Comments on a Proposed LMRP: Response (Rhode Island)

This response to SVT's comments on a proposed LMRP shows how your comments can make a difference

Anne Jones, RN
Society of Vascular Technology

Dear Ms. Jones:

Your letter of July 12, 2000 regarding the above draft local medical review policy (LMRP) came as something of a surprise as I do not recall communicating with the SVC about it. Generally, speaking, LMRPs are just that, i.e., local. However, since I have received a fair number of comments from physicians raising some of the concerns that your letter raised, I have no hesitation with sharing my overall reply to these comments with the SVT (Enclosure 1). As you can see from the enclosure, a number of items referenced in your letter have already been addressed. My subsequent comments will attempt to clarify items of concern to SVT that were not addressed.

Your comments on the issue of credentialing were particularly appreciated. I did not address this point for several reasons. The first reason is that fee-for-service Medicare has never had a mandate to operate in the quality assurance (QA) arena. This QA function is presumed to reside within the purview of the Peer Review Organization (PRO) and its local PRO contractors. A second reason is that Medicare, with the obvious exception of CLIA laboratory test certification, has historically had no accrediting requirements for most if not all tests performed either by an crashed Medicare provider of his or her agents. A third reason is that it would be well beyond the resources of most Medicare contractors to effectively establish, monitor and enforce credentialing requirements for test procedures done in an outpatient or office setting. For example, In 1999, 165 different Rhode Island providers filed for reimbursement for carotid ultrasound examinations, and we as a contractor just do not have the manpower available to link meaningful credentialing to test reimbursement.

Let me say at this point that the policy under review was drafted specifically to curb what I believe are clearly abusive practices with three procedures - CPT 93875, 93886 and 93922. Rhode Island is the fourth highest of all Medicare contractors in the performance per 1,000 beneficiaries for both codes 93875 and 93886, and therein lies the problem. CPT code 93922 is less of a problem since only one provider routinely uses this code on the same date of service (DOS) as CPT code 93880 to obtain data that is available by manual bilateral upper extremity blood pressure measurements. Thus our policy on code 93922 service will only apply to "same provider, same DOS" as 93880 (or 93886) and will not disallow coverage in any other circumstance. Put another way, single-level "physiologic" upper extremity studies have no role in the evaluation of subclavian steal. I will clarify this coverage limitation in the final policy.

By the same token, the elimination of non-invasive "physiologic" studies of the extracranial arteries, (CPT 93875) is appropriate given the state of the art defined by modern extracranial artery vascular testing. However, as you point out, blanket non-coverage would be in conflict with Coverage Issues Manual 50-37-Noninvasive Tests of Carotid Function. I am therefore clarifying this part of the policy to again reference "same provider, same DOS" as CPT code 93880 (or 93882). In rare cases where peri-orbital Doppler is actually medically necessary for the indirect support of the duplex exam findings, (and I can't really imagine such a case), provider appeal rights will always be available.

I appreciate the SVC's concerns with respect to this policy, but the SVC must also respect the need for local Medicare contractors to identify and address, insofar as possible, substantial unnecessary costs to the Medicare Program in an era of advancing technology and shrinking resources.

Sincerely,

Parker J. Staples, MD
Medical Director
Medicare Program

Additional response from Dr. Staples

Thank you for your thoughtful letter of June 27, 2000. You raise several very important issues and I appreciate the opportunity to address them sequentially. Your comments also were very helpful in terms of redefining the direction Rhode Island LMRP R12000B-102 should take.

The issues surrounding the diagnosis and follow-up of individuals who either might have or are known to have asymptomatic carotid artery stenosis are not simple ones. The first issue, and one raised by other commentators (though not yourself), is that of performing screening carotid ultrasound (US) in asymptomatic patients with risk factors for cerebrovascular disease. Unfortunately, most screening tests are currently not covered Medicare benefits, and this includes noninvasive vascular ultrasound studies. Medicare contractors are not allowed, by statute, to pay for screening tests, even if they wanted to, unless Congress passes a test-specific law indicating otherwise. Screening tests are non-covered, and charges for these tests become the responsibility of the beneficiary.

The issue becomes much more complex in terms of considering coverage for periodic subsequent US coverage in asymptomatic patients found to have pre-existing disease detected on an initial (non-covered) study. The study of lesional progression in these types of patients by Muluk et al (J Vasc Surg 29: 208-216, 1999) was certainly at variance with the conclusions drawn by Lewis et al (Ann Intern Med 127: 13-20, 1997), though neither study presented results stratified by age, e.g., results for patients 65 years of age and older- Even so, I am much more -inclined to look at the Lewis paper as much more reflective of what most physicians see in community practice since the Muluk study looked exclusively at VA patients (male) with an extraordinarily high prevalence of preexisting risk factors. Very recent publications continue to cast serious doubts on the benefit of carotid endarterectomy for stroke prevention in patients with asymptomatic high grade stenotic lesions (Inzatori et al, for the NACCET Trial collaborator, N.Eng J Med 342: 1693-1700, 2000). As such, I believe that the only reasonable conclusion one can reach is that the clinical value added to the care of asymptomatic patients undergoing periodic carotid US surveillance is just not known.

The conclusion cited in the above paragraph does not, however, take into account common clinical practice. As one commentator noted, "when many surgeons find hemodynamically significant carotid stenosis (>50%), they are inclined to follow the patients with periodic ultrasound evaluations." I am thus willing to modify the policy to allow periodic subsequent US coverage in asymptomatic Medicare patients found to have significant preexisting disease (> 50% carotid artery stenosis) detected on a prior study or studies. Also, your comments regarding the subclavian steal syndrome were well taken, and I will modify that portion of the policy as well.

Transcranial Doppler (TCD) studies continue to be controversial and Rhode Island is fourth in the nation in terms of TCD studies allowed by 1,000 Medicare beneficiaries. I suspect many of these are screening studies. As the benefits of TCD to refine the risk of an adverse clinical course following carotid endarterectomy are as yet unresolved, I am reluctant to grant blanket coverage to that indication at this time. If future research adds support to practice we can easily amend the policy accordingly.

Three other issues of importance were raised by other commentators, and I would like to share my replies to them on each topic. Firstly, I am dropping all references to testing frequency and feel I can do so based on 1999 Rhode Island Medicare utilization date for CPT 93880. In 1999, only 1.65 patients out of a total of 4,398 patients tested had two carotid US by the same provider within a twelve-month period of time (3% of all patients tested). Consequently, I will leave carotid US test frequency entirely up to the Rhode Island physician community provided other carotid coverage conditions of the policy are met. Secondly, there is the issue of whether or not duplex sonography following carotid endarterectomy is of any real clinical value. The paper by Ganesan et al (Cerebrovasc Dis 1998; 8: 338-44) looked at the clinical significance of routine surveillance following endarterectomy and concluded that carotid US does not appear to identify patients at higher risks for postoperative cerebrovascular events in the first 2 1/2 postoperative years.. However, a policy of blanket postoperative non-coverage probably goes heavily against common clinical practice, and I am willing to drop this restriction entirely from the final policy. Lastly, it was brought to my attention that good medical practice dictates evaluation of the extracranial carotid circulation in patients with extensive ASHD prior to coronary artery bypass grafting. I will specify a V-code in the final policy to identify this specific indication.

Once again let me thank you very much for the thoughtful comments. I am grateful for having had the opportunity to consider them prior to finalization of the policy.

Sincerely,

Parker J. Staples, MD
Medical Director
Medicare Program