Health Care Counsel Blog
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Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.
Headlines that Matter for Companies and Executives in Regulated Industries
Following nearly two years of litigation, Cigna Health and Life Insurance Company and the named plaintiffs in Hecht v. Cigna Health and Life Insurance Co., Case No. 1:24-cv-05926 (N.D. Ill.) have announced a class action settlement in principle.
Headlines that Matter for Companies and Executives in Regulated Industries
Federal enforcement of information blocking rules has entered a new era.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
In July, then-Chairman of the Energy and Commerce Health Subcommittee Rep. Buddy Carter (R-GA) announced that he would be “relinquish[ing] the gavel” to allow him to “put Georgians’ interests first.”
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs).
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Immigration enforcement actions are no longer a theoretical concern for health care facilities — they are happening now.
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These rules are the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule.
Headlines that Matter for Companies and Executives in Regulated Industries
As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.
On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device company would pay licensing fees to a third-party vendor for access to an electronic billing portal used by some of the medical device company’s provider customers.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations (MSOs).