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81528 CPT Code For Cologuard | Description & Billing Guide

The CPT code for Cologuard is CPT 81528. The non-invasive Cologuard screening, developed by Exact Sciences, is delivered to the patient’s home. Cologuard for CRC can be reported for people between 50 and 85 with an average risk of colorectal cancer. 

Medicare only covers the 81528 CPT code for Cologuard after every three years. In addition to taking Cologuard, patients at high risk should have a diagnostic colonoscopy.

The screening could detect a colorectal neoplasm linked to DNA markers and occult blood presence.

The CPT code for Cologuard (CPT 81528) should not be used in the following situations:

  • Colorectal cancer recipient with a personal or family history
  • A previous positive colorectal screening test result within the last six months

Here are some examples of risk factors:

  • Irritable Bowel Syndrome (IBS)
  • Crohn’s disease illness
  • A Long-Term Ulcerative Colitis Case
  • History of Polyps
  • Neurofibromatosis
  • Lynch syndrome is one of the most well-known hereditary cancer syndromes.

On January 1, 2016, the American Medical Association CPT Editorial Panel established the Medicare-approved CPT code for Cologuard (CPT code 81528.) CPT Category I codes and HCPCS Level I codes are examples of alternative names. 

These procedures will follow to process the member’s contract benefits. Furthermore, for plans that comply with the Affordable Care Act, the CologuardTM CPT code 81528 will be included as a preventive service that will process at no cost to the member.

Adults of either gender who are 50 or older and at low risk of colorectal cancer should screen with Cologuard. However, Cologuard can not be intended to use in high-risk patients in place of a diagnostic or surveillance colonoscopy. 

False positives and negatives are both possible. A diagnostic colonoscopy is the next logical step if a test has a positive effect.

Patients who receive a negative screening result should continue participating in the program regularly, using a method tailored to each individual’s needs. Cologuard’s dependability in repeated testing has yet to establish.

Description Of Cologuard CPT Code 81528

The American Medical Association currently maintains CPT 81528, Multianalyte Assays with Algorithmic Analyses, as a CPT® medical procedure code (AMA).

The Cologuard CPT code 81528 is officially described as: “Oncology (colorectal) screening, quantitative real-time target and signal amplification of ten DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result.”

A lab analyst uses algorithmic on patient information and laboratory results. The lab analyst performs technical lab tests for fiscal hemoglobin and real-time amplification of 10 DNA markers on a stool sample. Analysis to determine whether or not the colon cancer screening test was optimistic.

Colorectal cancer screening services beginning on or after January 1, 1998, could reimburse to aid in early detection.

A screening colonoscopy is one of the services covered by this benefit, which was previously available only to those at high risk until July 2001. Beginning July 1, 2001, patients, not at increased risk will be eligible for colonoscopy screening.

Colorectal cancer screenings include the following services:

  • Results of a guaiac-based fecal occult blood test (FOBT) with 1-3 simultaneous determinations
  • a versatile sigmoidoscopy
  • A colonoscopy is another option to consider.
  • Hemodialysis utilizing barium

As of January 1, 2004, the following colorectal cancer screening services are eligible for reimbursement in place of the guaiac-based FOBT, which makes 1-3 simultaneous determinations:

  • A multiplex feces-occult blood immunoassay could use to make 1-3 simultaneous determinations.
  • Fecal occult hemoglobin and DNA from feces as a screening tool for colon cancer: G0464 (e.g., KRAS, NDRG4, and BMP3).
  • Scope for colorectal cancer screening

Adults of either gender over 50 who are at moderate risk of developing colorectal cancer should screen with Cologuard. However, the use of Cologuard is limited, and high-risk patients should not forego a diagnostic or surveillance colonoscopy. 

False positives and negatives are both possible. After a positive test result, a diagnostic colonoscopy should perform as soon as possible.

Patients should continue participating in a screening program at regular intervals after receiving a negative effect, using a method that works for them. Cologuard’s dependability in subsequent testing could not establish. 

Billing Guidelines

The CPT code for Cologuard (Medical procedure CPT code 81528) is currently maintained by the American Medical Association (AMA). The lab analyst performs and analyses fecal hemoglobin testing and real-time amplification of 10 DNA markers on a stool sample.

 An algorithmic analysis of patient data and laboratory results positively impacts colon cancer screening. A wide range of major commercial insurers covers the entire cost of Cologuard.

