Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

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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

7/29/2015 - Biosimilars FDA Notification Requirements Orange Book Pharmacies Pharmacist

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

10/21/2014 - Affordable Care Act Ambulance Providers Anti-Kickback Statute CMP Law Gainsharing Hospitals OIG Pharmacies Physicians Proposed Regulation Safe Harbors

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

4/17/2013 - Beneficiaries CMS Controlled Substances Medical Reimbursement Plans Medicare Advantage Modification Pharmacies Point of Sale Terminals Prescription Drugs Waivers

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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