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February 2019

Coding Corner: Successful Coding of Device Failure
By Amalorpamary Sebastian
For The Record
Vol. 31 No. 2 P. 26

Recently, word of a legal case in which the attorney cited the use of the code for “device failure” to support suing the device manufacturer made its way through the health care arena. In Part 803 of the Code of Federal Regulations (revised April 1, 2018), failure of a device is defined as failure to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.

When a medical device adverse event occurs, coders must carefully consider whether to code it as device failure or complication due to a postoperative condition, which raises the question: Should a complication following a device implant be attributed to the device?

Adverse events are untoward medical occurrences, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the medical device. Adverse event reporting after medical device implantation is essential to understand the safety and performance of a device. Device-related adverse events are directly attributable to the device itself.

Procedure-Related Adverse Events
Events that occur from the procedure, irrespective of the device, are known as procedure-related adverse events. Examples include postoperative myocardial infarction following a peripheral vascular procedure and deep venous thrombosis following aneurysm repair.

Complications from anesthesia or other procedures incidental to the main procedure under study are classified as procedure related even if they occur before the actual implantation of the device.

When a medical device adverse event occurs, the physician must document the issue and the situation must be coded—as any complication code should be—to properly document care.

Coding for Complications
Complication coding is a hot topic among coding, clinical, and compliance professionals. It’s considered to be one of the more challenging aspects of coding. Physicians are hesitant to document postoperative complications because they negatively affect their quality scores on sites that publicly report hospital and physician quality scores, such as Healthgrades.

For a condition to be considered a complication, the following must be true:

• It must be more than an expected outcome or occurrence and show evidence that the provider evaluated, monitored, and treated the condition.

• There must be a documented cause-and-effect relationship between the care given and the complication.

• The physician must document that the condition is a complication.

ICD-10-CM has made it easier to code complications by incorporating intraoperative and postprocedural complications into the separate body system chapters.

Choosing Correct ICD-10 Diagnosis Codes
Complications of care can be found in each chapter as well as in T-series dependent on the following:

• site of surgery;

• organ/organ system affected by the complication;

• type of surgery, for example, joint replacement, skin grafting, and bypass; and

• type of complication, for example, mechanical (eg, breakage, displacement, protrusion, breakdown, leakage, obstruction), infection, embolism/thrombosis, pain, fibrosis, and hemorrhage.

Assigning the Correct Seventh Character
According to an AHA Coding Clinic for ICD-10-CM/PCS, First Quarter ICD-10 2015 article, applying the seventh character for injury, poisoning, and certain other consequences of external causes, active treatment refers to treatment for the condition described by the code, even though it may be related to an earlier precipitating problem.

For example, code T84.50XA, Infection and inflammatory reaction due to unspecified internal joint prosthesis, initial encounter, is used when active treatment is provided for the infection, even though the condition relates to the prosthetic device, implant, or graft that was placed at a previous encounter.

Seventh character “A,” initial encounter, is used while the patient is receiving active treatment for the condition. Examples of active treatment are surgical treatment, emergency department encounter, and evaluation and continuing treatment by the same or a different physician.

Seventh character “D,” subsequent encounter, is used for encounters after the patient has received active treatment of the condition and is receiving routine care for the condition during the healing or recovery phase. Examples of subsequent care are removal of external or internal fixation device, medication adjustment, other aftercare, and follow-up visits following treatment of the condition.

Seventh character “S,” sequela, is for used for complications or conditions that arise as a direct result of a condition. The specific type of sequela (eg, scar) is sequenced first, followed by the injury code.

External Cause Codes
If it is determined that there has been a device failure, the appropriate complication-of-care code related to the specific device/complication is coded. In addition, a related external cause code from code range Y70–Y82, Medical devices associated with adverse incidents in diagnostic and therapeutic use, is separately reported if the nature of the external cause is not already captured in the complication-of-care code itself.

ICD-10-CM Official Guidelines for Coding and Reporting, Section I.C.20, states: “An external cause code may be used with any code in the range of A00.0–T88.9, Z00–Z99, classification that represents a health condition due to an external cause. Assign the external cause code, with the appropriate 7th character (initial encounter, subsequent encounter, or sequela) for each encounter for which the injury or condition is being treated.”

Most categories in chapter 20 have a seventh character requirement for each applicable code. Most categories in this chapter have three seventh character values: A, initial encounter; D, subsequent encounter; and S, sequela. While the patient may be seen by a new or different provider over the course of treatment for an injury or condition, assignment of the seventh character for external cause should match the seventh character of the code assigned for the associated injury or condition for the encounter.

In addition, ICD-10-CM provides three sets of external cause codes to indicate medical or surgical care as the cause of a complication, one of which is specifically related to devices: Y70–Y82, Medical devices associated with adverse incidents in diagnostic and therapeutic use.

