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.
Representative Matters
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.
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.
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.
Insights
Speeches & Presentations
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"Anti-Kickback Statute and Stark Law Reform: New Opportunities for Value-Based Care," Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era
(February 25, 2021).
Presenters: Troy A. Barsky and Barbara H. Ryland.
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"Focus on Fraud, Waste and Abuse: Audits, Enrollment and Certification," Crowell & Moring's Healthcare Ounce Of Prevention Seminar (HOOPS), Washington, D.C.
(October 27-28, 2014).
Presenter: Barbara H. Ryland.
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"The Privacy Mega Reg: Understanding and Implementing Substantial Changes," America's Health Insurance Plans (AHIP) Webinar
(March 21, 2013).
Presenters: Jeffrey L. Poston, Robin B. Campbell, and Barbara H. Ryland.
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"Introduction to Antitrust," American Health Lawyers Association Antitrust Boot Camp
(September 15, 2011).
Co-Speakers: Arthur N. Lerner, Barbara H. Ryland and Shawn R. Johnson.
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"Impact of Healthcare Reform on Managed Care Drug Benefits and Programs," Payors, Plans, and Managed Care Practice Group and the Medicare Part D Task Force, AHLA
(May 18, 2010).
Co-Presenters: Christine M. Clements and Barbara H. Ryland.
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"The Reformed New World of Health Insurance Exchanges," Crowell & Moring's Healthcare Ounce Of Prevention Seminar (HOOPS)
(April 26-27, 2010).
Presenters: Arthur N. Lerner and Barbara H. Ryland.
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"Who's Afraid Of A Big Bad Breach?: Security Breach Updates For Covered Entities And Their Business Associates," Crowell & Moring Webinar
(September 16, 2009).
Co-Presenters: Christine M. Clements, Barbara H. Ryland, and Robin B. Campbell.
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"Cyber Security and Privacy Impacts of the American Recovery and Reinvestment (Economic Stimulus) Act of 2009," Webinar - American Council of Technology/Industry Advisory Council
(March 11, 2009).
Presenters: Barbara H. Ryland and Robin B. Campbell.
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"The American Recovery and Reinvestment Act of 2009: HIPPA Privacy and Security Implications for Covered Entities and Their Business Associates," Crowell & Moring LLP Webinar
(February 24, 2009).
Co-Presenters: Christine M. Clements, Barbara H. Ryland, and Robin B. Campbell.
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"Antitrust Issues Affecting Bundling Contracts in Health Care," Crowell & Moring's 2007 Healthcare Ounce of Prevention Seminar (HOOPS)
(October 2007).
Co-Presenters: Arthur N. Lerner and Barbara H. Ryland.
Publications
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"340B Contract Pharmacy Limits: The Conflict Continues," Crowell & Moring’s Health Law Blog
(February 6, 2023).
Author: Barbara H. Ryland.
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"CMS Delays but Finalizes Changes on Network Adequacy," Crowell & Moring’s Health Law Blog
(May 4, 2022).
Author: Barbara H. Ryland.
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"State PBM Regulation: The Struggle Continues – Oklahoma District Court Latest to Rule on ERISA, Part D Preemption," Crowell & Moring’s Health Law Blog
(April 7, 2022).
Authors: Barbara H. Ryland and Todd D. Rosenberg.
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"How Health Cos. Have Responded To Anti-Kickback Reform," Law360
(January 20, 2022).
Authors: Troy A. Barsky, and Barbara H. Ryland.
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"Tennessee Proposes First of Its Kind Block Grant Program for Medicaid," Crowell & Moring's Health Law Blog
(September 24, 2019).
Authors: Barbara H. Ryland, Christopher Flynn and Alice Hall-Partyka.
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"Highlights from the Comments on the Proposed Elimination of Discount Safe Harbors for Rebates," Crowell & Moring's Health Law Blog
(April 10, 2019).
Author: Barbara H. Ryland.
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"MA/PDP Star Ratings: Proposed Technical Changes for 2020," Crowell & Moring's Health Law Blog
(November 8, 2018).
Authors: A. Xavier Baker, Barbara H. Ryland, Joe Records and Payal Nanavati.
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"CMS Proposes Rule to Require Prescription Drug Manufacturers to Disclose Drug Prices in TV Ads," Crowell & Moring's Health Law Blog
(October 18, 2018).
Authors: Jodi G. Daniel, Barbara H. Ryland, Maya Uppaluru, and Shaina Vinayek.
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"Mount Sinai Health System to Pay $2.95 Million in 60-Day Overpayment FCA Settlement," Crowell & Moring's Health Law Blog
(August 25, 2016).
Authors: Diana Huang and Barbara H. Ryland.
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"Regulatory Forecast 2016: What Corporate Counsel Need to Know for the Coming Year," a Crowell & Moring LLP publication
(January 2016).
Contributor.
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"Health Care - In Search of Best Practices," Crowell & Moring's Regulatory Forecast 2016
(January 2016).
