CMS Proposes New Competitive Acquisition Program for Part B Drugs

On March 4, CMS published a proposed rule dealing with the competitive acquisition program (CAP) for drugs under Part B. This provision was part of the MMA of 2003. It is a voluntary program where physicians can elect to have a vendor(s) provide and bill for drugs provided to Medicare patients for use in the physician’s office. Physicians electing to participate in CAP would no longer need to bill the program nor the beneficiary for coinsurance for incident-to drugs. While the government indicates that this might yield some savings relative to the current system, its stated objective is to reduce the financial burden on physicians who no longer have to bill the program and beneficiaries for drugs. ASH submitted comments to CMS on the proposed rule that include a number of concerns about the proposed rule, particularly the administrative burden placed on participating physicians, the impact of the CAP on the calculation of the average sales price, and the impact of the CAP on patient access. The details of the program are outlined in ASH’s summary of the rule. 

ASH has submitted comments to CMS that include a number of concerns about the proposed regulations, particularly the administrative burden for participating physicians, the impact of the CAP on the calculation of ASP, and the impact on beneficiary access to drugs.  Following are several highlights from the comments:

• Handling unused drugs – The regulations need significant clarification on handling unused drugs obtained through the CAP program.  ASH recommended that CMS work closely with affected specialty societies to establish policies for dealing with this issue.
  
  
• Payment for administrative costs – ASH recommended that separate payment be established to capture the significant additional administrative costs associated with obtaining drugs through the CAP. 
  
  
• Integrity of drugs – ASH is concerned that prescribing physicians might be held liable for errors on the part of a CAP vendor due to mistakes in the drug delivered, contamination of the product, etc. ASH recommended that the contract should clarify that the vendor is solely responsible for such errors and the vendor needs to maintain adequate liability insurance to indemnify a physician for any damages.
  
  
• Availability of new drugs – ASH is concerned about the incorporation of new drugs, which were not considered by vendors in their bids or which were not on the market when physicians were asked to make their election to the program. To assure that Medicare beneficiaries have access to the most current drug therapy, ASH recommended that CMS require that vendors add all new drugs to the list of drugs covered under the CAP.