LCD Reference Article Response To Comments Article

Response to Comments: Non-Invasive Abdominal/Visceral Vascular Studies

A54402

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Article ID
A54402
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Article Title
Response to Comments: Non-Invasive Abdominal/Visceral Vascular 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 Abdominal/Visceral Vascular Studies (DL35755). Thank you for the comments.

Response To Comments

Number Comment Response
1 In the former policy, CPT codes 93975 and 93976 (abdominal/visceral vascular studies of abdominal, retroperitoneal, and pelvic organs) were covered with a diagnosis code of I70.1 (atherosclerosis of renal artery). Is this an omission, an error, or will this diagnosis no longer be considered medically necessary for these service? This diagnostic code has been added to this policy.
2 In the former policy, CPT codes 93978 and 93979 (visceral vascular studies of aorta, inferior vena cava, iliac vasculature, and bypass grafts) were covered with a diagnosis code of I70.211, I70.212, I70.213, I70.218, and I70.219 (atherosclerosis of native arteries of the extremities with intermittent claudication). Is this an omission, an error, or will this diagnosis no longer be considered medically necessary for these services? These diagnostic codes have been added to this policy except for I70.219, atherosclerosis of native arteries of extremities with intermittent claudication, unspecified extremity.
3 The ICD-10 codes of R19.00 - R19.09 describing abdominal or pelvic swelling, mass or lump should be included in the list of Group 2 diagnostic codes that support medically necessity. These diagnostic codes were added to Group 2 diagnostic codes and are already included in Group 1.
4 Comments received requesting that cirrhosis of the liver be added to the list of authorized indications for payment for abdominal Doppler ultrasound examinations of Medicare patients. Portal hypertension is currently listed as an approved indication for this procedure. Since cirrhosis is the etiology of 90% of cases of portal hypertension in the US, it is reasonable and logical to include cirrhosis as a recognized indication for these noninvasive studies. Diagnostic codes for cirrhosis of the liver have been added to this policy.
5 Comments received expressing concerns that there are surveillance protocols for patients post-operatively, that has been shown in the literature, to improve bypass graft patency rates and should be covered without symptoms of ischemia. Language and CPT codes were added to the policy to allow post-operative surveillance to be completed provided that there is documentation to support the medical necessity of ordering the studies.
6 Suggestions were made to make changes to Credentialing and Accreditation Standards or eliminate them altogether. While 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.
  1. All non-invasive vascular diagnostic studies must be performed meeting at least one of the following:
    1. performed by a licensed qualified physician, or
    2. performed by a technician who is certified in vascular technology, or
    3. performed in facilities with laboratories accredited in vascular technology.
  2. A licensed qualified physician for these services is defined as:
    1. 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
    2. Has the Registered Vascular Technologist (RVT), Registered Physician Vascular Interpretation (RPVI), or ASN: Neuroimaging Subspecialty Certification; and
    3. Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed.
  3. 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 certification includes the American Registry of Diagnostic Medical Sonographers (ARDMS), Registered Vascular Technologist (RVT) credential; or Cardiovascular Credentialing International’s Registered Vascular Specialist (RVS).
  4. 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.
7 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.
8 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.
9 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.
10 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. It was in the previous LCD (L28586), Non-Invasive Vascular Testing (NIVT), which was originally effective 05/18/2009.
11 Comments were received that there is a lack of policing the quality of the technicians and equipment which 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.
12 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 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.”
13 The statement that duplex scanning and physiologic studies may be reimbursed during the same encounter if the physiologic studies are abnormal and/or to evaluate vascular trauma, thromboembolic events or aneurysmal disease is problematic. Using the word “may” indicates that judgment will be used. If a group meets the criteria you have established, they should be reimbursed. We urge you to change the word. The covered CPT codes for this policy pertain only to duplex scan of arterial inflow and venous outflow studies.
14 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.
15 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.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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