October 2025

     In this issue we feature:

• Executive Summary 
• Government Shutdown: Impacts on Urology Practices and Patients
• LUGPA Submits Comments on CMS’s Proposed 2026 MPFS and OPPS Rules
• LUGPA Opposes CMS Proposal to Add Urological Supplies to Competitive Bidding 
• Revocation of Executive Order 14036 on Competition 
• Executive Order on Pharmaceutical Supply Chain Resilience 
• Policy Update: $50 Billion Rural Health Fund
• Executive Order on Reciprocal Tariffs: Cost Pressures for Practices
• Policy Update: Insurer Downcoding Threatens Independent Urology

Executive Summary

LUGPA continues to advocate for policies that protect the viability of independent practices and ensure patients have access to high-quality urologic care. The most pressing issues this month include:

• Government Funding Uncertainty
  The federal government shutdown beginning September 30, 2025, has immediate impacts on urology practices and patients, particularly through the expiration of Medicare telehealth flexibilities. Without congressional action, Medicare coverage will revert to pre-pandemic rules, resulting in the termination of coverage for most in-home and non-rural telehealth services, as well as audio-only visits, for certain types of providers. CMS has also placed a temporary two-week hold on claims processing due to the shutdown. 
  
  This is standard practice for a government shutdown, as it would allow CMS to pay out claims (including those for telehealth) if Congress backdates Medicare payment authorities and rates to October 1 without having to reprocess already paid claims, which is a very time-consuming and intensive process. As such, CMS is saying that it will still receive but hold on processing non-telehealth all claims for the next two weeks.
  
  For telehealth-related claims, CMS recommends that providers not submit them right now, as there is a possibility that Congress will resolve the shutdown in the next two weeks and backdate telehealth authorities to October 1. If the shutdown extends beyond two weeks, CMS will likely issue new guidance. LUGPA is monitoring developments closely and urges members to review telehealth compliance, prepare contingency plans, and stay tuned for updates.
  
  
• 2026 MPFS and OPPS Proposed Rules
  In September, LUGPA submitted formal comments to CMS on the 2026 Medicare Physician Fee Schedule (MPFS) and Outpatient Prospective Payment System (OPPS) proposed rules. Our comments emphasized the need for sustainable reimbursement, site-neutral payment reforms, and protections for independent practices. LUGPA will continue pressing CMS to adopt policies that safeguard patient access and practice stability.
  
  
• CMS DMEPOS Proposal
  LUGPA strongly opposes CMS’s plan to include urological supplies in the 2026 DMEPOS Competitive Bidding Program. This proposal risks compromising patient safety by restricting access to customized supplies, which could potentially lead to infections, hospitalizations, and increased Medicare costs. It would also disrupt practice operations and exceed CMS’s legal authority. LUGPA is urging CMS to withdraw this harmful policy.
  
  
• Insurer Downcoding
  Cigna and Aetna are downcoding high-level E/M services without conducting a medical record review, which results in reduced reimbursements and creates new administrative burdens. These actions threaten independent practices and accelerate consolidation, leading to higher costs and longer wait times for patients. LUGPA is pressing for a reversal and urges members to monitor claims and file appeals promptly.
  
  
• Revocation of EO 14036
  President Trump’s decision to rescind Executive Order 14036 may ease healthcare mergers, raising costs by an estimated 14.1% and reducing patient choice. LUGPA is advocating for more vigorous antitrust enforcement and site-neutral payment reforms to counter hospital and payer consolidation.
  
  
• New Reciprocal Tariffs
  The Administration’s Executive Order on reciprocal tariffs could increase medical device costs by 10–25%, straining practices as reimbursement fails to keep pace with these costs. LUGPA is advocating for broad exemptions to ensure continued access to critical urologic drugs and devices.

Government Shutdown: Impacts on Urology Practices and Patients

At midnight on September 30, 2025, the federal government entered a shutdown after Congress failed to pass a continuing resolution (CR) to extend funding for fiscal year 2025. While negotiations continue, the shutdown has immediate implications for independent urology practices, particularly through Medicare operations and the expiration of telehealth flexibilities.

Medicare Operations

• Claims Processing: CMS directed Medicare Administrative Contractors to implement a temporary 10-day claims hold. Providers can continue submitting claims, but payments will be delayed until the hold is lifted.
• Staffing Reductions: With CMS operating at reduced capacity, policymaking and rulemaking activities are paused. This could delay finalization of key regulations, including the 2026 Physician Fee Schedule.

Telehealth Flexibilities Expire
The shutdown coincides with the expiration of Medicare telehealth flexibilities first enacted during the COVID-19 Public Health Emergency. Unless Congress acts, coverage reverts to pre-pandemic rules for non-behavioral health services. This means:

• Telehealth delivered in a patient’s home or outside rural areas will no longer be covered.
• Audio-only services will not be reimbursed for most care.
• Certain practitioners lose billing authority for telehealth.
• FQHCs and RHCs cannot serve as distant-site providers.
• The Hospital-at-Home waiver program ends.

For urology practices, these lapses affect follow-up visits, chronic disease management, and post-procedure monitoring. Patients in rural or underserved areas, as well as those with mobility challenges, face increased barriers to care.

Practice Considerations

• Consider issuing Advance Beneficiary Notices (ABNs) for services that may not be covered.
• Practices may choose to hold telehealth claims until additional CMS guidance is released.
• Clinicians in applicable ACOs retain telehealth flexibilities through CY 2025, regardless of shutdown status.

