Today’s Top Story
Republicans raise questions about test of CMS Medicare Part B plan.
Both parties in Congress raised concerns at a House hearing Tuesday about the proposed plan from the Centers for Medicare & Medicaid Services (CMS) to institute incentives steering physicians away from prescribing high-priced drugs, reports Kaiser Health News. Republicans said the program, which would shift how physicians are reimbursed for drugs covered by Medicare Part B, would be tested across most of the Medicare system in the equivalent of a clinical trial, but without the opt-out usually offered to patients in such a trial. The plan would change the current price-plus-6-percent reimbursement to one adding 2.5 percent to the average price plus $16.80 per drug, per day. Republicans also say the CMS plan will hinder patient access to drugs for cancer and other diseases. Democrats were less critical, endorsing the broad aim of reducing the cost of prescription drugs while voicing some concerns about specifics of the plan.
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Read comments submitted by the AAOS (PDF)…

Other News

FDA publishes draft guidance on the use of EHR data in clinical investigations.
As reported by HealthcareITNews, the U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry on the use of data from electronic health records (EHRs) in clinical investigations regulated by the FDA. The draft guidance, which is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties, provides FDA recommendations focused on the following areas:

  • Whether and how to use EHRs as data sources in clinical investigations
  • Using interoperable EHRs with other electronic systems that support clinical trials
  • Safeguarding the integrity and quality of EHR data
  • Ensuring that electronic source data meet FDA requirements for record keeping and retention

“In general, EHRs are not under the control of FDA-regulated entities (eg, sponsors, clinical investigators), because in most instances, these systems belong to healthcare organizations and institutions,” notes the document. “However, FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits.”
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Read the draft guidance (PDF)…
Submit electronic comments (within 60 days of the publication in the Federal Register of the notice announcing the availability of the draft guidance)…

Study: Faster recovery, similar longer term outcomes for two-screw compared to single-screw device for IF fixation.
Findings from a study published online in the Journal of Orthopaedic Trauma (JOT) suggest similar 5-year outcomes for two devices designed for fixation of intertrochanteric fracture (IF). The researchers conducted a prospective, randomized study of 104 patients with mean age of 81.2 years, who were treated for IF using either an integrated two-screw cephalomedullary nail or a single-screw device. Based on 33 patients available at 5-year follow-up, they found that neither group had significant implant related complications or differences in terms of functional outcome. However, patients in the two-screw cohort had shorter hospital stays and were more likely to have returned to prefracture status at 6 months.
Read the abstract…

Study: Blood pressure algorithm may help identify patients who require posterior release for lower leg compartment syndrome.
According to a study published online in JOT, use of an algorithm based on preoperative diastolic blood pressure (DBP) may help avoid release of posterior compartments in patients with lower leg compartment syndrome (CS). The authors conducted a prospective cohort study of 37 patients who were managed by one surgeon at a single center. After a standard anterior and lateral compartment release via a full-length lateral incision was performed, the superficial and deep posterior compartments were measured with the heel resting on a bolster. A [DELTA]P
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Connecticut.
The state General Assembly passed a plan placing new restrictions on non-compete provisions for physicians. Under the bill, expected to be signed by the governor, the statute places the following conditions on a physician covenant not to compete, noting that it must be:

  • Necessary to protect a legitimate business interest
  • Reasonably limited in time, geographic scope, and practice restrictions as needed to protect that interest
  • Otherwise consistent with the law and public policy.

The statute, covering covenants made after July 1, 2016, also places the burden of proof on the party seeking to enforce a non-compete agreement, according to the law firm Jackson Lewis. It prohibits restrictions on a physician’s activities for longer than 1 year and those extending 15 miles or more beyond the primary site where a physician practices. It also spells out limits on agreements between physicians and hospitals, health systems, and medical schools.
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Please complete your 2016 AAOS Orthopaedic Surgeon Census now!
AAOS is asking all members to participate in the AAOS 2016 census of orthopaedic surgeons. The census is taken to ensure that AAOS members are accurately represented in advocacy, funding, and reimbursement efforts. The information also helps AAOS tailor programs, products, and services to address professional needs and interests of its members. All individual responses are kept confidential. Watch your email or postal mail for your census form. In addition, this year, AAOS is holding a census contest, with prizes awarded to the states with the highest per capita level of participation!
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For further information, please contact the AAOS research department, at: aaosresearch@aaos.org

Call for volunteers: ACS Board of Governors.
AAOS seeks to nominate two individuals to the American College of Surgeons (ACS) Board of Governors. Applicants for these 3-year positions should be ACS fellows and should be active in surgical practice. Special consideration of women and other underrepresented minorities is strongly encouraged. All applicants must provide the following: an online AAOS CAP Application; current curriculum vitae; a short biography (maximum 100 words) highlighting relevant experience/knowledge; and letter of interest highlighting their expertise. All supporting materials must be submitted to Kyle Shah at by June 20, 2016, at 11:59 p.m. (CT), at: shah@aaos.org
Learn more and submit your application…(member login required)