January 2007
Provider Types Affected
Physicians participating in the Medicare Part B Drug CAP
Impact on Providers
This article is based on Change Request (CR) 5259, which describes the process for adding Not Otherwise Classified (NOC) Drugs to the CAP beginning in 2007. It provides additional details, information and instructions for the implementation of the CAP as outlined previously in CRs 4064, 4306, 4309 and 5079 and the MLN Matters articles related to those CRs.
Background
As discussed in the November 21, 2005 CAP final rule (http://www.access.gpo.gov/su_docs/fedreg/a051121c.html) and in response to public comments about beneficiary access to new medications, CMS provided for the addition of NOC drugs to the CAP beginning in 2007. CMS believes that the addition of NOC drugs to the CAP will improve beneficiaries' access to newly marketed drugs that have a national sales price, will decrease the reliance on buy and bill acquisition and will further simplify the drug acquisition process for physicians who have elected to participate in the CAP.
Process To Add NOC Drugs to a CAP Vendor's Drug List
The process for adding NOC drugs to the CAP will basically follow the process for adding other drugs to the CAP as described in CR5079. An approved CAP vendor will be required to submit a written request to add specific NOC drugs to the CAP designated carrier. The request must include:
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 will be based on the ASP NOC list, but will include only drugs that are both likely to fit the existing CAP drug category (or categories) and drugs that have a single national ASP-based payment amount. The CAP NOC drug list will be posted on the CMS CAP website and updated quarterly.
If approved, changes will become effective at the beginning of the following quarter. CMS will post the changes on the CMS website (http://www.cms.hhs.gov/CompetitiveAcquisforBios/) and notify the carriers and participating CAP physicians of any changes on a quarterly basis. Participating CAP physicians will be notified of changes to their approved CAP vendor’s CAP drug list on a quarterly basis and at least 30 days before the approved changes are due to take effect. CAP drug list approvals apply only to the CAP vendor who submitted the request and to the 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 CAP NOC drug payment amount will be at the same rate as published on the ASP NOC file consistent with the next quarterly update, and the payment amount will be updated annually as for other CAP drugs.
CAP NOC Claims Submission Requirements
CMS requires the use of a CAP-specific Q code (Q4082 Drug/bio NOC part B drug CAP) for CAP NOC drug claims in order to distinguish CAP NOC drug claims from ASP NOC claims and to prevent the CAP claims from being paid outside the Medicare Part B drug CAP. Physician drug administration claims for CAP NOC drugs are required to use the CAP-specific NOC Q-code: Q4082 Drug/bio NOC part B drug CAP and identify the specific NOC drug that had been administered in Item 19 on paper claims or Loop 2300 Segment NTE on electronic claims. Physician claims must also contain the appropriate CAP modifiers (J1, J2, J3) All other CAP claim parameters will remain the same
Note: Physicians who have elected to participate in the CAP should continue to use ASP NOC codes when billing for NOC drugs that are outside the CAP. Also remember that physicians who participate in the CAP are required to obtain all CAP drugs on the updates from the approved CAP vendor unless medical necessity requires the use of a formulation not supplied by the vendor.
Returned CAP NOC Claims
For the following three situations, if:
Then:
Implementation
The implementation date for CR5259 is January 2, 2007.
Additional Information
Section 303 (d) of the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003, requires the implementation of a Competitive Acquisition Program (CAP) for Medicare Part B drugs and biologicals (“drugs”) not paid on a cost or prospective payment system basis. Beginning with drugs administered on or after July 1, 2006, physicians will be given a choice between buying and billing these drugs under the Average Sales Price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process. A participating CAP physician will submit a claim for drug administration to the Medicare local carrier. An approved CAP vendor will submit a claim for the drug product to the CAP Medicare designated carrier.
Change Request (CR) 5259 is not a stand-alone CR. It provides additional details, information, and instructions for the implementation of the Competitive Acquisition Program (CAP) as outlined in:
CR4064 (http://www.cms.hhs.gov/transmittals/downloads/R777CP.pdf; http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4064.pdf),
CR4306 (http://www.cms.hhs.gov/transmittals/downloads/R841CP.pdf),
CR4309 (http://www.cms.hhs.gov/transmittals/downloads/R866CP.pdf; http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4309.pdf) and
CR 5079 (http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4064.pdf; http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5079.pdf).
For complete details, please see the official instruction issued to your carrier regarding this change. That instruction may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R1034CP.pdf] on the CMS website.
If you have any questions, please contact your state's Provider Contact Center.
MLN Matters MM5259