A proposed rule issued by CMS on September 3, 2010 would withdraw certain provisions of the July 17, 2007 Medicaid average manufacturer price (AMP) final rule, along with the October 7, 2008 final rule defining "Multiple Source Drug." CMS explains that the withdrawal is being proposed in light of retail pharmacies’ legal challenges to
AMP Reporting
New Law Boosts Medicaid Funding to States, Modifies Medicaid AMP Policy
By Debra A. McCurdy on
On August 10, 2010, President Obama signed into law H R 1586, the Education Jobs and Medicaid Assistance Act. Among other things, the legislation provides an extra $16.1 billion in enhanced Medicaid matching funds to the states after temporary spending under the American Recovery and Reinvestment Act (ARRA) expires at the end of the year.…
Senate Rejects House Generic Drug Settlement, AMP Provisions
By Debra A. McCurdy on
On July 22, 2010, the Senate voted to reject House amendments to an emergency supplemental appropriations bill (H.R. 4899) that would block certain agreements in patent litigation settlements that delay generic drug market entry, and modify the definition of average manufacturer price (AMP).
Generic Drug Settlements, AMP Calculation Provisions Approved by House
By Debra A. McCurdy on
On July 1, 2010, the House of Representatives approved an amendment to a supplemental appropriations bill (H.R. 4899) that includes two provisions impacting prescription drugs. First, the House amendment includes a provision to block certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays…
Comparison of 4th Quarter 2009 Part B Drug ASPs/AMPs
By Debra A. McCurdy on
The OIG’s latest report comparing Medicare Part B drug ASPs and AMPs found 35 Healthcare Common Procedure Coding System (HCPCS) codes with ASPs that exceeded AMP by at least 5% in the fourth quarter of 2009. If reimbursement for these 35 codes had been based on 103% of the AMPs during the second quarter of…
CMS Issues Revised Program Instructions and Draft Manufacturer Agreement for Medicare Part D Coverage Gap Discount Program; Releases Medicaid AMP Reporting Guidance
By Debra A. McCurdy on
On May 21 CMS issued a revised version of its program instructions for the Medicare Coverage Gap Discount Program, which was established by the Patient Protection and Affordable Care Act (PPACA) as amended by the Health Care and Education Reconciliation Act of 2010. Also on May 21, 2010, CMS released a draft model agreement to be used by the HHS Secretary and manufacturers under the program. The CMS notice also announces a public meeting on June 1, 2010 in Baltimore, Maryland to discuss the draft agreement. Separately, on May 21, CMS posted a document entitled “Delayed, Incorrect, and Non-Reporting of Monthly & Quarterly AMP.”…
Continue Reading CMS Issues Revised Program Instructions and Draft Manufacturer Agreement for Medicare Part D Coverage Gap Discount Program; Releases Medicaid AMP Reporting Guidance
OIG Report Compares ASPs, AMPs
By Debra A. McCurdy on
The HHS Office of Inspector General (OIG) has released another in its series of reports comparing Medicare average sales prices (ASPs) for Part B drugs with average manufacturer prices (AMPs). In this latest report, the OIG identified 26 drug HCPCS codes with ASP that exceeded AMP by at least 5% in the third quarter of …
OIG Reports on ASP Reporting/Pricing
By Debra A. McCurdy on
The OIG has issued a report entitled "Average Sales Prices: Manufacturer Reporting and CMS Oversight." According to the OIG, for each quarter under review, over 40% of manufacturers submitted average sales prices (ASP) late, but most submitted the data within 10 days after the deadline. The OIG observes that current CMS methods for recording ASP data, …