Retina specialists perform many intravitreal injections. Their frequent use means they can garner extra attention from the Centers for Medicare and Medicaid Services (CMS).

Q. Why is Medicare focusing on these claims?

A. Intravitreal injections are so common that they are under scrutiny by Medicare and other payers. It is understandable for CMS to be interested in the procedure and associated drugs; in 2018 (the most recent data year) Medicare paid providers $2.9 billion for Eylea and Lucentis.¹ In 2017, Medicare paid a total of $9 billion to ophthalmologists, so expenses for intravitreal injection drugs accounted for more than 38%.² The sheer cost to the Medicare trust fund impels the Office of the Inspector General to carefully monitor physician billing for these drugs.

Q. What can we do to avoid audit traps?

A. To meet billing requirements for Medicare and most commercial payers, your medical record should include adequate information to support the charge. Before you begin, confirm that a minimum of 28 days has passed since the previous injection in the same eye. The likelihood of denial is high if you perform intravitreal injections more often than 28 days. With that trap in the process avoided, your clinic note should include the following:

• A surgical plan or order, which includes the name of the drug, the dosage, and the indication, along with the physician’s signature.
• The medical necessity for the procedure:
  • Diagnosis, indications, and changes to the patient’s condition,
  • Diagnostic test results, and
  • Patient consent for the procedure and acceptance of risks.
• Documentation of physician-informed consent:
  • Signed consent form for first-time injection or when there is a change in medication or eye condition, and
  • Annually signed consent thereafter.
• The operative note, which must include the volume and dose of the injected drug, the lot number and expiration date of the drug, and how much (if any) was wasted or discarded. Noting “manufacturer overfill was discarded” may satisfy a payer’s expectation for this information.
• A record of any complications that occur, with clear documentation of the complication (including medication errors); conversely, indicate if no complications occurred. If the wrong medication was used, be sure to educate the patient and consider not submitting a claim to insurance. Your malpractice carrier can advise you on next steps if this occurs.

As with all documentation guidance, your chart note must be clear and legible. For new patients, document why one drug was selected over other options. For established patients, document at each visit how the patient is responding to therapy.

Q. Why the requirement for a 28-day interval?

A. Medicare and other payers base their policies in part on the FDA approval for a given drug, device, or procedure. Ranibizumab (Lucentis; Genentech) specifies 28 days between doses³; although aflibercept (Eylea; Regeneron) is worded more broadly, the label does state that dosing once every 4 weeks is the maximum frequency.⁴

Rather than attempt to count weeks, CMS used the original anti-VEGF, ranibizumab, for ophthalmology as the standard for these drugs. Some Medicare carriers often apply the same requirement for intravitreal injections of bevacizumab (Avastin; Genentech), although no FDA guidelines for ophthalmic use exist.

Q. What happens if we’re audited?

A. If Medicare or another payer asks for injection documentation, be sure you or a highly trained staff member reviews any requested charts before sending anything. Include in the packet:

• Notes with patient name and date of service on every page.
• Relevant history and prior treatments to support medical necessity. If a prior visit contains the physician’s order for the treatment under review, be sure to send that note.
• If performed, send the results of diagnostic tests supporting the need for continued treatment, even if the test was performed at a prior visit.
• The operative note, including all the information cited earlier.⁵
• Relevant correspondence, such as referral letters, that support the therapy.

You should never alter any records after receiving a request. However, you may supplement the records you send to give the auditor assistance with their record review. Consider sending documentation that contains the following:

• Common abbreviations used in your practice.
• A signature log (for paper records) and/or your electronic health record protocol for physician signatures in EMR.
• The insurance coverage policy, especially if the reason for the treatment is uncommon.
• If the drug was used off label, consider including peer-reviewed articles supporting your use of the drug for the indication.

Q. What can we do to avoid an audit?

A. Be sure you know how your utilization compares to national averages. If you bill a significantly higher percentage of intravitreal injections compared with your peers, there is a strong likelihood that you will be audited. This does not mean you are doing anything wrong, it just means you need to be especially diligent with your documentation and be prepared. Remember that Medicare just sees you as an ophthalmologist; it has no way of tracking retina subspecialists separately.

Having a reliable, trained, and independent staff member or peer perform regular internal audits is invaluable to ensure that your documentation is adequate and appropriate. Update policies and checklists to formalize your intravitreal injection procedures whenever vulnerabilities are exposed. And don’t forget to attend periodic training for yourself and staff members. It can be easy to fall into a routine with an erosion in protocols over time; avoiding that trap is important. RP

REFERENCES

1. Frontz AJ. An ophthalmology clinic in California: audit of Medicare payments for eye injections of Eylea and Lucentis. Office of Inspector General, US Department of Health and Human Services. March 2021. Accessed April 18, 2022. https://oig.hhs.gov/oas/reports/region9/91903022.pdf
2. Corcoran Consulting Group. Information compiled from CMS data for claims in calendar year 2017.
3. US Food and Drug Administration. Lucentis (ranibizumab) intravitreal injection prescribing information. 2014. Accessed April 18, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf
4. US Food and Drug Administration. Eylea (aflibercept) injection prescribing information. November 2011. Accessed April 18, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf
5. Corcoran Consulting Group. Sample minor procedure operative report form. Accessed April 18, 2022. https://www.corcoranccg.com/products/forms/operative-report-forms/minor-procedure-operative-report/