Compliance
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Opioid Order Should Ease Physician Discretion
An order from the judge overseeing the National Prescription Opiate Litigation should make it easier for healthcare providers to comply with best practices designed to reduce opioid abuse. The order was in response to a motion from Webb County, TX, filed in September 2018, addressing the fact that pharmacy benefit managers' standard national offerings were not consistent with the CDC Guidelines, even though they had endorsed the guidelines as the standards of care.
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False Claims Act Ruling Is a Win for Healthcare Providers
A recent ruling in a False Claims Act Case affirms that relators must be specific with claims. Summary judgment was issued because the relator did not tie allegations to particular patients and bills.
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DOJ Specifies What Can Earn Credit in False Claims Investigations
The Department of Justice has released formal guidelines on how it will award credit to entities for cooperating with False Claims Act (FCA) investigations, giving healthcare organizations under scrutiny a way to reduce the potential effect. The guidelines state that entities will qualify for credit by voluntarily disclosing additional misconduct even after an FCA investigation is initiated.
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‘Second Victim’ May Not Be the Best Approach to Adverse Events
In the effort to more effectively and humanely address adverse events in healthcare, one common method has been to consider the clinicians involved the “second victims.” But is it time to stop that practice? This terminology has been used to highlight the effects on clinicians who are part of a patient’s adverse outcome, signifying that in addition to the patient being a victim, the doctor or nurse also can be traumatized. While well meaning, the “second victim” terminology may produce detrimental effects.
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Legislation Aimed at Surprise Billing Could Bring Liabilities
States and Congress are working to address the “surprise billing” that can hit consumers after a hospital stay or other care in which they learn that they owe thousands of dollars for services they thought were covered by insurance. The legislation is popular among consumers but could create significant potential liabilities for hospitals and health systems. Reducing the risk of those penalties and other consequences will require the risk manager to work with multiple departments within the organization to prevent surprise bills from going out to patients.
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Patients Leaving AMA Require Good Communication to Avoid Liability
Patients who leave against medical advice can be frustrating to clinicians who want to provide the best care and to risk managers who worry that the patient will blame the hospital if the decision leads to a bad outcome. The best way to avoid potential liability is by ensuring that clinicians understand the need to communicate effectively and document thoroughly. Involving the patient’s family members may not always be a good idea, and the risk manager should be careful about intervening.
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Diagnostic Errors Tied to Specific Diseases, Showing Focus for Risk Managers
Despite several years of attention from the medical community, diagnostic errors remain one of the largest threats to patient safety. Three disease categories — vascular events, infections, and cancers — account for nearly three-quarters of all serious harm from diagnostic errors, according to recent research.
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Indigenous People Grill NIH on All of Us Protections
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.
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Identifiable Data Are Not What They Used to Be
IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.
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Tips for IRBs Reviewing Pragmatic Trials
Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.