Tag Archives: Medicaid drug pricing

Trump Administrations’ Proposed FY 2020 Budget Targets Prescription Drug Prices

Reducing prescription drug prices is a major theme in the Trump Administration’s fiscal year (FY) 2020 budget proposal, with policies intended to increase competition, encourage better negotiation, incentivize lower list prices, and cut out-of-pocket costs for beneficiaries.  The Administration’s projected savings from its designated prescription drug budget proposals top $69 billion over 10 years, although … Continue Reading

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

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

CMS Delays Enforcement of Medicaid AMP Rules for 5i Drugs until July 1, 2016

CMS has announced that it is delaying until July 1, 2016 enforcement of new rules regarding the determination of the average manufacturer price (AMP) for inhalation, infusion, instilled, implanted or injectable drugs (“5i drugs”) that are not generally dispensed through retail community pharmacies. The 5i policy, which was included in CMS’s February 1, 2016 Medicaid … Continue Reading

Medicare and Medicaid Drug Policy Provisions in the Obama Administration’s Proposed FY 2017 Budget

The Obama Administration’s proposed fiscal year (FY) 2017 budget, released on February 9, 2016, includes a number of legislative proposals that would revise Medicare and Medicaid policies to achieve budget savings and make other program reforms.  The largest pool of Medicare savings would result from various Medicare prescription drug proposals, including the following (all savings … 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

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act.  Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes.  Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading

OIG Releases FY 2015 Work Plan Mid-Year Update

The HHS OIG has updated its FY 2015 Work Plan to reflect new and/or completed items since release of its Work Plan in October 2014. Of note, the OIG has announced its plans to conduct several new Medicare reviews addressing: intensity-modulated radiation therapy; hospital preparedness and response to high-risk infectious diseases; access to DME in competitive … 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

CMS Update on Status of Final Medicaid FULs

CMS has announced that while it still has no fixed date for releasing finalized Affordable Care Act (ACA) federal upper limits (FUL) for multiple source prescription drugs, it intends to release the finalized ACA FULs at or about the same time that it publishes a final rule pertaining to Medicaid reimbursement for covered outpatient drugs under … Continue Reading

GAO Highlights Differences in Federal Program Drug Prices

The Government Accountability Office (GAO) has released data comparing retail prescription drug prices paid by the Department of Defense (DOD), Medicaid, and Medicare Part D for a sample of 78 high-utilization/high-expenditure drugs. In general, the GAO determined that Medicaid paid the lowest average net prices for both brand-name and generic drugs in the sample based … Continue Reading

OIG Finds Drug Manufacturers’ Medicaid AMP Determinations Follow Federal Rules

In a recent report, “Average Manufacturer Price Determinations by Selected Drug Manufacturers Generally Were Consistent With Federal Requirements,” the OIG has determined that the methodologies used by 20 selected (unnamed) drug manufacturers to determine average manufacturer price (AMP) for drugs reimbursed by Medicaid generally were consistent with federal requirements. In particular, the manufacturers consistently included transactions … Continue Reading

CMS Abandons Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

In an email today to stakeholders, CMS announced that it will not be finalizing the ACA Medicaid federal upper payment limits (FUL) for multiple source drugs in July 2014, as previously intended. CMS attributes the change to a delay in providing detailed guidance to the states in preparation for implementation. CMS expects to announce a … Continue Reading

HHS OIG Identifies “Top 25” Priorities

The OIG has released its “Compendium of Priority Recommendations,” which lists 25 priority issues for which the OIG has open recommendation and that, if implemented, would best protect the integrity of HHS programs. The 25 top priorities are as follows: Medicare Policies and Payments: address wasteful Medicare policies and payment rates for clinical laboratories, hospitals, and … 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

GAO Urges CMS to Finalize ACA Medicaid Drug Pricing Reforms

The GAO recently issued a report on CMS efforts to implement Medicaid drug pricing reforms mandated by the Affordable Care Act (ACA). Specifically, the report discusses CMS development of the National Average Drug Acquisition Cost (NADAC) benchmark of retail pharmacy acquisition costs, and how NADAC amounts compare to ACA-based federal upper limits (FULs). Based on first quarter … Continue Reading

CMS Announces Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

After more than two years of releasing draft average manufacturer price (AMP)-based federal upper payment limit (FUL) files and methodology documents, CMS now expects to finalize the ACA Medicaid FULs for multiple source drugs in July 2014. While CMS intends to provide additional guidance in the months to come, the agency is encouraging states to … Continue Reading

OIG Urges CMS Action on Medicaid Drug Pricing Changes in Preparation of ACA Enrollment Expansion

In a recent report, “Medicaid Drug Pricing in State Maximum Allowable Cost Programs,” the OIG examines options for controlling state Medicaid prescription drug costs, particularly given a surge in Medicaid enrollment expected in the coming years as a result of the ACA. The OIG highlights the value of state Maximum Allowable Cost (MAC) programs as … Continue Reading
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