May 2024
Comorbidities
Table of Contents


About Our Issue
The human body is a complex network of intertwined systems—and this is what makes the art of diagnoses so difficult. A diagnosis is never made in a vacuum. Other health factors will always have an impact on the presentation, the treatment, and the results.
Comorbidities, defined as ongoing health conditions secondary to the primary diagnosis, will dramatically alter the possible treatment plans and likelihood of a successful outcome of medical procedures. Medication interactions, the risk of additional symptoms, limitations in treatment options, and the like must all be managed. And, as the frequency of chronic conditions increases—heart disease, diabetes, chronic pain, lung diseases, kidney failure, and so on—the need to balance these conditions while managing the diagnosis at hand has become the routine.
As chronic conditions stress public health and the healthcare system, there is a trickledown effect on the medical liability industry. An increase in poor outcomes increases the risk of patients filing a claim. New prescribing trends add to liability risk, which could fuel widespread litigation trends. The increased number of patients managing long-term health issues puts additional pressure on healthcare systems—pushing an already stressed system to a potential breaking point where mistakes are much more likely.
For our issue this month, we have selected key areas where the increased prevalence of comorbidities is impacting the liability environment. Throughout the issue we have selected case studies where an underlying health issue played a significant role in the outcome of a malpractice case—as well as risk management concerns surrounding health trends responding to the comorbidity crisis. We hope this will provide talking points as you meet with your clients.
Our regional teams are available to present case studies, claims trends, and other materials in your meetings, if you would find them useful. Please reach out to your Business Development or Underwriting representatives at any time for assistance.

Off-label Prescribing and Risk Considerations
There are significant concerns over prescribing practices for certain medications containing the active ingredient semaglutide. Classified as a glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide mimics the actions of GLP-1 hormones in the gastrointestinal tract, stimulating insulin production and reducing blood glucose levels. The FDA has approved products like Ozempic, an injectable semaglutide, for managing type 2 diabetes. Also approved is Wegovy, a high-dose semaglutide for weight loss and the treatment of obesity and other weight-related medical conditions in adults and adolescents.
A surge in the demand for expensive weight-loss drugs has led to many physicians prescribing antidiabetic medications off-label, including Ozempic, Mounjaro, and Rybelsus. These options, unlike Wegovy, are covered by insurance and are generally more easily obtainable. While potentially effective for weight loss and other conditions associated with type 2 diabetes, they are not explicitly approved by the FDA for these indications. The accelerated frequency of these off-label prescribing practices has perpetuated a shortage in the supply of drugs needed to treat diabetic patients. Subsequently, health insurance companies facing the elevated push for pricy medications are becoming stricter about coverage.
Questions linger over the ethical and legal challenges surrounding these and other drugs potentially prescribed off-label. There have, for example, been reports of adverse health effects from the compounding of semaglutide, as well as a lack of FDA review, primarily when compounders use salt forms like semaglutide sodium and semaglutide acetate. The FDA does issue a boxed warning for Ozempic in particular, for possible side effects that include thyroid tumors and thyroid cancer among others. The FDA has also issued warnings about counterfeit semaglutide drugs sold online, including fake Ozempic, urging patients to obtain prescriptions from licensed U.S. pharmacies to ensure medication safety and efficacy. Also of relevance in conversations about public health and patient well-being is the assertion that clinical research and patient-specific factors are critical in helping to determine the appropriateness of drugs like Ozempic for treatment. Off-label prescribing raises additional concerns regarding medication access, patient prioritization, and patient education and informed consent. Provider responsibility and government oversight are also important factors to consider. An understanding of these and other issues outlined below may help inform risk management strategies that effectively reduce the incidence of medication and treatment-related claims.
- Scientific Evidence: Physicians should evaluate available scientific research to determine the safety and efficacy of using semaglutide off-label for a particular indication. This evaluation involves reviewing clinical studies, case reports, and expert opinions to assess the potential benefits and risks.
- Patient-Specific Factors: Healthcare providers should consider various patient-related factors when considering off-label use, including the patient's age, medical history, current medications, allergies, and overall health status. These elements can influence the appropriateness and potential outcomes of off-label semaglutide use.
- Informed Consent: Obtaining informed consent from patients is essential when prescribing medications off-label. Physicians must discuss the rationale for using semaglutide off-label, as well as any potential benefits, risks, and alternatives, allowing patients to make well-informed decisions about their treatment.
- Professional Guidelines: Physicians should consider professional organization guidelines and consensus statements related to off-label use when making prescribing decisions. These guidelines provide valuable insights into the current standards of care and best practices for using medications off-label.
