LCD/NCD Portal

L33000

 

LOW DENSITY LIPOPROTEIN (LDL) APHERESIS

 

02/04/2013

 

Indications and Limitations of Coverage and/or Medical Necessity

 

For purposes of Medicare coverage, apheresis is defined as an autologous procedure, i.e., blood is taken from the patient, processed, and returned to the patient as part of a continuous procedure (as distinguished from the procedure in which a patient donates blood preoperatively and is transfused with the donated blood at a later date).

• Apheresis is covered only when performed:

o In a hospital setting (either inpatient or outpatient); or

o in a nonhospital setting, e.g., a physician directed clinic when the following conditions are met:

 A physician (or a number of physicians) is present to perform medical services and to respond to medical emergencies at all times during patient care hours;

 Each patient is under the care of a physician; and

 All nonphysician services are furnished under the direct, personal supervision of a physician.

• Low density lipoprotein (LDL) apheresis is used as long-term therapy to rapidly produce marked reductions in circulating lipids and lipoproteins in patients with homozygous or severe heterozygous familial hypercholesterolemia (FH) who are intolerant or not sufficiently responsive to diet and pharmacologic lipid therapy.

o Profound lowering of LDL-C (low density lipoprotein cholesterol) concentrations with LDL apheresis significantly reduces the rate of future cardiovascular events in this patient population.

o In a small group of patients, hypercholesterolemia may be refractory to diet and drug therapy.

o In some of these patients, elevated LDL-C may respond to selective apheresis.

o The prevalence of heterozygous FH (heFH) is approximately 1 case per 500 persons.

• The prevalence of homozygous FH (hoFH) occurs in approximately 1 of every 1 million people.

• LDL-C apheresis requires careful patient selection and long-term commitment to therapy.

o It is anticipated that only a very limited number of patients will qualify for coverage.

o Plasmapheresis for hypercholesterolemia (contrasted with component or selective apheresis) and apheresis for hypertriglyceridemia are not covered at this time.

• LDL apheresis must be performed using a device approved by the Food and Drug Administration (FDA).

o The FDA approved the Kaneka Liposorber LA-15 System in 1996, and the heparin induced extracorporeal LDL precipitation system (H.E.L.P.) in 1997.

o These are two different methods for removal of LDL-C. The Kaneka system uses an LDL adsorption column, and H.E.L.P. relies on heparin induced extracorporeal LDL precipitation.

Indications

• In order to initiate LDL apheresis, patients must

o have refractory familial hypercholesterolemia,

And

o have failed at least a six-month continuous trial of maximum-tolerated drug therapy (defined as a trial of drugs from at least two separate classes of hypolipidemic agents such as bile acid sequestrants, HMG-COA reductase inhibitors, fibric acid derivatives, or niacin/nicotinic acids)

And

o diet therapy

And

o have met the following FDA-approved indications:

 Group A. Functional Hypercholesterolemic Homozygotes with LDL-C > 500 mg/dl;

 Group B. Functional Hypercholesterolemic Heterozygotes with LDL-C > 300 mg/dl; or

 Group C. Functional Hypercholesterolemic Heterozygotes with LDC-C > 200 mg/dl and documented coronary heart disease.

• Documented coronary heart disease (CHD) includes documentation of one or more of the following:

o documented coronary artery disease by coronary angiography or CT coronary angiography ;

o a history of myocardial infarction (MI);

o coronary artery bypass surgery (CABG);

o percutaneous transluminal coronary angioplasty (PTCA) or alternative revascularization procedure (e.g., atherectomy or stent);

• Angina or angina equivalent and an abnormal stress test with evidence of inducible ischemia.

 

 

Coding Information

 

Bill Type Codes

• 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.

 

 

11x Hospital Inpatient (Including Medicare Part A)

12x Hospital Inpatient (Medicare Part B only)

13x Hospital Outpatient

85x Critical Access Hospital

 

Revenue Codes

• 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.

 

 

0940 Other Therapeutic Services - General Classification

 

CPT/HCPCS Codes

 

 

36516 THERAPEUTIC APHERESIS; WITH EXTRACORPOREAL SELECTIVE ADSORPTION OR SELECTIVE FILTRATION AND PLASMA REINFUSION

 

 

ICD-9 Codes that Support Medical Necessity

 

 

272.0 PURE HYPERCHOLESTEROLEMIA

 

 

Documentation Requirements

• The medical record must contain documentation that fully supports the medical necessity and justification of the procedure performed.

o The documentation must be made available to Medicare upon request.

o When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.

