Informed Consent and the Oncologist: Legal Duties to Discuss Costs of Treatment


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“To mitigate the risks of civil liability and disciplinary sanctions, the ethical and, arguably, legal consensus is that the prudent clinician should discuss the costs of treatment with his or her patients.”
— Thaddeus Mason Pope, JD, PhD

For 50 years, clinicians in the United States have had a legal duty to disclose to patients with cancer the risks, benefits, and alternatives to a proposed cancer treatment. Until recently, however, it has been unclear whether clinicians have a similar duty to discuss the costs of that treatment. Today, to mitigate the risks of civil liability and disciplinary sanctions, the ethical and, arguably, legal consensus is that the prudent clinician should discuss the costs of treatment with his or her patients. Here is a brief history of how this consensus evolved. 

Changing Standards 

THE TRADITIONAL RULE: For decades, legal commentators maintained that clinicians had no legal duty to discuss costs with their patients. Many pointed to a 1993 decision from the Supreme Court of California to support their position.1 The patient in that case, Miklos Arato, sued his oncologists for negligent nondisclosure, claiming that his near futile pursuit of pancreatic cancer treatments resulted in the “failure of his contracting business and to substantial real estate and tax losses.” The court rejected Mr. Arato’s claim, holding that physicians have no duty to disclose risks that might affect the patient’s “nonmedical rights and interests.” 

The New Rule: The law is different today. Subsequent legal developments have eclipsed the holding in the Arato case. Over the past 25 years, appellate courts in many states have expanded the scope of required disclosure beyond information pertaining solely to medical treatment. For example, clinicians now also often have legal duties to disclose information about themselves, such as their experience,2,3 their substance abuse and health conditions that might affect treatment,4,5 and their financial conflicts of interest.6-8 In short, informed consent duties are no longer limited to purely clinical risks, benefits, and alternatives.9 

Moreover, even if some courts were to continue the “therapeutic limitation” in the Arato case, overwhelming evidence now shows that financial toxicity has a direct and substantial impact on a patient’s health.10 Obviously, a patient’s finances are impacted by the high cost of cancer treatment, such as medications costing over $100,000, combined with higher deductibles of $6,000 or more, 20% copays, and lower income earnings. But “financial toxicity” also negatively impacts treatment and medical outcomes because patients frequently skip or adjust chemotherapy doses and appointments to reduce their oncology care costs.10 

The way courts measure the scope and extent of informed consent duties varies from state to state. Most states follow one of two dominant disclosure standards.11 About 25 states follow the malpractice (also known as “physician-based,” “professional,” or “custom-based”) standard. The other 25 states follow the material risk (also known as “patient-based” or “lay”) standard. There is probably now a duty to discuss costs under both standards for the following reasons. 

Legal Difference Between the Two Standards 

MEDICAL MALPRACTICE STANDARD: The medical malpractice standard requires physicians to provide only the information to patients that a hypothetical reasonably prudent physician would disclose in the same circumstances. The custom and practice of the medical profession set the standard. While a minority of states set geographic limitations, in most states a physician must disclose the same information that a reasonable physician in the United States would disclose under the same circumstances.11 

“Just as clinicians have a legal duty to warn patients about physical side effects like vomiting, neutropenia, and hair loss, they also have a duty to warn patients about the financial side effects of treatment.”
— Thaddeus Mason Pope, JD, PhD

Duty is based on professional custom. Traditionally, physicians did not discuss costs of treatment with their patients. Consequently, there was no duty to have such discussions. Today, however, professional standards have changed. Therefore, so, too, have physician disclosure duties. 

First, a significant percentage of oncologists discuss costs of treatment with their patients.12 Second, recognizing the clear consequences of financial toxicity, leading professional oncology societies, such as ASCO, have published guidance statements encouraging clinicians to discuss costs of treatment with their patients,13 as has the Institute of Medicine.14 

Because of these two developments, physicians in malpractice standard states probably have a legal duty to discuss the costs of cancer treatment with their patients, since that is what the reasonably prudent physician already does or would do. Indeed, survey evidence shows that nearly a majority of physicians are discussing treatment costs with their patients.15,16 Because the professional custom is to discuss costs, physicians have a legal duty to discuss costs. 

Material Risk Standard: While the medical malpractice standard is physician-defined, the material risk standard is patient-defined. It requires physicians to provide all the information that a hypothetical reasonable patient would consider important or significant in making a treatment decision.11 This disclosure duty is broader than the malpractice standard and increases the burden on physicians.17,18 After all, a reasonable patient may deem information important even if the medical profession does not customarily discuss that information. 

Indeed, significant survey evidence shows that with substantial increases in health-care cost sharing, most patients deem financial information important. One study reports that 59% to 80% of patients want to discuss health-care costs with their physicians.19 Another shows that more than 80% of patients report it is “extremely important” or “quite important” to know what they will personally be responsible to pay.20 Because the reasonable patient wants to discuss costs, physicians in material risk standard states probably have a legal duty to discuss costs. 