- Monitoring and Follow-Up: Close monitoring and regular follow-up are necessary when patients are prescribed semaglutide off-label. Healthcare providers should schedule follow-up appointments to assess the patient's response to treatment, check for adverse effects, and adjust the treatment plan as needed.
Physicians must ensure that their prescribing practices adhere to ethical principles such as beneficence, non-maleficence, and patient autonomy. Additionally, healthcare providers should be aware of any legal and regulatory implications of off-label use. Off-label prescribing raises various ethical and legal considerations for healthcare providers:
- Limited Access to Medication: The shortage of Ozempic due to its off-label use for weight loss potentially limits access to this medication for individuals with diabetes who rely on it for their treatment. This raises concerns about limited access to healthcare and whether the off-label use of Ozempic disadvantages patients with diabetes.
- Patient Prioritization: Healthcare providers may face ethical dilemmas in prioritizing patients for treatment with Ozempic, particularly when demand exceeds supply. Decisions regarding who receives the medication may raise concerns about fairness, justice, and prioritizing certain health conditions over others.
- Informed Consent and Patient Education: Patients prescribed Ozempic for weight loss should receive comprehensive information about the medication, including its off-label use, potential benefits, risks, and alternatives. Helping patients make informed decisions about their treatment is essential to upholding autonomy and patient-centered care principles.
- Professional Responsibility: Healthcare providers prescribing Ozempic off-label for weight loss must consider their professional responsibility to ensure patient safety and well-being. This includes carefully assessing patients' medical histories, monitoring for adverse effects, and making evidence-based decisions in the patient's best interest.
- Public Health Implications: Shortages of medications like Ozempic can have broader public health implications, particularly for individuals with diabetes whose management relies on this medication. Safety and legal concerns also arise when drug shortages result in black markets and illegal attainment of these drugs without a prescription. Healthcare systems may need to develop strategies to mitigate the impact of shortages and ensure continuity of care for affected patients.
- Regulatory Oversight: Regulatory agencies such as the FDA play a role in overseeing the use of medications, including off-label use. Ethical questions may arise about regulatory oversight of off-label prescribing practices and the balance between promoting innovation and ensuring patient safety.
Addressing these ethical considerations requires collaboration among healthcare providers, regulatory agencies, and policymakers to develop strategies that promote fair access to medications, prioritize patient safety, and uphold principles of ethical healthcare practice.
Off-label use of semaglutide can offer potential benefits for patients in certain clinical scenarios, but it also requires careful consideration and evaluation by healthcare providers. Adherence to these risk reduction strategies can help providers navigate the complexities of off-label semaglutide use, mitigate potential risks, and help ensure patient safety and well-being:
- Comprehensive Patient Evaluation: Conduct a thorough assessment to determine the appropriateness of off-label semaglutide use based on scientific evidence and patient-specific factors.
- Informed Consent: Discuss the rationale, potential benefits, and risks of off-label semaglutide use with patients, obtaining written consent to help ensure understanding and consent to the treatment.
- Professional Guidelines Adherence: Consider professional organization guidelines and consensus statements when prescribing off-label medications, ensuring adherence to national standards of care.
- Regular Monitoring and Follow-up: Schedule regular follow-up appointments to monitor patient response, effectiveness, and adverse effects of off-label semaglutide use, adjusting treatment plans as necessary.
- Reporting Adverse Events: Promptly report any adverse events or quality issues related to semaglutide or off-label use to FDA's MedWatch adverse event reporting program to ensure patient safety and regulatory compliance.
- Alabama Administrative Code 610-X-5-.12: “Prescriptions and Medication Orders by Certified Registered Nurse Practitioners,” https://casetext.com/regulation/alabama-administrative-code/title-610-alabama-board-of-nursing/chapter-610-x-5-advanced-practice-nursing-collaborative-practice/section-610-x-5-12-prescriptions-and-medication-orders-by-certified-registered-nurse-practitioners.
- Alabama Board of Medical Examiners & Medical Licensure Commission, “Concerns with Semaglutide and Other GLP-1 Receptor Agonists,” https://www.albme.gov/press-release/concerns-with-semaglutide-and-other-glp-1-receptor-agonists.
- “Ensuring Equitable Access to Affordable Prescription Medications,” American Public Health Association (APHA), https://www.apha.org/Policies-and-Advocacy/Public-Health-Policy-Statements/Policy-Database/2023/01/18/Affordable-Prescription-Medications
- Kate Delaney Chen. Understanding the Risks of Off-Label Use of Ozempic: What You Should Know. Selah House, https://www.selahhouse.com/resources/understanding-the-risks-of-off-label-use-of-ozempic/.
