May 2025

     In this issue we feature:  

• April DC Fly-In Recap
• House Committee Advances H.R. 2484 to Expand Access to Physician-Dispensed Medications
• Drug Pricing Executive Order: Positive First Steps
• Legal Win for Laboratory-Developed Tests (LDTs)
• The MA–MPFS Divide: Widening Inequity in Reimbursement
• LUGPA Joins Coalition to Support ASC Coinsurance Reform
• Senator Cassidy’s 340B Reform Report: LUGPA’s Perspective

April DC Fly-In Recap

LUGPA’s Spring Fly-In took place as Congress grappled with economic pressures and budget debates that could significantly reshape healthcare policy. Despite a volatile landscape, LUGPA members made a strong case for the vital role of independent urology. Meetings with key lawmakers emphasized three top priorities: reforming Medicare reimbursement, restoring in-office dispensing, and protecting access to Part B drugs. By leveraging compelling data, patient stories, and coalition support, we underscored how independent practices deliver cost-effective, high-quality care—and why their survival is essential.

Medicare Reform & MACRA Overhaul – H.R. 879

Medicare’s flawed payment system continues to jeopardize independent practices. The 2025 conversion factor cut of 2.83% (from $33.2875 to $32.3465), effective January 1, exacerbates a 33% real-dollar reimbursement decline since 2001. Urologic oncology faces an even steeper 41% reduction from 2002–2024, threatening practice viability and patient access to specialized care.

LUGPA is advocating for H.R. 879, the Medicare Patient Access and Practice Stabilization Act, which would:

• Halt the 2025 conversion factor cut
• Add a permanent 2% inflationary update
• Establish a long-term path toward payment stability

Budget neutrality rules continue to penalize specialties like urology, where care is complex and longitudinal, by shifting reimbursement from procedures to office visits. LUGPA is also pushing for comprehensive MACRA reform to replace MIPS with a quality framework that rewards outcomes, not paperwork.

Why It Matters: Without reform, practice closures will accelerate, reducing patient access, especially in rural and underserved areas. Hospital consolidation will raise costs and limit innovation. H.R. 879 is a first step toward restoring fairness and ensuring urologists can continue to deliver specialized, life-saving care in their communities.

Restoring In-Office Dispensing – H.R. 2484

H.R. 2484, the Seniors’ Access to Critical Medications Act, would restore physicians’ ability to mail Part D medications—an option widely used during the pandemic. This bill clarifies that in-office dispensing (IOD) is allowed under the In-Office Ancillary Services Exception, providing critical access for seniors, especially in rural areas.

The Seniors’ Access to Critical Medications Act, would:

• Clarify that in-office dispensing is allowed under the in-office ancillary services exception.
• Restore the ability to mail medications to patients—especially important for seniors and those in remote areas.
• Protect access and choice while disrupting PBM control over drug distribution.

Why IOD Matters:

• Improved adherence: Physicians can monitor patient compliance and adjust therapy.
• Lower costs: Practices help patients access financial assistance and reduce out-of-pocket costs.
• Better outcomes: IOD improves survival in advanced urologic cancers through coordinated, timely care.

LUGPA has documented PBM failures—including delays, misdeliveries, and medications sent to deceased patients. We’re building bipartisan support for H.R. 2484 by showing how IOD enhances care, strengthens the physician-patient relationship, and protects patients from PBM-driven errors and inefficiencies.

Bottom Line: This bill would restore autonomy to independent practices and protect patients from profit-first PBM policies that compromise care. It’s a win for both quality and access.

Preserving Access to Part B Drugs

The Protecting Patient Access to Cancer and Complex Therapies Act addresses a dangerous flaw in the Inflation Reduction Act (IRA)—which reduces reimbursement for negotiated Part B drugs, potentially pushing practices to stop offering them.

Key Reforms in the Bill:

• Maintain ASP + 6% payment structure to cover acquisition and delivery.
• Ensure manufacturers, not providers, bear the cost of Medicare savings.
• Preserve access to advanced therapies in community settings, not just hospitals.

The IRA’s current model could make it financially impossible for practices to provide Part B drugs, such as advanced cancer treatments, risking delays in care and worse outcomes.

LUGPA is fighting to protect these therapies in the community—where care is more affordable, accessible, and trusted by patients.

What’s at Stake: If access to Part B therapies disappears from independent urology, patients will be forced into costlier and more fragmented hospital systems—driving up costs for Medicare and worsening disparities in care.

House Committee Advances H.R. 2484 to Expand Access to Physician-Dispensed Medications 

On April 29, the House Energy and Commerce Committee advanced H.R. 2484, the Seniors’ Access to Critical Medications Act, with strong bipartisan support in a 38–7 vote. The bill would codify COVID-era flexibilities by allowing Medicare beneficiaries to receive physician-dispensed Part D medications via mail or caregiver pickup under a five-year Stark Law exception. This approach is especially important for patients undergoing cancer treatment or managing complex chronic conditions who benefit from timely, coordinated access to therapies.

The legislation includes guardrails such as a requirement for annual in-person visits and directs the Government Accountability Office (GAO) to study prescribing and utilization trends to ensure appropriate oversight.

LUGPA strongly supports H.R. 2484 and submitted a letter to lawmakers highlighting the bill’s role in preserving patient access, improving care coordination, and ensuring timely treatment. The letter also addressed misinformation from opponents, particularly Pharmacy Benefit Managers (PBMs), who dominate 80% of the market and oppose reforms threatening their profit-driven mail-order systems. Unlike PBMs, physician dispensing enhances adherence, reduces delays, and supports personalized, in-office care that is particularly critical for oncology and rural patients.

