FDA Publishes Proposed Rule To Align QSR With ISO 13485 And CMS Adds New HCPCs Code For Prescription Digital Therapeutics

 In Blog, Regulatory & Reimbursement Update


US FDA formally proposes aligning Quality System Regulations with ISO 13485

The US Food and Drug Administration has published a highly anticipated proposed rule to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. FDA’s proposed rule “would harmonize quality management system requirements for FDA-regulated devices with requirements used by many other regulatory authorities around the world,” the agency states. Greater alignment of FDA Quality System Regulation (QSR) with ISO 13485, first proposed by the regulator in May 2018, would bring US QMS requirements for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.

(EMERGO: 25th Feb 2022)

Device group urges FDA to refine software function guidance

The Advanced Medical Technology Association (AdvaMed) urged the US Food and Drug Administration (FDA) to refine its draft guidance on device software in premarket submissions, asserting that requiring enhanced documentation for certain types of devices is problematic. Advamed says the guidance fails to follow a risk-based approach as it would subject some devices to enhanced documentation based on the device’s intended use rather than the device function’s risk. The group said that “simply because a software function may be a constituent part of a combination product, used with blood screening assays, or a component of a class III device, does not mean that the software contributes significantly to the overall risk of that device… Grounding the documentation on the risk posed by the software is consistent with ANSI/AAMI/IEC 62304:2006/A1: 2016 (‘IEC62304’).”

(RAPS 2/14/22)

FDA resumes inspections in U.S. as omicron cases decline

The FDA announced that it is set to resume conducting domestic surveillance inspections after a brief postponement. In December, the agency confirmed temporary changes to inspectional activities due to COVID-19 as the omicron variant of the virus led to surges across the world. The FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, highlighting plans to continue mission-critical work while postponing certain inspectional activities. FDA determined on Feb 2nd, 2022, that it would resume the domestic surveillance inspections across all commodities following a decline in COVID-19 cases. The resumption went into effect on Feb 7th, 2022.

(MASSDEVICE: 7th Feb 2022)

FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021

In its 2021 annual report, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said that it cleared, approved or authorized a record 13 devices with breakthrough status, though the number of novel devices it authorized fell from its peak last year. The report also discusses the center’s actions to address device shortages, thanks to new funding from Congress, as well as its COVID-19 pandemic response, patient engagement and device safety.

(RAPS: 1St Feb 2022)

US FDA rolls out notification requirements to protect medical device supply chains

The US Food and Drug Administration has published new guidance on reporting and notification requirements to better mitigate supply disruptions when medical device manufacturers cease or suspend production during public health emergencies. The new guidance stems from legislation signed into law in March 2020 granting new authority to FDA to prevent or mitigate medical device shortages preceding or during public health emergencies such as COVID-19. Manufacturers of devices identified in the guidance must notify the agency either when they permanently discontinue manufacturing those devices or when a manufacturing interruption occurs that could potentially cause supply disruptions of those devices in the US during a public health emergency. The guidance covers policies regarding these manufacturers’ notification requirements and obligations in the event of a discontinuation or disruption.

(EMERGO: 3rd Feb 2022)

FDA Proposes Guidance on Notifying FDA Of A Permanent Discontinuance Or Interruption In Manufacturing Of A Medical Device

The FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) released draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, for public comment.  The FD&C Act Section 506J requires manufacturers to notify the FDA, during or in advance of a public health emergency, of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. When the FDA concludes that there is, or is likely to be, a shortage of a device, then inspections as well as review of submissions may be prioritized and expedited to help mitigate or prevent shortages.

(MEDDEVICE ONLINE: 21st Feb 2022)


A new HCPCs code for prescription digital therapeutics

Pear Therapeutics, a prescription digital therapeutics company, announced the addition of a new reimbursement code that will pave the way for prescription digital therapeutics to be billed like durable medical equipment. The new code is A9291 and the code description is “Prescription digital behavioral therapy, FDA cleared, per course of treatment”.  The coding decision was made by the Centers for Medicare and Medicaid Services in February and the code will be available for use in April.

(Business Wire 2/24/22)

AMA describes Appendix S: an AI taxonomy for reimbursement

The American Medical Association (AMA) is the organization in charge of the CPT codes used for reimbursement of medical procedures. An advisory committee within the AMA, called the Digital Medicine Payment Advisory Group, authored Appendix S which provides guidance on the classification of medical technologies that use artificial intelligence (AI). Appendix S consists of a taxonomy that divides AI applications into 3 categories: assistive, augmentative or autonomous. The assistive classification consists of technology that detects clinically relevant data without analysis. The augmentative classification is used when an AI provides analysis or clinically meaningful quantification of data. The autonomous classification denotes AI that interprets data and independently generates clinically relevant conclusions. Within the autonomous classification are three levels which reflect the amount of clinician involvement. Level 1 requires clinician action to implement the AI’s conclusion. Level 3 provides automatic conclusions and the initiation of care management, which requires clinician action to override.

(AMA 2/1/22)

Blog “Revisits MCIT with Numbers”

Bruce Quinn provided a quantitative analysis of the now-defunct Medicare Coverage for Innovative Technologies (MCIT). His modeling suggests that if MCIT had been enacted, it would have had a dramatic positive effect on product value and success rate for companies launching a breakthrough medical device.  He compares this to a model of the current status quo where it takes an average of 2 years to achieve coverage and companies have a 50% failure rate.

(Discoveries in Health Policy 2/20/22)

The AOTA summary on Remote Therapeutic Monitoring

The American Occupational Therapy Association (AOTA) had been silent about the addition of the new Remote Monitoring (RTM) codes, which became available for use in January 2022. A February 1st web post by Monica Wright, the AOTA manager of Coding and Payment Policy, provided a brief summary of the available codes. The AOTA did not follow the example of the American Physical Therapy Association in providing any additional commentary or billing guidance.  The RTM codes provide a new opportunity for physical and occupational therapists to be reimbursed for monitoring their patients’ response to therapy using connected medical devices and mobile or web-based dashboards.

(AOTA 2/1/22)

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 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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