Health Care Counsel Blog
816 total results. Page 24 of 33.
Stephanie Trunk
HRSA published a notice in the Federal Register on May 7, 2018 proposing its intention to delay – for the fifth time – the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices and the imposition of civil monetary penalties.
D. Jacques Smith, Randall A. Brater, Nadia Patel
The latest False Claims Act settlements indicate that the Anti-Kickback Statute continues to be an enforcement priority and a key tool for identifying and prosecuting healthcare fraud.
Stephanie Trunk
Pharmaceutical manufacturers whose drugs are reimbursed under Medicare Part B must now report certain product and financial data (including Average Sales Price, or ASP) to the Centers for Medicare & Medicaid Services through the Fee-for-Service Data Collection System.
Stephanie Trunk
On April 13, 2018, the US Court of Appeals for the Fourth Circuit found Maryland’s new drug price-gouging prohibition law unconstitutional under the dormant Commerce Clause of the United States Constitution.
Caroline Turner English, David S. Greenberg
In a new final rule released on April 9, 2018, CMS is allowing states substantially more flexibility in selecting Essential Health Benefits (EHB)-benchmark plans for the 2020 plan year.
James M. Westerlind
On March 21, 2018, South Dakota became the forty-ninth state to enact a data breach notification statute, which becomes effective July 1, 2018.
Caroline Turner English, Rebecca W. Foreman
Health plans and administrators subject to the Employee Retirement Income and Security Act have been warned: failure to comply with ERISA’s procedural requirements may strip them of the deference their benefit determinations enjoy.
Stephanie Trunk
The Centers for Medicare & Medicaid Services published a final notice in the Federal Register on March 23, 2018, to amend and update for the first time since its original release in 1991 the Medicaid National Drug Rebate Agreement.
Stephanie Trunk, Dan H. Renberg
the Centers for Medicare & Medicaid Services issued a National Coverage Determination on March 16, 2018 approving Medicare coverage and payment for diagnostic laboratory tests utilizing next generation sequencing, or NGS, for patients with certain types of advanced cancer.
Stephanie Trunk
Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California, Nevada, and Maryland, which have all adopted pricing and/or transparency laws of some variety over the past year.
Caroline Turner English
In a recent 8-6 en banc decision, Ariana M. v. Humana Health Plan of Texas, Inc., No. 16-20174, 2018 WL 1096980 (5th Cir. Mar. 1, 2018), the Fifth Circuit Court of Appeals overturned its precedent, to step in line with the majority of other circuits.
Stephanie Trunk
Starting in April 2018, the Centers for Medicare & Medicaid Services will begin to implement significant changes to the look and content of Medicare identification cards.
Stephanie Trunk, Hillary M. Stemple
A recent settlement announced by the US Department of Justice serves as a warning to pharmaceutical and device manufacturers that the government remains concerned about the provision of expensive meals to physicians and the impact such meals may have on a physician’s independent medical judgment.
Stephanie Trunk
A long time coming and after much anticipation and speculation, CMS is about to unveil an electronic reporting system in which manufacturers will report to CMS their quarterly ASP calculations.
Douglas A. Grimm, Hillary M. Stemple
Legislation included as part of the massive congressional budget deal reached earlier this month will pave the way for expanded use of telehealth technologies that improve access to care and reduce cost of health care.
Alexander H. Spiegler
Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.
Stephanie Trunk
The Bipartisan Budget Act of 2018 was signed into law on February 9, 2018 in order to avert another shut-down of the federal government.
Sarah G. Benator
On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) issued Survey and Certification Memorandum Number 18-10-ALL to the State Survey Agencies clarifying its position regarding texting health care information by providers.
D. Jacques Smith, Michael F. Dearington, Randall A. Brater
Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.
Dan H. Renberg
As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.
Stephanie Trunk
A new administrative rule promulgated and adopted by the Attorney General for the state of New Jersey (the AG) will “regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers.”
Alexander H. Spiegler
This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.
Stephanie Trunk
The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule soliciting recommendations for new Anti-Kickback Statute (AKS) safe harbors, modifications to existing safe harbors, and new OIG Special Fraud Alerts.
Stephanie Trunk
In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report titled "Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates."
D. Jacques Smith, Randall A. Brater, Michael F. Dearington
The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017.