LUGPA will continue working with Congress to advocate for the bill’s passage in the full House and Senate.

Drug Pricing Executive Order: Positive First Steps 

On April 15, President Trump issued an Executive Order on Drug Pricing aimed at lowering costs, improving transparency, and holding PBMs accountable. While the order reflects several LUGPA priorities, its success will depend heavily on how the reforms are implemented.

Positive Provisions Aligned with LUGPA’s Goals:

• Promoting site-neutral payments, a key reform to curb hospital consolidation and inflated costs.
• Increasing PBM transparency, including disclosure of rebate practices and drug pricing structures.
• Preserving the 340B program, which helps support access to medications for vulnerable populations.
• Encouraging payment model innovation that rewards value-based care instead of volume.

LUGPA is actively working with lawmakers to ensure that drug pricing reforms truly benefit patients and providers—not just large systems or middlemen. We will remain engaged as implementation rules are developed.

Legal Win for Laboratory-Developed Tests (LDTs)

In March, a federal court delivered a major win for providers and patients by striking down the FDA’s attempt to regulate Laboratory-Developed Tests (LDTs) as medical devices. The court ruled that oversight of these tests properly resides with CMS under the Clinical Laboratory Improvement Amendments (CLIA)—not the FDA.

Why This Matters to Urologists:

• Protects access to specialized testing used for genitourinary cancers and genetic screening.
• Avoids costly regulatory duplication, which would have forced independent labs to comply with both CLIA and FDA standards.
• Preserves innovation in precision medicine, especially for emerging cancer diagnostics that rely on flexibility and scientific advancement.

LUGPA supports a balanced regulatory approach that ensures quality while protecting access and innovation. We will remain vigilant, as the FDA may appeal the ruling or seek a legislative workaround.

The MA–MPFS Divide: Widening Inequity in Reimbursement 

The gap between Medicare Advantage (MA) and traditional Medicare Fee-for-Service (FFS) continues to grow—and it’s hurting independent physician practices. CMS’s recent announcement of a 5.06% rate increase for MA in 2026 comes just as the MPFS faces a 2.83% cut, widening a dangerous divide.

Impacts on Independent Urology:

• Threat to practice viability: Repeated MPFS cuts, coupled with inflation and workforce challenges, are making it increasingly difficult for independent practices to survive.
• Accelerated consolidation: Lower reimbursements push more providers into hospital systems, reducing patient choice and raising costs.
• Worsening access and burnout: Shrinking margins force reductions in services, hours, and staff—especially in rural or underserved areas where urology access is already limited.

LUGPA’s Policy Advocacy:

• Stabilize Medicare payments through permanent reform, including passage of H.R. 879.
• Advance site-neutral payment reform to reduce hospital price disparities and reward efficient care.
• End budget neutrality, which penalizes specialties like urology every time new services are added.
• Align MA and FFS reimbursement growth, to avoid creating a two-tiered system where patients in traditional Medicare are left behind.

Bottom Line: The current system is financially unsustainable and strategically short-sighted. LUGPA is leading the charge for fair, transparent, and sustainable Medicare payment reform that protects the future of independent urology and the patients who depend on it.

LUGPA Joins Coalition to Support ASC Coinsurance Reform 

LUGPA has joined a new national coalition advocating for the Medicare Beneficiary Co-Pay Fairness Act, legislation that would cap coinsurance for Ambulatory Surgical Center (ASC) services at the same level as Hospital Outpatient Departments (HOPDs). Under current policy, patients can pay more out of pocket at an ASC than at a hospital, even though ASCs often provide the same services at a lower overall cost to Medicare.

This bipartisan bill would eliminate that disparity, reduce financial barriers for patients, and promote access to cost-effective surgical care. LUGPA supports this targeted, commonsense reform as part of our broader push for site-neutral and patient-centered Medicare policy.

Senator Cassidy’s 340B Reform Report: LUGPA’s Perspective  

On April 24, 2025, Senator Bill Cassidy (R-LA), chair of the Senate HELP Committee, released a report on the 340B Drug Pricing Program, exposing transparency and oversight gaps that hinder patient benefits. The report, based on a multi-year investigation, found that hospitals and FQHCs generate significant 340B revenue but often fail to pass discounts directly to patients, while contract pharmacies and TPAs impose rising fees that divert resources. Drug manufacturers also face challenges ensuring program integrity.

Key Findings:

• Hospitals like Bon Secours Mercy Health and Cleveland Clinic use 340B revenue for vague “community benefits” without clear patient savings.
• FQHCs rely on a few drug classes for revenue, with inconsistent discount practices.
• Contract pharmacies charge complex fees, reducing funds for patient care.
• Manufacturers report rising 340B sales but struggle to prevent misuse.

Proposed Reforms:

• Mandate detailed reporting on 340B revenue use.
• Investigate contract pharmacy and TPA fees.
• Enhance transparency for all 340B participants.
• Clarify patient eligibility to ensure discounts reach intended recipients.

LUGPA’s Stance: LUGPA supports Cassidy’s call for transparency and accountability in the 340B Program, aligning with our advocacy for patient-centered reforms. Ensuring discounts directly benefit vulnerable patients is critical to preserving access to urologic care. We will engage lawmakers to shape reforms that protect independent practices and prioritize affordable, high-quality care for underserved communities.

Read the full report here.