Persius/hicric huggingface dataset:
Response to Comments: Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

The proposed policy Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound was presented at the
Open Meeting on July 13, 2023. The 45-day comment period began on 6/22/2023
and ended on 8/05/2023. This article is the response to comments received by
participating Medicare Administrative Contractors (MACs).
Response to Comments: Surgical Treatment of Nails

The comment period for the Surgical Treatment of Nails DL39258 Local Coverage
Determination (LCD) began on 08/31/23 and ended on 10/14/23. The notice period
for L39258 begins on 12/7/23 and will become effective on 1/21/24.

The comments below were received from the provider community.
Response to Comments: Urine Drug Testing

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from members of the public who may be affected by or interested
in our LCDs. The purpose of the advice and comment process is to gain the
expertise and experience of those commenting.

We would like to thank those who suggested changes to the Urine Drug Testing
LCD. The official notice period for the final LCD begins on November 9, 2023,
and the final determination will become effective on December 24, 2023.
Billing and Coding: Magnetic Resonance Image Guided High Intensity Focused
Ultrasound (MRgFUS) for Essential Tremor

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Magnetic Resonance
Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor
DL37761.
Response to Comments: Transurethral Waterjet Ablation of the Prostate

The proposed policy Transurethral Waterjet Ablation of the Prostate (JE-
DL38705) was presented at the Open Meeting on July 13, 2023. The 45-day
comment period began on 6/15/2023 and ended on 7/29/2023. This article is the
response to comments received by participating Medicare Administrative
Contractors (MACs).
Response to Comments: Transurethral Waterjet Ablation of the Prostate

The proposed policy Transurethral Waterjet Ablation of the Prostate (JF-
DL38707) was presented at the Open Meeting on July 13, 2023. The 45-day
comment period began on 6/15/2023 and ended on 7/29/2023. This article is the
response to comments received by participating Medicare Administrative
Contractors (MACs).
Response to Comments: Intraosseous Basivertebral Nerve Ablation

During the 45-day comment period the A/B MAC received a total of 12 comments.

The A/B MACs appreciate the comments received from stakeholders during the
open comment period on the proposed Intraosseous Basivertebral Nerve Ablation
Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

_In conducting a review, MACs shall use the available evidence of general
acceptance by the medical community, such as published original research in
peer-reviewed medical journals, systematic reviews and meta-analyses,
evidence-based consensus statements and clinical guidelines._

Accordingly, the final policy and our response to comments are based on the
best currently available published clinical evidence, in order to afford the
most optimal opportunity for success in Medicare-eligible beneficiaries with
Intraosseous Basivertebral Nerve Ablation.
Billing and Coding: Computed Tomography Cerebral Perfusion Analysis (CTP)

The information in this article contains billing, coding or other guidelines
that complements the Local Coverage Determination (LCD) for Computed
Tomography Cerebral Perfusion Analysis (CTP) DL38769.

****

**Documentation Requirements:**

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the related LCD (see
**_Coverage Indications, Limitations and/or Medical Necessity_** ). This
documentation includes, but is not limited to, relevant medical history,
physical examination, and results of pertinent diagnostic tests or procedures.
The documentation of the study requires a formal written report, with clear
identifying demographics, the name of the interpreting provider, the reason
for the tests, an interpretive report and copies of images. The computerized
image reconstruction data should also be maintained.
Response to Comments: Peripheral Venous Ultrasound

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL35451 Peripheral
Venous Ultrasound which was posted for comment on August 3, 2023 and presented
at the August 18, 2023 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Peripheral Venous Ultrasound

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL33693
Peripheral Venous Ultrasound which was posted for comment on August 3, 2023
and presented at the August 17, 2023 Open Meeting. All comments were reviewed
and incorporated into the final LCD where applicable.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The Comment period for the Implantable Continuous Glucose Monitors (I-CGM)
L38657 began on 09/21/2023 and ended on 11/04/2023. Comments were received
from the provider community,

All comments provided within the open comment period have been reviewed. Those
comments covering similar topics were collectively gathered and responded to.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The comment period for the Implantable Continuous Glucose Monitors (I-CGM)
DL38743 Local Coverage Determination (LCD) began on 10/5/23 and ended on
11/18/23. The notice period for L38743 begins on 1/11/24 and will become
effective on 2/25/24. The comments below were received from the provider
community. All comments provided within the open comment period have been
reviewed. Those comments covering similar topics were collectively gathered
and responded to.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The Comment period for the Implantable Continuous Glucose Monitors (I-CGM)
L38659 began on 09/21/2023 and ended on 11/04/2023. Comments were received
from the provider community,

All comments provided within the open comment period have been reviewed. Those
comments covering similar topics were collectively gathered and responded to.
Billing and Coding: Treatment of Abnormal Uterine Bleeding with Intrauterine
Device (Hormone-Eluting)

  
This Billing and Coding Article contains coding and other guidelines that
reflect proper billing for insertion of an Intrauterine Device (IUD) (Hormone-
Eluting) for the treatment of abnormal uterine bleeding.  
  
