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Current News
February 1, 2012
Today's Top Story
1. FDA; industry reach agreement on medical device user fee reauthorization.
Other News
2. Longer-term PPI use associated with hip fracture in women.
3. Coding differences increased costs of MA plans compared to FFS.
4. GAO: FDA needs to do more to ensure antibiotic label accuracy.
5. California.
6. Massachusetts.
7. Michigan.
8. February AAOS Now is online now and in your mailbox soon!
Today's Top Story
1. FDA; industry reach agreement on medical device user fee reauthorization.
According to the U.S. Food and Drug Administration (FDA), the agency and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. Although details are not yet finalized, the recommendations would authorize the FDA to collect $595 million in user fees over 5 years, an amount the agency says will allow it to hire more than 200 full-time equivalent workers and improve accountability, predictability, and transparency in its device review process. In addition, device industry representatives have asked for a reduction in FDA review times, greater interaction with industry during the review process, and an independent analysis of FDA’s management of the review process. When details of the agreement are finalized, FDA plans to develop a package of proposed recommendations and offer an opportunity for public comment. The current 5-year program is set to expire on Sept. 30, 2012. Read the FDA statement…
Read the industry statement…
Other News
2. Longer-term PPI use associated with hip fracture in women.
A study published online in the journal BMJ links chronic use of proton pump inhibitors (PPIs) to increased risk of hip fracture, particularly among women who smoke. The authors conducted a prospective cohort study of 79,899 postmenopausal women taking part in the Nurse’s Health Study. During 565,786 person-years of follow-up, they documented 893 incident hip fractures. Absolute risk of hip fracture among regular users of PPIs was 2.02 events per 1,000 person years, compared with 1.51 events per 1000 person years among non-users. Compared with non-users, risk of hip fracture among women who regularly used PPIs for at least 2 years was 35 percent higher, and longer use was associated with increased risk. In addition, among current and former smokers, PPI use was associated with greater than 50 percent increase in fracture risk. Read more...
Read the complete study…
3. Coding differences increased costs of MA plans compared to FFS.
The U.S. Government Accountability Office (GAO) estimates that diagnostic coding differences between private Medicare Advantage (MA) plans and Medicare fee-for-service (FFS) led 2010 MA beneficiary risk scores to be between 4.8 percent and 7.1 percent higher than they likely would have been if the same beneficiaries had been continuously enrolled in FFS. GAO calculates that the higher risk scores resulted in $3.9 billion to $5.8 billion in payments to MA plans. Analyses from both GAO and the U.S. Centers for Medicare & Medicaid Services (CMS) found that the impact of coding differences increased over time, suggesting that the cumulative impact of coding differences in 2011 and 2012 could be larger than in 2010. GAO recommends that CMS improve the accuracy of its MA risk score adjustments by incorporating adjustments for additional beneficiary characteristics, using the most current data available, accounting for all relevant years of coding differences, and incorporating the effect of coding difference trends. Read more...
Read the complete report (PDF)…
4. GAO: FDA needs to do more to ensure antibiotic label accuracy.
A report released by the U.S. Government Accountability Office (GAO) finds that FDA has failed to sufficiently ensure that antibiotic labels contain up-to-date breakpoints. Breakpoint is defined as an antibiotic’s "ability to kill or inhibit the growth of a specific bacterial pathogen." Outdated breakpoints can result in healthcare providers unknowingly selecting ineffective treatments, which can also contribute to additional bacterial resistance to antibiotics. According to GAO, FDA contacted sponsors of 210 antibiotics in early 2008 to request that they assess whether the breakpoints on their drugs’ labels were up to date. Sponsors were asked to submit evidence to FDA showing that the breakpoints were either current or needed revision. As of November 2011, more than 3.5 years after FDA contacted sponsors, the agency had not yet confirmed whether the breakpoints on the labels of 146 of the 210 antibiotics were up to date. GAO states that, despite FDA guidance, some sponsors remain confused about their responsibility to evaluate and maintain up-to-date breakpoints. In addition, GAO finds that, for submissions FDA has received, it has often taken more than a year for the agency to complete its review. Read more...
Read the complete report (PDF)…
5. California.
The Sacramento Bee reports that a district court judge in California has issued a tentative ruling stopping a 10 percent cut to reimbursement under the state’s Medi-Cal system. Critics of the cut say that it jeopardizes patient access to care. In the ruling, the judge criticized studies showing that the cuts would not affect patient access, noting that the state's count of Medi-Cal physicians includes providers who have billed to the program just once. Read more...
6. Massachusetts.
If enacted, a bill under consideration in the Massachusetts Senate would require physicians who prescribe controlled substances to register with the state’s prescription monitoring program, reports the Taunton Daily Gazette. Under the proposal, the top 30 percent of prescribers for 90 percent of all controlled substances in the state would be required to enroll immediately, with the rest of physicians having 3 years to register. In addition, patients with a history of prescription drug abuse would be restricted to using a single pharmacy, and healthcare providers would be required to notify the parents of minors treated for a drug overdose. Read more...
7. Michigan.
According to the Detroit News, Blue Cross Blue Shield of Michigan (BCBSM) has asked a Detroit federal judge to dismiss an antitrust lawsuit filed by Aetna Inc. Aetna claims that actions taken by BCBSM has prevented the company from expanding in the state. The company has asked for three times damages proven during trial and an end to BCBSM’s so-called "most-favored nation" deals with Michigan hospitals. Such clauses require providers to charge higher prices to the insurer’s competitors. Read more...
8. February AAOS Now is online now and in your mailbox soon!
AAOS members will soon receive the print edition of the February issue of AAOS Now, but the online edition is already available on the AAOS Now website. This month’s issue includes a look at the 2012 AAOS public service messages, an article about the use of checklists to improve patient safety, advice on the Medicare audit process, and much more… Read more...
Read "Academy Rolls out New Public Service Messages…"
Read "Checklists Put Guidelines Into Practice…"
Read "What You Should Know About Medicare Audits…"
Note: Next week, AAOS Headline News Now will be published Tuesday, Wednesday, Thursday, and Friday—direct from the 2012 AAOS Annual Meeting—to bring you the the latest information on orthopaedic research and coverage of Annual Meeting events.
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