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Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...

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CMS-1403-FC (70 FR 70236). The CY 2007 PFS final rule with comment period (72 FR 66260) then finalized portions of the July 6, 2005 IFC that had not already been finalized. The CAP is an alternative to the ASP (buy and bill) methodology of obtaining certain Part B drugs used incident to physicians’ services. Physicians who choose to participate in the CAP obtain drugs from vendors selected through a competitive bidding process and approved by CMS. Under the CAP, physicians agree to obtain all of the approximately 190 drugs on the CAP drug list from an approved CAP vendor. A vendor retains title to the drug until it is administered, bills Medicare for the drug, and bills the beneficiary for cost sharing amounts once the drug has been administered. The physician bills Medicare only for administering the drug to the beneficiary. The CAP currently operates with a single CAP drug category. CAP claims processing began on July 1, 2006. After the CAP was implemented, section 108 of the MIEA–TRHCA made changes to the CAP payment methodology. Section 108(a)(2) of the MIEA–TRHCA requires the Secretary to establish (by program instruction or otherwise) a post-payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological only if the drug or biological has been 154

CMS-1403-FC administered to a beneficiary. The Secretary is required to recoup, offset, or collect any overpayments. This statutory change took effect on April 1, 2007. Conforming changes were proposed in the CY 2008 PFS proposed rule (72 FR 38153) and finalized in the CY 2008 PFS final rule with comment period (72 FR 66260). In the CY 2009 PFS proposed rule, we proposed several refinements to the CAP regarding the annual CAP payment amount update mechanism, the definition of a CAP physician, the restriction on physician transportation of CAP drugs, and the dispute resolution process (73 FR 38522). However, since the publication of our proposed rule, we have announced the postponement of the CAP for 2009 due to contractual issues with the successful bidders. As a result, CAP physician election for participation in the CAP in 2009 is not being held this Fall, and CAP drugs will not be available from an Approved CAP Vendor for dates of service after December 31, 2008. Moreover, we are currently soliciting public feedback on the CAP from participating physicians, potential vendors, and other interested parties. We are soliciting public comments about a range of issues, including, but not limited to the following issues: the categories of drugs provided under the CAP; the distribution of areas that are 155

<strong>CMS</strong>-1403-FC<br />

administered to a beneficiary. The Secretary is required<br />

to recoup, offset, or collect any overpayments. <strong>This</strong><br />

statutory change took effect on April 1, 2007. Conforming<br />

changes were proposed in the CY 2008 PFS proposed rule<br />

(72 FR 38153) and finalized in the CY 2008 PFS final rule<br />

with comment period (72 FR 66260).<br />

In the CY 2009 PFS proposed rule, we proposed several<br />

refinements to the CAP regarding the annual CAP payment<br />

amount update mechanism, the definition of a CAP physician,<br />

the restriction on physician transportation of CAP drugs,<br />

and the dispute resolution process (73 FR 38522). However,<br />

since the publication of our proposed rule, we have<br />

announced the postponement of the CAP for 2009 due to<br />

contractual issues with the successful bidders. As a<br />

result, CAP physician election for participation in the CAP<br />

in 2009 is not being held this Fall, and CAP drugs will not<br />

be available from an Approved CAP Vendor for dates of<br />

service after December 31, 2008.<br />

Moreover, we are currently soliciting public feedback<br />

on the CAP from participating physicians, potential<br />

vendors, and other interested parties. We are soliciting<br />

public comments about a range of issues, including, but not<br />

limited to the following issues: the categories of drugs<br />

provided under the CAP; the distribution of areas that are<br />

155

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