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Health Care and FDA: Clinical Integration and Accountable Care

In today’s era of declining reimbursement, increasing regulatory complexity and scrutiny, and constantly changing political priorities, providers increasingly are turning to emerging value-based payment models and to the development of integrated networks with other providers.

We have a long history of working with leading academic medical centers, large regional health systems and community hospitals, and other local providers to structure clinically integrated networks, accountable care organizations, and other alternative payment model arrangements. Our vast experience dates back to the original formation of hospital networks, physician-hospital organizations, and independent physician associations, which were organized initially to respond to the advent of managed care by commercial payors. From these earlier days in which financial integration was paramount, our work has evolved in order to help our clients meet new market and governmental payor demands, including achieving clinical integration to provide better care for individuals, improved health for populations, and lower health care costs.

We partner with clients to design arrangements capable of sharing key operational and patient data, negotiating collectively with private payors, and participating in Medicare and Medicaid shared savings programs, bundled payment arrangements and other innovative payment models. Our team includes dedicated healthcare antitrust, regulatory, corporate, and transactional lawyers available to advise clients on key issues, such as:

  • Regulatory compliance in forming integrated network models, including antitrust, Stark Law, state and federal anti-kickback, prohibitions on gainsharing and inducements to beneficiaries, HIPAA, state insurance licensure, and tax/tax-exempt structuring.
  • Operationalizing integrated networks, including formation of joint venture networks, participating provider contracting, design of network policies, implementation of HIPAA compliant data sharing arrangements, contracting for population health software, electronic health record and health information exchanges, and other key network infrastructure.
  • Designing and negotiating innovative incentive and risk-based payment models with managed care plans and employers, and enrollment in alternative governmental shared savings and bundled payments programs.

Our health care lawyers have published and presented nationally on the opportunities and challenges associated with network development and innovative payment models and represent integrated provider networks at all stages along the clinical integration continuum.

Our lawyers also represent provider entities taking on insurance risk through provider-led insurance plans. Our experience includes advising Medicare Advantage plans and Medicaid Managed Care Organizations (MCOs), as well as Programs of All-Inclusive Care for the Elderly (PACE). This includes work providing compliance advice to Medicare Advantage Organizations and Medicaid MCOs. Our representation of PACE programs includes startup and ongoing compliance advice.

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