LCD Reference Article Response To Comments Article

Response to Comments: Non-Invasive Cerebrovascular Studies

A54398

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Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05101 - MAC A	J - 05	Iowa
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05102 - MAC B	J - 05	Iowa
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05201 - MAC A	J - 05	Kansas
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05202 - MAC B	J - 05	Kansas
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05301 - MAC A	J - 05	Missouri - Entire State
Wisconsin Physicians Service Insurance Corporation	MAC - Part B	05302 - MAC B	J - 05	Missouri - Entire State
Wisconsin Physicians Service Insurance Corporation	MAC - Part A	05401 - MAC A	J - 05	Nebraska
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Article ID
A54398

Article Title
Response to Comments: Non-Invasive Cerebrovascular Studies

Article Type
Response to Comments

Original Effective Date
10/01/2015

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Response to Comments

This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Non-Invasive Cerebrovascular Studies (DL35753). Thank you for the comments.

Response To Comments

Number	Comment	Response
1	A comment was received that the provider did not agree with the utilization of the carotid Doppler for the diagnosis of syncope. One vessel stenosis does not make for a syncopal episode. It is extremely rare to have all four vessels so stenotic that one would pass out. I have seen a lot of previous abuse of Dopplers for pure syncope and have never seen one of those test aid the diagnosis. Another provider suggested rewording the limitation to state if an echocardiogram is negative for a cardiac or cardiac valvular cause it may be medically appropriate for a carotid Doppler studies for the diagnosis of syncope. Another provider agreed and thought the test yielded good data on the vertebral arteries when appropriately indicated.	We have clarified indication 1 and it now reads “Drop attack or syncope is only covered with vertebrobasilar or bilateral carotid artery disease as suggested by the patient’s history. It may be medically appropriate to perform extracranial arteries studies for the drop attack or syncope, if an echocardiogram is negative for a cardiac or cardiac valvular cause. Documentation must support this study.
2	One provider did not think the use of a carotid Doppler to make the diagnosis of a carotid dissection was state-of-the-art and it is a waste of money to even complete one. It is not even adequate for a screening for this condition. At the recent international stroke conference, the evaluation of choice is either for conventional angiography or MRI/MTI, or CTA for diagnosing. It is not a good screening test to include for diagnosis. Another doctor commented that you would not do a carotid ultrasound because of bilateral cerebral artery disease is uncommon but you would not know if you did not do the study. You cannot reliably diagnose this by history.	According to the Cleveland Clinic, Doppler ultrasonography (DUS) is a useful tool in identifying carotid artery dissection. DUS can detect abnormal blood flow in a dissected artery. It has the advantages of being fast, noninvasive and easy to use at the patient’s bedside. The Cleveland Clinic felt that conventional angiography is not as accurate as the newer imaging technologies, is invasive and has a 1% risk of complications. American Institute of Ultrasound in Medicine (AIUM) lists suspected carotid artery dissection as an indication. We will leave this indication as written.
3	Multiple requests were made to add the indication of sickle cell anemia diagnostic codes (282.60-282.69) for transcranial Doppler (TCD) studies back into the policy. The preponderance of evidence notes that the use of transcranial Doppler as a gold standard in the diagnosis of intracranial arterial narrowing and timing of therapeutic transfusions. Abnormal results on transcranial Doppler ultrasonography with children with sickle cell anemia are preventing a first stoke. Detection of elevated intracranial flow velocities using TCD resulted in a 92% decrease in the risk of stroke. Unfortunately, WPS has omitted these codes even though they are critically medically necessary. When the STOP protocol is used, it lists the indications for the test.	The sickle cell anemia diagnostic codes (D57.00 – D57.819) were added back into the policy coding table and under indications for transcranial Doppler studies.
4	Suggestions were made to make changes to Credentialing and Accreditation Standards or eliminate them altogether. Others expressed the need for stricter requirements and enforcement due to potential adverse outcomes that could result from inappropriately performed or interpreted studies.	Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. All non-invasive vascular diagnostic studies must be performed meeting at least one of the following: performed by a licensed qualified physician, or performed by a technician who is certified in vascular technology, or performed in facilities with laboratories accredited in vascular technology. A licensed qualified physician for these services is defined as: Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty in ultrasound (US) or must reflect equivalent education, training, and expertise endorsed by an academic institution in ultrasound or by applicable specialty/subspecialty society in ultrasound, or Has the Registered Vascular Technologist (RVT), Registered Physician Vascular Interpretation (RPVI), or ASN: Neuroimaging Subspecialty Certification; and Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed. Nonphysician personnel performing tests must demonstrate basic qualifications to perform tests and have training and proficiency as evidenced by licensure or certification by an appropriate State health or education department. In the absence of a State licensing board, non-physician personnel must be certified by an appropriate national credentialing body. Appropriate personnel certifications include the American Registry of Diagnostic Medical Sonographers (ARDMS), Registered Vascular Technologist (RVT) credential; or Cardiovascular Credentialing International’s Registered Vascular Specialist (RVS). Laboratories accredited by the Intersocietal Accreditation Commission (IAC), American College of Radiology (ACR) Vascular Ultrasound Program, or Joint Commission must follow the accrediting body’s standards.
