Pharmacies

News & Analysis as of

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

New Anti-Kickback Safe Harbors

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more

HHS OIG Expands Safe Harbors, but Doubles Down with Enhanced Civil Monetary Penalties

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published two rules on December 7, 2016, updating certain existing safe harbor regulations, adding new safe harbor rules under...more

HHS OIG Adopts NewAnti-Kickback Safe Harbor and Civil Monetary Penalty Exceptions

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more

A Cautionary Tale: DOJ Intervenes in Another Web Accessibility Lawsuit

Seyfarth Synopsis: Fighting a web accessibility lawsuit could invite DOJ’s intervention, as did a Florida retailer’s recent Motion for Judgment on the Pleadings. Fighting a website accessibility lawsuit is very tempting...more

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

Deciphering Florida’s New Laws on ARNP and PA Controlled Substance Prescribing

During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their...more

Pharmacy Benefit Managers Face New Licensing Requirements

Two states recently enacted new pharmacy benefit manager licensing requirements that affect pharmacy benefit managers in Kentucky and New Mexico. It is important for Pharmacy Benefit Managers to ensure they are in compliance...more

Two Executives Charged in Valeant Pharmaceuticals Criminal Investigation

Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more

Your Daily Dose of Financial News

And we thought Brexit was something. Buckle up. It’s going to be a wild market ride... Whoa....more

Oklahoma Becomes the Latest State To Apply Learned Intermediary Principles To Pharmacies

Our learned intermediary rule “head count” lists Oklahoma as solidly in support of the doctrine: Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886...more

Pharmacy Drug Take-Back Programs Get Green Light in California

On October 26, 2016, the California Board of Pharmacy adopted regulations largely tracking the federal Drug Enforcement Administration’s program encouraging pharmacies to voluntarily collect and dispose of unwanted, unused or...more

CMS Issues Sweeping Final Rule, Significantly Changing the Requirements for Long-Term Care Facilities Participating in the...

On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities...more

Federal Court Finds That 2015 TCPA Safe Harbor Applies to Automated Flu Shot Reminders

A recent decision from a federal court in California found that a retail pharmacy’s “flu shot reminder” calls to mobile phones fall within the FCC’s TCPA safe harbor for exigent health care treatment messages. But the holding...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

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