PRACTICE RESOURCES > Regulation/AUA Positions, Letters, and Talking Points > AUA Comments to CMS on Device Pass-through Payment Criteria

AUA Comments to CMS on Device Pass-through Payment Criteria

January 13th, 2005

Mark McClellan, MD, PhD
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Attention: CMS-1427-FC
P.O. Box 8010
Baltimore, MD 21244-8018

Re: CMS-1427-FC: Medicare Program; Changes to Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates

Dear Dr. McClellan:

On behalf of the American Urological Association (AUA), representing 10,000 practicing urologists in the United States, I am pleased to submit comments on CMS's final rule on the 2005 Medicare hospital outpatient prospective payment system (OPPS).

Our comments focus on our concerns with CMS's current policy which requires that a device must be surgically implanted or used through a surgical incision in order to qualify for pass-through payment. We appreciate CMS opening up this issue for comment in the OPPS final rule based on concerns raised by device makers and other stakeholders.

Device Categories
Urologists use many different medical devices to treat a wide array of genitourinary conditions. The devices range from guidewires to prostastic ablation catheters to stone removal baskets. Most of these devices are inserted transurethrally and delivered through a cystoscope or ureteroscope. The benefit of devices delivered through a natural body opening is that the procedure is less invasive, patients recover quicker, and hospital costs are reduced by avoiding inpatient stays.

It is unclear to us why this "surgically-implanted" requirement has been created to evaluate the appropriateness of medical devices. New technology often employs less invasive approaches to treatment and restricting these devices from pass-through consideration seems short-sighted.

Moreover, there should be no budgetary concern, as Medicare pass-through spending is capped at two percent of OPPS spending, and any overruns in device pass-through spending would trigger pro-rata reductions to ensure this cap is not exceeded.

More importantly, we are concerned that the current pass-through restriction on devices delivered through a natural body orifice may reduce patient access to key urologic technologies. We are not aware that any patient group, physician organization or the Congress is pressing to exclude consideration of devices that do not require an incision, and cannot understand why this criterion is in place. The following section refers to the four questions posed by CMS on pages 65774-65775 of the final rule, our answers are as follows:

  1. We believe that distinguishing between natural and surgically created orifices is unnecessary, because other pass-through requirements sufficiently define technology that should be eligible. The merits of a device itself should determine whether a new pass-through category should be created, not the means of delivery of the device.
  2. In terms of what would constitute a "new" device, we believe that CMS should apply the same criteria for devices used without a surgical incision as for those devices that are surgically implanted.
  3. Devices eligible for pass-through categories can be distinguished from sutures, clips and other incident-to items by virtue of the rigorous substantial clinical improvement standard that CMS uses when considering whether to create new device pass-through categories.
  4. We strongly believe that there should be no distinction drawn between devices delivered through scopes. Gastroenterologists, gynecologists and urologists all use various types of endoscopes (colonoscopes, hysteroscopes, cystoscopes, ureteroscopes) as the primary means of delivery for most of the medical devices they use. Just as there should be no distinction drawn between natural and surgically created orifices, there should be no distinction drawn between devices used through scopes versus those delivered without scopes.

In sum, we believe dropping the surgical incision requirement would more appropriately make the device itself the primary item to be evaluated rather than dwelling on the means of delivering the device. This will enhance Medicare patient access to new less-invasive technologies, and we urge CMS to change its criteria accordingly.

We greatly appreciate CMS's consideration of these comments. If you have any questions, please contact Robin Hudson, Manager of Regulatory Affairs, at 410-689-3762 or


Brendan M. Fox, MD


Term of Use

© 2017 American Urological Association Education and Research Inc. All Rights Reserved.