Persius/hicric huggingface dataset:
Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
 **History/Background and/or General Information**  
  
Trigger point injection is one of many modalities utilized in the management
of chronic pain. Myofascial trigger points are self-sustaining hyperirritative
foci that may occur in any skeletal muscle in response to strain produced by
acute or chronic overload. These trigger points produce a referred pain
pattern characteristic for that individual muscle. Each pattern becomes part
of a single muscle myofascial pain syndrome (MPS) and each of these single
muscle syndromes are responsive to appropriate treatment, which includes
injection therapy. An injection is achieved with the insertion of a needle and
the administration of agents, such as local anesthetics, steroids and/or local
anti-inflammatory drugs.  
  
The diagnosis of trigger points requires a detailed history and thorough
physical examination. The following clinical symptoms may be present when
making the diagnosis:

  * History of onset of the painful condition and its presumed cause (e.g., injury or sprain)
  * Distribution pattern of pain consistent with the referral pattern of trigger points
  * Range of motion restriction
  * Muscular deconditioning in the affected area
  * Focal tenderness of a trigger point
  * Palpable taut band of muscle in which trigger point is located
  * Local taut response to snapping palpation
  * Reproduction of referred pain pattern upon stimulation of trigger point

The goal is to treat the cause of the pain and not just the symptom of pain.  
  
**Covered Indications**

After myofascial pain syndrome (MPS) is established, trigger point injection
may be considered medically reasonable and necessary:

  1. When noninvasive medical management is unsuccessful (e.g., analgesics, passive physical therapy, ultrasound, range of motion and active exercises).
  2. As a bridging therapy to relieve pain while other treatments are also initiated, such as medication or physical therapy; or as a single therapeutic maneuver. The logic behind such therapeutic decision making should be obvious in the medical record and available upon Contractor request.
  3. When joint movement is mechanically blocked as is the case of the coccygeus muscle.

  
**  Limitations  
**

The following are considered not medically reasonable and necessary:

  1. Medicare does not cover Prolotherapy. Its billing under the trigger point injection code is a misrepresentation of the actual service rendered.
  2. When a given site is injected, it will be considered one injection service, regardless of the number of injections administered.

  
For frequency limitations, please refer to the Utilization Guidelines section
below.  
  
 **Notice** : Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.
Nerve blocks cause the temporary interruption of conduction of impulses in
peripheral nerves or nerve trunks by the injection of local anesthetic
agent(s) and/or steroid.

The use of nerve blocks or injections for the treatment of multiple
neuropathies or peripheral neuropathies caused by underlying systemic diseases
is not considered medically necessary. Medical management using systemic
medications is clinically indicated for the treatment of these conditions.

**Limitations**

The use of nerve blocks with or without the use of electrostimulation, and the
use of electrostimulation alone for the treatment of multiple neuropathies or
peripheral neuropathies caused by underlying systemic diseases is not
considered medically reasonable and necessary.

At present, the literature and scientific evidence supporting the use of
peripheral nerve blocks with or without the use of
electrostimulation/electromagnetic stimulation, and the use of
electrostimulation/ electromagnetic stimulation alone for neuropathies or
peripheral neuropathies caused by underlying systemic diseases, is
insufficient to warrant coverage. These procedures are considered
investigational and are not eligible for coverage for the treatment of
neuropathies or peripheral neuropathies caused by underlying systemic
diseases.

The use of ultrasound guidance in conjunction with these non -covered
injections is also considered not medically necessary and will result in
denial.
Nerve blocks cause the temporary interruption of conduction of impulses in
peripheral nerves or nerve trunks by the injection of local anesthetic
solutions.  
  
The use of nerve blocks or injections for the treatment of multiple
neuropathies or peripheral neuropathies caused by underlying systemic diseases
is not considered medically necessary. Medical management using systemic
medications is clinically indicated for the treatment of these conditions.  
  
