Pharmacies

News & Analysis as of

CMS Releases 2016 Draft Call Letter

Last week, the Centers for Medicare & Medicaid (CMS) released its 2016 Advance Rate Notice and draft Call Letter (2016 Call Letter) for the Medicare Advantage (MA) and Medicare Part D programs. The 2016 Call Letter outlines...more

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Now's the Time to Comment on the FDA's New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more

California Prosecutors Settle PHI Breach with Retailer

Beginning in 2012, California environmental regulators and others began investigating the grocery store chain Safeway relating to the company’s waste disposal practices. During the investigation, certain documents listing...more

Texas Medical Board Issues Proposed Rule Restricting Online Prescribing

Last week, the Texas Medical Board issued a proposed rule (the “Rule”) clarifying that physicians must perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions...more

Practice Spotlight: Corporate Inversions and Related Transactions

The past several months have seen a flurry of business activity by and between U.S.-based corporations and foreign competitors. Mergers have been announced between foreign and domestic pharmaceutical companies, drug retailers...more

The Learned Intermediary Defense Advances in Nevada

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices. A learned intermediary is a medical expert, such as a...more

The Fraudulent Joinder Doctrine...It’s Not Just For Fraud Or Joinder

In Weidman v. ExxonMobil Corporation, et al., No. 13-2007 (4th Cir., January 8, 2015), the Fourth Circuit confirmed that the “fraudulent joinder” doctrine requires neither an allegation of fraud nor a situation involving a...more

OIG Reports Lack of Oversight on Hospital Use of Compounded Drugs

On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more

RICO Indictment of NECC Executives for Acts of Second-Degree Murder

An Unprecedented Approach to Regulatory Violations - In December 2014, the United States Attorney for the District of Massachusetts obtained a sweeping indictment that charges business executives of the New England...more

Beginnings and Endings: New Administration Moves In, Massachusetts Legislative Session Concludes

The last several months witnessed a flurry of activity on Beacon Hill: Governor Deval Patrick inked a number of bills as the two-year legislative session drew to an official end, and his successor, Governor Charlie Baker, has...more

First Circuit Reaffirms FCA’s “First-to-File” Bar as a Broad Jurisdictional Limit

In early December 2014, the United States Court of Appeals for the First Circuit reaffirmed that circuit’s broad interpretation of the False Claims Act’s “first-to-file” bar, 31 U.S.C. § 3730(b)(5), in United States ex rel....more

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more

EPA to Propose Health Care Facility-Specific Regulations for the Management of Hazardous Waste Pharmaceuticals Under RCRA

EPA plans to propose new regulations this year to address the management of hazardous waste pharmaceuticals under the Resource Conservation and Recovery Act (RCRA). The agency anticipates issuing a notice of proposed...more

When Is a Pharmacist Not a Pharmacist?

On January 14 the Texas Supreme Court will hear argument in an appeal that asks the question, When is a pharmacist not a pharmacist? The appeal is from a Texas Court of Appeals decision that answered the question this way: ...more

FTC Seeks Public Comments on Proposed Merger Study

The Federal Trade Commission (FTC) announced today that it is seeking public comments on a proposed study of the effectiveness of the FTC’s orders in merger cases where it ordered a divestiture or other remedy....more

Seventh Circuit Uses Rule 9(b) to Dismiss False Claims Act Case

The Seventh Circuit has been on quite a tear recently with cases involving the False Claims Act; we wrote about three of them, involving the federal assignment law, the worthless-services doctrine, and the public-disclosure...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

Employer Liability for Employees’ Privacy Violations: What your organization should learn from Walgreens’ expensive lesson (hint:...

You may already have read the scintillating facts surrounding a jury award of $1.44 million (recently challenged unsuccessfully on appeal) against Walgreen Co. (Walgreens) following its pharmacist’s alleged inappropriate...more

N.C. Court of Appeals: Restrictive Covenant Prohibiting "Store" Does Not Prohibit "Parking" for a Prohibited Store

How broadly will the appellate courts interpret a restrictive covenant applicable to real property? Not so broadly as to prohibit a parking lot to be used by customers for an otherwise expressly prohibited use....more

Refill Reminders and the TCPA

The Telephone Consumer Protection Act (“TCPA”) presents another challenge as health care providers continue to engage patients and seek to meet Meaningful Use reminder objectives. Over the past year, there have been several...more

Indiana Appeals Court Upholds Jury Verdict For Pharmacist’s Wrongful Use Of Patient Information

A recent decision by the Court of Appeals of Indiana reinforces the peril faced by health care employers when employees authorized to access confidential information do so for improper purposes. In Walgreen Co. v. Hinchy, the...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

Fundamentals of Hospital/Medical Staff Issues: Minimizing Risk and Maximizing Collaboration

In this presentation: - Health System Structure and Governance - Medical Staff Structure and Governance - Committee Structure - Medical Staff Categories - Medical Staff Governance...more

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