News & Analysis as of

Reimbursements

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

by Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Disparagement Allegations May Trigger Valuable Coverage

A recent case we handled highlights the importance of reading a complaint’s allegations very carefully. Competitors in high-stakes litigation may file complaints and cross-complaints against each other alleging a variety of...more

IRS Encourages Self-Assessment to Identify Fringe Benefit Errors

by Ruder Ware on

As much as I love tax law, filling out another tax form isn’t high on my list of fun things to do. So when the IRS issues a form that isn’t legally required to complete, should you? If you are an employer that provides one or...more

CMS’s 340B Proposal Is Likely Unlawful—Here’s Why

by Morgan Lewis on

The agency’s recent proposal to reduce certain drug reimbursement is unprecedented and not based on a reasonable interpretation of its statutory authority....more

Court Grants Most of Plaintiff’s Cost Recovery Request, Including All eDiscovery Costs: eDiscovery Case Week

by CloudNine on

In Ariel Inv., LLC v. Ariel Capital Advisors LLC, No. 15 C 3717 (N.D. Ill., July 17, 2017), Illinois District Judge Matthew F. Kennelly granted the prevailing plaintiff’s request to tax most requested costs in the amount of...more

ECJ: Clarification on Withdrawing State Aid from Companies Deemed "Undertaking in Difficulty"

by Jones Day on

The notion of "undertaking in difficulty" is a key element in State aid law because undertakings in difficulty can receive State aid only under the restrictive conditions for so-called rescue and restructuring aid. Any other...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Arrangement Fee Clauses in German Loan Agreements ruled invalid by German Federal Court

by Dechert LLP on

The German Federal Court issued a series of groundbreaking rulings on July 4, 2017. Arrangement fee clauses in German law loan agreements are invalid if they are included in general terms and conditions set by the lender....more

Updated Health Care Reform Legislation Comparison Chart

The chart below compares key provisions of the Affordable Care Act (ACA), the American Health Care Act (AHCA) and the Better Care Reconciliation Act (BCRA). This chart is current as of July 13, 2017, and as of that date,...more

Key funding issues for provider-operated allied health residency programs

by Dentons on

Medicare GME reimbursement is designed only to support the training of medical, dental and podiatric residents. The Medicare program does, however, provide separate funding to support certain programs that train nursing and...more

The Ultimate Misclassification Showdown Could Be Right Around The Corner

by Fisher Phillips on

Gig employers returning from the Fourth of July holiday were in for a rude awakening when they learned about the fireworks that just went down in a California federal court. Right before the holiday weekend, Judge Jacqueline...more

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

by Hogan Lovells on

By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more

Value-based health care: fraud & abuse laws

by Ropes & Gray LLP on

Michael Lampert, Ropes & Gray health care partner, discusses fraud and abuse law application to value-based health care arrangements. __ Much has been made about how the fraud and abuse laws, which were designed in order...more

The Uber Board Report – Part II: Internal Controls

by Thomas Fox on

I continue my blog post series on the Holder Report (Report) to the Board of Directors of Uber Technology, Inc. (Uber) where the Board asked Holder’s law firm, Covington & Burling LLP (Covington), to evaluate three issues:...more

Value-based health care: issues for pharmaceutical companies

by Ropes & Gray LLP on

Michael Lampert, Ropes & Gray health care partner, discusses issues facing pharmaceutical companies with the move towards value-based health care models. __ When I think about developing a value-based program for...more

Fifth Circuit Holds That SPD Was An Enforceable Plan Document Through Which The Administrator Could Properly Seek Reimbursement

by DeWitt Law, LLC on

In another victory for plan administrators seeking reimbursement under the terms of ERISA plans, in Rhea v. Alan Ritchey, Inc. Welfare Benefit Plan, No. 16-41032, 2017 U.S. App. LEXIS 9482 (5th Cir. May 30, 2017), the Fifth...more

Fifth Circuit Enforces Reimbursement Provision in One-Page Welfare Plan

The Fifth Circuit upheld the reimbursement and subrogation terms found in a welfare benefit plan’s one-page SPD that also served as the plan document. Plaintiff, a plan beneficiary, received $71,644.77 from the plan to cover...more

Debt Dialogue: May 2017 - Fiduciary Duty of Collateral Manager Bars Side Deal to Recover Expenses

A typical collateralized debt financing involves a variety of service providers that owe fiduciary duties to investors. In a recent decision handed down in New York State Supreme Court, Commonwealth Advisors, Inc. v. Wells...more

Picking a Fight: How California Makes Employment Law Peculiar

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Our mission here at Cal-Pecs is to illuminate how California employment law differs from the law that employers generally experience throughout America. In this back-to-basics piece, we provide some...more

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Ninth Circuit Issues Shocking Opinion Concerning Health Care Provider ERISA Claims

The Ninth Circuit Court of Appeals is not known for being employer-friendly. So, when the Ninth Circuit issued its latest opinion on health care provider ERISA claims, most thought it would be against employer-sponsored...more

Is It Time To Recall Some Of Your HR Policies?

by Fisher Phillips on

Factory recalls have become a fact of life for those who sell and drive vehicles. The scenarios have a common theme: a vehicle part does not operate as designed or is determined to present a possible risk of failure. Once...more

Employee Business Expenses must be Ordinary and Necessary

by Foodman CPAs & Advisors on

Employees may be able to deduct their work related expenses as an itemized deduction. These expenses must be unreimbursed expenses that are ordinary and necessary to their work as an employee. According to IRS, an ordinary...more

Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

by Foley & Lardner LLP on

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle....more

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