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Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).

Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a medical practitioner to conduct at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. There are seven exceptions, one of which is during a public health emergency.

For the past three years, many telehealth providers have become accustomed to prescribing controlled substances following a telehealth visit, without first conducting an in-person exam.

With the PHE coming to an end in May, an in-person exam will be required. However, the Drug Enforcement Agency (DEA) has proposed rules to that will create additional flexibilities on the timing and manner for obtaining an in-person exam.

Federal Register

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Telehealth Expansion in Texas

The COVID-19 pandemic forced many patients and practitioners to find new ways to connect. The most obvious tool is telehealth, the use of audio-visual platforms to allow practitioners to assess and communicate with patients remotely. Patients and practitioners both were encouraged by how beneficial and flexible telehealth can be. Federal and state governments alike are rushing to loosen restrictions to usher in wider adoption of telehealth tools. The Texas Legislature passed, and Governor Abbott signed, two telehealth bills that aim to provide greater access to care with telecommunication technology.

SB 40 expands the Texas Occupations Code to make permanent certain waivers granted by Gov. Abbott during the pandemic. For practitioners regulated by the Texas Department of Licensing and Regulation (TDLR), the definition of “direct” patient observation now allows the use of telehealth platforms. It also allows TDLR to adopt rules governing telehealth services that are provided by its regulated professionals.

HB 4 expands the Government Code and the Health and Safety Code to give practitioners more flexibility to use telehealth services with Medicaid, CHIP, and other public benefit program recipients. Health and Human Services Commission (HHSC) is tasked with implementing greater telehealth integration by the end of this year. Medicaid Managed Care Organizations (MCOs) are granted greater flexibility to conduct assessments and provide coordination of care services through telecommunication technology. Rural access hospitals and federally qualified health centers (FQHCs) are also eligible for reimbursements of telehealth fees.

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Patient Recruiter Convicted in $2.8 Million Telemedicine Scheme Against Medicare

The owner of an Orlando-area telemarketing call center was convicted for his role in a kickback scheme involving expensive genetic tests and fraudulent telemedicine services that resulted in the payment of approximately $2.8 million in false and fraudulent claims to Medicare.

Ivan Andre Scott, 34, of Kissimmee, Florida was convicted after a four-day trial of one count of conspiracy to commit health care fraud, three counts of health care fraud, one count of conspiracy to defraud the United States and pay and receive health care kickbacks, and three counts of receiving kickbacks.

The evidence showed that Scott targeted Medicare beneficiaries with telemarketing phone calls falsely stating that Medicare covered expensive cancer screening genetic testing, or “CGx.” The tests could cost as much as $6,000 per test. After beneficiaries agreed to take the test, the evidence showed Scott paid bribes and kickbacks to telemedicine companies to obtain doctor’s orders authorizing the tests.

Between November 2018 and May 2019, labs submitted more than $2.8 million in claims to Medicare for genetic tests Scott referred to them, of which Medicare paid over $880,000. In that timeframe, Scott personally received approximately $180,000 for his role in the scheme.

Source: Patient Recruiter Convicted in $2.8 Million Telemedicine Scheme Against Medicare

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HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health Law Blog

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OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty

In its final rule, the OIG defined what constitutes “telehealth technologies” more broadly than in its proposed rule, but otherwise chose to track the conditions for the exception contained in the underlying statute and not to implement any of the additional conditions that were included in the proposed rule.

Source: OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty