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Understanding the Difference Between Coding Guidelines, Rules, and Regulations in Healthcare

April 27, 2025

Understanding the Difference Between Coding Guidelines, Rules, and Regulations in Healthcare

In the complex world of healthcare coding, it’s essential to understand the distinction between guidelines, rules, and regulations. These terms are often used interchangeably but have different meanings, particularly when it comes to the legal implications for healthcare providers.

Coding Rules, Guidelines, and Regulations: What’s the Difference?

To clarify the terms:

  • Guidelines are suggested practices and recommendations that offer flexibility. They provide direction but don’t impose penalties for non-compliance. For example, a guideline might recommend how to code a diagnosis, but it allows for some judgment and interpretation based on the patient's situation. Terms like can, may, and consider are often used in guidelines.
  • Rules are mandatory and concrete instructions that must be followed. Failing to follow a rule can lead to consequences. These are more rigid than guidelines and often carry penalties. Words such as must, require, and will signal a rule.
  • Regulations are laws enforced by government agencies and carry legal consequences for non-compliance. These are established by federal or state authorities and are mandatory for healthcare providers to follow. Non-compliance with regulations can lead to legal penalties, audits, and fines.

The Role of Coding Guidelines

Official coding guidelines are crucial in the healthcare sector when using the ICD-10-CM and ICD-10-PCS classification systems for diagnosis and procedural coding.

While coding guidelines help ensure uniformity and accuracy in assigning codes, they are not without their complexities. They are often adaptable to different clinical scenarios and rely on professional judgment. For instance, when multiple diagnoses are equally relevant for a patient's principal diagnosis, the guidelines allow flexibility in sequencing the diagnoses.

Clarification of Official Coding Guideline I.A.19: Code Assignment and Clinical Criteria

The Official Coding Guideline I.A.19 states:

“The assignment of a diagnosis code is based on the provider’s diagnostic statement that the condition exists. The provider’s statement that the patient has a particular condition is sufficient. Code assignment is not based on clinical criteria used by the provider to establish the diagnosis.”

However, this guideline has been widely misunderstood by some coding professionals. It does not mean that any diagnosis documented by a provider must automatically be coded and included on the claim. It's important to emphasize that this guideline is part of coding standards, not federal regulations.

Key Points of Clarification:

  • Clinical Validation vs. Coding Guidelines: The introduction of this guideline coincided with the rise of clinical validation denials. Prior to this, denials were primarily due to coding guideline errors, such as incorrect sequencing of the principal diagnosis or a lack of a documented diagnosis.

Clinical validation focuses on whether the medical record contains sufficient evidence to support a documented diagnosis. This is a legal requirement, as claims must accurately reflect the patient’s medical condition.

  • Purpose of Guideline I.A.19: This guideline was introduced to protect coders from being held accountable for clinical validation issues, distinguishing coding errors from validation-related denials.

    It clarifies that the coder’s role is to assign codes based on the provider’s documentation, not to validate the clinical basis of the diagnosis. As explained by Coding Clinic, the guideline separates coding from clinical validation. Denials for lack of clinical evidence should not be classified as coding errors.

    Some have incorrectly interpreted this guideline to mean that every diagnosis documented by a provider must be included on the claim. This is not accurate and can lead to false claims, which are illegal under federal law.

  • Hospital Responsibility: Clinical validation is a separate process that hospitals must address. Each facility must determine how to manage this function in conjunction with coding.

    Hospitals should develop comprehensive policies and procedures to handle clinical validation issues effectively to ensure diagnoses are accurately documented and clinically supported to avoid potential compliance issues.

In summary, while Guideline I.A.19 provides clarification for coders, it does not override the requirement for clinical validation. Coding professionals must remember that clinical validation is the law—every diagnosis included in a claim must be supported by clinical evidence in the patient’s medical record. Coders should not be held liable for clinical validation issues, but they should be proactive in identifying trends and bringing issues to attention.

The responsibility for ensuring accurate coding and clinical validation rests with the healthcare organization. Failure to meet this standard could result in false claims and legal repercussions for the entire healthcare organization.

See our original CDI Pocket Guide® for more information on this topic.

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