Government Investigations & Program Integrity
- Representing telehealth providers in challenging CMS payment suspensions, including preparing record-based rebuttals addressing the services under review and seeking partial relief from the suspensions.
- Representing a home health and hospice provider in appealing the revocation of its Medicare enrollment and coordinating that appeal with challenges to the underlying claim denials.
- Representing a clinical laboratory in challenging a multimillion-dollar extrapolated overpayment arising from a UPIC audit and responding to a related Department of Justice (DOJ) civil investigative demand.
- Representing a wound care supplier in seeking reconsideration of the revocation of its Medicare billing privileges while coordinating its response to a parallel DOJ investigation.
- Representing health care providers and suppliers in False Claims Act and other civil, criminal, and administrative investigations conducted by DOJ, HHS-OIG, CMS, and CMS contractors.
- Conducting internal investigations involving billing, documentation, coding, physician certification, and exclusion issues.
- Representing health care entities and excluded providers in administrative appeals before HHS administrative law judges and the Departmental Appeals Board and in related federal court litigation.
Regulatory Counseling & Administrative Litigation
- Advising health care and pharmaceutical services companies on arrangements implicating the Anti-Kickback Statute, the Stark Law, fair market value, and OIG guidance.
- Advising providers on beneficiary inducement and compliance issues arising from financial assistance, billing deferral, and patient assistance programs.
- Advising health care companies on Medicare enrollment and change-of-ownership requirements in transactions and resolving enrollment and billing-privilege issues directly with CMS.
- Designing and evaluating compliance programs for health care and life sciences companies and serving as the interim compliance officer for a digital health provider.
- Representing a generic drug manufacturer in an FDA administrative hearing concerning the proposed withdrawal of approval of an abbreviated new drug application.
- Represented Medicare Advantage plans in an APA challenge to a CMS plan-rating decision.
- Represented public health scholars as amici curiae in APA challenges involving Medicaid work requirements and the federal public-charge rule.