MATRIX LEVEL CONDITIONS

TAKEN FROM THE AHP SETTLEMENT AGREEMENT

 

(1) MATRIX LEVEL I is severe left sided valvular heart disease without complicating factors, and is defined as one of the following:

(a)               Severe aortic regurgitation (AR) and/or severe mitral regurgitation (MR) and no complicating factors as defined below;

 

(b)               Mild or greater AR or moderate or greater MR with bacterial endocarditis contracted after commencement of Pondimin and/or Redux use.

(2) MATRIX LEVEL II is left sided valvular heart disease with complicating factors, and is defined as:

(a) Moderate AR or Severe AR with one or more of the following:

i)         Pulmonary hypertension secondary to severe aortic regurgitation with a peak      systolic pulmonary artery pressure > 40 mm Hg measured by cardiac catheterization or with a peak systolic pulmonary artery pressure > 45 mm Hg measured by Doppler Echocardiography, at rest, utilizing standard procedures assuming a right atrial pressure of 10 mm Hg; 

ii)       Abnormal left ventricular endsystolic dimension > 50 mm by Mmode or 2-D Echocardiography or abnormal    left ventricular enddiastolic dimension > 70 mm; 

 

iii)        Ejection fraction of < 50%; and/or

(b) Moderate MR or Severe MR with one or more of the following:

i) Pulmonary hypertension secondary to valvular heart disease with peak systolic pulmonary artery pressure >

40 mm Hg measured by cardiac catheterization or with a peak systolic pulmonary artery pressure > 45 mm Hg measured by Doppler Echocardiography, at rest; 

ii)                 Abnormal left atrial supero-inferior systolic dimension > 5.3 cm (apical four chamber view) or abnormal left atrial antero-posterior systolic dimension > 4.0 cm (parasternal long axis view)

iii)               Abnormal left ventricular endsystolic dimension > 45 mm;   

iv)               Ejection fraction of < 60%;   

v)                  Arrhythmias, defined as chronic atrial fibrillation/flutter that cannot be converted to normal sinus rhythm, or atrial fibrillation/flutter requiring ongoing medical therapy, any of which are associated with left atrial enlargement.

(3) MATRIX LEVEL III is left sided valvular heart disease requiring surgery or conditions of equal severity, and is defined as:

(a)               Surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin and/or Redux; or  

(b)               Severe regurgitation and the presence of ACC/AHA Class I indications for surgery to repair or replace the aortic and/or mitral valve(s) and a statement from the attending Board-Certified Cardiothoracic Surgeon or Board-Certified Cardiologist supported by medical records regarding the recommendations made to the patient concerning valvular surgery, with the reason why the surgery is not being performed; or 

(c)               Qualification for payment at Matrix Level I(b) or Matrix Level II and, in addition, a stroke due to bacterial endocarditis contracted after use of Pondimin and/or Redux or as a consequence of chronic atrial fibrillation with left atrial enlargement which results in a permanent condition which meets the criteria of AHA Stroke Outcome Classification Functional Level II, determined six months after the event.

  (4) MATRIX LEVEL IV is defined as follows:

(a)               Qualification for payment at Matrix Level I(b), II or III and, in addition, a stroke due to Bacterial Endocarditis contracted after use of Pondimin and/or Redux or as a consequence of chronic atrial fibrillation with left atrial enlargement which results in a permanent condition which meets the criteria of AHA Stroke Outcome Classification Functional Level III, determined six months after the event; or 

 

(b)               Qualification for payment at Matrix Level I.b, II, or III and, in addition, a peripheral embolus due to Bacterial Endocarditis contracted after use of Pondimin and/or Redux or as a consequence of atrial fibrillation with left atrial enlargement which results in severe permanent impairment to the kidneys, abdominal organs, or extremities, where severe permanent impairment means:

i)                   for the kidneys, chronic severe renal failure requiring hemodialysis or continuous abdominal peritoneal dialysis for more than six months; 

ii)                 for the abdominal organs, impairment requiring intra-

abdominal surgery;

iii)        for the extremities, impairment requiring amputation of a major limb; or  

