Instant Access: Alarming or Empowering?

As the 21st Century Cures Act’s information blocking requirements go into effect, clinicians face the realities of increased patient access.

Years ago, to share medical information with patient families, physicians at Texas Children’s Hospital simply printed it out and handed it to them.

“I would tell kids and their parents to keep a binder of all their paper records so that, when the child came of age [and transitioned to an adult specialist], they [would] have all the relevant staging work ups, diagnostic work ups, and a full set of medical records to take where they needed in the future,” Alexandra Stevens, MD, PhD, assistant professor in the hospital’s department of pediatrics, recalled.

That has all changed, she said. Now, all this information, including test results, is available on the patient portal, which most patients have instant access to from their phones before the clinician has even entered the room.

Improved access to medical records is a provision of the 21st Century Cures Act, the sweeping health care legislation passed by U.S. Congress in 2016. Known as the Cures Act, the law was designed to help accelerate medical product development and bring new innovations and advances to patients more quickly and efficiently.1 Title IV of the legislation focuses on advancing a concept called “interoperability”: supporting access, exchange, and use of electronic health information, and preventing data blocking.

In October 2020, the U.S. Department of Health and Human Services’ (HHS’) Office of the National Coordinator for Health Information Technology (ONC) announced that, in light of the COVID-19 pandemic, hospitals and providers would have about six additional months to come into compliance with the information blocking components of the Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program Final Rule.2 The projected start date for information blocking provisions is April 5, 2021.

According to ONC, the rule is designed “to give patients and their healthcare providers secure access to health information [and] increase innovation and competition by fostering an ecosystem of new applications to provide patients with more choices in their healthcare.”3 The rule also includes a provision requiring that patients can electronically access all their electronic health information at no cost through the use of application programming interfaces.

Additional requirements of ONC’s rule – slated for 2023 – will allow patients to download this information to their choice of a compliant third-party app.4

In theory, granting patients unrestricted access to their medical information is easy to support. In practice, however, physicians are having to come to terms with the repercussions of patients knowing things before they do.

What Can – and Can’t – Be Shared?

With an original start date of November 2020, some health care providers and hospitals, including Texas Children’s, had brought themselves into compliance with the information blocking rule prior to the announcement of the extension.

The rule outlines eight types of clinical notes that must be shared: consultation notes, discharge summary notes, history and physical notes, imaging narratives, laboratory report narratives, pathology report narratives, procedure notes, and progress notes.5

ONC has also defined eight specific exceptions to information blocking.6 Five exceptions involve not fulfilling requests to access, exchange, or use of electronic health information: preventing harm exceptions, privacy exceptions, security exceptions, infeasibility exceptions, and health IT performance exceptions. Three exceptions involve procedures for fulfilling requests to access, exchange, and use of electronic health information: content and manner exceptions, fees exceptions, and licensing exceptions. (See SIDEBAR 1 for details.)

“Congress was attempting to better engage patients in their health care and do so in ways that were beneficial to them,” said Robert James Horne, president of health care lobbying firm Forest Hill Consulting, and former staff on the health subcommittee of the House Committee on Energy and Commerce. “While progress has been made, it remains to be seen if the health care system can achieve the goal that Congress was legislating on.”

(The Centers for Medicare and Medicaid Services introduced a counterpart to the Cures Act’s information blocking requirements with its Interoperability and Patient Access final rule. Read more about this program in SIDEBAR 2.)

Real-World Benefits, Real-World Harms

“Patients absolutely have the right to have access to their medical records and their chart, which allows them to educate themselves about their diagnosis and treatment options. I encourage it,” said Jamile M. Shammo, MD, professor of medicine and pathology at Rush University Medical Center and American Society of Hematology Councillor. “In my experience, the more a patient knows about their disease and the more they are able to partner with their physicians, the better the outcomes.”

Another potential benefit of unfettered access to electronic health information is facilitating second opinions, added Dr. Stevens.

“Anybody who has gotten medical records through the typical pathways knows how challenging it can be,” Dr. Stevens said. “When people are seeking second opinions, [interoperability] will make it a million times easier to get the data that clinicians need to render a useful commentary.”

The rule’s interoperability requirements also will allow for a better exchange of information between institutions, according to Jean M. Connors, MD, associate professor of medicine at Harvard Medical School and medical director of the Anticoagulation Management Service at Brigham and Women’s Hospital and Dana-Farber Cancer Institute.

“A patient may not completely understand their diagnosis, why they are taking certain medications, or what those medications even are,” Dr. Connors said. “These newer requirements grant other providers access to records that tell them what happened and when it happened. That can be lifesaving information.”

“The provision was designed to create interoperability in the exchange of information, which is the bedrock of the entire health care system,” Mr. Horne told ASH Clinical News. Take for example, Medicare, Mr. Horne said. “People think of Medicare as one program, but it is actually nine, 10, 15 segmented payment systems or programs. This approach to care diminishes opportunities to improve functional outcomes for patients.”

