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From the Director
To our Readers: This issue of the newsletter highlights new information about osteoporosis drugs and alternatives. We also focus attention on the False Claims Act, which has had a significant role in recouping state Medicaid dollars and shining a light on conflicts of interest and ethics issues that have become rampant in our health care payment system. An ongoing new section of the newsletter will be the Legislators' Toolbox, where we link to model bills and policies and resources to help you implement the ideas discussed. Please SAVE THE DATE of January 21, 2011 for our next NLARx meeting, which will be in Washington, D.C. We are going to hear about important changes in the Medicaid rebates that could have implications for your state budgets, and we will lay out options going forward in the wake of the Affordable Care Act. We will also hear about how trade policy may impact state medicaid decisions and rebates, and have an opportunity for state legislators to share their 2011 agendas. We will be posting details and registration materials soon on our website. Remember that in addition to this biweekly newsletter, we share breaking news stories and interesting ideas through our Facebook page. Be sure to share this newsletter with newly-elected legislators! Sincerely,  |
New Data Strengthens the Link Between Bisphosphonate Medications and Rare Femur Fractures: Calls Into Question Preventative Use
There is increasing concern at the FDA and among physician groups that evidence of a connection between bisphosphonate osteoporosis medications and an increased risk of atypical femur fractures. This potential link calls into question what value states receive from funding long-term preventative prescription of these medications.
In light of recent data reported by a task force from the American Society of Bone and Mineral Research (ASBM), the FDA has released a new safety report on the link between bisphosphate osteoporosis medication and atypical femur fractures. These safety risks are being associated with long-term use of the drugs, which implicates not only the benefits of prophylactic use of these medications, but also the cost benefits of newer bisphosphate medications over cheaper generic alternatives. Women with pre-osteoporosis, osteopenia, are much less likely to suffer broken bones than women with full osteoporosis, but are often prescribed bisphosphate medications on the now-uncertain assumption that such treatment will halt or slow the progression into osteoporosis. While the healthcare costs of osteoporosis-related injuries are high, a detailed examination of the potential costs of the over-prescription of bisphosphonate medication must be considered in assessing the cost-effectiveness of prescription practices.
The uncertainty over osteoporosis prevention highlights the need for states to adopt academic detailing programs for publicly funded health programs to educate prescribers of bisphosphonates. Some physicians are waiting until a patient develops a higher risk of fracture prescription before using these medications than was common practice in the past. However, pharmaceutical industry representatives and detailers slow the adoption of evidence-based practices and put the industry's interests in selling newer, more expensive, medications to as many patients as possible ahead of effective patient treatment at optimum cost. At least three versions of alendronate, the generic form of the bisphosphonate drug Fosamax, have been available since 2008.The industry profits from the extensive prescription of brand-name bisphosphonates to currently healthy women, and states need to consider methods to disseminate the mounting data against such practices to prescribers. Rather than forcing physicians to sift through the data on their own while under countervailing pressure from pharmaceutical representatives, academic detailing programs provide best-practices guidelines based on scientific studies. Physicians can then tailor their prescribing practice to the most effective, cost-efficient treatments supported by data, rather than industry sales pitches. Washington D.C. has already instituted legislation that places strict guidelines on pharmaceutical industry detailing practices. This is a concern that affects all states however, and the costs of ignoring inefficient and risky prescription practices are already unacceptable.
Related Article:
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$3.1 Billion Recovered Through the False Claims Act During Fiscal Year 2010: Largest Recoveries From Pharmaceutical Manufacturers
The group Taxpayers Against Fraud (TAF) reports that the Department of Justice recovered $3.1 billion through the False Claims Act (FCA) during the fiscal year of 2010. Of that amount, 80% was from the healthcare industry. Among the biggest recoveries for 2010 have been $600 million from Allergan, $520 million from AstraZeneca, and $422.5 million from Novartis Pharmaceuticals.[1]As debates over controlling healthcare costs continue to rage, the FCA is showing itself to be a cost-effective method for recovering inappropriate payments, and for maintaining order and control over healthcare liabilities. In addition to its enormous success against fraud perpetrated by pharmaceutical and healthcare companies, the FCA also plays a critical role in enforcing standards for appropriate Medicare reimbursement. Under the FCA, a person who knowingly submits, or causes another person or entity to submit a false claim for government funds, is liable for three times the government's damages in addition to civil penalties ranging from $5,500 to $11,000 per false claim. The FCA's qui tam provisions incentivize and protect whistleblowers possessing evidence of fraudulent activity including the performance of inappropriate or unnecessary medical procedures, billing for brand-name medications when generics were actually used, billing at physician rates for work performed by a nurse or resident intern, and other phantom costs passed to the government that would otherwise go unrecognized.[2]
With groups such as the AARP predicting Medicare enrollment to increase by almost 80% in the next twenty years[3], the protections of the FCA will play an important role in maintaining Medicare liabilities. The FCA has also shown itself to be an efficient mechanism for detecting and recovering fraudulent activity. A 2006 report from TAF calculated that the FCA returns $15 of taxpayer money for every $1 invested in healthcare investigations and prosecutions.
[1]Over $3 Billion in Fraud Recoveries Under the False Claims Act in FY 2010, Taxpayers Against Fraud (Oct. 25, 2010) http://www.taf.org/whistle295.htm
[3] http://assets.aarp.org/rgcenter/health/fs149_medicare.pdf (from 34 million to 79 million). |
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LEGISLATORS' TOOLBOX
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