AdvaMed: Final CMS Payment Rules Contain Significant Victories for Patients

Washington, D.C. - AdvaMed, the Medtech Association, today said two new final payment rules from the Centers for Medicare and Medicaid Services (CMS) for 2025 contain several important provisions that will improve access to care and improve outcomes for millions of Medicare beneficiaries. The measures include longstanding priorities for patient groups, providers, and medtech innovators.

"CMS made welcome, much-needed changes that will improve the diagnosis and treatment for Medicare beneficiaries in important ways next year," said Scott Whitaker, president and CEO of AdvaMed. "I commend the agency for listening to patient groups, providers, and medtech innovators and expanding access to exciting medical technologies created to help as many patients as possible enjoy their best health. Medicare beneficiaries and their health care providers will appreciate these valuable new options."

The Calendar Year 2025 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System final rule and the Calendar Year 2025 Medicare Physician Fee Schedule final rule include:

• Separate reimbursement to hospitals for certain diagnostic radiopharmaceuticals to expand patient access to innovative imaging exams. The provision will help millions of patients benefit from this technology, used to diagnose illnesses including Alzheimer's, Parkinson's, heart disease, and certain types of cancer.

• Expanded access to colorectal cancer screening, including covering computed tomography colonography (CTC), also known as a virtual colonoscopy, to provide Medicare beneficiaries access to a minimally invasive colorectal cancer screening tool that can detect pre-cancerous polyps and does not require anesthesia. Medicare also will cover blood-based biomarker screening tests as part of the screening continuum. Given the rate of colorectal cancer in the United States and higher rates of colorectal cancer in African Americans, providing additional options for screening is critical to earlier diagnosis and treatment.

• Medicare payment for digital mental health treatment devices, a subset of FDA-regulated digital therapeutics, furnished incident to or integral to professional behavioral health care treatment under a behavioral health treatment plan of care. This new coverage policy is a good start to the conversation and reflects a narrow, but clear, subcategory of digital therapeutics for mental health disorders. FDA-regulated digital therapeutics stand to expand beneficiary access to evidence-based treatment for a wide range of mental and behavioral health conditions, and AdvaMed looks forward to continuing to engage with CMS to provide coverage for safe, effective medical devices.

• Establishing a process for extending temporary additional payments for certain non-opioid treatments for pain relief. This implementation process outlines evidence requirements for medical devices to demonstrate the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed. There are many ways to treat pain, and extending additional payment for medical devices in this space will help further combat the ongoing opioid epidemic.