News & Analysis as of

Rebates

California Advances PBM Licensing and “Transparency” Law

Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more

C-THRU’s Proposed Changes to Negotiated Prices – A Demonstration of the Part D Program’s Complexities and Misunderstandings

As described in last week’s post, Senator Wyden has introduced the C-THRU Act that seeks to require public disclosure of PBM rebate amounts, establish a minimum rebate percentage that PBMs must pass on to Part D and Exchange...more

Louisiana Insurance Regulator Confirms Innovator-Friendly Approach to Anti-Rebating

The practice of rebating has long been prohibited in nearly every state across the country. Despite this long-standing and widespread prohibition, the full scope of services that are and are not permissible under each state’s...more

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

East Hampton Considers New Laws Mandating Nitrogen-Reducing Sanitary Systems and Offering Rebates to Replace Existing Systems

by Farrell Fritz, P.C. on

The Town Board of the Town East Hampton (“Town Board”) is considering progressive new legislation that will require advanced nitrogen-reducing sanitary systems for all new commercial and residential construction and major...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

Five Key Takeaways: Promotional Tactics/Pitfalls and Opportunities in Coupons, Rebates, and Experiential Marketing (including the...

Barry M. Benjamin, partner in the New York office and chair of Kilpatrick Townsend’s Advertising and Marketing group, was honored to present at the 2016 ANA/BAA 38th Marketing Law Conference, held November 9-11, 2016 in...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

by Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Rooting Out Conflicts of Interest

Conflicts of interest do not thrive in sunlight. Just ask anyone in the advertising industry. Whatever follows in the wake of the recent eye-opening study of transparency in the media business, one thing is already...more

CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

by Reed Smith on

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s...more

Manatt on Health Reform: Weekly Highlights - July 2016

Massachusetts extends coverage of Hepatitis C treatments and New Hampshire extends substance use disorder coverage to more Medicaid enrollees; Alaska’s Medicaid expansion now moves ahead uncontested; and CMS reports...more

OIG Advisory Opinion Approves Drug Discount Program

Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug. The OIG concluded that while...more

OIG Faults State Efforts to Identify 340B Drug Claims; Cites Risk of Duplicate Discounts, Forgone Rebates

by Reed Smith on

The OIG recently examined how states that pay for drugs through Medicaid managed care organizations (MCOs) identify and exclude 340B drug claims when collecting Medicaid rebates, since states are prohibited from collecting...more

OIG Recommends that CMS Require States to Use Claim Modifier on Medicaid Claims to Identify 340B Drug Claims

by King & Spalding on

On June 8, 2016, OIG issued a report in which it recommended that CMS require states to use a claim-level method to identify 340B claims in order to prevent duplicate discounts for drugs and unclaimed rebates to which states...more

Manatt on Medicaid: CMS Clarifies Medicaid Managed Care Prescription Drug Access

Editor’s Note: This “Manatt on Medicaid” is the fifth in a series of updates focused on CMS’s new Medicaid/CHIP managed care regulations. In the coming weeks Manatt will continue to explore key provisions of the regulations...more

Breaking: Third Circuit Dismisses Antitrust Suit Concerning Marketing of Lovenox

Earlier today, the Third Circuit Court of Appeals upheld the decision of the District of New Jersey trial court dismissing the antitrust claims lobbed against Sanofi-Aventis by its rival pharmaceutical company Eisai. The...more

This Week In Securities Litigation

by Dorsey & Whitney LLP on

The SEC filed its first action against a municipal adviser for breach of fiduciary duty based on a provision amended by Dodd-Frank. The agency also continued to file insider trading actions in an administrative forum....more

FranCast: Good news for franchisors: Ontario Court of Appeal dismisses Pet Valu class action

by DLA Piper on

The recent Ontario Court of Appeal decision in 1250264 Ontario Inc. v Pet Valu Canada Inc.1 is good news for both Pet Valu Canada Inc. and Ontario franchisors....more

SEC Files Settled Financial Fraud Action

by Dorsey & Whitney LLP on

One of the key products of Monsanto Company is weed killer Roundup, sold to retailers and distributors but not directly to growers. After the product came off patent generics began to erode its profits. ...more

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

by Foley & Lardner LLP on

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

EU Nations Extend Electric Car Rebates, Consider New Ones

by Foley & Lardner LLP on

While Europe has been the land of small diesels for decades, air quality concerns and consideration of fossil fuels’ impact on global warming has led EU nations to offer incentives to purchasers of electric vehicles. In...more

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

by 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

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

by Morgan Lewis on

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

by Foley Hoag LLP on

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

Data Analytics Week – Part V: Bribes on the Other Side of the Ledger and Best Practices Going Forward

by Thomas Fox on

I end my review of the types of data analysis that can be used to help detect or prevent bribery through the case studies from Joe Oringel, co-founder and Managing Director of Visual Risk IQ, a firm that helps audit and...more

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