LCD : Natrecor� (Nesiritide) for Injection (L20724)

LCD for Natrecor� (Nesiritide) for Injection (L20724)

Contractor Information

Contractor Name ^{back to top}
BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)
Contractor Number ^{back to top}
00390
Contractor Type ^{back to top}
FI

LCD Information

LCD ID Number ^{back to top}
L20724

LCD Title ^{back to top}
Natrecor� (Nesiritide) for Injection

Contractor's Determination Number ^{back to top}
L20724

AMA CPT / ADA CDT Copyright Statement ^{back to top}
CPT codes, descriptions and other data only are copyright 2005 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. � 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy ^{back to top}
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Primary Geographic Jurisdiction ^{back to top}
New Jersey Tennessee

Secondary Geographic Jurisdiction ^{back to top}
Alaska Alabama Arkansas Arizona California - Entire State Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri - Entire State Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York - Entire State Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

Oversight Region ^{back to top}
Region IV


Original Determination Effective Date ^{back to top}
For services performed on or after 09/30/2005

Original Determination Ending Date ^{back to top}


Revision Effective Date ^{back to top}
For services performed on or after 01/01/2006

Revision Ending Date ^{back to top}


Indications and Limitations of Coverage and/or Medical Necessity ^{back to top}
BACKGROUND Acute heart failure is the single most common cause of hospitalization in the U.S. for patients older than 65 years of age resulting in approximately one million hospitalizations each year. Natrecor� (Nesiritide) has been FDA approved for the short term intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea (shortness of breath) at rest or with minimal activity. It has also been proven effective when used as a constant infusion for the patient needing a bridge to transplantation. Natrecor� (Nesiritide) is a recombinant form of human B-type natriuretic peptide (rhBNP), a naturally occurring protein secreted by the heart as part of the body's response to acute heart failure. Natrecor� binds to vascular smooth muscle and endothelial cells causing smooth muscle relaxation and dilation of veins and arteries. This dilation results in a decrease in pulmonary capillary wedge pressure (PCWP), decrease in systemic arterial pressure, and a diuretic effect. Natrecor� has novel properties that cause arteries and veins to dilate, alleviating symptoms in patients with acute heart failure by improving blood movement around the heart, without increasing heart rate or interfering with heartbeat regularity. Traditionally, medical literature has supported the use of Natrecor� for the treatment of patients diagnosed with acutely decompensated CHF as evidenced by all of the following: Documented New York Heart Association (NYHA) Classification Class III or IV Heart Failure; and Significantly elevated brain natriuretic peptide (BNP) results of greater than 500 (in the absence of CHF symptoms) or 100-500 (with acute clinical findings and CHF symptoms); and Recent hospitalization or more than one emergency department visit within 60 days prior to Nesiritide initiation for CHF symptoms/treatment; and The patient currently receiving optimal treatment with oral medications to include an ACE inhibitor, BETA-blocker, diuretic(s), and Digitalis, and all are administered at the maximum dosage tolerated by the patient, and not otherwise contraindicated. However, a panel of experts was convened to address Nesiritide use due to unresolved questions about the risk-benefit profile in some sub-populations. The report of the Nesiritide Advisory Panel (AKA the "Braunwald Report") resulted in several recommendations regarding Nesiritide use which have been endorsed by the manufacturer. Riverbend accepts and promotes those recommendations and incorporates them into policy: CURRENT INDICATIONS AND LIMITATIONS The use of nesiritide is limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest. These were the indications used in the largest trial that led to approval of the drug (VMAC). Physicians considering the use of nesiritide should consider its efficacy in reducing dyspnea, the possible risks of the drug, and the availability of alternate therapies to relieve the symptoms of congestive heart failure. This policy does not apply to acute inpatient care; nesiritide use on patients who have been admitted to an acute care facility is governed only by usual �reasonable and necessary� provisions, i.e. non-investigational use in accordance with product labeling and/or local standards of care. The use of nesiritide in the prehospital environment (i.e. the emergency department, observation ward or treatment room) is covered when used to attempt to abort an imminent admission. Such usage must be supported by a contemporaneous examination accompanied by a BNP. LIMITATIONS Sufficient evidence is not currently available to demonstrate benefit for the applications listed below. Nesiritide is therefore not medically necessary (investigational) for: intermittent outpatient infusion* scheduled repetitive use to improve renal function to enhance diuresis. The use of infusion to prevent admission of a patient who has established a pattern of recurring acute decompensation is not excluded. However, each use of nesiritide must be supported by a clinical exam and BNP consistent with evolving decompensation and clearly demonstrated by past admission patterns; it may not be determined by fixed schedule. This �acute on chronic� decompensation is considered to be a subset of acute decompensation and, due to the instability of patients requiring this level of intervention, is limited to the prehospital environments noted above. EXCEPTIONS TO LIMITATIONS* There is some evidence suggesting a role for nesiritide infusions in the management of chronicly decompensated patients as noted above in the Background. An acute care facility participating in external studies of nesiritide use in the cardiology clinic environment (an �academic facility�) may consider its use of nesiritide to be medically necessary both for patients involved in the study and for other similar but excluded patients. This use will be considered investigational in other settings. This determination recognizes the controlled advancement of the standard of care in an academic environment may be appropriate for a subset of their most challenging quaternary care patients and still be clearly investigational in other settings. Even in this environment nesiritide is not covered when the indication under study is a totally new unlabeled indication; this is in accordance with Medicare limitations on payment for investigational usages.For the patient awaiting cardiac transplantation, Natrecor� infusions will be covered when provided as part of a deemed clinical trial. FACILITY LIMITATIONS Nesiritide infusions must be administered under the supervision of a physician in a hospital environment only, with an appropriate level (ACLS) of care at all times and immediate access to a physician, code team, and ICU or CCU in the same physical structure. An ED physician and fully functional emergency department (capable of patient stabilization and short term management of life-treatening omplications) could be an appropriate alternative rescue facility but also must be present in the same physical structure. A supervising physician does not need to be present in the suite during infusion but does need to be immediately available if needed or requested. Nesiritide must only be infused with appropriate staff and equipment present to resuscitate a patient in the event of a cardiac arrest, pulmonary edema, life threatening arrythmias or hypotension.Nesiritide use is primarily anticipated in the inpatient environment but is covered in both the emergency department and observation ward as treatment for acute decompensation. It is not covered in an outpatient clinic or infusion clinic environment except in the very limited circumstances involving academic facilities noted above.

