AAMI and BSI Partner to Publish Guidance on Artificial Intelligence and Reimbursement lags for Prescription Digital Therapeutics

 In Blog, News, Regulatory & Reimbursement Update


AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices. AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine learning in artificial intelligence – Guide, derives from a 2022 AAMI consensus report (CR). The FDA recognized the CR as a guidance document “appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act.” Developed in collaboration with BSI, the CR was the first AI-related guidance to receive this level of recognition from the Agency. The content of the TIR is substantively the same as the CR content, with only minor spelling and formatting differences between the U.S. and British versions.

Medtech Intelligence 5/31/2023

Report Links Regulatory Submission Characteristics & Device Recalls

A Minnesota study explored the potential for class II devices to be recalled by analyzing the predicate devices cited in their 510(k) submissions. The authors examined the relationship between the devices seeking clearance, or “applicant devices,” and the predicate devices cited within the applicant devices’ 510(k) submissions. The study found “no significant associations between recall probability and predicate device dissimilarity as measured by nonmatching product types and nonmatching medical specialties.” There appeared to be no increased likelihood that an applicant device would be recalled because of citing predicates that did not match the kind of product the applicant device was or the kind of medical specialty the applicant device treated. They concluded that newer predicate devices may have underlying safety issues unknown to the manufacturers of both the applicant and predicate devices while older predicate devices may have undergone more intensive market scrutiny. It also may be that time allowed the market to develop an understanding of a predicate device’s safety profile. These reasons could explain why recalls appear to be less likely with older predicates. The authors recognized that this result conflicted with FDA’s guidance advising to retire outdated predicate devices.

MDDI Online 5/11/23

FDA CDRH Portal Now Offers Tracking of Pre-Submissions

On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include: written feedback (only), or written feedback followed by a meeting.

The agency noted that the CDRH Portal updates are a step forward in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions. All CDRH-led premarket submission types may be uploaded to the CDRH Portal at any stage of the review process. Official correspondents do not need to send a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal. Starting October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR, unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the Electronic Submission Template for Medical Device 510(k) Submissions guidance. Prior to October 1, 2023, companies may submit 510(k)s by mail or through the CDRH Portal in either the eSTAR or eCopy format. De Novo requests submitted using eSTAR remain voluntary until further notice.

MedTech Intelligence 5/24/23

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies

Medical device manufacturers that are in the process of—or interested in—exploring advanced manufacturing technologies can receive funding from the FDA through the Advanced Manufacturing Clearing House (AMCH). The program, which is being run by the Medical Device Consortium (MDIC) in partnership with the FDA, provides funding up to 30% or $300,000 of total project costs. The goal of AMCH is to speed adoption of advanced manufacturing technologies in the MedTech market. The program is funded through 2024 with a rolling application process.

MedTech Intelligence 5/30/23



Reimbursement lags for Prescription Digital Therapeutics

While the Food and Drug Administration (FDA) has cleared numerous software-based medicines, the Centers for Medicare and Medicaid Services (CMS) can’t reimburse providers due to the lack of approved billing codes for these therapies. Without government reimbursement, private insurers are reluctant to cover these innovative treatments, hindering their adoption. Bipartisan efforts are underway to change this situation, led by Rep. Mike Thompson and Sen. Jeanne Shaheen. However, some companies have already struggled, with Pear Therapeutics filing for bankruptcy due to Congress’s failure to pass relevant legislation. This highlights the need to strike a balance between the introduction of new treatments and the associated costs and evidence of effectiveness. Proponents argue that digital therapeutics have the potential to provide accessible care and improve outcomes, especially for mental health and substance use disorders.

(Politico 5/14/23)

Power seat reimbursement win for wheelchairs

The Centers for Medicare & Medicaid Services (CMS) has announced a landmark decision, making power seat elevation for power wheelchairs eligible for reimbursement as durable medical equipment (DME). The decision comes after advocacy from DME advocates, mobility manufacturers, and members of the disability community. CMS considers seat elevation for Medicare-covered power wheelchairs to be a clinically meaningful benefit for individuals who perform transfers from power wheelchairs or use their chairs for mobility-related activities of daily living. This decision is expected to improve the quality of life for wheelchair users. CMS is expanding coverage to include additional power wheelchair categories and has determined that power seat elevation equipment is reasonable and necessary for individuals using complex rehabilitative power-driven wheelchairs who meet specific conditions.

(HomeCare 5/16/23)

Integrating AI into DTx faces familiar reimbursement barriers

The next era of digital therapeutics (DTx) is characterized by the integration of AI/ML algorithms. While promising, these advancements bring regulatory challenges, including classification as medical devices, licensing requirements, payer coverage, and ongoing refinement of regulatory frameworks. Integration of AI algorithms in DTx holds promise for personalized and cost-effective treatments, but challenges remain in terms of payment and reimbursement. DTx companies often face barriers to adoption due to the lack of payer coverage and the absence of a clear reimbursement path. These technologies don’t neatly fit into existing benefit categories, and negotiations with payers and pharmacy benefit managers are typically conducted on a case-by-case basis. Efforts are underway to drive policy changes and incentivize payer coverage based on efficacy and real-world evidence, such as proposed legislation to expand Medicare and Medicaid coverage for FDA-approved DTx.

(JD Supra 5/17/23)

Medicare policy may perpetuate inequities in access to innovative treatments

Medicare’s use of the “coverage with evidence development” (CED) policy, which denies coverage for FDA-approved treatments unless provided through specific clinical studies, disproportionately affects older people with early Alzheimer’s in rural areas and communities of color. This regulatory tool, initially intended to expedite access to medical device treatments, is now being used to ration care for seniors. The misuse of CED not only delays access to treatments for conditions that disproportionately affect minority populations, such as sickle cell anemia and colorectal cancer, but also exacerbates health disparities. Patients of color are underrepresented in clinical studies for CED-designated treatments, further perpetuating inequities.

(Virginia Mercury 5/17/23)

Healthcare system braces for change with the end of the PHE

The Biden administration has announced that the COVID-19 Public Health Emergency (PHE) officially ended on May 11, 2023. The PHE declaration, which provided regulatory flexibilities for the healthcare industry during the pandemic, will now come to an end, requiring organizations to make significant changes as regulatory enforcement returns to status quo. One key area of impact is reimbursement changes for hospitals. The wind down of blanket waivers affecting hospitals’ operations and reimbursement will be triggered by the end of the PHE. Some waivers ended on May 11 and other waivers that may remain in effect through December 31, 2023 or beyond. Understanding these changes is crucial for hospitals to prepare for upcoming reimbursement changes. Home health agencies and hospices, as hands-on care providers, benefited from Medicare program regulatory flexibilities during the PHE. However, as the PHE ends, they will face significant changes in reimbursement, particularly as telehealth regulations revert to pre-COVID-19 status. The shift back to pre-pandemic reimbursement models and regulations will require adaptation and adjustment for these providers.

(Morgan Lewis 5/10/23)


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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