News & Analysis as of

Pharmacies

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into...more

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more

Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that...more

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

California Regents File State False Claims Act Case Against Healthcare Providers And Pharmacies For Allegedly Defrauding UC...

The Regents of the University of California (UC) have filed a lawsuit against Studio Pharmacy, Excel Care Pharmacy, Pharma Pro Solutions, California Clinical Trials, and 17 individual defendants, including four physicians and...more

News from Second and State

Weekly Wrap - Pennsylvania’s budget deadline is just about two months away, and the General Assembly got to work this week positioning bills that could eventually be used as part of a 2017-2018 state spending plan....more

Rite Aid Wins Summary Judgment in TCPA Action Involving Prerecorded, Automated Call for Flu Shot Reminder

In an outright win for pharmacies, the U.S. District Court for the Southern District of New York, in the attached opinion, granted Rite Aid’s motion for summary judgment in a class action alleging violations of the TCPA....more

California Advances PBM Licensing and “Transparency” Law

Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more

Legislative Update: State Biosimilar Substitution Laws

by Goodwin on

More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and...more

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

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Can You Fire The Needle-Phobic Pharmacist Who Refuses To Perform Immunizations?

As more and more pharmacies move into the role of providing immunizations, someone has to perform those immunizations. Often, this duty falls to the pharmacist. So, what happens when a pharmacist claims he cannot perform...more

Retail and Consumer Products Law Roundup - March 2017

Retailers Prevail Over Pharmacy Customers in California Tax Suit - Retailers have won a victory in the realm of California taxation in McClain v. Sav-on Drugs (March 13, 2017) __ Cal.App.5th __ (Nos. B265011 &...more

No “Relaxed” Pleading Standards for False Claims Act Relators, Says Sixth Circuit

by Saul Ewing LLP on

In United States ex rel. Hirt v. Walgreen Company, the United States Court of Appeals for the Sixth Circuit recently affirmed the dismissal of a pharmacy owner’s False Claims Act (“FCA”) lawsuit because he failed to plead his...more

Second Circuit Reverses ADA Jury Verdict for Pharmacist with Fear of Needles

by Robinson & Cole LLP on

In Stevens v. Rite Aid Corp., No. 15-277 (March 21, 2017), the U.S. Court of Appeals for the Second Circuit reversed a jury award of almost $2 million in favor of a pharmacist who suffered from a fear of needles because he...more

A New FBI Warning for Healthcare Providers

The FBI has issued new guidance specifically applicable to medical and dental facilities regarding the cybersecurity risk of File Transfer Protocol (“FTP”) servers operating in “anonymous” mode. FTPs are routinely used to...more

Needle and the Damage Done: Pharmacist’s Phobia Not Enough for ADA Claim

Can fear of an aspect of your job constitute a disability under the ADA? Depends on how essential the function is. In Stevens v. Rite Aid Corp, the Second Circuit Court of Appeals looked at the case of a Rite Aid pharmacist,...more

Monthly Update—Australian Labour & Employment - February 2017

by Jones Day on

MESSAGE FROM THE EDITOR - In this edition of the Update, we discuss two significant developments that are likely to have far-reaching impacts for employers and employees across Australia. First, we discuss the proposed...more

Tennessee Rule Change: Prohibition on Prescription Transfer Incentives

by Bass, Berry & Sims PLC on

Tennessee pharmacies can no longer offer patients financial rewards in exchange for the transfer of the patient's prescriptions. Effective February 20, 2017, the Tennessee Board of Pharmacy enacted a new rule providing that...more

Form Over Substance Sometimes Prevails in Tax Law – Estate of George H. Bartell et. al. v. Commissioner

by Garvey Schubert Barer on

In most areas of law, substance prevails over form. Code Section 1031 is possibly one of the few exceptions to this time-honored rule of jurisprudence. Under Code Section 1031, form may prevail over substance. The U.S. Tax...more

Superior Court of Québec Confirms Validity of Percentage Royalties Paid by Pharmacist-Owners to Franchisor

The Superior Court of Québec (Court), presided by Justice M. Monast, recently ruled on an important point of contention for franchise pharmacies, by confirming the validity of a percentage royalty clause contained in a...more

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

by Goodwin on

Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

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