Diabetes Access to Care Coalition Preliminary Comments to CMS Regarding Inherent Reasonableness

The Comments of the Diabetes Access to Care Coalition’s (DACC’s) initial comments in reponse to CMS’ Public Meeting on Inherent Reasonableness of Medicare Fee Schedule Amounts for Retail Diabetic Testing Supplies are attached here.

The Executive Summary of DACC’s comments states:

The DACC has long been concerned about the implications for beneficiary access if CMS required non-mail order settings to participate in the Competitive Bidding Program (CBP). Beneficiaries need to have immediate access to DTS to check their blood glucose level. As such, it would not acceptable to limit the number of retail DTS suppliers from which beneficiaries can access DTS. For that and other reasons, we continue to urge CMS to keep retail settings out of the CBP.

 

We have considerable concerns with respect to adjusting Medicare reimbursement for DTS using IR authority. The DACC is concerned that reductions in Medicare payment amounts will result in a significant reduction in the number and kinds of DTS brands available to beneficiaries, and in a deterioration in the quality of product available to beneficiaries. As such, the DACC urges CMS to study whether reimbursement changes will impact upon product choice and quality.

 

The DACC is likewise concerned by CMS’s indication that it plans to use information from the CBP to determine the reasonableness of prices in non-mail order settings. Product pricing in retail and mail order channels is very different. Use of pricing data from the mail order marketplace (whether under competitive bidding or otherwise) would not meet the statutory or regulatory requirements for CMS to determine that fee schedule amounts “are grossly excessive and should be adjusted” or to determine new fee schedule payment amounts. Before CMS can proceed with a determination that non-mail order reimbursement amounts are grossly excessive, the agency must first undertake its own study to determine whether there is sufficient overlap between products available through mail order channels versus those available through retail channels (on a volume-weighted basis) to determine whether products generally used by beneficiaries who make purchases from mail order suppliers are the same products generally used by beneficiaries who make purchases from retail suppliers, and whether price information gathered from one setting could be credibly used to determine prices for another setting. The DACC is assembling and is willing to share with CMS manufacturer retail average sales price information. If CMS is willing, we will arrange a meeting at a time that is convenient for you, and that is consistent with your timetable for considering further action on changes to the nonmail order fee schedule to share this information.

 

If CMS has other information upon which it would base a pricing determination, CMS should disclose that data.

 

Finally, should CMS proceed with adjusting the reimbursement amount for DTS, it should adopt patient protections in retail settings to minimize any adverse impacts upon beneficiary access.