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Five Trends in False Claims Act Enforcement: Take Two

In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

CMS Call Letter: Pharmacy Network Implications

As part of our continuing series on CMS’s 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks. In the Call Letter, CMS raises concerns about preferred...more

3/4/2015  /  CMS , Healthcare , New Guidance , Pharmacies

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes

After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes...more

12/13/2012  /  OIG , Pharmacies , Software
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