- Katrina Furey and Kirsten Wilkins, “Prescribing ‘Off-Label’: What Should a Physician Disclose?,” AMA Journal of Ethics 18, no. 6 (June 2016): 587-593, https://journalofethics.ama-assn.org/article/prescribing-label-what-should-physician-disclose/2016-06.
- “FDA Drug Shortages: Semaglutide (Ozempic) Injection,” U.S. Food & Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Semaglutide%20(Ozempic)%20Injection&st=c.
- Zain Mithani, “Informed Consent for Off-Label Use of Prescription Medications,” AMA Journal of Ethics 14, no. 7 (July 2012): 576-581, https://journalofethics.ama-assn.org/article/informed-consent-label-use-prescription-medications/2012-07.

Comorbidities Relating to Podiatry
Introduction
Diabetes, particularly type 2 diabetes, comes accompanied by a host of comorbidities that directly impact the type and effectiveness of care required in treating the lower extremity, specifically the foot and ankle. Podiatrists are trained in the recognition of these comorbidities as well as their influence in outcomes of treatment. We will examine prevalent comorbidities and relate them to the anatomical considerations of foot and ankle pathology and where issues in successful treatment can possibly arise.
Diabetes is essentially a systemic abnormality of insulin regulation or the body’s ability to process sugar correctly. This irregularity leads to many other organ issues that can then manifest in the lower extremity. In effect, the lower extremity mirrors systemic disease. The patient complaints and condition that can appear in a podiatrist’s office can be related to conditions that affect their whole body. The most common comorbidities related to diabetes that intersect with podiatric medicine and patient care are obesity, heart disease, cerebrovascular disease, peripheral arterial disease, kidney disease, neuropathy, retinopathy, immune system compromise, and mental health issues.
How do each of these comorbidities affect foot and ankle pathology in a holistic sense?
Obesity decreases balance and agility, and generally makes mobility more difficult and falls more frequent. Heart disease leads to shortness of breath, mobility issues, and circulatory problems. Cerebrovascular disease is directly linked to heart disease and stroke risk. Patients who suffer strokes most commonly live with restricted ambulation and spasticity that make formerly simple tasks such as inspecting one’s feet very difficult, if not impossible. Peripheral arterial disease is intimately linked to heart disease and presents complications such as slow or nonhealing wounds in the foot and ankle that in a patient with normal circulation would not be problematic. Kidney disease is a consequence of compromised circulation; and specific to foot and ankle pathology, it presents issues such as the ability of the body to correctly process adequate dosages of antibiotics and effectively resolve infections of the foot.
Diabetic peripheral neuropathy is perhaps the most common of the comorbidities that affect the foot and ankle: Neuropathy eliminates or dampens our response to painful stimuli. Therefore, what might normally be a painful blister or stepping on a nail may go unrecognized until a wound becomes infected and requires urgent treatment. Retinopathy affects vision and increases fall risks as well as complicates the ability of an individual to do daily foot inspections. This act, in a preventative sense, helps anticipate and avoid situations that could cause foot or ankle injury. Compromised immune systems in diabetic patients makes fighting and resolving infections much more challenging than in nondiabetic patients. This can lead to longer hospitalizations and more disruption in daily life due to wound care and dressing changes required as well as increased visits to doctors. It should come as no surprise that patients with diabetes that also suffer from any or multiple comorbidities have a higher prevalence of mental health issues such as depression and anxiety. It is challenging and disheartening to have a foot and ankle condition that can be complicated and lead to lengthy and protracted care due to the associated comorbidities.
Case Study
A modified case example will illustrate just how the comorbidities of diabetes create challenging management issues for patients and podiatrists alike.
A typical case involves a patient with an ingrown nail with cellulitis. The nail needed to be removed so that her infection would not worsen and risk osteomyelitis (bone infection), sepsis, amputation of the toe, or amputation of the leg below or above the knee. The podiatrist removed the nail and yet the patient went on to develop an infection that was treated by other care providers in the hospital environment. Due to peripheral arterial disease, the patient had previously had a popliteal bypass graft that subsequently occluded leaving her with little to no blood flow below the knee, which later caused the patient to undergo an above-knee amputation. Prior to the podiatrist’s treatment, this patient suffered two cerebral vascular incidents (strokes) which caused left-sided weakness, further complicating daily mobility as she required a walker for ambulation. This severely reduced mobility made even routine care of the feet and nails challenging. The patient also had kidney disease which required monitoring and adjustments to antibiotic dosages during the treatment of the ingrown toenail infection as well as required consultation with an infectious disease specialist. Due to the patient’s history of coronary artery disease, she had previously undergone a CABG (coronary artery bypass graft) procedure, numerous cardiac catheterizations, and angiograms and was very deconditioned and unhealthy with a poor quality of life in general. In addition, she suffered from depression and mental health challenges that complicated her ability and desire to comply with recommended care throughout the entire treatment process.
