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Legislative/Regulatory News: Comments to GovernmentComments on a Proposed LMRP (Indiana) |
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This letter can serve as a model on commenting on a local medical review policy (LMRP). Because all proposed LMRPs will vary to some extent, you will need to adopt this model to your specific situation. June 5, 2000 Claudia Benge, RVT Dear Ms. Benge: Thank you very much for the opportunity to comment on the proposed draft policy regarding non-invasive vascular services. You asked the Society of Vascular Technology ("SVT") to provide comments on the proposed local medical review policy ("LMRP") being offered by the Indiana carrier. We are writing to express SVT's basic support for the proposed draft and to note its serious disagreement with a few components of the draft. We thank you and the Indiana Medical Director for your commitment to the Medicare program and to the beneficiaries whom we, too, serve. We are eager to work with you to establish appropriate medical review policies. As you know, SVT was founded in 1977, is one of the oldest professional societies for vascular technologists and sonographers, and is the only professional organization completely dedicated to the advancement of non-invasive vascular technology in the diagnosis of vascular disease. SVT is comprised of more than 4,000 members, including 1,000 physicians and 3,000 vascular technologists. Because we believe very strongly that the accuracy of non-invasive vascular testing is substantially related to the qualifications of the person undertaking the technical component of the service, we urge that the LMRP require all non-credentialed practitioners providing non-invasive vascular testing to become credentialed as an Registered Vascular Technologist ("RVT") or Registered Vascular Specialist ("RVS"). In order to allow an appropriate transition period, we suggest a three-year period from the effective date in which non-credentialed personnel may perform services under the direct supervision of credentialed personnel. At this point, given the development of the credentialing mechanisms, the recent (and quite appropriate) attention focused on medical errors, and the disturbing evidence of sub-standard care provided by non-credentialed personnel (see enclosed tape), we believe very strongly that proof of a minimum level of competency is absolutely essential. We disagree that an ordering physician should be required to provide a "written order." Under current national policy, only independent diagnostic testing facilities are required to obtain written orders. Oral orders appropriately reduced to writing by the laboratory are a common way to proceed and entirely sufficient. Patients in need of urgent or emergency services or who have to travel significant distances to a laboratory, who are infirm, or who must be transported, as well as others, would be seriously and negatively affected by a written order requirement. See also our comments in the next to last paragraph of this letter for additional relevant observations. The Society of Vascular Technology would like to suggest some changes to the proposed draft policy entitled "Draft AdminaStar Federal Local Medical Review Policy Carrier" (Policy Number: CV-CAC-00-4-8) for your consideration. The comments will follow the outline and order of the draft policy to assist the reader. We note generally that new and revised CD-9 codes will be effective in October and that this policy will have to be revised in light of those changes. DESCRIPTION: In the Physiologic Studies section, SVT proposes that "laser Doppler studies" and "Doppler" be added to the list of studies included in this section. Doppler Procedures Performed with Analysis Non-Invasive Vascular Studies and Angiography In the third paragraph, fourth sentence, SVT is concerned that the statement "if it is obvious from the findings of the history and physical examination that the patient is going to proceed to angiography, then non-invasive vascular studies are not medically necessary" might be misinterpreted to mean that any non-invasive study preceding angiography should not be reimbursed. With the increasing accuracy of ultrasound and due to the patient's condition and risks associated with angiography, there may be instances where obtaining an ultrasound first is often prudent and safer for the patient. In many cases, the ultrasound services will lead to a definitive diagnosis and treatment decision. If the ultrasound does not permit a definitive diagnosis, the physician may then elect to proceed to angiography. In such cases, the progression to angiography should not lead to non-payment for the ultrasound. To do so would be to lead providers to refrain from attempting to secure a definitive diagnosis from the more safe and less costly ultrasound approach. To clarify this point for providers, SVT suggests that a sentence be added that reads as follows: "This does not mean, however, that when angiography follows a non-invasive study, the non-invasive study is automatically deemed to be medically unnecessary and therefore, nonreimbursable." In the first full paragraph, first