Pamela L. Popp, MA, JD

Pamela L. Popp, MA, JD

Disclosure to patients of medical errors and near misses is the most recent imperative to the health care industry from the Joint Commission on the Accreditation of Healthcare Organizations. How disclosure is done, its effect on organizational culture and patients, and how it affects malpractice litigation are concerns for providers and other health care entities.

Responding to consumer and government pressure, JCAHO added to its survey standards a requirement that each facility have a policy of full disclosure to patients of unanticipated outcomes and near misses. While JCAHO had planned to begin surveying those policies on July 1, it delayed this in light of overwhelming response from the health care industry that tracking and educating patients on "near misses" would be almost impossible.

Nonetheless, health care facilities and physician practices must commence development and implementation of a disclosure policy. The policy should include a statement of the need and willingness of the patient and physician to have an open and honest relationship and a constant dialogue about the patient's care, general health, and well being. Stating this philosophy clearly in the policy makes it the guiding principle for the conversations that follow.

The policy should also state who has the responsibility for primary communication with the patient when an unanticipated outcome, treatment-plan change, or other important information must be communicated. In most instances, this should be the treating physician, as patients want to hear important information from their doctors. This is true even in an emergency or surgical situation, where the patient may not have a relationship with the physician. Because the physician's clinical judgment sets the plan of treatment, patients will want him or her be the primary source of information.

In addition, the policy should outline who is responsible for documentation in the patient's records when a disclosure conversation takes place. The documentation, like all medical-record documentation, should be objective, complete, and accurate. This would include who was present for the conversation, what information was conveyed, what questions were asked by the patient (and answers given by the physician), as well as the agreed steps in the patient's plan of treatment.

Patient communication

In the hospital, who is responsible for patient communication always has been an area of dispute, often with significant turf battles between nurses and physicians. Where nurses may feel obligated to overcommunicate with a patient, very often the physician undercommunicates. The nurse's perspective may be more advocative, social, and interactive, while the physician's is more science-based and impersonal. Often, this does not cause a problem with treatment. However, when an error or medical misadventure occurs, this communication imbalance can be one of the deciding factors of whether the patient or family pursues litigation.

Done correctly, negative disclosure should be open, honest, and limited to the information truly known at the moment. Often, the result will be known before the cause or event sequence is identified, and therefore the communication should be limited to this information. Speculation on the cause, fault, or outcome is never beneficial. Instead, the provider should give the patient the information that is needed to understand how it affects a treatment plan, why any changes have taken place in that plan, and what to be aware of in terms of reactions or consequences. This way, patients have enough information to appreciate how a situation affects them, but do not have enough information to shift their focus to external forces or blame.

The disclosure conversation should be done in the patient's room, with the attending physician leading the conversation, if possible. If this is not possible, then a provider with whom the patient has developed a relationship should begin the conversation, explaining to the patient that something unexpected has occurred, that the outcome will be controlled as well as possible, and that the patient's treatment and care are of the utmost concern. Only when the immediate concerns about care and treatment are resolved should the caregiver proceed to answer any questions about the process or system that allowed for the error. Often, it is sufficient to simply explain that the matter (as in cause or system failure) will be investigated and appropriate changes made.

Done incorrectly, disclosure becomes simply an admission of liability — and immediately raises the possibility of litigation. It shifts the focus from the patient's condition, treatment plan, or concerns to the blame of an individual or process. This helps no one, and may even cause subtle reactions or changes in the patient's care to be missed due to the distraction.

It's unrealistic to think that every disclosure conversation will go as well as planned or that malpractice litigation will never result from these occurrences. Indeed, suits probably would result even without the disclosure conversation, because a primary factor in a patient's decision to pursue a malpractice case often is lack of communication from the provider on an unexpected outcome or undesirable result. Knowing this, one could speculate that having any conversation with the patient would decrease the chance of litigation, alleviate concerns (emotional, psychological, or financial), and thus potentially prevent litigation.

In situations where litigation does still occur, the disclosure conversation will be crucial to the trial strategy. What is said, how it is documented, and who was present are all key facts to consider once litigation is filed. Just because a disclosure conversation took place, it should not be assumed that a jury would immediately perceive this conversation as being an admission. Instead, the defendant should position the conversation, the provider's concern, and the information shared as a key advantage.

Advantage of disclosure

Why does disclosure work? It meets the expectations of jurors. Jurors feel that there should be an admission when there is a medical error, regardless of whether it resulted in any harm to the patient. The disclosing provider has immediate credibility before the jury, and could even become a key witness at trial for the defense.

Organizations that practice open-disclosure approaches with patients have found that it actually decreases litigation. Often, the conversation with the patient results in a small bill waiver, or facilitation of another medical resource (a continued stay, social services, discharge planning) to resolve the patient's resulting medical condition. Once these concerns are resolved, the patient no longer has the incentive to pursue litigation. Children's hospitals have learned this over the years, in that physicians often spend much more time communicating with concerned parents about their child's condition than do physicians who treat adult patients in acute-care settings.

A culture of disclosure does not need to be seen as a new fad or requirement, but a confirmation of an already existing culture of patient autonomy, honesty, and informed consent. Conveying the disclosure policy as "new" can raise suspicions among physicians and staff that the motivation is solely to prevent or lessen the harm of lawsuits. Instead, providers need to be reassured that free communication with patients always has been encouraged, and the embodiment of culture into a written policy documents its existence to JCAHO and allows for consistency in its application.

Pamela Popp, MA, JD, is director of DecisionQuest's health care practice in Dallas. Her career includes 20 years of litigation management in health care. Reach her at (972) 910-0555 or ppopp@decisionquest.com.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.