Persius/hicric huggingface dataset:
**Background**  
  
Nerve blocks, injections of local anesthetic solutions, cause the temporary
interruption of conduction of impulses in peripheral nerves or nerve trunks.  
  
There are also early studies using electrostimulation with or without nerve
blocks for treatment of multiple neuropathies or peripheral neuropathies
caused by underlying systemic diseases.  
  
 **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, and the
use of electrostimulation 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.
Neodymium-doped Yttrium Aluminum Garnet (YAG) laser capsulotomies are
performed in cases of opacification of the posterior capsule, generally no
less than 90 days following cataract extraction. YAG performed less than 90
days following cataract extraction should meet both the indications and
limitations of this Local Coverage Determination (LCD). The percentage of
patients having this procedure varies greatly among ophthalmologists.
Diagnosis of functional visual impairment due to capsular opacification is
based on clinical judgment regarding 1 or more of the following:

  1. Visual loss and/or symptom of glare (visual acuity 20/30 or worse under Snellen conditions, using contrast sensitivity, or simulated glare testing);
  2. Symptoms of decreased contrast;
  3. Amount of posterior capsular opacification or;
  4. Other possible causes of decreased vision following cataract surgery.

**Limitations**  
  
This procedure will not be covered within 3 months post cataract surgery
unless justified by 1 of the following indications:

  1. Posterior capsular plaque/opacity which cannot be safely removed during primary phacoemulsification cataract procedure
  2. Capsular block during which cataract remnants and fluid become trapped within the lens capsule and addressed with YAG laser posterior capsulotomy
  3. Contraction of the posterior capsule with displacement of the intraocular lens.
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% DFDR) between the EPclin high and low group. While the
difference between the EPclin high and low group are significant in node-
negative patients for the duration of the study (96% vs 85% DFDR), a subset
analysis (described above) of the best supported data (in the supplemental
data, Table S5, shown below) 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 DFDR 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 test is a "liquid biopsy". It is intended to assist physicians caring for
patients who suffer from a common form of lung cancer and who have advanced
disease.

This policy provides limited coverage for InvisionFirst \- Lung (InivataTM,
Research Triangle Park, NC) (hereafter InVision) a plasma-based, somatic
comprehensive genomic profiling (CGP) test for patients with advanced (Stage
IIIB/IV) non-small cell lung cancer (NSCLC):

  * **At diagnosis**
    * When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available **AND** when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated],

**or**

  * **At progression**
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; **or**
    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

Level of Evidence:

Quality - Moderate  
Strength -Limited  
Weight - Limited

The InVision assay provides a minimally invasive methodology to detect
actionable mutations with an informative test rate of 50-70% for providing
valuable guidance for patient genomic profile stratification. Clinical utility
has been demonstrated equivalent to tissue-based profiling outcomes. Patients
are limited to 1 test assay per cancer diagnosis, unless there is clinical
evidence of tumor evolution requiring additional testing for new genetic
content.
This test is a "liquid biopsy". It is intended to assist physicians caring for
patients who suffer from a common form of lung cancer and who have advanced
disease.

This policy provides limited coverage for InvisionFirst \- Lung (InivataTM,
Research Triangle Park, NC) (hereafter InVision) a plasma-based, somatic
comprehensive genomic profiling (CGP) test for patients with advanced (Stage
IIIB/IV) non-small cell lung cancer (NSCLC):

  * **At diagnosis**
    * When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available **AND** when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated],

**or**

  * **At progression**
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; **or**
    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

**or**

  * **At progression**
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAF, and for whom tissue-based CGP is infeasible;
    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

Level of Evidence:

Quality - Moderate  
Strength - Limited  
Weight - Limited

The InVision assay provides a minimally invasive methodology to detect
actionable mutations with an informative test rate of 50-70% for providing
valuable guidance for patient genomic profile stratification.  Clinical
utility has been demonstrated equivalent to tissue-based profiling outcomes.
Patients are limited to 1 test assay per primary diagnosis.
This test is a "liquid biopsy". It is intended to assist physicians caring for
patients who suffer from a common form of lung cancer and who have advanced
disease.

This policy provides limited coverage for InvisionFirst \- Lung (InivataTM,
Research Triangle Park, NC) (hereafter InVision) a plasma-based, somatic
comprehensive genomic profiling (CGP) test for patients with advanced (Stage
IIIB/IV) non-small cell lung cancer (NSCLC):

  * **At diagnosis**
    * When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available **AND** when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated],

**or**

  * **At progression**
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; **or**
    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

Level of Evidence:

Quality - Moderate  
Strength - Limited  
Weight - Limited

The InVision assay provides a minimally invasive methodology to detect
actionable mutations with an informative test rate of 50-70% for providing
valuable guidance for patient genomic profile stratification.  Clinical
utility has been demonstrated equivalent to tissue-based profiling outcomes.
Patients are limited to 1 test assay per primary diagnosis.
This test is a "liquid biopsy". It is intended to assist physicians caring for
patients who suffer from a common form of lung cancer and who have advanced
disease.

This policy provides limited coverage for InvisionFirst \- Lung (InivataTM,
Research Triangle Park, NC) (hereafter InVision) a plasma-based, somatic
comprehensive genomic profiling (CGP) test for patients with advanced (Stage
IIIB/IV) non-small cell lung cancer (NSCLC):

  * **At diagnosis**
    * When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available **AND** when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated],

**or**

  * **At progression**
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; **or**
    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

Level of Evidence:

Quality - Moderate  
Strength -Limited  
Weight - Limited

The InVision assay provides a minimally invasive methodology to detect
actionable mutations with an informative test rate of 50-70% for providing
valuable guidance for patient genomic profile stratification. Clinical utility
has been demonstrated equivalent to tissue-based profiling outcomes. Patients
are limited to 1test assay per cancer diagnosis, unless there is clinical
evidence of tumor evolution requiring additional testing for new genetic
content.
This test is a "liquid biopsy". It is intended to assist physicians caring for
patients who suffer from a common form of lung cancer and who have advanced
disease.

This policy provides limited coverage for InvisionFirst \- Lung (InivataTM,
Research Triangle Park, NC) (hereafter InVision) a plasma-based, somatic
comprehensive genomic profiling (CGP) test for patients with advanced (Stage
IIIB/IV) non-small cell lung cancer (NSCLC)

  * **At diagnosis** -
    * When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available AND when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated], 

**or**

  * **At progression** -
    * For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; 

**or**

    * For patients progressing on EGFR tyrosine kinase inhibitors (TKIs),

If no genetic alteration is detected by InVision or if circulating tumor DNA
(ctDNA) is insufficient/not detected, tissue-based genotyping should be
considered.

Level of Evidence:  
Quality - Moderate  
Strength -Limited  
Weight - Limited

The InVision assay provides a minimally invasive methodology to detect
actionable mutations with an informative test rate of 50-70% for providing
valuable guidance for patient genomic profile stratification. Clinical utility
has been demonstrated equivalent to tissue-based profiling outcomes. Patients
are limited to 1 test assay per cancer diagnosis, unless there is clinical
evidence of tumor evolution requiring additional testing for new genetic
content.