Category: Coverage and Reimbursement
OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory Opinion Rescission
As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP failed to fully, completely and accurately disclose all relevant and material facts to the OIG and failed […]
California Governor Signs Drug Price Reporting Bill
California Governor Jerry Brown signed S.B. 17 into law on Monday. As we reported when S.B. 17 was sent for Governor Brown’s signature, the law requires manufacturers of prescription drugs with a wholesale acquisition cost (WAC) of more than $40 to give 60 days’ notice of any increase in WAC […]
California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers related to certain price increases of some already marketed drugs and the introduction of new drugs onto the […]
Medicare Part B Demo Declared Dead
On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in […]
Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter
Health care policy issues continue to stream out of Congress and the Administration. The Senate held a markup of various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.
Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights
We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1. If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we […]
Final MDRP AMP Rule is Out! Will be Effective on April Fools Day 2016. (No joke.)
If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)! The publication of this Final AMP Rule follows the 2012 publication of […]