Interoperability creates new opportunities to coordinate care. “Now, at any point a patient touches the health care system, there are more data available to help decide on current or future actions. The expectation of the legislation is that greater efficiency and a fuller picture of what is going on with a patient will improve outcomes,” he explained.

The potential benefits of the information blocking rule are vast, but these benefits exist in parallel with concerns about its real-world implementation. Whether a physician’s “open access” to the electronic medical record is the best way to improve patient care is a matter of debate.

Colleen T. Morton, MBBCh, section chief of classical hematology at Vanderbilt University Medical Center, said that Vanderbilt previously had a 14-day delay in the release of sensitive test results that might have significant implications for the patient’s health.

“With the policy, we wanted to give the clinician time to contact the patients and discuss the results,” Dr. Morton said. “That is going away. Now patients may see their results before we do.”

Putting results into context is incredibly important to avoid unnecessary anxiety or confusion, she said.

For example, if patients see the word “leukemia” on bone marrow biopsy results they might panic. “They likely don’t understand that there are different types of leukemia,” Dr. Morton explained. “Getting a diagnosis of chronic lymphocytic leukemia at age 80 may not significantly impact your life and health – it is a common diagnosis and we often just monitor it – whereas a diagnosis of acute myeloid leukemia is a medical emergency.”

In addition, a single test might not paint the entire picture. Dr. Morton said that bone marrow biopsies are often first examined under a microscope and given a general description and differential diagnosis. Specimens are then sent for genetic testing. Those results may change a diagnosis.

“Genetic testing results come back a week or two later and are not included in the initial report,” Dr. Morton said. “That means a diagnosis may change from initial release to final report.”

In other situations, a patient may receive complete blood count results and panic about an abnormality.

“We have had people send us a barrage of messages asking what their slightly abnormal test results mean when, in the context of that patient’s history, the finding has no clinical significance. It still makes the patient anxious, leading to multiple patient phone calls or patient portal messages,” Dr. Connors said. “This often occurs after a patient has left the clinic, so we are faced with making unscheduled calls and answering emails. It is extra work and time that we haven’t budgeted for and are not reimbursed for.”

Preparing Patients

Knowing that patients will soon be privy to a massive amount of data, clinicians are now trying to determine the best ways to prepare their patients for the information dump.

“As a benign hematologist, I do a lot of blood tests, and results can take anywhere from a few hours to a week to come back,” Dr. Morton said. “I explain to the patient that I will look at the results as they come in, and if there is anything concerning to me, I will connect with them immediately. Otherwise, I let them know that I will call once the results are all back.”

So far, most patients have been satisfied with that because the expectation is set ahead of time, she said. “I still get some questions via the patient portal, but they are fewer and easier to manage.”

At Texas Children’s Hospital, Dr. Stevens prepares patients and their families to what might be coming to their portal, but also encourages them to reach out if they have questions after reviewing the results. “I would rather field the extra calls than have patients and parents feeling anxious if they see something bad or see an unexpected change,” Dr. Stevens said, acknowledging that this places an increased burden on health care providers.

She added that she has not yet seen a great difference in the workflow at her practice, but the hospital is discussing whether front desk staff will be trained to address calls from families who are anxious about early test results. The implementation of the information blocking rules also brings up concerns about adolescent privacy, inclusion of notes related to end-of-life discussions or chaplain’s notes, and other sensitive information.

At Rush, Dr. Shammo said that they are still determining the best way to handle the release of test results.

“We have been sharing notes and lab test results for quite some time, but we are always thinking of ways to perfect our system,” she said. Ideally, test results that are indicative of a malignancy are blocked until the physician can sit with the patient to discuss. A delay like this would fall under the Cures Act’s patient harm exception because the clinician would be worried about “unreasonable risks of harm” to the patient.

An Open Note Test

Another area of potential concern is the increased access to physician notes. Although some institutions have already moved to an “open access” platform for physician notes, many still require patients to request these records. Under the new ONC rule, patients will have complete access.

“Much of the information captured in notes is in medical language that is necessary to document the diagnosis and convey vital information accurately, so that other physicians can look at the chart and know exactly what the diagnosis is,” Dr. Morton said. Patients may not be able to interpret the language, which leads to questions, but the information often cannot be put into lay language.

“If we start writing notes differently to make them understandable to patients, the chart may lose some of the important medical information that we need to convey to other providers,” she said.

Dr. Shammo also worries that changing the way notes are written could cause physicians to inadvertently conceal some of the reality of what is going on in the patient encounter. “For example, if I know that a patient is going to see the notes, I may not write that a patient is obese. Although technically correct, I may have to find a more polite way of saying that,” she explained.

In similar situations, Dr. Connors has started to use patients’ body mass index, rather than the term ‘obese,’ as a workaround.

Other clinical scenarios do not have such an easy solution. Dr. Stevens offered the example of communicating sensitive information around drug-seeking behaviors or noncompliance.

“In our current era, awareness has increased about unconscious bias or insensitivity,” she said. “It is important that we are careful with how we communicate about these issues to families and recognize their value.”

