August 29, 2025

Centers for Medicare & Medicaid Services

Attention: CMS-1828-P

Submitted electronically via Regulations.gov

Re: Opposition to Proposed Updates to the DMEPOS Competitive Bidding Program (CY 2026 HH PPS Proposed Rule)

To Whom It May Concern:

I write on behalf of ONeal Medical – CPAP Plus, a locally owned DME supplier serving patients across central Alabama. As a winning contractor in the 2012 and 2016 rounds of Competitive Bidding, our company has firsthand experience with both the promises and the failures of the program. Based on this experience, we strongly oppose moving forward with the proposed 2026 iteration of the DMEPOS Competitive Bidding Program (CBP) without significant reforms.

1) Patient access and continuity of care were harmed in past rounds. In Birmingham, Alabama, we saw many awarded companies that were not physically located in the Metropolitan Statistical Area (MSA). These entities subcontracted or simply never built a presence to actually serve beneficiaries. Patients were left without proper local access to fittings, education, or timely service. Meanwhile, legitimate community-based providers like ours had to backfill care gaps while competing under reimbursement rates set artificially low. These dynamics worsened adherence, delayed discharges, and increased avoidable hospital utilization.

2) The proposal is not meaningfully reviewable as drafted. CMS has stated that neither the product categories nor the competition timeframe will be announced until later. Without this information, stakeholders cannot responsibly evaluate clinical impacts, capacity, or market readiness. CMS should publish categories, geographies, and timelines and re-open the comment window before moving forward.

3) Past program design undermined market integrity. In 2012 and 2016, subcontracting schemes and the lack of local presence by many bidders distorted true competition. CMS’s use of a median pricing methodology artificially lowered the pivotal bid, producing Single Payment Amounts (SPAs) that were far below actual market costs. These SPAs have acted as an artificial ceiling in all subsequent reimbursement determinations, regardless of economic reality. This is not sustainable for providers, and it compromises patient access to necessary care.

4) Tariffs and persistent supply chain pressures make long-term bidding unworkable. Under the current Presidential administration, tariffs on aluminum, steel, plastics, and computer microchips have increased volatility in DME costs. On top of this, CPAP manufacturers continue to hold device prices at inflated post-COVID and post-microchip shortage levels, with no return to pre-2020 pricing. No small supplier can responsibly predict costs under a three-year contract term in this environment. Competitive bidding in this macro-economic climate risks underbidding, supplier withdrawal, or worse—supplier collapse—leaving patients stranded.

5) New accreditation and survey burdens disproportionately impact small businesses. Annual reaccreditation and expanded survey requirements impose fixed costs that disproportionately hurt independent providers. When combined with artificially depressed SPA rates, these compliance costs will accelerate small business closures, reduce beneficiary choice, and consolidate the market further into the hands of large, absentee suppliers.

6) Lessons from past rounds must be applied. GAO, OIG, and CMS evaluations have already documented significant concerns: market concentration, single-supplier territories, utilization declines, and disruptions in respiratory care. OIG’s work even found that device access differed significantly from supply access, underscoring that CBP’s broad-brush design overlooks important clinical differences. Ignoring these warnings invites repeating past mistakes—this time under even more unstable economic conditions.

7) COVID highlighted the need for a viable DME supplier network. The experience of the COVID-19 pandemic demonstrated that Medicare beneficiaries and the broader U.S. healthcare system depend on a stable, well-supported network of DME suppliers who can not only bid responsibly, but also possess the physical infrastructure and financial strength to deliver care in times of crisis. A policy framework that emphasizes price above all else does not deliver true “value.” True value comes from ensuring that beneficiaries have uninterrupted access to quality equipment, timely service, and the ongoing clinical support necessary to keep them out of hospitals. Competitive bidding based solely on pricing risks dismantling that network when patients and providers need it most.

Requested revisions and safeguards:

• Publish categories and timelines up front and conduct formal access-impact analyses before bidding begins.

• Exclude high-touch respiratory devices and complex consumable supplies from remote-delivery CBAs; require local service options.

• Restore quality and service metrics (not price alone) to award methodology, with enforceable network adequacy and patient satisfaction standards.

• Prohibit awards to companies without a physical presence in the bidding MSA and limit subcontracting that disconnects patients from accountable suppliers.

• Establish small-supplier set-asides/lot caps to prevent monopolization and protect community providers.

• Base bid limits on transparent cost data (labor, shipping, compliance, tariffs, and persistently elevated device prices) and allow mid-cycle adjustments for inflation and supply shocks.

• Implement real-time patient access monitoring (delivery intervals, discharge delays, adherence rates) with public reporting and CMS corrective actions.

ONeal Medical – CPAP Plus supports fiscal stewardship, but not at the expense of patient outcomes or the survival of community-based suppliers. CMS must pause and redesign CBP to protect patients, restore fairness, and ensure that reimbursement reflects real-world economic conditions rather than artificial bid mechanics.