For patients who rely on urinary catheters or ostomy supplies, the product is not separate from the treatment. A small difference in catheter design, pouching system, adhesive, packaging, or drainage equipment can determine whether a patient can manage safely and independently.

That clinical reality is why the Centers for Medicare & Medicaid Services' (CMS) decision to include urological and ostomy supplies in the next round of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program deserves close attention from urologists; wound, ostomy, and continence nurses (WOCN); patients; and policymakers.

The American Association of Clinical Urology (AACU) and WOCN Society support responsible efforts to prevent fraud, strengthen documentation, and reduce unnecessary Medicare spending. The concern is narrower but consequential: A procurement system organized around price cannot be allowed to treat highly individualized products as interchangeable commodities.

What is changing

CMS has designated urological supplies, ostomy supplies, and hydrophilic urinary catheters as product categories for Round 2028. All will be included in a nationwide remote item delivery program. Under that model, only contract suppliers may furnish competitively bid items covered by Medicare Part B, and each contract supplier must serve beneficiaries across the country.

CMS expects the round to begin no later than January 1, 2028, with a 6-month transition period. The agency has also created important safeguards. When a physician prescribes a particular brand or mode of delivery to avoid an adverse medical outcome, a contract supplier must furnish it, help locate another contract supplier, or consult the physician about an alternative. If the physician determines that the alternative is unacceptable, the supplier must provide the prescribed item.

Those protections are important. Their value, however, will depend on whether patients and clinicians can use them promptly and without creating a new cycle of delays, repeated documentation requests, and unwanted substitutions.

For urologists, product selection is a clinical decision

Patients catheterize for many reasons, including neurogenic bladder, spinal cord injury, spina bifida, multiple sclerosis, prostate obstruction, urethral stricture, and complications following surgery. Many perform intermittent catheterization several times a day for years or for life.

Catheters vary in length, diameter, rigidity, tip design, coating, lubrication, insertion system, and packaging. A patient may need a coudé tip to navigate an obstruction or individual anatomy. Limited dexterity, recurrent infection, urethral trauma, visual impairment, or the need to catheterize outside the home may make a hydrophilic, pre-lubricated, touchless, or closed system clinically appropriate.

The wrong product may be painful or impossible to insert. Repeated attempts can cause bleeding or urethral trauma. Inadequate emptying can contribute to urinary retention, infection, emergency care, or hospitalization. A patient who cannot open the packaging or manipulate the device may lose the ability to catheterize independently.

The same concerns extend to Foley catheters, drainage bags, leg straps, securement devices, and related supplies. These products may share a billing category, but that does not make them clinically equivalent.

Competitive bidding will also affect the urology practice. If suppliers seek repeated orders, brand justification, or approval of alternatives, physicians and staff may face more calls, faxes, chart reviews, and urgent requests. A safeguard that exists on paper will not protect patients if the process takes longer than the patient's supply can safely last.

Ostomy care requires the same individualization

An ostomy pouching system must maintain a secure seal around a surgically created opening while protecting the surrounding skin. Selection depends on the type and location of the stoma, abdominal contours, scars or hernias, the character of the output, skin condition, dexterity, mobility, vision, and the patient's work and daily activities.

One patient may need a flat barrier, whereas another requires convexity. A person may tolerate one adhesive but develop irritation with another. Some patients need components from more than one manufacturer to prevent leakage and protect the skin.

For this reason, the WOCN Society describes ostomy product selection as an individualized clinical process, often requiring assessment and adjustment by a wound, ostomy, and continence nurse. Restricting choice can contribute to leakage, peristomal skin injury, loss of independence, emergency visits, and hospitalization. It can also cause patients to withdraw from work, travel, and social activity because they no longer trust the pouching system.

The policy test is total cost and clinical access

CMS has legitimate reasons to scrutinize this market. The agency has reported substantial improper payments for urological supplies and has pursued suppliers accused of billing for products that were not ordered, needed, or received. Yet much of the reported improper-payment problem has involved missing or insufficient documentation. Fraud and documentation failures should be addressed directly.

A lower unit price is not a savings if an unsuitable catheter causes trauma or infection, if a leaking pouching system leads to skin injury, or if patients discard products they cannot use. Medicare should evaluate the program by total cost and clinical outcomes, not product price alone. Relevant measures include substitutions, delivery delays, infections, skin complications, emergency visits, hospitalizations, loss of independence, caregiver burden, and the administrative burden placed on clinical practices.

What CMS should protect before 2028

Before implementation, CMS should make the physician-authorization process simple, rapid, and visible to patients, suppliers, and clinicians. A prescription that identifies a brand, design, feature, or mode of delivery as necessary to avoid an adverse outcome should be honored without serial appeals or repeated demands for the same records.

Contract suppliers should maintain a meaningful range of products, sizes, designs, and manufacturers. Substitution should never occur solely because another product costs less, and a clinically stable patient should not be forced to repeat a failed-product history merely to remain on an established regimen.

CMS should also require timely delivery, emergency replacement procedures, transparent complaint reporting, and early monitoring that can detect problems before they become national patterns. That oversight should include patients, urologists, WOC nurses, and other clinicians who see the consequences of product failure firsthand.

AACU and the WOCN Society share the same bottom line: Preventing fraud and protecting the Medicare Trust Funds should not require patients to surrender access to the product that allows them to manage safely. For urological and ostomy supplies, the right product is not a brand preference. It is part of the treatment.