MIR-2006-7A, July 2006

LCD and Article Revisions for July 2006  

Cardiac Rehabilitation - L534
LCD Revisions:

Under the “CMS National Coverage Policy” section, updated number 4 from:

4. CMS Manual, Publication 100-3, Chapter 1, Section 20.10. This section addresses coverage of cardiac rehabilitation services. (This reference is not available at this time. Please refer to reference in number 5 below.)

To show the following:

4. CMS Manual, Publication 100-3, National Coverage Determination Manual, Chapter 1, Part 1, Section 20.10. This section addresses coverage of cardiac rehabilitation services.

Removed number 5:

5. Coverage Issues Manual (CIM), Publication 6, Section 35-25. This section addresses coverage of cardiac rehabilitation services.

Added new numbers 5 and 6:

5. CMS Manual, Publication 100-4, Claims Processing Manual, Chapter 32, Section 140-140.1. The section refers to Cardiac Rehabilitation Programs and coding requirements.
6. Change Request 4401, dated April 21, 2006. This CR includes additional clinical indications for coverage of Cardiac Rehabilitation.

This section was also updated in the article.

Under the “Indications and Limitations of Coverage and/or Medical Necessity” section, updated the following paragraph from:

Cardiac rehabilitation is a comprehensive program of medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling designed to restore certain patients with coronary heart disease to active and productive lives. Cardiac rehabilitation, as described in the medical literature, is divided into three phases: Phase I is the immediate in hospital post-cardiac event phase; Phase II is the outpatient immediate post-hospitalization recuperation phase; Phase III is the long-term, maintenance phase. This policy encompasses outpatient post-hospital cardiac rehabilitation, or Phase II. The program consists of a series of supervised exercise sessions with continuous electrocardiograph monitoring (CEM). Clinically optimal results are obtained if these sessions are conducted three times per week over a 12-week period. Cardiac rehabilitation without continuous EKG monitoring is not covered.

To show as the following:

Cardiac rehabilitation is a comprehensive program of medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling designed to restore certain patients with coronary or valvular heart disease to active and productive lives. Cardiac rehabilitation, as described in the medical literature, is divided into three phases: Phase I is the immediate in hospital post-cardiac event phase; Phase II is the outpatient immediate post-hospitalization recuperation phase; Phase III is the long-term, maintenance phase. This policy encompasses outpatient post-hospital cardiac rehabilitation, or Phase II. The program consists of a series of supervised exercise sessions with continuous electrocardiograph monitoring (CEM). Clinically optimal results are more probable if these sessions are conducted 2 to 3 times per week over a 12-18 week period for no more than 36 sessions.

This section was also updated in the article under the “Article Text,” LCD Description.

Under the “Indications” section, updated the following from:

Cardiac rehabilitation is covered for only three groups of patients:

5. Patients who begin the program within 12 months of an acute myocardial infarction.
6. Patients who are status post-coronary artery bypass (CABG) surgery.
7. Patients with chronic stable angina.

To show the following:

Cardiac rehabilitation is covered for only six (6) groups of patients:

5. Patients who begin the program within 12 months of an acute myocardial infarction;
6. Patients who have had coronary-artery bypass (CABG) surgery;
7. Patients with stable angina pectoris;
8. Patients who have had heart valve repair/replacement;
9. Patients who have had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or
10. Patients who have had a heart or heart-lung transplant.

Under the “Limitations” section, letter B. Diagnoses: updated number 3 to include the following statement:

(See * in “Group II Services” below).

Also under this section, added numbers 4 - 6:

4. For patients with heart valve repair or replacement, the program should be early enough to provide a restorative benefit. Therefore, the date of entry must be within six months of surgery.
5. For patients who have had a percutaneous-transluminal angioplasty (PTCA) or stent placement, the program should be early enough to provide a restorative benefit. Therefore, the date of entry should be within six months of the procedure.
6. Patients who have had heart or heart-lung transplant may present special and complex post-transplant management problems. The date of entry is extended to within one year of the surgery.

Under letter C. Frequency and Duration: updated numbers 1 - 3 from:

1. The frequency and duration of the program are three sessions per week over 12 weeks. Sessions extending beyond the 12 weeks will be denied as not medically necessary, unless additional documentation of necessity is demonstrated.
2. Services at a frequency of less than 2 to 3 sessions per week will be considered not medically necessary.
3. For the purposes of this LCD, Phase II is divided into Phase IIA and Phase IIB. Phase IIA is the initial outpatient cardiac rehabilitation, not to exceed 3 sessions per week in 12 weeks.

Phase IIB consists of an additional series of 36 sessions in 12 weeks and will only be allowed if determined to be medically necessary. The total number of allowable sessions is 72. Phase IIB benefits must meet additional medical necessity criteria, specifically, there must be clear demonstration that the patient is benefiting from cardiac rehabilitation and that the exit criterion below has not been met.

