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Health Care

Overview

For health care organizations, the combined forces of complex regulations, increased competition, and new technology are putting businesses to the test. To help clients navigate these headwinds, Crowell & Moring’s nationally recognized team of health care practitioners in California, Denver, New York, and Washington, D.C. draws on decades of experience to deliver quality counsel and industry leadership on the most significant issues in the field.

We represent a wide range of health care companies and organizations, including all of the top ten health insurers and many of the nation's leading health care providers, non-profits, vendors, digital health companies, and manufacturers. We also work closely with Crowell Health Solutions (CHS), our strategic consulting firm focused on helping clients advance their digital health, health equity, and value-based health care products and services.

Year after year, clients and top legal and industry ratings agencies, including Chambers USA and other publications, have praised our work, describing us as “insightful” and as having “an encyclopedic knowledge of the area.” We are ranked as a leading health care practice by Chambers in California, New York, and Washington, D.C., and seven of our lawyers are ranked as individuals.

Client-focused solutions

At Crowell, we provide comprehensive, coordinated, and — above all — customized counsel that helps health care organizations address critical legal needs. We help clients with:

  • Health care transactions and corporate matters, including complex mergers between managed care plans and providers, joint ventures between providers and insurers, the establishment of accountable care organizations, physician practice acquisitions/affiliations, pharmacy benefit manager (PBM) agreements; and health care financing transactions.
  • Health care litigation in federal and state courts, arbitral forums, and before regulatory agencies around the country.
  • Fraud and abuse investigations, enforcement, and compliance, including the False Claims Act (FCA), anti-kickback requirements, and the Stark law.
  • Complex state and federal regulatory requirements, including the Affordable Care Act (ACA), Medicare Advantage, Medicare Part D, Medicare ACOs, cost contracting, MACs, Medicaid managed care, TRICARE, FEHBP, and the VA.
  • Digital health for tech and traditional health care companies, including assisting clients with policy and regulatory counseling, product counseling, business transactions, product risk management advice, and issues arising out of the use of artificial intelligence.
  • Health information privacy, including counseling on compliance with HIPAA, HITECH, GDPR, and other federal and state laws, as well as compliance programs related to data privacy.
  • Antitrust, including day-to-day counseling, mergers and acquisitions, structuring joint ventures among service providers and payers and other transactions, responding to investigations by the antitrust enforcement agencies, and helping clients protect themselves from the anticompetitive practices of others.
  • Health law reform, including providing regulatory and legislative analysis, strategic planning, and Congressional advocacy.

  • Crowell’s health care practitioners are among the most seasoned in the field, bringing impressive experience in both government and industry roles. Our team includes professionals who have played critical roles in the development and implementation of the ACA in the federal government, worked for Congressional leaders crafting health care policy, managed in-house corporate, federal, and state health care government affairs, held leadership roles in government agencies affecting the health care industry, and worked on the development of international trade policy affecting health care. Members of our team have worked for:

    • Department of Health & Human Services (HHS)
    • Centers for Medicare & Medicaid Services (CMS)
    • Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC)
    • Department of Justice (DOJ)
    • Federal Trade Commission (FTC)
    • Democratic and Republican Senators and Representatives
    • California Department of Managed Health Care (DMHC)
    • Office of the New York State Attorney General (NYAG)

    Members of our practice hold and have held numerous leadership positions in the industry, including leadership roles within the American Health Lawyers Association (AHLA).

    Crowell’s health care practitioners are among the most seasoned in the field, bringing impressive experience in both government and industry roles. Our team includes professionals who have played critical roles in the development and implementation of the ACA in the federal government, worked for Congressional leaders crafting health care policy, managed in-house corporate, federal, and state health care government affairs, held leadership roles in government agencies affecting the health care industry, and worked on the development of international trade policy affecting health care. Members of our team have worked for:

    • Department of Health & Human Services (HHS)
    • Centers for Medicare & Medicaid Services (CMS)
    • Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC)
    • Department of Justice (DOJ)
    • Federal Trade Commission (FTC)
    • Democratic and Republican Senators and Representatives
    • California Department of Managed Health Care (DMHC)
    • Office of the New York State Attorney General (NYAG)

    Members of our practice hold and have held numerous leadership positions in the industry, including leadership roles within the American Health Lawyers Association (AHLA).

  • To help clients better understand, influence, and comply with complex legislation and policy, we maintain longstanding relationships with key federal agencies, including the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG), CMC, FTC, DOJ, the Department of Defense TRICARE program, the Food and Drug Administration (FDA), and the Office of Personnel Management (OPM).

    To help clients better understand, influence, and comply with complex legislation and policy, we maintain longstanding relationships with key federal agencies, including the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG), CMC, FTC, DOJ, the Department of Defense TRICARE program, the Food and Drug Administration (FDA), and the Office of Personnel Management (OPM).

