Real-World Evidence Circles

19/02/2026

MOTIV™ – the MSK collaboration between RegenMed and OREF – is off to a strong start.

The initial MOTIV™ Observational Protocol (OP) is based upon the mandated CMS TKA PRO PM, but also collects product, surgical technique, pain management, and other real-world data. The OREF expert-reviewed OP was co-authored by Doctors Andrew Wickline and John Mercuri. WCG Clinical Services has issued its Certificate of Action confirming that the generation of Circle Datasets pursuant to that OP is exempt under 45 CFR 46.104(d)(4).

Orthopedic surgeons from around the country, and representing over 2,000 TKAs annually, have already joined as Circle Members and begun enrolling Cases. Many more have indicated their intention to join.

Last week’s initial Circle Hour brought together current and interested Circle Members. Topics included positive feedback on clinician and patient experience, benefits of national collaboration on topics of common interest, and the opportunities for publication and Circle Dataset licensing. RegenMed and OREF will be hosting another Circle Hour at the Academy meeting in New Orleans in early March.

The FDA TEMPO and CMS ACCESS programs are prioritizing fit-for-purpose, verifiable real-world evidence for several major therapeutic areas, including MSK. Circle Datasets not only meet these requirements, they do so with excellent physician UX, collaboration and ethical financial participation.

Please contact Alyssa Johncola at ajohncola@rgnmed.com or Erika Deleon at deleon@oref.org to learn more.

19/02/2026

𝐄𝐱𝐞𝐜𝐮𝐭𝐢𝐯𝐞 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 & 𝐓𝐡𝐞 𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲 𝐌𝐚𝐧𝐝𝐚𝐭𝐞

The 2026 healthcare landscape is defined by the "𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲 𝐌𝐚𝐧𝐝𝐚𝐭𝐞," a structural transition from administrative proxies to proven medical accuracy derived directly from the point of care. For healthcare executives, the era of relying on billing codes as evidence for efficacy has ended.

The integration of 𝐂𝐌𝐒 𝐀𝐂𝐂𝐄𝐒𝐒 and 𝐅𝐃𝐀 𝐓𝐄𝐌𝐏𝐎 creates a synergistic loop that solves the "chicken-and-egg" challenge of digital health adoption:

▪️ 𝐂𝐌𝐒 𝐀𝐂𝐂𝐄𝐒𝐒 provides a 10-year national test for Outcome-Aligned Payments (OAPs), rewarding measurable health improvements like a 10 mmHg reduction in blood pressure.

▪️ 𝐅𝐃𝐀 𝐓𝐄𝐌𝐏𝐎 offers a regulatory sandbox, allowing manufacturers to deploy devices within ACCESS organizations before receiving full clearance to generate real-world evidence.

▪️ 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐈𝐦𝐩𝐚𝐜𝐭: This model moves evidence generation from the lab into the patient’s "everyday life".

▪️ 𝐕𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐒𝐡𝐢𝐟𝐭: Organizations utilizing Circle Datasets can transition from a service business (valued at 6-8x) to a tech-enabled asset (valued at 12-15x) by providing audit-ready ground truth.

Precision in data is no longer a compliance burden; it is the primary driver of business valuation and clinical authority. Read more: https://hubs.li/Q043zZPy0

18/02/2026

𝐓𝐡𝐞 $𝟑𝟎𝟎 𝐌𝐢𝐥𝐥𝐢𝐨𝐧 "𝐑𝐞𝐝 𝐓𝐚𝐩𝐞" 𝐢𝐬 𝐆𝐨𝐧𝐞. 𝐖𝐡𝐨 𝐨𝐰𝐧𝐬 𝐭𝐡𝐞 𝐭𝐫𝐮𝐬𝐭 𝐧𝐨𝐰?

The just leveled the playing field for . Commissioner Marty Makary has eliminated the requirement for expensive "switching studies," moving the market toward 𝐈𝐧𝐭𝐞𝐫𝐜𝐡𝐚𝐧𝐠𝐞𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐛𝐲 𝐃𝐞𝐟𝐚𝐮𝐥𝐭.

