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De novo HBV infection in a Mayo Clinic hemodialysis population: Economic impact of reduced HBV testing and a call for changes in current US CDC guidelines on HBV testing protocols

Hemodialysis.com Author Interview:

Macaulay Onuigbo MD MSc FWACP FASN MBA

Associate Professor of Medicine, College of Medicine, Mayo Clinic, Rochester, MN.
Nephrologist, Mayo Clinic Health System, Eau Claire, WI
Vice Chairman, Nephrology department, MCHSEC. 
MBA Executive

Hemodialysis.com Editor Marie Benz: What are the main findings of the study?

Our study confirmed the very low incidence rates of de novo Hepatitis B Virus (HBV) infection among ESRD patients undergoing outpatient in-center hemodialysis in the USA as reflected in our Mayo Clinic Northwestern Wisconsin Hemodialysis Units 1. Indeed, a 2009 US CDC report on the surveillance of acute viral hepatitis in the United States posted an incidence rate of just 0.2% among hemodialysis patients 2. Over 10 years, only 1 of 965 hemodialysis (0.1%) patients had de novo HBV infection 1.  Furthermore, this index patient was a high risk IV drug user, known to have contracted Hepatitis C prior to starting hemodialysis in our unit 1.

Similarly, over 10 years, only 1 of 965 hemodialysis (0.1%) patients demonstrated the phenomenon of transient post-vaccination Recombinant HBsAgenemia 3. This was not unexpected since the administration of multi-dosed HBV Recombinant vaccinations are random events and the monthly blood tests for HBsAgenemia are not deliberately carried out to follow quickly after the vaccinations, which practice would otherwise increase the incidence of this phenomenon in routine ESRD care 3.

Hemodialysis.com: Were any of the findings unexpected?

Yes.

The finding that HBsAg tests, carried out monthly, on all hemodialysis patients, trigger a charge of $100.00 per patient per month to Medicare was almost alarming to the authors – simply too expensive!

Even more surprising was the huge amount of Medicare savings that would result by simply switching from a monthly to quarterly (3-monthly) HBsAg testing in non-high risk ESRD patients which would be the majority of our patients. This process management change would result in a mind-boggling mammoth savings of $4 billion over 10 years to Medicare 3. This is money being flushed down the drain. Moreover, at current healthcare expenditure trajectories, Medicare is going broke, simply put 4,5.

The fact that current US CDC guidelines controlling infectious disease control guidelines for hemodialysis were last revised in 2001 was also another surprising finding from our study 1. We posit that the US CDC should revise these outdated guidelines, to fall in line with current clinical realities on the ground 1. Gone are the days, as in the 1970s, when HBV outbreaks among hemodialysis units in the US were not uncommon and HBV rates as high as 30% were reported during such outbreaks 6,7. We have indeed come a long way.

Hemodialysis.com: What should clinicians and patients take away from your report? 

That here in the USA, the incidence of de novo HBV infection among hemodialysis patients, in general, remains very low.

The high risk (other than hemodialysis as a risk factor) patient such as the IV drug user, remains at higher risk of de novo HBV infection and demands increased infection disease surveillance measures.

That in non-high risk hemodialysis patients in the USA, which would represent the majority of our ESRD patients on hemodialysis, monthly HBsAg testing is wasteful and does not contribute to improved patient safety or outcomes.

That in this era of reimbursement bundling by Medicare, 3-monthly HBsAg testing among non-high risk hemodialysis patients would suffice.

Higher-risk hemodialysis patients (IV drug users, etc) must still be screened by monthly HBsAg testing. Same would apply to countries with de novo HBV infection rates in excess of 1% which would encompass most so-called developing countries and many countries in Eastern Europe.

Huge dollar savings are possible - $4 billion in Medicare charges over 10 years.

The phenomenon of transient post-vaccination Recombinant HBsAgenemia, albeit rare, must be considered as an important differential diagnosis for a newly positive HBsAg test among hemodialysis patients 3.

Hemodialysis.com: What recommendations do you have for future research as a result of this study?  

If our recommendation to reduce HBsAg testing among hemodialysis patients to 3-monthly is implemented, a historical comparison between monthly testing and 3-monthly testing of HBsAg among hemodialysis patients in a particular unit, comparing de novo HBV infection rates as well as savings in Medicare charges, after about five years of implementation of the new guidelines, would make for a good research perspective.

REFERENCES:

1. Onuigbo MAC, Onuigbo NTC. De novo HBV infection in a Mayo Clinic hemodialysis population: Economic impact of reduced HBV testing and a call for changes in current US CDC guidelines on HBV testing protocols. Hemodial Int. 2012 Oct;16 Suppl 1:S32-8. doi: 10.1111/j.1542-4758.2012.00748.x.
2. Daniels D, Grytdal S, Wasley A; Centers for Disease Control and Prevention (CDC). Surveillance for acute viral hepatitis - United States, 2007. MMWR Surveill Summ. 2009 May 22;58(3):1-27.
3. Onuigbo MAC, Nesbit A, Weisenbeck J, Hurlburt J. Hepatitis B surface antigenemia following recombinant hepatitis B vaccine in an 81-year old ESRD patient on hemodialysis. Ren Fail. 2010 May;32(4):531-2.
4. The Concord Coalition. Escalating Health Care Costs and the Federal Budget. April 2, 2009. http://www.concordcoalition.org/files/uploaded_for_nodes/docs/Iowa_Handout_final.pdf.Accessed September 12, 2011.
5. The Henry J. Kaiser Family Foundation. Snapshots: Health Care Spending in the United States and Selected OECD Countries. April 2011. http://www.kff.org/insurance/snapshot/OECD042111.cfm. Accessed September 12, 2011.
6. Snydman DR, Bryan JA, London WT, Werner B, Bregman D, Blumberg BS, Gregg MB. Transmission of hepatitis B associated with hemodialysis: role of malfunction (blood leaks) in dialysis machines. J Infect Dis. 1976 Dec;134(6):562-70.
7. Snydman DR, Bryan JA, Macon EJ, Gregg MB. Hemodialysis-associated hepatitis: report of an epidemic with further evidence on mechanisms of transmission. Am J Epidemiol. 1976 Nov;104(5):563-570.

    Routine ESRD care with monthly HBsAg tests superimposed on HB vaccines

onuigbo_table1
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onuigbo_table3

Reference:

Onuigbo, M. A. C. and Onuigbo, N. T. C. (2012), De novo HBV infection in a Mayo Clinic hemodialysis population: Economic impact of reduced HBV testing and a call for changes in current US CDC guidelines on HBV testing protocols. Hemodialysis International, 16: S32–S38. doi: 10.1111/j.1542-4758.2012.00748

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Hemodialysis.com Editor: Marie Benz, MD
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updated October 23 2012

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