Today’s Top Story
CMS and AHIP announce clinical quality measures covering orthopaedics and other areas.
The U.S. Centers for Medicare & Medicaid Services (CMS) and America’s Health Insurance Plans (AHIP) have released seven sets of clinical quality measures, covering areas such as orthopaedics, accountable care organizations, and patient-centered medical homes. The move is part of the Core Quality Measures Collaborative of healthcare system participants, including the American Association of Orthopaedic Surgeons (AAOS). Included among the core measures:

  • Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA)
  • Hospital-level 30-day, all-cause risk-standardized readmission rate following elective primary THA and/or TKA
  • Patient experience with surgical care based on the Consumer Assessment of Healthcare Providers and Systems® Surgical Care Survey
  • Use of imaging studies for low-back pain

CMS states that the measures “support multi-payer alignment, for the first time, on core measures primarily for physician quality programs. This work is informing CMS’s implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) through its measure development plan and required rulemaking, and is part of CMS’s commitment to ensuring programs work for providers while keeping the focus on improved quality of care for patients.” Read more…
Read more about the core measures…

Other News

FDA orders manufacturers of two types of MOM devices to submit to PMA application process.
The U.S. Food and Drug Administration (FDA) has issued a final order that requires manufacturers to submit a premarket approval (PMA) application for two types of metal-on-metal (MOM) THA devices: the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. The agency states that there is insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of such devices. Therefore, FDA states that such devices should remain Class III (higher risk), and manufacturers that wish to continue marketing or to market new MOM THA devices must file PMA applications no later than May 18, 2016. Manufacturers will be required to submit a PMA application that includes: any risks known, or that should be reasonably known, to the applicant; the effectiveness of the device that is the subject of the application; and full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the relevant device. Read more…
Read the final order…
     AAOS submitted comments in 2011 in support of the postmarket studies, and presented additional information at an FDA panel meeting in 2012. Read more (PDF)…

FDA proposes labeling change that some argue could limit manufacturer liability.
An article in the Minneapolis Star Tribune looks at a proposed revision of FDA regulations, under which manufacturers would no longer have to “provide adequate labeling” for known off-label uses of a product. Some patient advocates argue that such a change would insulate drug and device manufacturers from liability linked to off-label applications. According to an FDA spokesperson, the agency does not currently apply the regulation that it has proposed deleting, and the agency already has adequate monitoring of off-label uses. Read more…

Study: Patients may ambulate more quickly after management with liposomal bupivacaine compared to FNB for TKA.
A study published online in the journal Clinical Orthopaedics and Related Research compares the use of femoral nerve blocks (FNBs) and periarticular infiltration of liposomal bupivacaine for pain management after TKA. The research team conducted a retrospective analysis of 1,110 unilateral, primary TKAs performed by 24 surgeons, and compared 583 patients treated with an ultrasound-guided FNB against 527 patients treated with liposomal bupivacaine. They found no clinically important difference in pain scores throughout the hospital stay, but noted that patients treated with liposomal bupivacaine consumed very slightly less narcotics overall through postoperative day 2 of inpatient hospitalization. Overall, 77 percent (406 of 527) of patients who received liposomal bupivacaine cleared 100 feet of ambulation before discharge, compared to 60 percent (349 of 583) of patients who received FNB. In addition, 94 percent (497 of 527) of patients in the bupivacaine cohort completed stairs, compared with 73 percent (427 of 583) of those in the FNB cohort. Patients who received liposomal bupivacaine were also less likely to experience a fall during the hospital stay than patients treated with FNB. Read more…

Study: Findings suggest genetic link to increased risk of VTE among African-American population.
Data from a study published online in the journal Blood suggest that common genetic variants predominantly found in African Americans may increase the risk of venous thromboembolism (VTE). The researchers note that African Americans have been found to be at 30 percent to 60 percent increased risk of VTE compared to other ethnicities. They conducted a genome-wide association study of 578 African-American participants followed by replication of highly significant findings in an independent cohort of 159 African-American subjects. The researchers identified and replicated single-nucleotide polymorphisms (SNPs) on chromosome 20 (rs2144940, rs2567617, and rs1998081) that increased risk of VTE by 2.3-fold. The risk variants occurred more frequently among populations of African descent compared to other ethnic groups. Read more…
Read the abstract…

West Virginia.
The U.S. Federal Trade Commission (FTC) has submitted written comments regarding a bill under consideration in the West Virginia Senate. If enacted, the legislation would modify the supervision requirements imposed on Advanced Practice Registered Nurses (APRNs) in the state, and permit some APRNs—under limited conditions—to write prescriptions without a formal agreement with a particular supervising physician. In addition, the bill would place the regulation of certain APRNs under the authority of the state Board of Medicine or Board of Osteopathy. FTC states that the proposal “could benefit patients, as it would permit a route to independent prescribing, at least for some APRNs under certain conditions,” but also “raises significant competitive concerns nonetheless, first because of the many conditions and exclusions it would impose on independent APRN prescribing, and second because of the regulatory conflicts of interest that appear to be inherent in the Bill’s requirements of physician permission for and oversight of APRN prescribing.” The agency also notes that, “because the Bill would assign regulatory authority over APRN prescribing to the Boards of Medicine and Osteopathy, it raises concerns about potential biases and conflicts of interest.” FTC urges the legislature to consider whether the proposed requirements are necessary to assure patient safety, and notes that removing unnecessary requirements may benefit consumers by “increasing competition among healthcare providers.” Read more…
Read the comment letter (PDF)…

Call for volunteers: Members needed for work group on clinical performance measures for management of ACL injuries.
The Performance Measures Committee seeks AAOS fellows to participate in a work group to develop performance measures for management of anterior cruciate ligament (ACL) injuries. The Committee encourages subject matter experts to apply no later than Feb. 26, 2016. There will be a mandatory orientation webinar on Tuesday, May 24. Final decisions regarding the project scope and design will be determined at the mandatory first work group meeting in Rosemont, Ill., on Saturday, June 25. For more information, please contact Jackie Ryan, at 847-384-4337, or via email at: ryan@aaos.org
Learn more and submit your application (DOC)…

Last call for volunteers to help develop AUC for surgical management of OA of the knee.
The Appropriate Use Criteria (AUC) Section seeks AAOS fellows to participate on the voting panel of the Surgical Management of Osteoarthritis (OA) of the Knee AUC. The voting panel will participate in two rounds of voting, in which it will rate the appropriateness of various surgical treatments for patients who have OA of the knee. Voting panel members will be required to attend a 1-day, in-person meeting in Rosemont, Ill. Nominees for the voting panel are required to complete the AAOS conflict of interest enhanced disclosure form online. If you are interested in participating on the voting panel for this AUC topic, please contact Erica Linskey by Monday, Feb. 22, 2016, at: linskey@aaos.org