The ACC/AHA Practice Guidelines for Evaluation and Management of Heart Failure in the Adult Patient was published in 2001 by the American College of Cardiologists and the American Heart Association. Physicians and other clinicians treating heart failure patients often refer to these guidelines when making decisions related to infusion of inotropes or nesiritide. Although there are multiple other publications which discuss the pros and cons of inotropic therapy, especially in the outpatient setting, most experts agree that this is an appropriate therapy in a very select group of patients: those who are “bridge to transplant” or those who are “bridge to end of life”. One additional group, those who may still possibly be weaned from inotropic therapy but may require an extended period for weaning beyond their available hospital days, are potential candidates for inotropic therapy in an alternate care setting.

The ACC/AHA Guidelines state “once the clinical status of the patient has stabilized, every effort should be made to devise an oral regimen that can maintain symptomatic improvement and reduce subsequent risk of deterioration”. This is also a requirement for Medicare coverage of inotropic therapy outside of the hospital. The document also warns “the long term use of regularly scheduled intermittent infusions at home, in an outpatient clinic, or in a short-stay unit is strongly discouraged, even in advanced HF”. In spite of these very clear statements, experts agree that there are patients who have exhausted every other treatment and, in spite of risks of arrhythmias and/or sudden death, these patients may benefit from outpatient inotropic therapy. The ACC/AHA Guidelines address this patient population by stating, “In patients who cannot be weaned from intravenous therapy, continuous infusion of dobutamine or milrinone may be used in the outpatient setting in patients awaiting transplant… or those not being considered for transplant but who otherwise cannot be discharged from the hospital.” This comment is also reflected in the current Medicare guidelines for coverage. Addressing patients who don’t qualify for transplant, the document states “continuous inotropic support can provide palliation of symptoms as part of an overall plan to allow the patient to die with comfort at home”.

Once a physician has determined that outpatient inotropic therapy is the best option for his/her patient, focus turns to determining if the patient meets Medicare guidelines for coverage. The majority of these patients are covered by Medicare. Those who aren’t currently Medicare patients probably will be in the foreseeable future since they are usually designated as disabled and, after two years, qualify for Medicare coverage. Therefore, it is important for the infusion company and the patient that all appropriate Medicare-related documentation is obtained prior to hospital discharge.

Medicare criteria for coverage include: Prior to inotropic

The inotropic medications covered by Medicare must be ordered within specific dose parameters: dopamine < or = 5 mcg/kg/min, dobutamine 2.5 to 10 mcg/kg/min, milrinone 0.375 to 0.75 mcg/kg/min. Amrinone is not covered and, since nesiritide is not an inotrope but a synthetic hormone, it is not currently covered under these Medicare guidelines.

Additional Medicare guidelines for coverage include:

1. if infusions are continuous, there must be documentation of patient deterioration when therapy is discontinued,
2. if infusions are intermittent, there must documentation of repeated hospitalizations,
3. patient must be able to go to physician office or clinical at least monthly for outpatient evaluation,
4. patient does not require continuous electrocardiographic monitoring,
5. medication must be infused per an electronic infusion pump.

Early discharge planning and collaboration among the health care team, including MD, ANP, discharge planner, home infusion company clinical and remimbursement staff will benefit not only the physician, the hospital, and the infusion company but, most importantly, the patient and his loved ones.

The lay press has reacted strongly to an article published in the Journal of American Medical Association on April 20, 2005. This most recent article reported that 7.2% of patients died within 30 days of treatment with nesiritide (Natrecor), compared with a 4% death rate among a control group. Marie Robertson, Chief Science Officer of The American Heart Association, stated "When a question like this is raised, it has to be addressed.” Although Mark Wolfe, spokesman for J&J, manufacturer of nesiritide, stated their data showed no statistical difference in mortality, the company is conducting its own safety review. An article in the journal Circulation last month stated that the drug worsened kidney function by as much as 50 percent. Due to the increasing number of patients affected by heart failure, physicians and patients alike will be watching for further evidence related to the safety of this medication. [NM]

Reference: www.acc.org/clinical/guidelines/failure/pdfs/hf_fulltext.pdf