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September 2024
In this issue we feature:
Elevate Urology Practice: LUGPA's Online Advocacy Resources
As the premier advocate for independent urology group practices across the United States, LUGPA stands at the forefront of shaping legislative and regulatory landscapes to enhance integrated urologic care. Through robust grassroots efforts and informed analysis, LUGPA members drive impactful change by engaging public officials and policymakers on critical issues affecting urology practices nationwide.
Recent Advocacy Highlights
Throughout 2024, LUGPA has been actively advocating for policies supporting sustainable physician reimbursement, flexible reimbursement models, patient access to care, telehealth integration, and provider wellness. Recent updates include:
Explore these updates and more to stay informed about the latest developments shaping urology practice policy.
Tools and Resources:
Discover the tools essential for advocating change within your practice and community:
For more information on how to get involved or to access our latest advocacy updates, visit LUGPA's Health Policy and Advocacy webpage. Your participation makes a difference in the future of urology practice.
LUGPA Submits Comments to CMS on the CY 2025 OPPS and ASC Payment System Proposed Rule
On August 26, 2024, LUGPA submitted comments to CMS regarding the CY 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. In the comments, LUGPA expressed support for several key provisions to enhance urological care and ensure equitable access to innovative technologies.
Key Points from LUGPA's Comments:
- Reassignment of CPT Code 0655T: LUGPA supports reassigning this code to APC 5375, aligning with similar procedures, and recommending CMS monitor future impacts to ensure payment stability.
- Support for PFS-Equivalent Rate: LUGPA endorses continuing the PFS-equivalent payment rate for outpatient visits in non-excepted off-campus PBDs, as it aligns with CMS's site-neutrality goals.
- Invoice Pricing for OPPS-Payable Drugs: LUGPA advocates for the adoption of invoice pricing for drugs lacking pricing information, as it will improve patient access to novel therapies.
- ASC Reporting Burdens: LUGPA supports reducing reporting burdens on ASCs by applying only the most relevant measures and excluding Medicare Advantage data when determining case volume thresholds.
- ASC Payment Increases: LUGPA endorses the continued use of the hospital market basket methodology to increase ASC payment rates, ensuring alignment with hospital outpatient departments.
- Access to Technological Advancements: LUGPA emphasizes the importance of ensuring equitable access to the latest urological technologies, urging CMS to adopt policies that support the integration of innovative tools and treatments.
Our comments reflect LUGPA's ongoing commitment to improving patient outcomes and advocating for policies that support the sustainability and advancement of urological care in independent practice settings.
You can find the complete comment letter here.
LUGPA Leads New Community Practice Coalition
Effort on MPFS
In August, as part of our latest advocacy efforts on the Medicare Physician Fee Schedule (MPFS), LUGPA, as part of the Community Practice Coalition, voiced significant concerns over the proposed CY 2025 Physician Fee Schedule by CMS, which includes a troubling 2.8% cut to the Medicare Physician Fee Schedule. These cuts, coming on the heels of years of financial strain, threaten the viability of community-based and independent healthcare providers. The coalition highlights the ongoing disparity in payments between hospitals and independent practices, where Medicare reimburses hospitals significantly more for the same procedures and services. This discrepancy not only jeopardizes the financial sustainability of these practices but also imposes higher costs on patients, who often face greater out-of-pocket expenses for care delivered in community settings.
The coalition's letter to Congress underscores the urgent need for comprehensive reform to address these inequities. Key recommendations include eliminating the proposed Medicare cuts, aligning payment updates with actual care costs, and promoting community-focused payment models that support the unique needs of independent practices. Additionally, the letter calls for reforms to MIPS and quality metrics, emphasizing the need for clinically meaningful measures and equitable reward systems. By achieving site-neutral payments and supporting administrative reforms, the coalition believes that Congress can help ensure the financial stability of community-based practices, ultimately safeguarding patient access to high-quality, affordable care across the nation.
You can view the coalition letter here.
Coalition Letter to Congressional Leadership on PBM Reform and the Safe Step Act
In August, a coalition of patient and provider organizations, including LUPGA, sent a letter to congressional leaders urging the inclusion of the Safe Step Act in forthcoming pharmacy benefit manager (PBM) reform legislation. The letter was addressed to Senate Majority Leader Chuck Schumer, House Speaker Mike Johnson, Senate Minority Leader Mitch McConnell, and House Minority Leader Hakeem Jeffries.
The letter emphasizes the critical role of the Safe Step Act in ensuring that employer health plans, including those managed by PBMs, implement a step therapy exceptions process that is both expedient and medically appropriate. Step therapy is a practice where patients must try insurer-preferred medications before accessing treatments prescribed by their doctors. This process can lead to delays in care and, in some cases, severe or irreversible health outcomes.
