During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine. As reported in prior editions of the Quarterly Roundup, telemedicine is an expanding field, causing DOJ to pay particular attention to the industry.

In April 2019, DOJ indicted the owner and operator of 1stCare MD and ProfitsCentric with one

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success.

  1. Be accurate about quality.

Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.

Tech companies and non-traditional health industry players should take careful stock of the health sector’s unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.


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The federal government has offered substantial incentives to providers to adopt and use certified electronic health record (EHR) technology. As of October 2018, the federal government had paid over $38 billion in EHR incentive payments through the Promoting Interoperability Program (formerly, the Meaningful Use Program). Other federal health care program policies also encourage use

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments

The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and Human Services (OIG) describing inappropriate payments to physicians under the program. The report follows on the heels of a high-profile settlement under the False Claims Act between the US Department of Justice and an EHR vendor related to certified electronic health record technology (CEHRT) used in the EHR Incentive Program (which we’ve previously discussed in-depth).

The OIG reviewed payments to 100 eligible professionals (EPs) who received EHR incentive payments between May 2011 and June 2014 and identified 14 inappropriate payments. OIG extrapolated the results of the review to the 250,470 total EPs who received incentive payments during that time period and estimated that CMS made approximately $729 million in inappropriate EHR incentive payments out of a total of just over $6 billion in such payments during the review period.
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As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas,

Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, as it removes the controversial “face-to-face” or in-person consultation requirement to establish a physician-patient relationship and lawfully provide telehealth and telemedicine services within the state. This bill comes after a six-year-long battle between telemedicine stakeholders and