be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and meet all other applicable Medicare statutory and regulatory requirements. On or after January 12, 2017, Medicare began coverage of therapeutic CGM devices...
Because Dexcom doesn’t make the blood glucose monitoring system needed to calibrate a CGM, it had to find a partner to meet requirements. According to a statement from Ascensia, “The complete bundle will be available to people who are covered by Medicare and quality for therapeutic CGM.” A...
The result can be a series of overlapping and consecutive 30-month stays, greatly slowing the opportunity for a generic equivalent to hit the market, even if the generic has met all FDA requirements. A 2002 study by the FDA showed that multiple 30-month stays led to delays in generic ...