To show the following:

1. The frequency and duration of the program are generally a total of 36 sessions, 2 to 3 sessions per week over 12-18 weeks. Sessions extending beyond the 18 weeks will be denied as not medically necessary, unless additional documentation of necessity is demonstrated.
2. Services at a frequency of less than 2 to 3 sessions per week will be considered not medically necessary.
3. For the purposes of this LCD, Phase II is divided into Phase IIA and Phase IIB. Phase IIA is the initial outpatient cardiac rehabilitation, not to exceed a total of 36 sessions, 2 to 3 sessions per week for 12-18 weeks.

Phase IIB consists of an additional series of 36 sessions, 2 to 3 times per week, over 12-18 weeks and will only be allowed if determined to be medically necessary. The total number of allowable sessions is 72. Phase IIB benefits must meet additional medical necessity criteria, specifically, there must be clear demonstration that the patient is benefiting from cardiac rehabilitation and that the exit criterion below has not been met.

Under letter D. Exit Criterion, updated number 1 from:

1. This policy establishes an exit criterion to be met when the patient has achieved a stable level of exercise tolerance (7 METS). In the American Heart Association’s functional classification, Class I, or normal function status, begins at 7 metabolic equivalent units (METS). Therefore, completion of six minutes of exercise during a treadmill or stress imaging test, utilizing the Bruce protocol, without significant ischemia or dysrhythmia is a reasonable exit criterion.

To show the following:

1. For patients with ischemic heart disease, this policy establishes an exit criterion to be met when the patient has achieved a stable level of exercise tolerance (7 METS). In the American Heart Association’s functional classification, Class I, or normal function status, begins at 7 metabolic equivalent units (METS). Therefore, for the patients who are status post MI, status post CABG, status post PTCA or stent, or patients with angina,completion of six minutes of exercise during a treadmill or stress imaging test, utilizing the Bruce protocol, without significant ischemia or dysrhythmia is a reasonable exit criterion.

Also under this section, added numbers 2 and 3:

2. For patients with valvuloplasty or valve replacement benefits are available for phase IIA only. Data showing that extension of the program beyond the 36 sessions is reasonable and necessary is not available.
3. The post-transplant patient poses a special challenge for the cardiac rehabilitation team. Issues such as deconditioning, cachexic deterioration may complicate the definition of a reasonable exit criterion. Based on the study of long-term cardiopulmonary exercise performed after heart transplant by Osade et al, this carrier will use a peak oxygen consumption (VO 2) of greater than 90 percent predicted as the exit criterion for phase IIA. Patients whose VO 2 is less than 90 percent of predicted may qualify for the additional phase IIB.

Under the section for letter E. Noncovered Diagnoses, removed the following statement from number 1:

Congestive heart failure, post-heart or heart/lung transplant, status post coronary angioplasty, and post non-CABG cardiac surgery are not included as covered conditions for cardiac rehabilitation in the Coverage Issues Manual (CIM) 35-25 and cardiac rehabilitation for these conditions is excluded from coverage.

Also, added a new number 3:

3. Congestive heart failure in the absence of other covered conditions is not included as a covered condition of cardiac rehabilitation in the CMS manual, National Coverage Determination Manual, Publication 100-3, Section 20-10.

Under the section for letter F. Other services, updated number 1 to remove the following statement:

Forms of counseling, such as dietary counseling and stress management, are not separately reimbursed.

Added a new number 2:

2. Forms of counseling, such as dietary counseling, psychosocial intervention, lipid management, and stress management, are components of the cardiac rehabilitation program and are not separately reimbursed.

Under Letter G. Definition of Group Services, updated number 2 from:

2. Group II Services

a. New patient comprehensive evaluation, including history, physical, and preparation of initial exercise prescription.
* One will be allowed at the beginning of the program if not already performed by the patient’s attending physician, or if that performed by the patient’s physician is not acceptable to the program’s director.

b. ECG stress test (treadmill or bicycle ergometer) with physician monitoring and report.

One will be allowed at the beginning of the program and one after three months (usually the completion of the program).

c. Other physician services, as needed.

To show the following:

• Group II Services

a. New patient comprehensive evaluation, including history, physical, and preparation of initial exercise prescription.

* One will be allowed at the beginning of the program if not already performed by the patient’s attending physician, or if that performed by the patient’s physician is not acceptable to the program’s director:

• ECG stress test (treadmill or bicycle ergometer) with physician monitoring and report.

One will be allowed at the beginning of the program and one after 3 months (usually the completion of the program):

• Other physician services, as needed.

b. Cardiac rehabilitation without continuous ECG monitoring (per session) is not covered.

