Medicaid plans to end onerous AMP rules
WHAT IT MEANS AND WHY IT’S IMPORTANT It’s about time.
(THE NEWS: NACDS, NCPA in joint statement praise CMS’ move to withdraw provisions of AMP rule currently blocked by injunction. For the full story, click here)
The White House, or more specifically the Centers for Medicare and Medicaid Services’ division of Health and Human Services, announced in recent days that it plans at last to scrap its controversial and burdensome pricing policies for generic drugs bought by retail pharmacies to dispense to Medicaid patients. If CMS’ newly proposed rule goes through, it will mean the end of the current, much-disputed provisions that define the average manufacturer price of Medicaid me-too medicines.
The proposed rule, to quote the National Association of Chain Drug Stores, calls for “the withdrawal of existing provisions that define AMP, that determine the calculation of federal upper limits [FULs], and that define ‘multiple source drug.’”
As currently defined, Medicaid’s payment model for reimbursing pharmacists to dispense generics is based on a flawed formula for determining what retail pharmacies pay for those medicines, as determined by a set of controversial market metrics.
The current AMP policy almost is a guarantee that retail pharmacies would lose money on nearly every Medicaid generic prescription they dispense. It’s only a temporary court injunction that has thus far kept that new formula from being imposed.
Thus, CMS’ turnabout marks a real victory for the chain and independent pharmacy lobby, which has bitterly contested the AMP reimbursement formula since it was made policy by the Bush administration more than three years ago. But the plan to withdraw the current AMP model doesn’t end the long battle by pharmacy for a fair payment policy for dispensing generic drugs to Medicaid beneficiaries.
What the pharmacy industry –– and the U.S. healthcare system itself, for that matter –– need is a permanent solution to the Medicaid reimbursement mess. And that solution can only be achieved by congressional action and enactment of a new law governing Medicaid.
The 2010 health-reform law goes part way toward that solution, by holding the line on pharmacy cuts and setting the FULs on Medicaid prescription payments at no less than 175% of cost. It also includes what NACDS president and CEO Steve Anderson calls “a much-improved definition and calculation method for AMP” that will “better approximate pharmacies’ costs for purchasing generic drugs.”
Anderson said the injunction lawsuit filed in 2007 by NACDS and its independent pharmacy counterpart, the National Community Pharmacists Association, has saved pharmacy more than $5.3 billion in cuts since a federal court blocked the imposition of the new AMP formula in January 2008. It also may have prevented the closing of more than 11,000 community pharmacies that otherwise would have been forced to dispense Medicaid scripts at a loss or stop serving lower-income patients.
“When we filed the lawsuit in 2007, we knew that patient care was at stake,” Anderson asserted.
The bottom line is that the White House and Congress need to establish a federal payment system that rewards –– rather than penalizes –– pharmacies for dispensing lower-cost generics that provide the same safety and efficacy profiles as higher-cost pioneer medicines. Such a permanent fix would be a win both for the pharmacy industry and the American taxpayer, by saving tens or even hundreds of billions of dollars over the long term in federal health costs.
Abbott acquires Piramal’s Healthcare Solutions business
ABBOTT PARK, Ill. Abbott has gained a foothold in the Indian drug market through its acquisition of the Healthcare Solutions business from Piramal, Abbott said.
Abbott announced Wednesday that it had completed its acquisition of the business, saying it would further accelerate its growth in emerging markets, which currently account for more than 20% of its sales. The company expects its pharmaceutical sales in India to be more than $2.5 billion by 2020.
“The acquisition of Piramal’s Healthcare Solutions business further strengthens Abbott’s growing presence in emerging markets,” Abbott chairman and CEO Miles White said. “Piramal’s portfolio of well-known, trusted products has served patients in India for decades.”
Shire, Acceleron Pharma ink development deal
CAMBRIDGE, Mass. British drug maker Shire is working with Cambridge, Mass.-based Acceleron Pharma to develop treatments for serious muscular disorders, Shire said Thursday.
The drug maker announced that the two companies would investigate ACE-031, a drug in mid-stage clinical trials as a treatment for Duchenne muscular dystrophy, a rare and fatal muscle disorder with no current treatment. The drug belongs to a class known as activin receptor type IIB, or ActRIIB molecules.
The two companies will work together to advance ACE-031 into a global phase-2 and -3 clinical program designed to demonstrate disease modification in patients with DMD.
Under the agreement, Shire will pay Acceleron $45 million upfront, and the latter company will be eligible for milestone payments of up to $453 million for ACE-031 and other molecules. If the drug manages to win regulatory approval, Acceleron will have rights to commercialize it in the United States and Canada, while Shire will have rights in other countries.