In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions. On March 13, 2024, Indiana joined this trend as Indiana Governor Eric Holcomb enacted Senate Enrolled Act No. 9 (the Act). The Act mandates that, effective July 1, 2024, Indiana health care entities involved
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Forecasting the Integration of AI into Health Care Compliance Programs
This post was co-authored by Josh Yoo, legal intern at Robinson+Cole. Josh is not admitted to practice law.
Health care entities maintain compliance programs in order to comply with the myriad, changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial intelligence (AI) are…
Staying on Top of Medical Necessity and Marketer Compliance
Below is an excerpt of an article co-authored by Government Enforcement and White-Collar Defense Team co-chair Seth Orkand, published in G2 Intelligence on March 25, 2024 .
Recent enforcement actions have made clear that fraud, waste, and abuse is a continual concern of regulating agencies for the healthcare space, including for clinical laboratories.…
Status of 340B Payment Remediation and Manufacturer Litigation
Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.
The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”),[1] has experienced significant legal challenges over…
Remote Patient Monitoring Enforcement Initiatives
Below is an excerpt of an article published in the American Bar Association Health Law Section’s March 2024 Health eSource issue.
In recent years, there has been a significant increase in the use of digital technologies and innovative solutions in healthcare, including the increased use of remote patient monitoring (RPM) services. Telehealth and other digital therapies proliferated…
OCR Updates Online Tracking Technologies HIPAA Guidance
On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) updated its guidance on the “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” (Guidance). OCR’s Guidance was first published on December 1, 2022, and is the subject of a lawsuit brought by…
DOJ Announces New Whistleblower Compensation Pilot Program, Ratcheting Up Pressure on Corporate Voluntary Self-Disclosures
Below is an excerpt of a Robinson+Cole legal update co-authored by Government Enforcement and White-Collar Defense Team co-chair Seth Orkand and member David Carney.
On March 7, 2024, Deputy Attorney General (DAG) Lisa Monaco announced the contours of a new Department of Justice (DOJ) pilot program (Pilot) offering financial incentives to individual whistleblowers who…
CMS Updates Guidance to Allow Texting of Patient Orders
On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a quality standard memorandum (QSO Memo) updating and revising a memorandum it issued on January 5, 2018, to now permit the texting of patient orders among members of the patient’s health care team. CMS’s 2018 memorandum clarified CMS’s then-current position that texting…
HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42…
Health Care Transactions and Civil Investigative Demands: What Third Parties Need to Know
By Conor Duffy
Below is an excerpt of an article, co-authored with Antitrust and Trade Regulation Team lawyer Jen Driscoll and Internal Investigations and Corporate Compliance chair Ed Heath, published in the American Health Law Association’s Health Law Weekly newsletter on January 19, 2024.
Mergers and acquisitions in health care markets are viewed with heightened scrutiny by…