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May 2024
In this issue we feature:
LUGPA Advocates for 340B Reform
The 340B Program was established in 1992 to offer discounted medications to safety-net hospitals and clinics. While intended to enhance access to care for vulnerable populations, concerns have emerged regarding abuse by certain hospitals, which have not passed savings on to patients but have rather used funds derived from dispensing drugs at prices far above the 340B discounted price to unfairly compete with independent practices and in some cases buy up those practices.
The Trump Administration initiated a policy to cut Medicare reimbursement for 340B drugs to ASP – 22.5%, but that policy was later declared unconstitutional because CMS failed to undertake the required statutory survey of hospital acquisition costs. Legislative efforts have not gotten far in this area yet, but LUGPA has been active by submitting suggested policies to reform 340B to a Senate working group.
Numerous developments have influenced the discourse surrounding the 340B Program, including legal disputes, reimbursement strategies by CMS, and bipartisan reform proposals such as the SUSTAIN 340B Act. LUGPA has worked alongside other stakeholders in an ongoing effort to advocate for substantial reform of the 340B Program to protect its intended use as a safety net for vulnerable populations.
In late March, working with our allies in the Community Practice Coalition, LUGPA composed and circulated a letter to Senate healthcare leaders, urging their endorsement of crucial reforms to the 340B Program. Our recommendations encompass limiting 340B eligibility for hospital-acquired physician practices, tying Medicare payments to acquisition costs, and enforcing charity care minimums while refining patient criteria for targeted assistance.
LUGPA Works to Oppose Prior Authorization Demonstration for Certain Ambulatory Surgical Center (ASC) Services
In April, LUGPA, alongside several healthcare organizations, strongly opposed the Centers for Medicare & Medicaid Services (CMS)’s proposal to implement a prior authorization demonstration for specific ambulatory surgical center (ASC) services (CMS–10884) in the traditional fee-for-service Medicare program. Our joint objection arises from concerns regarding the potential negative consequences of such a demonstration, particularly the increased administrative burden it would place on healthcare providers and the associated costs to the Medicare program.
We highlighted the absence of compelling evidence indicating widespread fraud in ASCs, questioning the necessity of implementing such a demonstration without sufficient justification. Our position underscores the importance of ensuring that policy interventions are grounded in solid evidence and targeted toward addressing real issues within the healthcare system.
Furthermore, LUGPA advocates for greater clarity and specificity in the criteria used to determine which procedures necessitate prior authorization. We propose excluding procedures that fall below a certain volume threshold or have minimal financial impact on the Medicare program. This approach aims to balance preserving program integrity and reducing unnecessary administrative burdens on healthcare providers and their administrative infrastructure.
Our advocacy efforts reflect the broader objective of promoting policies that enhance efficiency, streamline administrative processes, and prioritize patient care within the healthcare system. Through engagement with CMS and other stakeholders, we aim to influence policy decisions that align with these goals and ultimately benefit healthcare providers and patients.
LUGPA Continues to Oppose Proposed FTC Rules Restricting Non-Competes in Healthcare
LUGPA strongly opposes the Federal Trade Commission's (FTC) recent regulatory proposals targeting non-compete agreements in healthcare. These rules, impacting nearly half of all physicians and various healthcare professionals, require careful scrutiny and advocacy on behalf of independent medical providers.
On April 23rd, the FTC voted on a final rule regarding non-compete agreements, passing by a 3-2 majority. The rule bans new non-compete agreements for all workers and requires companies to inform current and past employees that they won’t enforce them. Existing non-compete agreements for most workers will be invalidated, except for senior executives.
LUGPA opposes the FTC's proposed rules for several reasons: (1) enactment could heavily favor large hospital systems, threatening competitive balance and patient access to diverse healthcare options; and (2) as representatives of independent medical practices, LUGPA staunchly opposes measures eroding fair competition and patient choice.
The proposed rules lack specificity, encompassing a wide range of contractual agreements, extending well beyond traditional non-compete clauses, raising concerns about unintended consequences, and potentially stifling innovation and competition in healthcare.
Furthermore, the rules overlook the nuanced challenges independent medical providers face in protecting themselves as a resource to provide accessible, patient-centered care, particularly as specialty providers in rural and underserved communities.
Potential clashes with existing state laws, particularly in jurisdictions with corporate practice of medicine (CPOM) regulations, may introduce legal uncertainty and additional burdens for independent practices navigating an already complex regulatory landscape.
Legal challenges against the final rule are likely forthcoming. The U.S. Chamber of Commerce intends to sue to block the rule. The final rule won't become effective for at least 120 days, but litigation could delay implementation for months or even years. Uncertainty surrounds the rule's effective date, influenced by ongoing Supreme Court cases implicating Chevron deference.
LUGPA has actively advocated for independent medical providers and their patients, submitting detailed comments to the FTC opposing the rules and highlighting potential adverse effects on healthcare delivery and patient access.
Telehealth Reform Picks Up Steam in Washington
Telehealth has emerged as a cornerstone of healthcare delivery, particularly amidst the COVID-19 pandemic. Policymakers are now directing their attention toward updating regulations to balance patient access and quality care. Notably, during an April 10th House Energy and Commerce Committee hearing, experts deliberated on legislative proposals aimed at bolstering telehealth, among which was the Telehealth Modernization Act.