The coalition highlights that the Safe Step Act has already gained significant support, with endorsements from over 215 patient and provider organizations and has served as a model for legislation passed in 38 states. However, the letter points out that self-insured employer health plans, which cover a large portion of Americans, are exempt from state laws governing step therapy, making federal action crucial.
The coalition urges Congress to include the Safe Step Act in the final PBM reform package, stressing that its passage is vital to improving patient access to care and reducing unnecessary healthcare costs. The letter concludes by expressing appreciation for the leaders’ efforts to reform the prescription drug market and reiterating the importance of the Safe Step Act in these broader reforms.
2024 LUGPA Fly-In Recap and Call to Action for 2025
In 2024, LUGPA hosted two impactful fly-ins in Washington, DC, where our members came together to advocate for crucial healthcare reforms. These events were significant in advancing our legislative and regulatory agenda and strengthening relationships with key lawmakers.
March Fly-In Highlights
In March, our members focused on three primary issues:
- Physician Reimbursement & MACRA Reform: Advocated for sustainable Medicare reimbursement and reduced MACRA burdens to protect independent practices.
- Seniors Access to Critical Medications Act: Pushed for HR 5526/S. 3458 to allow physician practices to deliver Part D drugs to patients' homes.
- Protecting Patient Access to Cancer Therapies: Supported legislation to maintain physician reimbursement for Part B drugs.
Despite the challenges posed by the ongoing negotiations in Congress over a critical $1.2 trillion spending package, our members participated in twenty-one impactful meetings, expressing gratitude for the congressional support we've received while pushing for further reforms.
July Fly-In Highlights
In July, amidst heightened political tensions and logistical challenges due to security concerns in DC, our members remained committed to advancing our advocacy agenda.
July Fly-in highlights:
- Continued advocacy for HR 5526/S. 3458 and pushed for 340B Program Reforms and Site Neutrality to ensure fair Medicare reimbursement and transparency.
- Supported protecting physician payments for Part B drugs.
Looking Ahead: 2025 Fly-Ins
The progress we've made in 2024 underscores the importance of LUGPA's advocacy efforts. However, there is still much work to be done. We urge all LUGPA members to plan to attend our fly-ins in 2025. Your presence is crucial in advocating for healthcare reforms that directly impact independent medical practices and the patients we serve.
Your participation strengthens our collective voice and ensures that independent practices' perspectives are represented in policy discussions. We encourage members of our advocacy donor groups to join us, as your support and insights are invaluable.
Stay tuned for more information—we will send out requests for participation early in 2025. If you are interested in attending or would like more details, please contact Matthew Glans at [email protected].
CMS Announces Negotiated Drug Prices
under the Inflation Reduction Act
On August 15th, CMS revealed the negotiated prices for ten high-cost drugs selected for price negotiations under the Inflation Reduction Act (IRA). These drugs, which are among the most expensive and widely prescribed in the Medicare program, treat conditions such as heart disease, diabetes, and cancer. The selection of these drugs for negotiation, initiated in 2023, is a key component of the IRA, which was signed into law in August 2022. The law aims to expand Medicare benefits, reduce drug costs, and improve the program's sustainability.
Previously, these drugs represented a significant portion of Medicare Part D spending, leading to high out-of-pocket costs for patients. The new negotiated prices are intended to significantly reduce costs for Medicare beneficiaries, with savings projected at $6 billion in the first year alone. For example, the price of dapagliflozin (Farxiga), used to treat type 2 diabetes, heart failure, and chronic kidney disease, will drop by 68%, from $556 to $179. Other drugs will see price reductions ranging from 38% to 79%. The new prices will take effect on January 1, 2026.
The drugs included in this first round of negotiations and their new prices are as follows:
- Sitagliptin (Januvia): For type 2 diabetes; original price $527, negotiated price $113 (79% decrease)
- Insulin Aspart Injection (NovoLog, among others): For diabetes mellitus; original price $495, negotiated price $119 (76% decrease)
- Dapagliflozin (Farxiga): For type 2 diabetes, heart failure, and chronic kidney disease; original price $556, negotiated price $179 (68% decrease)
- Etanercept (Enbrel): For rheumatoid arthritis; original price $7,106 [$1,777 per weekly dose], negotiated price $2,355 (67% decrease)
- Empagliflozin (Jardiance): For type 2 diabetes and heart failure; original price $573, negotiated price $197 (66% decrease)
- Ustekinumab (Stelara): For Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis; original price $13,836, negotiated price $4,695 (66% decrease)
- Rivaroxaban (Xarelto): To prevent blood clots and reduce risks for patients with coronary or peripheral artery disease; original price $517, negotiated price $197 (62% decrease)
- Apixaban (Eliquis): To prevent stroke and blood clots; original price $521, negotiated price $231 (56% decrease)
- Sacubitril/Valsartan (Entresto): For chronic heart failure; original price $628, negotiated price $295 (53% decrease)
- Ibrutinib (Imbruvica): For chronic lymphocytic leukemia/small lymphocytic lymphoma and other blood cancers; original price $14,934, negotiated price $9,319 (38% decrease)
CMS intends to select up to 15 additional drugs for negotiation each year starting in 2027, with further expansions planned in the following years. This approach is designed to address the affordability and accessibility of essential medications within Medicare, a critical issue for both patients and healthcare providers.