Conclusion
Diabetes and its related comorbidities create important and challenging patient care and management considerations for podiatrists and all health professionals. Comprehensive medical education of these issues by practitioners and proactive patient and family education by all health professionals can assist in mitigating these issues. This awareness helps reliably ensure that most patient complaints that generate a visit to a podiatrist can be effectively resolved within a multidisciplinary team approach. The primary foot and ankle pathology as the presenting complaint with the backdrop of diabetes as a systemic multiorgan condition and the associated comorbidities, require a comprehensive knowledge and appreciation of all factors in achieving successful patient outcomes.

Comorbidities and Anesthesia Risk
There are a variety of perioperative concerns for patients with pre-existing conditions and comorbidities. Risk factors that increase the likelihood of surgical complications and mortality may include the patient’s underlying health problems. For more than 60 years, the American Society of Anesthesiologists (ASA) has used a Physical Status Classification System to determine the health of a person before a surgical procedure that requires anesthesia. The purpose of the system is to assess and communicate a patient’s pre-anesthesia medical comorbidities to help predict perioperative risks and surgical complications.
Assigning a physical status classification level is a clinical decision based on multiple factors. While the classification may initially be determined during the pre-operative assessment of the patient, the final physical status classification is made on the day of surgery by the anesthesiologist after evaluating the patient.
ASA classification uses a grading system of one (I) through five (V), with I identifying a person in good health and V as a person with a severe, life-threatening condition. The sixth (VI) status identifies deceased organ donors. The ASA provides adult, pediatric, and obstetric examples in each grade.
According to a study in the journal Critical Care Medicine, investigating the relationship between anesthetic care and complications has been historically difficult. Anesthesia complications including death may occur due to the administration of an excessive amount of anesthesia or the wrong medication. The researchers analyzed the association of patient comorbidities and anesthesia-related complications and found that a patient’s coexisting medical conditions may also contribute to anesthesia complications and may impact the outcome of surgery.
The comorbidities associated with a significant increase in mortality due to overdose or wrong anesthetic substance included:
- Peripheral vascular disease (43% increase)
- Coagulopathy (13% increase)
- Congestive heart failure (11% increase)
- Electrolyte and fluid disorders (2% increase)
The comorbidities associated with a significant increase in length of hospital stay included:
- Metastatic cancer (14.5 days)
- Valvular disease (3.9 days)
- Congestive heart failure (3.71 days)
- Renal failure (3.15 days)
- Coagulopathy (2.09 days)
According to the study, certain medical and physical conditions of patients appear to predispose them to increased risk for complications. The authors suggest focusing on the subset of patients who appear to be at greatest risk prior to their arrival to the operating room, especially those with the pre-existing conditions listed above.
There is similar concern within ambulatory surgical centers, where maintaining safety and good outcomes in high-risk patients for ambulatory surgery can be difficult. To remain competitive and economically viable, the modern ambulatory surgical center needs to expand its practice to include patients with medical comorbidities, according to research published in the journal Ambulatory Anesthesia. “Advances in medical science now allow people with significant medical issues to live at home,” write the authors. “As the outpatient population ages and surgical techniques advance, the ambulatory anesthesiologist has to be prepared to handle these ‘walking wounded.’”
Claims Case Review
The December 2023 issue of Claims Rx, “Ambulatory Anesthesia Care: Strategies to Mitigate Risk and Improve Patient Safety,” provides risk management considerations and guidelines to aid clinicians in assessing gaps in their practice and implementing strategies to improve patient safety when providing ambulatory anesthesia care.
Liability risks related to the anesthesia specialty may be better understood by examining closed claim trends from the MPL Association Data Sharing Project, a national medical liability claims database. Trends were published in their 2022 MPL Specialty Snapshot—Surgical Edition, which analyzed 889 anesthesia claims and lawsuits closed between 2017 and 2019. Notably, this revealed that anesthesia claims resulted in an average indemnity payment higher than the average indemnity payment for all specialties. Cardiac arrest was the most common and costly patient outcome associated with these claims, and 26% of all anesthesia claim incidents involved a patient death.
This data emphasizes the importance of both anesthesia emergency prevention and response to reduce liability risk and improve patient safety. While anesthesia emergencies can be difficult to manage regardless of the care setting, the case examples in this article highlight additional challenges and considerations unique to the delivery of ambulatory anesthesia care.