Categories Y70–Y82 are used to report breakdown or malfunction of medical devices during use, after implantation, or with ongoing use. This code range covers adverse incidents in a variety of devices including types used in anesthesiology, cardiology, obstetrics, and plastic surgery procedures. It is the coder’s responsibility to thoroughly review the ICD-10-CM index to ensure the correct code is reported.

Documentation of Complications of Care
How can documentation in these cases be more clear? The answer is to query. The importance of clear, concise physician documentation in these cases cannot be overstated. ICD-10-CM Official Guidelines for Coding and Reporting have specific documentation requirements that coders must adhere to for accurate code assignment and to remain in compliance with these published guidelines.

Cause-Effect Relationship Established by Provider
Code assignment is based on the provider’s documentation of the relationship between the condition and the care or procedure, unless otherwise instructed by the classification. The guideline extends to any complications of care, regardless of the chapter the code is located. It is important to note that not all conditions that occur during or following medical care or surgery are classified as complications.

Expected Outcome Cannot Be Coded as Complication
Not all conditions that occur during or following surgery are classified as complications. First, there must be more than a routinely expected condition or occurrence. The coder cannot make the determination whether something that occurred during surgery is a complication or an expected outcome. If it is not clearly documented, the coder should query the physician for clarification (ICD-9-CM Coding Clinic, First Quarter 2011).

Insignificant Incidental Findings
During a procedure, small injuries/tears may occur incidentally, which almost resolve during the intra/postoperative course without any intervention. The surgeon should be queried as to whether the small tear was an incidental occurrence inherent in the surgical procedure or whether the tear should be considered by the physician to be a complication of the procedure. If the provider documents that a tear/injury is a complication of the surgery, the coder must assign the appropriate chapter-specific code or T88.8 series code.

Iatrogenic Conditions
Coders should seek clarification before assigning iatrogenic—which means “relating to illness caused by medical examination or treatment”—codes.

When to Query
Queries should be generated in cases with incomplete, contradictory, or vague documentation. Key elements to include in queries are clinical indicators, positive findings, the physical exam, treatment provided, and an assessment regarding the documentation and whether information is missing or unclear.

For example, a query could be generated related to device failure in the case of periprosthetic fractures. There has been a lot of confusion about coding periprosthetic fractures. While ICD-9-CM Coding Clinic, Fourth Quarter 2005, considers periprosthetic fractures to be complications of prosthesis and coded to 996.43, a change took effect in 2016. However, that change has since been revised by the American Academy of Orthopedic Surgeons, which clarified that periprosthetic fractures are not complications of the prosthesis (the prosthesis itself is not fractured, the area around the prosthesis is fractured). As a result, they are now captured with code series M97.

Periprosthetic fractures occur as a result of trauma or pathological conditions. A code for any underlying condition as well as a code for the specific type of fracture (traumatic or pathological) should also be assigned. If the reason for admission/encounter is the fracture, the specific type of fracture (traumatic or pathological) should be sequenced first with the periprosthetic fracture code sequenced as a secondary diagnosis.

The “fracture” of the joint prosthesis can be coded as a complication when the joint prosthesis is broken under the following conditions:

• It must be clinically evaluated, diagnostically tested, and therapeutically treated.

• According to a recent HCPro newsletter, the complication must also result in an extended length of stay in the hospital necessitating increased resources related to care.

• The condition should not be part of routine care or the routine outcome of an expected procedure.

To help identify potential postoperative complications, including device failure, keep in mind the following:

• Not all conditions that occur in the postoperative phase are complications; look for a cause-and-effect relationship and clinical evidence of a complication.

• There is no time limit for the development of a complication of care. It can occur during the hospital stay, shortly after discharge, or in some cases, years later, which is often seen with implants such as orthopedic devices, mesh implants, and joint replacements.

• Postoperative complications or complications of care are defined as unexpected or unusual outcomes that occur following the care provided.

• Look for documentation such as “due to,” “resulted from,” and “the result of” to identify a complication of care.

• If there is a causal relationship that is documented and implicit of the condition, it is not necessary for the physician to provide further documentation for the link—for example, surgical wound infection or wound dehiscence.

• A preexisting condition that was present prior to the transplant can be coded as a complication if it impacts the function of the transplanted organ.

When coding complications from medical devices occur, extra caution is to be used in order to accurately represent the cause of the problem. Coding as medical device failure must be confirmed accurate; it can impact outcomes such as lawsuits against the manufacturer.

Certainly, coding affects value-based performance and quality metrics. Physician documentation must be accurate, and coders must follow the guidelines, query if the documentation is not clear, and ensure that codes are validated before submitting for claims.

— Amalorpamary Sebastian is senior manager of operations at nThrive.