Today’s Top Story
FDA announces Class I recall of Zimmer Biomet Comprehensive Reverse Shoulder.
The U.S. Food and Drug Administration (FDA) has announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder device. The Comprehensive Reverse Shoulder is a shoulder replacement device designed for patients with rotator cuff tears who have previously failed shoulder joint arthroplasty and have developed arthropathy. The manufacturer has received reports that the devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
CMS rule delays changes to CJR model.
A rule issued by the U.S. Centers for Medicare & Medicaid Services delays the effective date from Feb. 18 to March 21 for previously announced modifications to the Comprehensive Care for Joint Replacement (CJR) model and other Medicare bundled payment models. The rule cites a memorandum of Jan. 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review.” The rule delays for 60 days from the date of the memorandum the effective date of the rule entitled “Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model,” which was published in the Jan. 3, 2017, issue of The Federal Register. The models are currently set to begin July 1, 2017.
Read the rule…
Read the original rule…
ACA replacement plans start to take shape.
Leaders in the U.S. House of Representatives have released an outline for their plan to repeal and replace the Affordable Care Act (ACA). Among other things, the outline emphasizes increased choice and lower costs for healthcare insurance, maintenance of coverage, a streamlined research system, improved electronic health records, and alterations to sustain Medicare.
Read the outline (PDF)…
In related news, Reuters reports that House leaders have announced that they will introduce ACA repeal and replace legislation following a 10-day recess period that ends Feb. 27.
Study: Smoking may increase risk of reoperation for infection following TJA.
Findings from a study published in the Feb. 15 issue of The Journal of Bone & Joint Surgery suggest that smokers may be at increased risk of reoperation for infection following total joint arthroplasty (TJA). The authors reviewed data on 15,264 TJA patients (17,394 procedures), of whom 1,371 (9.0 percent) were current smokers, 5,195 (34.0 percent) were former smokers, and 8,698 (57.0 percent) were nonsmokers. Overall, former smokers reported a median of 22.2 years (range, 0.2 to 60 years) of abstaining from smoking prior to the surgical procedure. The authors found that current smokers were significantly more likely than nonsmokers to undergo reoperation for infection, while former smokers were at no increased risk. However, the number of cigarette packs smoked per decade was independently associated with an increased risk of 90-day nonoperative readmission regardless of smoking status.
Read the abstract…
The Miami Herald reports that, in an 8-3 decision, the full U.S. 11th Circuit Court of Appeals has overturned an earlier decision by a divided three-judge panel on a Florida law that restricts physicians and other healthcare providers from asking questions and recording information about patients’ gun ownership. The opinion applies only to portions of the law that restricted physicians from inquiring about firearms. The law has been opposed by medical groups, including the American Academy of Pediatrics, the American College of Physicians, and the American Academy of Family Physicians, which have argued that it infringes on physicians’ First Amendment rights.
According to Modern Healthcare, a bill under consideration in the Georgia General Assembly would, if enacted, require healthcare providers to log opioid prescriptions in a state database. With few exceptions, prescribers would also be required to consult the database whenever they prescribe a Schedule II, III, IV, or V drug to a patient the first time and every 90 days after, for as long as the prescription continues. The bill also limits the amount a provider can prescribe in the first prescription to five days. Under terms of the bill, failure to record a prescription within 24 hours of writing it would carry a prison sentence of between 1 to 5 years, a fine of up to $50,000, or both.
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The Pew Charitable Trusts reports that the governor of New Jersey has signed a bill setting a 5-day limit on first-time prescriptions for opioids. Physicians are allowed to add an additional 5 days to the prescription if a patient’s pain has not yet subsided. In addition, the law requires insurance companies to approve coverage for addiction treatment as soon as a patient seeks it.
Call for volunteers: Foot & Ankle section editor for OrthoInfo website.
Feb. 28 is the last day to submit your application to serve as Foot & Ankle section editor of the AAOS OrthoInfo website. OrthoInfo provides authoritative information on a wide range of musculoskeletal issues and treatments. The website features approximately 500 articles, with approximately 30 articles in the Foot & Ankle section. The section editor is engaged as an independent contractor on an annual basis, with contract subject to renewal up to 6 years. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, candidate member applicants for fellowship osteopathic, or emeritus fellows, with a practice emphasis in foot and ankle. In addition, all applicants must submit the following: an AAOS CAP application, a current curriculum vitae, and a cover letter detailing their interest and qualifications, along with three references, by Feb. 28, 2017, to Laura Giblin at firstname.lastname@example.org.
Learn more and submit your application…(member login required)