Whether it is responding to a complex patient safety event or dealing proactively with highly-sensitive matters that involve the clinical competency of caregivers or the mental capacity of those they treat, a robust risk management program is vital to mitigating the legal, financial and reputational harm that can threaten the viability of any healthcare organization. Understanding these risks and the expectations that regulators and accrediting bodies have in a provider’s ability to control them is why Pullman & Comley has assembled a dedicated and multi-disciplinary group of our firm’s attorneys that has many decades of experience supporting the compliance and risk management functions of hospitals and other healthcare entities.
Our attorneys possess years of experience in investigating and disclosing medical errors, privacy breaches and other adverse events, educating clients on legislative and administrative law changes and assisting in the review and revision of policies and procedures to maintain compliance, advising IRBs and principal investigators on clinical research studies, helping to implement compliant contract management and due diligence standards for procurement, supply chain and health information technology departments, and representing clients in regulatory investigations and audits, including those conducted by the OIG, OCR, DEA and CMS at the federal level and Medicaid agencies, boards of pharmacy and departments of health and protective services at the state level.
Recent representative matters in which our compliance and risk management lawyers have been involved, include:
- COVID-19 emergency preparedness measures involving expansion of telemedicine programs in conformance with state and federal supervision and scope of practice requirements, credentialing of out-of-state providers, bed allocation to maintain flexibility for surge capacity, implementing infection control processes for visitors and staff, procurement of specialty drugs and PPE, and adoption of OCR-compliant crisis standard of care policies in such areas as ventilator allocation, changes in code status and withdrawal of life support.
- Advising clients on the implementation and rollout of the ONC’s new information blocking rules and their interplay with HIPAA, GDPR, cybersecurity and EMR vendor requirements.
- Defending clients in HRSA audits of pharmacy services for compliance with 340B program child site and contract pharmacy requirements as well DEA and DCP investigations to ensure compliance with state and federal laws regulating the ordering, administration, dispensing, and wasting of controlled substances.
In addition to the above, our attorneys regularly represent hospitals and other facilities in Probate Court and related administrative proceedings involving psychiatric commitments, involuntary conservatorships, guardianships, medical futility cases and problematic discharges. For example, we recently represented a hospital in litigation and negotiations with the Connecticut Department of Development Services (“DDS”) to secure safe and appropriate discharges for teenage patients when the wishes of the payor, the patient’s legal guardians and the treating physicians were in dispute.
Our highly experienced team of attorneys also provides overnight, weekend and holiday on-call coverage on an as-needed basis to back up overstressed or temporarily understaffed legal departments or case management teams that ordinarily handle such issues. For further information on any of these services, please contact the co-chairs of our Healthcare Department, Collin Baron or Stephen Cowherd.