Pharmacies

News & Analysis as of

Pharmacists: Aren’t you really providers already? – Part One

While the passage of the Patient Protection and Affordable Care Act (“ACA”) ushered in a new era of access to health care, it only served to exacerbate a growing crisis in the provision of health care – lack of providers....more

Health Alert (Australia) - April 20, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 13 April 2015 - Sarah White v The Local Health Authority & Anor - [2015] NSWC 417 - The New South...more

What are the 2 leading causes of medication errors?

Every individual reacts to medication differently, as many a medical malpractice lawyer in Illinois knows. Discovering the appropriate drug and dosage for any given health issue is a process that requires careful attention by...more

Health Alert (Australia) - April 13, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: 27 March 2015 - Public consultation opens on draft Principles and guidelines for the care and use of non-human primates for scientific...more

Dazed and Confused: The TCPA’s Health Care-Related Call Exemption

In early 2012, Robert Kolinek received an automated call on his cell phone from Walgreens reminding him to refill an eligible prescription. Despite the fact that even the plaintiff’s lawyers ultimately acknowledged that these...more

Pharmacies: Watch Out for Future HHS Crackdowns on Security Rule Violations

As we all know by now, HIPAA required the Secretary of the U.S. Department of Health and Human Services (HHS) to adopt regulations protecting the privacy of "protected health information" (PHI). HHS responded to that...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

Also In The News - Health Headlines - March 2015 #4

Congressional Hearing on 340B Program Rescheduled for March 24, 2015 – The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health has rescheduled the hearing on the 340B program for Tuesday,...more

Context, Reasons, Hedges, and Disclaimers: The Supreme Court’s Ruling in Omnicare May Shape Whether and How Companies Express...

The Supreme Court’s decision yesterday in Omnicare Inc. v. The Laborers District Council Construction Industry Pension Fund, No. 13-435 (U.S. March 23, 2015) articulated the standard of liability for statements of opinion. At...more

Supreme Court’s Omnicare Decision Follows Middle Path Advocated by Lane Powell and WLF

In the opinion issued yesterday in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund (“Omnicare”), the Supreme Court rejected the two extremes advocated by the parties regarding how the truth or...more

Supreme Court Holds That Issuers Can Be Liable for Omitting Material Facts From Statements of Opinion in Omnicare Case

In its opinion in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, released yesterday, the U.S. Supreme Court held that a securities issuer’s statement of opinion in a registration statement,...more

Circuit Court Provides Clarification of Pleading Standards in FCA Cases - The Court's Holding Details Requirements for Alleging...

A recent U.S. Court of Appeals case from the Seventh Circuit has brought further insight into the heightened pleading standard required under the False Claims Act (FCA). The case, Thulin v. Shopko Stores Operating Co., LLC,...more

Health Law Wire: E-Prescribing Mandate (3/15)

New York State Governor Andrew Cuomo signed an extender for the electronic prescription mandate late last week, pushing the compliance date to March 27, 2016. The law generally provides that “no person shall issue any...more

California Continues Hazardous Waste Enforcement Campaign Against Retailers With Two New Multi-Million Dollar Settlements

The first quarter of 2015 brought two significant settlements against retailers for alleged violations of California’s hazardous waste laws. The settlements are the latest in a string of similar California enforcement...more

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more

CMS Call Letter: Pharmacy Network Implications

As part of our continuing series on CMS’s 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks. In the Call Letter, CMS raises concerns about preferred...more

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

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