Dorsey Health Law Blog

DOJ Levels False Claims Act at Pharmacies to Combat Opioid Crisis

John Marti

This month the Department of Justice rough a “first of its kind” action against two pharmacies, their owner, and three pharmacists for allegedly dispensing and billing Medicare for prescriptions in violation of both the Controlled Substances Act and the False Claims Act. For more on information on this, visit our FCA Now blog, linked here:...

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Benjamin Fee

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...

Getting Ready for Open Payments

Kristen Barlow

Today, the Centers for Medicare and Medicaid Services (“CMS”) released additional tips regarding submitting Open Payments data.[1] A quick refresher: Submitting data through CMS’s application, Open Payments, is the means to fulfill the Sunshine Act, a federal regulatory requirement that applicable manufacturers, group purchasing organizations (“GPOs”), and health care providers disclose: a) certain transfers of...

For FY2018, Justice Department Touts Nearly $3 Billion in False Claims Act Recoveries, Mostly From Qui Tams and Alleged Healthcare Frauds

Alex Hontos

The Justice Department announced in a recent press release that it obtained more than $2.8 billion in settlements and judgments from cases involving fraud and false claims against the government. For more information, visit our FCA Now Blog: For FY2018, Justice Department Touts Nearly $3 Billion in False Claims Act Recoveries, Mostly From Qui Tams...

Changes to Medicare Advantage Risk Adjustment Model Proposed to Phase-In Beginning 2020

Neal N. Peterson

On December 20, 2018, CMS announced the first part of its two-part advance notice to implement changes to the Medicare Advantage (“MA”) risk adjustment methodology for 2020 (the “Advance Notice”), which can be found here. A key element of the CMS proposal in the Advance Notice is to incorporate into the risk adjustment methodology the...

“Pathways to Success” – CMS Finalizes Overhaul of National ACO Program

Alex Stoflet

On December 21, 2018, CMS announced a final rule, subsequently published in the December 31 issue of the federal register, significantly overhauling the Medicare Shared Savings Program (“MSSP”). Among the important changes in the final rule is a redesign of MSSP’s participation options. Under MSSP, providers of services and suppliers participating in an Accountable Care...

FDA Testing New Approaches for Review of Digital Health Device Applications

Alex Stoflet

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program (“Pre-Cert”). Pre-Cert was originally announced in 2017 as part of the FDA’s Digital Health Innovation Action Plan. The FDA envisions the program as a streamlined process...

CMS Announces Strategy to Reduce Health IT and EHR Burden

Edwin N. McIntosh

On Wednesday, November 28, 2018, the U.S. Department of Health and Human Services (“HHS”) released a draft document titled, Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.  The report was developed by the Centers for Medicare and Medicaid Services (“CMS”) and the HHS Office of the National...

CMS Finalizes Site-Neutral Payments for Hospital Outpatient Clinics; Legal Battle with Hospitals Looms

Aaron Mohr

On Friday, November 2, 2018, the Centers for Medicare and Medicaid Services (“CMS”) issued its calendar year 2019 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center Payment System final rule. Despite significant resistance and concerns from hospitals, CMS finalized its proposed site-neutral payment policy for clinic visit services provided at off-campus provider-based...

CMS Proposed Rule to Require Drug Pricing Transparency

Randall Hanson

On October 18, 2018, the Centers for Medicare and Medicaid Services (“CMS”) proposed a new rule (“Proposal”) that would require direct-to-consumer (“DTC”) television advertisements of prescription drugs paid for by Medicare or Medicaid to include the drug’s wholesale acquisition cost (“List Price”). The Proposal comes as part of the current administration’s promise and attempt to...