Category Archives: Prescription Drug Coverage

Massachusetts Proposes to Dramatically Restructure Medicaid Benefits

On July 21, 2017, the Massachusetts Executive Office of Health and Human Services (“EOHHS”) announced its intent to submit a request to amend its existing MassHealth Section 1115 Demonstration to the Centers for Medicare and Medicaid Services (“CMS”).   If approved (by both the State legislature, and CMS), it would be the most sweeping change to any state’s Medicaid pharmacy benefit to date. We previously previewed some of the changes EOHHS was considering under the new flexibility granted to states under the Price/Verma administration on this blog.… More

CMS Proposes Fundamental Reimbursement Methodological Change for 340B Drugs Used in Hospital Outpatient Setting

We have noted before the link between the Medicaid prescription drug rebate program and the 340B program.  As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements.  First, the manufacturer must agree to provide a rebate to Medicaid equal to the greater of 23.1% of the average manufacturer price (AMP) of the drug, or AMP minus the best price of the drug. … More

Price and Verma to State Governors: Just Come and Ask Us for Flexibility – What Providers & Drug Manufacturers Could Expect

The last several weeks have been nothing short of enthralling, like an episode of House of Cards. After seven years of campaigning on the repeal of the Affordable Care Act (ACA), Republicans were ultimately unable to create consensus for their highly anticipated repeal-and-replace legislation known as the American Health Care Act (AHCA).  But as the drama on the Hill comes to an end (at least until tax reform is picked up),… More

Medicaid Waivers in Conservative States Hold Hints for What is to Come for Drug Manufacturers

Introduction

The nomination of Seema Verma by President-Elect Trump for the position of CMS Administrator sends a clear signal that the Trump Administration considers Medicaid one of its top healthcare reform priorities.  Seema Verma is the the “architect” of the Healthy Indiana Plan 2.0” waiver (HIP 2.0), a consumer-driven Medicaid expansion demonstration approved by the Obama Administration under a Section 1115 waiver.  Most recently, Verma was also involved in designing Kentucky’s proposed “Kentucky HEALTH” (“HEALTH”) Section 1115 waiver,… More

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

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

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

CMS enters the Hepatitis C drug pricing debate

Although outpatient prescription drugs are not a mandatory benefit under the Medicaid program, all 50 states do provide at least some coverage for prescription drugs.  Manufacturers that want their drugs covered under Medicaid must agree to pay rebates to the Medicaid program (for brand name drugs, rebates must equal at least 23.1% of the average manufacturers price of the drug); must agree to participate in the 340B program; and must agree to provide federal supply schedule pricing to federal government agencies.… More

Yet Another Blow to the Medicaid Expansion

The Affordable Care Act extends and simplifies Medicaid eligibility beginning January 1, 2014, by replacing Medicaid’s previous multiple categorical groupings and limitations with one simplified overarching rule: all individuals aged <65 years with incomes less than 138 percent of the federal poverty level ($15,415 for an individual or $26,344 for a family of 3 in 2012) who meet citizenship/lawful US status and state residency requirements are entitled to Medicaid benefits.… More