Contributors: A. Xavier Baker, Kevin B. Kroeker, Barbara H. Ryland, and Jodi G. Daniel.
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"The Long and Winding Road for BIOSIMILARS: Charting a Pathway through Patent, FDA, Antitrust, Prescription Filling, Reimbursement and Liability Law," Bloomberg BNA Pharmaceutical Law & Industry Report
(September 18, 2015).
Authors: Chiemi Suzuki, Deborah H. Yellin, Barbara H. Ryland, Lauren B. Patterson, and John Fuson.
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"Settlement in FCA Qui Tam Case Disposes of Claims Alleging Falsely Certified Compliance with Medicare Advantage Rating Instructions," Crowell & Moring's Health Law Blog
(February 6, 2015).
Co-Authors: David W. O'Brien and Barbara H. Ryland.
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"Navigating a Hostile Regulatory Climate: Practical Lessons Following OCR's Latest $4.8 MM HIPAA Settlements," Crowell & Moring's E-Discovery Law Insights
(May 9, 2014).
Co-Authors: Barbara H. Ryland and Elliot Golding.
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"Killing the Messenger: Is There Continuing Relevance to Messenger Model Contracting," chapter in the 2008 edition of the Health Law Handbook, published by Thomson/West
(2008).
Co-Authors: Arthur N. Lerner and Barbara H. Ryland.
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"Health Care Privacy in the 21st Century: Overview of the HIPAA Privacy Rule," The Consultant Pharmacist
(April 2001).
Co-Authors: Margit H. Nahra and Barbara H. Ryland.
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"Physician Incentive Plan Rules' Implications: Throw the Stone and Watch the Ripples," Analysis and Perspective, The Bureau of National Affairs' ("BNA's") Health Care Fraud Report
(March 26, 1997).
Co-Authors: Robert L. Roth and Barbara Ryland.
Client Alerts & Newsletters
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"CMS Proposes Major Change to Rules Governing Part D Plan Accounting,"
Health Care Alert
(January 19, 2022).
Contacts: Todd D. Rosenberg, Barbara H. Ryland
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"Supreme Court Sides with State Regulation of PBMs in Boost to Independent Pharmacies,"
Health Care Alert
(December 16, 2020).
Contacts: Todd D. Rosenberg, Barbara H. Ryland
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"HHS Lifts Major Barriers to Telehealth to Help Reduce the Spread of COVID-19,"
Health Care Alert
(March 20, 2020).
Contacts: Troy A. Barsky, Jodi G. Daniel, Barbara H. Ryland, Joe Records, Roma Sharma, Michelle Chipetine
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"Playing Catch-Up to Innovation and Value-Based Care: CMS and OIG’s Proposed Fraud and Abuse Regulatory Updates to Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty Laws,"
Health Care Alert
(October 16, 2019).
Contacts: Troy A. Barsky, Barbara H. Ryland
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"Payers, Providers, and Patients – Oh My!: Medicare Advantage Supplemental Benefits,"
Podcast: Payers, Providers, and Patients – Oh My!
(October 10, 2019).
Contacts: Barbara H. Ryland, Payal Nanavati, Joe Records
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"HHS Proposed Rule Takes Aim at Drug Rebates from Manufacturers to Health Plans/PBMs, Proposes Safe Harbors to Pass Savings to Consumers and Protect Some Manufacturer-PBM Payments,"
Health Care Alert
(February 1, 2019).
Contacts: Barbara H. Ryland, Todd D. Rosenberg, Troy A. Barsky, Roma Sharma
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"CMS Announces and Solicits Comments on Expanded RADV Audit Methodology,"
Health Care Alert
(November 8, 2018).
Contacts: Barbara H. Ryland, Joe Records
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"CMS's Proposed Rule for Contract Year 2019 Is a Mixed Bag for Medicare Advantage Organizations and Prescription Drug Plan Sponsors,"
Health Care Alert
(November 30, 2017).
Contacts: Gary Baldwin, Lauren R. Nunez, Rochelle-Leigh Rosenberg, Barbara H. Ryland, Matthew Vicinanzo
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"The FCA Payback on Medicare Overpayments,"
Government Contracts Bullet Points
(March 7, 2016).
Contacts: Troy A. Barsky, Lorraine M. Campos, Barbara H. Ryland
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"CMS Finalizes Rules for Reporting and Returning Overpayments,"
Health Care Alert
(February 29, 2016).
Contacts: Troy A. Barsky, Barbara H. Ryland
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"Context Matters: The Supreme Court Rules in Favor of ACA Subsidies,"
Health Care Alert
(June 26, 2015).
Contact: Barbara H. Ryland
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"Supreme Court Denies Review of Third Circuit Decision That MA Organizations Have a Direct Right of Recovery Under the Medicare Secondary Payor (MSP) Act,"
Health Care Alert
(April 16, 2013).
Contact: Barbara H. Ryland
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"HIPAA Final Rule Expands Liability for Violations, Clarifies Penalty Assessment Methodology,"
Health Care Alert
(February 22, 2013).
