Medicare Part B local coverage determination (LCD) comment summary

LCD Number

95921

Contractor Name

First Coast Service Options, Inc.

Contractor Number

09102 - Florida
09202 - Puerto Rico
09302 - U.S. Virgin Islands

Contractor Type

MAC Part B

LCD Title

Autonomic Function Tests

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

Start Date of Comment Period:

09/30/2010

End Date of Comment Period:

11/13/2010

Comments received:

Comment #1:    A comment was received that the second paragraph under the “Indications and Limitations of Coverage and/or Medical Necessity” of the LCD regarding drugs having substantial effects on the results of ANS testing and are a common cause of falsely abnormal results is not accurate for devices employing time-frequency analysis of respiratory activity with concurrent time-frequency analysis of heart rate variability (HRV). A recommendation was made to change language to read as follows (shown in bold) under this section of the LCD:

·         Drugs can have substantial effects on the results of ANS testing performed using HRV-alone devices and beat-to-beat blood pressure devices and are a common cause of falsely abnormal results with such devices. For tests performed using such devices, patients should refrain from caffeine, nicotine, and alcohol at least 3 hours prior to testing, and all medications with adrenergic and anticholinergic properties need to be discontinued at least 48 hours prior to the study.  These would include but are not limited to the following drugs: chlorpromazine, thioridazine, the tricyclic and tetracyclic antidepressants, bupropion, mirtazapine, venlafaxine, clonidine, alpha-blockers, betablockers, calcium channel blockers, opiates, topical capsaicin, diphenhydramine, selective serotonin and selective norephinephrine reuptake inhibitors, angiotensin and rennin antagonists, beta-2 agonists, and 4 alpha 1 agonists.

The foregoing warnings about drug influence upon Autonomic Function Testing do not apply to parasympathetic and sympathetic monitoring. Patients should not skip regular medications unless explicitly recommended by his/her physician. (They should refrain from use of caffeine and eating for one to two hours before the test).  Parasympathetic and sympathetic monitoring can help to document patient responses to medications with adrenergic and anti-chlinergic properties, and thereby assist in titrating treatment to optimize results.  Documentation should note all medications prescribed to and/or taken by the patient.

Contractor response:   The researched literature performed while developing this LCD supports the current language in this section of the LCD.  Therefore, FCSO will not incorporate the above recommended language to the LCD.

 

Comment #2:   A comment was received to change the second bullet point under the “Indications and Limitations of Coverage and/or Medical Necessity” section to read “or” instead of “and” when mentioning beat-to-beat blood pressure, R-R interval response and sustained hand grip.  With this suggestive change, the section of this bullet would read as follows:

·         The following tests are included: beat-to-beat blood pressure or R-R interval response to Valsalva maneuver or sustained hand grip, and blood pressure and heart rate responses to tilt-up or active standing.

Contractor response:    This bullet is describing CPT code 95922 and the descriptor in the 2011 CPT book reads as follows: “Testing of autonomic nervous system function; vasomotor adrenergic innervations (sympathetic adrenergic function), including beat-to-beat blood pressure and  R-R interval changes during Valsalva maneuver and at least 5 minutes of passive tilt.”  Based on this description, “or” would not be correct to use in this bullet.

 

Comment #3:    A comment was received to add a fourth bullet to the three bullets grouping three general categories listed under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD.  The fourth bullet would recognize parasympathetic and sympathetic monitoring as a separate category and would read as follows:

·         Parasympathetic and sympathetic monitoring (usually indicated by CPT codes 95921 and 95922 respectively) – methods that include time-frequency analyses of the two independent and simultaneous measures, respiratory activity and HRV are known as parasympathetic and sympathetic monitoring.  This method measures the parasympathetic and sympathetic branches independently and simultaneously.  It thus enables documentation of individual patient responses to diseases (acquired of congenital), lifestyle, injury and therapy, both in the advanced stages of disease as well as before disease states become advanced when intervention may reduce morbidity and mortality risk.  The test results are used to determine appropriated therapy given patient responses.  Parasympathetic and sympathetic monitoring should be distinguished from HRV-alone and beat-to-beat blood pressure tests, which do not include the measure of, and time-frequency analysis of, continuous, real-time, respiratory activity.

