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Keeping you afloat amidst the rising sea of regulations

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

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.

OIG Report Highlights Impact of Improper Drug Classification

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, which was conducted in response to a request from Congress to “evaluate the accuracy of manufacturer-reported drug classification data in the Medicaid rebate program.” The OIG determined that while the “vast majority” of some 30,000 drugs reimburs

The Healthy Indiana Plan: A National Model for Medicaid Reform?

Arent Fox Health Care Partner David Greenberg and Associate Sean Clerget recently published an article in Bloomberg Law discussing health care reform, specifically focusing on the Medicaid program and how innovations currently in place in Indiana may serve as the model for Medicaid reform under the current administration.   

HOPPS 2018 Final Rule Released, Confirming Changes to Medicare Part B Drug Reimbursement for Drugs Purchased Under the 340B Program

The advance copy of the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (HOPPS) final rule for calendar year 2018 (the Final Rule) was released on November 1, 2017. The official version of the Final Rule will be published in the Federal Register on November 13, 2017.