Industry News, May 2024

​Organizations including the American Society for Radiation Oncology (ASTRO), the American College of Radiation Oncology (ACRO), the American College of Radiology (ACR), the American Society of Clinical Oncology (ASCO), and American Association of Medical Dosimetrists (AAMD), among others, came together to lobby for newly introduced legislation which proposes a new payment model for radiation therapy. This is a result of Medicare payment cuts and the indefinite delay of the Radiation Oncology Alternative Payment Model (RO Model).

Radiation Oncology Organizations Lobby for Medicare Payment Reform

​The Radiation Oncology Case Rate (ROCR) Value-Based Program Act was introduced in Congress earlier this month. According to ASTRO, this bi-partisan legislation aims to “protect access to high value cancer treatments for patients across the country, enhance patient outcomes and reduce health disparities while generating savings for Medicare.” 

The ROCR Value Based Program Act outlines goals that include:

• Modification from fee-for-service to a more patient-centered approach for radiation therapy services;
• Creation of unified payments across settings for radiation therapy services based on hospital technical payments;
• Reduction in disparities in radiation therapy care by increasing access to these services close to the homes of the beneficiaries, particularly in rural or underserved communities;
• Enhancement of radiation care quality through practice accreditation and shorter courses of treatment for certain cancers, when appropriate;
• Promotion of state-of-the-art radiation therapy technology to improve patient care and outcomes; and
• Protection of Medicare resources by attaining reasonable spending reductions for Medicare radiation therapy services, generating a savings of approximately $200 over 10 years.

​“I’m proud to introduce the ROCR Act, which will provide a more stable and sustainable payment framework for life-saving radiation oncology services,” said Senator Tillis, one of the bill’s sponsors. “This legislation represents more than just the advancement of meaningful value-based payment reform; it’s a promise to those battling cancer that they’ll have uninterrupted access to high-quality care without facing financial or geographic barriers.”

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ACR Critiques USPSTF Breast Cancer Screening Recommendations

The U.S. Preventive Services Task Force (USPSTF) published final recommendations on breast cancer screening. The USPSTF now recommends that all women get screened for breast cancer every other year (biennially) starting at age 40 and continuing through age 74. The task force believes there is high certainty the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial. However, the USPSTF also believes there is insufficient evidence to make a determination as to whether any additional screening (including MRI or ultrasound) is recommended for women with dense breasts; as well as determine the benefits versus drawbacks of screening in women older than 75.

While the USPSTF, American College of Radiology (ACR), American Cancer Society (ACS), Society of Breast Imaging (SBI) and others agree the annual approach to breast cancer screening is beneficial, the ACR provided their position on these final recommendations in a recent statement: “The final United States Preventive Services Task Force breast cancer screening recommendations, while an improvement over previous guidance, do not go far enough to save more women’s lives.” The ACR recommends all women have a breast cancer risk assessment by age 25; and women at higher risk for breast cancer talk to their doctor about starting annual screening prior to age 40, to include additional screening methods as appropriate.
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The ACR believes medical experts must “clear the confusion caused by differing recommendations” and will continue to urge the USPSTF to recommend the ACR’s guidance for breast cancer screenings.

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Epic Releases Open-Source AI Validation Tool for Health Systems

Healthcare organizations are seeing a major increase in artificial intelligence (AI) features, which have the potential to improve clinician productivity and ultimately patient outcomes. Although predictive AI modes have been used for nearly a decade, generative AI and large language models (LLMs) are quickly emerging. In the healthcare arena, Generative AI can augment diagnostic exams, help research and develop new drugs, build patient medical records, and provide customized patient treatment plans. LLMs are similar to generative AI, except LLMs process large amounts of data to produce outcomes. For adoption of this technology, it is still a challenge to use the best methods in which to validate AI models for accuracy, consistency and safety.  

Epic has released an open-source tool to allow healthcare organizations to test and monitor artificial intelligence (AI) models. Epic recognizes evaluation criteria for AI has to be meaningful for each individual healthcare organization: “the standards need to be implemented correctly and consistently and used to test models on the local patient populations and embedded in the specific workflows that will be used.” As such, this tool is free to the public on GitHub, and can be used with existing EHR systems (not just Epic) to validate and monitor an AI model’s performance on a continual basis. The goal is to provide consistency, while eliminating the need for healthcare organization data mapping.
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In an interview with Seth Hain, Epic Senior Vice president of Research and Development, Hain expressed,

We'll provide health systems with the ability to combine their local information about the outcomes around their workflows, alongside the information about the AI models that they're using, and they will be able to use that both for evaluation and then importantly, ongoing monitoring of those models in their local contexts.”

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New Guideline for Management of Lower Extremity PAD

A new collaborative, multispecialty guideline has been established for the management of lower extremity peripheral arterial disease (PAD). The guideline  published in  Circulation and the Journal of the American College of Cardiology (JACC), entitled “2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines”, provides guidance for clinicians in the treatment of patients with lower extremity PAD across the following clinical presentation subsets – asymptomatic, chronic symptomatic, chronic limb-threatening ischemia (CLTI), and acute limb ischemia (ALI).

This guideline was led by the American Heart Association (AHA) and the American College of Cardiology (ACC) Joint Committee of Clinical Practice Guidelines; and developed and recommended by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), the American Podiatric Medical Association (APMA), the Association of Black Cardiologists (ABC), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine (SVM), the Society for Vascular Nursing (SVN), the Society for Vascular Surgery (SVS), the Society of Interventional Radiology (SIR), and the Vascular & Endovascular Surgery Society (VESS).

