Newswise — CHICAGO – February 9, 2018 – Today marked a big win for people in the diabetes community, after Congress included language from the Protecting Access to Diabetes Supplies Act in the FY2018 and FY2019 budget deal. The language will make several effective changes to the Competitive Bidding Program (CPB), including strengthening the 50 percent and anti-switching rules. This comes after AADE released several beneficiary surveys dating back to 2011, showing the program put people with diabetes at unnecessary risk.
“AADE applauds Congress and specifically Congressman Tom Reed and Congresswoman Diana DeGette for advocating for this bill that will not only help fix a broken system, but put the lives of people with diabetes first,” said AADE Director of Advocacy Kurt Anderson. “Our surveys show that the CMS CBP put beneficiaries at unnecessary risk through forced switching of diabetes supplies to unfamiliar or unsuitable products.”
AADE surveys in 2011, 2013 and 2017 showed the current program reduced beneficiary choice and access to commonly used diabetes testing supplies (DTS). A 2016 National Minority Quality Forum report showed a direct link to increases in mortality and complications, inpatient admission and supplier costs.
Major fixes to the CMS CBP include:
Strengthening of 50 Percent Rule
Under the CBP, suppliers are paid the same amount by Medicare for Diabetes testing supplies regardless of what they supply to a beneficiary. As such, suppliers have a powerful economic incentive to maximize profits by offering the least expensive supplies obtainable. Congress was concerned that these incentives would lead suppliers to no longer offer many of the test systems commonly used by beneficiaries, and that beneficiaries therefore might not be able to find replacement supplies for their current test systems. Congress enacted the “50 Percent Rule” to ensure that beneficiaries would continue to have access to the same test systems that they used prior to implementation of the CBP by requiring that mail order suppliers make available at least 50 percent of all types of DTS on the market before implementation of the CBP.
The manner in which CMS has implemented the 50 Percent Rule has rendered this statutory protection inadequate. CMS interpreted the statute as applying to supplier bids only; CMS does not require suppliers to comply with the 50 Percent requirement once a contract is awarded. Moreover, CMS gave suppliers a 10 percent credit toward satisfying the 50 percent requirement merely for selecting “Other—Not Listed,” a catch-all designation not associated with a particular test system or product. The current bill would include the following changes to this rule:
- Requiring bidding suppliers to attest to (subject to a good faith effort exception) an ability to obtain an inventory of strips by volume consistent with the inventory mix provided in that supplier’s bid;
- Establishing and maintaining a surveillance program to ensure that suppliers comply with the 50 Percent Rule, and authorizing CMS to terminate a supplier who fails to comply with the 50 Percent Rule;
- Requiring CMS to use multiple sources of data, and data that measures consumption and utilization of DTS by individuals other than just those Medicare beneficiaries who purchase DTS through Medicare-participating mail order suppliers, for purposes of measuring compliance with the 50 Percent Rule; and
- Barring CMS from giving bidding suppliers additional percentage credit toward satisfying the 50 Percent Rule by selecting “Other—Not Listed.”
Strengthening of Anti-Switching Rule
CMS established the anti-switching Rule to protect beneficiary and physician choice of glucose meters. This rule requires suppliers to furnish the test system requested by the beneficiary and prohibits contract suppliers from influencing or incentivizing beneficiaries to switch their current glucose monitor and testing supplies brand to another brand.
CMS has likewise rendered this protection inadequate. Recent Inspector General reports show a shift in brands purchased by beneficiaries through the CBP. This shift is inconsistent with beneficiary purchasing patterns from retail pharmacies, suggesting that mail order suppliers may be switching beneficiaries in spite of the rule. Once a beneficiary is switched, it becomes difficult for the beneficiary to purchase desired products from another supplier, like a retail pharmacy. When a mail order supplier sends Medicare beneficiaries unwanted supplies and submits a claim for payment for those supplies, claims for additional supplies (e.g., if the beneficiary were to go to a retail pharmacy seeking preferred supplies), will be denied because the beneficiary’s supply benefit has already been exhausted for that period. If the supplier continues to send supplies and submit claims, the beneficiary cannot break the cycle and obtain supplies of choice. This bill strengthens the anti-switching rule by making the following changes:
- Codifying the anti-switching rule.
- Allowing beneficiaries to break the claims cycle by requiring suppliers to contact and receive a refill order from the beneficiary not more than 14 days prior to dispensing a refill.
- Requiring suppliers to verbally provide beneficiaries with an explanation of the beneficiary’s rights, including the beneficiary’s right to receive DTS compatible with the beneficiary’s blood glucose testing system, the right not to be influenced or incentivized to switch blood glucose testing systems, the right to obtain strips from another mail order supplier or retail pharmacy, and the right to reject unwanted DTS.