Health Care Regulatory Compliance Counseling

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.