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
Below is an excerpt of an article published in the May 2023 issue of Health Law Connections, the member magazine of the American Health Law Association. Kate and Conor were assisted on this article by Health Law Group intern Paul Sevigny.
COVID-19 has driven increased telehealth access and technology-based health care services.
The Office of Inspector General (OIG) recently issued two notable compliance updates, of which health care organizations should take note as the COVID-19 public health emergency ends and regulatory compliance activities ramp up.Continue Reading OIG Compliance Updates
On April 11, 2023 – one month in advance of the end of the COVID-19 public health emergency (PHE) on May 11, 2023 – the federal Office for Civil Rights (OCR) confirmed that various Notifications of Enforcement Discretion issued under HIPAA during the PHE will expire at the end of the day on May 11, 2023.Continue Reading OCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.
Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
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 November 4, 2022, the Centers for Medicare & Medicaid Services (CMS) published the calendar year 2023 Home Health Prospective Payment System Rate final rule, which updates Medicare payment policies and rates for home health agencies. Some of the key changes implemented by the final rule are summarized below.Continue Reading CMS Issues Calendar Year 2023 Home Health Final Rule
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate officers, resolving alleged violations of the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly referred to as the “Stark Law”). One case settled claims that Carter had made improper payments to referring physicians in Oklahoma and Texas, while the other case settled claims that Carter had made false billing claims in Florida. Both matters were initiated by qui tam whistleblower complaints filed under the FCA. Carter agreed to pay more than $30 million to resolve the allegations.Continue Reading Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million
A physician in Washington state pled guilty on September 28, 2022, to a criminal charge of conspiring to accept kickbacks related to fraudulent genetic testing. According to the Department of Justice (DOJ), the physician ordered certain genetic testing for Medicare beneficiaries that he was not treating and with whom a physician-patient relationship was not established as part of the scheme. According to the plea agreement accepted by the physician, the physician would be connected by telemarketers to the beneficiaries for a few minutes, the physician would order the diagnostic test, the labs would then bill for the test, and another company billed Medicare for the purported telemedicine visit. The physician received almost $168,000 in kickbacks for ordering the medically-unnecessary testing and other services, which resulted in over $18 million being paid by Medicare.Continue Reading The DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth