In 2023, two large practices paid $2.9 million and $17 million, respectively, to settle cases alleging violations of anti-kickback statutes and False Claims Acts.1,2 Optometric co-management for cataract surgery and advanced technology services associated with cataract surgery were at the center of these cases. This heightened scrutiny has caused many practices to review their co-management strategies and their advanced technology pricing to ensure compliance.
Because Medicare allows patients to be billed directly for non-covered services related to preparing and performing cataract surgery with advanced technology lenses for refractive error correction, many practitioners believe that they are free from CMS scrutiny. However, the base procedure being performed is still covered by Medicare, keeping compliance in the forefront even though patients are receiving non-covered services. Reviewing pricing structures and the practice’s policies for refractive services packages, along with co-management procedures, will reduce the risk of violating any compliance regulations.
5 KEYS TO STAYING COMPLIANT
1. Delineate non-covered services for refractive cataract packages
Most practices have developed package pricing for services associated with correcting refractive errors during cataract surgery, including implantation of advanced technology lenses. Each practice should keep an internal document that clearly delineates the non-covered services included in the package and the fair market value for the services. This internal document serves as the basis for developing the associated materials, including:
- Patient education
- Financial disclosure materials
- Evidence of pricing at fair market value and compliance with the pricing transparency requirements.
2. Verify market range for pricing
Once a practice has developed its packaging, a second step to verify reasonable pricing might be to conduct market research. Pricing too high might lead to fines for gouging Medicare patients. The key considerations are whether pricing meets “usual and customary” standards and fair market value.
3. Follow co-management basics
When reviewing co-management policies, turn to your professional societies. Both ASCRS and the AAO have position papers outlining appropriate comanagement relationships.3,4 Ultimately, the surgeon is responsible for overseeing the post-operative care, and the patient must agree and indicate a preference for post-operative care to be provided by the non-surgeon provider. The recently settled cases also highlighted that:
- Medicare’s co-management acceptance of certain cases does not automatically equate to all cases. And the 80/20 surgeon fee to post-operative care fee for basic cataract surgery does not automatically set a standard for other fees.
- Comanagement cannot be the established standard. In the settled cases, the federal government made it clear that surgeons cannot guarantee the return of patients to the referring provider. The patient must always make an informed decision and the surgeon must ensure clinical appropriateness on a case-by-case basis. Having the patient sign a co-management consent/request form is a best practice.
- The primary reason for co-management is always that it is in the best interest of the patient.
- Practices should have written policies that align with the Office of the Inspector General Compliance program regarding anti-kickback statutes.
4. Know compliant financial arrangements
Traditional cataract surgery for Medicare patients is clearly defined, including appropriate billing by each provider. However, non-covered services may or may not be eligible for co-management consideration. It is important to work with a health-care attorney who is familiar with anti-kickback statutes both for CMS-covered patients and your local and state laws. Remember:
- The post-operative care provider must set their own fees and collect for their own services.
- If you are considering reducing a refractive services package when the patient is being transferred to another doctor for post-operative care, ask yourself: What service that has been included in this package is that doctor providing? (This is where your delineation of services is useful.) Is the reduction at fair market value for those services? Will the post-operative doctor provide those services?
- There are now financing companies that offer disbursement to surgeons and comanagers. However, this does not absolve you from the responsibility of setting fair market value pricing, and the co-managing doctor must also perform the services for which they are being paid.
- Provide a financial disclosure form for patients to sign. In the cases that were settled in 2023, it was found that many patients did not know there was a financial arrangement with the surgeon and post-operative care doctor. Again, an internal delineation of services document will assist in preparing the necessary forms to remain compliant, including a financial disclosure form, which will also meet your No Surprises Act requirements.
5. Avoid the “Don’ts” in ophthalmologist/optometrist relationships
Though discussed regularly from podium, the federal government specifically called out behaviors in these two cases that were unacceptable, including:
- Gifts of any kind to referral sources
- Meals, golf tournaments, sporting events and other entertainment to referral sources
- Free or subsidized continuing education programs for referral sources.
GETTING STARTED
Your regulatory health-care attorney is always a good place to start before implementing any new pricing and co-management strategy. If you are interested in preparing an internal delineation of services for your refractive packages and need support getting started, BSM Consulting has an Excel template available. Contact bsmsupport@bsmconsulting.com to learn more. Your professional societies and the Office of Inspector General all provide guidance and compliance manuals. The 2023 anti-kickback and false claim cases were a wake-up call for many, but they also provided key guidance for avoiding the federal government’s scrutiny. OM
References
1. US Department of Health and Human Services. Office of Inspector General. Ophthalmology practice agrees to pay over $2.9 million to settle kickback allegations. March 23, 2023. https://oig.hhs.gov/fraud/enforcement/ophthalmology-practice-agrees-to-pay-over-29-million-to-settle-kickback-allegations/. Accessed August 27, 2024.
2. Verkamp M. Southeast Eye Specialists pays $17 million to settle anti-kickback, False Claims Act allegations. May 1, 2023. https://www.prnewswire.com/news-releases/southeast-eye-specialists-pays-17-million-to-settle-anti-kickback-false-claims-act-allegations-301812112.html. Accessed August 28, 2024.
3. The American Society of Cataract & Refractive Surgery. Comanagement guidelines. https://ascrs.org/advocacy/regulatory/guidelines/co-management-guidelines. Accessed August 28, 2024.
4. American Academy of Ophthalmology. Comprehensive Guidelines for the comanagment of ophthalmic postoperative care. September 7, 2016. https://www.aao.org/education/ethics-detail/guidelines-comanagement-postoperative-care. Accessed August 27, 2024.
