(Medicare Claims Processing Manual)

The A/B MACs (B) s and the Designated A/B MAC (B) shall develop the capacity to manually add new vendor specific HCPCS codes and identify to which vendor lists these have been added for the table developed in 4064.1.1.2.1 on a quarterly basis upon notifica tion by CMS.  A/B MACs (B) shall add these codes to their table by 7 days after receipt of notification from CMS.   100.8.1 - Updating Fee Schedule for New Drugs in CAP  (Rev. 866, Issued: 02- 17-06, Effective: 07 -01-06, Implementation: 07- 03-06)  The Designated A/B MAC (B) shall develop the capacity to add the prices for the new vendor specified HCPCS codes to the pricing table.  Prices will be available on the CMS website for the quarterly update of prices to the of new drug prices.   100.8.2 - Changes to the List of Drugs Supplied by Approved CAP Vendors   (Rev. 1506; Issued:  05- 16-08; Effective Date:  10 -01-08; Implementation Date:  10-06-08)  The CAP will be implemented with a single category of drugs and one geographic area, however as the program evolves, additional geographic areas and additional drug categories may be created.  Approved CAP vendors will also be able to request approval for changes to the lists of drugs that they supply under the CAP.  As CMS continues to develop the CAP, additional geographical areas and additional drug categories may be created.  If additional drug categories are created, certain drugs may appear in more than one drug category.   Approved CAP vendors will be permitted to request certain changes to the list of drugs that they supply under the CAP.  Beginning in July 2006 with changes to be effective October 1, 2006, approved CAP vendors may request that CMS (or its designee) approve  the following types of changes:    Substitution:   Approved CAP vendor may request approval to replace one or more drug products as identified by national drug codes (NDCs) in a Healthcare Common Procedure Coding System (HCPCS) code supplied by the approved CAP vendor with one or more NDCs.    Add newly issued HCPCS Codes:  Approved CAP vendor may request that CMS allow it to supply additional drug products with new HCPCS codes under the CAP.    Additional NDCs:  Approved CAP vendor may request that CMS allow it to supply additional NDCs under a HCPCS code that the approved CAP vendor already supplies under the CAP.   Orphan Drugs:  Approved CAP vendor may request that CMS allowed it to supply single indication orphan drugs under the CAP.  Regulation text describing the above may be found at 42 CFR 414 Subpart K.  Changes to the drug list :  Written requests for changes to the approved CAP vendors drug list must be submitted to CMS and the CAP designated A/B MAC (B).  The requests 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.  If approved, routine changes will become effective at the beginning of the following quarter.  CMS will post the changes on the CMS Web site:  http://www.cms.gov/Medicare/Medicare -Fee-for-Service- Part-B-Drugs/CompetitiveAcquisforBios/index.html    and notify the A/B MACs (B) and participating CAP physicians of any changes on a quarterly basis via a recurring Change Request (CR).  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.  Please note that approved  changes will apply only to the list of drugs supplied by the approved CAP vendor who submitted the request; therefore, each vendors drug list may contain different drugs after changes to the initial drug list are approved.   Timeline for changes :  There will be one timeline for the submission of changes to the approved CAP vendors drug list.  For new HCPCS and/or NDC codes, and substitutions or changes to NDC codes supplied under an existing HCPCS code, the approved CAP vendor will be required t o submit requests for drug list changes no later than four months before the beginning of the quarter in which the changes will take effect.  Updated tables listing the HCPCS codes under a specific vendors drug categories will be avail able 30 days prior to the start of the following quarter.  NDC number changes will not require associated table modifications and will not affect established payment amounts.  Physicians will be notified of these changes 30 days before the start of a quart er.  Price files incorporating these changes will be available 7 -14 days prior to the effective date for the corresponding changes.  An example of the timeline for the July 1, 2008 HCPCS and NDC code changes appears below.   Example of Timeline for HCPCS and NDC Additions   Date  Action  3/1/2008  Vendor deadline to submit request for new HCPCS and/or NDCs  3/12/2008  CMS begins approval process to evaluate vendor request  5/24/2008  HCPCS and/or NDC changes approved to become effective July 1, 2008  5/30/2008  Per the approval of all clearance processes, CMS issues a CR regarding approved drug list changes and tables that will become effective July 1, 2008  6/2/2008  Designated A/B MAC (B) downloads HCPCS changes to the drug table.  List posted onto the CMS Web site.  Physicians receive updated list of drugs from the CAP vendor.  6/5/2008  A/B MACs (B) shall acquire HCPCS changes from the Designated A/B MAC (B)  6/17-6/24/2008  Price file with new codes posted  7/1/2008  Effective date for additional HCPCS codes; beginning of next quarter   Payment amount :  The payment amount for new HCPCS codes added to an approved CAP drug vendors drug list will be ASP + 6%.  Addition or substitution of NDC numbers under an existing HCPCS code supplied by an approved CAP vendor will not change the CAP single payment amount for that HCPCS code.  CMS will update the single payment amount base d on the approved CAP vendors reported net acquisition costs for the category of drugs on an annual basis.  100.8.3 - CAP Not Otherwise Classified (NOC) Drugs  (Rev. 1034, Issued:  08- 18-06; Effective:  01 -01-07; Implementation:  01 -02-07)   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 vendors 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 informatio n 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 quart er.  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 vendors 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 lea st 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 s hall 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.   100.8.3.1 - Editing for CAP NOC Drugs  (Rev. 3721, Issued: 02- 24-17, Effective: 05 -25-17, Implementation: 05- 25-17)  Should the A/B MAC (B) receive a CAP NOC code, but the description does not match a CAP NOC drug on the approved list, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.   Group Code: CO  CARC: 16  RARC: N350  MSN: N/A  Should a non- CAP physician submit the CAP NOC code, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scen ario Two.   Group Code: CO  CARC: 16  RARC: N56  MSN: N/A  Should a CAP physician submit a J NOC code with a description of a CAP approved NOC drug, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.   Group Code: CO  CARC: 16  RARC: N56  MSN: N/A  100.9 - Non-Participating Physicians Who Elect the CAP   (Rev. 866, Issued: 02- 17-06, Effective: 07 -01-06, Implementation: 07- 03-06)  Participating CAP physicians must appeal drug administration denials.  For a non-participating physician that elects to participate in the CAP, he or she must agree to accept assignment for all CAP drug administration charges to allow for the Medicare bene ficiarys and approved CAP vendors appeal rights.  A/B MACs (B) shall pay all HCPCS codes that provide payment for the administration of CAP drugs on an assigned basis.  101 - The Competitive Acquisition Program (CAP) for Drugs and Instructions on Special CAP Appeals Requirements and Delivery of Dispute Resolution Services  (Rev. 1076, Issued:  10- 13-2006; Effective:  07- 01-06; Implementation:  11- 13-06)