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
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New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care
On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the New York healthcare system, including home health, hospitals, laboratories, and reproductive health. It contains wide-ranging provisions…
Compliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?
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. After grappling with…
Addressing COVID-Related Staffing Shortages: Strategies To Recruit And Retain Employees
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 to be…
OIG Compliance Updates
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.
Changes to Form and Format of OIG Compliance Program Guidance
First, in an effort to modernize the accessibility and usability of publicly…
OCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023
By Conor Duffy
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,…
Stark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations
By Conor Duffy
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a regional hospital system (Hospital) and two individual physicians, respectively.
The Settlement resolves alleged violations of the False Claims Act (FCA),…
CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
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…
As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances
By Conor Duffy
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…
OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests
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”…