As noted last month, we regularly field a range of questions about medical professional liability (MPL) insurance, malpractice claims management, and patient safety. Some of those recently answered individually are shared below.

Informed Consent

Does MPL insurance cover complications from new procedures or medications that are not included on the patient’s consent form?

MPL insurance covers each provider based on policy stipulations. For example, CRICO covers licensed providers in alignment with their formal privileges, which may permit experimental or new procedures/equipment/therapies.

Regardless of policy wording, patients have a right to know what will be done and providers have an obligation to engage the patient in an informed consent discussion about any planned procedure, including those involving experimental or new techniques, equipment, or therapies—and alternative options (including doing nothing). A failure to inform the patient and secure his/her consent could be grounds for a malpractice allegation, or exacerbate an allegation based on another aspect of unsatisfactory care. CRICO’s list of FAQs about informed consent, offers additional details on optimal consent processes.

Population Management

Do population managers improve screening for cancers and closing loops on referrals?

Dr. David Bates, Chief of General Internal Medicine at Brigham and Women’s Hospital, states that the use of population managers who are following a specific process has been shown to be very effective for closing loops. Most work in this area indicates that centralizing this process results in much higher levels of completeness in closing loops and this is usually done by population managers. Kaiser Permanente is the national leader in this area.

Telemedicine

How can I navigate the different laws/regulations regarding telehealth visits when the patient and provider are in different states, especially the differences between established provider-patient relationships and new-patient encounters?

Dr Adam Licurse, who leads the Brigham and Women’s Physicians Organization’s telehealth strategy, recommends conferring with your practice leadership, who themselves may need compliance and legal input to guide you. Generally, patient-local licensure is required for both new and established patients. However, your site may decide that, for certain scenarios, limited out-of-state visits without a license may be conducted. Given the layers of risk involved, such decisions should certainly be made with leadership input.

Your compliance team also should advise on how to safely prescribe over state lines. For instance, some Massachusetts-based organizations only allow controlled substances to be prescribed for established patients in Massachusetts.

Breast Density

Should all patients noted to have dense breast tissue on mammogram be advised to have an MRI annually (even if at standard risk and their insurance does not cover it)? What are the practical options here?

Dr. Ted James, Chief of Breast Surgical Oncology and Medical Director of the Breast Care Center at Beth Israel Deaconess Medical Center, notes that not all patients with dense breasts necessarily need an MRI. Patients with dense breast tissue and no other risk factors may not meet criteria for breast MRI.

Studies indicate that low-risk patients with dense breast tissue may benefit from digital 3D tomosynthesis mammography. More information on risk stratification can be found at breast.massrad.org

Standard of Care

What are the standard protocols for determining whether there has been negligence in a malpractice case? Is it what's written in textbooks, recommendations in guidelines, conclusions from high-quality studies, or standards set by the hospital itself?

There is no universal “standard of care.” Health systems often adopt guidelines, policies, formal protocols (which may be based on those sources listed in the question) that serve as a proxy for a standard, but can differ from one setting or system to the next. For MPL litigation, the standard is established at trial through experts who opine as to the applicable standard of care of the average qualified physician* in the circumstances of the case. In cases of doubt, the physician is expected to have used his or her judgment in accordance with accepted medical practice for a physician in the same area of specialty. The fact that in retrospect, the defendant’s judgment was incorrect is not in and of itself enough to prove medical malpractice or negligence. Physicians are allowed a range in the reasonable exercise of professional judgment and are not liable for mere errors of judgment so long as the judgment they made does not represent a departure from the requirements of accepted medical practice.

This discussion between a physician and MPL defense attorney about the standard of care, offers a more detailed examination.

*Nurse practitioners, physician assistants, etc. are similarly assessed against their peers.

Prostate Cancer

Is there data to support an ideal position for the digital rectal exam (DRE) to obtain the best information on the prostate?

Dr. Marc Garnick is the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and founder of the Hershey Family Foundation for Prostate Cancer Research at BIDMC. His recommendation is based on having performed thousands of DREs:

I prefer having patients assume a left lateral decubitus position. This allows excellent visualization of the perianal area and anal area and allows elevation of the right gluteal muscle to allow easier insertion of the gloved examining finger. For patients who have difficulty getting into this position (due to arthritis or other mobility issues), I have the patient assume a standing position over the edge of the examining table, have his hands placed on the table for stability, and perform the exam in that fashion. This is more uncomfortable for the clinician, however, and does not allow the same visualization of the anal and perianal area.

Learn more from Dr. Garnick in this podcast about Prostate Perils in Primary Care.

If you have more questions, review this more extensive list of frequently asked questions, or reach out to your MPL insurance provider.

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