Failure to Communicate

Five steps you can take to harness the benefits and avoid the gaps in the 21st Century Cures Act

After many years of effort by patient advocate groups and individuals, there was general jubilation when the federal law known as the 21st Century Cures Act (21CCA) was enacted on April 5, 2021. Among its more important protections for patients was establishment of our right to own our health data.

In most cases, it’s been a big success. As long as you join and log into the patient portal, you can see your test results and physician notes as soon as they’re entered.

Having control of your medical data, including test results and visit notes, means your information is portable, checkable, easy-to-share and easy-to-reference. If you want a second opinion to check a diagnosis, before a surgery or beginning an invasive treatment plan, you can print out, email, or approve access for the new doctor to view. It saves the patient time and money and helps us avoid the issues of repeat testing. You can make sure that the information you shared with your doctor was properly recorded in your records and correct it right in the portal. Errors in your medical history can cause bigger errors in your care.

Before 21CCA, there were so many stories of patient harm from missing tests, results reported incorrectly and results that weren’t reported at all.

Pat’s Story

Susan Sheridan is an award-winning international activist for patients and a fierce advocate for the patient’s right to full access to their healthcare data. In the late 1990’s, her husband Pat experienced pain in his neck and shoulders. After a course of pain meds, physical therapy and acupuncture failed to reduce the pain, an MRI scan identified a mass in his cervical spine. It was removed by a neurosurgeon and tested. The preliminary pathology results were reassuring and the Sheridan’s were told the removed mass was a benign tumor.

It wasn’t. Additional tests took 23 days to complete and the final pathology report was faxed to Patrick’s neurosurgeon and filed by a staff member who never showed it to the surgeon.

Six months later, his pain was back and Pat returned to the doctor who reviewed his records and finally saw the missing results. Pat had an aggressive, malignant sarcoma which had now metastasized.

If the 21^st Century Cures Act had been in effect, the results would have been posted immediately. The report still might have been missed by the surgeon. But the Sheridan’s would have had the opportunity to contact him and give Pat a fighting chance. That six-month gap between a final diagnostic report and the patient’s knowledge was a deadly one yet completely preventable.

Seven surgeries and several rounds of chemotherapy and radiation did nothing to stop the cancer. Pat died in 2002 when he was 45 years old, leaving Sue and two young children.

Why the Act Matters

Statistically, most Americans won’t experience this level of harm from a missing test, especially now that the 21CCA protects patients by giving everyone the power of knowledge with automatic notifications. It’s a power that only works if we use it.

Most Americans seem to like the new rules. Almost all patients (96 percent) in a large study preferred getting their test results immediately online even if their doctor hadn’t reviewed it. Although patients who received abnormal test results reported they experienced increased worry, over 95 percent of them still wanted the opportunity to access them.

The biggest problem in this new world is us. Portal use has risen over the years but only 57 percent of Americans who have been offered a portal use it at least once each year. Only ten percent use it six times each year. Anyone with a smart phone can and should join their portal if their doctor offers one.

Doctors feared that immediate access to test results would increase patient complaints but according to this large study it didn’t. It did, however, change the type of complaints and increased the proportion of patient-initiated emails to discuss their diagnostic results, report an error in the medical record documentation, express their anxiety related to unexplained medical findings, a lack of medical team communication, and unexpected findings in the medical record. Patients were so interested in learning more about their health, that some practices felt inundated.

That’s why for some doctors and patients, immediate test result access has been a little too successful. From the earliest discussions about the 21st Century Cures Act, doctors have warned that patients aren’t smart enough or knowledgeable enough to understand the data in their charts. Excuse me as I bristle.

The terms used on test results can be daunting. However, many patient portals include links on blood and urine tests to explain what the results mean. There are also lots of reliable healthcare websites that provide a guide to reading and understanding your test results. They’re easy to use. See the #2 on the list below for two of the best.

Unintended Consequences

Despite the valuable benefits of unfettered access to our health data, there are valid concerns about how unfiltered test results might harm patients or others close to them. In the first version of the law, there were just two limited reasons a medical practice or hospital could block access to test results.

It protected clinicians who believe a patient is at danger of harming themselves or others when they read the information without guidance. Examples given included learning they were HIV positive or had a different sexually transmitted disease or had a significant mental health diagnosis. The second is about privacy laws (HIPAA) and if the records would expose another person’s medical history.

If a doctor blocked your access for any other reason than those two, they could be fined for “information blocking” and face fines up to $1 million per occurrence.

That list of exceptions recently got longer –– mostly for logistical and HIPAA reasons –– and the size of the patient population that could have their information blocked got larger.

The American Medical Association wants to add a new federal-level exception to give clinicians 72 hours to contact patients before releasing results that indicate a devastating diagnosis, like cancer and Huntington’s Disease, but it hasn’t been approved yet. Two states have passed those exceptions into law and others are considering it.

You have some measure of control here. If you request the results to be held until you can speak with your doctor, that’s a permitted loophole. Or you can choose to ignore the notification and make an appointment with your clinician when the tests are posted.

In a small study of cancer patients and caregivers, the majority wanted to wait until they could speak with their doctor. Fewer than one in five preferred viewing the reports before discussing them with their oncologist and only 20 percent wanted early access to them. It’s important to note that only 57 percent got to discuss their results with an oncologist within two days of receiving results.

