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
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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
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…
ONC’s HTI-1 Final Rule Updates Information Blocking Regulations
On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” and known as “HTI-1” (Final Rule). Among other issues addressed in the Final Rule, ONC revised the information blocking rules to add…
DOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities
On November 15, 2023, the U.S Department of Justice (DOJ) announced a $45.6 million consent judgment (Settlement) with six skilled nursing facilities (SNFs), as well as the owner of the SNFs and its management company which managed the SNFs, to resolve alleged violations of the False Claims Act (FCA) tied to medical director arrangements violating…
New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process
On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of larger legislative changes to the Public Health Laws passed in 2021. The new HEIA requirement applies…
CMS Announces 0.8 Percent Aggregate Home Health Payment Increase in 2024
On Wednesday, November 1, the Center for Medicare & Medicaid Services (CMS) released its Home Health Prospective Payment System Rate Update final rule for CY 2024 (the Final Rule). The Rule estimates that the aggregate increase to Medicare home health payments for 2024 will be 0.8 percent, or $140 million. This 0.8 percent increase results…
HHS Proposes Disincentives for Providers that Commit Information Blocking
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector…