CMS Pub. 100-04, ch. 17, § 100.8.3

As described in Section 100.8.2, approved CAP vendors are able to request approval for

changes to the list of drugs that they supply under the CAP. In an effort to improve

beneficiary access to newly marketed drugs, approved CAP vendors will be able to

request the addition of certain NOC drugs as defined by CMS to their drug lists for

claims with dates of service on or after January 1, 2007.

The process for adding NOC drugs to an approved CAP vendor’s drug list will generally

follow the process for adding new drugs to the CAP. An approved CAP vendor is

required to submit a written request to add specific NOC drugs to the CAP designated

A/B MAC (B). The request must include a rationale for the proposed change, and a

discussion of the impact on the CAP, including safety, waste, and potential for cost

savings. The CAP designated A/B MAC (B) will review the application and forward the

information to CMS along with a recommendation for approval or denial. CMS will

make a final decision upon review of the application and the designated A/B MAC (B)’s

recommendation. If approved, changes will become effective at the beginning of the

following quarter. CMS will post the approved NOC additions along with other changes

to the CAP Drug List on the CMS Web site:

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/CompetitiveAcquisforBios/index.html

Additions of NOC drugs apply only to the approved CAP vendor and the CAP category

identified on the request. Therefore, each vendor’s drug list may contain different drugs

after changes to the initial drug list are approved. The timeline for this process follows

the timeline for HCPCS code changes described in manual section 100.8.2. CMS will

also continue to notify A/B MACs (B) of any changes to the CAP drug list on a quarterly

basis. Participating CAP physicians will also be notified of changes at least 30 days

before the approved changes will become effective.

The process to approve CAP NOC drugs differs from the process for other CAP drug

approvals in two significant ways. First, CMS will define a list of CAP NOC drugs that

the approved CAP vendor must use when requesting the addition of NOC drugs to the

CAP. The CAP NOC drug list is based on the current ASP NOC list and is limited to

drugs that are likely to fit the existing CAP drug category (or categories) and drugs that

have a single national ASP-based payment amount. The list of CAP NOC drugs will be

posted on the CMS CAP Web site: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/CompetitiveAcquisforBios/index.html and updated quarterly. The

CAP NOC drug payment amount is set at the rate published on the ASP NOC file

consistent with the next quarterly update; the CAP NOC payment amount will be updated

annually.

Second, physician administration claims and vendor drug claims for services related to

CAP NOC drugs are required to use the CAP-specific Q-code for all CAP NOC drug

claims along with the appropriate CAP modifiers. This code is necessary to distinguish

CAP NOC drug claims from ASP NOC claims and to provide payment for CAP NOC

drugs within the CAP. In addition to the use of the CAP NOC Q-code, CAP NOC claims

must identify the specific NOC drug that had been administered. All remaining

requirements concerning the proper submission of a claim continue to be effective, and

claims processing for CAP NOC drug claims will follow procedures described in

previous CAP CRs and applicable Manual sections. All current editing for other NOC

codes shall also be applied to the CAP NOC code.

Participating CAP physicians will continue to use ASP NOC codes when billing for NOC

drugs that are not included in the CAP category they have chosen. Participating CAP

physicians are required to obtain all CAP drugs from the approved CAP vendor including

any drugs added to the CAP drug list under this process, unless medical necessity

requires the use of a formulation not supplied by the vendor.