CMS final rule increases payment rate for iTind procedure in HOPD and ASC

The Centers for Medicare & Medicaid Services (CMS) final rule includes increased payment rates for code C9769 covering the iTind procedure, Olympus Corporation announced in a news release.¹ iTind is a procedure indicated for the treatment of benign prostatic hyperplasia (BPH) in men aged 50 or older.

"We applaud CMS for recognizing the value of the iTind procedure. After significant evidence-based engagement with the agency, Olympus successfully demonstrated the value and science behind this technology, leading CMS to revise the APC assignment and enhance the payment rate, which will in turn support patient access to this important procedure," said Paul Skodny, Executive Director for Health Economics and Market Access at Olympus Corporation, in the news release.

The CMS CY2023 Outpatient Prospective Payment System (OPPS) Rule was finalized and announced on November 1, 2022, and the rates went into effect January 1, 2023. CY2023 fee schedules cover all procedures performed in the hospital-based outpatient department (HOPD) and ambulatory surgical center (ASC) facilities.

Specifically, the rule changes in the HOPD include a reclassification of the urology Ambulatory Payment Classification from a level 5 to a level 6. It also establishes a national average payment rate of $8221.74 per procedure in OPPS payments.

In the ASC, the rule establishes a national average payment rate of $7274.78 per procedure in ASC payments.

These changes were made with the hope of expanding access to care for Medicare beneficiaries who could benefit from treatment for lower urinary tract symptoms (LUTS) secondary to BPH.

"Olympus is changing the treatment paradigm for BPH by providing solutions beyond medical management and surgical intervention, which both come with some unwanted side effects. With advancements in minimally invasive BPH therapies, patients and providers have treatment options that allow for improved outcomes, such as maintaining sexual function. Clinical evidence demonstrates that the iTind procedure safely and effectively relieves symptoms while preserving sexual function,” said Chief Medical Officer for Olympus Corporation Ross "Rusty" Segan, MD, MBA, FAC, in the press release.

About iTind

iTind is a nitinol device that was developed by Israeli medical device manufacturer Medi-Tate and is distributed in the US by Olympus Corporation of the Americas. In April 2020, the device was granted de Novo classification by the FDA for the treatment of BPH symptoms in men aged 50 or older.²

The iTind procedure involves the temporary implantation of the nitinol device, which is designed to reshape the prostatic urethra over 5 days, allowing urine to flow more freely.³ The minimally invasive treatment can be performed in HOPDs, ASCs, or clinical office settings.

References

1. Medicare issues final rule that increase payment rate for iTind procedure in outpatient settings. News release. Olympus Corporation. November 3, 2022. Accessed January 4, 2023. https://www.prnewswire.com/news-releases/medicare-issues-final-rule-that-increases-payment-rates-for-itind-procedure-performed-in-outpatient-settings-301668121.html

2. The iTind device receives FDA de Novo classification order for benign prostatic hyperplasia (BPH) non-surgical treatment device. News release. Olympus Medical Systems Group. April 6, 2020. Accessed January 4, 2023. https://www.prnewswire.com/news-releases/the-itind-device-receives-fda-de-novo-classification-order-for-benign-prostatic-hyperplasia-bph-non-surgical-treatment-device-301035836.html#:~:text=CENTER%20VALLEY%2C%20Pa.%2C%20April,invasive%20treatment%20of%20Benign%20Prostatic

3. Chughtai B, Elterman D, Shore N, et al. The iTind temporarily implanted nitinol device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a multicenter, randomized, controlled trial. Urology. 2021;153:270-276. doi:10.1016/j.urology.2020.12.022