Device Firms Oppose Proposed 510(k) Exemptions and CMS Delays Coverage of Breakthrough Devices

 In Blog, Regulatory & Reimbursement Update


Device, digital health firms oppose HHS’ proposed 510(k) exemptions 

Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS) to permanently exempt 84 types of medical devices from premarket notification (510(k) requirements. The proposal was made in the final days of the Trump administration and was pushed through without consulting the US Food and Drug Administration (FDA), the agency that would typically issue such a notice. All the devices included in the proposal, which include 83 Class II devices and one unclassified device, were temporarily exempted from premarket review requirements during the COVID-19 public health emergency (PHE). Firms took issue with the methodology used to determine which devices to exempt based on the MAUDE database since the database has no mechanism to identify or correct missing, erroneous, or incomplete information.

(RAPS- 23 March 2021)

US FDA unveils online resource center for biocompatibility assessment 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) published its new Biocompatibility Assessment Resource Center to help companies navigate requirements relating to ISO 10993-1. Users of the website are advised to read the agency’s guidance document on evaluating and testing biocompatibility for medical devices, which was finalized in September 2020, in full. After this is complete, they are presented with a list of recommended steps along with the online resources to facilitate them. Rather than comprising a collection of all existing FDA resources on biocompatibility, the resource center provides a generalized procedural guide intended to be suitable for most companies.

(EMERGO- 24 March 2021)

FDA offers real-world evidence examples in device applications 

A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include premarket notification 510(k) submissions, De Novo classification requests, humanitarian device exemption (HDE) applications, premarket approval (PMA) original applications, PMA panel track supplements, and continued access programs. The FDA provided 18 examples of applications that relied on real-world data collection made through national registries, and several other using international registries, sponsor registries, or a combination of registries and other sources.

(RAPS- 18 March 2021)

Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites

Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients. FDA’s most recent effort to improve diversity in clinical trials – final guidance for trial sponsors, issued in November 2020, calls for broadening enrollment criteria and avoiding unnecessarily excluding participants. Other avenues outside of trials can yield important data on the outcomes of minority patients, including real-world data sources, like electronic health records and administrative claims data, as well as post-marketing studies and safety monitoring.

RAPS 3/29/31


CMS decides to delay coverage of breakthrough devices 

The Medicare Coverage of the Innovative Technology (MCIT) rule was issued in January before the federal administration change. In March, the Centers for Medicare and Medicaid Services (CMS) announced that the rule has been postponed for 60 days. This delay will provide opportunity for further public comment and may result in modifications to the MCIT rule. Medical device innovation advocates are expressing frustration over the lengthy process, especially since the MCIT rule had broad bipartisan support and the potential to improve access to medical devices that are approved through the FDA breakthrough device program.

(Medical Design and Outsourcing 3/19/21)

Germany approves new digital health app for prescription and reimbursement 

The 11th digital health application has been approved by the German medical system DiGA. The app, called Deprexis, is used to treat mental health. 21 more digital health apps are currently undergoing the ‘fast track’ approval process, which will allow them to be prescribed and reimbursed like traditional medical treatments, such as medications. The DiGA directory of digital health applications includes various behavioral health treatments and apps that help with chronic fatigue, tinnitus, sleep disorders and obesity.

(MobiHealthNews 3/5/21)

CMS coding bulletin clarifies prefabricated orthosis billing 

The Centers for Medicare and Medicaid Services (CMS) published a joint correct coding bulletin that addressed confusion around HCPCs code descriptors containing the phrase “prefabricated, includes fitting and adjustment”. Orthoses that are described with this language must be fit by a trained individual and the fitting process must include customization or modification. If an orthosis described by these codes does not need to be customized, or is not fit by a qualified individual, it should be billed using a “not otherwise specified” code such as L1499, L2999 or L3999. Orthoses that require fitting and adjustment may not be shipped to patients without being properly fit.

(AOPA 3/12/21)

Report on modernizing Medicare coverage of digital health devices 

The report was commissioned by AdvaMed from the consulting group CapView Strategies in September and was summarized for AdvaMed members in March. The report includes recommendations to improve Medicare coverage of digital health technology in home and community settings, alternative payment models and Medicare Advantage topics are also discussed. The report found “significant potential regulatory modernization and opportunities to support CMS’s leadership role in the health care marketplace.”

(AdvaMed Resource Center 3/10/21)

CMS updates fee schedule, adjusting payments for over 900 codes 

The Centers for Medicare and Medicaid Services (CMS) fee schedule adjustments range between -30% to +57% of the originally released 2021 fee schedule. This new release corrects some errors that were in the original version and also includes updates to increase the payment levels for non-rural areas by an average of .9% and an average increase of .5% for rural areas. The group of HCPCS codes with the largest changes are the accessory codes with a KE modifier.

(HomeCare 3/3/21)


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, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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