Under the “ICD-9-CM Codes That Support Medical Necessity” section, added the following ICD-9-CM codes:

V42.1** Organ or tissue replaced by transplant; heart

V42.2** Organ or tissue replaced by transplant; heart valve

V43.3** Organ or tissue replaced by other means, heart valve

V45.82** Other post-procedural states; percutaneous-transluminal coronary angioplasty status

V58.73** Aftercare following surgery of the circulatory system, not elsewhere classified

Also, under this section added the following:

* ICD-9-CM code 412 (Old myocardial infarction) refers to an MI that has occurred more than eight weeks prior to cardiac rehabilitation services.

** These codes are effective for services perform-ed on or after March 22, 2006.

Under the “Documentation Requirements” section, added number 4:

4. A cardiac rehabilitation record must be maintained. All the components, including ECG strips must be maintained. All components of the service (medical assessment, ECG monitoring, smoking cessation, dietary counseling, psychological counseling) must be assessed and provided where appropriate. It is not expected that every component is provided at each session, but the total phase II (A and B) record must reflect those benefits.

Under the “Sources of Information and Basis for Decision” section, added number 2:

2. Osada, N et al, “Long-term cardiopulmonary exercise performance after heart transplantation,” Am J Cardiol, 1997 Feb 15,79(4):451-6.

Article Revisions:
Under the “Coding Guidelines” section, added numbers 11 and 12:

11. The following indications are effective for services performed on or after March 22, 2006:

• Patients who have had heart valve repair/replacement; (ICD-9-CM code V42.2 and V43.3)
• Patients who have had percutaneous-transluminal coronary angioplasty (PTCA) or coronary stenting; (ICD-9-CM code V45.82) or
• Patients who have had a heart or heart-lung transplant.(V42.1)

12. A claim for cardiac rehabilitation submitted without an occurrence code 11, date of onset of event (for diagnosis CABG or MI), or without the date of the most recent stress test (for angina), will be returned to the provider.

Under the “Reasons for Denial” section, updated number 2 from:

2. The following conditions are not covered for cardiac rehabilitation:

1. Status post-heart or heart/lung transplant
2. Status post-coronary angioplasty
3. Status post non-(CABG) cardiac surgery
4. Congestive heart failure

To show the following:

1. The following conditions are not covered for cardiac rehabilitation:

1. Status post non-(CABG) cardiac surgery
2. Congestive heart failure

Also, under this section, updated number 4 and moved it to the Coding Guidelines section as number 12.  

Intravenous Immune Globulin (IVIG) - L699

LCD Revisions:
Under the “CMS National Coverage Policy” section, added number 13:

13. Change Request (CR) 4244, dated January 13, 2006. Medicare Payment for Pre-administration Related Services Associated with Intravenous Immune Globulin Administration.

This section was also updated in the article.

Under the “Indications” section, updated number 5 from:

To initiate intravenous immunoglobulins for this disease, the IgG level should be less than 600 mg/dl, or there should be evidence of specific antibody deficiency and the presence of repeated bacterial infections.

To show the following:

To initiate immunoglobulins for B-cell chronic lymphocytic leukemia, the IgG level should be less than 600 mg/dl, and/or the presence of repeated bacterial infections.

Under the “CPT/HCPCS Codes” section, added the following code:

G0332 Pre-administration related services for intravenous infusion of immunoglobulin, per infusion encounter

This section was also updated in the article.

Article Revisions:

Under the “Coding Guidelines” section, added numbers 15 and 16:

15. The HCPCS code G0332 is effective for services performed on or after January 1, 2006 and must be billed on the same claim as the IVIG product (J1566 and/or J1567) and have the same date of service as the IVIG product and drug-administration service.
16. Medicare will make separate payment to outpatient hospital departments for pre-administration related services associated with administration of IVIG (G0332). Payment for the pre-administration related services is payable no more than once per day per beneficiary.

Magnetic Resonance Angiography (MRA) - L513
LCD Revisions:

Under the “Indications and Limitations” section, letter C. Abdomen and Pelvis (HCPCS codes C8900, C8901, C8902, C8918, C8919, and C8920), added the following statement to the fourth paragraph to clarify the expanded coverage that includes imaging the aortoiliac arteries:

(including any vessel coming off of the aorta or iliac arteries)

Under the “ICD-9-CM Codes That Support Medical Necessity” section, added the following codes to the following sections:

For MRA of Lower Extremities (HCPCS C8912, C8913, and C8914) -447.0, 447.2, 747.64, 785.4, and 996.1

