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

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

Medicare and Medicaid Celebrate 50 Years

On July 30, the country marks the 50th anniversary of the enactment of the Medicare and Medicaid programs. Fifty years ago, President Lyndon Johnson signed the two programs into law.

I am very proud to say that I have been involved in health care law and policy for more than one-half of the lifetime of these important social programs. My first job out of college – right after the 15th anniversary of Medicare and Medicaid –… More

Medicaid Managed Care Proposed Rule: Provisions Relevant to the Biopharmaceutical Industry

On May 26, 2015 the Centers for Medicare & Medicaid Services (CMS) released its long-awaited proposed rule designed to modernize the Medicaid managed care regulations (last updated in 2002) to reflect changes in the use and growth of the managed care program and to align the program more closely with other existing healthcare programs, including Medicare/Medicare Advantage and qualified health plans offered by Exchanges.

As of FY 2011,… More