News & Analysis as of

Pharmacies Generic Drugs

Tarter Krinsky & Drogin LLP

The Federal Trade Commission Launches Investigation into Pharmacy Benefit Managers

The Federal Trade Commission (FTC) has launched an inquiry into the largest Pharmacy Benefit Managers (PBMs) in the United States, with the goal of scrutinizing the PBMs’ practices and influence on the pharmaceutical...more

Pullman & Comley - Connecticut Health Law

Post-Public Health Emergency – Connecticut Pharmacy Limitation Changes

Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...more

Patrick Malone & Associates P.C. | DC Injury...

California, calling drug price rises unbearable, leaps into making generics

Although President Trump has made California a favored object of scorn, the Golden State has put itself on a path to help patients better rein in Big Pharma price gouging on prescription drugs in a way that Washington hasn’t....more

Bricker Graydon LLP

“We’ll see you in court:” State expands lawsuit against pharmacy benefit manager in BWC contract dispute over generic drug prices

Bricker Graydon LLP on

After months of unsuccessful mediation, Ohio Attorney General Dave Yost filed an amended complaint in the Franklin County Court of Common Pleas against pharmacy benefit manager (PBM), OptumRx. The complaint, which brings...more

Foley Hoag LLP - Medicaid and the Law

Senate Finance Committee Proposes Significant Drug Pricing Reforms in Medicaid

On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Patrick Malone & Associates P.C. | DC Injury...

Price-fixing scandal ensnares ‘white-hat’ makers of lower-cost generic drugs

To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,”...more

Hogan Lovells

CMS releases Medicare Advantage/Part D final rule

Hogan Lovells on

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

Farrell Fritz, P.C.

Pharmaceutical Reforms in 2018-19 New York State Budget

Farrell Fritz, P.C. on

Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more

Patrick Malone & Associates P.C. | DC Injury...

Sick of woes with Big Pharma, hospitals moving to make own generic drugs

Some big hospitals and hospital chains are on the brink of expanding into another aspect of health care. Let’s give them a rare cheer, because they’re taking on Big Pharma and its skyrocketing drug prices and too frequent...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Hogan Lovells

CMS Releases Major MA/Part D Proposed Rule

Hogan Lovells on

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

Mintz - Health Care Viewpoints

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

Davis Wright Tremaine LLP

New Year, New Possibilities: OIG Final Rule Amends Beneficiary Inducement Rules

The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more

Proskauer Rose LLP

HHS OIG Adopts NewAnti-Kickback Safe Harbor and Civil Monetary Penalty Exceptions

Proskauer Rose LLP on

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more

Knobbe Martens

Third Circuit Upholds Dismissal of Doryx ‘Product Hopping’ Suit

Knobbe Martens on

On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more

Mintz - ML Strategies

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Mintz - ML Strategies on

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

King & Spalding

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

King & Spalding on

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

Epstein Becker & Green

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

Epstein Becker & Green on

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

King & Spalding

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

King & Spalding on

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

Mintz - Health Care Viewpoints

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

Robinson & Cole LLP

KMART Settles False Claims Act Allegations for $1.4 Million

Robinson & Cole LLP on

The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

Ballard Spahr LLP

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

Ballard Spahr LLP on

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Pharma, Inc. et al. v. Actavis Laboratories FL., Inc. et al. 3:15-cv-03322; filed May 13, 2015 in the District...more

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