Risk Reduction Strategies
One of the first steps in risk reduction is to obtain and document an appropriate history and physical exam prior to the initiation of treatment. Does the patient have other conditions that need to be co-managed with other specialists? Does the patient have risk factors for a potential complication? Is a patient’s hypertension or diabetes under control? Do not just take the patient’s word that all is well. Consider obtaining copies of the patient’s lab work and other physician’s patient records.
A well-thought-out pre-operative evaluation and patient selection process ensures a better understanding of a patient’s overall health status, which is vital to properly assess ambulatory surgery candidacy. Policies and procedures supporting these processes and thorough documentation throughout the delivery of anesthesia care strengthen the defensibility of claims and help improve patient safety.
Consider the following risk reduction strategies to support pre-operative anesthesia processes in the ambulatory setting.
- Develop policies and procedures that define patient selection criteria protocols.
- Ensure consistency in the approach to determining readiness for surgery.
- Determine exclusionary criteria or contraindications requiring referral to the inpatient surgical setting.
- Avoid making exceptions to policies and procedures regardless of a patient’s desire to accept additional risks that may apply to their unique medical history.
- Ensure that there is a well-documented pre-anesthesia evaluation performed or verified by an anesthesiologist within 30 days of surgery.
- On health questionnaires, inquire about medical conditions that may increase risk of complications and, if sections are left blank, do not assume a negative response.
- Ensure that pre-operative testing and medical clearances are ordered, obtained, and reviewed prior to the day of surgery.
- If there are any changes in the patient’s pre-operative medical history or there are unexpected physical exam findings on the day of surgery, postpone the procedure.
More than half of anesthesiologists report being named in a lawsuit at least once in their career and the specialty continues to have one of the highest malpractice premiums, according to the Medscape Anesthesiologist Malpractice Report 2021. Across all specialties, anesthesiologists paid some of the highest malpractice premiums.

Potential Complications in Diagnosis and Treatment in Patients with Comorbidities
From the healthcare professional’s perspective, the simple definition of a comorbidity is a medical condition that exists alongside a primary diagnosis, or morbidity. A patient may have kidney disease as a primary diagnosis, with comorbidities of high blood pressure and type 2 diabetes, for example. A study of adult inpatients at U.S. hospitals in 2019 found that over 84% of hospital stays involved patients with one or more comorbidities, with 50% of this group having at least three.
A physician must acknowledge all conditions when evaluating a patient and consider the ways diseases might interact to impact patient health and guide diagnosis, treatment, and care management. A consideration of the broader implications of comorbidities on public health and research, including epidemiology is also warranted in the pursuit of better quality care and health services.
The following cases demonstrate complications associated with patient comorbidities and how they might impact a patient’s clinical course, including physician impressions and diagnoses, treatment decisions and outcomes.*
This case represents a projection error and failure to account for patient comorbidities in anesthesia planning. One might consider how the outcome may have been different if the anesthesiologist had strategies in place to handle adverse impacts associated with these comorbidities. Of note, among the four most common “associated” or secondary issues stated in claims against anesthesiologists is patients with comorbid conditions (11%, based on claims data gathered in 2020).
Allegations: A patient was prematurely extubated, and her hypoxia/anoxia was not recognized in a timely manner, which resulted in her death.
A 40-year-old morbidly obese woman with hypertension, asthma, and obstructive sleep apnea (OSA) was referred to an orthopedic surgeon because of shoulder pain. Prior to surgery, the patient received midazolam 4 mg, fentanyl 250 mcg, and an interscalene block. General anesthesia was then induced with propofol. Rocuronium was used for muscle relaxation. The surgery was uncomplicated, and no respiratory issues were noted. Following surgery, the muscle relaxation was reversed, and the patient was transferred from the surgical table to a gurney. The anesthesiologist extubated the patient after he verified she was awake and breathing adequately through the ETT. A supplemental oxygen mask was placed following extubation, and the anesthesiologist observed spontaneous breathing, with normal oxygen saturation and ETCO. The patient was then detached from the monitors so she could be moved to the post-anesthesia care unit (PACU). Four minutes later, the anesthesiologist noticed the patient was not steaming her mask from breathing. He started bag ventilation. No pulse or heartbeat could be found. A code was called, but the patient could not be resuscitated. The patient’s family filed a wrongful death lawsuit against the anesthesiologist, surgeon, and hospital, contending the patient was prematurely extubated and her hypoxia/anoxia was not recognized in a timely manner.
Discussion: According to experts, the patient presented a classic risk profile for post-anesthesia respiratory arrest and hypoxia—she was morbidly obese; had a history of OSA, a thick neck, and an otherwise difficult airway; and had received an interscalene block and was heavily sedated. Experts also believed the anesthesiologist should have anticipated that the patient’s obesity and hypertension would significantly decrease the effectiveness of cardiopulmonary resuscitation (CPR) and bag ventilation.
