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Posted: Feb. 26, 2013

Addenda:

 

Therapeutic Phlebotomy for Testosterone Replacement? REVISITED

In 2011 e-Network Forum query, Jay Brooks, MD [now Medical Director of Blood Bank and Transfusion Service, University of Florida College of Medicine], wrote: "We are starting to see referrals for therapeutic phlebotomies for patients with elevated hematocrits undergoing testosterone replacement therapy. I am unable to find a good reference for this and would appreciate knowing how others are handling the issue."

Michael Petzar, MD, Transfusion Medicine Physician (Interim) at Puget Sound Blood Center in Seattle (attribution used with permission) responds that his region has numerous healthcare providers focused on “restoration” of their clientele, so requests for therapeutic phlebotomy for secondary polycythemia related to testosterone are not at all uncommon. Dr. Petzar states that in his review of the literature, well-controlled clinical outcome trials for therapeutic phlebotomy have not been done. Most clinical evidence of hyperviscosity with erythrocytosis is from the altitude sickness literature where symptomatic hyperviscosity is rarely seen with hematocrits less than 65%. The ACC/AHA consensus guidelines for treatment of erythrocytosis secondary to heart disease is to treat with therapeutic phlebotomy only if there is clinical evidence of hyperviscosity (e.g. focal neurologic symptoms) or prophylactically if hematocrit >65%. (Circulation 2008; 118:2395-2451).

Dr. Petzar’s opinion is that the endocrine community appears to be influenced by physiology laboratory studies quoted in Harrisons Textbook of Medicine which show increasing resistance to blood flow with hematocrit >45%, increasing above 55% in a logarithmic pattern. There is precious little in the way of studies of actual clinical outcomes. There are some trends towards cardiovascular events as hematocrit increases in some major trials, which at best show association, not causation. One trial in patients with polycythemia vera appeared to show some clinical benefit with lower hematocrits, but had few patients and the reliability of the conclusions is in question (Idiopathic erythrocytosis: a disappearing entity. Hematology Education Book ASH 2009, pp 629-635).

Dr. Petzar’s institution has not finalized its policies regarding more oversight of the therapeutic phlebotomy orders received, but for those requesting erythrocytosis due to testosterone therapy with Hct < 65%, in the absence of settled science, Dr. Petzar is proposing that the patient sign an informed consent including the following acknowledgements:

  • Medical necessity is not well established when Hct <65%
  • The patient and healthcare provider have weighed the benefits and risk of therapeutic phlebotomy vs dose reduction and wish the procedure performed
  • Reimbursement by third party payers is unlikely (Advance Beneficiary Notice required)

According to Dr. Petzar billing is also an issue. The only allowable reason for billing Medicare/Medicaid for procedures deemed not medically necessary by CMS National or Local Coverage Determinations is for the purpose of eliciting a Medicare denial of coverage document so the patient can submit it to for “Medi-Gap” policies. Should Medicare/Medicaid accidentally pay, and you fail to return the payment, your facility may be subject to penalties.

The Editors believe that the prior e-Network Forum Donors presenting to donate blood in order to decrease hematocrit is also germane to this discussion.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator

James Iqbal, MD
CBBS e-Network Forum Associate Editor & Moderator

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