(c)        The individual has the following:

i)                    Qualification for payment at Matrix Level III; and 

 

ii)                   New York Heart Association Functional Class I or Class II symptoms; and

 

i)                   Valvular repair and replacement surgery or ineligibility for surgery due to medical reasons; and  

ii)                 Significant damage to the heart muscle, defined as: (a) a left ventricular ejection fraction < 30% with aortic regurgitation or a left ventricular ejection fraction < 35% with mitral regurgitation in patients who have not had surgery and meet the criteria of Section IV.B.2.c.(3)(b) above or (b) a left ventricular ejection fraction < 40% six months after valvular repair or replacement surgery in patients who have had such surgery; or 

(d)               The individual has had valvular repair or replacement surgery and has one or more of the following complications which occur either during surgery, within thirty (30) days after surgery, or during the same hospital stay as the surgery:

 

i)                   Renal failure, defined as chronic, severe renal failure requiring regular hemodialysis or continuous abdominal peritoneal dialysis for greater than six months following aortic and/or mitral valve replacement surgery;

 

ii)                 Peripheral embolus following surgery resulting in severe permanent impairment to the kidneys, abdominal organs, or

extremities;

iii)               Quadriplegia or paraplegia resulting from cervical spine injury during valvular heart surgery; or

iv)               A stroke caused by aortic and/or mitral valve surgery and the stroke has produced a permanent condition which meets the criteria of the AHA Stroke Outcome Classification Functional Levels II or III determined six months after the event; 

 

v)                  The individual has had valvular repair or replacement surgery and suffers from post operative endocarditis, mediastinitis or sternal osteomyelitis, any of which requires reopening the median sternotomy for treatment, or a post-operative serious infection defined as HIV or Hepatitis C within six months of surgery as a result of blood transfusion associated with the heart valve surgery.

 

vi)               The individual has had valvular repair or replacement surgery and requires a second surgery through the sternum within eighteen months of the initial surgery due to prosthetic valve malfunction, poor fit, or complications reasonably related to the initial surgery.

          (5) MATRIX LEVEL V is defined as: 

(a)               The deadline for this injury (endo fibrosis) has passed for all DDRs; or 

(b)               Left sided valvular heart disease with severe complications, defined as Matrix Levels I(b) above with one or more of the following:

i)                   A severe stroke caused by aortic and/or mitral valve surgery or due to bacterial endocarditis contracted after use of Pondimin and/or Redux or as a consequence of chronic atrial fibrillation with left atrial enlargement and the severe stroke has resulted in a permanent condition which meets the criteria of AHA Stroke Outcome Classification Functional Levels IV or V, determined six months after the event;  

ii)                 The individual has the following:

a)                  Qualification for payment at Matrix Levels III or IV; and 

b)                  New York Heart Association

Functional Class III or Class IV symptoms; and 

c)                  Valvular repair or replacement surgery or ineligibility for surgery due to medical

; and

d)                  Significant damage to the heart muscle, defined as:  (i) a left ventricular ejection fraction < 30% with aortic regurgitation or a left ventricular ejection fraction < 35% with mitral regurgitation, in patients who have not had surgery and meet the criteria in Section IV.B.2.c.(3)(b) above or (ii) a left ventricular ejection fraction < 40% six months after valvular repair or replacement surgery in patients who have had such surgery; or 

 

iii)               Heart transplant; 

iv)               Irreversible pulmonary hypertension (PH) secondary to valvular heart disease defined as peak-systolic pulmonary artery pressure > 50 mm Hg (by cardiac catheterization) at rest following repair or replacement surgery of the aortic and/or mitral valve(s); 

 

v)                  Persistent non-cognitive state caused by a complication of valvular heart disease (e.g., cardiac arrest) or valvular repair/replacement surgery supported by a statement from the attending Board-Certified Cardiothoracic Surgeon or Board-Certified Cardiologist, supported by medical records; or

 

(c)               Death resulting from a condition caused by valvular heart disease or valvular repair/replacement surgery which occurred post-Pondimin and/or Redux; or 

(d)               The individual otherwise qualifies for payment at Matrix Level II, III, or IV and suffers from ventricular fibrillation or sustained ventricular tachycardia which results in hemodynamic compromise.

 


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