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LCD Reference Article Response To Comments Article

Response to Comments: Non-Invasive Peripheral Venous Vascular and Hemodialysis Access Studies

A54400

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Source Article ID
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Article ID
A54400
Original ICD-9 Article ID
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Article Title
Response to Comments: Non-Invasive Peripheral Venous Vascular and Hemodialysis Access 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 Peripheral Venous Vascular and Hemodialysis Access Studies (DL35751). Thank you for the comments.

Response To Comments

Number Comment Response
1 Comments received stating that if the studies are performed in the preoperative or pre-procedural setting, both physiologic studies and duplex scanning should be allowed at the same time as this facilitates assessment of the adequacy of revascularization and serves as a baseline for postoperative and post-procedural evaluation. These are often complimentary and not redundant studies. Some of the patients come to us with studies and we are unaware of the quality of them so we repeat all tests that are sent to us since we are making critical decisions affecting the patient’s health from medical assessment, imaging or surgery. All testing covered by Medicare must be medically reasonable and necessary. Documentation must demonstrate why there was a need for repeat testing or additional testing.
2 Podiatrists asked if a podiatrist chooses to only perform the technical (TC) and not the professional component (26), does this LCD qualifying criteria apply to the physician performing the technical component independent or to the MD/DO vascular specialist interpreting the evaluation data and making/confirming the diagnosis? Whether doing the TC or PC, physicians would need to meet the criteria for qualification listed in the policy. The physician performing the technical component would use the modifier TC and physician interpreting the results would bill using modifier 26 for professional services.
3 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.
4 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.
5 Podiatrists wrote that requiring a physician to have staff privileges to interpret vascular laboratory studies in a hospital or working in a certified vascular lab is neither a standard nor universally required within states or by vascular organizations, associations, or societies It is not the intent of WPS to restrict the podiatric scope of practice. WPS uses Medicare’s definition of physicians which includes doctors of podiatric medicine. (CMS Pub 100-01 Medicare General Information, Eligibility, and Entitlement, Chapter 5 – Definitions, Section 70.3 – Doctors of Podiatric Medicine.) The section of the policy on credentialing and accreditation standards has been revised.
6 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.
7 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.
8 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.
9 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.
10 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.
11 Comments were received regarding routine venous mapping prior to bypass graft surgery not being covered. Commenters stated that it has been shown to reduce complications and facilitate earlier discharge. All testing covered by Medicare must be medically reasonable and necessary. Documentation must demonstrate why there was a need for additional testing.
12 A 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. This also removed the references to arterial segments.
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 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 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. WPS has added the following paragraph to Utilization Guidelines: “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. The documentation must support the medical necessity.” The word “may” will continue to be used, because if it is determined to not be medically necessity or the documentation does not support medical necessity, the studies would be denied.
15 Received a statement that the policy states, “generally, it is expected that noninvasive vascular studies would not be performed more than once in a year, excluding inpatient hospital (21) and emergency room (23) places of services. Comments noted that this was “not true of an AVF (arteriovenous fistula) that has maturation procedures, and is being followed to assess improvement vs. need for further intervention.” All testing covered by Medicare must be medically reasonable and necessary. Documentation must demonstrate why there was a need for repeat testing or additional testing.
16 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.
17 Comment received that nephrology and vascular access labs were not mentioned in the credentialing and accreditation section of the policy. None of the medical specialties were discussed in this section. The physician must been the requirements of a licensed qualified physician and the vascular lab must be accredited by one the accrediting bodies recognized by CMS.
18 Comments were received regarding information written in italics in the policy. This italic information is taken directly out of the CMS Publication Manuals. WPS is not able to change how this information is written.
19 Writer request that the following ICD 10 codes be added to match the ICD 9 codes that are present. V12.51 Personal History of Venous Thrombosis and Embolism- ICD 10 Z86.718 V12.52 Personal History of Thrombophlebitis- ICD 10 Z86.72 V12.55 Personal History of Pulmonary Embolism- ICD 10 Z86.711 V67.09 Follow up examination other surgery- ICD 10 Z08 and Z09 Diagnostic codes Z86.711. Z86.718 and Z86.72 are already the ICD 10 policy L35751. Z08 and Z09 will not be added to the policy since they are encounters for follow-up examination after completed treatment for malignant neoplasm and for conditions other than malignant neoplasm.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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