Catch up - MACS story

Wanted to post this for potential new investors, they may find it useful to get caught up on what happened with MACS through 2023 and 2024 since these events stalled the share price growth. In my opinion, lack of understanding has further stunted valuation.

This GPT generated based on the ASX market updates, provides a well structured explanation:

October 2023: Initial Medicare Coverage Challenges

Nova Eye Medical (ASX: EYE) first encountered changes when Medicare Administrative Contractors (MACs) in six U.S. states, including Kansas, Missouri, and Michigan, proposed cutting Medicare reimbursement for certain minimally invasive glaucoma surgeries (MIGS). Specifically, they targeted ab interno canaloplasty using Nova Eye's iTrack™ device for Medicare patients. While reimbursement for other techniques like ab externo canaloplasty remained unaffected, the proposed changes created uncertainty. These six states represented a significant market for Nova Eye’s iTrack™ portfolio.

---

November 2023: Impact Spreads Across 38 States

Shortly after, four additional MACs expanded the proposed changes to 38 states, which collectively account for 40% of Nova Eye’s global revenues. The broader scope threatened to impact more sales of iTrack™. Despite this, the company experienced strong U.S. sales growth, with a 74% increase to $3.34 million by October 2023. While Molteno3® products remained unaffected, the threat to iTrack™ led Nova Eye to contest the "investigational" label being applied to canaloplasty. Nova Eye also geared up initiatives to educate surgeons and mitigate potential short-term impacts.

---

Late November 2023: Positive Delay by One MAC

A significant development occurred when National Government Services (NGS), one of the five MACs, deferred the implementation of the proposed changes from December 23, 2023, to March 23, 2024. This delay provided much-needed breathing room for Nova Eye Medical, allowing it to maintain sales in states like New York and Illinois, where iTrack™ had gained market penetration. However, the other four MACs still intended to enforce changes by the original December date.

---

December 2023: Industry-Wide Deferral

A few weeks later, all five MACs, including NGS, collectively decided to delay the implementation of the reimbursement changes to January 29, 2024. This gave Nova Eye more time to sell the iTrack™ Advance device and implement initiatives aimed at managing the situation. The delay also helped sustain momentum, with iTrack™ Advance performing well in the U.S. market since its launch in May 2023.

---

December 29, 2023: Full Withdrawal of Proposed Changes

In a significant positive turn for Nova Eye Medical, all five MACs decided to withdraw the proposed reimbursement changes altogether. This means that canaloplasty procedures using iTrack™ devices would continue to receive Medicare reimbursement across all U.S. states. The decision not only secured Nova Eye’s current market position but also paved the way for further sales growth of the iTrack™ Advance device, which had already seen strong demand.

Nova Eye credited medical societies like the American Glaucoma Society (AGS) and the American Academy of Ophthalmology (AAO), alongside thousands of ophthalmologists, for their critical role in reversing the proposed changes.

---

May 2024: Regulatory Stability

By May 2024, the previously proposed reimbursement restrictions were fully withdrawn, securing the future of canaloplasty procedures using iTrack™ Advance. This allowed Nova Eye Medical to maintain strong U.S. sales growth and expand its market reach without disruption.

---

Summary

Nova Eye Medical faced a series of challenges when Medicare coverage for their iTrack™ device was at risk due to changes proposed by multiple U.S. MACs. However, through strategic responses, industry advocacy, and temporary delays, the company successfully navigated these hurdles. Ultimately, the proposed changes were fully withdrawn, allowing Nova Eye to maintain its U.S. market position and continue growing its sales of the iTrack™ Advance device without any reimbursement-related disruptions. This outcome solidifies Nova Eye’s position as a key player in the minimally invasive glaucoma surgery (MIGS) market, ensuring continued momentum.

Further to this, I also asked GPT to generate a SWOT table of competing products:



Personally speaking, if I was needing treatment - I would opt for the iTrack Advance. No stent sounds much better.