​Development of this guideline was the result of a comprehensive literature review from October 2020 to May 2023, including relevant studies, reviews and databases, and other evidence considered during the peer review process. Highlights include (for all clinical subcategories) clinical assessment for PAD; diagnostic testing for PAD; special considerations, such as risk amplifiers, health disparities and older patients with PAD; medical therapy/preventative foot care; exercise therapy for PAD; revascularization techniques and registries; and follow-up of PAD.

The guideline also includes the top 10 take-home messages, which state:

1. Peripheral artery disease (PAD) is a common cardiovascular disease associated with increased risk of amputation, myocardial infarction, stroke, and death, as well as impaired quality of life (QOL), walking performance, and functional status.
2. This guideline defines 4 clinical subsets of PAD: asymptomatic PAD (may have functional impairment), chronic symptomatic PAD (including claudication), chronic limb-threatening ischemia, and acute limb ischemia.
3. Detection of PAD in most patients is accomplished through the history, physical examination, and resting ankle-brachial index.
4. Health disparities in PAD are associated with poor limb and cardiovascular outcomes and must be addressed at the individual patient and population levels, with interventions coordinated between multiple stakeholders across the cardiovascular community and public health infrastructure.
5. Effective medical therapies for patients with PAD should be prescribed to prevent major adverse cardiovascular events and major adverse limb events for patients with PAD, including antiplatelet (generally single antiplatelet) and antithrombotic therapy, lipid-lowering (i.e., high-intensity statin) and antihypertensive therapy, management of diabetes, and smoking cessation. Rivaroxaban (2.5 mg twice daily) combined with low-dose aspirin (81 mg daily) is effective to prevent major adverse cardiovascular events and major adverse limb events in patients with PAD who are not at increased risk of bleeding.
6. Structured exercise is a core component of care for patients with PAD. It includes supervised exercise therapy and community-based (including structured home-based) programs.
7. Revascularization (endovascular, surgical, or hybrid) should be used to prevent limb loss in those with chronic limb-threatening ischemia and can be used to improve QOL and functional status in patients with claudication not responsive to medical therapy and structured exercise.
8. Care for patients with PAD, and especially those with chronic limb-threatening ischemia, is optimized when delivered by a multispecialty care team.
9. Foot care is crucial for patients with PAD across all clinical subsets and ranges from preventive care and patient education to advanced care in the setting of chronic limb-threatening ischemia. Podiatrists and other specialists with expertise in foot care, wound-healing therapies, and foot surgery are important members of the multispecialty care team.
10. The PAD National Action Plan outlines 6 strategic goals to improve awareness, detection, and treatment of PAD nationwide. Implementation of this action plan is recognized as a top advocacy priority by the writing committee.

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Ransomware Awareness: Mitigating Attacks

​According to the Office of Information Security (OIS), part of the Department of Health and Human Resources (HHS),  ransomware is a type of malicious software, or malware, that encrypts computer data. This encryption makes the data unusable to the organization. In addition, this data is often stolen and then held hostage until the ransom is paid by the organization. If the ransom is not paid, the data remains unavailable and may be sold to other cyber criminals for their use.

Although ransomware attacks have been around for decades, they are becoming more frequent and widespread. Even the execution of these attacks has progressed from a single individual or cybercrime group to Ransomware-as-a-Service (RaaS). RaaS is considered a “business model” in which ransomware operators develop and keep malware and sell or lease this malware to hackers (aka RaaS affiliates) to be used in ransomware attacks. These ready-made RaaS kits can be used by affiliates that only need to have a limited technical skill set to execute the attacks. However, as part of the RaaS model, these ransomware attacks may be carried out by many groups responsible for specific aspects of the attack.    

The motivation for these attacks is simple – monetization. The OIS has identified this modern ransomware attack in which the RaaS model is frequently used as Big Game Hunting (BGH). The goal of BGH is to “focus efforts on fewer victims that can yield a greater financial payoff. Victims are chosen based on their ability to pay a ransom, as well as the likelihood that they will do so to resume business operations or avoid public scrutiny.”
 
Hospital systems, other healthcare institutions, and organizations that hold personal data such as medical records are common targets. Recent ransomware attacks, including Change Healthcare and Ascension Health System, have resulted in a critical disruption of direct patient care and processing of claims.

The Federal Bureau of Investigation (FBI) issued their annual Internet Crime Report for 2023. In this report, 249 healthcare and public health sectors were affected by ransomware attacks. In addition, the number of reported ransomware attacks directed at U.S. hospital systems nearly doubled from 2022 to 2023, indicating that cybercriminals are progressively targeting healthcare institutions. However, only 63% of healthcare organizations have a cybersecurity response plan in place, according to a survey from advisory firm Software Advice.

To promote cybersecurity for the health care and public health (HPH) sector, the HHS released voluntary Cybersecurity Performance Goals earlier this year to help the HPH sector prepare for and respond to cyber threats and attacks. This document includes “essential goals to outline minimum foundational practices for cyber security performance and enhanced goals to encourage adoption of more advanced practices.” Examples of essential goals include mitigating known vulnerabilities, email security, multifactor authentication, basic cybersecurity training for users and strong encryption. Examples of enhanced goals include asset inventory, cyber security testing, network segmentation and third-party vulnerability disclosure/incident reporting.

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