TechHealth Perspectives

Insights on the Laws and Regulations Related to New Health Technologies

On February 14, 2019, the Centers for Medicare & Medicaid Services (“CMS”) announced the Emergency Triage, Treatment and Transport reimbursement model (the “ET3 Model”), a demonstration project that aims to provide improved flexibility to ambulance crews addressing 911-initiated emergency calls for Medicare beneficiaries. CMS plans to release its Request for Applications (“RFA”) to solicit participation in the ET3 Model from Medicare-enrolled ambulance providers and suppliers in the summer of 2019. The ET3 Model start date…
The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a pharmaceutical manufacturer could temporarily loan a limited-functionality smartphone to financially needy patients enrolled in federal health care programs. OIG concluded…
The telehealth industry has experienced constant developments in the regulatory landscape at both the federal and state level over the past several years, and we are confident these changes will continue into 2019 as the utilization of telehealth services continues to evolve and mature. A notable area of activity is how regulators are approaching the telehealth industry, in particular remote prescribing applications of this platform. On the federal level, we should expect to see promulgation…
The SUPPORT for Patients and Communities Act (“the Act” or “the SUPPORT Act”), signed into law by President Trump on October 24, 2018, is intended to combat the growing opioid crisis in the United States. The Act aims at preventing opioid addiction and misuse and enhancing access to care for those who have substance use disorders. A key aspect of the Act is the expanded Medicare coverage of telehealth services to beneficiaries in…
The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)) (the “Ryan Haight Act” or “Act”) expanded the federal Controlled Substances Act to define appropriate internet usage in the dispensing and prescribing of schedule drugs, and in doing so effectively banned the issuance of prescriptions via telemedicine services for any controlled substances unless the ordering physician has conducted at least one in-person evaluation of the patient. The Act includes multiple exceptions that permit prescribing…
At first blush, the passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), appears to address the issue concerning the lack of regulatory guidance regarding the “Special Registration” exception to the Ryan Haight Act of 2008; however, a deeper and more careful analysis reveals that the Bill may not be as effective as most health care practitioners may hope. The Bill, sponsored by Rep. Carter (R-Georgia),…
Effective June 11, 2018, all Department of Veterans Affairs (“VA”) health care providers will be able to offer the same level of care to all beneficiaries regardless of the beneficiary’s or the health care provider’s location. In its recently released final rule, the VA stated that in December 2016 Congress mandated that the agency provide veterans with a self-scheduling, online appointment system, and that the agency meet the demands for the provision of health…
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently released a report revealing that during OIG’s 2014 and 2015 audits of telehealth claims, more than half of the professional telehealth claims paid by the Medicare program did not have matching originating-site facility claims. According to the report, Medicare telehealth spending increased from $61,302 in 2001 to $17,601,996 in 2015. Among the 191,118 Medicare paid distant-site telehealth claims (totaling $13,795,384), the…
In March 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) made its 2018 report to Congress, which included the Commission’s evaluation of telehealth services provided through the Medicaid program. Chapter 2 of MACPAC’s report had a positive outlook on telehealth’s contribution toward better accessibility of health care services to underserved individuals as well as individuals with disabilities. Unlike its larger counterpart, Medicare, federal policy has not placed many restrictions on state Medicaid programs…
Our collegues Helaine Fingold, Daniel Kim, and Amy Lerman at Epstein Becker Green have a post on the Health Law Advisor blog that will be of interest to many of our readers: “CHRONIC Care Act, Title III of the Bipartisan Budget Act of 2018, Signals Meaningful Change for Medicare Advantage Plans and Telehealth Coverage.” Following is an excerpt: “…[T]he [Bipartisan Budget Act of 2018 (BBA)] includes certain provisions taken from the CHRONIC…