Tag Archives: Drug Pricing

CMS Releases Updated Draft Medicaid FUL Files

CMS has posted the September 2012 draft average manufacturer price (AMP)-based Medicaid federal upper limit (FUL) files, along with updated three-month rolling average FUL file consisting of the weighted average of the current and two previous monthly draft AMP-based FULs. CMS continues to accept comments on the monthly and three-month rolling average draft AMP-based FULs … Continue Reading

D.C. Circuit Decision Upholding DOD Rule May Leave Drug Manufacturers on the Hook for Refunds

The D.C. Circuit recently upheld a Department of Defense (DOD) rule that will require drug manufacturers to provide partial refunds on certain prescription drugs, dating back to 2008. The rule that was the subject of the case imposes a cap on the retail price of drugs and requires manufacturers to refund the difference between the … Continue Reading

CMS Medicaid Drug Pricing Webinar: Draft Federal Upper Limits and Draft Survey of Retail Prices (Dec. 5)

On December 5, 2012, CMS is hosting a webinar on various Medicaid drug pricing issues. The webinar will cover the CMS draft three-month rolling average FUL file; draft National Average Drug Acquisition Cost (NADAC) file; draft National Average Retail Price (NARP) file; and draft Monthly New Drug Report.  A taping of the event and slides will be … Continue Reading

GAO Finds Part D Coverage Gap Discount Program Did Not Spur Increased Drug Prices

The GAO has issued a report that responds to concerns raised by certain Democratic lawmakers that manufacturers participating in the Medicare Part D drug “Coverage Gap Discount Program” would raise prices for brand-name drugs used by beneficiaries in the coverage gap to offset the 50% discount that manufacturers must provide under the Affordable Care Act. … Continue Reading

OIG Calls on CMS to Implement Medicaid Drug AMP-Based FUL Payments

The OIG has issued a report on Medicaid pharmacy reimbursement that compares FUL amounts based on published prices to FUL amounts based on AMP and pharmacy acquisition costs. According to the OIG, FUL amounts based on published prices (from the fourth-quarter 2011 Redbook file) were more than four times greater than sampled pharmacy acquisition costs. … Continue Reading

CMS Posts Updated Draft Medicaid Drug Pricing Files

CMS has posted the August 2012 draft average manufacturer price (AMP)-based Medicaid federal upper limit (FUL) files, along with updated three-month rolling average FUL file consisting of the weighted average of the current and two previous monthly draft AMP-based FULs. CMS continues to accept comments on the monthly and three-month rolling average draft AMP-based FULs … Continue Reading

OIG Issues FY 2013 Work Plan

The HHS Office of Inspector General (OIG) has released its FY 2013 Work Plan, which outlines audit, inspection, and investigative initiatives that the OIG intends to conduct in the coming year. The OIG plans activities in a wide range of areas, including reviews of Medicare fee-for-service reimbursement and program integrity policies involving virtually all types … Continue Reading

CMS Invites Comments on Draft Medicaid Drug Pricing Data (FULs, NARP, NADAC)

On October 5, 2012, CMS released a number of draft Medicaid drug pricing files and related documents for review and comment. Among other things, CMS has posted the June 2012 and July 2012 draft average manufacturer price (AMP)-based Medicaid federal upper limit (FUL) files.  Based on comments that month-to-month fluctuations in the AMP-based FULs “may … Continue Reading

OIG Report Reviews Updated Medicare Part B Drug Pricing Data

The Social Security Act requires the OIG to notify the HHS Secretary if the average sales price (ASP) for a particular drug exceeds the drug’s average manufacturer price (AMP) or widely available market price (WAMP) by a threshold, currently set at 5%. If that threshold is met, the Secretary is authorized to disregard the drug’s … Continue Reading

CMS Webinar on Medicaid National Average Drug Acquisition Cost Survey (June 28)

CMS is hosting a webinar on June 28, 2012 to discuss its “Draft Methodology for Calculating the National Average Drug Acquisition Cost,” which may be used as a reference price for states to consider when setting their Medicaid drug reimbursement methodology.  Advance registration is required.  CMS will post a taping of the webinar and related … Continue Reading

CMS Accepting Comments on Draft Methodology for Calculating National Average Drug Acquisition Cost (NADAC)

CMS has released its “Draft Methodology for Calculating the National Average Drug Acquisition Cost,” which may be used as a reference price for states to consider when setting their Medicaid drug reimbursement methodology. Among other things, the draft methodology indicates that CMS plans monthly surveys of chain and independent – but not specialty – pharmacies, … Continue Reading

Congressional Health Policy Hearings

Recent hearings on health policy issues include: Senate Health, Education, Labor and Pensions Committee hearings on HIV/AIDS drug costs, health care delivery reforms, and federal laws to ensure patients’ access to care and privacy. A Senate Finance Committee hearing on “Progress in Health Care Delivery: Innovations from the Field.” A House Judiciary Subcommittee on Intellectual … Continue Reading

CMS Releases Long-Awaited Proposed Rule to Implement ACA Medicaid Manufacturer Rebate and Pharmacy Reimbursement Provisions

On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services ("CMS") released its long-awaited proposed rule to implement the provisions of the Affordable Care Act ("ACA") relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program ("MDRP").… Continue Reading

CMS Releases Additional Draft ACA Medicaid Drug Pricing/FUL Files

As previously reported, the ACA modified the statutory federal upper limit (FUL) provisions for Medicaid reimbursement for multiple source drugs. While CMS has not yet promulgated regulations to implement this policy, the agency has issued several sets of draft FUL reimbursement files, including the draft methodology used to calculate the FULs in accordance with the … Continue Reading

CMS Posts Third Draft Federal Upper Limit (FUL) Files Under ACA

As previously reported, the ACA modified the statutory FUL provisions for Medicaid reimbursement for multiple source drugs. In short, the ACA directs the Secretary to calculate FULs as no less than 175% of the weighted average (determined on the basis of utilization) of the most recently reported monthly average manufacturer prices (AMP), effective October 1, 2010. … Continue Reading

CMS Issues Final Medicare Physician Fee Schedule Rule for 2012

Medicare physician fee schedule (MPFS) payments are scheduled to be cut by 27.4% in 2012 under the Centers for Medicare & Medicaid Services’ (CMS) final rule to be published November 28, 2011. The steep reduction is a result of the statutory Sustainable Growth Rate (SGR) formula. While Congress is widely expected to take action to mitigate the … Continue Reading
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