And therein lies the rub. Cancer test results not only need to be reported and explained to the patient quickly, they require swift action from the doctor or oncologist if the test reveals a problem. Every day counts with a cancer diagnosis.

Michael’s Story

Kathy Day RN is a retired registered nurse and an active patient advocate. She never expected the 21st Century Cures Act would cause her and her husband Michael significant emotional harm. In 2023, Michael experienced decreased appetite, weight loss and some weakness. He developed severe right side back pain. Day said, “He couldn’t even walk the dogs.” The PCP referred them to a gastroenterologist (GI) for an endoscopy and a colonoscopy. Day says she called daily until there was a cancellation. Meanwhile, “I watched my husband deteriorate before my eyes.”

The GI squeezed Michael in for both tests just before she left on vacation. She even called him from there on July 4, a Tuesday, to see how he was feeling and promised to call as soon as the results were available. The test results dropped into Michael’s patient portal the next evening and the news was devastating. It identified adenocarcinoma, a cancerous tumor, in his esophageal biopsy results.

Kathy said they expected to hear from the GI the next morning for explanation and a referral to an oncology practice. The vacationing doctor never called. She called the gastroenterology practice to speak to the covering doctor. The GI practice advised them Michael needed an “urgent gastro consult” but they sent him in circles back to his primary care doctor. “I can’t tell you how many calls I made after that trying to get him the guidance and care that he needed,” Kathy said. Michael’s PCP told them to go to the local hospital’s emergency department. They did, late on Friday, to an overburdened emergency department without a bed for him. When he finally got his urgent gastro consult, he was still in a hallway outside the emergency department, without privacy, where the specialist announced loudly his cancer was “incurable.”. Despite finally getting treatment at an oncology center, Michael died on August 7, 2023, just five weeks after his colonoscopy.

Kathy Day doesn’t blame the 21st Century Cures Act for her husband’s death, but she believes much of the trauma and emotional upheaval Michael and she experienced was due to receiving shattering results unfiltered and unexplained by the expert who ordered the test. She blames 21CCA for the poor communication and lack of support they received. No one should get such life-altering news in the same way they get family photos and Facebook posts.

They shouldn’t have had to wait for the vacationing GI. The practice should have had another doctor cover while the doctor was on vacation. They didn’t. That gap cost Michael much; the dignity of a caring and informative explanation of his cancer and an immediate referral to the appropriate oncology center for treatment.

To be fair, most clinicians expect to communicate serious test results directly to patients once they have had the opportunity to review them. They do this after their normal work hours without pay. If a test result or a diagnosis is serious enough, they want the patient to come in for an appointment so they can carve out time to answer questions and discuss the diagnosis and treatment plan options in more depth. The practice or health care organization is compensated for these meetings, in person or via telehealth.

In the text of 21CCA it never says that doctors are expected to contact patients in a timely fashion to discuss any significant findings. It was presumed. Nor does it mention compensation for the time-consuming follow-up calls to discuss test results. Physicians aren’t compensated for this by insurance or Medicare/Medicaid. The new exceptions do permit medical practices to charge fees for printed copies of medical records and test results, “including fees that result in a reasonable profit margin.” That adds an onerous extra cost for patients who can’t afford it and contradicts the original spirit of the law. According to Open Notes, the original nonprofit that advocated for patients to have full access to their medical records, including visit notes, 21CCA mandates that healthcare providers offer patients access to all the health information in their medical records “without delay” and “without charge.”

Five Things You Can Do

There’s much to celebrate in the 21st Century Cures Act. Here’s how you can take full advantage of it.

1. Sign up for the patient portals your doctors offer and set up automatic notifications to your primary email account. Then pay attention to those notifications every time it says you have a new test result. Full and instant access to your test results means you can check if that MRI or prostate cancer test result has been received. If you’re expecting a test that’s not upload to your portal, you can get your doctor’s staff to track it down or contact the lab yourself. Errors can still happen but the odds are reduced when patients use the portal.

2. Unless you’re concerned about receiving life-altering news, read the reports. They will always tell you if your results are within the expected parameters or not. Also, if you have been tested by the same healthcare system before, the portal should be able to compare the new results to your old results. If your lab report shows flags or out-of-reference-range results, the portal may give you links to explain those out-of-range numbers or you can visit AAAC’s website LabTestsOnline.org to learn how to read your lab report. It has lots of information about the lab tests you’ve been given, and about different types of tests by medical condition. If you are scheduled for an imaging test (i.e., MRI, Ultrasound, Mammogram, CT scan), there’s another reliable website run by the Radiological Society of North America, Inc. (RSNA). They explain the different types of tests, how to prepare, and help you to read and understand your imaging test report. They also have a thorough A-to-Z list of tests and medical conditions.

3. Download the results and save them on your computer, smartphone or in the cloud. Or print them out and keep them all in a folder. Then you can keep track of worrisome results and bring them in to discuss with your doctor.

4. If you have questions and your doctor’s staff doesn’t call you to discuss the results within two to three business days, call them or email them through the portal and ask for an explanation. If you still don’t get a response –– an ongoing problem given the shortage of clinicians –– make a telehealth appointment.

5. Do not ask random people on Facebook or Twitter to explain your results. Without your full medical history and a medical degree, they’re just guessing or sharing what it meant for them. They’re not you. You deserve real answers.

© Helene M. Epstein 2024