The rapid shift to reliance on digital healthcare technologies has successfully produced convenient ways to diagnose and treat patients. However, that shift comes with its share of telehealth legal issues that clinicians and practitioners must address. This article will explore the current climate of digital health regulation to inform providers of critical issues to move forward with the necessary awareness.
Telehealth Legal Issues
The telehealth boom called for the creation of a variety of temporary waivers, executive orders, and regulations that would apply in the medical field. However, there is still uncertainty concerning licensure and reimbursement. Now that many of these temporary rules are set to expire, clinicians and practitioners are keenly interested in digital health regulation and the doors that will open or close moving forward.
For example, the Centers for Medicare & Medicaid Services (CMS) Medical Physician Fee Schedule Final Rule of 2023 made specific temporary measures permanent. However, there is no guidance regarding the Ryan Haight Act, which involves controlled substances prescribed via telehealth without an in-person examination. See Telehealth.org’s previous article Telehealth Opioids, and Ryan Haight Act Update, for more information. There have also been changes on the state level regarding telehealth delivery. Specifically, many states have removed restrictions concerning digital communication methods like email, phone, texts, etc.
Companies that develop medical software devices should know the FDA’s digital health regulation actions. The FDA has been publishing multiple resources clarifying its expectations regarding medical software development.
Although the FDA is still developing these resources, software creators can proactively determine expectations by engaging in FDA premarket submissions. The FDA is also expected to finalize its guidance resources on Clinical Decision Support software before the end of the year. This software helps clinicians and practitioners educate patients on their healthcare options. Once the guidelines are released, developers will better understand the FDA’s expectations.
Privacy and Cybersecurity
Privacy and cybersecurity are other important telehealth legal issues. During the COVID health crisis, there were several instances where individuals attempted to apply HIPAA laws to protect information outside of its scope. While the Office for Civil Rights (OCR) guided the operation of drive-through test and vaccination sites and telehealth protocol, some medical professionals took the legislation to apply to cybersecurity issues. This has caused many clinicians and practitioners to apply HIPAA as a best practice, whether it is integral to their business model or not. While this may seem admirable, it can result in false claims under federal and state laws.
As a result, companies that fall outside the OCR jurisdiction will be scrutinized. They will be examined closely regarding how they share private information and whether they have insurance to protect them from cybersecurity attacks.
Fraud and Abuse
During the pandemic, the increase in digital healthcare created the need for temporary waivers and flexibilities. However, the response to these temporary actions is not entirely positive. For example, the HHS Office of the General Inspector (OIG) issued a policy statement making clinicians and practitioners aware of new cost-sharing obligations incurred for telehealth services consistent with appropriate coverage and payment rules put in action during the pandemic. And while the OIG sees the benefits of telehealth, they are currently reviewing it, particularly regarding Medicare and Medicaid requirements for documenting and billing home health services. See Telehealth.org’s article Telehealth Home Health for more information.
There have also been various fraud and abuse telehealth legal issues that have appeared during the pandemic. One major incident was Operation Rubber Stamp which occurred in October 2020. In this case, the Department of Justice investigated 345 practitioners and clinicians across 51 federal states for fraudulent medical activity. The activity resulted in the revocation of Medicare billing privileges for over 250 medical professionals. This fraudulent activity has resulted in strict digital health regulations, including ongoing audits and systems examinations that may result in high costs and patient harm.
Antitrust Telehealth Legal Issues
The new digital healthcare climate has produced an atmosphere of antitrust. With two heavily targeted industries coming together, healthcare and technology, the Federal Trade Commission (FTC) will be devoting more of its resources to investigating clinicians and practitioners in the digital healthcare field. The Department of Justice is also doing its part to keep an eye on the industry. The organizations are focusing on a corporate crisis in America that may be detrimental to competition. As a result, digital healthcare companies should be paying close attention to how they handle joint ventures, even if those transactions don’t affect their competition.
Essential Telehealth Law & Ethical Issues
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