News & Analysis as of

Reimbursements

German Supreme Court Issues Landmark Ruling on Unfair Trading Practices

by Jones Day on

The Situation: Market-dominant and powerful companies in Germany are subject to a number of rules that are significantly broader and stricter than the European Union's, Article 102 AEUV, which prohibits the abuse of a...more

Advisory Committee on Petroleum Storage Tanks – February Meeting

As noted in previous blog posts, Arkansas operates a petroleum storage tank trust fund that provides reimbursement for eligible storage tanks for certain corrective actions and third party damage claims due to a release of...more

Top 5 Ways Telehealth Will Change Under the New Federal Funding Bill

by Foley & Lardner LLP on

The telemedicine industry has been abuzz upon learning that provider-friendly legislation was included in the new federal Bipartisan Budget Act of 2018, signed into law by the President on February 9, 2018. But telehealth...more

Medicare’s New Remote Patient Monitoring Reimbursement: What Providers Need to Know

by Foley & Lardner LLP on

The new year continues to offer big opportunities for telemedicine and digital health companies, and one of the most notable developments is CMS’ decision to reimburse providers for remote patient monitoring (RPM). Effective...more

Guide To The New Rules For The Deductibility Of ‘Misconduct’ Payments: Government- And Quasi-Government-Imposed Penalties, Fines,...

by Morgan Lewis on

Recent US tax reform legislation P.L. 115-97, commonly known as the Tax Cuts and Jobs Act, made sweeping changes to when and how a taxpayer will be able to deduct payments made to settle claims of particular acts of...more

FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders

by Morgan Lewis on

The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and announced a public meeting on enrollment criteria, signaling the agency’s...more

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

by Hogan Lovells on

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more

Tax Cuts and Jobs Act: Implications for Health and Welfare Plans and Fringe Benefits

by Snell & Wilmer on

On December 22, 2017, the Tax Cuts and Jobs Act (“the Act”) was signed into law, and it has various implications for employers who sponsor employee benefit plans. This newsletter focuses on the provisions in the Act that...more

Supreme Court to Decide Whether Crime Victims Are Entitled to Mandatory Reimbursement of Internal Investigations Costs

by Seyfarth Shaw LLP on

On January 12, 2018, the United States Supreme Court granted certiorari in Lagos v. United States, No. 16-20146 (2018), which presents the question of whether victims (including corporate victims) are entitled to have their...more

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

President Trump Signs Tax Reform Bill into Law

On December 15, 2017, the House and Senate conference committee agreed on the terms of the final tax reform bill, previously referred to as the “Tax Cuts and Jobs Act” (the “Act”), which was subsequently approved by both...more

The Impact of the Tax Cuts and Jobs Act on Employee and Fringe Benefits

The Tax Cuts and Jobs Act makes some notable, though targeted, changes to the employee benefits landscape. We summarize some of the more significant changes in the Question and Answers set out below....more

Telehealth In 2017: What Changed And What's Ahead

As the U.S. shifts from a fee-for-service (FFS) system to a value-based system, health care information technology will become an increasingly important component in fostering patient engagement, coordinating care, increasing...more

I Believe in Father Christmas and Internal Controls for Gifts in the Holiday Season

by Thomas Fox on

In considering the effectiveness of controls, you must always keep in mind the most frequently used method for defeating an internal control, which is driven by a dollar amount criteria, is splitting the item into multiple...more

Health Update - December 2017

Part 1: Megatrends Reinventing How Patients Think - Editor’s Note: In a recent webinar for PharmaVOICE, Manatt Health revealed the megatrends reinventing the life sciences industry—and how they relate to new thinking by...more

Value-based health care: compliance infrastructure

by Ropes & Gray LLP on

Brett Friedman, Ropes & Gray health care partner, discusses the impact to compliance organizations as payment models transition from traditional fee-for-service to value-based. ------- As the payment models have shifted...more

Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

by McDermott Will & Emery on

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to...more

Fifth Circuit Decision in Highway Guardrails Case Provides Important Guidance on Materiality in False Claims Act Cases

by Mintz Levin on

The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.” In U.S. ex rel. Joshua...more

Another Obstacle to Medicare and Medicaid Compliance

by McGuireWoods LLP on

When investigating whether an individual or entity is excluded from the federal healthcare programs, healthcare organizations must be on the alert for yet another method for defrauding the government: alias names. Alias names...more

C-Suite Employment Contract Clauses Companies and their Boards Must Consider in the Wake of Weinstein

by Bowditch & Dewey on

The Harvey Weinstein scandal has struck a nerve in American society and empowered individuals to speak out about sexual harassment and retaliation in the workplace. The nation appears to be at a tipping point, with...more

Tax Reform Contains Drastic Welfare Plan Changes

As you may have heard, the House and Senate are currently considering separate tax reform bills. If these separate bills are approved by the House and Senate, they will then go to a conference committee, whereby a single,...more

Large Contractors – Time to Take Your Protests to Court?

by Bass, Berry & Sims PLC on

Congress recently concluded the conference on the 2018 National Defense Authorization Act (NDAA), resolving the differences between the House and Senate versions of the FY18 NDAA passed earlier this year. Pilot Program...more

Tax Reform Proposal Nixes Favorable Tax Treatment of Several Employee Benefits

by McNair Law Firm, P.A. on

On November 3, 2017, House Ways and Means Committee Chairman Brody began the legislative consideration of Tax Reform by releasing an amendment (in the nature of a substitute) to the Tax Reform and Jobs Act (H.R. 1 hereinafter...more

Telehealth Report Offers Glimpse Into Variety And Complexity Of State Telehealth Laws And Policies

by Cozen O'Connor on

In the recently published fall update of the fifth annual edition of its telehealth report, the Center for Connected Health Policy, the federally designated National Telehealth Policy Resource Center, provides a current...more

Tax Reform Contemplates Changes to Employee Benefits

The House Committee on Ways and Means publicly released a working draft of the Tax Cuts and Jobs Act for the first time on Thursday. In the weeks leading up to the release of the draft, speculation has swirled as to whether...more

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