The anesthesiologist’s first projection error involved his anesthesia plan. Nothing in the anesthesiologist’s documentation indicated he adjusted the course of the patient’s anesthesia or otherwise took her increased risk of respiratory arrest into consideration when planning the anesthesia. With an interscalene block, paralysis of the phrenic nerve secondary to local anesthetic administration can be an expected consequence leading to hemiparalysis of the diaphragm. Assuming the patient’s respiratory capacity was already compromised because of her obesity, asthma, and OSA, experts questioned the administration of 4 mg of midazolam (a benzodiazepine), 250 mcg of fentanyl (an opioid), and the interscalene block. The combination of neuromuscular-blocking drugs, anesthetics, and opioids most likely significantly reduced the patient’s respiratory drive, muscle strength, and airway patency. Furthermore, considering the administration of multiple depressive agents, experts believed continuous pulse oximetry was warranted postoperatively, and failure to do so was a breach of the standard of care. Anticipating a worst-case scenario could have prevented the outcome.
Immediate extubation following surgery was also a projection error. Respiratory problems may not occur immediately after extubation. Experts believed that because of her risk factors and the medications, the patient should have been intubated for a longer period of time. They pointed out that the anesthesiologist could have weaned the patient off the ventilator in the PACU, when it could be assured that she was awake and able to breathe independently.
In this example, multiple comorbidities including a history of hypertension, obesity, and anxiety, along with medication noncompliance, impacted the patient’s clinical course, including the physician’s impressions, diagnosis, and treatment decisions.
Allegations: Failure to investigate symptoms of acute coronary syndrome, perform an EKG, and refer to the ER resulted in a patient’s death five days after office visit.
A 51-year-old male with a history of hypertension, high cholesterol, obesity, and smoking visited a primary care physician in November 2012 for the first time in several years. He had an elevated BP of 142/108, and labs revealed high LDL cholesterol of 168. The physician discussed with him the risks of hypertension as well as the importance of lifestyle changes. She requested he follow up in one to four weeks, but the patient did not.
An EKG three weeks later identified a probable old anterior infarction and ischemic ST-T changes in the lateral leads, prompting the physician to order a stress test. The patient did not obtain a stress test but did follow up through several appointments over the next six years. The same physician ordered simvastatin, HCTZ, lisinopril, amlodipine, Norvasc, and other medications over this course and recommended diet and exercise for the patient. However, the patient was not compliant with BP medications. The physician assessed a hypertensive crisis at three of these appointments in 2013 and 2014. In October 2014, she assessed sinus bradycardia on the patient’s EKG printout but no active disease on a cardiology EKG overread, which was unchanged since 2012. On another visit in 2015 the patient again had an elevated BP of 161/110 and reported he had not taken BP medications for several months. In October 2017, his BP was 160/90, and the physician again warned him of the dangers of untreated hypertension.
At his last appointment in November 2018, the patient reported a two-week history of chest tightness, palpitations, shortness of breath, anxiety (related to his work and his son), and sleep disturbances. He had not taken his BP medication for two weeks and denied chest pain, cough, weakness, or night sweats. The physician assessed uncontrolled essential hypertension due to medication noncompliance and recommended a low-salt diet and exercise. She discussed anxiety with the patient and gave him information sheets on both anxiety and hypertension. She told him to return for his annual exam a little over a month later. She told him to return in one week or visit the ER if his symptoms worsened, though this was not documented. The physician prescribed him Zoloft 25 mg as well as chlorthalidone and metoprolol, and the pharmacy filled his medications the same day. Five days later the patient’s son found the patient dead on the couch in his home.
An autopsy was performed, and the medical examiner assessed cause of death to be acute coronary thrombosis due to hypertensive and arteriosclerotic cardiovascular disease, with obesity and COPD as contributing causes. The deceased had 80% stenosis of the LCA and LAD, and 70% stenosis of the RCA, with a thrombus occluding the lumen of the RCA. There was also emphysema of the pleural surfaces and red-purple pulmonary parenchyma with emphysema. Pulmonary arteries showed suggested emboli in multiple vessels. The deceased’s physician certified the death certificate, noting the patient died of natural causes, with a primary diagnosis of hypertension.
Opinions from experts were mixed. Both Plaintiff and Defense witnesses stated the patient did have multiple cardiac risk factors, including chest tightness, hypertension, obesity, COPD, hyperlipidemia, and smoking. There was agreement about the patient’s medication noncompliance and his physician’s repeated counseling to him about the importance of BP medication compliance and lifestyle changes. There was also some concurrence about the physician not collecting a thorough history of the patient, as well as some debate over the patient’s chest symptoms (whether they should be considered as pain or tightness, typical or atypical).