Contacts

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Insights

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024....

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Representative Matters

  • Lead antitrust counsel for Coventry Health Care, Inc., in its pending $7.2 billion acquisition by Aetna Inc. The combination of two of the largest 10 commercial health insurance companies in the country is subject to antitrust review by the Department of Justice Antitrust Division.
  • Work with 19 hospital regional health care system on legal and operational compliance and defense against government investigations concerning federal health care program anti-kickback statute and regulations, the federal prohibition on physician self-referrals (the "Stark Law"), related civil monetary penalty laws, and Medicare billing rules and regulations, e.g., provider-based billing requirements and hospital outpatient supervision requirements.
  • Represented Health Net in renegotiation of its pharmacy benefits management arrangements with Caremark CVS and the $160 million sale of Health Net's Medicare Prescription Drug Plan business to Caremark CVS and in securing clearance from the Department of Health & Human Services Centers for Medicare & Medicaid Services and the Antitrust Division of the Department of Justice.
  • Successfully defended Health Net against a putative class action complaint alleging a price-fixing conspiracy under California's Cartwright Act and Unfair Competition Law.  Plaintiffs, a group of independent retail pharmacies, alleged that Health Net had entered into a conspiracy to not reimburse patients or their pharmacies for generic versions of Lipitor. Crowell & Moring convinced the plaintiffs to dismiss Health Net without any compensation or remedy, before filing of a motion to dismiss, based on a presentation of facts demonstrating that our client had not engaged in the alleged anticompetitive misconduct. 
  • Defense of client in the first action by a State Attorney General under 2009 amendments to the HIPAA statute. The Connecticut Attorney General sued our client based on the disappearance of a portable disk drive from a Connecticut facility containing 32 million pages of patient information. After months of negotiation, a favorable settlement was reached for the client, acknowledging the measures that our client had voluntarily taken to protect the identity and credit of its members.
  • Internal review of a major national health insurer's compliance with the new medical loss ratio (MLR) requirements under the Affordable Care Act health reform law.
  • Representation of an attorney and law firm that are under investigation by the Department of Justice for his/their role in issuing a legal opinion to a hospital client concerning the legality of a hospital-physician group relationship.  The government asserts separately that the hospital-party to the hospital-physician group arrangement violated the Stark Law and the False Claims Act, and that the attorney and law firm who represented the hospital in this matter are also potentially liable for these violations. The focus of the Department of Justice on whether an attorney's legal opinion can be a False Claims violation raises unprecedented issues.
  • Representing a hospital responding to a federal investigation into whether the hospital paid kickbacks to cardiologists in exchange for patient referrals through free rent, higher than appropriate medical director compensation or other measures.
  • Representation of a major medical device manufacturer in responding to a whistleblower complaint alleging that the company paid kickbacks to certain "group purchasing organizations" (GPOs) in order to qualify its medical devices for eligibility for purchase by the GPO's hospital members. The whistleblower alleged that the numerous hospitals who bought these products filed false claims for Medicare payment when they certified on their claims for payment that the services for which payment was sought were provided "in accordance with applicable law."
  • Counsel a large health insurer regarding a possible defined contribution health arrangement for a Fortune 100 company, addressing the meaning of "insurance" for purposes of Internal Revenue Code section 105 and various nondiscrimination concerns.
  • Provide counsel to large insurers, trade associations, and third-party administrators regarding implications to their business of health reform legislation, the Patient Protection and Affordable Care Act (PPACA). Engage in advocacy before various federal agencies (including the Departments of Treasury, Labor, and Health and Human Services) on behalf of trade associations and other entities with respect to PPACA.
  • Obtained dismissal of patent infringement claim against our clients, one of the world's largest generic drug manufacturers.  On appeal, the Federal Circuit agreed with the district court that the FDA had only approved one of the drug's three effects, contraception, which was not protected by any patent. This decision allows generic drug companies to enter the market with a generic – and substantially less expensive – version of a beneficial drug, but also provides guidance to all pharmaceutical companies on the interplay between the scope of FDA approval for a drug's use and the enforcement of patents relating to the use of the drug, in particular whether a method-of-use patent listed in the FDA's "Orange Book" is properly asserted in a Hatch-Waxman litigation against a generic applicant.

Contacts

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Insights

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024....

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Insights

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

Blog Post | 11.05.24

Stringent Requirements for Pleading Fraud Under Rule 9(b).

Blog Post | 11.01.24

General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss

Podcast | 11.01.24

Payers, Providers, and Patients – Oh My!: Presidential Health Care Proposals
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Professionals

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Insights

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024....

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Practices

Contacts

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Insights

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024....

View All Insights