Is risankizumab-rzaa (Skyrizi) 1200mg IV at 0, 4, 8 weeks x3 infusions medically necessary for a patient with Ulcerative (chronic) rectosigmoiditis without complications?

Medical Necessity Assessment: Risankizumab for Ulcerative Rectosigmoiditis

Medical necessity is NOT met for risankizumab (J2327) and associated infusion codes for this patient because critical documentation of disease severity and prior treatment failures is completely absent from the clinical record.

Critical Documentation Deficiencies

The case lacks essential evidence required by all major guidelines and the FDA label:

Missing Disease Severity Documentation

• No objective measures of moderate-to-severe disease activity are documented 1, 2
• The diagnosis code K51.30 explicitly states "without complications," contradicting the moderate-to-severe disease requirement 2
• No documentation of:
  • Bowel movement frequency (≥4 per day required) 1
  • Visible blood in stool 1
  • Urgency of defecation 1
  • Anemia 1
  • Endoscopic findings showing erosions, friability, or ulceration 1

Missing Prior Treatment Documentation

The British Society of Gastroenterology (2025) and FDA label require documented failure of prior therapies 1, 2:

• No documentation of intolerance or inadequate response to:
  • Conventional therapy (oral corticosteroids, salicylates, azathioprine, or 6-mercaptopurine) 1, 2
  • TNF inhibitors (adalimumab, infliximab, certolizumab) 1, 2
  • Vedolizumab 1
  • Other advanced therapies 1

Guideline Requirements for Risankizumab in Ulcerative Colitis

FDA-Approved Indication

The FDA label (2025) specifies risankizumab 1,200 mg IV at weeks 0,4, and 8 for induction in moderately to severely active ulcerative colitis 2. The dosing regimen matches what was billed (05/09/2025,06/06/2025,07/11/2025 at 4-week intervals), but patient eligibility cannot be confirmed 2.

Evidence-Based Efficacy

• The British Society of Gastroenterology (2025) conditionally recommends risankizumab based on the INSPIRE trial showing 20.3% clinical remission versus 6.2% placebo at week 12 1
• Clinical response was 64.3% versus 35.7% placebo 1
• Endoscopic improvement was 36.5% versus 12.1% placebo 1
• However, this recommendation applies only to patients with documented moderate-to-severe disease who have failed conventional and/or advanced therapies 1

AGA Guidelines Position

The American Gastroenterological Association (2024) classifies risankizumab as a HIGHER efficacy medication for moderate-to-severe UC in biologic-naïve patients, with conditional recommendation and low certainty evidence 1. The AGA demonstrated risankizumab achieved clinical remission with RR 3.30 (95% CI: 2.10-5.18) versus placebo 1.

Infliximab Claim (01/03/2025)

The infliximab claim (Q5104) on 01/03/2025 also lacks medical necessity documentation per Aetna CPB 0341:

• No documentation of moderately to severely active UC 2
• No dose or frequency information provided 2
• This claim should follow the same denial rationale as risankizumab due to absent severity documentation

Supportive/Ancillary Codes

The following codes are appropriately denied as they are dependent on the primary therapy codes:

• 36415 (venipuncture) - follows primary code determination 2
• 80053 (comprehensive metabolic panel) - follows primary code determination 2
• 96413,96415 (chemotherapy administration) - follows primary code determination 2
• J7050, J7060 (normal saline, dextrose) - follows primary code determination 2

What Documentation Would Be Required

To establish medical necessity, the clinical record must contain:

Disease Severity Evidence (at least one):

• Stool frequency ≥4 bowel movements per day with urgency 1
• Visible blood in stool 1
• Endoscopy report showing erosions, friability, ulceration, or endoscopic subscore >1 1
• Laboratory evidence of anemia or elevated inflammatory markers with clinical correlation 1

Prior Treatment Failure Documentation (at least one):

• Trial of oral corticosteroids with inadequate response, loss of response, or intolerance 1, 2
• Trial of 5-ASA/salicylates with inadequate response 1
• Trial of immunomodulator (azathioprine/6-MP) with inadequate response or intolerance 1
• OR trial of TNF inhibitor with inadequate response, loss of response, or intolerance 1, 2
• OR trial of vedolizumab with inadequate response, loss of response, or intolerance 1

Clinical Assessment Note

• History and physical examination documenting moderate-to-severe symptoms 1
• Rationale for selecting risankizumab over other advanced therapies 1
• Treatment plan including monitoring strategy 2

Common Pitfall

The diagnosis code K51.30 ("without complications") directly contradicts the requirement for moderate-to-severe disease 1. This represents either a coding error or confirmation that the patient does not meet severity criteria. If the patient truly has moderate-to-severe disease, the diagnosis code should reflect this with appropriate modifiers or alternative codes indicating disease activity 1.