Zieroth v. Azar

Background

Sharon Zieroth had type 1 diabetes and hypoglycemic unawareness, a condition in which a person may not recognize early symptoms of low blood sugar. She used a Medtronic MiniMed 530G continuous glucose-monitoring system, which included sensors. Between July 2017 and May 2018, she submitted three Medicare Part B claims seeking reimbursement for the sensors.

The Medicare Appeals Council denied all three claims. It relied on CMS-1682-R, a ruling issued by the Centers for Medicare and Medicaid Services, and concluded that a continuous glucose monitor like the MiniMed 530G did not qualify as durable medical equipment under 42 C.F.R. § 414.202. Sharon Zieroth filed this action seeking judicial review under 42 U.S.C. §§ 405(g) and 1395ff. She later died, and Gary Zieroth proceeded as representative of her estate.

Issues and analysis

Zieroth argued that CMS-1682-R had been issued without the notice and public-comment process required by 42 U.S.C. § 1395hh. The Secretary argued that this procedural challenge had been waived because Zieroth did not raise it before the Medicare Appeals Council.

The court agreed that the procedural challenge was waived. It explained that issues generally must be raised before the Appeals Council so the administrative record can be developed and parties cannot withhold backup arguments until judicial review. The court rejected Zieroth’s argument that raising the challenge earlier would have been futile. It also found that the Secretary had not waived the waiver defense merely by raising it for the first time in the summary-judgment motion, because Zieroth had not shown prejudice.

The court then reached the coverage issue. The regulation defines durable medical equipment as equipment that, among other things, is primarily and customarily used for a medical purpose, can withstand repeated use, has an expected life of at least three years, generally is not useful without illness or injury, and is appropriate for home use.

The court found the regulation clear on its face. It concluded that the MiniMed 530G was primarily and customarily used for a medical purpose because it continuously estimated glucose levels and could automatically suspend insulin delivery when glucose fell below a specified level and the user did not respond to an alarm. The court noted that this function was particularly important for a person with hypoglycemic unawareness.

The court also held that the Secretary’s distinction between monitors approved to replace blood glucose monitors and monitors approved as adjunctive devices was not reasonable. The regulation did not require covered equipment to serve a primary medical purpose rather than an additional or supporting medical purpose. The court therefore found that the MiniMed 530G qualified as durable medical equipment. It stated that the record showed the other regulatory requirements were satisfied and that Sharon Zieroth used the device for a medical purpose.

Disposition

The court granted Zieroth’s motion for summary judgment and denied the Secretary’s cross-motion for summary judgment. It remanded the action under sentence four of 42 U.S.C. § 405(g), with instructions to authorize coverage for the three MiniMed 530G sensors at issue. The court also found that Zieroth was entitled under Medicare Part B to reimbursement for their costs.