 **Limitations**  
  
The use of nerve blocks with or without the use of electrostimulation, and the
use of electrostimulation alone for the treatment of multiple neuropathies or
peripheral neuropathies caused by underlying systemic diseases is not
considered medically reasonable and necessary. Medical management using
systemic medications is clinically indicated for the treatment of these
conditions.  
  
At present, the literature and scientific evidence supporting the use of
peripheral nerve blocks with or without the use of
electrostimulation/electromagnetic stimulation, and the use of
electrostimulation/ electromagnetic stimulation alone for neuropathies or
peripheral neuropathies caused by underlying systemic diseases, is
insufficient to warrant coverage. These procedures are considered
investigational and are not eligible for coverage for the treatment of
neuropathies or peripheral neuropathies caused by underlying systemic
diseases.  
  
The use of ultrasound guidance in conjunction with these non -covered
injections is also considered not medically necessary and will result in
denial.
**Abstract:**  
B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in
the left ventricle. It is secreted in response to ventricular volume expansion
and pressure overload, conditions often present in congestive heart failure
(CHF). Used in conjunction with other clinical information, measurement of BNP
levels _(either total or N-terminal)_ is useful in rapidly establishing or
excluding the diagnosis or worsening of CHF in patients with acute
exacerbation of dyspnea. Also, BNP levels determined in the first few days
after an acute coronary syndrome or event (ACS) may be useful in the
prediction of longer-term cardiovascular risk but this risk assessment does
not change the management of ACS and is non-covered by regulation.  
  
**Indications:**  
BNP measurements may be considered reasonable and necessary when used in
combination with other medical data such as medical history, physical
examination, laboratory studies, and chest x-ray.

    * to diagnose or to differentiate heart failure from other potential clinical conditions **if** the patient's signs and/or symptoms are consistent with both heart failure and one or more other conditions, e.g., acute dyspnea in a patient with known or suspected pulmonary disease.

    * to diagnose or differentiate worsening heart failure if use of the test replaces other diagnostic tests, such as chest film; and/or to confirm the diagnosis when other diagnostic tests are equivocal.

**Limitations:**

    * BNP measurements must be assessed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not been established yet.

    * BNP measurements for monitoring and management of CHF are non-covered. Treatment guided by BNP has not been shown to be superior to symptom-guided treatment in either clinical or quality-of-life outcomes.

    * The efficacy but not the utility of BNP as a risk stratification tool (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina) has been established. However, the assessment of BNP level has not been shown to alter patient management. The BNP is not sufficiently sensitive to either preclude or necessitate any other evaluation or treatment in this group of patients.

    * Screening examinations are statutorily non-covered.
The sacroiliac (SI) joints are formed by the connection of the sacrum and the
right and left iliac bones. The sacrum is the triangular-shaped bone in the
lower portion of the spine, below the lumbar spine. While most of the bones
(vertebrae) of the spine are mobile, the sacrum is made up of five vertebrae
that are fused together and do not move. The iliac bones are the two large
bones that make up the pelvis. As a result, the SI joints connect the spine to
the pelvis. The sacrum and the iliac bones (ileum) are held together by a
collection of strong ligaments. There is relatively little motion at the SI
joints. There are normally less than 4 degrees of rotation and 2 mm of
translation at these joints.  
  
 **Indications**  
Percutaneous minimally invasive fusion/stabilization of the sacroiliac joint
(SIJ) for the treatment of back pain is indicated for the treatment of SIJ
pain for patients with low back/buttock pain who meet all of the following
criteria:

a) Have undergone and failed a minimum six months of intensive non-operative
treatment that must include medication optimization, activity modification,
and active physical therapy;

b) Patient's report of non-radiating, unilateral pain that is caudal to the
lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent
with SIJ pain;

c) Localized tenderness with palpation of the posterior SIJ in the absence of
tenderness of similar severity elsewhere (e.g. greater trochanter, lumbar
spine, coccyx) and other obvious sources for their pain do not exist;

d) Positive response to the thigh thrust test OR compression test AND 2 of the
following additional provocative tests: Gaenslen's test, Distraction test,
Patrick's sign;

e) Absence of generalized pain behavior (e.g. somatoform disorder) or
generalized pain disorders (e.g. fibromyalgia);

f) Diagnostic imaging studies that include ALL of the following:

