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Heart (Cardiac) PET With CT for Attenuation - CAM 763

GENERAL INFORMATION

It is an expectation that all patients receive care/services from a licensed clinician. All appropriate supporting documentation, including recent pertinent office visit notes, laboratory data, and results of any special testing must be provided. If applicable: All prior relevant imaging results and the reason that alternative imaging cannot be performed must be included in the documentation submitted. 

Where a specific clinical indication is not directly addressed in this guideline, medical necessity determination will be made based on widely accepted standard of care criteria. These criteria are supported by evidence-based or peer-reviewed sources such as medical literature, societal guidelines and state/national recommendations.

Policy
All criteria are substantiated by the latest evidence-based medical literature. To enhance transparency and reference, Appropriate Use (AUC) scores, when available, are diligently listed alongside the criteria.

This guideline first defaults to AUC scores established by published, evidence-based guidance endorsed by professional medical organizations. In the absence of those scores, we adhere to a standardized practice of assigning an AUC score of 6. This score is determined by considering variables that ensure the delivery of patient-centered care in line with current guidelines, with a focus on achieving benefits that outweigh associated risks.

This approach aims to maintain a robust foundation for decision-making and underscores our commitment to upholding the highest standards of care.4,5,6,7,8

INDICATIONS FOR HEART PET WITH CT FOR ATTENUATION9,10,11
Suspected CAD
When neither SE nor MPI have provided or are expected to provide optimal imaging 

  • Symptomatic patients without known CAD. No imaging stress test within the last 12 months. The terms "typical," "atypical," and "non-anginal symptoms" can still be observed in medical records (consult the Diamond Forrester table in the Definitions section). However, the ACC has simplified its terminology to "Less likely anginal symptoms" and "Likely anginal symptoms" (refer to Definitions section) and utilized below.
    • Less-likely anginal symptoms (AUC 4 – 6)
      • When a patient cannot walk a treadmill
      • When baseline EKG makes standard exercise test inaccurate (see Definitions section).
      • When a noncardiac explanation is provided for symptoms, no testing is required (AUC 8)
    • Likely Anginal Symptoms (typical angina)
      • < 50 years old with ≤ one risk factor if an ECG treadmill test cannot be done. **AUC scores for this bullet point are identical for MPI, stress echo, and ETT (AUC 7). Although the ACC guideline does not specify youth and gender, decisions should be guided by best medical judgment, considering factors such as safety and radiation exposure.
      • ≥ 50 years old (AUC 8)
    • Repeat testing in a patient with new or worsening symptoms and negative result at least one year ago AND meets one of the criteria above
  • Asymptomatic patients without known CAD
    • Previously unevaluated ECG evidence of possible myocardial ischemia including substantial ischemic ST segment or T wave abnormalities (see Background section)
    • Previously unevaluated pathologic Q waves (see Background section)
    • Unevaluated complete left bundle branch block (AUC 8)3

Abnormal Calcium Scores (CAC)9,12,13,14,15
When neither SE nor MPI have provided, or are expected to provide, optimal imaging

  • STABLE SYMPTOMS with a prior Coronary Calcium Agatston Score of > 100. No prior MPI done within the last 12 months16
  • ASYMPTOMATIC high global CAD risk patient with a prior Coronary Calcium Agatston Score of > 100. No prior MPI done within the last 12 months16
  • Asymptomatic patient with Coronary Calcium Agatston Score > 400. No prior MPI done within the last 12 months

Inconclusive CAD Evaluation and Obstructive CAD Remain a Concern
When neither SE nor MPI have provided, or are expected to provide, optimal imaging

  • Exercise stress ECG with low-risk Duke treadmill score (≥ 5) (see Background section) but patient’s current symptoms indicate increasing likelihood of disease
  • Exercise stress ECG with an intermediate Duke treadmill score (AUC 8)3
  • Inconclusive/borderline coronary computed tomography angiography (CCTA) or SPECT nuclear stress testing (e.g., 40% – 70% lesions) (AUC 9)3
  • Cardiac PET stress-rest perfusion and metabolic activity study (with 18F-FDG PET) is appropriate in patients with ischemic cardiomyopathy to determine myocardial viability prior to revascularization following an inconclusive SPECT9,17 (AUC 9)3
  • Non-diagnostic exercise stress test with physical inability to achieve target heart rate (THR)
  • An intermediate evaluation by prior stress imaging
  • Coronary stenosis of unclear significance on previous coronary angiography9 (AUC 8)3

