Clinical denials are rising sharply, now costing U.S. health systems over $20 billion annually in unrecovered reimbursement. Payers are tightening policies around high-cost outpatient and infusion services, deploying sophisticated utilization review, clinical validation edits, and post-payment audits that often overlook the full clinical picture and documentation intent.
The successful overturn of a $61,000 outpatient infusion denial for one of our clients underscores both the magnitude of the problem and the value of focused, expert clinical appeals support.
Challenges
This was a 47-year-old female with a past medical history that included Metastatic ER+/HER2+ Breast Cancer, Secondary Malignant Neoplasm to the Bone, Anemia, Generalized Anxiety Disorder, and Muscle Spasms. The patient had been originally diagnosed with breast cancer. Her initial treatment regimen included Herceptin, Perjeta, Femara, and Zometa, and tolerated it well with minimal myelosuppression.
However, due to severe muscle spasms, the Femara was discontinued. Treatment with Arimidex 1 MG daily was initiated as an alternative treatment. Months later, the patient presented to to her Medical Oncology for a follow-up appointment. At that time, the Oncologist also noted her had been previously treated with Taxol, which she had a significant allergic reaction therefore it was discontinued. The Oncologist recommended continuing treatment with Herceptin, Perjeta, and Zometa.
Anthem Medical Drug Clinical Criteria
- Perjeta (Pertuzumab)
- “Individual has a diagnosis of HER2-positive (HER2+) breast cancer (NCCN 2A); Confirmed by one of the following:
- Immunohistochemistry (IHC) is 3+;
- In situ hybridization (ISH) positive; AND II.
- Individual is using in one of the following ways: A. Individual has a diagnosis of metastatic breast cancer (Label, NCCN 1, 2A);
- Individual is using in combination with trastuzumab (or trastuzumab biosimilars) and either docetaxel* or paclitaxel*;
- The combination chemotherapy will be used as single-line anti-HER2 chemotherapy for metastatic disease until progression;
- If docetaxel or paclitaxel treatment is contraindicated upon initiation or discontinued (for example, related to toxicity), treatment with Pertuzumab and trastuzumab (or trastuzumab biosimilars) may continue.”[1]
- “Individual has a diagnosis of HER2-positive (HER2+) breast cancer (NCCN 2A); Confirmed by one of the following:
- Herceptin (Trastuzumab)
- When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Herceptin (trastuzumab); Ogivri (trastuzumab-dkst); Herzuma (trastuzumab- pkrb); Ontruzant (trastuzumabdttb); Trazimera (trastuzumab-qyyp); Kanjinti (trastuzumab-anns) Requests for Herceptin (trastuzumab) Ogivri (trastuzumab-dkst) Herzuma (trastuzumab- pkrb) Ontruzant (trastuzumab-dttb) Trazimera (trastuzumab-qyyp) or Kanjinti (trastuzumab-anns) may be approved.”[2]
Solution
As part of Managed Resources’ industry-leading clinical appeals process, the denial was reviewed and assigned to a specialized RN to begin the appeal process.
We appealed this denial based on both Physician Judgment and the Anthem Medical Drug Clinical Criteria. We provided imaging, office notes and radiology notes. We described the events leading to the medical decision making for the administration of IVPB Trastuzumab 600 MG, IVPB Pertuzumab 420 MG, and IV Zometa 4 MG.
Results
After a comprehensive appeals process, Managed Resources successfully overturned the entire balance in the amount of $61,000.
This case reinforces how the right clinical denials management expertise can transform a high-risk, high-dollar denial into recovered revenue that would otherwise be lost.
View or download case study here.
To learn more about our Clinical Appeals & Denials Management services, contact us here.
[1] https://www.anthem.com/ms/pharmacyinformation/Perjeta.pdf
[2] https://www.anthem.com/ms/pharmacyinformation/TrastuzumabAgentsStepTherapy.pdf