Prepare for the inevitable with proper documentation.

Injectable drugs for retinal disease — particularly ranibizumab (Lucentis; Genentech) and aflibercept (Eylea; Regeneron) — are the focus of audits for Medicare and other payers. How can you avoid problems?

Q. Why does Medicare devote so much attention to anti-VEGF drugs?

A. The simple answer is there is an enormous volume of payments made by the Medicare program for just 2 drugs — Lucentis (J2778) and Eylea (J0178). In 2017, Medicare Part B paid more than $3.4 billion for injectable eye drugs; of this amount, more than $3.3 billion was comprised of just these 2 drugs, as shown in Table 1. Of the more than $9 billion paid by Medicare for all services and supplies to ophthalmologists, the supply of Lucentis and Eylea alone accounted for nearly 38%, according to information compiled by Corcoran Consulting Group from CMS data for claims in calendar year 2017.

Q. What documentation is required to support claims for anti-VEGF drugs?

A. There are a number of specific elements to include in medical records.

• Confirm that at least 28 days have passed between injections in the same eye. If fewer than 28 days have passed, ensure that the rationale is well documented and useful in a possible appeal.
• Document a surgical plan, which includes the name of the drug, the dosage, and the indication, along with the physician’s signature.
• Document medical necessity, including diagnosis, indications, and changes to patient condition; diagnostic test results; and patient desire to have the injection.
• Obtain informed consent for first-time injection and if there is a change in medication or eye.
• For new patients, document why the specific drug was selected.
• For established patients, document at each visit how the patient is responding to therapy.
• In your operative note, document the volume and dose of the injected drug, and how much (if any) was wasted or discarded. Noting “no drug was wasted” or “only manufacturer overfill was discarded” may satisfy a payer’s expectation for this information.
• Remember that all documentation must be clear and legible.

Q. Why does Medicare use a 28-day interval between injections?

A. This is based on the FDA package labeling for ranibizumab,¹ which specifies this interval. Aflibercept package labeling is more flexible, but also states that once every 4 weeks after the initial loading does is the maximum frequency.² Medicare also often applies the same requirement for intravitreal injections of Avastin, which has no FDA guidelines for ophthalmic use.

Q. What audits are currently active?

A. According to the American Academy of Ophthalmology website,³ Novitas, the Medicare Administrative Contractor (MAC) for jurisdictions H and L, is currently sending target, probe, and educate (TPE)⁴ audit letters to high-volume users of Eylea in these jurisdictions (jurisdiction H encompasses Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas, while jurisdiction L encompasses Delaware, Maryland, New Jersey, Pennsylvania, and the DC metro area). They are being required to submit up to 40 medical records for patients being treated with Eylea for wet macular degeneration. In 2016, a similar round of TPE audits looked at Lucentis in a number of states.

Q. How should we respond to a TPE or other audit?

A. Review the charts before sending anything. Be sure to include the following:

• Patient name and date of service on every page.
• Relevant history and any prior treatment to support medical necessity. Often, prior visits will include the physician’s order for the treatment and documentation of tests used to make the determination to perform the injection.
• Results of diagnostic tests (legible images and interpretation) supporting the need for continued treatment.
• An operative note including patient name; date of service; the treated eye; a description of the procedure; the drug administered, including the volume administered and any discarded amount; a note of any complications; and discharge instructions.⁵
• Any relevant correspondence, such as referral letters that add to or support the therapy. It is not unusual for correspondence between physicians to include an “easy to understand” summary.

Of course, do not alter any records, but you may supplement the records you send, and you probably should. Supplementary documentation might include 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 the electronic health record.
• MAC local coverage determination, 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. How can we protect ourselves from an audit?

A. If you are a high-volume biller of intravitreal injections, the likelihood is that you will be audited. The key is being prepared. Perform your own internal audits to ensure that you have adequate systems in place, and that your protocols are being followed. Conduct periodic training for physicians and staff. Remember that they are human and can easily fall into bad habits or become careless. RP

REFERENCES

1. Lucentis (ranibizumab injection) intravitreal injection. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf . Accessed May 24, 2019.
2. Eylea (aflibercept) injection. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf . Accessed May 24, 2019.
3. American Academy of Ophthalmology. Payer documentation requirements when injecting Eylea. April 11, 2019. https://www.aao.org/practice-management/news-detail/payer-documentation-requirements-when-injecting-ey . Accessed May 28, 2019.
4. Corcoran SL. A kinder, gentler audit? Get ready. Ophthalmol Manag. 2018;22(3):13,45.
5. Corcoran Consulting Group. Sample minor procedure operative report that may be used as a starting point. https://www.corcoranccg.com/products/forms/operative-report-forms/minor-procedure-operative-report/ . Accessed May 24, 2019.