1\. Imaging (plain radiographs and a CT or MRI) of the SI joint that excludes
the presence of destructive lesions (e.g. tumor, infection) or inflammatory
arthropathy that would not be properly addressed by percutaneous SIJ fusion;

2\. Imaging of the ipsilateral hip (plain radiographs) to rule out
osteoarthritis;

3\. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or
other degenerative condition that can be causing low back or buttock pain;

g) At least 75 percent reduction of pain for the expected duration of the
anesthetic used following an image-guided, contrast-enhanced SIJ injection on
two separate occasions.

**Limitations**  
Percutaneous SIJ fusion for SIJ pain is not indicated in the presence of:

Systemic arthropathy such as ankylosing spondylitis or rheumatoid arthritis;  
  
Generalized pain behavior (e.g. somatoform disorder) or generalized pain
disorder (e.g. fibromyalgia);  
  
Infection, tumor, or fracture;  
  
Acute, traumatic instability of the SIJ;  
  
Neural compression as seen on an MRI or CT that correlates with the patient's
symptoms or other more likely source for their pain.
Hormones, both endocrine and exocrine, are secreted into various bodily fluids
and their measurement can often diagnose diseases or be used to follow the
course of a disease. Traditionally endocrine hormones are measured in serum,
plasma, or urine. Measurements of hormones at certain times of the day, or
after various attempts at suppression or stimulation can be used for diagnoses
of endocrine diseases. Recently some labs have attempted to develop
measurement of hormones in salivary secretions. Material is collected from
saliva and sent to a lab for measurement. The convenience of collection
without need of arterial or venipuncture simplifies collection, but the
accuracy of measurement and lack of standardization makes the values
determined still investigational. Noridian Healthcare Solutions currently
considers salivary cortisol collected in the evening for diagnosis of
Cushing's syndrome as the only medically necessary and reasonable hormone
measurement from salivary fluid. All other determinations of salivary hormones
(e.g., thyroid, testosterone, estrogen, parathyroid, growth hormone, etc.) are
considered investigational.
This Medicare contractor will provide limited coverage for the EndoPredict
breast cancer gene expression test (Myriad Genetic Laboratories Inc., Salt
Lake City, UT) for the management of post-menopausal women diagnosed with
early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive,
Her2-negative breast cancer, who are either lymph node-negative or who have
1-3 positive nodes, and for whom treatment with adjuvant endocrine therapy
(e.g., tamoxifen or aromatase inhibitors) is being considered. The test is
used by physicians in the management of these patients by identifying those
who have sufficiently low risk of distant recurrence (DR) at 10 years and may
safely forego chemotherapy.

The EndoPredict assay is reasonable and necessary to assist physicians in the
management of early stage breast cancer by identifying those patients with a
sufficiently low risk of 10-year distant recurrence who may safely forgo
chemotherapy. While EndoPredict may help assess risk of late recurrence after
ET is complete, it is not clear at this time if this test is useful for
identifying which patients should receive EET.

This contractor believes the clinical utility of this test for determining
which patients would benefit from EET is not clear based on these data. This
test is indicated in node-negative and 1-3 node-positive patients. First, the
data presented in Filipits et al. for 1-3 node-positive patients was not
significant for the period studied (5-15 years), and the difference in DRFR
was 84% vs 87% between the EPclin high and low groupWhile the difference
between EPclin high and low groups are significant in node-negative patients
for the duration of the study (96% vs 85% DRFR), a subset analysis (described
above) of the best supported data (in the supplemental data, Table S5, shown
above) shows that 5-10 years after ET therapy there is little difference in
the performance of these patients; neither the EPclin high or low group would
be defined as "high risk" (>10% risk of recurrence), and the difference in
DRFR between these two groups is 97.9% vs. 94.1%. Based on this study, this
contractor does not believe there is sufficient evidence that this test can
clearly delineate patients who can benefit from EET (whose benefits are
already known to be 'modest'). Given that EET carries significant risk for
adverse events, it is not clear how much, if any, weight an oncologist should
place on EndoPredict results for determining the use of EET in patients who
have not recurred after initial ET.

