When They Just Say No: Documenting Patient Refusals in the Era of HIPAA

Have you ever speculated about the origin of a word or phrase used in your occupation? Contemplate the word confuse, and how it may apply to the prehospital industry. What is the origin of the word confuse? Cynics may suggest that the Health Insurance Portability and Accounta­bility Act (HIPAA) has blended two common prehospital terms, consent and refuse, to yield a new term: con-fuse.1

In a November EMS Magazine article addressing HIPAA and documentation, providers were introduced to strategic documentation-simple, savvy, on-the-street strategies that promote a HIPAA-compliant and legally defensible prehospital run sheet. That article discussed the relationship between consent and your written "word picture," the documentation of your prehospital care, and how these intertwined building blocks are crucial to meeting the core demands of the HIPAA privacy rule.

The HIPAA rule centers on the fundamental concept of consent resulting from an informed decision made by the patient (or, as applicable, the patient's authorized decision-maker). The issue of consent to treatment and the sharing of protected health information (PHI) is intended to safeguard the patient's privacy and PHI. As you well know, in order to satisfy the strictures of the Act, literal documentation of such consent is demanded in your written report.2

Are there similar documentation implications for refusal-of-service situations? Does HIPAA demand that a prehospital provider apply these same strategic documentation tactics in the case of a refusal (commonly referred to in the prehospital arena as an AMA) situation?

Much confusion still surrounds the intricacies of HIPAA and the documentation that proves compliance. Strategic documentation will marry the complex requirements of the rule's demand for information with the information required in a legally defensible run sheet to create a practical report-writing style.3 Strategic documentation focuses on straightforward simplicity in recording the prehospital call, regardless of consent or refusal. It not only complies with HIPAA guidelines, but promotes a legally defensible prehospital report. From the legal perspective, your run sheet is written testimony and can be utilized as such in court proceedings. Whether the call features consent or refusal, strategic documentation is vital for the protection of you, your crew and your agency. It provides valuable information not only to subsequent healthcare providers, but also to privacy officers and enforcement agents analyzing your report for compliance.4

What HIPAA Requires

On the scene, the informed decision-making process will yield one of two results: informed consent for your prehospital services, or informed refusal of them. These two terms share a common descriptor: the word informed, which can be defined as having or simply based on information.5 The issue of informed consent/refusal is not judged on an "all or nothing" basis in the prehospital arena; thus, the process can be further pared down into consent or refusal of particular components of care or service.

As part of the decision-making process, consent cannot be deemed valid unless distinct criteria are met. The same criteria that apply to informed consent are in fact applicable to informed refusal.6 The informed-consent doctrine presented earlier in this series discussed the prerequisites that constitute informed consent. Consent is the inverse of refusal, yet these opposing circumstances share distinct criteria, and all of the prerequisites associated with informed consent apply equally to informed refusal.7 These prerequisites are:

• Legal capacity (the patient having the legal standing to refuse treatment);
• Mental capacity (the patient's ability to understand the proposed treatment and its benefits and risks); and
• Knowledge or disclosure of information (from the provider to the patient, in accordance with the provider's level of expertise).

Further complicating HIPAA's effect on prehospital documentation is its demand that communication from provider to patient about use or disclosure of protected health information be in plain language, or understandable terms for a patient. Does this pertain to a refusal-of-service situation?

Consider section 164.506 ("Consent for Uses or Disclosures to Carry Out Treatment, Payment or Health Care Operations") of HIPAA's Standards for Privacy of Individually Identifiable Health Information.8 Consent obtained at initiation of the patient-provider relationship-prior to care, as required by the rule-serves distinct functions: It is used for purposes of actual consent for treatment, and from there for disclosure of protected health information in facilitating payment and/or further healthcare operations.9 So if a patient initially consents to treatment, thus consenting to disclosure of protected health information, then refuses an element of continued treatment, service or even transport, does the plain-language directive apply to your refusal form, which the patient acknowledges by means of a signature?