Plaintiff experts agreed on the emergent nature of the patient’s condition and the necessity of obtaining an EKG or of sending the patient to the ER. One physician asserted that the physician failed to equate the patient’s chest tightness with chest pain in an obese patient with uncontrolled BP on his final appointment in 2018. He asserted failure to follow up on abnormal EKGs from 2012 and 2014, and that the physician should have performed an EKG or sent the patient to the ER for EKG and troponins at that visit. The witness stated the patient’s chest tightness should have been viewed in consideration with the patient’s comorbid conditions, including the chronic hypertension, obesity, COPD, and dyslipidemia. This expert admitted chest tightness, shortness of breath, and palpitations could be caused by the patient’s anxiety; however, the physician should have first noted that standard of care required her to first rule out conditions that could potentially kill the patient. Another witness testified the physician failed to complete a thorough patient history. The witness felt an EKG, which was required for complaints of chest tightness and shortness of breath, should have been performed before the physician diagnosed anxiety as a cause of symptoms. The EKG, the expert argued, was warranted especially considering the patient’s comorbidities, and would have ruled out a cardiac origin or coronary syndrome. This witness stated that, yes, the patient was medication noncompliant, but that this put him at a greater risk for a cardiovascular event.
Defense experts elaborated on the patient’s chest tightness, stating the physician did not document the onset, number of episodes, location, evolution, and quality and characteristics of pain nor what was typical vs. atypical. A family physician testified the physician also did not recheck the patient’s 160/30 BP, which represented a hypertensive crisis. The same witness asserted the physician needed to send the patient to the ER or order an EKG, which would have shown ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI). An interventional cardiologist opined that the physician should have ordered a nuclear stress test in 2014 and referred the patient to a cardiologist after the EKG suggested an old myocardial infarction (MI). This cardiologist said a stress test and cardiac consult could have resulted in a timely diagnosis at his last appointment, with possible initiation of heparin to shrink the right coronary blood clot. The witness argued the patient might have had the benefit of catheterization, a stent placement, or even bypass surgery.
Another physician for the Defense testified the patient’s physician appropriately addressed the patient’s high BP, cholesterol, and anxiety on that visit but did not address his history and chest symptoms. The standard of care, the expert said, did require an EKG, but it could be argued the physician addressed the chest symptoms by prescribing metoprolol. The physician did chart palpitations but not chest pain, and the witness argued she should have charted atypical chest pain and recommended the patient to the ER. This expert agreed, however, that the patient was not open to aggressive treatments and had exhibited a history of noncompliance. She also stated chest tightness, palpitations, and shortness of breath were common in anxiety. Lastly, it was her opinion that the thrombus noted in the autopsy was most likely caused by plaque in the artery due to longstanding high cholesterol.
Finally, a family practice DO stated it was appropriate to adjust medications and schedule a follow-up exam for this patient. Further, though it would have been reasonable to order an EKG and repeat BP before the patient’s discharge, especially in a patient who was hypertensive with palpitations, it was not required as part of the standard of care. The standard of care also did not require labs. This witness did note a concern that the physician did not follow up on the 2014 EKG, which was shown as unremarkable but did show prior heart injury.
This case resulted in a reasonable settlement.
*The above case examples were taken from ProAssurance closed claims. Certain details have been changed to protect the identities of the patients, physicians, and other individuals involved in these claims.
NORCAL Mutual Insurance Company, Claims Rx: Clinical & Risk Management Perspectives: Current Issues in Anesthesiology Claims, October 2020.
Ohio Rate Change
We are committed to responsible pricing that reflects the current risk environment. Upon recent review of our rate plan and rating factors, we have updated the rate strategy for new and renewal accounts in Ohio. A 6% base rate increase, which has been filed and approved, may impact NORCAL insureds. These changes went into effect May 1, 2024, and are applicable to new and renewal accounts. We will notify affected policyholders of the change.
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The United States spent $772.5 billion on prescription drugs in 2023, a 13.5% increase from 2022, driven largely by the proliferation and popularity of blockbuster weight-loss drugs, a new report shows.
Despite the dramatic increase in overall drug expenditures in 2023, drug cost increases were marginal (2.9%) and for the fourth straight year lagged inflation in the overall economy (3.4%) as measured by the Consumer Price Index, according to the American Society of Health-System Pharmacists' National Trends in Prescription Drug Expenditures and Projections for 2024. (Health Leaders Media)
Drug shortages have reached a record high in the first three months of 2024.