Follow-Up of Patient’s Post Coronary Revascularization (PCI or CABG)
When neither SE nor MPI have provided, or are expected to provide, optimal imaging9

  • Asymptomatic, follow-up stress imaging at a minimum of 2 years post coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI), (whichever is later), is appropriate only for patients with:
    • High risk: diabetes with accelerated progression of CAD, CKD, PAD, prior brachytherapy, ISR, or SVG intervention.
    • A history of silent ischemia or
    • A history of a prior left main stent

OR

  • For patients with high occupational risk (e.g., associated with public safety, airline and boat pilots, bus and train drivers, bridge and tunnel workers/toll collectors, police officers, and firefighters)

New, recurrent, or worsening symptoms post coronary revascularization treated medically or by revascularization is an indication for stress imaging, if it will alter management for typical anginal symptoms or symptoms documented to be similar to those prior to revascularization if no imaging stress test within the last 12 months. (AUC 8)

Follow-Up of Known CAD9
When neither SE nor MPI have provided, or are expected to provide, optimal imaging

  • Follow-up of asymptomatic or stable symptoms when last invasive or non- invasive assessment of coronary disease showed hemodynamically significant CAD (ischemia on stress test or FFR ≤ 0.80 or significant stenosis in a major vessel [≥ 50% left main coronary artery or ≥ 70% LAD, LCX or RCA]), over two years ago, without intervening coronary revascularization is an appropriate indication for stress imaging in patients if it will alter management

Special Diagnostic Conditions Requiring Coronary Evaluation
When neither SE nor MPI have provided, or are expected to provide, optimal imaging

  • Unevaluated ACS
    • Prior acute coronary syndrome (as documented in MD notes), without subsequent invasive or non-invasive coronary evaluation within the last 12 months
    • Has ventricular wall motion abnormality demonstrated by another imaging modality and myocardial perfusion imaging is being performed to determine if the patient has myocardial ischemia. No imaging stress test within the last 12 months
    • The addition of Coronary CTA to the PETCT study may be considered for patients facing complex coronary interventions, suspected global myocardial ischemia, necessitating correlation between anatomy and perfusion17 (AUC 7)
  • Heart Failure
    • Newly diagnosed systolic heart failure or diastolic heart failure, with reasonable suspicion of cardiac ischemia (prior events, risk factors), unless invasive coronary angiography is immediately planned or adequate stress imaging has been done within the last 12 months10,18,19 (AUC 9)3
  • Suboptimal Revascularization
    • To diagnose microvascular dysfunction in patients with persistent stable anginal chest pain with suspected ischemia and nonobstructive coronary artery disease (INOCA), as documented in provider notes (no MPI diversion required13
  • Viability
    • Reduced LVEF ≤ 50% requiring myocardial viability assessment to assist with decisions regarding coronary revascularization. (Diversion from PET not required when LVEF less than or equal to 40%)18,19,20 (AUC 9)3
  • Ischemia and Nonobstructive Coronary Artery Disease (INOCA)
    • To diagnose microvascular dysfunction in patients with persistent stable anginal chest pain with suspected ischemia and nonobstructive coronary artery disease (INOCA), as documented in provider notes (no MPI diversion required).
  • Arrhythmias
    • Ventricular arrhythmias
      • Sustained ventricular tachycardia (VT) > 100 bpm, ventricular fibrillation (VF), or exercise-induced VT, when invasive coronary arteriography is not the immediately planned test21
      • Non-sustained VT, multiple episodes, each ≥ 3 beats at ≥ 100 bpm, frequent PVC’s (defined as greater than or equal to 30/hour on remote monitoring) without known cause or associated cardiac pathology, when an exercise ECG cannot be performed
  • Anti-Arrhythmic Drug Therapy
    • Class IC antiarrhythmic drug
      • In the intermediate and high global risk patient prior to initiation of Class IC antiarrhythmic drug initiation (Propafenone or Flecainide)
      • Annually for intermediate and high global risk patients taking Class IC antiarrhythmic drug (Propafenone or Flecainide)22 (AUC 7)3
  • Coronary Anomaly and Aneurism
    • Assessment of hemodynamic significance of one of the following documented conditions:23
      • Anomalous coronary arteries24
      • Muscle bridging of coronary artery9,25
    • Coronary aneurysms in Kawasaki’s disease26 or due to atherosclerosis
  • Radiation
    • Following radiation therapy to the anterior or left chest, at 5 years post initiation and every 5 years thereafter27
  • Cardiac Sarcoidosis29,29,30
    • May be approved as a combination study with MPI for the evaluation and treatment of sarcoidosis31
      • Evaluation and therapy monitoring in patients with sarcoidosis, after documentation of suspected cardiac involvement by echo or ECG, when CMR has not been performed
      • Evaluation of suspected cardiac sarcoid, after CMR has shown equivocal or negative findings in the setting of a high clinical suspicion30
      • Evaluation of CMR findings showing highly probable cardiac sarcoidosis, when PET could serve to identify inflammation and the consequent potential role for immunosuppressive therapy30 (AUC 9)3
      • Initial and follow-up PET in monitoring therapy for cardiac sarcoid with immunosuppressive therapy, typically about 4 times over 2 years
  • Infective Endocarditis
    • In suspected infective endocarditis with moderate to high probability (i.e., staph bacteremia, fungemia, prosthetic heart valve, or intracardiac device), when TTE and TEE have been inconclusive with respect to diagnosis of infective endocarditis or characterization of paravalvular invasive complications32,33,34
  • Aortitis
    • For diagnosis and surveillance of aortitis, PET/CT or PET/MRI‡ hybrid imaging35
    • ‡NOTE: If PET/MR study is requested, there is no specific CPT Code for this imaging study and a Health Plan review will be required.

