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

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

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

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