Proposed policy would impact blepharoplasty, blepharoptosis repair, brow ptosis repair and BOTOX injection services in 10 states.
The Centers for Medicare & Medicaid (CMS) have proposed initiating a 5-year demonstration project (Prior Authorization Demonstration for Certain Ambulatory Surgical Center [ASC] Services [CMS-10884]) that will require ASCs to receive prior authorization (PA) for Part B Medicare carriers for services that include blepharoplasty, blepharoptosis repair, brow ptosis repair and botulinum toxin injection. The project will encompass these services in Arizona, California, Florida, Georgia, Maryland, New York, Ohio, Pennsylvania, Tennessee and Texas. The CMS does not anticipate the changes taking effect before fall 2024.
In a joint letter to the CMS, the AAO, Outpatient Ophthalmic Surgery Society (OOSS) and American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) expressed significant concerns about expanding PA requirements to the ASC care setting and urged that the CMS halt implementation of the demonstration.
In the letter, the AAO, OOSS and ASOPRS stated that the plans outlined by CMS will erect barriers to accessing medically necessary care for Medicare fee-for-service beneficiaries. The organizations also stated that the planned demonstration ignores important lessons learned from the hospital outpatient department (HOPD) PA program and is deeply flawed due to:
- Unresolved problems with the HOPD PA program
- Insufficient evidence to support the rationale for PA in the ASC setting, including lack of demonstrated evidence of fraud for provision of these services in the ASC
- Failure to include lessons from the HOPD PA program, inaccurate administrative burden estimates
- The potential for patient harm due to delayed care.
In a letter to its members, OOSS further clarified the key points outlined in the joint letter, stating:
- The HOPD PA program must be further evaluated and improved before extending PA to surgery centers.
- CMS should remove all ophthalmic procedures (ie, the codes listed under (i) Blepharoplasty, Blepharoptosis Repair, and Brow Ptosis Repair and (ii) Botulinum Toxin Injection) from the ASC PA Demonstration.
- The agency has significantly understated the true administrative burden of compliance with the Demonstration and overlooks many other problems associated with PA, including treatment delays and blocked patient access to medically necessary care.
- Since the ASC does not possess the requisite patient records that support the need for surgery, CMS should clarify that the practice, not the ASC, is responsible for obtaining the PA.
In a statement released to its members, the AAO says, “The Academy will come out strongly against adding a new administrative burden for Medicare services in the ASC setting, highlighting our members’ tumultuous experience with HOPD prior authorization.”
Melissa Toyos, MD, partner and research director of Toyos Clinic in Nashville, Tenn., performs these procedures in office, except for potentially medically unstable patients. She says this proposal adds an additional administrative burden for practices.
“I can say this is disappointing but not surprising. It seems to be one more action in a series to add to the back-breaking administrative burdens practices currently face and is designed to delay care for our patients. I hope it follows in the path of the proposed PA regulation Aetna recently tried to impose on cataract surgery [that was later rescinded].” OM
IN THE NEWS
Reichert Technologies’ Tono-Vera Tonometer with patented ActiView Positioning System is now available in the United States. The tonometer provides quick, automated and reliable IOP measurements utilizing rebound tonometer technology.
New World Medical received 510k indication expansion from the FDA for KDB (Kahook Dual Blade) Glide, expanding its use for reduction of IOP in adult patients with primary open-angle glaucoma either during cataract surgery or as a standalone procedure. KDB is designed to precisely excise trabecular meshwork tissue during goniotomy procedures, the company said.
Haag-Streit’s new Imaging Module 910 3D (IM 910 3D) now features a dynamic 3D live-stream. IM 910 3D comes equipped with a second 4K camera for an immersive depth impression, unveiling more detail and a richer viewing experience, the company says.
Topcon Healthcare is partnering with Microsoft Corp. to deliver AI-powered ‘Healthcare from the Eye’ solutions through a connected health-care platform, which the company says is aimed at improving health care access, cost and quality.
RetiSpec Inc. and Topcon Healthcare announced that Topcon invested in RetiSpec and the companies are collaborating to bring the RetiSpec technology to market. RetiSpec’s eye diagnostic AI aims to help health-care providers predict amyloid burden, a core biomarker of Alzheimer’s disease, even before symptoms emerge.
WHAT'S NEW IN RETINA
AEYE Health received FDA clearance for AEYE Diagnostic Screening technology (AEYE-DS), a fully autonomous artificial intelligence (AI) that diagnoses referable diabetic retinopathy (DR) from retinal images obtained by a handheld camera. The portable solution is suited for point-of-care screening.
Eye2Gene and Heidelberg Engineering announced a partnership combining Eye2Gene’s AI algorithm with Heidelberg’s workflow solutions. The partnership aims to advance the care pathway for patients with inherited retinal disease (IRD), Heidelberg stated.
Haag-Streit launched the Eyesi Indirect Ophthalmoscope ROP Simulator (Eyesi Indirect ROP) for the training of retinal examinations on premature babies and classification of retinopathy of prematurity. The simulator offers a training environment for proper device handling, with an embedded, didactically structured simulator curriculum.
Iridex Corp. announced the launch of its Iridex 532 and Iridex 577 Lasers. Both lasers harness multiple treatment modes including continuous-wave and Iridex’s patented MicroPulse Technology and a touchscreen interface providing a wide range of clinical control options and features.
Iveric Bio, An Astellas Company, announced the CMS assigned a unique, permanent Healthcare Common Procedure Coding System J-code for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to AMD.
Johnson & Johnson debuted its EYE-RD Global Registry, an observational, non-interventional global IRD registry created to make clinical information on IRDs more accessible. The registry will serve as a centralized repository of longitudinal data collected on genetically tested patients who are diagnosed or have a suspected diagnosis of IRDs.
NeoLight announced FDA Class 2 clearance for ICON GO, its portable ophthalmic retinal imaging system with expanded fluorescein angiography (FA) capabilities. The system provides sharp retinal imaging quality across diverse patient care environments such as the pediatric intensive care unit, neonatal intensive care unit, OR and ER.
NIDEK Inc. launched the Mirante Scanning Laser Ophthalmoscope for the US market. The multimodal fundus imaging platform combines high-definition scanning laser ophthalmoscopy and OCT with ultra-wide-field imaging. Mirante captures high-quality color images, FA, indocyanine green angiography, fundus autofluorescence, Retro mode images and OCT.
The FDA granted De Novo marketing authorization to Notal Vision’s SCANLY Home OCT device. The patient-operated SCANLY is the first home retinal imaging service to monitor wet AMD. The device captures spectral-domain OCT images in a 10 X 10° area centered on the point of fixation.
Ocutrx Technologies introduced the OcuLenz AR/XR headset for AMD patients. OcuLenz enhances vision by overlaying high-contrast, pixel-manipulated images onto the user’s remaining viable field of view. The system processes real-world video imagery then recreates it as an augmented reality display tailored to the user’s remaining good vision.
The FDA approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection 8 mg for the treatment of wet AMD, DME and DR. The recommended dose is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks in wet AMD and DME and every 8 to 12 weeks for DR.