In the first quarter of the year, 323 drugs were running low, surpassing the 2014 high of 320, according to data provided by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service.
Since 2001, the groups have tracked shortages using voluntary reports from practitioners and patients that are confirmed by drug makers. (USA Today)
Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.) (KFF Health News)
Eighteen percent of oncologists said their burnout is so severe that they may leave medicine, according to a Medscape report. The "Oncologist Burnout & Depression Report 2024" surveyed 9,226 physicians across more than 29 specialities between July 5 and Oct. 9.
Thirty-six percent of oncologists said they have felt burnout for more than two years, 28% said they have felt it for 13 months to two years and 24% said they have felt burnout for seven months to one year. (Becker’s Hospital Review)
In a recent study published in The Lancet Digital Health, a group of researchers analyzed severe coronavirus disease 2019 (COVID-19) outcomes in patients with immune-mediated inflammatory diseases (IMIDs), focusing on the effects of medications, comorbidities, and vaccination status during different pandemic phases. (News Medical)
New Leapfrog Group findings show patient perspectives on hospital care indicate significant signs of improvement since the fall 2023 Safety Grades. The spring 2024 Hospital Safety Grades show preventable healthcare-associated infections have decreased after unprecedented rates during the height of the pandemic, according to Leapfrog, an independent nonprofit patient safety organization. (Healthcare Finance)

A Tale of Two Surgeons
I've long been intrigued by the personas of surgeons. Nearly all of them exude high intelligence and carry themselves with the confidence and self-assurance necessary for wielding a scalpel as their primary instrument of healing.
Surgeons tend to be fiercely competitive in drawing patients to their practice and maximizing their caseload. Yet, at the same time, some routinely steer clear of patients deemed poor surgical risks, partly to sustain a good track record and mitigate legal repercussions should a poor result occur. Two memorable encounters demonstrate how dramatically different surgeons might deal with less-than-optimal surgical candidates.*
Dr. Andy
I waited for Dr. Andy to finish with a patient to review some x-rays. He approached me, shaking his head.
"Unbelievable!" he began. "The patient I just saw has severe joint disease and desperately needs a total knee. But she's morbidly obese and diabetic. I'm not taking that risk. I told her to come back after she loses 50 pounds, and then we can talk about it."
Curious, I asked, "Did you tell her how to lose 50 pounds?"
Dr. Andy scoffed. "It's not my job. I can fix her knees but not her weight."
I unbit my lip. "If your patient knew how to lose 50 pounds, she wouldn't be morbidly obese." Dr. Andy just shrugged it off.
Dr. Harvey
Dr. Harvey had one of the busier orthopedic practices. I was waiting in his office to catch him between patients when a jovial man walked in pushing a cooler on wheels.
He said, "I'm providing lunch today. Would you like a sandwich or a salad?"
I politely declined. "That's very nice of you. What's the occasion?"
"Dr. Harvey saved my life. He did my total knee."
I was well aware of how total knee replacement can change someone's life, but I never thought of it as life-saving. So I asked, "How did it save your life?"
The man explained. "When I first saw Dr. Harvey, I weighed over 100 pounds more than I do now, and my knee was so bad, walking was agony. He said he could fix my knee, but there was really no point because I'd probably be dead soon because of my weight and my health. He had me in tears, then asked, 'Are you ready to get healthy? Because if you are, I'll help you, and then I can fix your knee.' He referred me to a bariatric surgeon and a personal trainer, and in a little over a year, I lost 100 pounds and had my knee replaced. Thanks to Dr. Harvey, I'm in the best shape of my life."
When I met with Dr. Harvey moments later, I said, "You're a good doctor and a good person. You care about your patients."
He said, "Thanks, but the guy was a bad surgical risk, so there was no way I would operate, but I had a chance to help him. I didn't expect him to do so well, but I can't tell you how good I feel."
Both surgeons were presented with similar situations. One told the patient what she should do and walked away. In contrast, the other involved himself in what we know as the continuum of care. Over the years, I've shared this story of Dr. Andy and Dr. Harvey in my territory (concealing their identities). While I couldn't measure the impact on other physicians, it’s an example of how some physicians reflexively avoid risk, whereas others work within their means to manage risk and ultimately do what's best for the patient.
*Names have been altered to protect the identities of the subjects.
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Written by Mace Horoff of Medical Sales Performance. Mace Horoff is a representative of Sales Pilot. He helps sales teams and individual representatives who sell medical devices, pharmaceuticals, biotechnology, healthcare services, and other healthcare-related products to sell more and earn more by employing a specialized healthcare system. Have a topic you’d like to see covered? Email your suggestions to AskMarketing@ProAssurance.com. |
