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»  Posts By   August 2016 

The FDA’s Role in Increasing Drug Competition in the Wake of Price Hikes

Pharmaceutical drug pricing is back in the national debate in the wake of Mylan's recent price increases to its EpiPen medication. This recent action has renewed the focus and attention by lawmakers and regulators alike, and once again raises the question of the role to be played by the Food and Drug Administration (FDA) in regulating drug pricing and ensuring drug competition in the wake of these recent drug price...

OCR to Advance Investigations of Breaches Affecting Fewer Than 500 Individuals

The Office for Civil Rights (OCR) has announced that it will begin to more actively investigate breaches of Protected Health Information (PHI) affecting fewer than 500 individuals in order to evaluate the primary, and likely, causes of such incidents, and develop appropriate corrective action. Under the Health Insurance Portability and Accountability Act (HIPAA), breaches of under 500 affected individuals are reported to the Department of Health and Human Services (HHS)...

Cost Sharing Limitations Imposed by the Affordable Care Act May Level the Playing Field Between Specialty Pharmacy and PBMs

The enactment of the Patient Protection and Affordable Care Act (PPACA) aimed not only at expanding access to health insurance coverage, but also sought to limit out-of-pocket expenses for individuals that have health insurance. Therefore, beginning on January 1, 2014, PPACA implemented out-of-pocket expense limitations for patients with respect to in-network insurance coverage of Essential Health Benefits (EHB). These out-of-pocket expense limitations are "little known" in the healthcare industry, but...

First Circuit Dismisses FCA Suit against CVS, Taking an Expansive View of Public Disclosure Bar

In U.S. ex rel. Winkelman et al v. CVS Caremark Corporation et al., 2016 WL 3568145 (1st Cir. 2016), the First Circuit dismissed a False Claims Act (FCA) qui tam action against CVS Caremark brought by former employees turned whistleblowers. These whistleblowers, referred to as "relators" under the FCA, alleged their previous employer had defrauded Medicaid and Medicare Part D to the tune of hundreds of millions of dollars. The...

FDA Provides Guidance to Manufactures and Pharmacies on Biological Drug Interchangeability

The prevalence of biologic drugs has led to the demand for "generic" alternatives of these products. The Biologics Price Competition Innovation (BCPI)  Act enacted as part of the Affordable Care Act amended the Public Health Services Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar and interchangeable. Importantly, "Biosimilarity" and "interchangeability" are not equivalent; a drug can qualify as biosimilar but not...
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