sentence, SVT suggests deleting the phrase "potentially impact the clinical management of the patient" and substituting the phrase "be utilized to avoid and/or modify angiograms; plan medical or rehabilitation therapy; and plan and/or modify surgical or radiological endovascular interventions." HCPCS CODES FOR NONINVASIVE VASCULAR DIAGNOSTIC STUDIES SVT agrees with the HCPCS codes selected for inclusion in the draft LMRP. INDICATIONS AND LIMITATIONS In section I.A., SVT endorses the indications for Cerebrovascular Examination contained in the Draft LMRP. 8. Patients with known extra-cranial or intra-cranial atherosclerotic disease. In section I.B., SVT suggests that the word "typically" be added to the introductory phrase. The suggested phrase reads: "Examples of signs and symptoms that typically do not demonstrate medical necessity." This modifier is important because there are patients who will present with atypical signs and symptoms who may require non-invasive testing. These patients should not automatically be excluded from medically necessary testing. In section I.C., Methods of Testing, first line, SVT recommends that the term "Transcranial ultrasound imager" be deleted and replaced with the term "Transcranial Duplex Imager ("TCDI")." TCDI more accurately reflects current terminology in the literature. In section I.C.1., SVT suggests three (3) changes. First, in section I.C.1.a., we suggest that the percentages for extracranial and intracranial artery stenosis or occlusion reflect the most recent scientific evidence. We believe that the American Society of Neuroimaging may be able to provide the most current guidance. Second, in section I.C.1.e., second sentence, SVT suggests that the phrase "operative procedure" be deleted and replaced with "perioperative period." This phrase change reflects the monitoring that occurs in medical practice. Third, we urge that TCD testing for cerebrovascular disease in sickle cell anemia patients be added to the list of allowed tests as section I.C.1.h. Multi-center trials have demonstrated the efficacy of TCD in identifying patients with sickle cell anemia who are at risk for stroke. II. Peripheral Arterial Examinations In the first paragraph, SVT suggests that the phrase after the word "present" be deleted and the following phrase be added: "and (2) the patient is a candidate for rehabilitation, invasive, medical, and/or surgical intervention." The sentence would read: "Noninvasive peripheral arterial examinations, performed to establish the level and/or degree of arterial occlusive disease are medically necessary if (1) significant signs and/or symptoms of possible limb ischemia are present and (2) the patient is a candidate for rehabilitation, invasive, medical, and/or surgical intervention." The reason for deleting the requirement that the patient be a candidate for invasive therapeutic procedures is that a patient's condition may be amenable to non-invasive therapy, such as medical management or rehabilitation. Hence, peripheral arterial examinations would be appropriate for the following CPT codes: 93922 Non-invasive physiologic studies of upper or lower extremity arteries, single level, bilateral In the third paragraph, last sentence, SVT urges that the word "therapeutic" be substituted for "invasive" for the same reasons outlined above. There may be appropriate interventions other than invasive for a specific patient. In the fourth paragraph, which discusses an ABI, SVT has two (2) concerns. First, the second sentence should indicate that an abnormal ABI is < 0.9 at rest, not > 0.9. A vast body of scientific literature has documented that an abnormal ABI is < 0.9 at rest. Second, the policy then makes reference to "more sophisticated or complete studies." This meaning of this phrase is unclear to SVT and SVT requests more specific information about the studies to which the carrier is referring and the specific meaning of this phrase. A. Indications In section II.A.1., SVT suggests that the word "Claudication" be replaced with the phrase "Exertional leg pain." This substitution is a more accurate statement of the indication for a peripheral arterial examination. SVT urges the addition of this phrase to the end of the sentence: "or claudication with an inability to stress the patient." Some patients are not able to walk a block because of other medical conditions. The addition of this phrase would allow such patients to receive medically necessary peripheral arterial examinations. B. Medical Necessity In section II.B.4., SVT urges the deletion of "relatively minor" from the first sentence. The words are redundant in the context of a patient with no symptoms. The second sentence enunciates the correct rationale for this course of action. III. Peripheral Venous Examinations: In section III.C., SVT proposes that the policy include the following indication: 2. Peripheral venous testing may be performed in superficial thrombophlebitis involving the proximal thigh to evaluate for the presence of thrombus at the saphenofemoral junction which would demand either anticoagulation or surgical ligation. This additional indication allows such a patient to obtain a peripheral venous study so