Murky waters

By Allison Evans, Assistant Managing Editor, January 1, 2022

In 2016, Congress passed the 21st Century Cures Act, which included provisions that push for greater interoperability of health systems and easier access to patients’ medical records. In May 2020, the Office of the National Coordinator for Health Information Technology (ONC) and CMS published two separate but interrelated final rules based on the Cures Act’s interoperability, patient access, and information blocking provisions.

Physicians and other health care providers (in addition to health IT developers of certified health IT and health information networks or exchanges) must comply with the federal regulations aimed at ending the practice of information blocking, which is defined as preventing or interfering with the access, exchange, or use of electronic health information (EHI).

According to the ONC, patients should be able to access their electronic medical records at no additional cost, and physicians should be able to choose the IT tools that allow them to provide the best care for patients without excessive costs or technical barriers. 

“Information is expected to flow across the health care ecosystem,” said Jeffrey R. Coughlin, MPP, senior director of government relations at the Healthcare Information and Management Systems Society (HIMSS).

What does this mean for physicians?

Physicians must share a wide variety of medical information — including clinical progress notes, prescription medications, and lab test results (including pathology) — either with the patient, their representative, or another individual or entity requesting that information for or on behalf of the patient, when readily available, in a timely manner, and without delay, whichever comes first, unless an exception applies, said William Brady, the Academy’s associate director of health care policy. 

“Many institutions have interpreted the laws governing patient access to medical information to require release of results simultaneously to the patient and ordering health care provider immediately once they become available. Because many patients now have electronic access to their records, it is possible that patients will view their results before their physician has even had a chance to see them,” said Swapna Pachauri, MPH, manager of health technology and informatics at the Academy.

Pennsylvania dermatologist Lorraine Rosamilia, MD, FAAD, was part of her institution’s efforts to plan for the implementation of the new information blocking regulations. She spoke with many physicians across various practice types in hopes of finding a workaround for the immediate release of lab results — one that would prevent patients from viewing lab results outside the context of a physician’s explanation. Unfortunately, Dr. Rosamilia’s quest did not return any plausible or legally uniformly implemented options. “Is there a need for lab results to be delivered real-time when that can fragment patient care?” she questioned.

Preventing Harm Exception

ONC identified eight exceptions to the information blocking rule. The one that has attracted the most concern among Academy members is the Preventing Harm Exception, Brady said. A common question among dermatologists is whether the Preventing Harm Exception covers a “blanket” several-day delay on the release of lab or other test results to patients so an ordering clinician can evaluate each result for potential risk of harm associated with the release of information. 

Unfortunately, the answer is no, Coughlin said. “The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.” Through webinars and FAQs, the ONC has confirmed that emotional harm to a patient does not constitute a reason to delay the results as a specialty or in a “blanket” fashion. The ONC has made it clear that this exception currently limits the concept of “harm” to physical harm, rather than emotional or psychological harm. 

“Patient harm caused by diagnosis results without context of a treatment plan may be an enormous unintended consequence of this regulation,” Brady said. As such, dermatology and others in the house of medicine, including the American Medical Association (AMA), have urged the ONC to adopt a broader and more flexible definition of patient harm that considers emotional and psychological harm. (See the sidebar for more about the Academy’s advocacy efforts.)

Even if a health care provider does not meet all the conditions of an exception, it does not mean that they are going to be automatically cited for information blocking, Coughlin said. Instead, they will be evaluated on a case-by-case basis to determine whether information blocking has occurred.

Patient-centered care

In theory, giving patients access to their health records should empower them to have more control of and be more engaged in their health care. “Patients can make changes, input and update missing information, monitor underlying or chronic conditions they may have, follow treatment plans, and more,” said Pachauri.

“The ability for patients to own their medical data, securely access and maintain it in their portable devices, and provide time and health care worker economy for data transfer, are good technology advances and patient-centered care,” Dr. Rosamilia agreed.

“In April we went to automatic release of our lab reports,” said Khang Nguyen, MD, FAAD, chair of the Academy’s Health IT Committee. “It was an overnight shift.” Despite many physician concerns, Dr. Nguyen has reported that the transition to immediate release of results has gone fairly seamlessly for his academic medical center. “I think some patients are especially motivated and engaged in their care, and this has been helpful for them. If a patient is anxiously waiting for a report and it turns out well, then it can be a source of relief that comes very quickly.”

Physician-patient relationship

There have been experiences in which dermatologists have received panicked phone calls from patients, or simply patients who are confused by their results, Dr. Nguyen said. “It’s not always something worrisome like a skin cancer. Sometimes it’s just patients confused by the terminology in the report. However, in my experience, it has not been nearly as common as we might have worried about.”

For Michigan dermatologist Leonard Kerwin, MD, FAAD, the term “melanocytic” has caused anxiety for some of his patients — who often confuse it with “melanoma.” He believes that patients have a right to their records in a timely manner, although “patients do not understand reports of ‘commensal flora’ or growths such as ‘candidiasis,’ causing them more unnecessary anxiety.”

