The US Food and Drug Administration (FDA) and the Diabetes Technology Society (DTS) will be meeting on September 9, 2013 to establish tighter performance standards for approval of blood glucose monitors and testing strips and ramp up post-licensure surveillance of the devices. The reasons for the need to revise standards are related to quality issues and standards that date back to 2003. Most of the less accurate meters are manufactured outside the United States and sold at lower cost than the name brands. (Medscape, August 22, 2013)
Additionally, Centers for Medicare & Medicaid Services (CMS) made a major change in Medicare reimbursement rules beginning July 1 to save money, but it will drastically limit the number of vendors from which beneficiaries with diabetes can obtain glucose-testing supplies. In fact, there will only be 18 contract suppliers chosen by Medicare via a competitive bidding process for the nationwide Medicare National Mail Order Program. The program applies only to enrollees in “Medicare” and not to private Medicare Advantage plans. (Medscape, June 20, 2013)
People who prefer to buy their supplies at retail stores can still do so, but they need to make sure that the store accepts Medicare “assignment” to avoid higher charges for the supplies. Many independent retail pharmacies may decide to not carry blood glucose supplies anymore related to the new regulations, but chain or big box pharmacies will probably continue to carry the supplies. Independent community pharmacies will also be prohibited from providing same-day, home delivery of diabetes testing supplies to homebound seniors. (Medscape, June 20, 2013)
Here are a couple of other new rules related to reimbursement changes:
- “50% Rule” requires the 18 contract suppliers to carry at least half of the available testing supply brands on the market. The formularies will consist of primarily low-cost brands but still allow for brand names.
- “Anti-switching Rule” prohibits contract suppliers to influence or incentivize beneficiaries to switch glucose monitoring and testing supplies to a lower-cost brand.
If a physician prescribes a particular brand of testing supplies and documents why it is necessary to avoid an “adverse medical outcome” the contract supplier has 3 options:
- Furnish the specific brand as prescribed
- Consult with the physician to find another appropriate brand and obtain a new prescription
- Assist the beneficiary in locating another contract supplier that can provide that specific brand
ACCURACY TIP: Patients should check their own blood glucose testing equipment at the same time they are having blood drawn during home health visits or at the clinical laboartory or physician’s office and compare the results.