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Keeping you afloat amidst the rising sea of regulations

White House ‘Blueprint to Lower Drug Prices’: Large Aspirations, Little Detail

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. The plan is known as the “American Patients First” program, as outlined in “The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (the Blueprint).

Secure Sweet Home Alabama: Alabama Is Last State to Enact Data Breach Notification Statute

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. (Click here for alert on South Dakota’s act). 

The Medicaid Expansion Fight Goes From Ballot Initiative to Court in Maine

Medicaid expansion continues to be a hot button issue in the numerous states that have yet to expand the program under the Affordable Care Act of 2010 (“ACA”), and the latest battlefield is a Maine courthouse. 

HRSA Kicks the Can Down the Road (Again) on 340B Rules

The Health Resources and Services Administration (HRSA) published a notice in the Federal Register on May 7, 2018 (the Proposed Rule) proposing its intention to delay – for the fifth time – the implementation of a January 5, 2017 Final Rule (the Final Rule) regarding calculation of 340B ceiling prices and the imposition of civil monetary penalties on noncompliant organizations related to the 340B Drug Pricing Program (the 340B Program).

Surviving the Public Disclosure Bar Just Got Easier for Relators in the Ninth Circuit

Developments in the Original Source Standard A development out of the Ninth Circuit makes relators more likely to qualify as an original source under the False Claims Act and thus survive the public disclosure bar.

Recent Anti-Kickback Settlements Continue to Generate Substantial Revenue for DOJ

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. The United States Department of Justice recently settled three FCA lawsuits involving alleged violations of the AKS, which prohibits the offering, solicitation, or acceptance of any type of gift or remuneration in exchange for physician referrals for services covered by federally funded healthcare programs.

Reminder: Pharma Manufacturers Now Required to Report Average Sales Price (ASP) Data for Part B Drugs Via New System

As discussed in a prior blog post, 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 (CMS) through the Fee-for-Service Data Collection System (FFSDCS).

Maryland’s Drug Price-Gouging Law Struck Down As Unconstitutional

On Friday, April 13, 2018, in an opinion that may have far-reaching effects, the United States 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, which generally constrains states’ power to enact legislation that interferes with or burdens interstate commerce. Given the number of states seeking to impose either reporting and transparency requirements on drug manufacturers related to drug price incre

New CMS Final Rule Gives States Increased Flexibility to Define Essential Health Benefits Despite Disapproval from Patient Advocacy Groups

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. Citing the desire to permit insurers to offer more affordable health plans, CMS is providing states many new options for selecting the set of benefits for each state’s EHB-benchmark plan.

FDA Proposes New Class II Device Marketing Pathway

The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to largely rely on declarations of conformity and/or summary data. Though attractive, the proposed program raises certain regulatory and business questions for manufacturers of class II devices.