UNITED STATES COURT OF APPEALS August 12, 2022

Christopher M. Wolpert FOR THE TENTH CIRCUIT Clerk of Court _________________________________

LINDA P. SMITH,

Plaintiff - Appellant,

v. No. 22-4012

XAVIER BECERRA, in his capacity as Secretary of the United States Department of Health and Human Services,

Defendant - Appellee. _________________________________

Appeal from the United States District Court for the District of Utah (D.C. No. 1:21-CV-00047-HCN) _________________________________

James C. Pistorino, Parrish Law Office, Pittsburgh, Pennsylvania, (Phillip Wm. Lear, Lear & Lear PLLC, Salt Lake City, Utah, with him on the briefs), for Plaintiff-Appellant.

Joshua M. Koppel, Appellate Staff Attorney, Civil Division, United States Department of Justice, Washington, DC (Brian M. Boynton, Principal Deputy Assistant Attorney General, Andrea T. Martinez, Interim United States Attorney, and Abby C. Wright, Appellate Staff Attorney, Civil Division, United States Department of Justice, Washington, DC, and Of Counsel: Daniel J. Barry, Acting General Counsel, Gerard Keating and Linda Keyser, Attorneys, Department of Health and Human Services, with him on the brief), for Defendant-Appellee. _________________________________

Before TYMKOVICH, Chief Judge, EID, and CARSON, Circuit Judges. _________________________________

TYMKOVICH, Chief Judge. _________________________________ Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 2

Like many diabetics, Linda Smith uses a prescribed continuous glucose

monitor (CGM) to track and regulate her glucose levels. When Smith purchased

her CGM and its necessary supplies between 2016 and 2018, she sought

reimbursement for her expenses through her medical insurance program,

Medicare Part B. Medicare administrators denied her claims. Relying on a 2017

ruling issued by the Centers for Medicare and Medicaid Services (CMS),

Medicare administrators concluded that Smith’s CGM is not “primarily and

customarily used to serve a medical purpose” and therefore is not covered by

Medicare Part B. Smith appealed the denial of her reimbursement claims through

the multistage Medicare claims review process. At each stage, the respective

adjudicator confirmed the denial of her claims.

Smith then sued the Secretary of the Department of Health and Human

Services in federal court, seeking monetary, injunctive, and declaratory relief.

Contending that her CGM and supplies satisfied the requirements for Medicare

coverage, Smith requested that the district court (1) order the Secretary to pay her

claims; (2) declare that CGMs are covered by Medicare; and (3) set aside the

2017 ruling as unlawful because it did not go through the proper rulemaking

process.

Instead of asking the court to uphold the denial of Smith’s claims, the

Secretary admitted that Smith’s claims should have been covered and that the

agency erred by denying her claims. The Secretary requested a remand so the

agency could reimburse Smith’s claims. Rather than accept the Secretary’s

2 Appellate Case: 22-4012 Document: 010110723774 Date Filed: 08/12/2022 Page: 3

admission of error, Smith argued that the Secretary only admitted error to avoid

judicial review of the legality of the 2017 ruling.

During Smith’s litigation, CMS changed its Medicare coverage policy for

CGMs. Prompted by several adverse district court rulings, CMS promulgated a

form

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