Policy & Medicine

HHS Recommendations to Reduce Fraud, Waste and Abuse Take Aim at CMS and Increased…

Thomas Sullivan Sep 20, 2019 0

The Health and Human Services Office of Inspector General (“OIG”) released its annual report entitled Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations. The report specifically contains the top 25 unimplemented recommendations that would “most positively” affect cost savings, program effectiveness and…

The Chaos Over Drug Compounding Continues As Judge Throws…

Thomas Sullivan Sep 17, 2019 0

The Year of the State

Thomas Sullivan Aug 23, 2018 0

HHS Recommendations to Reduce Fraud, Waste and Abuse Take Aim at…

Cannabidiol Confusion Continues As The FDA Weighs In

The FDA’s regulation of medicinal cannabidiol containing products is an ongoing work in progress. However, the FDA’s recent spate of Warning Letters demonstrates that companies selling CBD products…

CMS OPPS Proposed Rule Seeks Comments on Potential Remedies for…

The Centers for Medicare and Medicaid Services (“CMS”) published its annual proposed rule detailing changes to the Medicare Outpatient Prospective Payment System (“OPPS”) for the 2020 calendar year.…

DME Suppliers Remain In The Spotlight – ResMed Announces…

ResMed recently announced that it reached a tentative settlement agreement with the DOJ in conjunction with an investigation pertaining to ResMed’s business practices involving DME product support…

Grassley Expresses Concern Over DOJ Dismissal of FCA Cases

Earlier this month, Senator Chuck Grassley sent a letter to Attorney General William Barr, expressing concern over the Department of Justice (DOJ) “efforts to dismiss greater numbers of qui tam (false…

Small Companies Are Not Immune From Prosecution – The Case Of…

n July 2019, the Department of Justice announced a False Claims Act suit filed against Life Spine, Inc., for violations of the Act, alleging the company and two of its executives caused hospitals and…

Repackage Your CME Programs for MIPS Compliance

On September 16, 2019, Policy & Medicine editor Thomas Sullivan presented an interactive working session during the 17th Annual Independent Medical Education and Grants Summit, “Repackage Your CME…

The Chaos Over Drug Compounding Continues As Judge Throws Out…

A federal judge in Boston recently overturned the convictions of two former NECC executives who had been convicted of defrauding the FDA. In some respects, this case represents a historical anomaly.…

Pelosi Draft Plan Would Allow Price Negotiations on Select Drugs

A supposed draft plan summary to lower drug prices by House Speaker Nancy Pelosi has been circulating around Capitol Hill recently. While it isn’t clear what changes, if any, have been made since the…

Opioid Case Tests The Boundaries Of Liability – Oklahoma,…

The first opioid case to go trial has just concluded in Oklahoma with J&J as the sole defendant. This case is important for all life science companies because of its approach to the concept of…

HHS OIG Posts Findings Following Opioid Prescribing Review

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently posted its findings following a review of opioid prescribing in Medicaid using the Transformed Medicaid…

Florida AHCA Submits Concept Paper to HHS

Recently, the Florida Agency for Health Care Administration (AHCA) recently submitted a “concept paper” to the United States Department of Health and Human Services (HHS) outlining its proposal to…