Prior To Elective Non-Cardiac Surgery
When neither SE nor MPI have provided or are expected to provide optimal imaging

  • An intermediate or high-risk surgery with of one or more risk factors (see below), AND documentation of an inability to walk (or < 4 METs) AND there has not been an imaging stress test within 1 year36,37,38
    • Risk factors: history of ischemic heart disease, history of congestive heart failure, history of cerebrovascular disease, preoperative treatment with insulin, and preoperative serum creatinine > 2.0 mg/dL.
    • Surgical Risk:
      • High-risk surgery: Aortic and other major vascular surgery, peripheral vascular surgery, anticipated prolonged surgical procedures associated with large fluid shifts and/or blood loss
      • Intermediate-risk surgery: Carotid endarterectomy, head and neck surgery, intraperitoneal and intrathoracic surgery, orthopedic surgery, prostate surgery
      • Low-risk surgery: Endoscopic procedures, superficial procedure, cataract surgery, breast surgery
  • Planning for any organ or stem cell transplantation is an indication for preoperative stress imaging, if there has not been a conclusive stress evaluation, CTA, or heart catheterization within the past year, at the discretion of the transplant service39

Post Cardiac Transplant
SE diversion not required40

  • Annually, for the first five years post cardiac transplantation, in a patient not undergoing invasive coronary arteriography

Rationale
A PET study is a diagnostic test used to evaluate blood flow to the heart. During the test, a small amount of radioactive tracer is injected into a vein. A special camera, called a gamma camera, detects the radiation released by the tracer to produce computer images of the heart. Combined with a medication, the test can help determine if there is adequate blood flow to the heart during activity versus at rest. The medication simulates exercise for patients unable to exercise on a treadmill or stationary cycle.

PET prefusion studies illustrate myocardial blood flow by demonstrating tracer uptake. PET metabolic evaluation studies are used to demonstrate inflammation produced by infiltrative disease such as sarcoidosis, but also enhance the detection of viable (hibernating) myocardium. Hybrid PET-CT scanning combines anatomical information with blood flow assessment and is useful for assessing viable myocardium, especially in CHF patients with global ischemia, or in patients with multivessel diffuse coronary artery disease as opposed to focal stenotic lesions.

