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Barbara H. Ryland

Senior Counsel

Overview

Barbara H. Ryland is a senior counsel in the Washington office of Crowell & Moring's Health Care Group. Ms. Ryland brings more than 20 years of experience navigating the complex health care regulatory environment in working with health care clients in counseling, litigation and internal investigations.

Examples of Ms. Ryland’s work include helping health care industry clients with:

  • Investigating and resolving False Claims Act (FCA) disputes arising out of government health care programs.
  • Administrative disputes before CMS involving Medicare Advantage and Part D plans.
  • Disputes with state agencies involving Medicaid managed care plans.
  • Making voluntary disclosures to the OIG and CMS in matters involving potential overpayments, pricing disputes and general non-compliance.

In addition to having experience in the regulatory and business issues that affect managed care companies, Ms. Ryland has significant experience in working with pharmacy benefit managers in contractual and government program matters, and in advising clients in HIPAA privacy and security issues.

Specific to the area of pharmacy, Ms. Ryland has worked on pharmacy and PBM transactions involving licensure transfer and business arrangements that raise fraud and abuse, contracting, and licensure issues (e.g., outsourcing, backend and central fill arrangements). She has also counseled clients on 340B compliance in such areas as outside pharmacy contracting, the interface between 340B and the Medicaid program, and the permissible scope of 340B pricing to an entity’s covered patients.

During law school, Barbara was an editor of Law & Contemporary Problems. Prior to her employment at Crowell & Moring, she clerked for the U.S. Court of Appeals for the Fourth Circuit, and was an associate in the tax and employee benefits practice at Miller & Chevalier Chartered, and a principal at Michaels & Bonner, P.C. Ms. Ryland is a member of the District of Columbia and Maryland bars. She has published articles and lectured on a variety of issues of concern to managed care organizations and healthcare providers including confidentiality of health care information, e-commerce issues in health care, antitrust and fraud and abuse. She is the co-author of A Guide to Health Care Financial Ventures and has recently edited an ABA treatise on health care joint ventures and antitrust law.

Career & Education

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    • University of Virginia, 1983
    • Duke University School of Law, 1987
    • University of Virginia, 1983
    • Duke University School of Law, 1987
    • District of Columbia
    • Maryland
    • District of Columbia
    • Maryland

Representative Matters

Representative Fraud and Abuse Matters

  • Counseling and review of fraud and abuse related issues for physician incentive initiative for ESRD patients.
  • Drafting and review of comments on proposed rules to add value based safe harbors.
  • Fraud and abuse counseling and “Best Price” impact of value based arrangements between plans and/or purchasers and pharmaceutical manufacturers.

Representative FCA Matters

  • Defending Inpatient Rehabilitation Facility (IRF) against allegations of incorrect coding in order to meet CMS threshold for maintaining IRF status.
  • Defending Medicare Advantage Organization (MAO) against allegations of false certification of bid information; network adequacy; and failure to meet “model of care” requirements for special needs plans.
  • Defending hospital against claim for vicarious FCA liability with respect to physician who engaged in deliberately incorrect coding in order to bill for “routine” visits otherwise not covered under Medicare.

Representative Pharmacy/Pharmaceutical Related Work

  • Ongoing counseling including regulatory comments on administration initiatives, including proposed amendments to Discount Safe Harbor to exclude rebates; ANPRM for the International Pricing Index (IPI) Model for Part B Drugs; and Proposed Rule for Importation of Drugs from Canada.
  • Regulatory and contracting support related to 340B pricing disputes between plans, purchasers, and pharmaceutical manufacturers.
  • Due diligence and licensure transfer in acquisition of national specialty pharmacy.
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