Your out-of-pocket expenses could range from $0 to $649, depending on your payer’s plan-specific or pre-authorization requirements.

The 81528 CPT code for Cologuard can be reported for a single patient 50-85 years of age, and all of the following elements would require for a successful biomarker screening blood test:

  • The FDA has granted market clearance for colon cancer screening.
  • If the criteria for covering an unfinished procedure will meet, Medicare will pay for a partially completed colonoscopy. 

The shared working file will not include screening colonoscopy frequency standards (CWF).

If necessary conditions for coverage could meet, Medicare will pay for a repeat attempt and completion of a covered colonoscopy following its payment methodology. CWF will apply the frequency standards.

This plan covers both routine and emergency colonoscopies. Providers must include the colonoscopy as part of the facility claim when reporting an interrupted colonoscopy.

A cross-sectional study should conduct to determine the effectiveness of Cologuard (i.e., a single point in time). There has been no research into Cologuard’s programmatic performance or the advantages and disadvantages of repeated testing over a set period. 

Adults who have previously undergone Cologuard testing have not had their performance evaluated. However, the sensitivity of the Cologuard screening program will not be superior to or equal to any of the other suggested screening methods for CRC and AA.

A negative Cologuard test result does not rule out the presence of cancer or advanced adenoma. However, there is no standard screening period in place for this follow-up at the moment.

How To Use Modifier 33 & Modifier 53 With CPT 81528

The 81528 CPT code for Cologuard can be reported with Modifier 33 and Modifier 53.

Modifier 33 (preventative service) is applied if the Cologuard test (CPT code 81528) is part of a screening exam. It informs the payer that the patient’s copayment or deductible is irrelevant to the reimbursement of the service. 

After this qualifier, a therapeutic colonoscopy code, for example, the 81528 CPT code for Cologuard, may be added (colonoscopy, with the removal of the tumor, polyp, or another lesion by snare technique).

By adding this modifier to the appropriate diagnosis codes, the endoscopist alerts the payer that the diagnostic procedure should perform for screening purposes.

One of the most confusing aspects of colonoscopy coding is the difference between colonoscopies performed for screening and those performed for diagnosis.

A colonoscopy performed on a symptom-free individual to look for polyps or colorectal cancer is called a screening colonoscopy. Whether a polyp or cancer discover during screening, the goal of the procedure is the same.

 Surveillance colonoscopy is a subset of screening performed earlier than the typical ten years after the last colonoscopy when cancer or polyps could find during the previous exam (or earlier in some high-risk patients).

Furthermore, the patient, in this case, shows no signs of illness. In contrast to the first two methods, a diagnostic colonoscopy can evaluate conditions like anemia, rectal bleeding, abdominal pain, and diarrhea.

When the modifier 33 could add to the name of a procedure, it indicates that it is one of several preventive services mandated by law or regulation. These services must provide by a current medicare A or B rating. 

The addition of the 33 modifier to the procedure name indicates that the service’s primary goal is to provide an evidence-based service by the current A or B rating from the US Preventive Services Task Force and other preventive services identified in preventive services mandates (legislative or regulatory). Therefore, the modifier should not apply to preventive services reported separately from other services. 

Because modifier 53 does not apply if the provider modifies the course of a procedure in a way that was expected or planned, you must first determine why the provider decided to end the system after it had already begun.

The modifier should not use when reporting preventive services. Incomplete screening colonoscopies are subject to the same payment policies as complete screening colonoscopies.

Reimbursement For The 81528 CPT Code For Cologuard

CMS has considered the new CPT billing code for Cologuard (CPT 81528) and a request to reevaluate the current reimbursement rate for Cologuard.

As a result of CMS’s national coverage determination, the G code for Cologuard was replaced by the new CPT code for Cologuard.

CMS approves a crosswalk of the new CPT code for Cologuard to three previously approved regulations. This resulted in the current reimbursement for the 81528 CPT code for Cologuard of $492.72.


Patients with the symptoms of developing colorectal cancer, Crohn’s disease, ulcerative colitis, and Crohn’s disease are examples of inflammatory bowel diseases.

The doctor suggests Cologuard for the early detection of colorectal cancer and its symptoms. The Cologuard colorectal cancer screening test detects colorectal cancer and its early stages using a stool sample from your bowel movement.

The cells that line your colon are constantly dying and shedding. As a result of precancerous or cancerous conditions, normal and abnormal cells should release into the colon.

CPT 81528 for the Cologuard test can be reported in the case described above.

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