Health Provider Operational Issues

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Kutak Rock’s national health care lawyers regularly advise hospitals and hospital systems across the country on day-to-day clinical and health care issues. Our health care attorneys serve as “on-call” resources to assist our clients in making day-to-day decisions on patient informed consent, emergency treatment, disruptive physicians, patients and families, and dealing with criminal conduct and difficult psychiatric issues. Many such issues require decisive action, and our attorneys play a part as a member of the risk management and administrative team to arrive at solutions to difficult problems.

HIPAA and Confidentiality

Patient confidentiality historically has been a key concern for health care providers, and Kutak Rock has a longstanding tradition of assisting providers with difficult disclosure issues. Prior to HIPAA, the health care practice group worked with hospitals and physician providers to design and implement privacy policies and procedures. Since HIPAA, our privacy practice has become more formalized. We are familiar not only with HIPAA, but also with a wide variety of federal and state privacy statutes. These privacy laws have a number of common features, all of which are within the health care practice group’s experience:

  • Patient rights. When patients seek to exercise the individual rights afforded by these statutes, we advise clients as to whether the request is valid and, if so, the time, place and manner of meeting the request.
  • Limited disclosure. When someone other than the patient requests a disclosure of medical information, we advise the client regarding whether, and to what extent, the client must or may comply with the request. If we anticipate that the request will reoccur, we often develop a policy or procedure for the client so future requests can be handled internally.
  • Vendor agreements. Hospitals must often ensure that their vendors comply with federal and state privacy laws. We have experience negotiating the agreements that detail the vendors’ obligations.

Many of the federal and state statutes also have a security component. We have prepared security policies and procedures addressing the transmission, storage, retrieval and handling of electronic medical data. We are familiar with the technical processes that allow providers to submit HIPAA-compliant claims to third-party payers, and receive remittances from them. We have negotiated numerous trading partner agreements that allow providers, vendors and payers to “speak” to each other electronically.

Where privacy and security lapses are suspected, we have helped clients conduct investigations and have documented the results. When necessary, we have helped to develop remediation plans. In many cases, we help clients avoid these issues altogether by conducting privacy and security audits.

Medical records requests are among the most frequent areas of attorney-client interaction with our provider clients. On a daily basis, we handle litigation and law enforcement requests for medical records. Our responses range from HIPAA-compliant authorizations, to response letters, to motions to quash.

EMTALA

Kutak Rock's national health care attorneys have the expertise and experience needed to advise hospitals about EMTALA compliance. We routinely advise hospital clients on EMTALA issues and prepare EMTALA policies and procedures. We assist clients in evaluating alleged violations, resolving unfounded complaints, and preparing corrective action plans, and work with hospitals to ensure future compliance. Our health care lawyers help hospitals work through difficult patient diversion issues, patient “dumping” issues, and physician call coverage issues. We also can also assist providers in implementing EMTALA audit and chart review tools.

Conditions of Participation, Accreditation and Licensure 

Our national health care lawyers regularly advise hospital clients regarding the Medicare and Medicaid Conditions of Participation, Joint Commission accreditation, and institutional and professional licensing and regulatory requirements. In an era of decreased funding, we have assisted clients with accreditation options other than the Medicare option or “deemed” accreditation. We are actively engaged in the investigation, assessment and defense, as appropriate, of cited deficiencies, and in the preparation of hospital responses and plans of correction to address deficiencies. We respond immediately to secure withdrawals of "fast track" termination notices from CMS and facilitate resolution of agency-identified issues on terms most favorable to our client hospitals. We also have successfully defended against an allegation of fraudulent hospital conduct during a Joint Commission accreditation survey and obtained withdrawal of threatened loss of Joint Commission accreditation related to the allegation.

Clinical Research

Kutak Rock regularly advises hospitals and their Institutional Review Boards regarding compliance with DHHS and FDA regulations on the Protection of Human Subjects. This includes determining whether research involving drugs and devices may be treated as exempt from review, subject to expedited review or requiring full IRB review. Our attorneys assist hospital clients in determining whether research is appropriate for a particular institution by balancing risk, reimbursement options and potential conflicts of interest among research founders, physician researchers and human research subjects. We advise hospitals on disciplining researchers who fail to properly observe regulatory and institutional restrictions. Kutak Rock's health care attorneys review and revise research-related informed consents and trial agreements. We assist clients in evaluating policies and procedures to ensure compliance with the most recent federal and state regulations and in maximizing reimbursement through proper coding and billing of experimental drugs and devices.

Consent and Risk Management Issues

Members of our national health care practice group assist many hospitals in a role as “outside in-house counsel” by analyzing factually complicated patient informed consent issues, including when consent is “informed” and adequately documented, as well as issues of minor’s consent, implied consent in emergency circumstances, consent in the context of end-of-life and medically futile situations, and when and how to obtain court-ordered consent or a legal guardianship. We also represent hospitals with psychiatric units where consent issues are governed by an additional level of laws and regulations. Finally, we assist risk managers in understanding and training hospital employees in making best judgments when difficult consent issues arise.