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718 F.3d 436
5th Cir.
2013
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Background

  • Southwest filed July 11, 2011 in district court challenging CMS on Medicare Part D’s Preferred Pharmacy Rule (PPR).
  • 42 U.S.C. § 405(h) requires exhaustion of administrative remedies before federal court review of Medicare claims.
  • Illinois Council v. Sebelius created a narrow exception to § 405(h) where no judicial review would be available absent agency channeling.
  • CMS argued the district court lacked jurisdiction absent § 405(h) review through DHHS; Southwest argued Illinois Council applies.
  • Court analyzes whether PPR claims are “coverage determinations” (reviewable) or “grievances” (not reviewable).
  • Key questions include whether enrollees or proxies can pursue review and whether amount-in-controversy requirements can be satisfied.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether Illinois Council exception applies Southwest: exception applies if no review available otherwise. CMS: exception does not apply; channeling through agency remains. Illinois Council exception not triggered; review foregone.
Whether CMS interpretation as coverage determinations can be reviewed Southwest: PPR challenges are grievances, not reviewable. CMS interpretation treats PPR challenges as coverage determinations and reviewable. CMS interpretation entitled to deference; review available via administrative channel.
Whether enrollees or proxies can initiate review for providers Southwest: enrollees cannot be represented by providers; Illinois Council applies. Enrollees may appoint representatives; proxies (enrollees’ interests) can pursue review. Representations allowed; proxies sufficient; Illinois Council not satisfied.
Whether aggregation can satisfy the amount-in-controversy requirement Southwest: impossible to aggregate enough enrollees to meet $1,300 per regulations. Aggregation possible; several enrollees or high-cost drugs can reach threshold. Illinois Council not satisfied; aggregation thresholds not shown to preclude review.
Whether the district court properly dismissed for lack of subject matter jurisdiction Southwest contends there is a pathway to review under Illinois Council. Dismissing is proper if Illinois Council exception not proven. Affirmed district court's dismissal; no complete preclusion shown.

Key Cases Cited

  • Illinois Council v. Sebelius, 529 U.S. 1 (S. Ct. 2000) (narrow exception to channeling where no review would be possible)
  • Physician Hospitals of Am. v. Sebelius, 691 F.3d 649 (5th Cir. 2012) (channeling requirement and narrow Illinois Council exception discussed)
  • Council for Urological Interests v. Sebelius, 668 F.3d 704 (D.C. Cir. 2011) (illustrates when third-party incentives undermine review under § 405(h))
  • National Athletic Trainers’ Ass’n v. U.S. Dept. of Health & Human Servs., 455 F.3d 500 (5th Cir. 2006) (third-party proxies with incentives can constitute reviewable representation)
  • Tex. Clinical Labs, Inc. v. Sebelius, 612 F.3d 771 (5th Cir. 2010) (agency interpretation of regulation reviewed for consistency and deference)
Read the full case

Case Details

Case Name: Southwest Pharmacy Solutions, Inc. v. Centers for Medicare & Medicaid Services
Court Name: Court of Appeals for the Fifth Circuit
Date Published: May 1, 2013
Citations: 718 F.3d 436; 2013 WL 1830853; 2013 U.S. App. LEXIS 8923; 12-40097
Docket Number: 12-40097
Court Abbreviation: 5th Cir.
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