In late 2022, at the Foundation’s 8th International Symposium on Focused Ultrasound, I presented information about the current status of reimbursement for procedures that use focused ultrasound technology. Now, I am writing about all of the exciting reimbursement news that have taken place since then.
Reimbursement 101
To provide some brief background, what we refer to as reimbursement has three components:
- Coding. A billing code is designated for each defined procedure. Although a treatment can be billed using a non-specific code, the probability that the claim will be rejected is substantially higher without a procedure-specific code.
- Payment Rate. This is the amount the treatment site and the treating physician will be reimbursed for performing the procedure.
- Coverage. A procedure is covered when an insurer has officially stated that it will reimburse that procedure with its billing code and at the prescribed payment rate. This is called a positive coverage determination.
All of the above processes are undertaken by government or private insurers with the exception that, in the United States, certain billing codes are also created by the American Medical Association (AMA).
Note that the billing code and the payment rate are generally necessary, but not sufficient, for reimbursement. All three of the items listed above need to be in place before a physician and treatment site are paid for a procedure. Case-by-case authorizations are possible, but the process is most often arduous and complex.
A Timeline of Recent Reimbursement Milestones
Since the Focused Ultrasound Foundation’s 2022 Symposium, we have been made aware of significant advances related to reimbursement. I have summarized the most notable milestones below.
On December 22, 2022, Anthem Blue Cross Blue Shield, which provides benefits to 36 million patients in 22 states across the US, agreed to reimburse the treatment of essential tremor using Insightec’s Exablate Neuro focused ultrasound platform. The first effective date – or the first treatment date on which the procedure will be reimbursed – was August 11, 2022.
Cigna, a national insurer with 15 million beneficiaries in the US, agreed to reimburse for the treatment of essential tremor using the Exablate Neuro focused ultrasound platform. The first effective date is January 15, 2023.
With a retroactive effective date of July 1, 2023, Swiss healthcare authorities approved reimbursement for the treatment of prostate cancer using EDAP TMS’s Focal One device.
On September 22, 2023, Humana, a national insurer with 9 million beneficiaries in the US, agreed to reimburse for the treatment of essential tremor using the Exablate Neuro focused ultrasound platform. This ruling has a retroactive first effective date of July 27, 2023.
The US Centers for Medicare and Medicaid Services (CMS) announced the creation of three new Category 1 CPT codes (5X006, 5X007, and 5X008) for transurethral ultrasound ablation of prostate cancer. Currently, Profound Medical’s TULSA-PRO device is the only system that utilizes this technology. These codes go into effect on January 1, 2025, and will replace the existing temporary code C9734. CPT 1 codes are highly desirable because they are permanent and are highly preferred by private insurers.
The US Centers for Medicare and Medicaid Services (CMS) announced an increase from $12,500 to $17,500 in the payment rate for histotripsy of liver tumors procedures on November 6, 2023. This procedure has been assigned a billing code (0686T) to accompany this payment rate, but to our knowledge, it has not yet received a positive coverage determination.
Also notable, on October 6, 2023, the US Food and Drug Administration (FDA) granted de novo status (a form of device registration that allows the company to market the device) to HistoSonics’ Edison System, which uses histotripsy to target and destroy liver tumors. We anticipate that an announcement of coverage will be forthcoming.
At the same time came an announcement that a similar procedure for histotripsy of kidney tissue has been assigned a billing code of X201T. Treatment of kidney tissue has not yet been assigned a payment rate, nor has it received any form of FDA registration.
Both the payment rate increase and the new billing code went into effect on January 1, 2024.
Fondo di Assistenza Sanitaria per i Dirigenti di Aziende Commerciali, di Trasporto e Spedizione – or Fasdac – is a private Italian insurer that provides healthcare benefits to managers of commercial transport and shipping companies, general warehouses, and hotels and maritime agencies. In November, Fasdac agreed to reimburse for essential tremor treatments using Insightec’s Exablate Neuro focused ultrasound platform, with a payment rate of €16,000. To our knowledge, this is the first instance of a private insurer in Italy providing coverage for the procedure.
The Medical Services Advisory Committee (MSAC) of the Australian government issued a positive coverage determination for the treatment of essential tremor using Insightec’s Exablate Neuro focused ultrasound platform on November 22, 2023. This determination creates a pathway for focused ultrasound–based treatment to receive a Medical Benefits Scheme (MBS) listing in 2024.
The French National Authority for Health (HAS) released a favorable recommendation for the reimbursement of prostate cancer treatment using EDAP TMS’s Focal One device on December 12, 2023. The next likely step will be to receive a positive coverage determination from the French Social Security authorities, which will have the procedure covered under Sécurité Sociale, the French national universal health system. We have been aware of reimbursement for prostate cancer treatments in France for some time now, although this will now officially extend coverage to treatments using the Focal One device.
Conclusion
In summary, these reimbursement wins in 2023 made focused ultrasound more accessible to countless patients worldwide. In the US alone, 60 million more people now have access to focused ultrasound for essential tremor.
However, the Foundation would like to see access to focused ultrasound–based procedures for all patients. Needless to say, there is much work to do. The majority of people cannot pay out-of-pocket for a focused ultrasound procedure; so without proper reimbursement, the cost will remain a huge barrier to adoption. It is our hope that 2024 ushers in a new wave of gains in patient access.
Michael Broad, PhD, is the Foundation’s Data Strategy Director. He also leads the Reimbursement Education Program, helping treatment sites better align their internal costs to future Medicare reimbursement levels.