AUC Score
A reasonable diagnostic or therapeutic procedure care can be defined as that for which the expected clinical benefits outweigh the associated risks, enhancing patient care and health outcomes in a cost-effective manner.4

  • Appropriate Care — Median Score 7 – 9
  • May be Appropriate Care — Median Score 4 – 6
  • Rarely Appropriate Care — Median Score 1 – 3

Definitions

  • Coronary application of PET includes evaluation of stable patients without known CAD, who fall into two categories9,10,11
    • Asymptomatic, for whom global risk of CAD events can be determined from coronary risk factors, using calculators available online (see Websites for Global Cardiovascular Risk Calculators section).
    • Symptomatic, for whom we estimate the pretest probability that their chest-

related symptoms are due to clinically significant (≥ 50%) CAD (below)

  • The medical record should provide enough detail to establish the type of chest pain:
    • Likely Anginal symptoms encompass chest/epigastric/shoulder/arm/jaw pain, chest pressure/discomfort occurring with exertion or emotional stress and relieved by rest, nitroglycerine or both.
    • Less-Likely Anginal symptoms include dyspnea, or fatigue not relieved by rest/nitroglycerin, as well as generalized fatigue or chest discomfort with a time course not indicative of angina (e.g., resolving spontaneously within seconds or lasting for an extended period unrelated to exertion).
  • Risk Factors for Coronary disease include (but not limited to): diabetes mellitus, smoking, family history of premature CAD (men age less than 55, females less than 65), hypertension, dyslipidemia.
  • Beginning 2023, the classification terms for angina were updated within the ACC’s Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease to Less Likely Anginal Symptoms and Likely Anginal Symptoms. Previously, the document referred to “Typical Angina”, “Atypical Angina” and “Non-Anginal” symptoms, defined by the Diamond Forrester Table. We still provide this information for your reference (9,10,11):

Diamond Forrester Table43,44

Age

(Years)

Gender

Typical/ Definite Angina

Pectoris

Atypical/ Probable

Angina Pectoris

Nonanginal Chest

Pain

≤ 39

Men

Intermediate

Intermediate

Low

Women

Intermediate

Very low

Very low

40 – 49

Men

High

Intermediate

Intermediate

Women

Intermediate

Low

Very low

50 – 59

Men

High

Intermediate

Intermediate

Women

Intermediate

Intermediate

Low

≥ 60

Men

High

Intermediate

Intermediate

Women

High

Intermediate

Intermediate


Very low: < 5%pretest probability of CAD, usually not requiring stress evaluation Low: 5 - 10% pretest probability of CAD
Intermediate: 10% – 90% pretest probability of CAD High: > 90% pretest probability of CAD

  • ECG Stress Test Alone versus Stress Testing with Imaging
    • Prominent scenarios suitable for an ECG stress test WITHOUT imaging (i.e., exercise treadmill ECG test) require that the patient can exercise for at least 3 minutes of Bruce protocol with achievement of near maximal heart rate AND has an interpretable ECG for ischemia during exercise:9
      • The (symptomatic) low or intermediate pretest probability patient who can exercise and has an interpretable ECG9
      • The patient who is under evaluation for exercise-induced arrhythmia
      • The patient who requires an entrance stress test ECG for a cardiac rehab program or for an exercise prescription
      • For the evaluation of syncope or presyncope during exertion45
      • When exercise cannot be performed, pharmacologic stress can be considered.
  • Duke Exercise ECG Treadmill Score46
    • Calculates risk from ECG treadmill alone:
      • The equation for calculating the Duke treadmill score (DTS) is: DTS = exercise time in minutes - (5 x ST deviation in mm or 0.1 mV increments) - (4 x exercise angina score), with angina score being 0 = none, 1 = non-limiting, and 2 = exercise-limiting
      • The score typically ranges from -25 to +15. These values correspond to low-risk (with a score of ≥ +5), intermediate risk (with scores ranging from -10 to +4), and high-risk (with a score of ≤ -11) categories
  • An uninterpretable baseline ECG includes:10
    • ST segment depression 1 mm or more; (not for non-specific ST- T wave changes)
    • Ischemic-looking T waves; at least 2.5 mm inversions (excluding V1 and V2)
    • LVH with repolarization abnormalities, pre-excitation pattern such as WPW, ventricular paced rhythm, or left bundle branch block
    • Digitalis use with associated ST segment abnormalities
  • Previously unevaluated pathologic Q waves (in two contiguous leads) defined as the following:
    • > 40 ms (1 mm) wide
    • > 2 mm deep
    • > 25% of depth of QRS complex

