For more than 25 years, Frier Levitt has represented home infusion providers across a broad range of legal, regulatory, transactional, and reimbursement matters. Our experience spans corporate transactions and regulatory compliance to pharmacy benefit manager (PBM) audits, investigations, network disputes, and other challenges affecting home infusion providers.
Frier Levitt’s attorneys include clinicians who bring firsthand knowledge of the clinical and operational issues unique to home infusion therapy. This combination of legal and clinical experience enables our team to understand the complex relationships among home infusion pharmacies, patients, physicians, hospital discharge planners, health plans, payors, PBMs, and home health agencies.
Home infusion therapy plays an increasingly important role in delivering care outside of traditional hospital and skilled nursing settings. When appropriately structured, home infusion programs can improve access and continuity of care, support patient adherence and safety, and reduce costs for both patients and payors. At the same time, providers operate within a complex and evolving regulatory and reimbursement environment that requires careful attention to compliance, contracting, licensing, and payor requirements.
Frier Levitt helps home infusion providers navigate these challenges while protecting their businesses and supporting opportunities for growth. Our attorneys provide a comprehensive range of legal services tailored to the home infusion industry, including the following:
How Frier Levitt Helps Home Infusion Providers
- As payers continue to transition from fee-for-service plans, Frier Levitt negotiates optimal value-based reimbursement with payers by leveraging the numerous benefits of home infusion providers. By way of example and not limitation, home infusion providers contribute to cost savings and increased compliance, while decreasing mortality and morbidities and increasing patient safety and medication adherence.
- Frier Levitt assists home infusion providers seeking to improve cost savings and collect data related to home infusion provider benefits by formation of Clinically Integrated Networks in which providers with like-minded objectives and service models utilize standard operating procedures and GPOs to ensure compliant home therapy services.
- Frier Levitt has a transactional group of attorneys dedicated to mergers and acquisitions, joint ventures with hospitals and physicians, and private equity transactions, in addition to contracts with payers.
- Frier Levitt also structures contracts with drug manufacturers which fall within the relevant rebate and discount safe harbors.
- Frier Levitt works with clients to create intercorporate documents for entity owners, shareholders, and employees including sales contracts.
- Frier Levitt analyzes existing relationships with physician referral sources while also developing relationships with physicians and other industry stakeholders in compliance with State and Federal law.
- Frier Levitt regularly counsels its clients to develop and implement comprehensive HIPAA compliance plans, data breach analysis, and reporting, as well as physician and staff required annual training.
- Frier Levitt counsels clients on State Board of Pharmacy and Department of Health rules and regulations.
- Frier Levitt fights the abusive tactics of PBMs and has achieved success in all stages of audits and network termination disputes, from the initial appeal up through arbitration proceedings.
- Frier Levitt assists providers with obtaining various accreditations as well as successful completion of PBM credentialing processes.
- With respect to reimbursement issues, Frier Levitt can help home infusion pharmacies and providers receive proper reimbursement rates for drugs, supplies, and services rendered for commercial and Medicare and Medicaid payers.
- Frier Levitt has extensive experience with respect to Medicare Audit appeals for claims which have been denied or reopened for providers as well as beneficiaries seeking an exception to access a drug not on formulary.
In addition to the services above, Frier Levitt assists in a variety of other matters related to Home Infusion Providers including, but not limited to:
- Combatting prescription leakage and PBM prescription “trolling”–a practice wherein a PBM receives a drug claim for adjudication by the home infusion pharmacy, but instead reroutes the prescription to the PBM’s wholly owned specialty pharmacy without the patient or prescriber’s consent
- Developing compliant copayment collection policies and copayment assistance programs
- Change of ownership
- Prior Authorization PBM and regulatory compliance
- Structuring arrangements and relationships between Wholesalers/Manufacturers and pharmacies to maximize profitability
- Participation in HUB arrangements
- Relationships with pharmacy services administrative organizations (PSAO)
- Compliance with State Boards of Pharmacy rules and regulations
- State pharmacy licensing issues
- Prescriber relations and physician marketing
- Evaluating telemedicine and telehealth compliance
- Off-label dispensing and REMS compliance
- Drug sourcing and inventory maintenance practices
- Structuring central fill and shared-services arrangements
- Direct-to-physician marketing of physician infused medications
- Pharmacy transactions and related real estate
- OIG and governmental self-disclosure protocols
- Mail order practices
- Access restricted PBM and payor networks
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