𝐓𝐡𝐞 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐲: Biosimilar development costs are plummeting, and the market is set to hit $33B+ by 2034.

𝐓𝐡𝐞 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞: Faster approval doesn't solve the "Trust Gap" with doctors and patients.

𝐓𝐡𝐞 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧: You need 𝐕𝐞𝐫𝐢𝐟𝐢𝐞𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲. With , every clinical encounter generates 𝐀𝐮𝐝𝐢𝐭-𝐑𝐞𝐚𝐝𝐲 "𝐆𝐫𝐨𝐮𝐧𝐝 𝐓𝐫𝐮𝐭𝐡" that proves equivalence in the real world. Don't just switch the drug—own the data that proves it works.

More: https://hubs.ly/Q043xQF10

FDA removes biosimilar switching studies, enabling automatic substitution and shifting market success to real-world evidence proving clinical equivalence.

17/02/2026

In modern biomedicine, correlations are everywhere—but true causation is alarmingly rare. This article exposes how seductive signals mislead medicine, distort policy, and harm patients—and shows the path back to real understanding. Read more:

Modern biomedicine overproduces correlations without proving causation. This article explains why causal design—not association—must guide clinical decisions.

12/02/2026

𝐓𝐡𝐞 𝐁𝐢𝐨𝐥𝐨𝐠𝐢𝐜 𝐄𝐫𝐚 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐬 𝐚 𝐧𝐞𝐰 𝐌𝐒𝐎 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲: 𝐎𝐮𝐭𝐜𝐨𝐦𝐞 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠.

The legacy MSO model focused on geographic arbitrage and billing efficiency. But in 2026, the real margin is in 𝐈𝐧𝐬𝐮𝐫𝐚𝐛𝐥𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲.

As biologics hit 51% of drug spend, payers are demanding more than just a bill; they are demanding 𝐀𝐮𝐝𝐢𝐭-𝐑𝐞𝐚𝐝𝐲 "𝐆𝐫𝐨𝐮𝐧𝐝 𝐓𝐫𝐮𝐭𝐡".

With the 𝐂𝐢𝐫𝐜𝐥𝐞𝐬 platform, we help MSOs transition from low-margin "Service Businesses" to high-valuation 𝐓𝐞𝐜𝐡-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐀𝐬𝐬𝐞𝐭𝐬. We provide the infrastructure to capture 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐢𝐳𝐞𝐝 𝐋𝐨𝐧𝐠𝐢𝐭𝐮𝐝𝐢𝐧𝐚𝐥 𝐒𝐜𝐨𝐫𝐞𝐬 that make your enterprise 𝐒𝐮𝐫𝐠𝐢𝐜𝐚𝐥-𝐃𝐞𝐥𝐚𝐲 𝐏𝐫𝐨𝐨𝐟 and ready for a 𝟏𝟐-𝟏𝟓𝐱 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐞𝐱𝐢𝐭.

It’s time to move beyond the service and own the veracity.

Learn more in the article: https://hubs.li/Q042QK_00

Fast 60-day FDA reviews risk evidence gaps. This article explains why real-world, verifiable clinical data is essential for payer acceptance and real-world performance.

12/02/2026

12/02/2026

🔔 𝐓𝐨𝐝𝐚𝐲’𝐬 𝐭𝐡𝐞 𝐃𝐚𝐲: 𝐂𝐢𝐫𝐜𝐥𝐞 𝐇𝐨𝐮𝐫 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐌𝐎𝐓𝐈𝐕™ 𝐓𝐊𝐀 𝐎𝐛𝐬𝐞𝐫𝐯𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐏𝐫𝐨𝐭𝐨𝐜𝐨𝐥!

Join Dr. Andrew Wickline, Dr. John J. Mercuri, MD, MA, and representatives from OREF for a focused exploration of the MOTIV™ TKA Observational Protocol and its role in advancing real‑world clinical evidence.

Already, surgeons representing 𝟏,𝟔𝟎𝟎+ 𝐓𝐊𝐀𝐬 𝐚𝐧𝐧𝐮𝐚𝐥𝐥𝐲 have joined or indicated their intent to participate.