Global Risk of Cardiovascular Disease

  • Global risk of CAD is defined as the probability of manifesting cardiovascular disease over the next 10 years and refers to asymptomatic patients without known cardiovascular disease. It should be determined using one of the risk calculators below. A high risk is considered greater than a 20% risk of a cardiovascular event over the ensuing 10 years. High global risk by itself generally lacks scientific support as an indication for stress imaging. There are rare exceptions, such as patients requiring IC antiarrhythmic drugs who might require coronary risk stratification prior to initiation of the drug.
      • CAD Risk — Low
        • 10-year absolute coronary or cardiovascular risk less than 10%
      • CAD Risk — Moderate
        • 10-year absolute coronary or cardiovascular risk between 10% and 20%
      • CAD Risk — High
        • 10-year absolute coronary or cardiovascular risk of greater than 20%

Websites for Global Cardiovascular Risk Calculators*47,48,49,50,51

Risk Calculator

Websites for Online Calculator

Framingham

Cardiovascular Risk

https://reference.medscape.com/calculator/framingham-

cardiovascular-disease-risk

Reynolds Risk Score Can use if no diabetes

Unique for use of

family history

http://www.reynoldsriskscore.org/

Pooled Cohort

Equation

http://clincalc.com/Cardiology/ASCVD/PooledCohort.aspx?example

ACC/AHA Risk

Calculator

http://tools.acc.org/ASCVD-Risk-Estimator/

MESA Risk Calculator

With addition of Coronary Artery Calcium Score, for

CAD-only risk

https://www.mesa- nhlbi.org/MESACHDRisk/MesaRiskScore/RiskScore.aspx

*Patients who have already manifested cardiovascular disease are already at high global risk and are not applicable to the calculators.

  • Definitions of Coronary Artery Disease10,11,14
  • Percentage stenosis refers to the reduction in diameter stenosis when angiography is the method and can be estimated or measured using angiography or more accurately measured with intravascular ultrasound (IVUS).
    • Coronary artery calcification is a marker of risk, as measured by Agatston score on coronary artery calcium imaging. Its incorporation into global risk can be achieved by using the MESA risk calculator.
    • Ischemia-producing disease (also called hemodynamically or functionally significant disease, for which revascularization might be appropriate) generally implies at least one of the following:
      • Suggested by percentage diameter stenosis ≥ 70% by angiography; intermediate lesions are 50% – 69%9
      • For a left main artery, suggested by a percentage stenosis ≥ 50% or minimum lumen cross-sectional area on IVUS ≤ 6 square mm10,52
      • FFR (fractional flow reserve) ≤ 0.80 for a major vessel52
      • Demonstrable ischemic findings on stress testing (ECG or stress imaging), that are at least mild in degree
    • A major vessel would be a coronary vessel that would be amenable to revascularization if indicated. This assessment is made based on the diameter of the vessel and/or the extent of myocardial territory served by the vessel.
    • FFR (fractional flow reserve) is the distal to proximal pressure ratio across a coronary lesion during maximal hyperemia induced by either intravenous or intracoronary adenosine. Less than or equal to 0.80 is considered a significant reduction in coronary flow.
    • Newer technology that estimates FFR from CCTA image is covered under the Evolent Clinical Guideline 062-1 for Fractional Flow Reserve CT.
  • Anginal Equivalent10,45
    • Development of an anginal equivalent (e.g., shortness of breath, fatigue, or weakness) either with or without prior coronary revascularization should be based upon the documentation of reasons to suspect that symptoms other than chest discomfort are not due to other organ systems (e.g., dyspnea due to lung disease, fatigue due to anemia), by presentation of clinical data, such as respiratory rate, oximetry, lung exam, etc. (as well as d-dimer, chest CT(A), and/or PFTs, when appropriate), and then incorporated into the evaluation of coronary artery disease as would chest discomfort. Most syncope per se is not an anginal equivalent.

