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Response to CMS MPFS Proposed Rule 2022

The Centers for Medicare & Medicaid Services (CMS) recently issued the 2022 Medicare Physician Fee Schedule (MPFS) Proposed Rule

The proposed reductions affect a range of office-based procedures in a variety of surgical specialties, including Prostatic Urethral Lift (PUL) using the UroLift® System. This proposed CMS rule does not impact hospital outpatient or ASC settings reimbursement for the UroLift System. We anticipate the 2022 MPFS Final Rule will be published during the fourth quarter of 2021. The public comment period is open until 5pm EST September 13.

Physician advocacy is critical to ensuring Congress hears your voice to protect patient access to office-based surgical care. You can reach out to your lawmakers to share your concerns or submit comments directly to CMS by going to Regulations.gov. You can also view submitted comments at this site.

 

NeoTract l Teleflex strongly opposes the CMS 2022 MPFS Proposed Rule. We are committed to advocating for patient access to minimally invasive procedures in lower-cost settings to enable you and your patients to determine the best site of care through shared decision-making.

When the UroLift System was developed, both urologists and patients indicated their need for a minimally invasive procedure to treat BPH that can be performed in physicians’ offices. The UroLift System can be successfully performed in any standard care setting, and office site of care is preferred by many patients because of its convenience and accessibility. The UroLift System is now part of the standard of care and a BPH treatment of choice for many of you and your patients based on the strength of supporting clinical studies, real-world data, and low rates of complication and reintervention.1, 2 For these reasons, it is important to retain the flexibility that would allow this procedure to be offered in the comfort and convenience of the office setting for appropriate patients.

We are concerned the proposed rule will have unintended consequences that could impact Medicare beneficiaries’ ability to be treated with the UroLift System in an office site of service. It is also worth noting that, when given a choice, many patients would prefer to have minor procedures performed in their physician’s office rather than having to go to a hospital or other facility.3

We are engaging with CMS and with professional and patient organizations to discuss the impact of the Proposed Rule through the public comment period. During a call we had recently with CMS on this topic, we believe we helped them understand the potentially significant impact this could have on patient access to proven, safe, effective, and less invasive procedures, including the UroLift System, in lower-cost settings such as the physician's office. Our comments were submitted to CMS at the end of August. Here are highlights:

  • Implementation of this proposal is likely to restrict some procedures to the more costly ASC or HOPD settings, effectively reducing Medicare beneficiaries’ access to care
  • Even a phase-in of the proposed rate revisions would likely negatively impact accessibility of device-centered procedures in physician offices
  • Alternatives should be considered to meet the goals of improving health equity and access for Medicare beneficiaries
As David B. Hoyt, MD, FACS and Executive Director of the American College of Surgeons stated, “Our patients deserve a health care system that invests in surgical care. CMS is taking notable strides to improve health equity; however, this proposal would achieve the opposite by threatening patient access to critical treatments and procedures.”3