 **Coding Guidance  
  
** Chronic abnormal uterine bleeding (AUB) describes irregularities in the
menstrual cycle involving frequency, regularity, duration, and volume of flow
outside of pregnancy for at least six months. The following conditions causing
AUB can be treated with levonorgestrel-releasing intrauterine device (Hormone-
Eluting IUD) depending on the patient's desire for fertility, medical
comorbidities, symptoms, and distortion of the uterine cavity: Leiomyomas
(fibroids), malignancy or endometrial hyperplasia, and iatrogenic causes of
AUB.  
  
First Coast is aware that the insertion of a progestin-containing IUD is an
alternative method of managing endometrial hyperplasia for patients who wish
to preserve fertility or are not surgical candidates. First Coast has
determined that the use of a progestin-containing IUD may be approved for the
use in the Medicare beneficiary with endometrial hyperplasia without atypia.  
  
Medicare does not allow payment for contraceptive devices or medication. For
this reason, the service 58300, insertion of intrauterine device (IUD) has an
"N" status in the Medicare Physician Fee Schedule, which means the service
cannot be covered when billed to Medicare.  
  
The CPT code for IUD insertion (58300) will be auto-denied, therefore,
providers should bill this service using CPT code 58999, unlisted procedure,
female genital system (non-obstetrical), with an appropriate diagnosis for
endometrial hyperplasia. Providers must also include the product description
"hormone IUD for endometrial hyperplasia" in item 19 of the CMS-1500 form or
electronic equivalent.  
  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.  
  
 **Notice:** It is not appropriate to bill Medicare for services that are not
covered as if they are covered. When billing for non-covered services, use the
appropriate modifier.  
  
 **Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record must clearly document the specific clinical circumstances evidencing this medical necessity.
Billing and Coding: Treatment of Abnormal Uterine Bleeding with Intrauterine
Device (Hormone-Eluting)

  
This Billing and Coding Article contains coding and other guidelines that
reflect proper billing for insertion of an Intrauterine Device (IUD) (Hormone-
Eluting) for the treatment of abnormal uterine bleeding.  
  
 **Coding Guidance  
  
** Chronic abnormal uterine bleeding (AUB) describes irregularities in the
menstrual cycle involving frequency, regularity, duration, and volume of flow
outside of pregnancy for at least six months. The following conditions causing
AUB can be treated with levonorgestrel-releasing intrauterine device (Hormone-
Eluting IUD) depending on the patient's desire for fertility, medical
comorbidities, symptoms, and distortion of the uterine cavity: Leiomyomas
(fibroids), malignancy or endometrial hyperplasia, and iatrogenic causes of
AUB.  
  
Novitas is aware that the insertion of a progestin-containing IUD is an
alternative method of managing endometrial hyperplasia for patients who wish
to preserve fertility or are not surgical candidates. Novitas has determined
that the use of a progestin-containing IUD may be approved for the use in the
Medicare beneficiary with endometrial hyperplasia without atypia.  
  
Medicare does not allow payment for contraceptive devices or medication. For
this reason, the service 58300, insertion of intrauterine device (IUD) has an
"N" status in the Medicare Physician Fee Schedule, which means the service
cannot be covered when billed to Medicare.  
  
The CPT code for IUD insertion (58300) will be auto-denied, therefore,
providers should bill this service using CPT code 58999, unlisted procedure,
female genital system (non-obstetrical), with an appropriate diagnosis for
endometrial hyperplasia. Providers must also include the product description
"hormone IUD for endometrial hyperplasia" in item 19 of the CMS-1500 form or
electronic equivalent.  
  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.  
  
 **Notice:** It is not appropriate to bill Medicare for services that are not
covered as if they are covered. When billing for non-covered services, use the
appropriate modifier.  
  
