## Facts

- HHS contracted with a Maine peer review organization (PRO) to review Medicare cases for departures from professional standards.
- The PRO reviewed Dr. Robert Doyle’s Medicare cases and concluded he seriously departed from professional standards in certain treatments.
- After hearing from Doyle, the PRO’s Maine Advisory Committee found “gross and flagrant” violations in three instances and recommended a five-year exclusion from Medicare.
- The HHS Inspector General issued an order excluding Doyle from Medicare reimbursement for at least five years.
- Doyle sued in federal district court to block the exclusion, asserting (1) due process and vagueness challenges to the statutory/administrative standards and procedures and (2) that the PRO and Inspector General failed to apply an HHS regulation governing selection of the sanction.
- The district court rejected the constitutional challenges but enjoined enforcement because it concluded the PRO had not followed the sanction-selection regulation.
- The Secretary appealed, arguing the district court lacked authority to intervene because Doyle had not exhausted administrative remedies.

## Issues

1. Whether a Medicare provider sanctioned by HHS must exhaust the Medicare administrative review process before seeking injunctive relief in federal district court.
2. Whether a district court may enjoin enforcement of an exclusion sanction based on alleged noncompliance with an HHS regulation governing sanction selection before exhaustion.
3. Whether alleged vagueness in statutory standards and alleged procedural unfairness in the PRO/HHS process constituted due process violations that excused exhaustion.

## Decision

- The First Circuit reversed the district court’s injunction.
- The court held that Doyle was required to exhaust the administrative review process before seeking judicial relief.
- The court concluded that alleged regulatory error in sanction selection should be addressed through the agency’s review channels, not by pre-exhaustion judicial intervention.
- The court rejected Doyle’s vagueness challenge to standards requiring care meeting “professionally recognized standards of health care.”
- The court rejected Doyle’s procedural due process challenge, finding adequate notice and opportunity to be heard and no showing of actual bias from the combination of investigative and adjudicative functions.

## Legal Principles

- Medicare claims and provider-sanction challenges generally must be presented to the agency and channeled through the statutory administrative process before judicial review is available.
- Pre-exhaustion judicial intervention is limited; challenges tied to the merits, regulatory application, or sanction calibration ordinarily are not “collateral” and typically benefit from agency factfinding and expertise.
- Professional-regulation standards referencing accepted professional norms are not unconstitutional for vagueness merely because they are general.
- Combining investigative and adjudicative functions within an administrative process does not, by itself, violate due process absent evidence of actual bias and where procedures provide notice and an opportunity to respond.

## Conclusion

The First Circuit required Doyle to pursue and complete the Medicare administrative review process before obtaining judicial relief and held that neither alleged misapplication of an HHS sanction-selection regulation nor Doyle’s vagueness and due process claims justified a district court injunction at the pre-exhaustion stage.


Doyle v. Sec’y of Health & Hum. Servs., 848 F.2d 296 (1st Cir. 1988)