The assay is covered for women with T1-3, N0-1 breast cancer when the
following criteria are met:

  * Patient is post-menopausal, and
  * Pathology (excisional or biopsy) reveals invasive carcinoma of the breast that is ER-positive, Her2-negative, and
  * Patient is either lymph node-negative or has 1-3 positive lymph nodes, and
  * Patient has no evidence of distant metastasis, and
  * Test result will be used to determine treatment choice between endocrine therapy alone vs. endocrine therapy plus chemotherapy.

  
Note: The EndoPredict test should not be ordered if a physician does not
intend to  act upon the test result.
This Medicare contractor will provide limited coverage for the EndoPredict
breast cancer gene expression test (Myriad Genetic Laboratories Inc., Salt
Lake City, UT) for the management of post-menopausal women diagnosed with
early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive,
Her2-negative breast cancer, who are either lymph node-negative or who have
1-3 positive nodes, and for whom treatment with adjuvant endocrine therapy
(e.g., tamoxifen or aromatase inhibitors) is being considered. The test is
used by physicians in the management of these patients by identifying those
who have sufficiently low risk of distant recurrence (DR) at 10 years and may
safely forego chemotherapy.

The EndoPredict assay is reasonable and necessary to assist physicians in the
management of early stage breast cancer by identifying those patients with a
sufficiently low risk of 10-year distant recurrence who may safely forgo
chemotherapy. While EndoPredict may help assess risk of late recurrence after
ET is complete, it is not clear at this time if this test is useful for
identifying which patients should receive EET.

This contractor believes the clinical utility of this test for determining
which patients would benefit from EET is not clear based on these data. This
test is indicated in node-negative and 1-3 node-positive patients. First, the
data presented in Filipits et al. for 1-3 node-positive patients was not
significant for the period studied (5-15 years), and the difference in DRFR
was 84% vs 87% between the EPclin high and low group. While the difference
between EPclin high and low groups are significant in node-negative patients
for the duration of the study (96% vs 85% DRFR), a subset analysis (described
above) of the best supported data (in the supplemental data, Table S5, shown
above) shows that 5-10 years after ET therapy there is little difference in
the performance of these patients; neither the EPclin high or low group would
be defined as "high risk" (>10% risk of recurrence), and the difference in
DRFR between these two groups is 97.9% vs. 94.1%. Based on this study, this
contractor does not believe there is sufficient evidence that this test can
clearly delineate patients who can benefit from EET (whose benefits are
already known to be 'modest'). Given that EET carries significant risk for
adverse events, it is not clear how much, if any, weight an oncologist should
place on EndoPredict results for determining the use of EET in patients who
have not recurred after initial ET.

The assay is covered for women with T1-3, N0-1 breast cancer when the
following criteria are met:

  * Patient is post-menopausal, and
  * Pathology (excisional or biopsy) reveals invasive carcinoma of the breast that is ER-positive, Her2-negative, and
  * Patient is either lymph node-negative or has 1-3 positive lymph nodes, and
  * Patient has no evidence of distant metastasis, and
  * Test result will be used to determine treatment choice between endocrine therapy alone vs. endocrine therapy plus chemotherapy.

Note: The EndoPredict test should not be ordered if a physician does not
intend to act upon the test result.
This Medicare contractor will provide limited coverage for the EndoPredict
breast cancer gene expression test (Myriad Genetic Laboratories Inc., Salt
Lake City, UT) for the management of post-menopausal women diagnosed with
early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive,
Her2-negative breast cancer, who are either lymph node-negative or who have
1-3 positive nodes, and for whom treatment with adjuvant endocrine therapy
(e.g., tamoxifen or aromatase inhibitors) is being considered. The test is
used by physicians in the management of these patients by identifying those
who have sufficiently low risk of distant recurrence (DR) at 10 years and may
safely forego chemotherapy.

