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Keeping you afloat amidst the rising sea of regulations

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.

New CMS System to Report Average Sales Price (ASP) Data for Part B Drugs

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. Manufacturers must begin to use this system to report ASPs for their Medicare Part B eligible drug products beginning with the Q2 2018 reporting, due April 30, 2018. For Q2 2018 only, the data also must be sent using the current manual process, which will be replaced by the electronic system permanently beginning with the Q3 2018 ASP submission.

Fighting the Opioid Epidemic: New DOJ Prescription Interdiction & Litigation Task Force To Target Drug Manufacturers & Distributors

On February 27, 2018, Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force (PIL Task Force), which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors. This is the latest development in the government’s increasing focus over the past year on the opioid epidemic.

Recently-Passed CHRONIC Act Allows for Increased Medicare Coverage for Telehealth Services

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.

Patent Office’s Rulebook Update Supports Personalized Medicine Claims

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.1 At best, patent owners and applicants with such claims are experiencing mixed results in district court and the Patent Office. And, to date, the Federal Circuit has not issued a precedential decision involving a subject matter eligibility challenge of personalized medicine. However, the Patent Office’s recent update to its Manual of Patent Examining Procedure (MPEP) could signal a turning point for life science companies.