Pharmacies

News & Analysis as of

DEA Authorizes Take-Back Programs for Pharmacies

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee...more

HIPAA Business Associate Agreements – Reminder of September 22, 2014 Deadline

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) issued a final rule under HIPAA making substantial changes to the rules for vendors that provide services to HIPAA-covered plans, such as third-party...more

Specialty Pharmacy Per-fill Fee Rejected by OIG

On August 15, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a “negative” opinion regarding a specialty pharmacy’s proposal to pay a per-fill fee to local pharmacies for support...more

The Increasingly Murky World of 340B: What’s Next?

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more

OIG's Rejection of Payments for Prescription Transfers Leaves Questions about Central Fill Pharmacy Arrangements.

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently refused to bless a specialty pharmacy's request to pay a per-prescription fee to retail pharmacies for "support services" to be...more

OIG Rejects Specialty Pharmacy Request to Pay “Per-Fill” Payents to Retail Pharmacies

In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the...more

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more

OIG Rejects Pharmacy’s Plan for Per-Fill Referral Fees, Or Be Careful What You Ask For

Advisory Opinion No. 14-06, issued August 15, addressed a plan by the chain to reimburse local pharmacies for referrals of patients in need of specialized drugs that the local pharmacies did not dispense. In the scenario...more

OIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal

In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal...more

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

California Court Limits Liability for Loss of Certain Patient Information under CMIA

California appellate courts are clarifying potential liability under California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”) of health care providers, health plans, pharmaceutical...more

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the...more

America's Largest Drug Store Chain to Pay $180,000 to Settle EEOC Disability Discrimination Suit

South San Francisco Walgreens Fired Longtime Employee With Diabetes Over a $1.39 Bag of Chips, Federal Agency Charged - SAN FRANCISCO - Drugstore giant Walgreens has agreed to pay $180,000 to a longtime employee with...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Health Care E-Note - June 19, 2014

In This Issue: - Report Ranks U.S. Last Out of 11 in Health Care System Quality - Analysis Identifies Un-Tracked Avoidable Hospital Complications - Number of Doctors Employed by Hospitals Grew 34% Over 10...more

CMS Announces Final Regulatory Changes to Medicare Advantage and Part D

- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year. - New requirements for the reporting and return of Medicare Advantage and Part D...more

FDA Regulatory Update: International Crack Down on Online Pharmacies Identifies Over 1,900 Websites Selling Unapproved or...

By participating in the organized, global action known as Operation Pangea VII, the U.S. Food and Drug Administration (“FDA”) made good on its promise to continue working with the international community to investigate online...more

CMS Changes to Medicare Advantage and Prescription Drug Benefit Programs for Contract Year 2015

On May 19, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule, published in the Federal Register on May 23, 2014, that sets forth changes to requirements for Medicare Advantage (“MA”) and...more

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The Office of the Inspector General (OIG) for HHS recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (OIG Report) in which it recommended that CMS implement changes to the way...more

Pharmacy Manager Fails To Prove Kaiser Had Actual Or Constructive Notice That He Was Working Off-The-Clock

In an appeal from summary judgment, a non-exempt Outpatient Pharmacy Manager (“OPM”) for Kaiser contended that the trial court erroneously held his proffered evidence insufficient to create a triable issue as to whether...more

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

Mississippi CON Report - May 2014

In this Report: - I. April 2014 – Mississippi Certificate of Need Meeting - II. Certificate of Need Program Report – Filings/Reports Since March 2014 - A. Letters of Intent to Change Ownership - B....more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

$100 Million for Victims of Meningitis Outbreak

We’ve previously written about the 2012 meningitis outbreak caused by contaminated drugs originating from the New England Compounding Pharmacy (NECC). The meningitis outbreak from these tainted steroids was linked to 64...more

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