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 August 8, 2023, the Connecticut Supreme Court issued opinions in Mills v. Hartford HealthCare Corp. and Manginelli v. Regency House of Wallingford, Inc. that addressed the scope of immunity for health care workers and facilities under Governor Ned Lamont’s Executive Order No. 7V. Executive Order No. 7V provided immunity for health care professionals and facilities from civil suits when providing health care services in support of the state’s COVID-19 response. Interestingly, the Mills ruling notes that this was the first time the Connecticut Supreme Court addressed the principles that govern interpretation of executive orders. Summaries of these two decisions appear below.Continue Reading Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7V

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.

Below is an excerpt of an article co-authored with Robinson+Cole Labor and Employment Group lawyer Sapna Jain and published in the April/May 2023 issue of the Massachusetts Bar Association’s (MBA) eJournal. Yelena and Sapna will also be presenting an informative MBA webinar on the same topic on May 10, 2023.

Health care staffing continues

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

As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023.  On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a Report entitled, “Labs With Questionably High Billing for Additional Tests Alongside COVID-19 Tests Warrant Further Scrutiny” (Report).  The Report discusses why the study pertaining to the billing of additional tests alongside COVID-19 testing was conducted, how it was conducted, and what the key takeaways of the study are.  This was followed by OIG’s issuance in mid-December of a Data Brief reviewing Medicare Part B spending on lab tests entitled, “Medicare Part B Spending on Lab Tests Increased in 2021, Driven by Higher Volume of COVID-19 Tests, Genetic Tests and Chemistry Tests” (Data Brief). Continue Reading OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests