AdvaMed: Final CMS Hospital Outpatient Payment Rule Contains Significant Improvement for Patient Access to Care

WASHINGTON - AdvaMed, the Medtech Association, today praised The Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System rule for CY25 for having significant wins for patient access to care while also urging the agency to "implement policy changes that will ensure beneficiary access to medically necessary" services "delivered through a Food and Drug Administration (FDA) approved or cleared medical device, that utilizes artificial intelligence (AI), machine learning (ML)."

In its letter on the final HOPPS rule AdvaMed highlighted the following topics:

• The need for a formalized payment pathway in the HOPPS for algorithm-based healthcare services;
• Support for CMS's proposed payment policy for diagnostic radiopharmaceuticals;
• Support for the Centers for Medicare and Medicaid Services' (CMS) proposal to cover CT colonoscopy (CTC); and
• Appropriate payment for cardiac CT services.

Payment Policies for Algorithm-Based Healthcare Services, Including Software as a Service

In its letter, AdvaMed wrote that "ABHS is a service delivered through a Food and Drug Administration (FDA) approved or cleared medical device, that utilizes artificial intelligence (AI), machine learning (ML), or other similar technology to produce quantitative and/or qualitative clinical information that cannot otherwise be obtained by a health care provider and provides "clinicians with new or additional information that cannot always be discerned from a previously acquired medical image or service."

AdvaMed cautioned that "the current HOPPS framework does not support access to or adoption of ABHS in all of its forms. Without such a framework, we are deeply concerned that the future of ABHS will overwhelm CMS's ability to assess reimbursement using existing pathways. We therefore recommend that CMS implement policy changes that will ensure beneficiary access to medically necessary ABHS technologies."

Separate Payment for Certain Radiopharmaceuticals

AdvaMed praised CMS's final rule "to separately pay for diagnostic radiopharmaceutical with a per day cost greater than $630" writing it will "reduce financial barriers for providers that limit beneficiary access to such imaging."

AdvaMed wrote that the agency's continued engagement with stakeholders results in a final rule with "payment methodology that will pay more appropriately for nuclear imaging using advanced diagnostic radiopharmaceuticals."

Coverage of CT Colonography

AdvaMed's letter strongly supports CMS's proposal to cover computed tomography colonography (CTC) to provide beneficiaries access to a minimally invasive colorectal cancer screening tool that can detect pre-cancerous polyps and does not require anesthesia.

"Given the rate of colorectal cancer in the US and higher rates of colorectal cancer in African Americans, providing an additional option for screening is welcome," AdvaMed wrote. To ensure that CTC is appropriately adopted, AdvaMed said it agrees with the American College of Radiology and other stakeholders urging CMS to "assign this service to a higher APC to recognize the resources involved in providing this procedure."

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