Coverage Topic ^{back to top}
Outpatient Hospital Services

Coding Information

Bill Type Codes: ^{back
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Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)

Revenue Codes: ^{back
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Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0250	Pharmacy-general classification
0260	IV therapy-general classification
0450	Emergency room-general classification
0489	Cardiology-other
0760	Treatment or observation room-general classification
0761	Treatment or observation room-treatment room (eff 9/93)

CPT/HCPCS Codes ^{back
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J2325

INJECTION, NESIRITIDE, 0.1 MG

ICD-9 Codes that Support Medical Necessity ^{back
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428.0	CONGESTIVE HEART FAILURE UNSPECIFIED
428.21	ACUTE SYSTOLIC HEART FAILURE
428.23	ACUTE ON CHRONIC SYSTOLIC HEART FAILURE
428.31	ACUTE DIASTOLIC HEART FAILURE
428.33	ACUTE ON CHRONIC DIASTOLIC HEART FAILURE
428.41	ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE
428.43	ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

Diagnoses that Support Medical Necessity ^{back
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ICD-9 Codes that DO NOT Support Medical Necessity ^{back
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All those not listed under the "ICD-9 Codes That Support Medical Necessity" section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation ^{back
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Diagnoses that DO NOT Support Medical Necessity ^{back
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General Information

Documentation Requirements ^{back
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Documentation Requirements

Documentation in the patient's medical records must support the use of Natrecor� infusions for the treatment of the patient diagnosed with acutely decompensated CHF as evidenced by all of the following:

Documented New York Heart Association (NYHA) Classification Class III or IV Heart Failure; and
Clinical history and physical; and
Documented results, prior to the Natrecor� infusion, of a significantly elevated brain natriuretic peptide (BNP) test greater than 500 (in the setting of acute on chronic decompensation and an absence of dyspnea at rest) or 100-500 (with classic acute clinical findings); and
Clinical documentation of the emergent presentation of acute decompensation.

Documentation must be made available to Medicare upon request

Appendices ^{back
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Utilization Guidelines ^{back
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A regular cyclic pattern of recurrence of "acute decompensation" related to the last administration of Nesiritide is possible but unlikely. Multiple patients experiencing this phenomenon would be outside the realm of expected utilization within the coverage guidelines of this policy.

Sources of Information and Basis for Decision ^{back
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Burger AJ, Horton DP, LeJemtel T, Ghali JK, Torre G, Dennish G, Koren M, Dinerman J, Silver M, Cheng ML, Elkayam U: Effect of Nesiritide (B-type natriuretic peptide) and Dobutamine on Ventricular Arrhythmias in the Treatment of Patients with Acutely Decompensated Congestive Heart Failure: The PRECEDENT Study. Am Heart J, 2002 Dec 144:1102-8

Campana C, Scelsi L, Serio A: Infusion Therapy in Severe Heart Failure. A Reappraisal. Ital Heart J., 2003 May; 4 Suppl 2: 15S-21S.

Colbert K, Greene MH: Nesiritide (Natrecor)- a New Treatment for Acutely Decompensated Congestive Heart Failure. Crit Care Nurs Q 26:40-4

Colucci WS, Elkayam U, Horton DP, Abraham WT, Bourge RC, Johnson AD, Wagoner LE, Givertz MM, Liang CS, Neibaur M, Haught WH, LeJemtel TH: Intravenous Nesiritide, a Natriuretic Peptide, in the Treatment of Decompensated Congestive Heart Failure. Nesiritide Study Group. N Engl J Med. 2000 Jul 27; 343(4): 246-53.