Contacts: Jeffrey L. Poston, Barbara H. Ryland
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"Supreme Court Nixes "State Action" Immunity for Hospital Acquisition in Georgia,"
Health Care Alert
(February 20, 2013).
Contact: Barbara H. Ryland
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"Final HIPAA Rules Clarifies Direct Liability of Business Associates and Subcontractors,"
Health Care Alert
(February 8, 2013).
Contacts: Jeffrey L. Poston, Barbara H. Ryland
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"Conduit Exception Remains Narrow Under New HIPAA Rule,"
Health Care Alert
(January 29, 2013).
Contacts: Jeffrey L. Poston, Barbara H. Ryland
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"HHS Issues Final HIPAA Regulations and Eliminates Risk of Harm Standard,"
Health Care Alert
(January 18, 2013).
Contacts: Jeffrey L. Poston, Barbara H. Ryland
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"Third Circuit Holds that MA organizations have a direct right of recovery under the Medicare Secondary Payer (MSP) Act,"
Health Care Alert
(June 28, 2012).
Contact: Barbara H. Ryland
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"CMS Announces One Year Delay Of Requirement To Report Liability Payments Under The Medicare Secondary Payer Statute,"
Health Care Alert
(November 15, 2010).
Contact: Barbara H. Ryland
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"Updates on the HIPAA Breach Notification Requirements,"
Health Care Alert
(October 15, 2009).
Contact: Barbara H. Ryland
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"FTC Sues Virginia Health System for Alleged Anticompetitive Acquisition of Imaging Center and Outpatient Surgery Center,"
Health Care Alert
(July 28, 2009).
Contacts: Barbara H. Ryland, Shawn R. Johnson
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"Changes in American Recovery and Reinvestment Act of 2009,"
Health Care Alert
(February 18, 2009).
Contacts: Thomas P. Gies, Barbara H. Ryland
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"FTC Finds Evanston Hospital Merger Unlawful, But Refuses to Order Spin-Off,"
Health Care Alert
(August 14, 2007).
Contact: Barbara H. Ryland
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"CMS Releases Final Medicare Advantage and Prescription Drug Plan Marketing Guidelines,"
Health Care Alert
(July 27, 2006).
Contact: Barbara H. Ryland
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"DC Insurance Commissioner Clarifies Charitable Obligations of Blue Cross/Blue Shield Plan,"
Health Care Alert
(May 17, 2005).
Contact: Barbara H. Ryland
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"New Developments on Drug Reimportation,"
Health Care Alert
(February 7, 2005).
Contact: Barbara H. Ryland
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"Final Health Coverage Portability Regulations Clarify Preexisting Condition Exclusion Requirements,"
Health Care Alert
(February 7, 2005).
Contact: Barbara H. Ryland
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"Promotion of HSAs May Raise Broker-Dealer and Investment Adviser Registration Concerns,"
Health Care Alert
(September 1, 2004).
Contact: Barbara H. Ryland
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"FTC/DOJ Report Pushes Competition for Health Care Industry Ills,"
Health Care Alert
(July 26, 2004).
Contacts: Wm. Randolph Smith, Barbara H. Ryland
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"IRS Expands Period for Provider Incentive Payment Deductibility,"
Health Care Alert
(July 26, 2004).
Contacts: Charles C. Hwang, Barbara H. Ryland
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"CMS Issues Proposed Regulations Implementing Medicare Part D Drug Benefit and Medicare Advantage Program,"
Health Care Alert
(July 26, 2004).
Contact: Barbara H. Ryland
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"ERISA Preempts State Law Claims Challenging Coverage Denials,"
Health Care Alert
(June 22, 2004).
Contact: Barbara H. Ryland
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"Congressional Investigation of Pharmacy Rebates on Medicaid Drugs,"
Health Care Alert
(January 16, 2004).
Contact: Barbara H. Ryland
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"HHS OIG Publishes Proposed Rules on Exclusion of Providers for Charging Medicare Substantially in Excess of Usual Charges,"
Health Care Alert
(September 16, 2003).
Contact: Barbara H. Ryland
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"U.S. Supreme Court Upholds Kentucky "Any Willing Provider" Laws that Restrict HMOs' Ability to Select Providers,"
Health Care Alert
(April 3, 2003).
Contact: Barbara H. Ryland
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"HHS Issues New HIPAA Security Rule,"
Health Care Alert
(February 23, 2003).
Contact: Barbara H. Ryland
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"Changes To HIPAA Privacy Rule Proposed By HHS Secretary - Public Comments Due By April 26, 2002,"
Health Care Alert
(March 28, 2002).
Contacts: Laurel Pyke Malson, Barbara H. Ryland
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"On Behalf of Sagamore Health Network, Crowell & Moring Attorneys Successfully Defeated a Preliminary Injunction Motion Brought by Gateway Contracting Services in the Southern District of Indiana,"
Health Care Alert
(March 19, 2002).
Contact: Barbara H. Ryland
Press Coverage
Firm News & Announcements