The 21st Century Cures Act: What a difference a day makes

By Warren R. Heymann, MD, FAAD
Sept. 24, 2025
Vol. 7, No. 38

The 21st Century Cures Act (Cures Act, CA) was signed into law on Dec. 13, 2016. (1) In April 2021, the Information Blocking Rule (IBR) of the CA went into effect, giving patients immediate access to notes, radiology reports, laboratory results, and surgical pathology reports. (2) How has the CA affected your practice?

I was very anxious about the ramifications of the IBR when it became enforced. Would we be deluged by portal messages left by worried patients questioning the meaning of their reports? Four years into the CA offers some perspective.

The current era of health care is characterized by shared decision making between patients and clinicians, with patients desiring unrestricted access to their medical records. Although patients who are confused or upset about a laboratory report may not submit a formal complaint, a retrospective study comparing the number of unsolicited patient complaints at a single academic institution before and after implementing the immediate release of electronic records was performed. No change in the overall rate of patient complaints before and after the CA policy was implemented was found. (3,4)

Congelosi et al. surveyed surgeons, advanced practice providers, and clinic nurses in their surgical department before implementing the IBR; a follow-up survey occurred 3 months later. Although 43.9% of respondents reported that the CA had changed their practice, there was no difference in self-reported electronic health record usage, preferred method of interaction with patients, overall workload, or burnout. Initial concerns regarding the IBR’s effect on job satisfaction, patient anxiety, and quality of care had lessened. (2)

Although diagnostic errors are often multifactorial, failure to complete diagnostic tests and referrals (“loop closure”) is a well-recognized contributory factor. Bell et al reported that in 12,849 tests/referrals, loop closure was more common among Portal+Note-readers compared to their counterparts for all tests/referrals (54.2% No Portal, 57.4% Portal Account Only, 61.6% Portal+Notes, P < .001). I agree with their supposition that patients registering for the portal and reading their notes are more “activated,” and, therefore, more likely to close testing/referral loops. The authors conclude, “Compared to no portal registration, the odds of loop closure were 20% higher in tests/referrals for patients with a portal account, and 40% higher in tests/referrals for note readers, after controlling for sociodemographic and clinical factors. However, important safety gaps from unclosed loops remain, requiring additional engagement strategies.” (5)

Falitico et al. compared the emotional component of 505 portal messages obtained pre-versus-post-CA mandate in 2021. Positive sentiments included trust and anticipation; negative sentiments were anger, disgust, fear, and sadness. “Dermatology patient messages were significantly more negative post-mandate, with fewer expressing trust. Message content showed patient confusion and difficulty interpreting test results. Therefore, automatically releasing results without dermatologist counseling may increase patient stress and threaten physician-patient relationships.” (6)

Responding to the IBR, many radiology departments are investigating methods to improve patient communication by making reports more patient-friendly. (3) A study of prostate cancer patients demonstrated that participants could not extract basic information — including whether they have cancer — from standard prostate cancer pathology reports but were able to understand this diagnostic information from patient-centered pathology reports (PCPRs). Additionally, patients discriminated between risk levels (lower levels of perceived worry in the low-risk condition) with PCPRs compared with standard reports. (7)

My trepidation about the IBR has proven unjustified. Perhaps it is because of how I set patient expectations. (Dambrino calls this “precounseling.” [4]) I tell patients they will get the laboratory reports after I interpret them, even though they may see them first. I prefer it that way to avoid any confusion or alarm. Most — not all — patients comply with that request. (As an aside, some patients exclaim, “So If I don’t hear from you, everything is okay?” I reiterate that they should always get the results of every laboratory study they ever obtain. It is too easy to fall between the cracks.) I also remind patients to call me if they have not heard from me within a couple of days of obtaining the requested study. Tests may not be obtained for weeks to months after prior authorizations or scheduling issues. After waiting a month for a study, will discussing the results a day later be detrimental? As for generating dermatopathology PCPRs, I need to give that more thought. There are innumerable variables and ambiguities in dermatopathology. How would I construct PCPR on an atypical Spitz nevus, a questionable dermatofibrosarcoma protuberans, or explain parapsoriasis? (8)

The IBR of the CA is here to stay. More studies are being published about its effect on patients and clinicians — perhaps with enough data, the law could be modified. If I had my druthers, I would request that patients have complete access to their studies 24 hours after their release to the requesting clinician. Dinah Washington was correct —

What a difference a day makes
24 little hours
Brought the sun and the flowers
Where there used to be rain

Point to Remember: The Information Blocking Rule (IBR) of the 21st Century Cures Act has been in effect for four years. The impact of this rule is being assessed, and suggestions to improve its implementation will be forthcoming.

