This article will be referenced in episode 39 of the Juicebox Podcast (to post at midnight 11/23/15). A conversation with Insulet's CCO Shacey Petrovich.

reposted from Medpage Today
by Parker Brown
Staff Writer, MedPage Today

A Medicare provider must cover a continuous blood glucose monitor (CGM) for one of its patients with type 1 diabetes, an administrative law judge has ruled.

The patient, Jill Whitcomb, had recently become eligible for Medicare, which does not cover continuous glucose monitoring devices, provided through United Healthcare of Wisconsin/Secure Horizons. Whitcomb has had type 1 diabetes for more than 35 years, with diabetic neuropathy and a history of hypoglycemia unawareness. A video of Whitcomb having a severe episode of hypoglycemia when she was not using a CGM because she lacked a Certificate of Medical Necessity from the doctor was used as evidence in a trial earlier this year.

United has not yet offered to cover the device and has until Dec. 14 to appeal the decision, said Dan Kraft, Whitcomb's caretaker.

Courts may be forcing CMS' hand for coverage of continuous glucose monitors

George Grunberger, MD, president of the American Academy of Clinical Endocrinologists (AACE), said in an interview with MedPage Today that he has been following this case with interest for several years. The AACE has tried to convince the Centers for Medicare & Medicaid Services to cover CGM for patients with type 1 diabetes who age into Medicare coverage, he added.

"All of our meetings, petitions, and lobbying have met with rejections thus far in spite of uniform recommendations of all relevant professional societies," Grunberger said. "This ruling will hopefully re-energize the efforts to bring 21st century thinking into Medicare decisions. It's all about safety, not just better care for our insulin-requiring patients."

Since the ruling last month, other administrative law judges have cited Whitcomb's case and have ordered that CGMs be covered for the plaintiffs, Kraft said. He provided a document of a recent ruling in which the judge found that the Whitcomb decision was "well reasoned and on point" and that "coverage of a continuous glucose monitor should turn on whether or not the item is medically reasonable and necessary for the beneficiary."

The costs of the monitors and supplies can be substantial: the device alone can cost $400 to $2,000, and the associated consumables can add up to $300 a month. But Medicare considers the device to be "precautionary" and therefore not eligible for coverage.

The court disagreed, ruling that the CGM falls under what Medicare calls a Durable Medical Equipment statutory benefit and is eligible for coverage. The judge also concluded that the device is "medically reasonable and necessary" for Whitcomb, citing evidence by the American Diabetes Association that CGM, "in conjunction with intensive insulin regimen, is a useful tool to lower A1C in adults with type 1 diabetes mellitus, and for those with hypoglycemia unawareness and/or frequent hypoglycemic episodes."

The judge wrote in the final decision that it was clear that Whitcomb was a "brittle diabetic" and that the device is medically reasonable and necessary in her case.

Appealing Medicare decisions is a five-step process. In 2013, an administrative law judge concluded that United must cover the device for Whitcomb, but United filed a request for a review by the Medicare Appeals Council -- the fourth step. That council reversed the decision, according to court documents, and Whitcomb and her attorney filed a complaint in U.S. District Court in November of that year.

But in May 2015, the district court remanded the case to the Secretary of Health and Human Services, saying that the secretary had erred in one of her conclusions. The Medicare Appeals Council vacated its earlier decision and the case was sent to the Office of Medicare Hearings and Appeals, where the latest decision was issued and United was ordered to process Whitcomb's claim.

"As far as moving forward, it will take patients themselves, individually and through patient advocacy groups, to pressure their legislators to change the Medicare coverage language to recognize the tangible benefits this technology represents to their constituents' lives," Grunberger said. "The professional societies have done their part in incorporating the technology into their position statements and guidelines."