Medicare proposes paying for interventional radiology procedure to treat resistant hypertension
Medicare is proposing payment for a key image-guided procedure used to treat high blood pressure.
The federal government first released the coverage decision in July, saying it will cover renal denervation for uncontrolled hypertension in certain circumstances. This minimally invasive procedure involves using energy, either from radiofrequency or ultrasound, to disrupt nerves in the renal arteries and reduce blood pressure that has not responded to medication.
Aug. 9 was the deadline to submit comments, with CMS expected to finalize the National Coverage Determination by October. The Society of Interventional Radiology recently weighed in, urging the agency to make modifications “to provide clarity and strengthen” the proposal.
SIR highlighted one provision—requiring facilities to employ a nonphysician who provides support and education—as potentially problematic.
“While we support the inclusion of dedicated blood pressure management as a key component of care, mandating a hypertension navigator is an unrealistic expectation for most facilities, particularly given workforce constraints,” Robert A. Lookstein, MD, Society of Interventional Radiology president, wrote to CMS Aug. 8. “We recommend that the criteria allow for flexibility in how comprehensive hypertension management is achieved, without requiring specific roles that may not be feasible to implement universally.”
CMS proposes several criteria for it to cover renal denervation. Physicians must have the interventional skills and training to handle the procedure and be able to navigate complications. Those who do not must complete at least 10 supervised cases, half as primary operator, and at least five proctored procedures with each approved device. Facilities, meanwhile, require a multidisciplinary hypertension program, preprocedural imaging capabilities (e.g., ultrasound, CT, MRI, etc.) and possess an appropriate interventional cardiology or radiology suite.
In its comment letter, the Society of Interventional Radiology urged for greater clarity and simplicity around patient selection criteria. This included “strongly” recommending that coverage guidelines require a minimum of 90 days of management, prior to a referral, rather than six months. SIR also asked for clarity around whether proctoring requirements apply to all approved renal denervation devices or just the ones a radiologist intends to use in clinical practice.
“Given the procedural and technical differences across RDN systems, we believe it is most appropriate—and practical—for physicians to be trained and proctored only on the device(s) they will use,” wrote Lookstein, who also is an interventional radiologist and professor with Mount Sinai in New York. “This approach maintains high standards of procedural competency while avoiding unnecessary redundancy and administrative burden.”
The Society of Interventional Radiology also highlighted the National Coverage Determination and its comment letter in a news update published Tuesday (log in required).
