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On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of action” with respect to the prescribing of controlled substances via telemedicine. DEA is issuing a limited extension in order to give itself more time to finalize new standards governing tele-prescribing of controlled substances.Continue Reading DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in excess of 38,000 comments on its March 1, 2023 proposed rules (previously discussed here) to extend certain of those flexibilities but allow others to end upon expiration of the COVID-19 public health emergency on May 11, 2023.  The Temporary Rule provides the DEA with additional time to assess feedback on its proposed rules for post-pandemic tele-prescribing, and provides practitioners and patients with additional time to utilize pandemic-era flexibilities and to transition away from such flexibilities once final rules are issued.Continue Reading DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic.  The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination (Tele-Prescribing Rule), and (2) expansion of buprenorphine prescribing via telemedicine encounters (Buprenorphine Rule).  Below please find a high-level summary of the Tele-Prescribing Rule.  A separate post will follow addressing the Buprenorphine Rule in detail.Continue Reading As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for his role in a kickback scheme. The sentencing follows a plea agreement by Mr. Bojorquez in which he pleaded guilty to conspiracy to violate the federal anti-kickback statute. According to the DOJ and court documents, Mr. Bojorquez, through his company, provided marketing services to various compounding pharmacies. Mr. Bojorquez’s company conspired with the compounding pharmacies to pay kickbacks to physicians in exchange for those physicians referring prescriptions to the compounding pharmacies. The compounding pharmacies then paid Mr. Bojorquez (through various shell companies) a percentage (approximately 45%) of the fees generated from the prescriptions referred by the physicians. The pharmacies billed and received payment from the US Department of Labor’s (DOL) Office of Workers Compensation Program, which is a federal health care benefit program. Over the course of the conspiracy, the DOL paid over $8 million for the kickback-induced prescriptions.
Continue Reading Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

Excerpt of a contributed article published in Medical Economics on November 18, 2020.

Past Special Fraud Alerts have portended heightened enforcement activity.

On November 16, 2020, the Office of Inspector General of the Department of Health & Human Services (OIG) issued a Special Fraud Alert (Alert) highlighting the fraud and abuse risks posed by speaker…

The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an in-person visit due to the COVID-19 pandemic. DCP explains that “practitioners may issue prescription refills for controlled substances using their professional discretion for a patient under their care without seeing the patient in-person within certain parameters.” The parameters are as follows:

  • Schedule-Specific Requirements for Controlled Substance Prescriptions
    • Schedule II prescriptions cannot be refilled; however, practitioners with a pre-existing relationship with a patient who have prescribed a particular controlled substance for the patient previously can reissue the prescription without an in-person visit. Additionally, no prescription for a Schedule II controlled substance can contain more than one (1) prescription.
    • Schedule III and IV prescriptions can be refilled up to five (5) times every six (6) months as authorized by the prescribing practitioner.
    • Schedule V prescriptions can be refilled as authorized by the prescribing practitioner.

Continue Reading Connecticut DCP Issues Guidance for Remotely Refilling Prescriptions

Massachusetts executive agencies have been issuing an array of further guidance to the healthcare provider community regarding COVID-19.  All orders and guidance are available at https://www.mass.gov/2019coronavirus. Review of this website and CDC websites for periodic updates is strongly encouraged, as the situation is fluid and continually evolving.
Continue Reading Massachusetts COVID-19 Guidance for Health Care Providers, Payors and Laboratories on Issues Including Telehealth, Elective Procedures, COVID-19 Testing, and Provider Licensure