The EndoPredict assay is reasonable and necessary to assist physicians in the
management of early stage breast cancer by identifying those patients with a
sufficiently low risk of 10-year distant recurrence who may safely forgo
chemotherapy. While EndoPredict may help assess risk of late recurrence after
ET is complete, it is not clear at this time if this test is useful for
identifying which patients should receive EET.

This contractor believes the clinical utility of this test for determining
which patients would benefit from EET is not clear based on these data. This
test is indicated in node-negative and 1-3 node-positive patients. First, the
data presented in Filipits et al. for 1-3 node-positive patients was not
significant for the period studied (5-15 years), and the difference in DRFR
was 84% vs 87% between the EPclin high and low groupWhile the difference
between EPclin high and low groups are significant in node-negative patients
for the duration of the study (96% vs 85% DRFR), a subset analysis (described
above) of the best supported data (in the supplemental data, Table S5, shown
above) shows that 5-10 years after ET therapy there is little difference in
the performance of these patients; neither the EPclin high or low group would
be defined as "high risk" (>10% risk of recurrence), and the difference in
DRFR between these two groups is 97.9% vs. 94.1%. Based on this study, this
contractor does not believe there is sufficient evidence that this test can
clearly delineate patients who can benefit from EET (whose benefits are
already known to be 'modest'). Given that EET carries significant risk for
adverse events, it is not clear how much, if any, weight an oncologist should
place on EndoPredict results for determining the use of EET in patients who
have not recurred after initial ET.

The assay is covered for women with T1-3, N0-1 breast cancer when the
following criteria are met:

  * Patient is post-menopausal, and
  * Pathology (excisional or biopsy) reveals invasive carcinoma of the breast that is ER-positive, Her2-negative, and
  * Patient is either lymph node-negative or has 1-3 positive lymph nodes, and
  * Patient has no evidence of distant metastasis, and
  * Test result will be used to determine treatment choice between endocrine therapy alone vs. endocrine therapy plus chemotherapy.

  
Note: The EndoPredict test should not be ordered if a physician does not
intend to act upon the test result.
**Indications**  
  
An active trigger point has pain at rest, has pain on palpitation, has
radiation of pain, and has a local twitch response. Trigger point injections
are indicated in symptomatic trigger points. The history of onset of the
painful condition and its presumed cause, location, duration, failed therapies
and recommendations for injection therapy of each clearly delineated muscle
must be in the patient's chart and made available to Medicare upon request.
The goal is to treat the cause of the pain and not just the symptom of pain.  
  
 **Limitations**

  1. Trigger point injections accompanied by appropriate adjunctive care should provide moderate-to-long term benefits. There is no peer-reviewed literature to substantiate more than four trigger point injections in a year.
  2. Prolotherapy is not covered by Medicare. If prolotherapy is billed using trigger point therapy codes it will be considered not reasonable and necessary.
**Indications**

 Pelvic pain undiagnosed by standard exam:

  1. Dysmenorrhea
  2. Menorrhagia
  3. Metrorrhagia
  4. Menometrorrhagia
  5. Postmenopausal bleeding
  6. Abnormal pelvic examination
  7. Further evaluation of abnormality found on other imaging studies
  8. Cancer

**Limitations  **

The accuracy of ultrasonographic studies depends on the knowledge, skills and
experience of the technologist and interpreter. Consequently, the providers of
interpretations must be capable of demonstrating documented training and
experience and maintain documentation of such for possible audit. Further,
ultrasonographic studies must be either (1) performed by persons with
appropriate training that have demonstrated minimum entry level competency by
being credentialed by a nationally recognized credentialing organization in
ultrasound technology (e.g., American Registry of Radiologic Technologists
(ARRT) in sonography), (2) performed by or under the direct supervision of a
physician, or (3) performed in facilities with laboratories accredited in
ultrasonography.