The CMS announcement marks a significant milestone in the ongoing efforts to manage drug costs within Medicare. LUGPA will continue to monitor these changes closely and assess their impact on urology practices and patient care. For more detailed information, a fact sheet on the ten drugs and their negotiated prices is available here.
Congress Considers New Legislation to Address Healthcare Workforce Shortages
The United States is grappling with a critical shortage of physicians, especially in specialized fields like urology. Over 60 percent of U.S. counties are without a practicing urologist, underscoring the urgent need to address workforce shortages in specialty care.
The shortage in urology is exacerbated by financial pressures on residents, with over half carrying student loan debts exceeding $150,000. Additionally, the aging physician population raises concerns about the long-term sustainability of urology practices and their capacity to meet future patient demands.
The shortage extends beyond physicians to key allied health professionals. The Health Resources and Services Administration (HRSA) predicts shortages in roles such as respiratory therapists, physical therapists, and pharmacists through 2036. These shortages could worsen healthcare disparities, particularly in rural and underserved areas.
Health Workforce Innovation Act: This proposed legislation addresses workforce shortages through a Health Care Workforce Innovation Program. It would provide funding for community health centers and rural clinics to implement innovative training models for allied health professionals, focusing on underserved communities. The latest version of this bill was introduced in August and represents a significant step toward creating scalable solutions for these critical shortages.
Cybersecurity Legislation Moves Forward
in the Senate
In late July, key cybersecurity legislation moved forward in the Senate, with bipartisan support driving three critical bills to the next stage of consideration. The Senate Homeland Security and Governmental Affairs Committee approved the legislation to streamline federal cybersecurity regulations, enhance healthcare sector protections, and bolster the federal cybersecurity workforce.
Streamlining Federal Cybersecurity Regulations Act: Co-sponsored by Senators Gary Peters (D-MI) and James Lankford (R-OK), this bill aims to simplify and harmonize federal cybersecurity regulations for the private sector. A new committee will evaluate and streamline existing rules to reduce complexity and overlap.
Healthcare Cybersecurity Act: Introduced by Senators Jacky Rosen (D-NV), Todd Young (R-IN), and Angus King (I-ME), this legislation seeks to bolster cybersecurity in the healthcare sector by enhancing collaboration between CISA and the Department of Health and Human Services. It also establishes a CISA liaison for healthcare cybersecurity support.
Federal Cyber Workforce Training Act: Proposed by Senators Mike Rounds (R-SD) and Jon Ossoff (D-GA), this bill focuses on developing a centralized training center for federal cybersecurity personnel. It aims to improve workforce skills through partnerships with academia and the private sector.
For additional resources on enhancing cybersecurity in healthcare, visit LUGPA’s dedicated page: Improving Cybersecurity for Healthcare Providers.
Federal Courts Challenge FTC’s Noncompete Ban
In August, Florida federal judge Timothy Corrigan issued a temporary injunction blocking the FTC’s noncompete ban for Properties of the Villages. This decision follows a similar ruling from a Texas federal court, both halting the rule before its effective date of September 4th. Judge Corrigan expressed concerns that the ban might have a significant economic impact and questioned whether the FTC had clear Congressional authorization for such a sweeping rule.
This ruling marks the third federal court review of the FTC’s ban. In contrast, a Pennsylvania judge recently denied a request to block the ban, finding it within the FTC’s statutory authority. The Texas challenge is still pending, with a decision expected by August 30th.
Since the FTC floated this proposal back in January 2023, LUGPA has staunchly opposed it for a multitude of reasons. Should these regulations come into force, we fear they could disproportionately benefit large hospital systems, potentially disrupting the competitive balance and impeding patient access to a diverse range of healthcare choices.
LUGPA has previously taken proactive steps to advocate for the interests of independent medical providers and their patients. In response to the original rule, we submitted detailed comments to the FTC, articulating our opposition to the proposed rules and highlighting the potential negative impact on healthcare delivery and patient access.
As we continue to monitor regulatory developments and advocate for policies that promote fairness and competition in healthcare, we urge all stakeholders to remain engaged and informed. LUGPA will work towards solutions that preserve the integrity of the healthcare marketplace and ensure that patients receive high-quality, accessible care from a diverse array of providers. LUGPA will respond to the new final rule and continue to work towards solutions that preserve the integrity of the healthcare marketplace and ensure that patients receive high-quality, accessible care from a diverse array of providers.
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