Healthcare Facilities (Hospitals, Labs, Pharmacies, DME, Imaging)
Healthcare facilities face an array of legal and regulatory challenges in today’s ever-changing healthcare legal environment.
Counseling Healthcare Facilities
Our healthcare and FDA lawyers counsel a variety of licensed and non-licensed healthcare facilities and ventures on regulatory and corporate compliance issues. Our clients include:
- Addiction treatment centers
- Ambulatory care facilities
- Clinical laboratories
- Clinical research organizations (CROs)
- Cord blood banks
- Diagnostics and screening facilities (including IDTFs)
- Clinical laboratories (CLIA and state law clinical laboratory issues)
- Home health agencies
- Information technology companies
- Long-term care facilities
- mHealth, telemedicine, and information technology companies
- Outpatient service providers
- Psychiatric facilities
- Rehabilitation facilities
- Residential treatment facilities
- Senior services facilities
- Skilled nursing facilities
- Sober living facilities
- Urgent care centers
Our transactional practice includes mergers and acquisitions, restructurings, financings, joint ventures, and other arrangements.
Regulatory Issues for Healthcare Facilities
The regulatory issues on which our healthcare facility clients seek legal counsel, can range from HIPAA compliance to California Department of Public Health licensing issues to FDA regulations.
- For example, we assisted one of our clients in responding to an investigation by the California Department of Public Health’s Laboratory Field Services Blood Bank and Biologics Section. This Section enforces various sections of California’s Health & Safety Code which include, for example, provisions for periodic inspection of health facility for which a license or special permit has been issued. Among other penalties, the statute provides for suspension, denial, or revocation of licenses, and for prosecution by district and city attorneys upon evidence of violations within their respective jurisdictions submitted by the Department. We were able to clear misunderstandings, resolve deficiencies in the client’s documentation, and negotiate for lesser enforcement penalties.
- We advised another client on a plan to create a clinic to provide patients with cord blood-based, stem cell injections. Here our counsel required knowledge of relevant FDA regulation of biologics and drugs; FDA regulation of cord blood and stem cell products (principally through the FDA guidance on Human Cells, Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations and related guidance); FDA and FTC rules about substantiation, state law licensing requirements for biologics products and/or stem cell products; and consumer protection laws.
- A healthcare facility asked us to opine on whether its business model met California’s statutory definition of a “congregate health facility” and related regulatory requirements. According to California law, such a facility is “a residential home with a capacity, except as provided in paragraph (4), of no more than 18 beds, that provides inpatient care, including the following basic services: medical supervision, 24-hour skilled nursing and supportive care, pharmacy, dietary, social, recreational, and at least one type of service specified in paragraph (2). The primary need of congregate living health facility residents shall be for availability of skilled nursing care on a recurring, intermittent, extended, or continuous basis. This care is generally less intense than that provided in general acute care hospitals but more intense than that provided in skilled nursing facilities.”
California has a confusing landscape of regulatory definitions, including: “adult residential facility,” “clinic,” “community care facility,” “crisis nursery,” foster family agency,” “group home,” “health facility,” “residential care facily for the elderly” (RCFE), “residential care facility for the chronically ill,” “social rehabilitation facility,” and “transitional housing placement program.”
- We advised several healthcare facilities on data breaches involving theft of electronic and/or paper records.
- We counseled a provider of ambulatory EEG services on Medicare IDTF, billing, and fraud and abuse issues.
- We developed an informed consent process for a healthcare facility specializing in the needs of patients with autism.
- We counseled a hospital on whether it could bill the patient’s insurance provider in circumstances under which the admitting physician could not obtain the patient’s signature at the time of admission.
- We drafted and negotiated an agreement for a physician group to provide telemedicine, remote healthcare services, including primary care services, to a hospital’s inpatients.
We also advise on corporate practice of medicine, Physician/provider contracts, Professional Services agreements, medical staff bylaws, risk mitigation, Stark, anti-kickback and fee-splitting, rural/underserved areas and related regulatory issues, which affect healthcare facilities seeking to grow their market share.
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