• Medical record documentation maintained by the physician must substantiate the medical need for LDL apheresis and must include, but is not limited to, the following:

o Office notes/hospital record, including history and physical by the attending/treating physician

o Medication record

o Documentation of the history and duration of unsuccessful medical management

o Interpretation and reports for lab results and/or diagnostic studies (as applicable)

o Complete procedure report outlining LDL apheresis

• Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient.

• To meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives, and the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition).

• Lacking compelling arguments for an exception in the supporting documentation, the hospital and physician services can be denied.

• If in certain circumstances the patient does not meet all of the required criteria outlined in the LCD for a procedure, but the treating physician feels that the procedure is a covered procedure given the current standards of care, then the documentation must clearly outline the patient’s episode of care that supports the procedure and must clearly address the reason(s) for coverage.

• For example, if clinical findings (or lack of) for an indication are not consistent with the LCD criteria, it should be directly addressed in the pre-procedure documentation.

• Also, if certain conservative therapies are not necessary for a given patient, it should be directly noted in the pre-procedure documentation.

• The clinical judgment of the treating physician is always a consideration if clearly addressed in the pre-procedure record and if consistent with the episode of care for the patient as documented in patient’s records and claims history.

 

Treatment Logic

• Apheresis (also known as pheresis or therapeutic pheresis) is a medical procedure utilizing specialized equipment to remove selected blood constituents (plasma, leukocytes, platelets, or cells) from whole blood.

• The remainder is retransfused into the person from whom the blood was taken.

 

Sources of Information and Basis for Decision

 

Abstracts from the American Society for Apheresis 33rd Annual Meeting, April 11–14, 2012 Atlanta, Georgia. Therapeutic Apheresis in a Patient with Familial Hypercholesterolemia—30 Year Experience; Lipid Apheresis for Treatment of Familial Hyperlipoprotein (a) with a Comparison to Lipid Apheresis for Hypercholesterolemia J. Clin. Apheresis, 27: 1–40.

 

Citkowitz, Elena MD, PhD, FACP. Familial Hypercholesterolemia. Medscape, updated January 12, 2012. Accessed at: http://emedicine.medscape.com/article/121298-overview

 

Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996: Kaneka America Corp.; FDA Premarket Approval of Liposorber LA–15 System. Accessed on August 27, 2012 at http://www.gpo.gov/fdsys/pkg/FR-1996-07-01/pdf/FR-1996-07-01.pdf?bcsi_scan_EF5B9DB7FD0B1BFD=0&bcsi_scan_filename=FR-1996-07-01.pdf

 

Gordon BR, Saal SD. Low-density lipoprotein apheresis using the Liposorber dextran sulfate cellulose system for patients with hypercholesterolemia refractory to medical therapy. J Clin Apher. 1996; 11(3):128-31.

 

Helmbold AF. The effects of extended release niacin in combination with omega 3 fatty acid supplements in the treatment of elevated lipoprotein (a). Cholesterol. 2010; Article ID 306147.

 

Lee WP, Datta BN, Ong BB, et al., Defining the role of lipoprotein apheresis in the management of familial hypercholesterolemia. Am J Cardiovasc Drugs. 2011 Dec 1; 11(6):363-70.

 

Martin SS, et al. Waiting for the National Cholesterol Education Program Adult Treatment Panel IV Guidelines, and in the meantime, some challenges and recommendations. The American Journal of Cardiology. 2012 July; 110(2): 307-313.

 

Raper A, Kolansky DM, Cuchel M. Treatment of familial hypercholesterolemia: is there a need beyond statin therapy? Curr Atheroscler Rep. 2012 Feb; 14(1):11-6.

 

Szczepiorkowski ZM, Bandarenko N, Kim HC, et al. Guidelines on the use of therapeutic apheresis in clinical practice: evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher. 2007 Jun; 22(3):106-75.

 

Thompsen J, Thompson PD. A systematic review of LDL apheresis in the treatment of cardiovascular disease. Atherosclerosis. 2006 Nov; 189(1):31-8.

 

U.S. Food and Drug Administration (FDA). July 2010 Premarket Approvals (for H.E.L.P. System) Accessed August 24, 2012. Available at URL address: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm223712.htm

 

Winters JL. Apheresis medicine state of the art in 2010: American Society for Apheresis fifth special edition of the Journal of Clinical Apheresis. J Clin Apher. 2011; 26(5):239-42.

 

Winters, JL. Low-Density Lipoprotein Apheresis: Principles and Indications. Seminars in Dialysis, March/April 2012; 25(2):145–151.

 

Other Medicare Contractor’s policies: NHIC, Corp. (MAC Part A and Part B contractor) (L29875).

 

02/04/2013

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/ .

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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 LCD L33000 Low Density Lipoprotein (LDL) Apheresis