BlueCross and BlueShield of Montana Medical Policy/Codes
Multivariant Analysis of Patient-Specific Findings
Chapter: Administrative
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Description

The multivariant analysis of patient-specific findings utilizes a software program, such as the PRETest Consult© from BreathQuant Medical Systems, Inc., of North Carolina, which allows the provider to perform a quantitative probability assessment using information collected during a patient’s history and physical examination. The software program is designed to distinguish life-threatening illnesses from less serious medical problems in hopes of reducing unnecessary testing and reducing further necessity of hospitalization. Presently, PRETest Consult modules exist for the conditions of acute coronary syndrome (ACS) and pulmonary embolism (PE). The analysis may be performed in the physician’s office or clinic, outpatient facility, or hospital emergency room.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers multivariant analysis of patient-specific findings experimental, investigational and unproven as a method to screen for life-threatening illnesses.

Rationale

The developers of the multivariant analysis assessment system have marketed the use of this software program for utilization by the attending provider at the patient’s bedside as a non-invasive diagnostic evaluation method to:

  • Inexpensively screen for life-threatening illnesses, such as acute coronary syndrome (ACS) or pulmonary embolism (PE);
  • Reduce medical errors and unnecessary diagnostic test ordering;
  • Provide rapid and inexpensive triage with improved patient care outcomes, which improves throughput in resources for managing patient flow in the emergency room departments; and
  • Provide physicians with statistical documentation of their admission and/or discharge decisions. (1)

The risk score generated by this assessment system is believed to aid providers in their decision making process to pursue further testing, the “test-do not test threshold”, and additional hospitalization, while improving patient care and patient satisfaction. (2)

Originally, the assessment system was developed as the Geneva and Wells pre-test probability scores, also known as the “Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED)” to replace empirical assessment of patients with suspected PE. In 2002, Iles and colleagues reported this scoring system was the least variable method and most consistent method utilized by “junior or senior doctors”, thus implying as physicians gain experience, they recognize that the diagnosis of PE can be difficult to assess and are reluctant to exclude it on clinical grounds. The authors reviewed questionnaires from thirty physicians, using Geneva and Wells scoring methods in addition to their empirical assessment of pre-test probability (PTP). The physicians were blinded to the results of the tests used to diagnose PE. The Geneva PTP score was the most consistent of the three methods used to determine the PTP of PE (Geneva = 0.73, Wells = 0.38, empirical = 0.23). The authors believe PTP using a scoring method in combination with non-invasive diagnostic methods may be a solution to exclude PE. (3)

In 2006, Mitchell et al. evaluated 1,114 patients from three academic emergency departments for ACS. The physicians collected data required for PTP assessment BEFORE protocol-driven chest pain unit testing was performed. A PRETest probability greater than two percent was considered “test positive”. The criterion standard was the outcome of ACS (death, myocardial infarction, revascularization, or greater than 60% stenosis prompting new treatment) within 45 days. Fifty-one of enrolled patients (4.5%) developed ACS within 45 days, including four of 991 patients discharged after a negative chest pain unit evaluation result, who developed ACS. Unstructured estimate identified 293 patients with PTP ≤ 2%, two had ACS.  Attribute matching identified 304 patients with PTP ≤ 2%; one had ACS. The Acute Coronary Insufficiency-Time Intensive Predictive Instrument (ACI-TIPI) identified 56 patients, none of whom had the PTP of ACS. The authors concluded that in a low risk emergency room department, patients with symptoms suggestive of ACS, along with a PTP ≤ 2%, may not require additional diagnostic testing. (4)

A clinical trial is underway focusing on ACS, showing that there will be statistically significant reductions in time spent in emergency room departments, charges billed to the patient or to their insurance carrier, hospital length of stay, and number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome. Enrollment for this randomized, controlled trial for the use of PTP to reduce unnecessary testing of low-risk patients presenting with chest pain is underway. (5)

2010 Update

According to the National Institutes of Health (NIH) web site for clinical trials, the “Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients with Chest Pain (NCT00243516)” study is still recruiting. There is no completion date listed on the NIH web site. (5)

A search of peer-reviewed literature through January 2010 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2012 Update

A review of the NIH web site revealed an unknown status for clinical trial NCT00243516, discussed earlier in this Rationale. (5) No other clinical study has been posted by the NIH.    

A search of peer reviewed literature through June 2012 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies     

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

Experimental, investigational and unproven for all diagnoses.

ICD-10 Codes

Experimental, investigational and unproven for all diagnoses.

Procedural Codes: 0185T
References
  1. PRETestConsult – PRETest Consult Product information. Charlotte, North Carolina: Carolinas Medical Center and The Cannon Research Center. Available at http://PRETestconsult.com (accessed on 2007 October 12).
  2. Mann, J. A critical review of PRETestConsult.com’s ACS risk module – Position Paper (2004 September). Available at http://jeffmann.net (accessed on 2007 October 11).
  3. Iles, S., Hodges, A.M., et al. Clinical experience and pre-test probability scores in the diagnosis of pulmonary embolism. OJM: An International Journal of Medicine, Oxford (2003) 96(3):211-5.
  4. Mitchell, A.M., Garvey, J.L., et al. Prospective multicenter study of quantitative PRETest probability assessment to exclude acute coronary syndrome for patients evaluated in emergency department chest pain units. Annals of Emergency Medicine (2006 May) 47(5):438-47.
  5. NIH – Trial for the use of pretest probability to reduce unnecessary testing for low-risk patients with chest pain (NCT00243516). U.S. National Institutes of Health (2006 September 27). Available at http://clinicaltrials.gov (accessed on 2012 July 6).
History
July 2013  New 2013 BCBSMT medical policy.  Multivariant analysis of patient-specific findings is considered experimental, investigational and unproven as a method to screen for life-threatening illnesses. 
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Multivariant Analysis of Patient-Specific Findings