For MRA of Abdomen (HCPCS C8900, C8901 and C8902) - 223.0, 250.70 - 250.73, 401.0, 401.1, 401.9, 402.00, 402.01, 402.10, 402.11, 402.90, 402.91, 403.00, 403.01, 403.10, 403.11, 403.90, 403.91, 404.00 - 404.03, 404.10 - 404.13, 404.90 - 404.93, 405.09, 405.19, 405.99, 440.21 - 440.24, 440.30 - 440.32, 442.3, 442.84, 443.1, 443.81, 443.9, 444.0, 444.22, 444.81, 445.02, 447.0 - 447.2, 447.5, 447.8, 587, 593.81, 902.0, 902.10, 902.11, 902.19, 902.20 - 902.27, 902.29, 902.31 - 902.34, 902.39, 902.40 - 902.42, 902.49, 902.50 - 902.56, 902.59, 902.81, 902.82, 902.87, 902.89, 902.9, 904.0 - 904.3, 904.40 - 904.42, 904.51 - 904.54, 904.6 - 904.9, V42.0

For MRA of the Pelvis (HCPCS C8918, C8919 and C8920) - 250.70 - 250.73, 440.21 - 440.24, 440.30 - 440.32, 441.4, 442.3, 442.84, 443.1, 443.81, 443.9, 444.0, 444.22, 445.02, 447.0 - 447.2, 447.5, 447.6, 447.8, 625.9, 789.00, 902.0, 902.10, 902.11, 902.19, 902.20 - 902.27, 902.29, 902.31 - 902.34, 902.39, 902.40 - 902.42, 902.49, 902.50 - 902.56, 902.59, 902.81, 902.82, 902.87, 902.89, 902.9, 904.0 - 904.3, 904.40 - 904.42, 904.51 - 904.54, 904.6 - 904.9, V42.0

Article Revisions:
Under the “Coding Guidelines” section, added number 13:

13. MRA coverage has been expanded to include imaging the renal arteries and the aortoiliac arteries (including any vessel coming off of the aorta or iliac arteries) in the absence of AAA (abdominal aortic aneurysm) or aortic. The following ICD-9-CM codes have been added to the policy for this indication and are effective for services performed on or after July 1, 2003:

For MRA of Lower Extremities (HCPCS C8912, C8913 and C8914) -447.0, 447.2, 747.64, 785.4, and 996.1

For MRA of Abdomen (HCPCS C8900, C8901 and C8902) -223.0, 250.70 - 250.73, 401.0, 401.1, 401.9, 402.00, 402.01, 402.10, 402.11, 402.90, 402.91, 403.00, 403.01, 403.10, 403.11, 403.90, 403.91, 404.00 - 404.03, 404.10 - 404.13, 404.90 - 404.93, 405.09, 405.19, 405.99, 440.21 - 440.24, 440.30 - 440.32, 442.3, 442.84, 443.1, 443.81, 443.9, 444.0, 444.22, 444.81, 445.02, 447.0 - 447.2, 447.5, 447.8, 587, 593.81, 902.0, 902.10, 902.11, 902.19, 902.20 - 902.27, 902.29, 902.31 - 902.34, 902.39, 902.40 - 902.42, 902.49, 902.50 - 902.56, 902.59, 902.81, 902.82, 902.87, 902.89, 902.9, 904.0 - 904.3, 904.40 - 904.42, 904.51 - 904.54, 904.6 - 904.9, V42.0

For MRA of the Pelvis (HCPCS C8918, C8919 and C8920) - 250.70 - 250.73, 440.21 - 440.24, 440.30 - 440.32, 441.4, 442.3, 442.84, 443.1, 443.81, 443.9, 444.0, 444.22, 445.02, 447.0 - 447.2, 447.5, 447.6, 447.8, 625.9, 789.00, 902.0, 902.10, 902.11, 902.19, 902.20 - 902.27, 902.29, 902.31 - 902.34, 902.39, 902.40 - 902.42, 902.49, 902.50 - 902.56, 902.59, 902.81, 902.82, 902.87, 902.89, 902.9, 904.0 - 904.3, 904.40 - 904.42, 904.51 - 904.54, 904.6 - 904.9, V42.0

Zoledronic Acid - L690
LCD Revisions:
Under the “ICD-9-CM Codes That Support Medical Necessity” section, to coordinate with Empire Part B, moved the codes 733.00 - 733.09 from number 4 and added them to number 5, under the section for primary codes.

Article Revisions:
Under the “Coding Guidelines” section, updated number 4 from:

4. The ICD-9-CM codes 733.00 - 733.09 are effective for services performed on or after June 1, 2005.

To show the following:

4. The ICD-9-CM codes 733.00 - 733.09 are effective for services performed on or after July 1, 2004 for osteoporosis as a consequence of the endocrine treatment of malignancy and July 1, 2005 for osteoporosis where the patient is unable to take oral biphosphonates.