Additional Impacts
Short-term Medicare payment delays are expected; however, prolonged disruptions could impact cash flow. Some community health programs have limited funding buffers, and FDA device approvals are paused for new submissions.

Next Steps
LUGPA continues to monitor the shutdown and its effects on payment systems, telehealth coverage, and agency operations. Advocacy remains focused on securing permanent telehealth reforms and ensuring stability for independent practices.

LUGPA Submits Comments on CMS’s Proposed 2026 MPFS and OPPS Rules

In September, LUGPA submitted formal comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed 2026 Medicare Physician Fee Schedule (MPFS) and Outpatient Prospective Payment System (OPPS) rules. These annual rulemakings have a significant impact on physician reimbursement, regulatory requirements, and the delivery of care to Medicare patients.

Our comments emphasized four priorities:

• Protecting Independent Practices – Opposed policies that accelerate hospital consolidation.
• Ensuring Fair Reimbursement – Called for accurate payment rates that reflect the resources required for urologic services.
• Promoting Efficient Care Delivery – Supported reforms that expand access to advanced treatments in lower-cost, patient-preferred settings.
• Reducing Administrative Burdens – Urged CMS to scale back duplicative and unnecessary reporting requirements.

LUGPA also responded to CMS’s requests for information on deregulation, identifying outdated rules that increase costs and interfere with patient care. We will keep members updated as CMS finalizes the rules later this year.

LUGPA Opposes CMS Proposal to Add Urological Supplies to Competitive Bidding   

On August 29, 2025, LUGPA submitted comments opposing CMS’s proposed rule that would redefine “item” under the DMEPOS Competitive Bidding Program (CBP) to include urological supplies.

Key Concerns Raised:

1. Threat to Patient Access & Outcomes
• Urological supplies are not interchangeable and must be matched to patient needs.
• Restricted access could cause infections, hospitalizations, and higher Medicare spending.
2. CMS Legal Overreach
• Congress never authorized CMS to include prosthetic devices such as urological supplies in CBP.
• Expanding the definition of “item” exceeds statutory authority and undermines Congressional intent.

Why It Matters:

• Patient safety is at risk if patients cannot access the correct supplies.
• Practice operations would be disrupted, especially for groups that provide supplies directly to patients.
• Medicare costs may rise due to increased hospitalizations.
• Regulatory precedent could open the door for CMS to overreach into other physician-directed services.

LUGPA strongly urges CMS to withdraw this proposal and will continue to advocate for protecting patient access and practice viability.

Revocation of Executive Order 14036 on Competition   

On August 13, 2025, President Trump revoked EO 14036, which had promoted stronger federal scrutiny of healthcare mergers. While core antitrust laws remain intact, the revocation may ease smaller or regional healthcare mergers.

Why It Matters:

• Studies show hospital acquisitions raise service costs by an average of 14.1%.
• Consolidation reduces patient options and increases costs.
• Independent practices remain at risk from growing hospital and payer dominance.

LUGPA’s Recommendations:

• Strengthen antitrust enforcement.
• Advance site-neutral payment reforms.
• Ensure Congressional oversight of mergers.
• Continue to promote policies that protect independent medicine.

Executive Order on Pharmaceutical Supply Chain Resilience

In August, the White House issued an EO directing HHS to fill the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to strengthen the drug supply chain security.

Key Provisions:

• Identify ~26 critical drugs for immediate API stockpiling.
• Maintain a six-month reserve of essential medicines.
• Expand domestic API manufacturing.

Implications for Urology:

• Greater supply stability during shortages.
• Possible incentives for domestic production.
• Unclear short-term impact on drug prices.

LUGPA will monitor SAPIR implementation and its effect on access to urologic medications.

Policy Update: $50 Billion Rural Health Fund

CMS will soon release the Notice of Funding Opportunity for the Rural Health Fund, designed to expand access, sustain hospitals, and modernize care in rural America.

Opportunities for Independent Urology:

• Recruitment and retention support for clinicians.
• Investment in telehealth, AI, and cybersecurity upgrades.
• Strengthened partnerships with hospitals in underserved areas.

Applications are state-led, with awards structured as cooperative agreements under the oversight of CMS. LUGPA will provide guidance this fall to help members leverage these resources.

Executive Order on Reciprocal Tariffs: Cost Pressures for Practices 

On September 5, 2025, President Trump signed an EO on reciprocal tariffs, revising exemptions and creating a new framework for trade negotiations.

Implications for Urology:

• Removal of exemptions for resins, silicones, and aluminum hydroxide could raise medical device costs by 10–25%.
• Key urologic drugs may qualify for tariff relief, but only if trade agreements are reached.
• Independent practices face reimbursement pressure as supply costs rise without parallel payment increases.

LUGPA is advocating for broader medical exemptions to safeguard access to essential drugs and devices.

Policy Update: Insurer Downcoding Threatens Independent Urology 

Recent policies by Cigna and Aetna target higher-level E/M codes through automatic downcoding, thereby reducing payments without requiring a review of the medical record.

Why It Matters:

• For Practices: Adds administrative strain, reduces reimbursements, and increases consolidation pressures.
• For Patients: Risks include reduced access to specialty care, longer wait times, and higher costs.

LUGPA’s Advocacy:

• Urging Cigna to suspend its downcoding policy.
• Pressing Aetna to improve transparency and due process.
• Supporting targeted audits for true outliers—not blanket downcoding.

Members are encouraged to monitor claims for downcoding indicators and appeal promptly when necessary.