Pharmacies

News & Analysis as of

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

Also In The News - Health Headlines - January 2016 #3

CMS Finalizes Medicaid Prescription Drug Rule – On January 21, 2016, CMS finalized a rule detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs, which the agency estimates “will save...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Legal Considerations for Retail Clinics

Retail clinics have grown substantially in number and popularity since their emergence in the early 2000s. Retail clinics are limited healthcare clinics that operate outside of physician offices and hospitals, typically in...more

Blame Flows Downhill: All the Way to Sales Clerks

What if a store clerk sells a product that, unbeknownst to him, is illegal? Can the clerk be convicted of a crime, despite not knowing the product was illegal and not intending to sell an illegal product? On January 14,...more

New York State Requires PBM Contracts to Include a Mechanism for Appealing Disputes Related to Generic Drug Pricing

On December 11, 2015, Senate Bill 3346-B[1] was signed into law by New York State Governor Andrew Cuomo. The new bill requires contracts between pharmacy benefit managers (“PBMs”) and pharmacies (or pharmacies’ contracting...more

Competition News January 2016

Record fine imposed on Orange by the French Competition Authority despite being reduced by the early application of the settlement procedure - By decision of December 17, 2015, the French Competition Authority imposed a...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Morton Salt Presumption Of Injury Under Robinson-Patman Act

Plaintiffs and appellants, the disfavored purchasers in a Robinson-Patman Act case, were twenty-eight retail pharmacies who alleged that the pharmaceutical manufacturer defendants had charged them higher prices than those...more

The Department of Justice is Committed to Protecting Consumers from “Bad Medicine”

Last month, the Acting Associate Attorney General Stuart F. Delery, announced that the Department of Justice (DOJ) would continue to target illegitimate online pharmacies, which pose a threat to drug safety and undermine...more

Health Alert (Australia) - January 18, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: New South Wales 14 January 2016 - Health Care Complaints Commission v Athour [2016] NSWCATOD 5 The New South Wales...more

Second Circuit tells pharmacies the antitrust claims they cooked up need more than a little Morton Salt

Cash & Henderson Drugs, Inc. v. Johnson & Johnson, recently decided by the Second Circuit, concerns Robinson-Patman Act claims that retail pharmacies brought against pharmaceutical manufacturers. The retail pharmacies alleged...more

NACDS Files Amicus Brief in Support of Petitioner Rite Aid in Consolidated Appeal of FCC’s TCPA Order

On December 2nd, the National Association of Chain Drug Stores, Inc. (“NACDS”) submitted an amicus brief in support of member organization and petitioner Rite Aid in the consolidated appeal of the FCC’s July 10, 2015...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

Massive Fraud Alleged by Camarillo Pharmacist

Russell Reitz, a Camarillo pharmacist, with a modest prescription-filling service, R&O Pharmacy, sold his business to Philidor Rx Services, a mail-order pharmacy, for $350,000. Reitz stayed on as manager, only to see an...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

OMNICARE and its Implications

In the spring of this year, the Supreme Court issued its long-awaited decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S.Ct. 1318 (2015), resolving a circuit split regarding the...more

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Effective November 1, 2015: New Jersey Expands Scope of Prescription Monitoring Program

In July, New Jersey Governor Chris Christie signed legislation that expands the access, registration, and utilization of the New Jersey Prescription Monitoring Program (NJPMP). The legislation, Senate Bill 1998 (S-1998), is...more

Health Alert (Australia) - October 26, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Queensland 22 September 2015 - Metro South Hospital and Health Service & Leighton v Luthje [2015] QCATA...more

Privacy Tip #5 — Retail store reward cards

Many retail pharmacies, supermarkets and other retailers offer rewards cards that offer discounts on certain items to be purchased in the store. They give you the cards that contain a bar code in regular size, which looks...more

PharMerica Corporation Settles Anti-Kickback Allegations by Paying Over $9 Million to Government

On October 7, 2015, the Department of Justice announced that PharMerica Corporation (“PharMerica”), the nation’s second-largest nursing home pharmacy, agreed to pay $9.25 million to resolve allegations that it received...more

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

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