Today’s Top Story
Senate committee approves bill to streamline approval process for some devices.
Fortune reports that the U.S. Senate Committee on Health, Education, Labor, and Pensions has approved several bills this week, including a proposal that would streamline the approval process for certain medical devices. Among other things, a new “breakthrough” designation for medical devices would allow shorter or smaller clinical studies to be used to demonstrate the efficacy of a medical device. Some patient safety advocates have opposed the Advancing Breakthrough Devices for Patients Act of 2015, arguing that a faster approval process could raise patient safety concerns. Read more…
Read more about the Advancing Breakthrough Devices for Patients Act of 2015…
Other News
FDA issues two recall notices for drug products.
The U.S. Food and Drug Administration (FDA) has issued two safety notices. The first is a recall of Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva Pharmaceuticals. The recall is due to the potential presence of particulate matter identified as glass in one vial. The recalled lot # is 4750915, expiration date 9/2017. Amikacin sulfate injection USP is used in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, and has also been shown to be effective in staphylococcal infections. It may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease. The agency states that anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Read more…
FDA is also alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., of Austin, Texas, due to lack of sterility assurance. During a recent inspection of I.V. Specialty, FDA investigators observed insanitary conditions, including poor sterile production practices, that raise concerns about the company’s ability to assure the sterility of the drug products it produces. The agency recently recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. However, the company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting healthcare professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty. Read more…
Study: Surgical decompression treatment of OPLL offers similar outcomes to those seen in patients with other forms of DCM.
Findings from a study published in the March 2 issue of The Journal of Bone & Joint Surgery suggest that patients with ossification of the posterior longitudinal ligament (OPLL) who are treated with surgical decompression may have similar outcomes to surgically treated patients with other forms of degenerative cervical myelopathy (DCM). The authors conducted a prospective study of 479 patients with symptomatic DCM, of whom 135 (28.2 percent) had radiographic evidence of OPLL and 344 (71.8 percent) had other forms of DCM. At 2-year follow-up, they found similar outcomes across cohorts in quality of life, Neck Disability Index, and most SF-36 subscales. The authors did note an increased risk of perioperative complication in the OPLL group, although the relationship did not reach statistical significance. Read the abstract…
Few physician groups see increases under VBM program.
According to Modern Healthcare, for the second year in a row, relatively few provider practices benefited from the U.S. Centers for Medicare & Medicaid Services (CMS) value-based payment modifier (VBM) program. According to CMS data, 13,813 physician groups participated in the program, but only 128 group practices will see reimbursement increases, while 8,208 will remain unchanged and 5,477 will be penalized. CMS is gradually phasing in the VBM program; it only applied to group practices of 100 or more eligible professionals during 2015, and to groups of 10 or more in 2016. In 2017, it will apply to all physicians and physician groups. Read more…(registration may be required)
View the CMS data (PDF)…
Senate passes bipartisan opioid abuse bill.
The Hill reports that the U.S. Senate has passed an opioid abuse bill with strong bipartisan support. If enacted, the Comprehensive Addiction and Recovery Act of 2016 would, among other things, authorize grants to expand educational efforts to prevent abuse of opioids, heroin, and other substances of abuse, understand addiction as a chronic disease, and promote treatment and recovery; support treatment alternatives to incarceration programs; and develop plans for integrated opioid abuse response initiatives. A similar bill is under consideration in the U.S. House of Representatives, and the Obama administration has indicated support for addressing opioid abuse. Read more…
Read more about the Comprehensive Addiction and Recovery Act of 2016…
CJR to begin April 1; 10 percent of orthopaedic departments say they’re fully prepared.
An article in HealthLeaders Media looks at the upcoming CMS Comprehensive Care for Joint Replacement (CJR) initiative, which will begin April 1. Under the model, all eligible hospitals in 67 select geographic areas will be accountable for all costs associated with hip and knee arthroplasty procedures, from the time of surgery through 90 days postoperative. The writer notes that a recent survey of more than 100 hospital orthopaedic departments found that only 10 percent reported feeling fully prepared for CJR. Read more…
Learn more about CJR…
Read “Unintended Consequences of CJR” in the February 2016 issue of AAOS Now…
Pennsylvania.
Lexology reports that as of Feb. 4, 2016, sports team physicians visiting Pennsylvania with teams from outside the state are now permitted to treat their players without violating Pennsylvania law. An amendment to the Pennsylvania Medical Practice Act exempts visiting sports team physicians from the state’s licensure requirements, provided that the physician has an agreement with a sports team to treat team members and coaches traveling with the team for a specific sporting event in the state. In certain cases, the exemption also extends to physicians invited by a national sport governing body to provide services within the state at a national training center or an event or competition sanctioned by that governing body. Read more…
Apply now for the 2016 AAOS/OREF/ORS Clinician Scholar Career Development Program.
March 31 is the last day to submit your application to participate in the Clinician Scholar Career Development Program (CSCDP). The program is a joint project of AAOS, the Orthopaedic Research and Education Foundation (OREF), and the Orthopaedic Research Society (ORS). CSCDP seeks applicants in years PGY2 to PGY5 of orthopaedic residency, fellows, and junior faculty through year 3 who have the potential and desire to become orthopaedic clinician scholars (scientists and investigators). Up to 15 applicants will be selected to participate in the 1.5-day training workshop, with up to 10 additional participants sponsored by orthopaedic specialty societies. The 2016 AAOS/OREF/ORS CSCDP will take place Sept. 15-17, 2016, in Rosemont, Ill. Please submit applications, along with curriculum vitae and a letter of support, by 11:59 PM CT on March 31, 2016 to: csdp@aaos.org
Learn more and submit your application…
