XiFin CEO Lâle White’s Message at the California Clinical Laboratory Association (CCLA) Annual Conference

In October, XiFin CEO Lâle White spoke at the California Clinical Laboratory Association (CCLA) Annual Conference. The conference covered several important topics, including the VALID Act and PAMA, as well as what is being done and can still be done to help SALSA move forward. Information was shared on payor policies and a Medicare panel where experts spoke and answered questions.

Lâle’s presentation addressed the challenges diagnostics organizations face today and underscored how important it is for the industry to work together to stop the aggressive fee schedule cuts for laboratories and diagnostic providers. The following is a synopsis of her main remarks.

The clinical laboratory business is not getting any easier. Every day, it gets more complex with new challenges introduced, such as:

• Ongoing staffing shortages continue to strain the healthcare system at every level.
• Complex payor requirements and increased compliance and regulatory restrictions (e.g., Price Transparency and Surprise Billing Legislation).
• Non-traditional providers continue to put competitive pressure on conventional healthcare providers (e.g., consumer-oriented tech companies, pharmacy chains, payors).
• Large consumer businesses are becoming healthcare companies; those with self-insured employee plans have aligned incentives. They want to keep employees healthy, and at the same time, they want healthcare delivery to be cost-effective.
• As patients become responsible for a larger portion of their medical expenses, consumer-directed healthcare changes access points.
• Increased requirements to provide patients with enhanced digital engagement options for scheduling, reminders, test results, pricing, payments, and more.
• An increasingly distributed healthcare ecosystem requires sophisticated data exchange capabilities.

All of these challenges contribute to ongoing interoperability requirements, continued growing technology needs, and increased demands for effective artificial intelligence (AI) and better cybersecurity.

Simultaneously, the Medicare ecosystem is facing challenges, disruptions, and opportunities. The Medicare trust fund is projected to run out of money in 2031. Medicare Advantage (MA) plans are projected to drive the most profit for payors in 2026. Payors will be losing billions of dollars in direct and indirect remuneration fees. The quality of the member experience, including expanded digital engagement, will be a competitive differentiator for MA plans. So, payors are considering:

• Investing in enablement partnerships and working with physicians to improve outcomes.
• Supplementing the care delivery footprint to address care gaps.
• Aligning incentives with those of physicians and patients.
• Using advanced analytics to match members with effective care models.

A mature care delivery ecosystem would meet every member where they are.

Consumers Want Convenient and Cost-effective Options

Consumers experiencing higher out-of-pocket expenses for healthcare and who have more access to information on the internet are becoming more involved with their choices and care. Consumers are seeking out both cost-conscious alternatives and convenience. Younger consumers are particularly looking for walk-in options, where no appointment is needed. Cost, quality, and convenience are the factors that are driving consumers.

Retail pharmacy clinics are continuing to improve and play an important role in fulfilling this consumer need, particularly when it comes to managing chronic conditions. While people often consider pharmacies a care option serving rural communities, many retail pharmacy clinics are starting by serving urban areas. The expectation is that as these retail pharmacy clinics gain a foothold in urban centers, they will move into rural areas of healthcare deserts where there is limited access to primary care physicians.

AI-informed Revenue Cycle Management (RCM) Improvements

The ultimate role of AI in healthcare is clinical decision support. In diagnostics, this means clinical decision support for selecting the right test at the right time for the patient. Once the result is delivered, next comes clinical decision support that helps the physician pick the next best therapy.

But AI isn’t there yet. That doesn’t mean, however, that it can’t provide value in other ways.

AI is used for simple analysis in clinical trials, looking at biomarkers and patient symptoms and selecting patients for trials. These are lower-risk activities because a physician reviews them.

AI is also well-suited for revenue cycle management. It is used for processing errors, managing denials, resolving front-end errors, and for patient financial responsibility estimation. Automating critical processes helps us eliminate labor and keep costs down.

In our AI-driven process optimization, AI modules integrate directly into the RCM workflow architecture and train on historical data. Here are some examples of how XiFin is using AI in RCM:

• User-configurable workflow automation.
• Payor discovery. Identifying what you are and aren’t getting paid on, and what your staff should be focusing on in order to maximize what you receive.
• Auto assignment of error processing work. Distributing work according to who is best suited to obtaining the best results regarding specific error types.
• Patient co-pay and co-insurance estimation, particularly out-of-network scenarios.
• Payor-informed workflow optimization, based on payor coverage and denial behavior and responses.
• Revenue and cash forecasting.
• Customer service and appeal letter optimization.

Strategic Advocacy Drives Industry Transformation

As an industry, we have a fairly weak voice, representing only 3% of healthcare spending. This means that to be heard, we have to do a lot more on the advocacy front, including getting personally involved, whether writing to our congressperson or participating in an ACLA or CCLA advocacy cause. When one of our associations or advocacy partners requests you to contact your senator or your congressperson, it’s because we need your grassroots support. Please do it.

We all need to examine the root cause of the issues impacting our industry more deeply and understand how these issues can escalate if we don’t address them at the source. Take the overly aggressive and targeted rate cuts of PAMA as a perfect example. PAMA was supposed to give market rates in the US. It did not give us market rates. It became a race to the lowest price and had a very detrimental impact on our industry.

SALSA attempts to remedy that. It’s probably as good a remedy as we can get right now. So, we all need to be behind it and push for SALSA to pass.

The VALID Act and the FDA are yet another example of an opportunity for us to work together to try to prevent a looming issue that could become a huge problem for laboratories. We are practicing medicine in the laboratory industry. We are not manufacturing devices. Trying to fit laboratory-developed tests (LDTs) into a device framework is detrimental. As an industry, we need to understand the impact of FDA oversight of LDTs in this manner. We must roll up our sleeves and do all the advocacy we can together.

The key to successful advocacy is working with groups. Work with your lab associations. Understanding what they’re doing and supporting them is critical.

Moving Toward a Distributed Healthcare System

Laboratories must collaborate within the broader healthcare ecosystem to deliver the best care to patients and the best outcomes. This means working more closely with radiology and the pathologist, for example. When these three groups collaborate on a specific precision medicine patient or oncology cancer scenario, XiFin finds that the therapy decision changes 50% of the time.

Integrated diagnostics, such as in the scenario described above, is key to getting the best outcome for the patient. Just talking to each other improves outcomes.