Omnibus Bill Sets New Cybersecurity Requirements in the US and Common remote monitoring misconceptions

 In Blog, News, Regulatory & Reimbursement Update


IMDRF guidance aims to harmonize, streamline review reports

The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not just for medical device sponsors but also for reviewers to improve consistency and reduce burdens for companies bringing products to different markets. The final guidance entitled, Medical Device Regulatory Review Report: Guidance Regarding Information to be Included is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF [regulatory authorities] RAs to effectively use the regulatory review reports in accordance with their legislation and regulations, the guidance states. “This document is intended to identify the type of information a [Conformity Assessment Body (CAB)] would be expected to review during evaluation of a regulatory submission.” While IMDRF said the document doesn’t apply to any specific regulatory authorities (RA), some RAs may decide to use the document to help them when considering regulatory submission.

(RAPS 2/27/23)

Stakeholders want clarity from FDA on circumstances for delaying or limiting inspections

AdvaMed and industry stakeholders urged the FDA to allow manufacturers more latitude in being able to delay or limit inspections before deeming products adulterated. They also urged FDA to clarify what constitutes a reasonable explanation for delaying, denying or refusing an inspection. Under current FDA guidance, only drugs can be adulterated if FDA inspectors are barred the door. The draft guidance aligns with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices to be deemed adulterated and refused entry for firms that block FDA inspections. AdvaMed took issue with language in the draft which stated that “if a facility fails to respond following FDA’s attempts to contact the facility’s designated contact in scheduling a pre-announced inspections that may cause drugs or devices to be adulterated.” The group suggested the text be modified to state that device should be deemed adulterated if “a facility fails to respond following FDA’s multiple attempts to contact the facility’s designated contact without reasonable explanation.” AdvaMed also said it wanted more clarity on examples of delays during an inspection which would result in the device being deemed adulterated. The guidance states that an example of a delay is when “a facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individual for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection.”

(RAPS 2/17/23)

European Parliament votes to extend MDR transition period

The European Parliament voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the economic region. The vote also supported nixing the sell-off date provision for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR). The extension provisions apply to a device if: (1)  It was certified by a notified body under the Medical Device Directive 93/42/EC (MDD) or the Directive on Active Implantable Medical Devices 90/385/EEC (AIMD); (2)  The MDD or AIMD certificate was valid at the date of application of the MDR (26 May 2021), and not later withdrawn (even if the certificate expired prior to the date of this new extension legislation); and (3) Either: i) before the certificate expired the manufacturer and a notified body have signed a written agreement with a notified body for the conformity assessment of the device or a device intended to substitute for the legacy device or ii) a competent authority has granted an Article 59(1) or 97(1) derogation in respect of the device.

(RAPS 2/16/23)

Maintained software, Supported software, Required software, and SOUP

What are the differences between SOUP and Maintained software, Supported software, and Required software? Each software type comes with its own set of requirements per IEC 62443 and IEC 80001-5-1. Check out this article to see which category of software applies to your medical device and/or system.

(MD101 Consulting 2/20/23)



Common remote monitoring misconceptions

Use of remote monitoring has undergone rapid acceleration since the COVID-19 pandemic. But increased usage has lead to common misconceptions among healthcare providers. Reports show that healthcare organizations report fewer readmissions (and lower costs) when using remote monitoring. It is expected that 76% of practices will be using some form of remote monitoring by 2024. Misunderstandings around remote monitoring include physicians thinking that they are required to have at least 20 minutes of live interactions with each patient per month in order to bill CPT code 99457. This is incorrect – that code includes 20 minutes of some combination of monitoring and interaction. Both components must be present each month, but the ratio of monitoring to visit time is at the discretion of the clinician.  Another misconception is that the monitoring device itself must be covered by the patient’s insurance. This is not necessarily the case because the remote monitoring payments total about $133 in the first month, which can cover the practice expense of providing the patient with a monitoring device.

(Medical Economics 2/27/23)

Digital Therapeutics Alliance pursues Medicaid Coverage

The Access to Prescription Digital Therapeutics Act seeks to add a new benefit category to Medicare to cover new modern medical treatments that use technology, rather than traditional drugs or devices to treat patients. The bill, which was introduced last year, would extend Medicare coverage only to digital therapeutics that are prescribed by physicians. A similar bill, called the Medicaid and CHIP Access to Prescription Digital Therapeutics, was also introduced last year. Medicaid coverage is currently decided on a state-by-state basis and some states have already individually introduced reimbursement.

(Managed Healthcare Executive 2/17/23)

Remote patient monitoring increased by 1,300%

A report by Definitive HC found that usage of the newly-formed remote monitoring codes has increased rapidly from 2019 to 2022. Claim volume increased the most in internal medicine, cardiology, and family medicine. The report attributes this trend to the monitoring of patients with heart disease, diabetes and chronic lung disease, which are among the most prevalent conditions in the US. The region of the US with the heaviest usage of remote monitoring was the Southeast, which represented 26.9% of claims for remote monitoring-related procedures. The Southwest was lightest region for remote monitoring, with only 12.1% remote monitoring claims.

(mHealth Intelligence 2/3/23)

Telehealth proponents advocate for flexibility and payment 

With the end of the public health emergency looming, opinions regarding access to telehealth vary widely, as some states try to curtail telehealth services while others look to maintain or expand virtual health visits. Patients as well are divided, with those living in rural areas particularly interested in maintaining telehealth services while those who are uncomfortable with technology and may lack Internet access preferring in-office visits. The rheumatology community is working to keep telehealth options available for their chronically ill patients, noting that reimbursement is a critical component and trying to convince payors that increased access to health care through technology can improve patient health.

(Healio 2/3/23)

The future of virtual reality in health care is uncertain

Views on the impact of virtual reality in healthcare are mixed with proponents describing it as transformative and disruptive while skeptics stating the impact will be minimal. VR technology is currently being tested in several healthcare arenas, particularly for clinician training and in pain management.  Although VR equipment is relatively inexpensive compared to most hospital equipment, the lack of official billing codes means that, outside of clinical trials, patients are having difficulty with reimbursement and are paying out-of-pocket.

(Advisory.com 2/7/23)


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, RAC, Simbex Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant. A story’s inclusion does not imply endorsement by Simbex.

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