients to stop treatment after 2 years.

Results of the MURANO trial were presented last year at the American Society of Hematology annual meeting and published earlier this year in the New England Journal of Medicine.

Minimal residual disease (MRD)-negativity was also improved with the venetoclax/rituximab combination. At 9 months, the rate of MRD-negativity was 62.4% versus 13.3% with bendamustine/rituximab, as well as at any point during the trial (83.5% versus 23.1%, respectively).

The rate of complete remissions or complete remissions with incomplete hematologic recovery was 8% in the venetoclax group versus 4% in the bendamustine group.

“What we don’t have is any data on how durable those remissions will be,” said Susan O’Brien, MD, of the University of California, Irvine, in an interview with MedPage Todayprior to the new approval. “But I think there is an expectation based on the high MRD-negativity rate that those will be pretty durable.”

The most common adverse events seen among patients with the venetoclax/rituximab combination were neutropenia, diarrhea, upper respiratory tract infection, cough, fatigue, and nausea.

And with the more serious adverse events of tumor lysis syndrome, there could be barriers to widespread use of venetoclax even in this approved, second-line setting.

“To most people in private practice, venetoclax is not regarded as that user friendly, and it’s not just because they are worried about tumor lysis, it’s because of the monitoring” said O’Brien, who explained that patients need to be followed carefully during treatment to ensure that tumor lysis syndrome doesn’t develop, even in those not at high risk.

LAST UPDATED 06.09.2018

• Primary Source

  The New England Journal of Medicine

  Source Reference: Seymour JF, et al “Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia” N Engl J Med 2018; 378(12): 1107-1120.

https://bit.ly/2Mb6h9z

Biogen late-stage clinical chief heads to Sarepta

Gilmore O’Neill, formerly Biogen’s senior vice president, late-stage clinical development, jumped ship and will be Sarepta Therapeutics’ chief medical officer.

While at Biogen, O’Neill held various leadership roles in Alzheimer’s development, movement disorders, acute neurology, multiple sclerosis, pain, neuromuscular disease, cell therapy and rare diseases. He was involved in the eventual approval for Biogen’s drugs Tecfidera, Zinbryta, Plegridy and Spinraza.

In his new position at Sarepta, he will lead all clinical development, medical affairs, pharmacovigilance, and regulatory affairs.

A physician licensed to practice medicine in Massachusetts, O’Neill previously served as a Harvard Medical School clinical instructor and as chief resident in neurology at the Massachusetts General Hospital. His subspecialty focus was on neuromuscular diseases and inherited leukodystrophies. He received his Bachelor of Medicine from University College Dublin and a Master of Medical Sciences from Harvard University.

He replaced Catherine Stehman-Breen, who joined Sarepta in April 2017. Prior to coming on as chief medical officer, Stehman-Breen had been vice president, clinical development and regulatory affairs at Regeneron Pharmaceuticals since 2015. She is currently Entrepreneur in Residence at Atlas Venture and interim chief medical officer.

“I feel extremely fortunate to welcome Dr. O’Neill to Sarepta and to our executive team as we advance our 21 pipeline programs and build ourselves into one of the most meaningful precision genetic medicine companies in the world,” said Doug Ingram, Sarepta’s president and chief executive officer, in a statement. “Gilmore is uniquely positioned to successfully lead our development strategy. He has deep expertise in neurobiology, genetic medicine and clinical development, having driven some of biotech’s most successful clinical programs. And his proven leadership ability and passion for our mission of changing lives through genetic medicine will be essential as we advance toward our goals with a sense of urgency, creativity and purpose.”

This is just another in a long line of prominent executives leaving Biogen in the last year. In August 2017, Alpna Seth, the head of Biogen’s biosimilars division, left to join former chief executive officer George Scangos at Vir Biotechnology. In June of 2017, Paul Clancy, Biogen’s chief financial officer, left to join Alexion Pharmaceuticals. Earlier in the year, Spyros Arvavanis-Tsakonas, chief scientific officer, shifted to part-time visiting scientist after making a deal with Harvard University. In March 2017, Adriana Karaboutis, executive vice president of technology, business solutions, and corporate affairs, left to become chief information and digital officer of National Grid.

O’Neill’s shift is sure to raise eyebrows given his leadership in Alzheimer’s disease at Biogen. All eyes are on the company’s efforts to move its aducanumab through an ongoing Phase III clinical trial in Alzheimer’s disease. Although the company has a strong presence in multiple sclerosis (MS) and its Spinraza for spinal muscular atrophy (SMA) is growing sales, much of its fortunes are tied to the success or failure of aducanumab.

At the same time, the company appears to be broadening its pipeline for neurology-related diseases. Yesterday Biogen inked an exclusive option deal with Tokyo-based TMS for TMS-007 and backup compounds for acute ischemic stroke (AIS). It also recently expanded an alliance with Ionis Pharmaceuticals to develop RNA-based drugs for brain diseases. And in March, it bought a Phase IIb-ready AMPA receptor potentiator for cognitive impairment associated with schizophrenia from Pfizer.

O’Neill said in a statement, “I was inspired to join the Sarepta leadership team by the quality of Sarepta’s pipeline and the sense of urgency within the company to advance these programs and improve the lives of patients. I’m looking forward to making a fast start, and one of my most pressing priorities will be to meet with and learn from the DMD (Duchenne muscular dystrophy) patient community.”

https://bit.ly/2HyNp0k

Pfizer, AbbVie: Nice yields!

AbbVie (ABBV), Pfizer (PFE), Merck (MRK), Bristol-Myers Squibb (BMY), Johnson & Johnson (JNJ) and Eli Lilly (LLY) sport nice yields, concerns about slow growth notwithstanding, Lawrence Strauss writes in this week’s edition of Barron’s: https://bit.ly/2kZngPt

https://bit.ly/2xTc5Bg