5	Comments were received that the proposed requirement that certified technologists directly supervise and review the work of noncertified technologists as problematic.	We agree that the Medicare regulations do describe the requirements for physician supervision and defines general, direct, and personal supervision. We have removed this statement since the ultimate responsibility for supervision and the quality of images is with the physician.
6	The LCDs indicate, "it is recommended that noninvasive vascular studies either be rendered in a physician’s office by/or under the direct supervision of persons credentialed in the specific type of procedure performed or performed in laboratories accredited in the specific type of evaluation." The Medicare physician fee schedule identifies the services in these LCDs as requiring general supervision, not direct. Any suggestion that direct supervision of these services is required should be removed from the LCDs such that they are compatible with national policy.	We have removed this language.
7	Comments were received that stated that Intersocietal Commission for Accreditation of Vascular Laboratories (ICAVL) is now the Intersocietal Accreditation Commission (IAC). The “ARRT” represents a radiologic credentialing body (The American Registry of Radiologic Technologists. Absent from this list is the American College of Radiology (ACR). ACR technologist certification should be added to this list. The ACC supports participation in physician certification and/or laboratory accreditation programs. Exceptions to mandates may be necessary to ensure that patients have access in underserved areas.	Thank you. We have corrected Intersocietal Accreditation Commission (IAC) throughout the policy. We have added American College of Radiology (ACR) to the list of credentialing boards. We removed the types of credentialing for individuals that each organization offers.
8	We are concerned the proposed LCDs do not give a timeframe for requiring accreditation. We request that you allow groups a three year period within which they would become accredited.	Credentialing is not a new requirement and will remain in the policy. It was in the previous LCD (L28586), Non-Invasive Vascular Testing (NIVT), which was originally effective 05/18/2009.
9	Comments were received that there is a lack of policing the quality of the technicians and equipment with leads to repeating tests. Vascular labs should be required to be certified rather than what is currently in the policy that states the labs may be certified. That would take care of the technician requirements.	The LCD outlines the requirements for these procedures. Documentation of credentialing and qualifications of staff could be reviewed on a post pay basis.
10	One comment was received that each draft LCD makes reference to documentation standards. While generally appropriate, some of the standards quoted from an American College of Radiology practice parameter would be overly proscriptive if applied universally. That practice parameter clearly states it would be inappropriate to take standards from an educational tool and apply them as “inflexible rules or requirements of practice.” The detailed, numbered documentation requirements should be deleted.	We agree and the four detailed, numbered parameters from ACR have been removed.
11	Only licensed MDs or DOs are allowed to sit for the ARDMS RPVT examination, this functionally barring all other individuals with licenses to practice medicine from sitting for the examination.	Medicare does not set the requirements for organizations that provide certifications for physicians and technicians.
12	Requested addition of carotid stenting as an indication for extracranial artery and transcranial Doppler studies. Also requested that transient ischemic attacks (TIAs) be added to the list of indications for extracranial studies.	Carotid stenting has been added as an indication for extracranial arteries and transcranial Doppler testing. Carotid stenting has also been addressed under the utilization guidelines. TIA was already listed in the indications for extracranial studies.
13	Comment received that in the Utilization Guidelines only one preoperative scan is considered reasonable and necessary for bypass surgery, yet sometimes a second non-invasive vascular ultrasound is ordered rather than a CTA or MRA which are more expensive. If the operative planning is occurring in a tight time frame then only one scan might make sense. But when you are dealing with patients with lots of comorbidities and trying to get them stable and ready for surgery the data would be old and you need to repeat a scan. Another physician states that the literature does not speak to an interval when it would be appropriate to repeat the studies but it is based more on whether or not there is a change in patient symptoms that would necessitate a reinvestigation.	The following has been added to Utilization Guidelines: Only one Doppler preoperative scan is considered reasonable and necessary for bypass surgery. “If a more current preoperative scan is indicated for a patient with multiple comorbidities having difficulty being stabilized for surgery or a change in condition, the medical record would need to support the medical necessity of the second scan.”
14	There are no validated duplex criteria to separate a < 30 % from a > 30% carotid artery stenosis so this will be a policy which the clinician cannot relate to in practice. A normal duplex can be separated from one with atherosclerosis this might be possible to document.	This was removed from the policy.

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Associated Documents

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LCDs
L35753 - Non-Invasive Cerebrovascular Studies

Updated On	Effective Dates	Status
06/25/2015	10/01/2015 - N/A	Currently in Effect	You are here

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Response to Comments: Non-Invasive Cerebrovascular Studies

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