How to Ensure Proper Reimbursement For Eylea

Here's guidance on cutting through the red tape.

Kirk A. Mack, COMT, COE, CPC

A new antiangiogenic agent, Eylea (aflibercept) from Regeneron Pharmaceuticals, was introduced to the retinal community upon approval by the FDA on November 18, 2011.¹ According to the product label,² Eylea is packaged in a single-use vial of 0.278 mL of 40 mg/mL aflibercept.

The sole indication for Eylea is neovascular age-related macular degeneration. The directions for use describe a treatment regimen of intravitreal injections of 2 mg (0.05 mL) every four weeks for the first three months, followed by additional injections of the same amount every eight weeks.

When new therapies become available, new codes, as well as new coverage and payment policies, must be developed, which can take time. Meanwhile, ophthalmologists and other providers face some administrative challenges. For instance, while it is anticipated that Medicare and other third-party payers will cover Eylea in due course, there was a dearth of local policies on this topic at the time of this writing.

CODING

CPT coding for the administration of the drug by intravitreal injection uses 67028, the same code that is used for injecting other anti-VEGF agents. In the Medicare Physician Fee Schedule, this service is assigned a global period of zero (0) days. For unilateral injections, use modifier –RT or –LT with this code; for bilateral injections, use modifier –50.

Unlike Lucentis, which CMS has assigned a unique HCPCS code, J2778, Eylea has only been assigned an HCPCS code, C9291, for facility-based services (ie, hospital or ASC) effective April 1, 2012.³ For in-office use, a miscellaneous HCPCS code, J3590 (unclassified biologics), is the only suitable choice at this time. In addition, use box 19 on the CMS-1500 claim form to identify the product name, National Drug Code (NDC) number, 61755-055-02, and dosing.

MEDICAL RECORDS

Documentation in the medical record must include the indication for treatment, a description of the procedure, identification of the medication and the dosage, and follow-up instructions. As we will see below, the actual amount of Eylea given to the patient is a very important part of this note.

PAYMENT

In 2012, the national Medicare Physician Fee Schedule allowable for 67028, when performed in the office setting, is $116. When performed in a facility, the physician reimbursement is slightly lower ($104) due to the site-of-service differential. For an HOPD, Medicare's national payment rate for 67028 falls within the ambulatory payment classification (category APC-238), and for 2012, it is $217; for an ASC, it is $60. These payments do not include the supply of Eylea, which is reimbursed separately. These amounts are adjusted by local wage indices in each area. Other third-party payers set their own rates, which may differ significantly from Medicare's rates.

Eylea is listed in the Medicare NOC (not otherwise classified) Pricing File.⁴ For the first quarter of 2012, a payment rate $1,961.00 has been assigned for the 2 mg vial. Under CMS's Conditions for Coverage for hospitals and ASCs, $1,961 is the full payment for a single-use vial, and providers must discard the vial after treating one patient.

SPLITTING SINGLE-USE VIALS

A different CMS policy applies to in-office use of injectable medications. In the Medicare Claims Processing Manual, Chapter 17 §40 — Discarded Drugs and Biologicals, it states, “The CMS encourages physicians, hospitals and other providers and suppliers to care for and administer to patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label.”⁵

Because a single-use vial of Eylea contains enough medication to treat five patients due to the overfill, and CMS's efficient use policy encourages you to consider ways to use the extra supply, ophthalmologists might think of splitting the vial among several patients to save money. Assuming that the clinical issues of sterility can be satisfied in practice, this raises an important question about Medicare's payment policy: Is each dose reimbursed at $1,961?

The answer is no. This issue of reimbursement for drugs and determination of Average Sales Price by Medicare is discussed in 42 Code of Federal Regulations Chapter IV §414.904(a)(3):

(i) CMS calculates an average sales price payment limit based on the amount of product included in a vial or other container, as reflected on the FDA-approved label.
(ii) Additional product contained in the vial or other container does not represent a cost to providers and is not incorporated into the ASP payment limit.
(iii) No payment is made for amounts of product in excess of that reflected on the FDA-approved label.

In addition, the final rule of the 2011 Medicare Physician Fee Schedule, published November 29, 2010, addresses intentional overfills.

“We further understand that when a provider purchases a vial or container of product, the provider is purchasing an amount of drug defined by the product pack aging or label. Any excess product (that is, overfill) is provided without charge to the provider. In accordance with our current policy as explained above, providers may not bill Medicare for overfill harvested from single use containers, including overfill amounts pooled from more than one container, because that overfill does not represent a cost to the provider. Claims for drugs and biologicals that do not represent a cost to the provider are not reimbursable, and providers who submit such claims may be subject to scrutiny and follow up action by CMS, its contractors, and OIG.”⁶

Attention to the issue of multidosing from a single vial has arisen partly from a criminal case involving an ophthalmologist, Seth Yoser, MD.⁷ In 2009, Dr. Yoser was convicted of criminal wrongdoing and was sentenced to 42 months in prison. To covertly procure the unused prescription drugs that he resold, Dr. Yoser would obtain the number of vials he believed necessary to treat his patients on a particular day, but as he treated his patients, he would administer multiple doses of medication from a single vial. In this particular case, the drugs were Visudyne and Lucentis.

CONCLUSION

In summary, a new antiangiogenic medication is a welcome addition to our treatment armamentarium for wet AMD. However, the reimbursement rules for this new product have not yet been fully elucidated, and much uncertainty remains. For billing purposes, use CPT 67028 to report the intravitreal injection and C9291 or J3590 to report the supply of Eylea; the former HCPCS code applies to facilities, while the latter code applies to physician's offices.

Finally, there are some important issues raised by the overfill in a single-use vial, which have engendered controversy in one criminal case, as well as amplification of Medicare's rules regarding efficient use of drugs and biological agents. As a result, it is essential to document in the medical record the amount of Eylea given to the patient. RP

REFERENCES

1. US Food and Drug Administration. FDA approves Eylea for eye disorder in older people. November 18, 2011. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280601.htm. Accessed March 27, 2012.
2. US Food and Drug Administration. Eylea product label. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf. Accessed March 27, 2012.
3. US Centers for Medicare and Medicaid Services. Medicare claims processing. Available at: https://www.cms.gov/transmittals/downloads/R2418CP.pdf. Accessed March 27, 2012.
4. US Centers for Medicare and Medicaid Services. 2012 ASP drug pricing files. http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a17_2012ASPFiles.asp. Accessed March 27, 2012.
5. US Centers for Medicare and Medicaid Services. Medicare Claims Processing Manual. http://www.cms.gov/manuals/downloads/clm104c17.pdf. Available at: Accessed March 27, 2012.
6. US Government Printing Office. CY 2011 PFS final rule. Federal Register. 2010; 75(228):73466.
7. US District Court for the Western District of Tennessee. VRF Eye Specialty Group, PLC v. Seth L. Yoser. Available at: http://tn.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20110119_0000015. WTN.htm/qx. Accessed March 27, 2012.