 **Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record must clearly document the specific clinical circumstances evidencing this medical necessity.
Response to Comments: Cataract Extraction

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Cataract Extraction DL39716. Thank you for the comments.
Response to Comments: Bisphosphonate Drug Therapy (DL34648)

This article summarizes the comments WPS received for Draft Local Coverage
Determination (LCD) Bisphosphonate Drug Therapy (DL34648). We did not receive
any comments on this draft.
Billing and Coding: Artificial Hearts and Percutaneous Endovascular Cardiac
Assist Procedures and Devices

Effective for dates of service on/after February 3, 2014.  
  
Noridian will cover the percutaneous insertion of an endovascular cardiac
assist device itself under limited conditions. Until the literature clearly
demonstrates the efficacy of the treatment approach, coverage may be made only
in the following two life-threatening situations and only when external
counterpulsation (intraaortic balloon pump, IABP) is not expected to be
sufficient; Cardiogenic shock or Severe decompensated heart failure with
threatening multi-organ failure.  
  
This service will only be covered when the FDA approval guidelines are
strictly followed.

Due to the expansion of NCD 20.9.1-Ventricular Assist Devices (VADs) to
include left ventricular assist devices for long-term (destination therapy)
mechanical circulatory support per Change Request 12290, Noridian will cover
artificial hearts for destination therapy when **all** the criteria outlined
NCD 20.9.1 are met and the FDA approval guidelines are strictly followed
effective December 1, 2020.
**Abstract:**  
  
An electroencephalogram (EEG) is a diagnostic test that measures the
electrical activity of the brain (brainwaves) using highly sensitive recording
equipment attached to the scalp by fine electrodes. It is used to diagnose
neurological conditions.  
  
EEGs can be recorded by ambulatory cassette. Ambulatory cassette-recorded EEGs
offer the ability to record the EEG on a long-term, outpatient basis.
Electrodes for at least four (4) recording channels are placed on the patient.
The cassette recorder is attached to the patient's waist or on a shoulder
harness. Recorded electrical activity is analyzed by playback through an audio
amplifier system and video monitors.  
  
Ambulatory EEG monitoring may facilitate the differential diagnosis between
seizures and syncopal attacks, sleep apnea, cardiac arrhythmias or hysterical
episodes. The test may also allow the investigator to identify the epileptic
nature of some episodic periods of disturbed consciousness, mild confusion, or
peculiar behavior, where resting EEG is not conclusive. It may also allow an
estimate of seizure frequency, which may at times help to evaluate the
effectiveness of a drug and determine its appropriate dosage.  
  
**Indications:**

  * Inconclusive EEGs;
  * Experiencing episodic events where epilepsy is suspected but the history, examination, and routine EEG do not resolve the diagnostic uncertainties;
  * Patients with confirmed epilepsy who are experiencing suspected non-epileptic events or for classification of seizure type (only ictal recordings can reliably be used to classify seizure type (or types) which is important in selecting appropriate anti-epileptic drug therapy;
  * Differentiating between neurological and cardiac related problems;
  * Adjusting anti-epileptic medication levels;
  * Localizing seizure focus for enhanced patient management;
  * Identifying and medicating absence seizures;
  * For suspected seizures of sleep disturbances;
  * Seizures which are precipitated by naturally occurring cyclic events or environmental stimuli which are not reproducible in the hospital or clinic setting.

Ambulatory monitoring, however, is not necessary to evaluate most seizures,
which are usually readily diagnosed by routine EEG studies and history.  
  
**Limitations:**

  * Study of neonates or unattended, non-cooperative patients;
  * Localization of seizure focus/foci when the seizure symptoms and/or other EEG recordings indicate the presence of bilateral foci or rapid generalization.
**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, factors often found in congestive heart failure (CHF).
Used in conjunction with other clinical information, rapid measurement of BNP
is useful in establishing or excluding the diagnosis and assessing the
severity of CHF in patients with acute dyspnea, so that appropriate and timely
treatment can be initiated. This test is also used to predict the long-term
risk of cardiac events or death across the spectrum of acute coronary
syndromes, when measured in the first few days after an acute coronary event.  
  
**Indications:**  
  
1\. BNP measurements are used to distinguish cardiac cause of acute dyspnea
from pulmonary or other non-cardiac causes.  
  
2\. BNP is particularly useful in distinguishing decompensated CHF from
exacerbated chronic obstructive pulmonary disease (COPD) in a symptomatic
patient with combined CHF and COPD.  
  
3\. BNP is a risk stratification tool used to assess risk of death, myocardial
infarction or CHF among patients with acute coronary syndrome (myocardial
infarction with or without T-wave elevation and unstable angina).

4\. Routine assays of BNP can be used to assess the effectiveness of CHF
therapy and for titration of heart failure therapy.  
  