🔍 𝐖𝐡𝐚𝐭 𝐭𝐨 𝐄𝐱𝐩𝐞𝐜𝐭 𝐓𝐨𝐝𝐚𝐲:
• Overview of RWD’s growing role in orthopedic medicine
• OREF’s objectives within MOTIV™
• Clinical hypotheses behind the protocol
• Aggregated data report samples
• Live demonstration of user experience
• Extended Q&A

Looking forward to a productive and insightful discussion.

🔗 Secure your spot: https://us06web.zoom.us/webinar/register/WN_ZYuCyFJuS2y9diE6HuiqwA #/registration

11/02/2026

When patients share their truths, who owns the value created from them? This article reveals how a new model turns contributors into stakeholders — restoring dignity, agency, and rightful ownership in the future of medical data: https://hubs.li/Q042D-LR0

Contact us to learn more: https://hubs.li/Q042D_sL0

This article explores how traceable consent and participation transform medical data from extractive systems into shared value for patients and contributors.

11/02/2026

Register here: https://us06web.zoom.us/webinar/register/WN_ZYuCyFJuS2y9diE6HuiqwA #/registration

Find the registration link in bio.

10/02/2026

𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐏𝐞𝐩𝐭𝐢𝐝𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞: 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞-𝐁𝐚𝐬𝐞𝐝 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐂𝐥𝐢𝐧𝐢𝐜𝐢𝐚𝐧𝐬

The field of peptide-based therapies is evolving rapidly—but with so much commercial noise, how can physicians access reliable, unbiased, and peer-reviewed information?

The Canadian Peptide Research Society (CPRS) is bridging this gap with new clinician-focused resources designed to support 𝐬𝐚𝐟𝐞, 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭, 𝐚𝐧𝐝 𝐞𝐯𝐢𝐝𝐞𝐧𝐜𝐞-𝐛𝐚𝐬𝐞𝐝 peptide use.
Their programs offer:

✅ 𝐄𝐱𝐩𝐞𝐫𝐭-𝐥𝐞𝐝 𝐰𝐞𝐛𝐢𝐧𝐚𝐫𝐬 & 𝐰𝐨𝐫𝐤𝐬𝐡𝐨𝐩𝐬
✅ 𝐏𝐞𝐞𝐫-𝐫𝐞𝐯𝐢𝐞𝐰𝐞𝐝 𝐠𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞𝐬 & 𝐬𝐚𝐟𝐞𝐭𝐲 𝐫𝐞𝐯𝐢𝐞𝐰𝐬
✅ 𝐔𝐩-𝐭𝐨-𝐝𝐚𝐭𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐨𝐫 𝐂𝐚𝐧𝐚𝐝𝐚 & 𝐔𝐒𝐀
✅ 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐟𝐨𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 & 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡

As proud partners in this initiative, we’re excited to help bring these resources to the medical community.

If you or your team are incorporating peptide‑based therapies—or evaluating how to do so responsibly—these resources offer a trusted, science‑driven foundation.

👉 Read the full announcement and explore the programs here:

Explore unbiased, evidence-based peptide therapy resources for clinicians. Stay updated on safety, regulations, and best practices with CPRS’s expert-led tools.

06/02/2026

Discover how federated AI transforms medicine from mere prediction to trustworthy proof. Learn why verification, transparency, and accountability are essential for clinical trust—and how innovative data governance is reshaping healthcare’s future:

Healthcare AI predictions lack trust without verification. This article explains how auditability, provenance, and reproducibility turn AI outputs into clinical proof.

04/02/2026

AI in healthcare dazzles with record-breaking scores—yet 92% of top-performing models fail in real-world clinics. The problem? Benchmarks lie. Discover why trustworthy AI demands more than metrics—and how the future belongs to systems built on verifiable truth, not just impressive numbers:

High AI benchmark scores don’t ensure real-world reliability. This article explains why healthcare AI needs continuous, outcome-based validation instead of static benchmarks.