Many of you may recall when the FDA issued a black box warning in March of 2007 for erythropoiesis-stimulating agents (ESAs) including Aranesp, Epogen, and Procrit. This announcement would have occurred nearly 17 years after the drugs hit the market. Clinical studies revealed an association with tumor growth, adverse cardiovascular events, and increased death with higher than normal doses or target hemoglobin levels of 13 g/dL or higher. New dosing regimens and guidelines were later published to reflect the updated findings.
Changes to treatment plans and dosing regimens were not the only things impacted by the black box warning. CMS and many other commercial insurers shortly followed suit and began applying coverage and billing requirements for initiation and ongoing maintenance of an ESA. This change has made ESA’s one of the most complex drug classes to manage clinically and financially. This newsletter provides only high level attributes of ESA billing and further research is required to fully understand all elements of ESA billing. Furthermore, each clinical setting (i.e. facility, professional clinic, dialysis center, etc.) have variations in billing that should be considered.
To break down the billing of an ESA, let’s begin with the assignment of the appropriate HCPCS. Each drug, for example darbeopoetin alfa, is assigned with two HCPCS codes based on patient status of renal disease. J0881 represents “injection, darbepoetin alfa, 1 microgram (non-ESRD use)” and J0882 represents “Injection, darbeopoetin alfa, 1 microgram (for ESRD on dialysis). Retacrit has an additional element of complexity in which the billing unit conversion is also different based on the HCPCS assigned and indication. Q5105 represents 100 units for ESRD on dialysis and Q5106 represents 1000 units for non-ESRD use.
A modifier should be applied to each HCPCS code to further represent the indication of the ESA.
EA – ESA administered to treat anemia due to anti-cancer chemotherapy
EB – ESA administered to treat anemia due to anti-cancer radiotherapy
EC – ESA administered to treat anemia NOT due to anti-cancer chemotherapy or anti-cancer radiotherapy
Each HCPCS reported on the claim must be accompanied by a modifier or the claim will be returned to the provider. Only one modifier should be reported per claim line. Some Medicare Administrative Contractors (MAC) may require additional modifiers to be applied based on the hemoglobin or hematocrit readings and are outlined further in the LCD.
Another requirement implemented January 2008, was the reporting of the most recent hematocrit or hemoglobin reading on the claim. Institutional claims require a value code of 48 or 49 to be reported alongside the hemoglobin or hematocrit reading respectively. Professional claims report test results in item 19 of the CMS 1500 paper claim form. For electronic claims lab values are reported in Loop 2400 MEA segment, MEA01=TR (for test results), MEA02=R1 (for hemoglobin) or R2 (for hematocrit), and MEA03=the test results.
Lastly, each Medicare Administrative Contractor (MAC) has published coverage determination articles that provide the clinical requirement to meet medical necessity. The medical record documentation must fully support the outlined criteria.
Coding, billing, and revenue integrity teams – recommend designating key experts who understand the coverage and billing requirements for ESAs. Implementing an edit or other process may be prudent to ensure all elements of the coding and billing are present on the claim prior to billing to avoid denials.
Pharmacy teams should collaborate with medical and laboratory teams to establish a process to obtain a Hct/Hgb prior to an ESA administration that satisfies the “most recent” date.
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Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.