that a therapeutic intervention decision can be made. IV. Non-Covered Procedures In the first paragraph, after the second sentence, SVT suggests that the following sentences be added: "Acceptable indications include a sudden onset of a pulsatile mass, pseudoaneurysm, and trauma. Ultrasound guided repair of an arterial pseudoaneurysm (CPT Code 37204) with thrombin injection is supported by the medical literature." In the first paragraph, third sentence, SVT disagrees with the statement that "when performed in conjunction with an invasive vascular procedure, procedure 76936 is considered part of the invasive procedure and is not separately reportable." SVT can find no support for this position in the CCI and urges that this statement be changed to reflect the current policy, i.e., that CPT code 76936 is a separately reimbursable procedure when performed in conjunction with an invasive vascular procedure. If AdminaStar believes that these procedures should be bundled, it should state this policy in the CCI. In the second paragraph, second sentence, SVT disagrees with the statement that requires that a patient "have a pulsatile mass indicating a pseudoaneurysm" and be "at least three days status-post invasive vascular procedure" in order for the provider to be reimbursed for ultrasonography under that scenario. There may be some patients with a clinical indication for performing the ultrasound in less than three days depending on the severity of the symptoms. The policy should not be unnecessarily restrictive so as to exclude these patients. SVT suggests that a third paragraph be added to section IV. as follows: "Follow-up examinations are considered medically necessary if not performed within 24 hours of the initial examination and intervention or if significant signs and symptoms indicate possible recannulation of the pseudoaneurysm or arterial ischemia. ICD-9 CODES SUPPORTING MEDICAL NECESSITY SVT supports the inclusion of all of the ICD-9-CM codes listed. SVT requests that the following codes be added because these diagnoses, signs or symptoms also are indicated for the indicated evaluation and are not covered under any of the ICD-9-CM codes listed. Cerebrovascular Evaluation (93875-93888): 1. 437.0 Cerebrovascular atherosclerosis; and
1. 440.0 Arterial embolism or thrombosis of abdominal aorta Extremity Venous Evaluation (93965-93971): 1. 707.8 Chronic ulcer of unspecified site REASONS FOR DENIAL: In Section 1., SVT proposes that the words following services in the first sentence and service in the second sentence be deleted. These services are not covered pursuant to exclusions under the Medicare program. In Section 2.e., SVT proposes that the words "sickle cell" be stricken from the sentence. Research has clearly demonstrated the efficacy of TCD in children with sickle cell anemia.
In section 2., SVT proposes that the second sentence be deleted, i.e., "If a unilateral study is performed, use modified -52 (reduced services)." This deletion is suggested because all duplex scans codes are unilateral or limited codes. Cerebrovascular Examination: In section A., the policy notes that multiple procedures may be performed on the same day if medically necessary. However, effective July 1, 1999, the CCI considered CPT code 93875 to be a component code of CPT codes 93880 and 93882. Therefore, a modifier, such as Peripheral Arterial Evaluation (93922 through 93931): In section A., second paragraph, SVT proposes that the following phrase be added to the end of the sentence: ", unless the patient's condition changes or there is a therapeutic intervention." This language is necessary to ensure that measurements can be taken more frequently if the clinical conditions warrant such measurements. In section C., first paragraph, SVT suggests that the following language be added to the end of the sentence: ", provided there is no known disease. After nonsurgical and surgical intervention, studies may be allowed when new, recurrent or worsening signs and/or symptoms have developed." This language is necessary to ensure that in cases where there is known disease, reimbursement for a patient's bilateral study will not automatically be denied. DOCUMENTATION REQUIREMENTS: In the first paragraph, second sentence, the policy states that a physical examination must be a part of the documentation in a patient's medical record. The policy should state that a technologist may reasonably rely on medical information supplied by a qualified practitioner. In the second paragraph, at the end of the sentence, SVT believes that the following phrase should be added:"effective January 1, 2002." This would allow laboratories that currently lack accreditation sufficient time to obtain accreditation. In the fifth paragraph, the word "medial" should be changed to "medical." In the sixth paragraph, SVT suggests adding the phrase "or the provider must document the telephone order" after the word "order." This allows the provider to perform a medically necessary study in an emergent or urgent situation when the patient may not present with a written order. Anne Jones, BSN, RN, RVT, RDMS, FSVU Frank West, BSN, RN, RVT, FSVU
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