Friday, March 18, 2022

Nerd Note: March 9, 2022: CMS Updates ADUHELM Pricing

There has been extensive news pro and con the Alzheimer drug ADUHELM.  I noted an unexpected reference to ADUHELM pricing when I was looking up ASP pricing on other products.   I'll quote CMS in full; I don't claim to fully understand the inner details of ASP pricing rules.  This points up the complexity of the longstanding ASP pricing rules for injectable Part B drugs.

"WAMP" is "Widely Available Market Prices," see an OIG report here from 2012.

See a February 2022 notification from OIG to CMS, here.

Relatively complicated WAMP rules are online here, with a key section at (d)(3):

(3) Widely available market price and average manufacturer price. If the Inspector General finds that the average sales price exceeds the widely available market price or the average manufacturer price by the applicable threshold percentage specified in paragraph (d)(3)(iii) or (iv) of this section, the Inspector General is responsible for informing the Secretary (at such times as specified by the Secretary) and the payment amount for the drug or biological will be substituted subject to the following adjustments...[continues]

2022 ASP Drug Pricing Files

Notice of Pricing Changes for the April 2022 Medicare Part B Quarterly Average Sales Price Pricing File

This announcement serves as notification of the process that we used to substitute the WAMP for the ASP for Aduhelm in the April 2022 ASP pricing files, consistent with our regulations at 42 CFR 414.904(d), based on the findings of the OIG that the ASP used to set the Medicare Part B payment amount for Aduhelm exceeds the WAMP.

 Based on the findings of the OIG that identify the WAMP for a drug, we will substitute the WAMP for the ASP for the HCPCS code that identifies the drug for the following quarter, and we will announce the substitution through the ASP pricing files, which will reflect the substituted payment allowance and include a notation of the substitution.

Consistent with this process, based on findings of the OIG transmitted to CMS in February 2022, we have substituted the WAMP for the ASP for HCPCS code J0172 (Inj, aducanumab-avwa, 2 mg) for the quarter beginning April 1, 2022.

Consistent with the Calendar Year 2011 Physician Fee Schedule final rule (75 FR 73470), we are providing an opportunity to comment on the process and the WAMP substitution for Aduhelm. Comments should be directed to by March 30, 2022.

Jeopardy question - Answer, WAMP.   Question, "Alex, what is Medicare Widely Available Market Price?"