 **Limitations:**

1\. Measurement of BNP as part of cardiovascular risk assessment panels,
consisting of various combinations of biochemical, immunologic, hematologic
and molecular tests is considered a screening when performed on an
asymptomatic patient and is not a Medicare benefit. Refer to the **MolDX:
Biomarkers in Cardiovascular Risk Assessment L36129 Local Coverage
Determination (LCD)**.

2\. Routine assays of only BNP to screen for the development of left
ventricular dysfunction or new onset Heart Failure in asymptomatic patients is
not covered due to statutory limitations.
Hemoglobin A1c (HbA1c) refers to the major component of hemoglobin A1.  
  
Performance of the HbA1c test at least 2 times a year in patients who are
meeting treatment goals and who have stable glycemic control is supported by
the American Diabetes Association Standards of Medical Care in Diabetes - 2016
(ADA Standards).1 For beneficiaries with stable glycemic control (defined as 2
consecutive HbA1c results meeting the treatment goals) performing the HbA1c
test at least 2 times a year may be considered reasonable and necessary. The
ADA framework for considering treatment goals recognizes that "patient
characteristics/health status" are important factors when considering glycemic
goals.2 Beneficiaries eligible for the Medicare home health benefit, for
example, often have multiple coexisting chronic illnesses that would support a
higher target goal for the HbA1c (e.g., < 8.5%), in order to avoid adverse
events (e.g., hypoglycemia-related emergency department visits and acute
inpatient hospitalization).  
  
Palmetto GBA will allow 1 additional HbA1c test every 3 months for a total of
8 tests per year in patients with uncontrolled blood glucose levels.
Additional tests beyond that frequency may be reimbursed on appeal with
appropriate documentation of medical necessity.  
  
HbA1c may be inaccurate in certain situations including anemia, transfusions,
hemoglobinopathies and conditions of rapid red cell turnover. Other tests to
assess diabetes, including glucose, glycated protein, or fructosamine levels,
may be used and are described in the Lab National Coverage Determination
190.21 (NCD for Glycated Hemoglobin / Glycated Protein). This NCD lists the
ICD-10 codes for HbA1c for frequencies up to once every 3 months.
Octreotide acetate is the acetate salt of a cyclic octapeptide. It is a long-
acting octapeptide with pharmacologic properties mimicking those of the
natural hormone, somatostatin. [Octreotide acetate for injectable suspension
](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021008s043lbl.pdf)is
a long-acting dosage form containing octreotide. It maintains all of the
clinical and pharmacological characteristics of the immediate-release dosage
form, octreotide acetate, with the added feature of slow release of octreotide
from the site of injection, reducing the need for frequent administration.  
  
Octreotide exerts pharmacologic actions similar to the natural hormone,
somatostatin. It is an even more potent inhibitor of growth hormone, glucagon,
and insulin than somatostatin. By virtue of these pharmacological actions,
octreotide has been used to treat the symptoms associated with metastatic
carcinoid tumors (severe diarrhea and flushing) and vasoactive intestinal
peptide (VIP) secreting adenomas (profuse watery diarrhea).  
  
Octreotide substantially reduces, and in many cases, can normalize growth
hormone and/or IGF-1 (somatomedin C) levels in patients with acromegaly.  
  

    * Octreotide acetate for injectable suspension is Food and Drug Administration (FDA) approved for the reduction of growth hormone and IGF-1 in patients with acromegaly, for whom medical treatment is appropriate, and who have been shown to respond to and can tolerate short-acting subcutaneous octreotide acetate. The goal of treatment is to reduce growth hormone and IGF-1 levels to normal. It is also used in patients who have had an inadequate response to surgery or in those for whom surgical resection is not an option. It is also used in patients who have received radiation and have had an inadequate therapeutic response.



  * It is FDA approved for the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.  
  

  * It is FDA approved for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been shown to be effective.  
  

  * The approved route of administration of octreotide acetate for injectable suspension is intragluteally, and it must be administered under the direct supervision of a physician.  
  

  * Octreotide acetate for injectable suspension is covered only when it is used according to FDA guidelines.  
  

  * A trial of therapy using the short-acting, subcutaneous form of octreotide acetate is a prerequisite prior to administering the long-acting octreotide acetate suspension. However, the short-acting, subcutaneous form of octreotide is noncovered by Palmetto Government Benefit Administrators (GBA), because it is self-administrable.  
  

  * Octreotide is covered for chemotherapy-induced diarrhea (CID) when oral antidiarrheal medications, such as loperamide, have become ineffective.