Throughout the hearing, concerns were voiced regarding potential telehealth overutilization and the necessity for CMS and Medicare to have access to more comprehensive data. Highlighted as a significant stride forward, the bipartisan bill H.R. 7623, known as the Telehealth Modernization Act of 2024, seeks to expand telehealth services, refine reimbursement mechanisms, and mitigate regulatory obstacles.
Moreover, other legislative proposals were discussed, such as H.R. 134, which aims to eliminate geographic restrictions on telehealth services, and H.R. 3875, which focuses on broadening telehealth access by addressing regulatory barriers. As the significance of telehealth continues to escalate, policymakers must collaborate to modernize regulatory frameworks and ensure equitable access to telehealth services. LUGPA remains vigilant in monitoring Congress for telehealth reforms and aiding members in integrating these services into their practices.
The Ways and Means Committee has continued to be active regarding telehealth policy, last marking up telehealth legislation in March.
AI Reform Takes Center Stage
Artificial Intelligence (AI) is revolutionizing healthcare, enhancing diagnostic precision, treatment planning, and overall patient care. In urology diagnostics, AI-powered tools analyze medical imaging data, facilitating early detection of urological conditions and refining diagnostic accuracy. These algorithms also assist in treatment planning, enabling personalized strategies for patients.
The integration of AI in healthcare necessitates a review of reimbursement policies to ensure equitable compensation for its usage. This involves developing new models that accurately account for AI integration into medical practices and standardizing training programs to equip healthcare professionals with the necessary skills. Congress is currently focused on striking a balance between fostering innovation and upholding rigorous safety standards in AI regulation, aiming to ensure seamless integration into existing healthcare infrastructure.
While AI holds promise in enhancing operational efficiency and tailoring patient care strategies, its integration requires careful attention to data security, patient privacy, and alignment with HIPAA regulations. Despite rapid expansion, comprehensive AI regulations in the U.S. still lag behind Europe. Several bills introduced in Congress aim to address AI use, covering areas such as bias elimination, prescription authorization, biosecurity risk assessment, and risk management frameworks.
On April 29th, federal agencies announced the completion of all 180-day actions outlined in the White House’s October AI executive order, marking progress in addressing AI's safety, security, and societal impacts. Key reforms include establishing frameworks to mitigate risks associated with AI's misuse, releasing guidance for safe AI deployment in critical infrastructure and workplaces, and ensuring nondiscriminatory AI use in various sectors such as housing and healthcare. Additionally, efforts have been made to harness AI's potential, such as advancing its application in scientific research and clean energy initiatives.
Progress is also being made in Congress. On April 16, Senators Mitt Romney, Jack Reed, Jerry Moran, and Angus King unveiled a congressional framework to regulate extreme risks associated with advanced AI models. This framework aims to establish federal oversight for frontier AI models, focusing on mitigating risks in high-risk fields like bioengineering and cybersecurity. Collaboration among stakeholders is crucial for maximizing AI benefits while maintaining high care standards.
LUGPA recognizes AI's transformative potential and advocates for regulations that encourage responsible integration, prioritizing patient safety and ethical considerations.
LUGPA is also currently working on comments that will be sent to Congress in response to Representative Ami Bera’s Request for Information on the current state of artificial intelligence and how it shapes the healthcare industry.
LUGPA Joins Efforts to Promote Prostate Cancer Screening in Tennessee
LUGPA, alongside healthcare organizations in Tennessee, supports SB 2883, a bill allowing cost-free prostate cancer screening championed by Sen. Kyle. This legislation, aligned with evidence-based guidelines, empowers physician-patient decision-making. SB 2883's amendments ensure compliance with current laws without impacting premiums or state spending. The aim is to enhance early detection of prostate cancer, which is critical for survival, especially among high-risk populations.
With prostate cancer ranking second in cancer-related deaths among Tennessee men and African American men disproportionately affected, early detection is pivotal. SB 2883 removes financial barriers to screening, ensuring equal access to life-saving services. LUGPA approves SB 2883's amendments, urging lawmakers to improve screening access for at-risk men in Tennessee.
Success followed as the Tennessee House concurred with amended HB 2954. LUGPA collaborates with ZERO Prostate Cancer to spotlight vital aspects of prostate cancer awareness. Emphasizing genetic testing and PSA screenings, especially for high-risk individuals like Black men, the joint effort promotes early detection and personalized risk assessment.
Medicare Advantage Reform Being Considered in Congress
The Biden administration's proposal to reduce next year's base payments to Medicare Advantage (MA) plans by an average of 0.16% signals a significant shift in healthcare policy that resonates throughout the industry. While insurers express concerns about potential benefit cuts and subsequent premium increases, regulators emphasize the critical need to uphold fiscal responsibility and program integrity within the Medicare system. Balancing cost control with maintaining care quality for beneficiaries underscores the complexity of healthcare policymaking in today's environment.
Amid these changes, LUGPA remains vigilant in monitoring the evolving landscape of MA payment policies. As an organization dedicated to advocating for healthcare providers' interests and ensuring access to high-quality care for Medicare beneficiaries, we acknowledge MA plans' vital role in delivering healthcare services to millions of Americans.
For more details, refer to the fact sheet: CMS Fact Sheet.
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