Health Care Counsel Blog

807 total results. Page 23 of 33.

Stephanie Trunk
On June 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) dropped their lawsuit challenging the constitutionality of Nevada’s recent drug price transparency law.
Stephanie Trunk
In-house counsel for health industry organizations face unique challenges – but those challenges can be met.
Caroline Turner English, Alison Lima Andersen
The Fifth Circuit recently held that plaintiffs seeking benefits, under plans governed by the Employee Retirement Income Security Act of 1974 and non-ERISA plans, need not identify and include specific plan provisions in their complaints to survive motions to dismiss.
Douglas A. Grimm, Hillary M. Stemple, Kathryn L. Steffen
On June 20, 2018, the Centers for Medicare & Medicaid Services issued a Request for Information seeking input from the public on how to address the undue regulatory impact and burden imposed on health care providers under the Stark Law.
Douglas A. Grimm, Hillary M. Stemple
Geoffrey Starks testified on Wednesday, June 20, 2018 before the Senate Committee on Commerce, Science, and Transportation.
M. Scott Peeler, Andrew Dykens
The US Department of Justice remained busy in its first year of the Trump Administration, charging 20 individuals with violations under the US Foreign Corrupt Practices Act — the second highest year of individual prosecutions since 1977.
Douglas A. Grimm, Hillary M. Stemple
Edwin Simcox, Acting Chief Technology Officer for the US Department of Health and Human Services (HHS), lauded telehealth as an innovation that potentially offers ways to address HHS’s four key priorities.
Douglas A. Grimm, Hillary M. Stemple
The Department of Health and Human Services OIG has issued an advisory opinion approving an arrangement involving the provision of free telemedicine equipment and services by a provider to a potential referral source.
Stephanie Trunk
The California Office of Statewide Health Planning and Development (OSHPD) has posted a preliminary working draft of the regulations implementing California’s prescription drug price transparency law.
Stephanie Trunk
Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the Maine Law) became effective on May 1, 2018.
Stephanie Trunk, Thomas E. Jeffry, Jr.
The Centers for Medicare and Medicaid (CMS) is overhauling the Electronic Health Records (EHR) Medicare and Medicaid program for hospitals.
James M. Westerlind
South Carolina has become the first state to enact an insurance data security act based on the Insurance Data Security Model Law drafted by the National Association of Insurance Commissioners, which is based on New York’s Cybersecurity Regulations (23 N.Y.C.R.R. Part 500).
Stephanie Trunk
On May 17, 2018, CMS issued a strongly-worded letter to Part D plan sponsors stating that pharmacy “gag clauses” are unacceptable.
Caroline Turner English, Katie Heilman
In a recent decision, the US Court of Appeals for the Ninth Circuit held that a surgical center lacked standing to bring ERISA claims against a health plan because the plan had a valid anti-assignment provision.
Stephanie Trunk
Following delays and much build up, the White House and the Department of Health and Human Services (HHS) have released their plan to address rising pharmaceutical prices and out-of-pocket costs directly impacting patients.
James M. Westerlind
On March 28, 2018, the Governor of Alabama, Kay Ivey, signed SB 318, the Alabama Data Breach Notification Act, which becomes effective June 1, 2018. Alabama is just behind South Dakota, which enacted its data breach notification statute this past March.
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.