“If we start writing notes differently to make them understandable to patients, the chart may lose some of [what] we need to convey to other providers.”

—Colleen T. Morton, MBBCh

Clinicians are often charting until midnight as it is just to meet the bare minimum of what needs to be recorded, Dr. Stevens noted. Having extra eyes on notes and charts will add to that burden.

“To add the step of now considering how the information will be read or interpreted by patients and their caregivers is challenging,” she said. “If you care about the families and the therapeutic alliance, it adds another layer of complexity.”

The transparency mandated by the Cures Act could also have consequences for billing and coding, according to Dr. Morton. As of January 1, 2021, physicians must select an evaluation and management (E/M) code based on the total time spent on the date of the patient encounter or medical decision making, per new guidelines from the American Medical Association.

With that in mind, Dr. Morton explained, “if a patient has a life-threatening disease, we would code it at a higher level, because we have to document the significance of the diagnosis in more detail. I wonder whether we might end up putting more concerning language in our notes for coding purposes,” she said. “I might not want to emphasize to a patient how life-threatening a diagnosis like immune thrombocytopenia could be, because most people do fine, but from a coding standpoint, I have to document it as such if the patient’s platelet count is very low.”

Theory Versus Practice

The providers who spoke with ASH Clinical News agreed that the intention of the ONC’s Cures Act rule on interoperability and information blocking is admirable and it could benefit patients and providers. Still, real-world implementation introduces several new predicaments.

“When [patient questions about early test results] come up, we have to go through all the patient messages, look at their chart, and provide an explanation about the significance or lack of significance of a result,” Dr. Connors said. “Patients having this immediate access has added to physician workload. It needs to be addressed.”

Dr. Shammo has also witnessed a disruption to her workflow since access to health records has increased. Recently, a single patient sent 15 emails about complete blood count results sent prior to a telehealth visit, she recalled.

“It would be great if someone gathered data to better understand the magnitude of additional time that physicians are spending on addressing patients’ concerns and questions outside of a clinic visit as a result of the implementation of this rule,” she said. “How will this impact our productivity, our livelihood, our burnout levels, our job satisfaction, and the time we spend with our families?”

“The concept behind open access for families and patients is important,” Dr. Stevens added, “but I think there are definitely some issues with its implementation.” —By Leah Lawrence

References

  1. U.S. Food and Drug Administration. 21st Century Cures Act. Accessed January 5, 2021, from https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act.
  2. Health and Human Services. HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule. October 29, 2020. Accessed January 5, 2021, from https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html.
  3. The Office of the National Coordinator for Health Information Technology. ONC’s Cures Act Final Rule. Accessed January 5, 2021, from https://www.healthit.gov/curesrule/.
  4. The Office of the National Coordinator for Health Information Technology. New Applicability Dates included in ONC Interim Final Rule. Accessed January 6, 2021, from https://www.healthit.gov/cures/sites/default/files/cures/2020-10/Highlighted_Regulatory_Dates_All.pdf.
  5. HealthIT.gov. Clinical Notes. Accessed January 6, 2021, from https://www.healthit.gov/isa/uscdi-data/clinical-notes#uscdi-v1.
  6. The Office of the National Coordinator for Health Information Technology. Cures Act Final Rule. Information Blocking Exceptions. Accessed January 6, 2021, from https://www.healthit.gov/cures/sites/default/files/cures/2020-03/InformationBlockingExceptions.pdf.

HHS’ Office of the National Coordinator for Health Information Technology has finalized eight exceptions through which practices can delay access, exchange, or use of electronic health information (EHI). All of these exceptions have key conditions that need to be met to qualify.

  1. Preventing harm exception: It will not be information blocking for an actor to engage in practices that are reasonable and necessary to prevent harm to a patient or another person.
  2. Privacy exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI in order to protect an individual’s privacy.
  3. Security exception: It will not be information blocking for an actor to interfere with the access, exchange, or use of EHI in order to protect the security of EHI.
  4. Infeasibility exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI due to the infeasibility of the request.
  5. Health IT performance exception: It will not be information blocking for an actor to take reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT’s performance for the benefit of the overall performance of the health IT.
  6. Content and manner exception: It will not be information blocking for an actor to limit the content of its response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI.
  7. Fees exception: It will not be information blocking for an actor to charge fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI.
  8. Licensing exception: It will not be information blocking for an actor to license interoperability elements for EHI to be accessed, exchanged, or used.

Source: Office of the National Coordinator for Health Information Technology, “Cures Act Final Rule: Information Blocking Exceptions.”

A counterpart to the Interoperability, Information Blocking and the ONC Health IT Certification Program Final Rule is the Centers for Medicare and Medicaid Services’ (CMS’) Interoperability and Patient Access final rule. According to CMS, this rule places new requirements on Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plans (QHP) issuers on the Federally Facilitated Exchanges (FFEs) to improve the electronic exchange of health care data, and streamline processes related to prior authorization. This rule, which had a compliance date of January 1, 2021, focuses on health-care payers instead of providers.