Our Focus

We have worked closely with Medicare Part D Prescription Drug Plans since the program’s inception and have watched the regulatory and sub-regulatory requirements grow in complexity for Medicare Part C (Medicare Advantage) and Medicare Part D. Representing Medicare Advantage and Part D plans, we:

  • Counsel plan sponsors on strategic decisions, such as product expansions, outsourcing portions of operations, and marketing strategy
  • Draft and negotiate contracts subject to Centers for Medicare & Medicaid Services (CMS) regulation, including agreements with pharmacy benefit managers (PBMs) and vendors for health plan functions such as disease management and sales and marketing
  • Prepare and negotiate healthcare provider and pharmacy agreements
  • Design and develop compliance program policies and procedures
  • Advise and assist plans undergoing government audits or responding to CMS demands for corrective action
  • Perform regulatory due diligence for acquisitions and other transactions

We counsel Medicaid Managed Care plans, their partners, and their subcontractors on day-to-day legal issues, regulatory intricacies, and compliance matters. Specifically, we:

  • Interpret, analyze, and implement new legal and regulatory requirements affecting federal healthcare programs
  • Perform analysis of federal and state Medicaid managed care requirements
  • Draft and negotiate contracts subject to Medicaid managed care regulation, including downstream or subcontracted vendors for functions such as risk adjustment data services
  • Design and implement compliance programs, including the development of policies and procedures
  • Conduct compliance and fraud, waste, and abuse training for senior executives, boards of directors, and employees

We represent and advise health insurers, managed care organizations (MCOs) and pharmacy benefit managers with respect to actual or potential disputes arising within the dynamic and complex healthcare industry.

Some examples of our litigation and dispute resolution services include:

  • Payor-provider disputes
  • Affordable Care Act issues
  • Third-party subpoenas and investigations
  • Prosecution and defense of claims based on contract, equity, breach of fiduciary duty, racketeering, conspiracy and fraud
  • False Claims Act liabilities or opportunities
  • Licensing disputes
  • Takings Clause violations
  • Directors and Officers liability
  • ERISA violations
  • Insurance coverage and reinsurance issues and claims

With experience in both state and federal courts as well as arbitration forums, Strategic Health Law is well-equipped to guide healthcare entities through an evolving legal landscape. Our seasoned litigators devise strategies to successfully navigate complicated conflicts and challenges, achieve results and mitigate risk.

Representative Clients and Matters

  • Representing Humana Inc. and Humana Pharmacy Solutions in responding to subpoenas related to allegations of conspiracy and price fixing of EpiPen drug devices.
  • Representing Premera Blue Cross in the prosecution of claims for over $117 million in risk corridors underpayments under the Affordable Care Act.
  • Defended an Illinois Medicaid plan against a major hospital system for alleged underpayment of claims.
  • Representing the Blue Cross Blue Shield Association as amicus curiae in a federal appeal implicating health insurers’ entitlement to over $12.3 billion in risk corridors payments under the Affordable Care Act.
  • Representing a national health insurer in reimbursement dispute opposite laboratory as part of a confidential AAA arbitration.
  • Represented a national health insurance company in connection with the successful recovery of victim restitution amounts as part of a $125 million criminal and civil settlement between the federal government and a global pharmaceutical company. The pharmaceutical manufacturer was alleged to have engaged in multiple fraudulent schemes involving the improper sales and promotion of various drugs, anti-kickback schemes and other fraud.

Our deep experience in Medicare Part D regulations and healthcare anti-fraud laws such as the False Claims Act and Anti-Kickback Statute make us a valuable resource for PBMs as well as pharmaceutical manufacturers. We understand health plans’ regulatory environment and can help drug companies market and distribute products, with their health plan customers’ risks and concerns, as well as their own, in mind. In our pharma engagements, we:

  • Analyze developments in Medicare Advantage and Medicare Part D law, policy and regulations that affect drug purchasing and pricing
  • Prepare and negotiate rebate agreements
  • Provide counsel regarding treatment of Employer Group Waiver Plans (EGWPs) under Medicare Part D’s benefit structure
  • Support care management initiatives and review materials targeted at health plan and provider customers

We support our clients during CMS program audits, making sure they’re well-prepared to meet the government’s expectations and demands. We also help health plans meet CMS requirements through our own annual Medicare Compliance Program Audits.

Our Compliance Program Audit process is designed to mirror The Compliance Program Effectiveness (CPE) portion of a CMS audit. Our tools reflect the CMS CPE Audit materials, and we emphasize the use of tracer samples to demonstrate compliance so that clients are prepared for their next CMS Program Audit.

Our goals in Compliance Program Reviews are to:

  • Identify gaps in current compliance programs
  • Prepare clients for CMS Program Audits
  • Help clients enhance their compliance programs to support compliant operational results

At the end of our review, we provide a detailed report with the information needed to act on our recommendations.

We conduct dynamic, practical in-person and computer-based compliance training that addresses legal and regulatory requirements for health plans contracting with the federal government, including the False Claims Act, Anti-Kickback Act, and Medicare Advantage and Part D regulatory and sub-regulatory requirements. Strategic Health Law provides customized training for different audiences, including:

  • Senior executives
  • Board members
  • Employees
  • Contractors
  • Sales agents

In developing training programs, we work with our clients to identify areas of risk specific to their organization and target those company-specific concerns. We also track trends in regulatory enforcement to know which hot topics need to be addressed in that year’s compliance training.

We have extensive experience helping health plans work within the laws and regulations governing Medicare Supplement or Medigap plans. Our services in connection with Medicare Supplement plans include:

  • Advise on development of eligibility and underwriting standards in light of regulatory requirements
  • Counsel on sales and marketing strategy for entire suites of products for Medicare beneficiaries
  • Perform regulatory review of marketing materials
  • Prepare for audits by state Departments of Insurance and implementation of required corrective actions

The highly regulated environment of federal healthcare programs presents challenges for companies who contract to provide services to Medicare Advantage, Part D, or Medicaid Managed Care plans.

Let us make your life easier when it comes to responding to client requests, interpreting regulatory requirements, and negotiating contracts with your clients. We can also work with you in developing the compliance program that will meet your contractual obligations.

Investors evaluating health care opportunities look to us for support with their due diligence efforts. We use our experience and insight to:

  • Assess the strength and effectiveness of a healthcare company’s compliance program through full compliance program audits or more streamlined reviews
  • Advise on trends in the Medicare and Medicaid regulatory environment
  • Counsel investors on strategic decisions, such as the legal risk implications of entering the Medicare Advantage and Part D or Medicaid market, product expansions, or outsourcing portions of operations
  • Interpret, analyze, and implement new legal and regulatory requirements affecting federal healthcare programs
  • Evaluate contracts subject to federal regulation, including agreements with health plans, hospitals and other providers, pharmacy benefit managers (PBMs), and administrative services vendors