Devices & Diagnostics

How CMS decided to ultimately cover a CGM connected to an iPhone

One episode shows how CMS evolved its thinking of how to cover continuous glucose monitoring when Medicare beneficiaries wanted to use it with their iPhones to share data with caregivers, family and physicians.

Digital is hard.

That’s how Carol Blackford, director of the hospital and ambulatory policy group at the Centers for Medicare and Medicaid Services, said, while narrating challenged posed by reimbursing digital health for Medicare beneficiaries.

Later, on the same panel with top CMS coverage and payment officials at the annual MedTech conference hosted by AdvaMed in Philadelphia Tuesday, her colleague offered up an example of how the agency overcame a payment issue involving a medical device connected to the iPhone.

Laurence Wilson, director for chronic care policy Group at CMS responsible for coverage of durable medical equipment and home health among other products and services, described how the agency’s thinking evolved as continuous glucose monitors to manage diabetes became approved, covered and then got linked to iPhones.

Traditionally, CGMs transmit readings to a receiver device and the entire CGM category could be reimbursed under the definition of a durable medical equipment that also covers the blood glucose meters that CMS has long covered. But companies like Dexcom were able to develop the capability for the CGM sensor to transmit readings directly to the iPhone. Not surprisingly, Medicare beneficiaries wanted to use CGMs with their iPhones. This presented a dilemma for CMS.

“The only device that we could cover them under was the durable medical equipment benefit like the historic standard with glucose meters,” Wilson said. “Essentially the sensor and the transmitter, the disposable supplies could be used with an iPhone instead of the durable medical device and that’s what the beneficiaries wanted to do.”

He added that with the iPhone, Medicare beneficiaries could share data with their physician and caregiver and it was just easier on them.

sponsored content

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

“That was a challenge that we faced and it was as much a legal analysis as anything else to find a way for us to say last year that as long as patients use their iPhones in conjunction with the durable part … that we could cover it. But we still had to essentially hook it to the use of the durable monitor because Medicare pays for durable monitors. It doesn’t pay for iPhones which are a standard consumer device and not a medical device.”

However, last year after this decision, CMS reportedly received a lot of pushback and changed.

“CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones, preventing them from sharing data with family members, physicians, and caregivers. After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data sharing function they provide for patients and their families,” per CMS’ website. ”

Dexcom greeted this policy change with glee per a June press release:

“On behalf of our Medicare population, Dexcom would like to recognize and thank CMS for this policy coverage update,” said Kevin Sayer, President and CEO of Dexcom in a statement. “This update allows patients to access the full functionality of the Dexcom G5 CGM system as approved by the Food and Drug Administration (FDA). By doing what is right for the patient, CMS is creating value for the entire healthcare system.

A colleague echoed his sentiment.

“We would also like to recognize the diabetes community for their efforts in voicing the necessity for this change. CMS listened and recognized the need to allow the sharing of glucose data in this population,” said Claudia Graham, SVP of Global Access.

While such changes were accommodated under the current system, Wilson noted just because something is digital that doesn’t mean it will gain CMS coverage. And if the health system moves that way, then the broader issue will need to be addressed by Congress.