340B Program Basics and Recent Updates and Changes
Original Program Date :
Length: 39:15
Topics covered will include:
The Origin of 340B Program
Purpose of 340B Program
How 340B Program Works
Covered Entity Program Requirements
HRSA Program Integrity Audits
350B Pricing
340B Reimbursement
340B Statistics
Genesis v. Becerra: Definition of “Patient”
Pharma v. McClain: Contract Pharmacies
HRSA Policy on “Child Sites”
Proposed Federal Legislation
Alice Harris is an experienced health care, reimbursement, and compliance attorney based in the Firm's Columbia, South Carolina office, where she assists hospitals, health care systems, FQHCs, clinical laboratories, physicians and physician practices, skilled nursing facilities, assisted living/Community Residential Care Facilities, hospice agencies, home health care agencies, Continuing Care Retirement Communities, behavioral health providers, pharmacy providers, and other health care providers with a wide variety of matters. Her practice focuses on health care regulatory compliance, payor audit appeals and defense, reimbursement, billing and coding, Medicare and Medicaid exclusion and termination matters, credit balance issues, COVID-19 advice, 340B compliance and audit defense, Medicare and Medicaid reimbursement issues, FQHC compliance and reimbursement issues, health care licensing and CHOW, compliance program guidance, response to federal and state contractor audits, internal investigations, fraud and abuse analysis and litigation matters, federal and state survey and certification matters, Medicaid Cost Report appeals, EMTALA investigations, transactional compliance due diligence and health care CON and licensing, and other health care regulatory and litigation matters.
Alice has experience handling overpayment and extrapolated overpayment appeals related to Medicare, Medicaid, and Commercial payor audits, including UPIC, MIC, TPE, Medicaid Integrity, and other contractor audits. She also assists providers with proactive compliance assistance to reduce exposure to audits, as well as root cause examinations and the development of corrective action plans to address underlying issues related to ongoing payor audits.
Her compliance analysis and advice experience ranges from initial formation and restructuring of compliance programs, including policy and procedure development, to internal investigations, potential whistleblower exposure, and coordination of ongoing coding reviews. Alice also has extensive health care litigation experience.