In its General Compliance Program Guidance (GCPG) issued in November 2023, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced its intent to publish industry segment-specific...more
On Jan. 17, 2024, McGuireWoods partners Kimberly Kannensohn and Sam Bernstein conducted a webinar regarding how the Health Insurance Portability and Accountability Act (HIPAA) applies to medical device companies and certain...more
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more
On Nov. 30, 2023, the Illinois Supreme Court, in Mosby v. The Ingalls Memorial Hospital et al., held that certain healthcare providers’ biometric data, used for healthcare operational purposes under the Health Insurance...more
On Oct. 31, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced it had settled with Doctors’ Management Services Inc. (DMS) over a self-reported ransomware attack that occurred in...more
On Oct. 25, 2023, in light of a “significant rise in the number and severity of cyber-attacks against hospitals and health systems in the last few years,” the U.S. Department of Homeland Security Cybersecurity and...more
On Nov. 1, 2023, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) issued a proposed rule, the “21st Century Cures Act:...more
On Oct. 27, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year (CY) 2024. The ESRD prospective payment system...more
On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more
On Oct. 13, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07 approving a multispecialty physician practice’s proposal to pay bonuses to each of its...more
On Sept. 11, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced that the Local Initiative Health Authority for Los Angeles County (LA Care) entered into a $1.3 million settlement...more
On June 23, 2023, the Department of Justice (DOJ) and Federal Trade Commission (FTC) announced a stipulated resolution with Easy Healthcare Corporation to address allegations that Easy Healthcare violated Section 5 of the FTC...more
Since mid-2022, the macro acquisition environment has faced the challenges of inflation and increasing interest rates, among a variety of other headwinds. Global deal flow is down from its 2021 peak. Yet, as this white paper...more
In an effort to formalize its Sept. 15, 2021, Statement of the Commission on Breaches by Health Apps and Other Connected Devices, as previously discussed in a McGuireWoods Oct. 5, 2021, alert, the Federal Trade Commission...more
In 2023, the Department of Health and Human Services (HHS) is expected to finalize proposed modifications to its regulations under the Health Insurance Portability and Accountability Act of 1996, as modified by the Health...more
The Department of Health and Human Services’ Office for Civil Rights (OCR) announced the expiration of its enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of 1996...more
On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons...more
Under a new California law, effective Jan. 1, 2023, physicians and their employers must begin notifying their California patients during a patient’s initial visit of the Open Payments database, and documenting such notice in...more
Rule Addresses Rate Increases, Outlier, Add-On and ETC Model Payments, Oral-Only Drugs and QIP Reporting -
On Oct. 31, 2022, the Centers for Medicare & Medicaid Services issued a final rule implementing an increase in...more
On Feb. 28, 2022, the Center for Medicare and Medicaid Innovation (CMMI) published a Request for Applications for the second cohort of the Kidney Care Choices (KCC) Model, including the Centers for Medicare & Medicaid...more
In response to the COVID-19 public health emergency (PHE), many states expanded access to healthcare via telehealth through regulatory waivers. Experts have speculated how governments will regulate and reimburse telehealth...more
On May 7, 2021, the operator of a major pipeline system that transports fuel across the East Coast fell victim to a ransomware attack that resulted in a six-day shutdown. Over the following week, East Coast stockpiles of...more
On March 9, 2021, the Department of Health and Human Services (HHS) announced an extension of the public comment period from March 22, 2021, to May 6, 2021, for its proposed modifications to regulations implementing the...more
On March 5, 2020, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced that it is delaying the inception of the Kidney Care Choices (KCC) Model’s first performance year until Jan. 1, 2022. The CMS’...more
On January 21, 2021, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for...more