Medicare Proposes Expanding Coverage of Continuous Glucose Monitors

Advocates for patients with diabetes are applauding a proposed rule announced Tuesday by the Centers for Medicare & Medicaid Services (CMS) that would expand coverage for continuous glucose monitors (CGMs).

"We appreciate CMS' recognition that many of the rules limiting access for patients to CGMs are without clinical merit and limit access for patients who need them, especially lower-income Americans," Laura Friedman, vice president for payment policy at the American Diabetes Association (ADA), in Arlington, Virginia, said in a statement. "We are eager to continue to work with CMS to bring down barriers to technology access, particularly for people with diabetes who have no other way to get this important diabetes management device if their insurance will not cover it."

Currently, CMS "only covers therapeutic CGMs or those approved by the FDA for use in making diabetes treatment decisions, such as changing one's diet or insulin dosage based solely on the readings of the CGM," the agency explained Tuesday in a press release. "Therapeutic" CGMs do not need their readings verified by a blood glucose test, as opposed to "adjunctive" CGMs that require such a test before changes in treatment can be made. "CMS is proposing to classify all CGMs (not just limited to therapeutic CGMs) as DME [durable medical equipment] and establish payment amounts for these items and related supplies and accessories."

CMS added that "CGMs that are not approved for use in making diabetes treatment decisions can be used to alert beneficiaries about potentially dangerous glucose levels while they sleep and that they should further test their glucose levels using a blood glucose monitor. With one in every three Medicare beneficiaries having diabetes, this proposal would give Medicare beneficiaries and their physicians a wider range of technology and devices to choose from in managing diabetes. This proposal will improve access to these medical technologies and empower patients to make the best healthcare decisions for themselves."

The agency also dropped its limitation on smartphone use in conjunction with a CGM. "CMS previously concluded that therapeutic CGMs, when used in conjunction with a smartphone, still satisfied the definition of DME because the durable receiver, used as a backup, was generally not useful to a person in the absence of an illness or injury, even if the smartphone might be," CMS said. "CMS is now proposing that both therapeutic and non-therapeutic CGMs, when used in conjunction with a smartphone, satisfy the definition of DME."

Like the ADA, the Endocrine Society in Washington, also praised the proposal. "The Endocrine Society is pleased that CMS has proposed to expand Medicare coverage and payment for CGMs," Robert Lash, MD, the society's interim CEO, said in a statement. "The current rules governing CGMs often result in significant burdens on both patients and physicians. We are therefore looking forward to working with CMS on this important initiative."

The proposed rule "will remove some red tape around proving different things to get access," said Jim Scott, a healthcare consultant in Alexandria, Virginia who has worked on the CGM issue. "It's just a proposal, so we've got a ways to go before it is a final rule, but to me it is a step in the right direction to eliminate barriers between doctor and patient caused by Medicare."

Nathan West, a principal associate at health research firm Abt Associates, called it a "clear win" for Medicare beneficiaries with diabetes who are looking for more options for monitoring their condition.

Scott also applauded CMS's embracing of smartphone use as part of the CGM system. "It really looks like CMS is accepting that and is talking about use of smartphones as part of CGM therapy," he said, something they had been a little resistant to before.

In addition to the CGM changes, the proposed rule also would expand the classification and payment for external infusion pumps under the DME benefit, "making home infusion of more drugs possible for beneficiaries," CMS said in the release. It would allow infusion pumps to be considered DME "in cases where assistance from a skilled home infusion therapy supplier is necessary for safe infusion in the home, allowing beneficiaries more choices to get therapies at home instead of traveling to a healthcare facility."

https://www.medpagetoday.com/endocrinology/diabetes/89382