Tag Archives: Drug Rebates

CMS Delays Expanding Medicaid Rebate Program, Price Reporting Requirements to Territories Until 2020

CMS has announced that it is delaying until April 1, 2020 its controversial change in the definitions of “States” and “United States” included in the February 1, 2016 Medicaid covered outpatient drug final rule with comment period.  Specifically, in that rulemaking CMS defined “States” and “United States” to include the U.S. territories (American Samoa, the … Continue Reading

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number … Continue Reading

CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s Medicaid best price and increase their Medicaid rebate obligations.  In recent guidance, CMS notes that, in general, prices included in best price include all prices, such as … Continue Reading

OIG Faults State Efforts to Identify 340B Drug Claims; Cites Risk of Duplicate Discounts, Forgone Rebates

The OIG recently examined how states that pay for drugs through Medicaid managed care organizations (MCOs) identify and exclude 340B drug claims when collecting Medicaid rebates, since states are prohibited from collecting “duplicate discounts” (i.e., when manufacturers pay Medicaid rebates on drugs sold at the discounted 340B price).  The OIG also reviewed potential vulnerabilities that … Continue Reading

CMS Releases Long-Awaited Final Medicaid Covered Outpatient Drug Rule

After months of speculation and waiting, CMS yesterday released its final rule to revise Medicaid reimbursement for covered outpatient drugs and reform Medicaid drug rebate requirements.  While we are still digesting what the rule means for drug manufacturers and other health care providers, we promise a full analysis of the final rule, as well as … Continue Reading

Bipartisan Budget Law Extends Medicare Sequestration, Includes Medicaid Drug Rebate, Off-Campus Hospital Outpatient Department, CMP Inflation Policies

On November 2, 2015, President Obama signed into law H.R. 1314, the “Bipartisan Budget Act of 2015” (BBA).  The two-year, $80 billion budget/debt-ceiling deal is funded in part by several significant Medicare and Medicaid policies, including an extension of Medicare sequestration, changes to Medicare payment for services provided in “new” off-campus hospital outpatient departments (OPDs), … Continue Reading

Pending Budget Deal Includes Medicare Sequestration Extension, Other Medicare/Medicaid Cuts

Outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending. For instance, while the budget would provide $80 billion in discretionary spending sequestration relief over two years, it would extend Medicare sequestration for an additional year, … Continue Reading

OIG Examines Medicaid/Part D Drug Rebate Policy

The OIG has issued a report, Medicaid Rebates for Brand-Name Drugs Exceeded Part D Rebates by a Substantial Margin,” comparing statutory Medicaid rebate amounts for brand name drugs with rebates Part D plan sponsors negotiate with drug manufacturers for such drugs. Based on 2012 data, the OIG determined that total rebates under Medicaid were substantially higher … Continue Reading

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider … Continue Reading

Medicaid Drug Rebate Disputes between Manufacturers & States are Limited, OIG Finds

A recent OIG report, “Medicaid Drug Rebate Dispute Resolution Could Be Improved,” focuses on the extent to which drug manufacturers and states disagree on the amount of money that manufacturers owe states in Medicaid rebates, and how such disputes are resolved. Most states providing data (29 of 31) estimated that only a small percentage of … Continue Reading

Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015. Virtually all types of health care providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed – an unlikely scenario given the Republican House leadership’s reaction to the document. Nevertheless, the … Continue Reading

OIG Call for Medicare Part B Drug Rebates Rejected by CMS

A new OIG report estimates that Medicare could realize significant savings if drug manufacturers were required to pay rebates on Medicare Part B drugs, similar to rebates under the Medicaid program. Specifically, Medicare could have collected $3.1 billion in 2011 if manufacturers had been required to pay rebates based on average manufacturer price (AMP) for 60 … Continue Reading

Obama Administration’s Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

Today, the Obama Administration released its proposed federal budget for fiscal year 2014. As widely reported, the budget incorporates an offer the President made to Congress in December 2012 to achieve nearly $1.8 trillion in additional deficit reduction over the next 10 years, including $401 billion in health savings (the Administration observes that this level of … Continue Reading
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