Health Care and Life Sciences > Health Care Regulatory Compliance Counseling

Akin Gump Strauss Hauer & Feld LLP’s health industry practice encompasses virtually every aspect of federal and state regulation of the health care industry. For more than 30 years, Akin Gump has helped hospitals and other health care providers, pharmaceutical and device manufacturers, and physicians comprehend and comply with the many legal and regulatory requirements that affect their ever-evolving industry.

Representative engagements in regulatory compliance matters include:

  • regularly advising hospitals on disproportionate share hospital (DSH), graduate medical education (GME), bad debt, geographic reclassification and a variety of other issues involving Medicare and Medicaid payment 
  • advising hospital and health systems on the payment and other implications of affiliations and joint ventures 
  • providing advice regarding the Medicare Part D prescription drug benefit program
  • counseling hospitals on compliance with the requirements of the 340B Drug Discount Program
  • evaluating and structuring financial arrangements between and among health care providers, physicians and other entities consistent with federal and state anti-kickback and physician self-referral prohibitions
  • assessing clients’ health regulatory compliance programs, policies and procedures
  • assistance with responses to adverse payment or certification actions by Medicare integrity or administrative contractors
  • advising a leading pharmacy benefit management company on various federal and state regulations affecting the provision of pharmacy services under Medicaid managed care contracts 
  • providing advice regarding Centers for Medicare and Medicaid Services (CMS) coverage determinations and policies, including coverage and coding for new medical technologies
  • developing a strategy for obtaining Medicare coverage for off-label use of pharmaceutical products
  • conducting health regulatory due diligence in connection with securities offerings, extensions of credit facilities and financial restructurings
  • analyzing and developing potential causes of action for contesting exclusion of a client’s products from a state Medicaid formulary
  • monitoring the implementation of statewide Medicaid managed care waivers and analyzing their impact on the pharmaceutical industry
  • analyzing Medicaid managed care requirements affecting a pharmaceutical company client
  • analyzing numerous Medicaid rebate program issues and working with CMS officials in implementing related requirements, including issues relating to discounts for pharmacy benefit managers (PBMs)
  • analyzing remedies for exclusion of clients’ products from state Medicaid Preferred Drug Lists
  • conducting comprehensive, multistate analyses of—and holding discussions with state regulators with regard to—various state law requirements, including the corporate practice of medicine, all-payor anti-kickback prohibitions, privacy laws and consumer protection laws
  • analyzing Medicare and Medicaid waiver eligibility and enrollment standards as they relate to Medicare DSH payments to hospitals in numerous states.