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Keeping you afloat amidst the rising sea of regulations

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.

South Dakota Becomes the Forty-Ninth State to Enact Data Breach Notification Statue

On March 21, 2018, South Dakota became the forty-ninth state to enact a data breach notification statute, which becomes effective July 1, 2018. California was the first state to enact a data breach law in 2002 and, since then, nearly every state has followed suit. Alabama is now the only state to not have enacted such a law.

Second Circuit Decision Warns Plan Administrators to Strictly Adhere to ERISA Regulations & Plan Terms

Health plans and administrators subject to the Employee Retirement Income and Security Act have been warned: failure to comply with ERISA’s procedural requirements—and interpret plan terms as a non-industry expert would—may strip them of the deference their benefit determinations enjoy and result in higher payments to providers.

Pharma Manufacturers Must Take Action: CMS Releases First Revised Version of the Medicaid Drug Rebate Program National Rebate Agreement Since 1991

The Centers for Medicare & Medicaid Services (CMS) 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 (NDRA). The updates incorporate legislative and regulatory changes that have been promulgated in the intervening years, such as the release of the Final AMP Rule in January 2016.

First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) 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. According to CMS, “NGS oncology panel test

Oregon Joins Growing Number of States with New Drug Pricing Transparency Laws

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California,

The Fifth Circuit Takes a Fresh Look at ERISA Benefit Claims Review Standard

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.  

Providers Take Note: CMS to Hold Special Open Door Forum Related to New Medicare Cards

Starting in April 2018, the Centers for Medicare & Medicaid Services (CMS) will begin to implement significant changes to the look and content of Medicare identification cards. The most notable change will remove beneficiaries’ Social Security Numbers and replace that number with a new Medicare Beneficiary Identifier (MBI) on the face of the card. CMS is sponsoring a conference call on March 20 from 2-3pm EST to allow providers to ask questions about the new cards. The dial in and conference ID number is as follows: Participant Dial-In Number: 1-800-837-1935, Conference ID #: 4588156.

FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic test for use in screening consumers for select BRCA1/BRCA2 breast cancer gene mutations that are most commonly found in people of Ashkenazi (Eastern European) Jewish descent.

Some Things Never Change: Lavish Meals Result in Significant FCA Liability for Device Manufacturer

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.