 

Contractor response:    This LCD was developed to give guidelines for reasonable and necessary testing. The first step in any diagnostic evaluation is the history and physical examination. When testing is medically necessary, the outcome of the test must be used in the medical management of the patient.  To focus on continuous monitoring with AFT is not the intent of this LCD.  Therefore, the suggested verbiage for a 4th bullet in this section of the LCD is not considered necessary and in keeping with the purpose of the LCD.

 

Comment #4:   A comment was received to change the first paragraph under the “Indications” section to add the following language shown in bold:

·         With methods solely based on HRV and/or beat-to-beat BP, appropriate application and interpretation of ANS testing requires a detailed knowledge of the testing criterion and a match between the tests of suspected clinical/functional impairment with the autonomic activity being tested.

·         With parasympathetic and sympathetic monitoring, quantitative measures of parasympathetic and sympathetic function are documented, both in response to rest and challenges, including paced breathing, and Valsalva and postural change.  Parasympathetic and sympathetic monitoring thus enable detection of autonomic dysfunction as well as autonomic neuropathy, whether congenital or acquired, or primary or secondary.

Contractor response:    All ANS testing requires a detailed knowledge of testing.  Language regarding ANS testing must meet the description of the AFT CPT codes. See comment response # 3 above regarding the issue of monitoring.

 

Comment #5:    A comment was received stating the second paragraph under the “Indications” section of the LCD does not adequately address recognized indications for parasympathetic and sympathetic monitoring.  The following additional language is suggested for the first sentence in this section and recommended addition of paragraph at the end of this section (shown in bold):

·         Autonomic function testing (i.e., methods solely based on HRV and/or beat-to-beat blood pressure) is covered by FCSO Medicare as reasonable and necessary when…..

·         In addition to the foregoing, coverage is also provided for parasympathetic and sympathetic monitoring (but no other types of ANS testing) to assess the progression of autonomic dysfunction, including autonomic neuropathy, in patients that present with primary autonomic failure or chronic disease, for the purposes of documenting patient response to disease or injury, documenting morbidity or mortality risk, or titrating therapy to reduce morbidity or mortality risk resulting from parasympathetic or sympathetic imbalance.

Contractor response:     Refer to comment responses # 3 & 4 above.

Comment #6:      A comment was received stating some of the limitations are not appropriate for parasympathetic and sympathetic monitoring.  The following additional verbiage was suggested to add to the first paragraph in this section:

·         With respect to parasympathetic and sympathetic monitoring, independent and simultaneous measures of parasympathetic and sympathetic activity excludes and confirms autonomic disorders, and also documents morbidity and mortality risk and enables titration of therapy to restore parasympathetic and sympathetic balance so as to slow the progression of autonomic dysfunction and reduce mortality and morbidity risk.

Contractor response:    As stated in comment response # 3 above, continuous monitoring with AFT is not the intent of this LCD.  Therefore, the suggested verbiage in this section of the LCD is not considered necessary and in keeping with the purpose of the LCD.

 

Comment #7:      The following comments (in bold) were made regarding the four bullets under the “Limitations” section that are not considered medically reasonable and necessary by FCSO Medicare and will not be covered:

·         To screen patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease;

o    Comment: We agree screening without signs or symptoms is not appropriate.  However, the literature is replete with evidence that autonomic dysfunction is associated with diabetes as well as hepatic and renal diseases. Thus, monitoring parasympathetic and sympathetic function for patients who are diagnosed with these chronic conditions is not “screening,” but part of the proactive treatment of the chronic condition by assessing and monitoring a related condition.

·         Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease;

o    Comment:  We agree that ANS monitoring, including parasympathetic and sympathetic monitoring, should not be used for the sole purpose of monitoring disease intensity or treatment efficacy, however, parasympathetic and sympathetic monitoring does document patient response to disease and treatment for the purposes of titrating therapy to establish and maintain parasympathetic and sympathetic balance to minimize morbidity and mortality risk, reduce medication-load and hospitalizations, reduce health care costs while improving patient outcomes. Thus, we recommend this point be clarified to reflect that coverage is appropriate when parasympathetic and sympathetic monitoring is used clinically to determine the course of treatment (either by adjusting some component or by concluding no adjustment is necessary).

·         Testing where the results are not used in clinical decision-making and patient management;

o    Comment:  As reflected in our response to the last bullet point, we agree that parasympathetic and sympathetic monitoring should not be covered where the results are not used in clinical decision-making and patient management.