In addition to amplifying or creating anxiety for patients, dermatologists are worried about how the immediate release of lab results may undermine the physician-patient relationship. “It causes major distrust in patients because we haven’t called them with results (because we haven’t even seen them yet),” said Erin Ducharme, MD, FAAD, a dermatologist in private practice in Iowa. 

“Patients call the office for answers expecting that their physician has seen and reviewed the results when this is in fact not true, particularly when results are released late in the day and patients then have to wait one or multiple days or contact on-call staff,” Dr. Rosamilia explained. 

“The AADA maintains that this well-intentioned requirement for immediate, automatic, or ‘without delay’ release of lab results to patients can strain and undermine the integrity of the physician-patient relationship by creating clinical workflow burdens and compliance challenges for medical specialties that rely on surgical pathology lab testing,” Brady explained.

“All of us are spending more time in the room trying to prepare the patient for what they may or may not see. And that’s taking up time that really doesn’t need to be spent if you’ve already developed a good rapport with your patients and explained to them that you’ll communicate the results when they’re not only ready, but fully interpreted” Dr. Rosamilia said. “Sometimes after results come back, I want to talk to the pathologist, or talk to oncology, or talk to people who would help me coordinate a patient’s care. I don’t like to call the patient until I’ve started to implement that plan.”

“Subliminally, will the pathology reports soon include less diagnostic verbiage, truncated microscopic descriptions, and fewer items in the differential diagnoses? The psychology of this process seems to detract from the goal of smooth and effective care and the privilege of methodical clinical documentation and discussion without the possible paranoia of wondering who’s reading it,” Dr. Rosamilia said.

Are there options?

“First, our discussions with patients in the room about the biopsy differential, the method by which they would prefer to receive results, and how the patient should optimally contact you are paramount, but are also likely things most of us already do,” Dr. Rosamilia said. “We should also try to understand the logistics and workflow of our own patient portal, as the way in which the patient is alerted, the alert language, and the report format influence the patient’s next steps. You may be able to serve on a committee that designs or monitors this flow at your workplace or speak to your legal team to determine how they deem the EMR compliant with the rules.”

It is worth considering that not all patients want this immediate access to test results, which are often presented with an email and/or phone alert. The ONC has clarified that physicians can simply ask their patients how they want to receive their results, and delay release until the news comes first from the doctor with patients’ consent, although many physicians find this to be unrealistic.

“The ONC assumes that we all have the technological capacity to tailor the timing of release to every patient’s request,” said Jack Resneck Jr., MD, FAAD, president-elect of the AMA, in an article in MedPage Today. “But we’re not quite there yet.” Some of the larger EHR companies are trying to adjust their programs to provide that option, but many have not, he said.

Dr. Rosamilia has considered the idea of an institution and/or health IT vendor changing the language of the alert, although for many physicians in larger practices or academic institutions, there may not be a choice yet. “Maybe there could be a disclaimer that lets the patient know the results have not been viewed by their doctor.” She also believes it would be better if patients didn’t receive an immediate email notification, which makes it all the more enticing to read the results. “The report would still be in the medical record so that the patient could check if interested.” 

Enforcement

Currently, the HHS Office of the Inspector General (OIG) has only proposed, and not yet finalized, an enforcement approach for certified health IT developers and health information exchanges/networks. It has yet to even propose a rule on how it will enforce any violations caused by health care providers. “Civil Money Penalties of up to $1 million per violation for these regulated actors are in place, with this regulation moving toward its final stage,” Coughlin said.

“Right now, we’re in a period of enforcement discretion for providers. A whole other set of rulemaking must occur to define whether a health care provider is an information blocker and what ‘appropriate disincentives’ will be,” Coughlin said, “Although we still don’t know what this means just yet and when to expect the proposed rule from the OIG.” 

Until this proposed rule is published, health care providers have additional time to ensure practices and IT systems are compliant. However, patients still retain rights to access their medical records under HIPAA, which physicians must comply with, Brady said.   

Two sides

“As with any change, there are two sides,” Dr. Nguyen said. “While there is concern regarding immediate access to pathology and other laboratory test results, it has been helpful at times as well. Sometimes I take care of patients who come from other practices, and the patients and myself have access to previous test results which can prevent duplication of tests and provide me with a more complete picture of their care.”

“As we move toward value-based care, we focus more on patient outcomes, which will be helpful as we think about how to support interoperability,” Coughlin said. “We are in a new era now. Patients are more engaged and more involved than they ever have been. It’s up to doctors, hospitals, networks and information exchanges, and health IT vendors to make an individual’s data available and try to provide the context and background and as much information as possible so that patients can understand their test results and understand the information that’s included in their medical records.”

Additional DermWorld Resources