CMS Updates the Medicaid Drug Rebate Agreement For the First Time in 25 Years

As we continue our coverage of the potentially seismic changes to the Medicaid Program under a Trump Administration, we’d like to take a momentary detour into the weeds—it’s inevitable in Medicaid after all—and touch on a recent development that may be of interest to some of our readers.

On November 9, 2016, the Center for Medicare and Medicaid (CMS) published a notice announcing proposed changes to the Medicaid National Drug Rebate Agreement (NDRA),… More

Medicaid under a Trump Administration: Rethinking the Medicaid Program

Last week, we wrote about the importance of the Medicaid program, especially given its size as, by far, the largest health insurance plan in the United States.  We noted that Medicaid covers 71 million people (this number increased dramatically after the Affordable Care Act was enacted in 2010).  We said that “Medicaid is important for all of us” – whether you are a program beneficiary, a taxpayer who helps pay for it,… More

Medicaid under a Trump Administration: What the Next Four Years Might Look Like

Dear readers: this post is going to be a bit different from our regular posts, in that we are going to try to refrain from getting too far in the weeds, and avoid too much legalese. Why? Because the results of the November election will likely have major implications not only for the Medicaid program itself, but for the millions of individuals it serves. We are fortunate to have a platform here and it is our hope that,… More

CMS and Massachusetts Advance Delivery System Reform with Approval of New 1115 Waiver

On November 4, 2016, the Centers for Medicare & Medicaid Services (“CMS”) sent word to the Massachusetts Executive Office of Health and Human Services (EOHHS, referred to here as “MassHealth”) that it approved a major amendment to Massachusetts’ section 1115 demonstration project through June 30, 2017.  At the same time, CMS also approved an extension of this same demonstration through June 30, 2022. Approval of Massachusetts’ waiver amendment comes after nearly a year of negotiations and may ultimately result in the transition of the vast majority of MassHealth enrollees into newly-formed Accountable Care Organizations (“ACOs”) operating under one three models,… More

Summary of the “340B Drug Pricing Administrative Dispute Resolution” Proposed Rule

Overview & Analysis

On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule entitled “340B Drug Pricing Program; Administrative Dispute Resolution” (Proposed Rule).  The Proposed Rule follows the Advanced Notice of Proposed Rulemaking (APRM) issued by HRSA on September 20, 2010 and aims to establish requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.  Interested parties may submit written comments on or before October 11,… More

CMS releases guidance to states and manufacturers on Medicaid value based purchasing arrangements

In light of the growing cost (and demand for) specialty pharmaceutical products, and the corresponding stress this growth has had on state Medicaid coffers, CMS is now actively encouraging states Medicaid programs to engage in value based purchasing (VBP) arrangements with manufacturers.  On Thursday July 14, CMS released guidance documents to state Medicaid agencies and manufacturers regarding participation in these VBP arrangements.

Background

As states consider creative ways to finance high cost drug spend,… More

Video: Medicaid Fiscal Issues

Here is another video from my recent guest lecture at George Mason University. Discussing the evolution of U.S. healthcare delivery and financing was particularly challenging because of the many ongoing and approaching changes, such as the Medicare Part B Drug Payment Model, the implementation of MACRA, the launch of CMMI’s Oncology Care Model, and the steady expansion of value-based arrangements in the private market.

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OIG Says State Methods For Preventing Duplicate Discounts Are Vulnerable

Introduction

The Office of Inspector General (OIG) recently issued a report titled “State Efforts to Exclude 340B Drugs from Medicaid Managed Care Rebates.”  In its report, OIG wanted to study the different methods that states were using to prevent illegal “duplicate discounts” that occur as a result of the interaction between the Medicaid drug rebate program and the 340B drug-discount program.  OIG revealed that the systems a majority of states have for preventing duplicate discounts are actually quite vulnerable,… More

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) published a long-awaited final rule entitled “Medicaid Program:  Covered Outpatient Drugs.”  CMS actually proposed this rule in February, 2012, so it’s taken almost four years for the agency to finalize the many policies on which they sought comment – almost all of which flow from the enactment of the federal health care reform law that was enacted in 2010,… More