Hospitals and health systems operate in a regulatory environment that has grown increasingly complex, involving heavy scrutiny from various federal and state regulatory bodies.
Additionally, these providers encounter unique business challenges as they continue to focus on vertical and horizontal mergers and affiliations, expansion of health care systems to include the entire continuum of service providers, and grapple with the never-ending challenges of changing reimbursement models. As a unique boutique health law firm with a national practice, Frier Levitt’s deep bench of over 50 attorneys counsel hospital and health care systems regarding transactional, regulatory, corporate compliance, managed care and reimbursement issues, mergers and affiliations and corporate transactions. In addition, Frier Levitt is a national leader in the area of pharmacy purchasing and drug supply, as well as 340B, issues.
The following is a listing of just some of the issues and ideas confronting hospital and health systems in the current environment which Frier Levitt attorneys address:
- Fraud and Abuse, Including Stark and Anti-Kickback Laws on Both the Federal and State Level
- Proactive Compliance Programs and Reviews
- CMS/OIG/DOJ Self-Disclosures
- Hospital and Health System Pharmacy Matters
- Pharmacy Compliance-Drug Diversion
- Pharmacy-Integrated Delivery Network
- Pharmacy Purchasing and Drug Supply Chain Issues
IDN pharmacies face specific challenges operating in the specialty pharmacy space:
- Reimbursement Challenges and Direct and Indirect Remuneration (DIR) Fees
- Pharma-Pharmacy Relationships
- Specialty Pharmacy Network Access: In order to dispense specialty drugs the IDN pharmacy must be “in network” with a PBM
- Specialty Pharmacy Accreditation
- Automation, Remote Dispensing and Telepharmacy: 340B Programs
Pharmacies with 340B matters, including:
- Becoming a 340B In-House or Contract Pharmacy, including eligibility and compliance with on-going requirements, such as 340B database compliance, recertification, drug diversion, duplicate discounts, and program audit preparation
- Service Agreements between Contract Pharmacy and Covered Entities with an emphasis on regulatory compliance with Federal and State Laws and tailored to evolving PBM reimbursements
- Vendor agreements related to 340B operations of In-House and Contract Pharmacies
- PBM and third-party payor audits pertaining to the Pharmacy’s 340B claims
- Implementation of 340B operations Compliance Programs
- Response and defense of HRSA Section 340B audits
Transactional Matters:
- Hospital-Ambulatory Surgery Center (ASC) Joint Ventures
- Hospital/ Health System- Medical Group Partnership
- Medical Staff and Professional Licensure Matters
- Government Reimbursement Matters
- Managed Care Negotiations and Appeals
- HIPAA/Cybersecurity/Data Breach Analysis and Reporting
- Nonprofit Corporation Formation and Governance Best Practices
How Frier Levitt Can Help
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