Legal Obligation to Discuss Costs 

MEDICAL BOARD DISCIPLINE: Informed consent duties are not solely a matter of medical malpractice liability. That is only one form of legal sanction. The state medical licensing boards also impose discipline when physicians provide inadequate informed consent.21 Increasingly, health-licensing boards have amended their informed consent regulations to include an explanation of “financial obligations.” Notably, some state medical boards have recently brought charges against physicians for failing to disclose the costs of cancer treatment.22 

Implementation: A key objection to imposing a duty on clinicians to discuss costs of treatment is that clinicians do not know the actual costs. But clinicians can provide patients with useful information without calculating either specific prices or out-of-pocket costs for individual patients. There are already tools and resources for oncologists to start these difficult conversations with patients, including the National Comprehensive Cancer Network’s® Evidence Blocks™23 and ASCO’s Value Framework.24 Moreover, feasibility is amply demonstrated by the fact that many physicians are also already reducing the cost of oncology care for their patients. Two common approaches include using lower-cost drugs when appropriate that have the same efficacy as newer, more expensive ones and helping patients secure drug copayment assistance through drug manufacturer patient programs.25 Notably, medical malpractice insurance companies are recommending such measure as “risk mitigation strategies.”26 

Conclusion 

TODAY’S CANCER TREATMENTS are more effective and less toxic. But just as clinicians have a legal duty to warn patients about physical side effects like vomiting, neutropenia, and hair loss, they also have a duty to warn patients about the financial side effects of treatment. 

DISCLOSURE: Dr. Pope reported no conflicts of interest. 

REFERENCES 

1. Arato v Avedon, 858 P2d 598 (Cal 1993). 

2. Howard v University of Medicine & Dentistry of New Jersey, 800 A2d 73 (NJ 2002). 

3. Johnson v Kokemoor, 545 NW2d 495 (Wis 1996). 

4. Hidding v Williams, 578 So2d 1192 (La Ct App 1991). 

5. Faya v Almaraz, 620 A2d 327 (Md 1993). 

6. DAB v Brown, 570 NW2d 168 (Minn Ct App 1997). 

7. Moore v Regents of the University of California, 793 P2d 479 (Cal 1990). 

8. Shea v Esensten, 208 F3d 712 (8th Cir 2000). 

9. Silva v Baptist Health South Florida, 856 F3d 824 (11th Cir 2017). 

10. de Souza JA, Yap BJ, Wroblewski K, et al: Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the comprehensive score for financial toxicity (COST). Cancer 123:476-484, 2017. 

11. Pope TM: Certified patient decision aids: Solving persistent problems with informed consent law. J Law Med Ethics 45:12-40, 2017. 

12. Wollins DS, Zafar SY: A touchy subject: Can physicians improve value by discussing costs and clinical benefits with patients? Oncologist 21:1557-1600, 2016. 

13. Meropol NJ, Schrag D, Smith TK, et al: American Society of Clinical Oncology guidance statement: The cost of cancer care. J Clin Oncol 27:3868-3874, 2009. 

14. Levit LA, Balogh EP, Nass SJ, et al (eds): Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. Washington, DC; National Academies Press; 2013. Available at www.nap.edu/read/18359/chapter/1. Accessed November 7, 2017. 

15. Glode AE, May MB: Rising cost of cancer pharmaceuticals: Cost issues and interventions to control costs. Pharmacotherapy 37:85-93, 2017. 

16. Schmittdiel JA, Steers N, Duru OK, et al: Patient-provider communication regarding drug costs in Medicare Part D beneficiaries with diabetes: A TRIAD study. BMC Health Serv Res 10:164, 2010. 

17. Canterbury v Spence, 464 F2d 772 (DC Cir 1972). 

18. Wisconsin Medical Examining Board, Clearinghouse Rule 14-040, Admin Reg (April 26, 2015). 

19. Hunter WG, Zhang CZ, Hesson A, et al: What strategies do physicians and patients discuss to reduce out-of-pocket costs? Analysis of cost-savings strategies in 1,755 outpatient clinic visits. Med Decis Making 36:900-910, 2016. 

20. Kelly RJ, Forde PM, Elnahal SM, et al: Patients and physicians can discuss costs of cancer treatment in the clinic. J Oncol Pract 11:308-312, 2015. 

21. Miller T: Informed consent: A medical board analysis. J Med Regul 96:16-22, 2011. 

22. Texas State Office of Administrative Hearings, SOAH Docket No. 503-14-1342 MD. Available at www4.burzynskimovie. com/images/burzynsk/Responsdents%20Answers%20 to%20the%20Second%20Amended%20Complaint-2.pdf. Accessed November 7, 2017. 

23. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence Blocks™. Available at www.nccn.org/evidenceblocks. Accessed November 7, 2017. 

24. Schnipper L, Davidson NE, Wollins DS, et al: Updating the American Society of Clinical Oncology value framework: Revisions and reflections in response to comments received. J Clin Oncol 34:2925-2934, 2016. 

25. Hunter WG, Zafar SY, Hesson A, et al: Discussing health care expenses in the oncology clinic: Analysis of cost conversations in outpatient encounters. J Oncol Pract. August 23, 2017 (early release online). 

26. Diamond R: Internal medicine closed claims: What can we learn? Doctor’s Advocate 3rd Quarter 2016. Available at http://www.thedoctors.com/KnowledgeCenter/ Publications/TheDoctorsAdvocate/Internal-Medicine- Closed-Claims-What-Can-We-Learn. Accessed November 8, 2017.


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