Telemedicine: Part III – Regulation
Healthcare is arguably the most heavily regulated endeavor in our society. Anything touching upon healthcare by definition touches upon telemedicine and is thus subject to the myriad of existing regulations in place. Because telemedicine also involves aspects of telecommunication, that regulatory framework is implicated as well. For obvious reasons, any discussion of the telemedicine regulatory framework in anything less than a multi-volume treatise is inadequate. In this installment, we aim to merely highlight those regulatory areas receiving the greatest attention currently in the field of telemedicine, with the caveat that what is here is far from exhaustive.
The areas we will be commenting on are Medicare and the False Claims Act; state regulatory frameworks, the privacy and security rules of HIPAA and its Wisconsin counterpart, Wis. Stat. § 146.82; licensure and credentialing; and standard of care concerns. Each of these will be summarized here and explored in greater detail in future articles.
Medicare, while directly applicable to a smaller defined set of patients, sets the standard for reimbursement for the vast majority of third party payments making its views on reimbursement for various services disproportionally large. Not only do many providers depend on accurate and timely Medicare payments to survive, Medicare has been a primary focus of enforcement action under the False Claims Act. The False Claim Act imposes liability on those who would defraud the government. This law was deemed applicable to submitting claims to Medicare and Medicaid in a 1996 case out of Massachusetts, Franklin v. Parke-Davis. Since that time, Medicare and Medicaid fraud has grown to nearly fifty percent of all False Claim Act prosecutions. Given the draconian penalties associated with even inadvertent overbillings, and the fact that many of these cases are instituted by whistleblowers, makes compliance with Medicare billing regulations a particularly sensitive topic for telemedicine practitioners where the rules are sometimes less clear.
Also relevant to reimbursement are the Telehealth Parity laws. Presently 29 states have some form of parity law on the books. Wisconsin does not. These laws range from simple requirements that audio-visual appointments be reimbursed at the same rates for in-person visits to far more involved provisions outlining both providers and scope of services to be covered. Legislation has been introduced to Congress, the Telehealth Parity Acts of 2014 and 2015, designed to streamline or eliminate some of the Medicare barriers to reimbursement for telemedicine services and further define and expand covered practitioners.
While lagging behind federal counterparts, such as Medicare, state regulatory bodies are getting involved in telemedicine as well. While one would naturally presume such to be the case, this has become a major battleground between those who wish to advance telemedicine and those who seek to preserve a status quo. Actions from regulatory bodies have taken the form of both rule adoption and enforcement actions against practitioners of telemedicine. In a particularly egregious case out of Idaho, the Idaho Board of Medicine imposed not just discipline but a license restriction on a telemedicine provider whose transgression was to prescribe a common antibiotic to a patient without having had a face-to-face meeting. Telemedicine providers have been fighting back against these regulatory activities; legal practitioners in this area are closely watching the case of Teledoc v. Texas Medical Board unfold where a large telemedicine provider is alleging antitrust claims against the state regulatory body.
Privacy and security are always key concerns to health care practitioners. Given the centrality of technological communications to the telemedicine industry, it is no surprise that telemedicine is receiving a lot of attention in this area. Particularly problematic are concerns such as the cross-reliance on other providing institutions’ systems requiring carefully crafted business associates agreements and the growing expectation from patients that they be able to communicate with their providers through less-than-perfectly-secure channels. Complicating this analysis are the similar, but not identical, requirements of the federal law, HIPAA and its state counterpart, Wis. Stat. § 146.82.
Quality of care and accountability for that care are always central to the healthcare delivery. These prescriptions exist in medical malpractice law as well as within regulatory frameworks. In Wisconsin, practitioners are required to exercise the care, skill and judgment that is exercised by other similarly situated professionals given due regard for the state of medical science at the time the care was delivered. Large questions loom about how the state of medical science will be impacted by various technologies in use with telemedicine. State regulators oversee practice standards for licensed professionals including physicians, nurses and behavioral health professionals. Many mid-level providers work within scope of practice rules. Additionally, the Drug Enforcement Agency has oversight on many aspects of prescriptive practices. Providers must be appropriately credentialed at all institutions that make use of their services. In each of these aspects that are in place to assure patient safety and standards of care, it is easy to see the special challenges of compliance that telemedicine can pose.
These are some of the most basic regulatory concerns telemedicine providers need to be aware of. In future articles, we will expand on some of these principles. If you have questions concerning these or any regulatory issues, feel free to contact us.