Cost-Effectiveness

Approximately $26 billion is spent annually in the United States for the initial medical care of premature infants and their mothers.1 Not only is premature ROM (PROM) checked for in over 30% of pregnant women, but preterm premature ROM (pPROM) is responsible for 25-30% of premature births. These statistics demonstrate the need for a highly accurate yet cost-effective ROM diagnostic method. The costs associated with ROM diagnosis can be split into two categories: direct and indirect costs.

Direct Cost

Materials Cost

On average, nitrazine/pH and fern tests cost $2.80 and $0.70, respectively.2,3 On average, ultrasound costs $200 when used, and indigo carmine amnioinfusion costs between $600 and $1200 when used.4,5

Labor Costs

Using older methods in combination has been known to take up to 4 hours or more, especially when they produce discrepant results. Moreover, more than one provider must participate in the diagnosis: a nurse to test with nitrazine/pH, a physician to run the fern test, several lab technicians to provide quality control and document competencies, etc. On the other hand, the AmniSure ROM Test procedure takes, at most, 15 minutes to run. Additionally, it can be performed by a nurse or nurse-midwife instead of a physician, thereby reducing overall labor costs.

Indirect Costs

Costs Associated with False Positive Results

Cases of false positive diagnoses can lead to the following:

  • Unnecessary admissions: The average cost per inpatient admission (based on 2-day ALOS) is $3,048.10.6
  • Unjustified administration of medications: antibiotics, tocolytics, corticosteroids, and prostaglandin analogs/oxytocin cost $77.24 per patient (weighted average based on probability of use per patient).1
  • Unwarranted patient transfers: Typically, small hospitals transfer ruptured patients to high-risk, tertiary care facilities. The average cost of a single patient transfer starts at $400 and can cost more than $2,000.14

Therefore, a single false-positive result can add significant and unnecessary costs, ranging from $800 to $5,000 for small hospitals, and over $2,000 for medium and large hospitals. These costs may be avoided by using the AmniSure ROM Test.

Costs Associated with False Negative Results

Cases of false negative diagnoses can lead to the following:

  • Patient returns: All direct costs (materials & labor) are repeated. The longer a ruptured patient remains undiagnosed, the more likely that costly complications will develop, resulting in additional treatments that could have been avoided through the use of a more accurate diagnostic method.
  • Medico-Legal Costs: Adverse outcomes from false-negative diagnoses result to dangerous infections that may lead to maternal/fetal death. This may result in malpractice costs reaching up to $4 million.15

Conclusion

AmniSure ROM Test's accuracy has made it a cost-effective solution that is quickly being recognized in international guidelines in maternal and fetal health.

  • Drum, Kevin. The High Cost of Premature Babies. Mother Jones. March 9, 2011.
  • Fisher Scientific: Products Web site. Available at: http://www.fishersci.com/ecomm/servlet/home?storeId=10652. Accessed October 13, 2011.
  • MedEx Supply: Bristol-Myers Nitrazine Paper with Dispenser, 15 ft. MedEx Supply Web site. Available at: http://www.medexsupply.com/diagnostic-tests-urine-tests-bristol-myers-nitrazine-paper-with-dispenser-15-ft--x_pid-96.html. Accessed October 13, 2011.
  • Vintzileos, Ananth. Routine second-trimester ultrasonography in the United States: a cost-benefit analysis. Am J Obstet Gynecol. March 2000.
  • Sullivan, Scott A. PPROM: Diagnosis and Management. Palmetto Health Web site. Available at: http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&sqi=2&ved=0CDwQFjAE&url=http%3A%2F%2Fwww.palmettohealth.org%2Fdocuments%2FBaptist%2520CME%2FPPROMMUSC.ppt&ei=3T-5TsSABoeCtgeekvC9Bw&usg=AFQjCNFKzOjz_QA9o48XKeuheTWHiAOvsg&sig2=loIeAyx-ierzJ9_ZKButKQ. Accessed November 8, 2011.
  • 2008 Medical Cost Reference Guide. Blue Cross Blue Shield Association Web site. 2008. Available at: https://www.bcbsnd.com/docs/newsroom/2008_bcbs_cost_reference.pdf. Accessed October 2, 2011.
  • Berman S, Byrns PJ, Bondy J, et al. Otitis media-related antibiotic prescribing patterns, outcomes, and expenditures in a pediatric Medicaid population. Pediatrics. 1997;100(4):585-92. 8. Harman JR. JH, Kim A. Current Trends in Cervical Ripening and Labor Induction. American Academy of Family Physicians. August 1999.
  • Fox N, Gelber S, Kalish R, Chasen S. Contemporary Practice Patterns and Beliefs Regarding Tocolysis Among U.S. Maternal-Fetal Medicine Specialists. Obstetrics & Gynecology. 2008 July;112(1):42-47.
  • Hayes E, Moroz L, Pizzi L, Baxter J. A cost decision analysis of 4 tocolytic drugs. Am J Obstet Gynecol. 2007 Oct;197(4):383.e1-6.
  • Maternal Care Manual: Preterm Labour and Preterm Rupture of the Membranes. Perinatal Education Programme Web site. 2006. Available at: http://www.gfmer.ch/PEP/pdf-MCM-2006/MCM_UNIT-5-2006.pdf. Accessed October 8, 2011.
  • Pharmacy Checker: Celestone Soluspan. Pharmacy Checker Web site. Available at: http://www.pharmacychecker.com/Pricing.asp?DrugName=Celestone+Soluspan&DrugId=19697&DrugStrengthId=32083. Accessed October 13, 2011.
  • Gardner MO, Goldenberg RL. The clinical use of antenatal corticosteroids. Clin Obstet Gynecol. 1995;38:746–754.
  • Baucus, Max. Report to Congressional Committees: Ambulance Providers. United States Government, Accountability Office Web site. May 2007. Available at: http://www.gao.gov/new.items/d07383.pdf. Accessed October 2, 2011.
  • Legally Speaking. AmniSure International LLC Web site. Available at: http://www.amnisure.com/site/en/resources/legally-speaking/. Accessed October 2, 2011.

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