FDA to discuss EtO Sterilization and Providers are Unprepared for Upcoming Interoperability Rules

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Regulatory News

Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

On 6 and 7 November, FDA medical devices advisory committee will meet to discuss the use of ethylene oxide (EtO) to sterilize medical devices. The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions. The panel plans to discuss how to reduce EtO emissions without compromising the sterility or effective processing of devices. FDA reports that about 50% of all sterile medical devices in the US are sterilized with EtO and those likely to use the method include devices that are made from certain polymers, metals or glass, have multiple packaging layers or hard-to-reach places like catheters. But long-term exposure to elevated EtO levels in the air increases the risk of certain cancers, the EPA says. (RAPS 10/28/19)

IMDRF Offers New Guidance on Cybersecurity

IMDRF released new general principles and best practices to facilitate better international regulatory convergence on medical device cybersecurity. It includes both Pre-market and Post-market cybersecurity considerations, regulators, health providers and other stakeholders. On the pre-market end, IMDRF includes recommendations on risk management, security testing and regulatory submission requirements where manufacturers can document their cybersecurity activities. On the post-market end, the draft discusses measures to enhance transparency for different stakeholders, such as via coordinated vulnerability disclosure. The draft also features discussions on vulnerability remediation and incident response, among other topics. (RAPS- 10/02/2019)

Medical Device Tax Still Weighs on the Minds of Medtech Execs

The medical device industry has enjoyed a four-year suspension of the 2.3% medical device excise tax (two consecutive two-year periods) but Congress has yet to permanently repeal the unpopular tax. At this point, the tax is scheduled to kick back in on Jan. 1, but industry advocates like AdvaMed are pressing hard for repeal. (MDDI 10/22/19)

FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

FDA proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements (MQG, MQL, QBO, LXJ, OSD). FDA is limiting the proposed exemption of optical position/movement recording systems (LXJ) to such devices that are for prescription use only. The LXJ product code includes types of rehabilitation devices other than optical position/movement recording systems; therefore, to more accurately reflect the devices which fall within this device type, the device type has been renamed ‘Interactive Rehabilitation Exercise Devices’. (RAPS- 10/24/2019)

Ethical use of artificial intelligence in radiology requires careful consideration

A statement issued by leading radiology groups urges stakeholders to give careful consideration about the use of data, the development, and the operation of artificial intelligence (AI) in the field of radiology. AI can potentially lead to radical improvements in care delivery, but also has the potential for unexpected and unplanned risks. The statement recommends that whenever an AI model is implemented in patient care, the patient should be notified about how their data will be used and any potential inherent biases used in training algorithms. Ultimately, the responsibility for the patient’s care remains in the hands of the radiologists, therefore there is a need to develop an ethical framework to guide the development and use of AI tools in radiological practice.

 (Health IT Analytics 10/2/19)


Payment News

Providers, payers unprepared for data blocking, interoperability rules: Accenture survey

The Office of the National Coordinator for Health IT released its proposed information blocking rule that outlines seven exceptions to the prohibition against information blocking and provides standardized criteria for application programming interface (API) development. CMS also issued a proposed interoperability rule that requires insurers participating in CMS-run programs like Medicare, Medicaid and the federal Affordable Care Act exchanges by Jan. 1 to have the capability to give 125 million patients electronic access to their personal health information at no cost to patients. Of the healthcare executives surveyed, only 18% said they are “very familiar” with the implications of the regulations. (FierceHealthcare 10/15/19) 

Adoption of virtual reality depends on practical considerations such as reimbursement

A panel of experts at the Connected Health Conference recently discussed the barriers for providers using virtual reality (VR) technology in their practice. Whereas VR technology has been highly developed, the implementation still needs to be improved. Considerations should include the integration of VR into the existing hospital infrastructure and the expansion of billing codes to provide payment for VR treatment. Currently, providers are using traditional therapy billing codes to cover the cost of using VR in their office appointments. Until reimbursement paths are standardized, VR treatment may remain a niche offering.

(Mobile Health News 10/21/19)

California considers increase in telehealth reimbursement rates

The state of California is considering the passage of a bill which may impact the reimbursement of telehealth throughout the United States. The current telehealth reimbursement rates are lower than the payments for comparable in-person care. Increasing these rates would act as an incentive to encourage a wider adoption of telehealth treatments and may help to address physician-shortages in rural areas.

(Healthcare Finance 10/07/19)


The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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