·        Testing performed by physicians who do not have evidence of training, and expertise to perform and interpret these tests. (Physicians must have knowledge, training, and expertise to perform and interpret these tests, and to assess and train personnel working with them.  This training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as category I credit.)

o    Comment:  We agree that autonomic testing (i.e., methods solely based on HRV and/or beat-to-beat blood pressure) requires training and expertise to perform and interpret, due to the need to understand the specific effects of the assumptions and approximations that must be made to assess the data.  For those early generation tests, the data are mixtures of parasympathetic and sympathetic activity.  However, quite the opposite is true for parasympathetic and sympathetic monitoring.  With independent, simultaneous measures of parasympathetic and sympathetic activity, the fundamental physiology is elucidated.  The associations between parasympathetic and sympathetic imbalances and anti-cholinergic and adrenergic treatments are simple to assess and are within the physician’s expertise to perform and interpret.

Contractor response:    All the comments mentioned in # 7 above are related to monitoring.  Please refer to comment response # 3 above.

 

Comment #8:  A recommendation was received to expand the ICD-9-CM codes to include the following codes and/or ranges because all of these diseases are well known to involve sympathetic or parasympathetic excess, either as the primary autonomic disorder or as the secondary disorder:

246.9 – Unspecified disorder of the thyroid

250.0 – 250.9 – Diabetes mellitus

311 – Depressive disorder, not elsewhere classified

332.0 – Paralysis agitans

337.2 – Reflex sympathetic dystrophy

401.0 – 405.99 -  Hypertensive disease

425.4  - Other primary cardiomyopathies

427.9 – Cardiac dysrhythmia, unspecified

428.0 – Congestive heart failure, unspecified

493.2 – Chronic obstructive asthma

780.2 – 780.8 - Symptoms

         

Contractor response:    Diagnosis code range 337.20 – 337.29 is included in the “ICD-9 Codes that Support Medical Necessary” section of the LCD.  Therefore, reflex sympathetic dystrophy is a covered diagnosis when medical necessity is met based on the criteria in the LCD.  In keeping in line with at least one private insurer and one Medicare contractor, as well as other researched literature, the ICD-9-CM codes currently listed in the LCD are appropriate.

Comment #9:  A comment was received that under the second paragraph of the “Documentation Requirements” section of the LCD, language should be revised to reflect “parasympathetic and sympathetic monitoring may be used for more than confirmation of ANS” after more common causes of autonomic signs or symptoms have been excluded.

Contractor response:    See comment response # 3 above.

 

Comment #10:  A comment was made that under the third paragraph of the “Documentation Requirements” section of the LCD, physicians who perform ANS testing are required to have specialized expertise and training.  While this is appropriate for early generation ANS testing, it is not appropriated for parasympathetic and sympathetic monitoring. These results come with no additional formal training, because the fundamental physiology underlying patient response to diseases and therapy are elucidated quantitatively and reliably.

Contractor response:    The focus of this LCD is not on AFT monitoring and FCSO feels any physician performing this type of testing should have detailed knowledge of the testing and meet training requirements as outlined in the LCD.

 

Comment #11:   A comment was received stating the utilization limitation in the LCD is not appropriate for parasympathetic and sympathetic monitoring.  Repeat testing would be governed by a change in clinical status or response to a therapeutic intervention. It is recommended that when initial testing confirms chronic disease or autonomic symptoms, parasympathetic and sympathetic monitoring should be covered at least once every six months, but no more than once every three months, based on documented intervention.

Contractor response:    Repeat testing is not warranted for every patient.  If the sole purpose of the testing is for monitoring a disease regardless of new symptoms, and /or when the testing is not used in the management of the patient, FCSO does not feel it would be reasonable and necessary to perform ANS testing.

 

Comment #12:    Multiple comments were received supporting the use of ANS testing with the ANSAR system as a valuable tool for treating patients with diverse medical conditions.  It was mentioned that this testing is easy to use and does not require extensive training.

Contractor response:    FCSO is happy to hear ANS testing has been a beneficial tool for treating physicians.  The goal of this LCD is to give coverage guidelines to help utilize this service as reasonable and necessary and to restrict potential abuse of services that are not medically necessary.