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October 2024
In this issue we feature:
LUGPA Advocacy Victory: House Passes Seniors' Access to Critical Medications Act of 2024
On September 23, the U.S. House of Representatives passed H.R. 5526, the Seniors’ Access to Critical Medications Act of 2024, by voice vote under Suspension of the Rules. Sponsored by Rep. Diana Harshbarger (R-TN), this bipartisan legislation enhances Medicare patients’ access to essential medications.
Key Highlights:
- Home Delivery: Allows physician practices to deliver Part D medications directly to patients’ homes.
- Mail-Order Option: Patients can receive medications via mail from their physician’s office.
- Caregiver Access: Authorizes caregivers to pick up medications for Medicare patients.
Critical amendments were negotiated to address concerns raised by Ranking Member Frank Pallone (D-NJ), including a 5-year waiver of the Stark Law for mailing medications, a requirement for annual in-person visits, and a CMS study on the legislation's impact on healthcare utilization and costs.
Next, the bill moves to the Senate, where bipartisan support is expected and potentially included in year-end legislative packages. LUGPA actively supported this legislation through direct engagement with Congress and legislative fly-ins to Washington, D.C.
We'll provide updates as the bill progresses through the Senate.
LUGPA Submits Comprehensive Feedback on CY 2025 MPFS and OPPS Proposed Rules, Advocating for Independent Urology Practices
LUGPA has provided extensive feedback on the Centers for Medicare & Medicaid Services’ (CMS) CY 2025 Medicare Physician Fee Schedule (MPFS) and the Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rules. In its comments, LUGPA opposed the proposed 2.8% reduction in Medicare physician payments, highlighting its detrimental impact on independent urology practices already grappling with rising costs, workforce shortages, and inflation. LUGPA strongly urged CMS to reconsider this cut and proposed several key changes:
- Mitigate the 2.8% payment cut to ensure the financial viability of independent practices.
- Improve the complexity add-on code G2211, which reimburses physicians for the extra time spent managing patients with complex health conditions.
- Reevaluate proposed cuts to chronic care management services, ensuring practices are adequately compensated for coordinating care for patients with multiple chronic illnesses.
LUGPA’s OPPS submission also emphasized the importance of site-neutral payment reform to ensure that independent practices receive equitable reimbursement for services compared to hospital-based systems. Additionally, LUGPA advocated for reducing the administrative burdens on Ambulatory Surgical Centers (ASCs) and urged CMS to reassign key urological procedure codes to better reflect the specialized nature of urology care.
These recommendations align with LUGPA’s ongoing commitment to preserving the financial sustainability of independent practices and ensuring patients have continued access to high-quality, specialized urologic care.
Visit our page on the two comments here.
DC Update: Senate Hearings Highlight Lowering Health Care Costs, the IRA, and Telehealth Modernization Act
The Senate Committee on Finance held a hearing on September 17 titled “Lowering Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act.” Discussions included the impacts of the Medicare Negotiation Program on drug formularies and patient access, as well as enhanced premium tax credits for ACA marketplace coverage. LUGPA's DC team provided updates on the key points that were discussed.
Expert testimonies highlighted immediate benefits for seniors under the IRA, such as out-of-pocket caps and Part D redesign, while addressing concerns about impacts on premiums and innovation. Chairman Wyden pledged to address pharmacy benefit managers in a potential lame-duck session.
On September 18, the Energy and Commerce Committee marked up 16 bills, including the Telehealth Modernization Act of 2024 (H.R. 7623). This bipartisan legislation aims to extend pandemic-era telehealth flexibilities through December 31, 2026, and includes provisions for rural health clinics, federally qualified health centers, and home settings as telehealth sites. The bill also enhances program integrity for Medicare equipment and includes reforms for pharmacy benefit managers.
LUGPA Continues to Push for the Safe Step Act
In September, LUGPA continued to join forces with a broad coalition of patient and provider organizations advocating for the inclusion of the Safe Step Act in upcoming Pharmacy Benefit Manager (PBM) reform legislation. Step therapy, or "fail-first" protocols, requires patients to try and fail on less expensive treatments before accessing the therapy originally prescribed by their physician. This process can cause dangerous delays in care, especially for patients managing chronic and complex diseases.
This month, LUGPA joined a coalition letter and social media campaign to support the Safe Step Act. This legislation would create a more efficient, transparent, and medically sound step therapy exception process, enabling patients to bypass step therapy when necessary. In our advocacy, LUGPA urged Congress to prioritize this patient-focused legislation to ensure timely access to appropriate treatments.
Medicare Physician Fee Schedule: LUGPA Opposes Further Cuts to Medicare Payments
LUGPA remains committed to opposing further cuts to Medicare physician payments, which could place unsustainable financial strain on independent practices—particularly in rural and underserved areas. The scheduled 2.8% reduction for 2025 poses a serious threat to patient access to care, as many practices would be forced to reduce services or close their doors.
LUGPA has joined a bipartisan coalition calling on Congress to pass legislation that provides stable, inflation-adjusted payment updates. This would ensure that Medicare patients continue to receive the care they need from their trusted physicians.
LUGPA Monitors New FDA Rules on Laboratory-Developed Tests (LDTs)
In April 2024, the FDA finalized its long-awaited regulation on Laboratory-Developed Tests (LDTs), bringing all LDTs under the same regulatory framework as other medical devices. The rule, which will be fully enforced by 2028, represents a significant shift in the oversight of diagnostic testing.
LUGPA is closely monitoring these developments to ensure that patient safety remains a priority while advocating for regulatory policies that do not overly burden independent practices or stifle innovation in diagnostic testing. We will continue to engage with policymakers to ensure that LDT regulations balance patient safety with the need for rapid advancements in diagnostic technologies.
For additional information, please visit the FDA’s website on LDTs here.
Cybersecurity in Healthcare – A Call to Action
The healthcare sector faces a growing threat from cybercriminals, with data breaches affecting more than 133 million individuals in 2023—a figure that more than doubled from the previous year. A significant breach in 2023 impacted over 900,000 Medicare beneficiaries, exposing personal data and revealing vulnerabilities in healthcare’s digital infrastructure. The financial toll of such breaches is staggering; for instance, a single incident in 2023 is estimated to have cost over $15 billion.
Another major concern is the rise of ransomware attacks. In 2023, 46 healthcare systems were targeted, up from 25 in the previous year. These breaches come with a hefty price tag, costing healthcare organizations an average of $10.93 million per incident.
To combat these rising threats, healthcare providers must act now by adopting robust cybersecurity measures, including:
- Multi-factor authentication to secure access to sensitive data.
- Encryption of data in transit and at rest.
- Firewalls to filter and monitor network traffic.
- Regular data backups stored in secure locations.
- Comprehensive staff training on cybersecurity protocols.
With a 256% increase in healthcare data breaches over the past five years, the time for action is now.
Visit LUGPA’s Improving Cybersecurity for Healthcare Providers page for more information.
Clinical Trial Modernization Act: Expanding Access to Innovative Therapies
In September. LUGPA joined a new coalition effort to LUGPA support H.R. 8412, the Clinical Trial Modernization Act, which seeks to eliminate the barriers preventing patients from participating in clinical trials, especially those from underserved or minority populations. Clinical trials are essential for developing new treatments, but many patients cannot participate due to financial, geographic, or logistical challenges.
This legislation aims to address those obstacles by providing grants for outreach, recruitment, and support for patients in underserved areas. This will allow more diverse patient populations to access cutting-edge therapies. By removing these barriers, the bill promotes healthcare equity and accelerates the development of innovative treatments. LUGPA is working with other healthcare groups to promote this effort.
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