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Response to Comments: Non-Invasive Peripheral Arterial Vascular Studies

A54399

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Article ID
A54399
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Article Title
Response to Comments: Non-Invasive Peripheral Arterial Vascular Studies
Article Type
Response to Comments
Original Effective Date
10/01/2015
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Article Text
Response to Comments
This article summarizes the
comments WPS received for Draft Local Coverage Determinations (LCD) Non-Invasive Peripheral Arterial Vascular Studies (DL 35761). Thank you for the comments.

Response To Comments

Number Comment Response
1 Comments were received regarding the removal of 93922, stating that these limited studies were applicable and need to be covered. The CPT code 93922 will be added into the policy as a covered code when the testing provided meets the definition of the CPT code. However, if it is just a simple ankle-brachial index (ABI) test, it is part of the physical examination or if done with a hand held Doppler, it will not be covered and should not be billed separately using this CPT code 93922.
2 A comment was received about not covering a number of peripheral arterial study testing methods that were previously covered including thermography, mechanical oscillometry, inductance or capacitance plethysmography, photoelectric plethysmography and differential plethysmography. These studies are useful on diabetic patients with arterial calcification as demonstrated by artifactually elevated ankle blood pressures resulting in a normal ABI. In this situation, the current LCD covers the aforementioned non-invasive vascular tests when ischemic signs and symptoms are present. The ability to use this testing both in our office and in a facility is extremely useful in evaluating the potential to heal a wound or to determine the most distal level of surgical amputation likely to heal. We feel that these studies should continue to be covered. CMS lists the following test as experimental and not covered. The information can be found in CMS Pub 100-03 Medicare National Coverage Determinations (NCR) Manual, Chapter 1 – Covered Determinations, Part 1 Section 20.14 – Plethysmography (2003): mechanical oscillometry, inductance plethysmography, capacitance plethysmography, and photoelectric plethysmography. Thermography is addressed in CMS Pub 100-03 Medicare National Coverage Determinations Manual, Chapter 1- Coverage Determinations, Part 4 Section 220.11 – Thermography (1992). These tests also were noncovered in the current policy since the WPS must also follow CMS NCDs.
3 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.
4 Members of the CAC expressed concerns that the surveillance protocol in patients without symptoms has been shown in the literature to improve bypass graft patency rates and should be covered without signs or symptoms of ischemia. If they are asymptomatic but vein graft surveillance is necessary it would be appropriate. It would apply to synthetic grafts as well since they are more likely to have outflow issues or thrombus. If the synthetic graft becomes infected the autogolous option is gone. Both autogolous and synthetic grafts should be appropriately surveyed for limb preservation. 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.
5 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. Transcutaneous oxygen tension measurement should be performed by personnel possessing the following credentials obtained from the National Board of Diving and Hyperbaric Medicine Technology (NBDHMT): Certified Hyperbaric Technologist (CHT), or Certified Hyperbaric Registered Nurse (CHRN).
6 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.
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 One physician wrote that the new policy has added certain diabetes codes and certain coronary artery codes. I appreciate these improvements. However, I am uncertain, why other diabetes codes and coronary artery codes were omitted. Please consider expanding your coverage for additional diabetes and coronary artery disease codes. The diabetic codes E08.51 through E13.59 (diabetic peripheral angiopathy and diabetes due to other circulatory complications) more appropriately describe the diabetic that would be having symptoms requiring non-invasive peripheral arterial vascular studies. If a diabetic patient is asymptomatic, the studies would be considered screening and would not be covered by Medicare. Also requested, was the addition of I25.10 through I25.812 (coronary atherosclerosis of by vessel, native or graft). These codes have been added.
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 Several comments were received on the statement that the performance of both the physiologic studies and duplex study during the same encounter is usually not medically necessary. If it is performed in the preoperative or pre-procedural setting both studies should be allowed since it allows for the assessment of the adequacy of revascularization and serves as a baseline for postoperative or post procedure evaluation. They felt these were complementary studies. 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 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.
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.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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