January 3, 2018 | Today’s News

FDA announces recall of certain PharMEDium Services drug products; Auromedics Pharma flexible bags

The U.S. Food and Drug Administration (FDA) has announced a recall of certain lots of PharMEDium Services drug products due to a lack of assurance of sterility. The company identified 55 product lots of concern. The company states that no defects have at this time been identified in the products, but as a conservative measure, a recall has been initiated.

Read more, with a list of recalled products…

FDA also states that AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007, with an expiration of August 2018. The product was found to contain white particulate matter that has been identified as mold.

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CMS clarifies texting policy: Medical orders are not HIPAA compliant; most other texts are permitted

The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a clarification to its policy on texting by healthcare providers. A recent report from the Health Care Compliance Association suggested that CMS was requiring healthcare providers to halt all texting. In response, the agency says that it “recognizes that the use of texting as a means of communication with other members of the healthcare team has become an essential and valuable means of communication among the team members. However, the agency states that the “practice of texting orders from a provider to a member of the care team is not in compliance with the Conditions of Participation (CoPs) or Conditions for Coverage (CfCs),” and goes on to note that, in order to be compliant with the CoPs or CfCs, “all providers must utilize and maintain systems/platforms that are secure, encrypted, and minimize the risks to patient privacy and confidentiality as per HIPAA [Health Insurance Portability and Accountability Act] regulations and the CoPs or CfCs. It is expected that providers/organizations will implement procedures/processes that routinely assess the security and integrity of the texting systems/platforms that are being utilized, in order to avoid negative outcomes that could compromise the care of patients.”

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Read the CMS statement (PDF)…

CMS has updated the Physician Compare website with 2016 Physician Quality Reporting System performance information. In addition, the website now includes 2016 data for the Shared Savings Program, Pioneer, and Next Generation Accountable Care Organizations (ACOs). ACO measures are reported as percent performance rates, while Consumer Assessment of Healthcare Providers and Systems for ACO summary survey measures are reported as means. The Physician Compare site also now includes information about group ACO affiliation; if a group is part of an ACO, there will be a link to that ACO’s Physician Compare profile page from the group profile page.

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In addition, CMS has announced that physicians and other eligible clinicians participating in the Quality Payment Program (QPP) can begin submitting 2017 performance data using a new system on the QPP website. The agency states that the system is an improvement over CMS legacy programs, which required clinicians to submit data on multiple websites. Most eligible clinicians should submit data using the new QPP site during the 2017 submission period (Jan. 2, 2018, to March 31, 2018).

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Visit the QPP site…

Data from a study published in The Journal of the American Medical Association suggest that use of calcium or vitamin D supplements may not be associated with a reduction in risk of fracture for older adults. The researchers conducted a meta-analysis and systematic review of 33 randomized trials covering 51,145 adults aged 50 years or older. Compared with placebo or no treatment, they found that calcium or vitamin D supplementation had no significant association with risk of hip fracture or with incidences of nonvertebral fracture, vertebral fracture, or total fractures. In subgroup analyses, the researchers noted generally consistent similar results regardless of calcium or vitamin D dose, sex, fracture history, dietary calcium intake, and baseline serum 25-hydroxyvitamin D concentration.

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Read the abstract…

Reuters reports that a 2.3 percent tax on the sale of medical devices went back into effect on Jan. 1, 2018, after a 2-year suspension. The tax was imposed under the Affordable Care Act (ACA) and was projected to raise about $30 billion in revenue over a decade. However, it drew criticism from both Republican and Democratic lawmakers, and it was suspended in 2015. Unsuccessful ACA repeal efforts included repeal of the medical device tax, but the levy remained in recently enacted tax reform legislation that overturned portions of the ACA.

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The Federal Communications Commission (FCC) is seeking suggestions on expanding the agency’s Rural Health Care Program. FCC is considering several possible changes to the program, including increasing a $400 million cap on funding for broadband upgrades, changing the definition of “rural health care,” and intensifying efforts to reduce waste, fraud, and abuse.

The American Association of Orthopaedic Surgeons intends to provide comments on the proposal.

Read the FCC notice (PDF)…

Learn more about the Rural Health Care Program…

Last call: Committee positions closing soon

A number of openings on the AAOS Committee Appointment Program website are closing in the next week. Act now to apply for the following positions:

• Committee on Evidence-Based Quality and Value (one member opening—AUC Section Leader; closes Jan. 4)
• National Quality Registry Network Advisory Committee (one member; Jan. 7)
• Orthopaedic Video Theater Committee (chair; Jan. 4)

Learn more and submit your application…  (Learn more and submit your application)