Infusion, Home Health and Non-Physician Provider Services
Counsel that delivers effective results and demonstrated value to providers of infusion pharmacy services, including standalone infusion suites and ambulatory infusion clinics, home health agencies, hospital-at-home health care providers, hospice providers, and infusion and therapeutic service providers.
Capabilities at a glance
- Attorneys with significant experience representing health care clients, including infusion clinics and infusion providers, in-home health care providers, hospice and therapeutic service providers.
- A nationally recognized health care practice with significant resources and a deep bench of licensed health care professionals (e.g., RN/JD, PharmD/JD, PT/JD).
- A one-stop shop for nursing and infusion providers, covering the gamut of legal issues, such as health care regulatory law, scope of practice and contracting considerations, and licensure and certification requirements for nontraditional service offerings.
- Long-standing relationships with state and federal regulators, including professional licensing boards and regulatory agencies.
Shared purpose with clients on health law
Our attorneys have extensive experience representing clinics, in-home health care providers, infusion providers, and hospice and therapeutic service providers. Due to our relationships with licensing and certification agencies as well as practitioner boards, we are familiar with the legal and regulatory compliance landscape and regularly assist clients in analyzing and navigating difficult business considerations in the provision of their health care services. This unique insight allows us to assist with resolving compliance concerns with identified licensure barriers and help structure innovative health care delivery models. It also allows us to offer clear, practical and strategic advice that fits squarely within the parameters of applicable law. For many of our clients, we serve in a role similar to in-house counsel. We have the tools and sophisticated experience to help our clients negotiate the ever-changing health care landscape and the constant new regulations emerging from both state and federal lawmakers.
Services
Experience-led advice for health care providers
Few law firms of any size have the varied experience, resources and in-depth legal and health care knowledge found at Quarles. Many of our attorneys have health care industry experience as well as technical legal skills in the area. Our clients often seek advice in the following areas:
- Structuring in-home services provided by non-physician practitioners and nontraditional provider entities.
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Advising on multijurisdiction licensure strategy and managing licensing board investigations and concerns.
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Scope of practice, collaboration and supervision of non-physician practitioners and agreements related to same.
- Drafting and assistance executing policies, procedures, standing orders, protocols and order sets.
- Handling specialty pharmacy licensure and compliance issues related to home infusion.
- Advising on patient care-related legal and strategic issues.
- Guidance on patient informed consent.
- Setting up decentralized clinical trials.
- Creating pharmacy alternate staffing (e.g., using nursing students, or RNs) models to assist with immunization clinics.
- Counsel on regulatory compliance.
- Assessment and optimization of the nurse license compact (NLC).
Experience
- Representing clients that offer alternative health care delivery models, physicians and non-physician practitioners in becoming licensed or negotiating licensing board actions.
- Assisting clients that offer alternative health care delivery models, physicians and non-physician practitioners navigate scope of practice regulations and license requirements, including certificate of need applications and brick and mortar location requirements.
- Assisting with mergers and acquisitions (M&A), including due diligence and conducting licensure gap analyses for infusion providers.
- Advocating for innovative health care business proposals before state regulatory bodies.
- Advising on credentialing and licensure requirements for telehealth services.
- Conferring with regulatory boards to obtain waivers and approval for novel methods of operation and service delivery.
- Providing counsel on collaboration and supervision requirements for non-physician practitioners and drafting required agreements.
- Analyzing and revising clinical trial agreements.
- Advising on supervision requirements for ambulatory infusion clinics.
- Drafting service contracts with pharmacies, other home health providers, infusion providers, staffing agencies, health care practitioners, medical directors and health care facilities.
- Analyzing contemplated arrangements to ensure compliance with health care laws and regulations, including the Stark Law, the Anti-Kickback Statute and the False Claims Act.
- Reviewing and drafting compliance plans and policies.
- Advising on a variety of nursing issues, including the Nurse Licensure Compact, telenursing, use of nurses in call centers and nursing agency licensure.
Successes
- Helped client navigate regulatory barriers for the administration of investigational drugs in the home.
- Managed the purchase and sale of infusion pharmacy, home health agencies and hospice providers, including analyzing compliance with applicable state and federal laws.
- Assisted a physician assistant who was the subject of multiple reports by an angry ex-patient in successfully getting all such reports dismissed and deterring the patient from filing future unwarranted complaints.
- Successfully represented multiple health care professionals in front of state licensing boards in disciplinary action investigations and hearings, including physical therapy boards, medical boards, nursing boards and pharmacy boards.
