Pharmacies

News & Analysis as of

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

SCOTUS Hearing Arbitration Case Wednesday; Spotlight On State Cases

While the Supreme Court has put off hearing a more contentious arbitration case until the fall (presumably in hopes that it will have nine justices by then), tomorrow it will hear the nursing home arbitration case from...more

Noodle This! The Yin and Yang of Two Courts, Two Antitrust Cases, Two Class Certification Motions, Two Daubert Challenges, Two...

Noodle this: Two significant orders on class certification in antitrust matters issued last week. Both were heavily influenced by the threshold determination of Daubert challenges to the plaintiffs’ expert evidence. In one...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017

The Agency of Transportation has submitted a proposal to the House Transportation Committee that would allow the agency to seek damages from a utility that fails to move or adjust a utility line that is in a state or local...more

340B Update: Trump Administration Withdraws Omnibus Guidance, Delays Final Rule on 340B Drug Pricing and CMPs

The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

Automated Drug Dispensing

Despite its plain text, the California Board of Pharmacy (the “BoP”) has adopted an interpretation of state statute requiring stocked removable pockets for automated drug dispensing systems (“ADDS”) to be transported to and...more

Relax, Sixth Circuit Opinion Indicates Rule 9(b) Pleading Requirement Still Has Bite

A recent Sixth Circuit opinion in U.S. ex rel. Hirt v. Walgreen Co. should come as welcome news for FCA defendants concerned about the implications of the Sixth Circuit’s application last year, for the first time, of a...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

News from the Vermont State House - An Analysis from DRM’s Government & Public Affairs Team - January 2017 #2

Treasurer Will Build Public Pension Plan for Small Business - State Treasurer Beth Pearce on Wednesday asked the Senate Economic Development, Housing and General Affairs Committee to create the framework for a...more

Big Pharma found to exploit ‘orphan’ drug law to jack up product prices

Big Pharma has ruthlessly exploited a well-intentioned measure that sought to provide medications to treat patients with rare diseases that might otherwise have been ignored. Drug companies, instead, have manipulated the 1983...more

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission...

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to...more

OIG Rings in the New Year With New Anti-Kickback Statute Safe Harbors

Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more

Burr Alert: New Requirements of Participation for Skilled Nursing Facilities

On October 4, 2016, The Centers for Medicare and Medicaid Services (“CMS”) released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

New Year, New Possibilities: OIG Final Rule Amends Beneficiary Inducement Rules

The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more

Eighth Circuit Rules That ERISA Expressly Preempts Iowa Pharmacy Benefit Law

The United States Court of Appeals for the Eighth Circuit recently held that ERISA expressly preempts an Iowa law that imposes onerous regulatory requirements on pharmaceutical benefit managers operating in Iowa. The reversal...more

Guest Post – MDL Court: Preemption Leaves No “Glimmer of Hope” for Labeling Claims Against a Pharmacy

What follows is a post authored by Jaclyn Setili, a Reed Smith associate. She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously...more

Healthcare Transactions: Year in Review - January 2017

Healthcare transactional activity continued unabated throughout 2016, continuing a years long trend of sustained growth. This activity is due to a number of factors: innovative technology, pharmaceuticals, and services that...more

Drug Pricing Update

In August 2016, we reported that CVS dropped Neupogen® (filgrastim) and Lantus® (insulin glargine) from its standard formulary and replaced them with biosimilar versions. Hikes in insulin drug prices have prompted pharmacies...more

HHS OIG Expands Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions; Issues Guidance on Gifts of Nominal Value

On December 7, 2016, the Office of Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a final rule modifying the safe harbors to the anti-kickback statute1 and the civi monetary...more

OIG Creates New AKS Safe Harbors, Codifies Others

On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the...more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Court Grants Motion to Dismiss for Lack of Case or Controversy Even Though Patent Holder Did Not Provide Covenant Not to Sue

Tech Pharmacy filed a patent infringement action against Defendant Alixa Rx LLC and Defendant Golden Gate National Senior Care LLC d/b/a Golden LivingCenters (collectively, "Defendants"). Tech Pharmacy subsequently filed its...more

OIG Finalizes New and Amended Anti-Kickback and CMP Safe Harbors

On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...more

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