Reimbursement, AI top list of priorities for new digital health lobbying group

ANAHEIM, CA – The medical device group AdvaMed has formed a new digital health division focusing on lobbying lawmakers and the US Food and Drug Administration (FDA) on digital health regulations and legislation.

AdvaMed CEO Scott Whitaker announced the launch of AdvaMed Digital Health Tech on 9 October at the annual MedTech Conference. The new division will work on issues including artificial intelligence and machine learning (AI/ML) regulation and reimbursement.

AdvaMed has had a Center for Digital Health that focused on developing policies and strategies to assist digital health manufacturers for more than five years. As digital health has gained prominence in healthcare delivery, AdvaMed leadership concluded that the group needed to advance and present a public face.

The group will be led by Executive Director Shaye Mandle, the former CEO of the Medical Alley Association, and Board Chair Taha Kass-Hout, chief technology officer at GE Healthcare and a former FDA chief health informatics officer. The board includes digital health executives from companies such as Johnson & Johnson, Medtronic, Apple, Amazon and Google.

“We determined it was critical to have a leader and a team and a board that could really help to shape where things are heading from cybersecurity and data privacy to AI,” Mandle told Focus.

Reimbursement reality

Mandle said the group’s top priority is to work on the Transitional Coverage of Emerging Technologies (TCET) pathway, proposed by the Centers for Medicare and Medicaid Services (CMS) to address payment for breakthrough medical technologies. He argued that the current reimbursement models used by CMS do not work for digital therapeutics coming to market.

"Some clarity around payment is probably going to be one of [our] primary issues," Mandle said.

For example, Mandle pointed out that Pear Therapeutics, which developed apps to treat conditions such as post-traumatic stress disorder, irritable bowel syndrome, and substance use disorder but, filed for bankruptcy after failing to secure reimbursement from CMS. Other companies, such as Applied VR, have obtained reimbursement under current codes that do not fully fit the product description.

Adapting AI

On the regulatory side, Mandle said the group’s priority is AI. There are a lot of potential opportunities to bring industry leaders and FDA together to address how the technologies should be regulated, he said. “We need to help [FDA], and they need to help us," he said. "How are we going to regulate emerging technologies, in particular AI, over the next five years?"

Last year, Congress included language in the 2023 Consolidated Appropriations Act that gave FDA authority to let products enter the market with predetermined change control plans (PCCP) that allow the products to update themselves without requiring sponsors to submit new product applications. Mandle said he sees the group working with FDA on how PCCP can be used to advance how AI technology is regulated (RELATED: Stakeholders seek clarity, risk-based approach in AI/ML PCCP guidance, Regulatory Focus 10 July 2023).

Mandle also sees a role for the new group in addressing concerns about the potential risks associated with AI by helping to set principles and standards and ensure that biases don't creep into products. FDA has been ahead of the curve, Mandle said, compared with other federal agencies and other regulators around the world.

"We'd like to be working with FDA to ensure that the US is leading on these issues," Mandle said. He added that while FDA has been thoughtful about allowing AI products on the market, they have also tried to work to allow innovation in the sector.

A new path for digital health

In recent years, FDA and the medtech industry have worked to develop a precertification (Pre-Cert) program that was intended to allow a new pathway for digital health products. Though the program was popular with industry, regulators ultimately concluded that they lacked the authority to move it beyond the pilot stage (RELATED: FDA acknowledges shortcomings of Pre-Cert pilot in report, Regulatory Focus 3 October 2023).

Mandle said he would like to have conversations with FDA about what authorities it has and where it may need additional authorities from Congress. “I wouldn't commit us right now to saying, ‘Yes, we're definitely going to go back to [the Pre-Cert Program],’” Mandle said. “But I think we're going to have a lot of conversations about what the right type of program could look like and should look like.”

Mandle said the new group is also interested in working with FDA on a voluntary alternative pathway (VAP) program that would offer greater regulatory flexibility for innovative products. VAP is a priority for Jeff Shuren, director of the FDACenter for Devices and Radiological Health (CDRH). Mandle said AdvaMed has already had conversations with Shuren about how a program like that could be used for digital health products (RELATED: Shuren: Getting QMSR out by year’s end a ‘high priority,’ Regulatory Focus 23 May 2023).

Reimbursement, AI top list of priorities for new digital health lobbying group

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