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On December 13, 2016, Congress passed the 21st Century Cures Act, which, among other things, sought to promote electronic health record (“EHR”) interoperability by prohibiting the practice known as “information blocking” – where an EHR prevents the sharing of electronic health information (“EHI”). In addition, the Act sought to promote patient access to their own EHI. In May, 2020, the Office of the National Coordinator for Health Information Technology (the “ONC”) published a final implementing rule for compliance by April 5, 2021.

Health care providers (including physicians), health information exchanges (HIEs), health information networks (HINs), and software developers must share with patients a specified range of information with some exceptions. While the right of a patient to access their records already exists under HIPAA, this new rule requires that information to be provided to patients immediately, such as through a patient portal. The regulations are complex, and include similar terminology to that used in the HIPAA regulations, but with different definitions (e.g., a “health care provider” is defined differently under the two sets of rules). Blocking of data includes the delay of data availability.

As a practical matter, health care providers must examine their policies and procedures, and revisit how and when they provide patients access to their EHI. This issue may be especially concerning to physicians who are not used to providing patients with such wide-ranging access to their records, or who otherwise place limits on how and when information is shared with patients. (e.g., “We don’t send lab results to the patient portal until 2 days after the doctor has reviewed them.”) Existing practices and policies that may restrict patient access to information will need to be carefully considered. Dan has developed a DFS List as a practical checklist to begin confronting this challenge.

Physician and other practitioner documentation of Medicare services has been made easier. In the 2020 Medicare Physician Fee Schedule, regulations now permit a physician to merely review and verify (by signing and dating) notes in a patient’s medical record that were made by other members of the medical team, including students, rather than re-documenting the notes. This change both shortens the time physicians spend documenting, will cut down on “note bloat,” where physicians and other health care practitioners have had to reiterate past notes to otherwise comply with documentation requirements. These new rules do not apply only to E/M services: they apply regardless of the type of services including diagnostic testing and procedures. Physicians, however, still need to be careful regarding how they document their services, and ensure that their documentation can withstand scrutiny by auditors.

As new rules go into effect for documenting E&M Codes, the government is now offering what they consider a more streamlined approach to documenting based on the medical decision-making. We are neither clinicians nor coders, but their rules don't seem so simple to us. They have offered a variety of guidances about how to document based on medical decision-making, but for the other option, documenting on time alone, they have offered almost no guidance as to what records are required. First, all clinicians documenting E&M services must be sure that the scope of the service they render was medically necessary. You can spend the time of a level 5, when that service is not appropriate for the patient's condition, a problem your good documentation cannot cure. Assuming the time spent with the patient has been necessary, using the suggested timeframes associated with the levels 2-4 now combined and level 5, we suggest that clinicians take a page out of the lawyers' playbook and keep hour sheets. This is a discipline that most young lawyers have to learn. The quality of time-keeping is directly associated with how contemporaneous the documentation is to the time spent. We suggest documenting time spent both in the medical record and on separate hour sheets.

Because of COVID-19, CMS issued an emergency waiver of certain telehealth requirements, and made additional changes in coverage and reimbursement for a range of telehealth services. Physicians can be paid for the performance of certain telephone visits for both new and established patients; telehealth services no longer need to be provided only in rural settings only; additional telehealth visits may be performed more frequently than previously; nursing home residents may be “visited” using telehealth instead of requiring in-person visits; and direct supervision for services may be provided virtually using real-time audio-video technology. These and other changes are shifting how care is provided to patients for the duration of the federal COVID-19 emergency declaration (still in effect, as of November, 2020). In a video interview, Dan discusses how COVID-19 and increased usage of telemedicine has changed how health care practitioners are caring for their patients now, as well as what may come in the future, in a video interview with Infection Control Today. As he has observed, with health care providers forced to meet with patients remotely, the health care industry is learning just how effective and efficient telemedicine can be. As a result, it is likely that telemedicine will become more widely covered and, hopefully, reimbursed at equal rates in comparison with in-person visits. Watch the 15 minute interview for more of Dan’s thoughts on this issue.

While we previously noted the arrival of the draconian EKRA statute, passed in dark of night, enforcement has begun. Among the earliest settlements announced by the Department of Justice was a conspiracy to broker patients to recovery centers. While we don't think our clients would engage in such activities, the point of reporting these settlements and guilty pleas is that the government will enforce and whistleblowers are likely to pay attention to the less scandalous challenges this law presents to otherwise law abiding providers.