Health Care

A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for billing agents.

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug Rebates for EpiPen.

The U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model.

On the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place ("MCEP") against Premier Health Partners ("Premier") have been dismissed with prejudice. This case represents an important development in the body of case law addressing the antitrust risk introduced by joint ventures. 

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo.

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.

Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017.

A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit.

It has been some time since we provided a detailed update on the status of FDA's user fee legislation making its way through Congress, so that's what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

Last week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made minor changes to the interface for breach reporting.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017.  This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA)Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017. This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA).

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017. This week's preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules. 

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force.  As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud.

While we continue to follow the recreational marijuana legalization saga and the Massachusetts Department of Public Health’s Medical Marijuana Program, our colleagues on the employment law side of the equation are monitoring decisions regarding the ability of employers to take disciplinary action against employees for using marijuana at work.

In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next, I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.”

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the Better Care Reconciliation Act (BCRA), the User Fee Acts (UFAs), the National Defense Authorization Act (NDAA), and the health care Minibus.

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA).

Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus.

It appears that - at least for now - the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch's efforts to tackle the increasingly contentious debate about prescription drug prices.