Acronyms/Abbreviations

ADLs

Activities of daily living
BMI Body mass index
CABG Coronary artery bypass grafting
CAC Coronary artery calcium

CAD

Coronary artery disease
CCTA Coronary computed tomography angiography
CMR Cardiac magnetic resonance imaging
CT(A) Computed tomography (angiography)
DTS Duke Treadmill Score

ECG

Electrocardiogram

FFR

Fractional flow reserve
IVUS Intravascular ultrasound

LBBB

Left bundle-branch block

LVEF

Left ventricular ejection fraction

LVH

Left ventricular hypertrophy
MESA Multi-Ethnic Study of Atherosclerosis
MET Estimated metabolic equivalent of exercise

MI

Myocardial infarction

MPI

Myocardial perfusion imaging
MR(I) Magnetic resonance (imaging)
PCI Percutaneous coronary intervention
PET Positron emission tomography

PFT

Pulmonary function test

PVCS

Premature ventricular contractions

SE

Stress echocardiography
TEE Transesophageal echocardiography
THR Target heart rate
TTE Transthoracic echocardiography
VF  Ventricular fibrillation

VT

Ventricular tachycardia

WPW

Wolf Parkinson White

References 

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Coding Section 

Codes

Number

Description

CPT 

78429 (effective 01/01/2020) 

With concurrently acquired computed tomography transmission scan

 

78430 (effective 01/01/2020)

Single study, at rest or stress (exercise or pharmacologic), with concurrently acquired computed tomography transmission scan

 

78431 (effective 01/01/2020)

Multiple studies, at rest or stress (exercise or pharmacologic), with concurrently acquired computed tomography transmission scan

 

78432 (effective 01/01/2020)

Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), dual radiotracer (e.g., myocardial viability);

 

78433 (effective 01/01/2020)

With concurrently acquired computed tomography transmission scan

 

78434 (effective 01/01/2020)

Absolute quantitation of myocardial blood flow (AQMBF), positron emission tomography (PET), rest and pharmacologic stress

 

78459

Myocardial imaging, positron emission tomography (PET), metabolic evaluation

 

78491

Myocardial imaging, positron emission tomography (PET), perfusion; single study at rest or stress

 

78492

Myocardial imaging, positron emission tomography (PET), perfusion; multiple studies at rest and/or stress

 

0482T 

Absolute quantitation of myocardial blood flow, positron emission tomography (PET), rest and stress (List separately in addition to code for primary procedure) 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,  and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward 

12/01/2024 Annual review, policy updated for clarity and consistency, including adding AUC scores and calcium score. Also updating rationale and references.
12/06/2023 Annual review, updating title to indicate this is HEART (Cardiac) PET with CT for Attenuation. A new CAM policy will be published to address Cardiac Pet Scanning without Attenuation. Removing two year time limitation for further evaluation adding coronary stenosis of unclear significance, ischemia and nonobstructive CAD, clarified statement for PET/MPI for the evaluation cardiac sarcoidosis.  
12/07/2022 Annual review, multiple updates to coverage criteria.

12/2/2021 

Annual review, adding criteria for class IC antiarrhythmic drugs and history of diabetes mellitus, >40 years old with a calcium score >400. Also updating references. 

12/01/2020 

Annual review, clarifying policy verbiage, updating background and references.

06/02/2020 

Annual review, no change to policy intent. 

12/13/2019 

Added codes '78429, 78430, 78431, 78432, 78433', and '78434' 

12.04.2019 

Interim review, reformatting policy, including much more specificity for medical necessity indications and criteria. 

06/11/2019 

Annual review, no change to policy intent. Updating rationale and references. 

06/28/2018 

Annual review, no change to policy intent.Updating background, description, regulatory status, rationale and references. 

06/14/2017 

Annual review, no change to policy intent. 

06/24/2016 

Annual review, adding the following statement to the policy verbiage: Cardiac PET scanning is INVESTIGATIONAL for quantification of myocardial blood flow in patients diagnosed with CAD. Updating background, description, regulatory status, guidelines, rationale and references.

06/04/2015 

Annual review, no change to policy intent. Updating FDA status, rationale and references. Adding coding. 

06/18/2014

Annual review. Added related policies.  Updated references. No change to policy intent.
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