It would be sensible to apply HIPAA's plain-language directive to your documentation of informed refusal. The patient has refused service, not revoked consent for use and disclosure of protected health information. In the course of your encounter, you have likely generated protected health information for this patient. What about this information? Does this refusal of service constitute revocation of consent to release of protected health information? Not likely, but this aspect of HIPAA has not been thoroughly tested, so any response is qualified at this time. Health information acquired or generated during a refusal situation is granted the same protection as that of a consent situation. Be reminded that the basic prerequisites of refusal (legal capacity, mental capacity and knowledge or information) must be evident through your written documentation.

The Fine Points

At the risk of redundancy, it seems beneficial to review the fine points of strategic documentation and apply them to the issue of informed refusals.

The prerequisite of legal capacity is relatively straightforward state by state, yet rules covering the emancipation of minors and authorization of decision-makers can vary. Your agency's legal advisor can guide you in determining the parameters of legal capacity.

The second prerequisite, mental capacity, forces you to capture critical aspects of your assessment in your word picture. For the informed refusal to be valid, the patient must be mentally or cognitively competent to make an informed decision. At a minimum, the provider must document the four points of orientation, utilizing intangible tools to form a tangible assessment and create a convincing word picture, while considering possible physiological or chemical interferences or influences to the patient's cognition.10 A tool as simple as the Glasgow Coma Scale lends broad character to your word picture.

The third prerequisite concerns the knowledge gained by the patient based on information you provide (the proposed treatment and its risks or consequences). Simple, straightforward documentation accurately portraying your verbal exchange constitutes strategic documentation of the patient encounter.

Backtrack for a moment. As specified by the rule, the initial consent obtained prior to commencement of care serves as consent for treatment, and for disclosure of protected health information. Thus, consent for disclosure of PHI comes as a result of consent for treatment, and consent for treatment must commence before protected healthcare information is generated. As well, HIPAA permits you to waive the consent requirement (via the emergency exception to treatment provision) when there are barriers to communication with a patient who requires treatment. But how does a barrier to communication overshadow the informed-refusal process? Strategic documentation is strongly recommended. In the circumstance of barriers to communication, document any language liaisons or interventions employed to overcome the barriers. Strategic documentation of an informed patient refusal shows a clear word picture of your physical assessment, any treatment rendered and/or the proposed treatment refused by the patient. Most important, clear, concise documentation of the risks or consequences, described to the patient per your scope of expertise, is paramount.

Conclusion

New HIPAA rules call for new on-the-street practices. If an issue as simple as consent can be challenged in the absence of strategic documentation, then a known catalyst for trouble like refusal situations can prove problematic as well. Take the HIPAA-induced confusion out of consent and refusal by knowing that the same strategic documentation tactics apply to both. Simply put, strive to create a written word picture that is clear and concise. If assessments are performed, fortify them with meaningful descriptors, qualifiers and quantifiers. Any treatment received by the patient should be reflective of your protocols, and any refusal should be documented verbatim. Alleviate confusion fueled by HIPAA-document all of your calls strategically.

References

1. Graham D. The Missing Protocol-A Legally Defensible Report (second edition). Montgomery County: MidAtlantic Medical Legal Publishers, 2004.
2. Graham D. Strategic documentation: A key for survival in the HIPAA era. Emerg Med Serv 32(11): 41-44, Nov. 2003.
3. Op cit, The Missing Protocol, 2nd ed.
4. Ibid.
5. Ibid.
6. Ibid.
7. Graham D. The Missing Protocol-A Legally Defensible Report. Ashton: Clemens Publishing, 1999.
8. Standards for Privacy of Individually Identifiable Health Information. 164.506: Consent for Uses or Disclosures to Carry Out Treatment, Payment or Health Care Operations.
9. Ibid.
10. Op cit, The Missing Protocol, 2nd ed.