Our expert’s viewpoint

Lorraine Rosamilia, MD, FAAD
Medical dermatologist, DuBois Dermatology & Cosmetics and DermDox Dermatology Centers Telehealth in central Pennsylvania

When I wrote a commentary on this topic in 2021 (9), ‘trepidation’ was a common feeling amongst us all. Luckily, as Dr. Heymann comments, real data about the current implementation and practical consequences of the IBR morphs our trepidation into a digestible feeling of ‘resignation.’ Moreover, judicious portal communication for the purpose of ‘closing the loop’ for shared patient care is always a step forward.

As for any IBR nuances, there were provisions made at the end of 2024 to protect patients and physicians regarding reproductive health-related documentation and testing. (10) Also, Kentucky and California enacted state laws that allow for some delay in result release particularly with malignancy-related testing, and the AMA drafted model legislation as a tool for other states’ potential policies. (11) Otherwise, efforts by physician groups to clarify the IBR definition of the ‘preventing harm’ exception were not implemented, despite hopes that it could place the physician determination of their own patients’ risk of harm back into the discussion to preserve patient trust. Further, IBR violation disincentives were finalized in July 2024 (12), delineating physician penalties in MIPS and other reimbursement diminutions, so its enforcement now seems much more real and relevant.

Spending more time in the exam room warning patients that “you may receive results before I do” and “your results deserve my time and thought, and I will always relay them to you with our next steps” is a small but measurable burden, especially when patients may ignore these preemptive efforts and send frantic portal messages at 11 p.m. anyway. Alas, we have adjusted. But should we? Patients should obviously have the right to access and transfer their records as they choose, and EHRs and health systems should provide facile and safe avenues for this to occur, but should that topic have breached our exam room time with each patient? How many more minutes per visit and time fielding portal messages should we spare?

Dr. Heymann’s song reference perfectly depicts the simplicity of a ‘fix’ for ethically complying with this complex rule. Allowing the 24-hour window for result release would give us some hope that federal policymakers honorably see us as human caregivers and not machines fueled and accelerated by pings and reimbursement carrots. That distinction is worth fighting for. “...What a difference a day made. And the difference is us.”

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References

1. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

2. Congelosi PD, Eid MA, Sorensen MJ. Surgical Providers' Perceptions of the Patient Portal: Before and After the 21st Century Cures Act. J Surg Res. 2023 Sep;289:234-240. doi: 10.1016/j.jss.2023.03.007. Epub 2023 May 4. PMID: 37148857.

3. Vincoff NS. Beyond the AJR: Study Finds No Increase in Patient Complaints After Implementation of the 21st Century Cures Act Information-Blocking Rule. AJR Am J Roentgenol. 2024 Aug;223(2):e2330656. doi: 10.2214/AJR.23.30656. Epub 2023 Dec 13. PMID: 38090806.

4. Dambrino RJ 4th, Domenico HJ, Graves JA, et al. Unsolicited patient complaints following the 21st Century Cures Act information-blocking rule. JAMA Health Forum 2023; 4:e233244

5. Bell SK, Amat MJ, Anderson TS, Aronson MD, Benneyan JC, Fernandez L, Ricci DA, Salant T, Schiff GD, Shafiq U, Singer SJ, Sternberg SB, Zhang C, Phillips RS. Do patients who read visit notes on the patient portal have a higher rate of "loop closure" on diagnostic tests and referrals in primary care? A retrospective cohort study. J Am Med Inform Assoc. 2024 Feb 16;31(3):622-630. doi: 10.1093/jamia/ocad250. PMID: 38164964; PMCID: PMC10873783.

6. Falotico JM, Shah A, Desai AD, Curtis KL, Lipner SR. Automatic release of dermatology test results is associated with increased negative emotions and decreased trust in a retrospective analysis of 505 electronic patient portal messages. J Am Acad Dermatol. 2023 Nov;89(5):1058-1060. doi: 10.1016/j.jaad.2023.06.047. Epub 2023 Jul 7. PMID: 37422016.

7. Lapedis CJ, Kurnot SR, Bergholtz SE, Owens SR, Hawley ST, Morgan TM, Zikmund-Fisher BJ. Knowledge and Worry Following Review of Standard vs Patient-Centered Pathology Reports. JAMA. 2025 Jan 2. doi: 10.1001/jama.2024.25461. Epub ahead of print. PMID: 39745765.

8. Heymann WR. Reply to "Shall we exclude parapsoriasis from the medical vocabulary?". J Cutan Pathol. 2021 Nov;48(11):1435. doi: 10.1111/cup.14121. Epub 2021 Aug 26. PMID: 34406669.

9. staging.aad.org/dw/dw-insights-and-inquiries/archive/2021/cures-act-immediate-pathology-report-release-to-patients

10. www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-protecting-care-access

11. www.ama-assn.org/system/files/model-bill-sensitive-life-changing-test-results-protection-act.pdf

12. www.ama-assn.org/system/files/hhs-provider-info-blocking-penalties-summary.pdf

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