Drugs Approved by the FDA: Natrecor, CenterWatch Clinical Trials Listing Service, http://www.centerwatch.com

Hachey, DM; Smith,T: Use of Nesiritide to Treat Acute Decompensated Heart Failure. Pharmacology. 2003 Feb

HFSA: Nesiritide Edges Nitroglycerin for Heart Failure, Doctors Guide Personal Edition, http://www.docguide.com

Karch, A, 2004 Lippincott�s Nursing Drug Guide, Nesiritide (Natrecor), 849-850

Keating GM, Goa KL: Nesiritide: a Review of Its Use in Acute Decompensated Heart Failure. Drugs 2003 63:47-70

Medlineplus Drug Information: Nesiritide, U.S. National Library and the National Institutes of Health, http://www.nlm.nih.gov

Mills RM, Hobbs RE: How to Use Nesiritide in Treating Decompensated Heart Failure. Cleve Clin J Med, 2002 Mar 69:252-6

Mills RM, LeJemtel TH, Horton DP, Liang CS, Lang R, Silver M, Lui C,

Chatterjee K: On Behalf of the Natrecor Study Group - Sustained Hemodynamic Effects of an Infusion of Nesiritide (human b-type natriuretic peptide) in Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. This study was presented in part at the 45th Annual Scientific Session of the American College of Cardiology, 1997.

National PBM Drug Monograph, Nesiritide (Natrecor�), VHA Pharmacy Benefits Management Strategic Healthcare Group and Medical Advisory Panel.

Natrecor� package insert

Natrecor� U.S. Food and Drug Administration Consumer Information, http://www.fda.gov

Nesiritide Improves Symptoms and Hemodynamics in Acute Congestive Heart Failure (CHF) Patients Regardless of Disease Severity. University of Cincinnati Medical Center, http://medcenter.uc.edu

New CHF Drug Shown to Ease Breathing Distress Among Hospitalized Patients.
Clin Resour Manag 2002 May 3:68-70, 65

Physician�s Desk Reference, Edition 58, 2004: 3100-3102

Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous Nesiritide vs Nitroglycerin for Treatment of Decompensated Congestive Heart Failure: A Randomized Controlled Trial. JAMA, 2002 Mar 27;287(12):1531-40.

Research Programs: Outpatient Nesiritide Therapy Research Enhances Quality of Life. Mid America Heart Institute, https://www.saintlukeshealthsystem.org

Ross, M.: Nesiritide Rx Update, Virtual Hospital, University of Iowa Health Care, http://www.vh.org

U.S. Food and Drug Administration FDA Talk Paper, FDA Approves Acute Congestive Heart Failure Treatment, August 13, 2001. http://www.fda.gov

Vichiendilokkul A, Tran A, Racine E: Nesiritide: A Novel Approach for Acute Heart Failure. Ann Pharmacother 2003 Feb 37:247-58

Press Release: Scios Announces Investigator-Sponsored Study Demonstrating Natrecor is Associated with Lower Costs and Fewer Complications in Heart Failure Patients-Results Show Lower Health-Care Resource Use. Orlando, FL and Fremont, CA, November 11, 2003

Press Release: Scios Announces Four Abstracts Presented at American Heart Association's 75th Scientific Sessions Sunnyvale, Calif., November 14, 2002, http://www.sciosinc.com

Press Release: Scios Study Published in American Heart Journal Shows Clinical Advantage Of Natrecor for Acute Heart Failure Sunnyvale, Calif., December 19, 2002, http://www.sciosinc.com

Press Release: Scios Announces FUSION 1 Study Shows Natrecor to be Safe For Use in Heart Failure Patients in Outpatient Setting-- Results Also Demonstrate Positive Clinical Outcomes - Las Vegas, NV and Fremont, CA, September 23, 2003, http://www.sciosinc.com

Other Contractor's (Veritus, HGSA) Medical Policy

Braunwald, Eugene et al, Report of the Natrecor Advisory Panel, 13 June 2005 (www.natrecor.com)

Advisory Committee Meeting Notes ^{back
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This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups that include representatives from acute care hospitals.

Start Date of Comment Period ^{back
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06/30/2005

End Date of Comment Period ^{back
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08/14/2005

Start Date of Notice Period ^{back
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08/15/2005

Revision History Number ^{back
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20724b

Revision History Explanation ^{back
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v.3 Updated and re-issued to reflect the recently released blue-ribbon "Report of the Natrecor Advisory Panel."
v.5 Typographical correction

11/26/2005 - CPT/HCPCS code J2324 was deleted from group 1
02/08/2006 - CPT/HCPCS code J2325 was added to group 1
03/21/2006 - CPT/HCPCS code J2325 was again added to group 1.

Last Reviewed On Date ^{back
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03/21/2006