Comments on a Proposed LMRP:
Pennsylvania

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.

See the another comment to the Pennsylvania carrier.

September 19, 2000

Dr. Andrew Bloschichak
Medical Director
HGSAdministrators
P.O. Box 890413
XACT Medicare Services
1800 Center Street, 1A-L4
Camp Hill, PA 17089

Re: Supervision Requirements for an Independent Diagnostic Testing Facility Draft Local Medical Review Policy

Dear Dr. Bloschichak:

First, on behalf of the Society of Vascular Technology ("SVT") and the Society of Diagnostic Medical Sonography ("SDMS"), we want to thank you for the dedication and leadership you have demonstrated in serving the Medicare beneficiaries of Pennsylvania. We want you to know that we, too, are committed to serving Medicare beneficiaries. It is because of our shared commitment to serve these patients' best interests that we are writing to express our belief that HGSAdministrators' ("HGSA") new policy, that would appear to require more than general supervision for basic ultrasound services, is inconsistent with existing national policy, the national standard of practice, and a program memorandum that the Health Care Financing Administration ("HCFA") is preparing. We are eager to work with you to establish a medical review policy for these procedures that is consistent with national policy.

Except in the case of certain services, such as cardiac stress testing, SVT and SDMS believe that general supervision is appropriate for diagnostic ultrasound procedures and that the proposed local medical review policy ("LMRP") should be revised. SVT and SDMS believe that the proposal will have the unintended effect of undermining access to medically necessary testing to Medicare beneficiaries.

SVT, founded in 1977, is a professional society for vascular surgeons, nurses, and technologists, 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.

SDMS, which represents vascular technologists and sonographers practicing in all specialties of ultrasound, has a membership of 11,000. SDMS members are involved in the delivery of high-quality echocardiography, neurosonography, obstetrical, abdominal, ophthalmic, and vascular ultrasound services.

SVT and the SDMS first would like to make some general comments on the draft LMRP, followed by comments on specific provisions of the draft LMRP.

I. Regulatory Background

A. Independent Diagnostic Testing Facility

On October 31, 1997, the Health Care Financing Administration ("HCFA") published a final rule that established the requirements for an Independent Diagnostic Testing Facility ("IDTF") that replaced the prior Medicare designation, called Independent Physiologic Laboratories ("IPL"). HCFA reviewed IPL and other diagnostic providers and provided for various levels of supervision for different diagnostic services. Because the levels of supervision established by HCFA were not, in many cases, consistent with established medical practice and because of the objections of more than thirty medical societies, HCFA withdrew its supervision policy less than one (1) month after its effective date. See Barbara O. Wynn Letter Dated January 28, 1998, Exhibit 1. This decision followed a meeting at HCFA involving more than thirty medical societies. Except for one society, the American College of Radiology, every other society at the meeting to address the issue of the appropriate and established level of supervision for basic ultrasound services, including the American Medical Association, the Society for Vascular Surgery, the American Society of Neuroimaging, the American Academy of Neurology, and so many others, supported general supervision.

The letter included a specific instruction to the carriers that they "should continue to follow their existing policies on physician supervision of diagnostic tests." Emphasis added. Since then, HCFA has specifically acknowledged that, when it implements a national policy, it will require general supervision for non-stress ultrasound services. See Terrence L. Kay Letter Dated January 1999, Exhibit 2.

B. Coverage Determinations and LMRP

Title XVIII of the Social Security Act sets forth the categories of services covered under the Medicare program. Specific medical coverage decision determinations for the Medicare program are delegated to the Secretary of Health and Human Services.

In the absence of a national policy decision, a carrier may develop an LMRP to explain when an item or service will be considered reasonable and necessary and, therefore, eligible for coverage under Medicare. However, a local carrier may not issue a policy that conflicts with a national policy. In this case, Mr. Wynn's instruction of January 28, 1998, the October 31, 1997 final rule on IDTFs, and the Medicare Carriers Manual discussion of supervision for basic radiology services contain national determinations inconsistent with the supervision components of the LMRP.

As noted above, the January 28, 1998 letter specifically instructs carriers to continue to implement "their [then] existing" policies in this area; it does not permit changes in these policies. In the October 31, 1997 final rule, HCFA also declared that "[o]nce an entity becomes an IDTF it is no longer subject to local medical review policies that . . . preclude IPLs from furnishing procedures or groups of procedures while allowing other entities to perform them." This would appear to be the effect of the proposal. The Medicare Carriers Manual also contains an exception to the incident to standards for basic radiology services which authorizes them to be provided under general supervision. Officials at HCFA, including the former Medical Director, have informed us that basic ultrasound is included in this provision. This interpretation is consistent with HCFA's apparent conclusion, reflected in the October 31, 1997 rule, that it had to address supervision issues in a published regulatory proposal.

HGSA stated that the supervision requirements proposed in the draft LMRP were in response to a statement from a HCFA auditor for having articulated no HGSA-drafted supervision standard for IDTFs. Unfortunately, HGSA may not answer this inquiry criticisms by creating an LMRP in violation of Medicare regulations. HGSA could address the situation by formalizing a general supervision standard which, by default, must have been the standard (otherwise the draft LMRP would not be necessary).

C. Publication of Program Memorandum

Based on HCFA's statements to us, HCFA will release a Program Memorandum ("PM") addressing the supervision requirements for IDTFs and other diagnostic testing providers in the near future. HCFA circulated a draft of the supervision requirements for many ultrasound procedures for comment by relevant stakeholders. See Paul Kim E-mail Transmission Dated April 26, 2000, Exhibit 3. The draft PM provides that general supervision is the appropriate standard for essentially all non-stress ultrasound services, with a few enumerated exceptions. In light of HCFA's imminent release of a general supervision requirement for most diagnostic ultrasound performed by IDTFs, implementation of the draft LMRP supervision requirements, as written, at this time seems unwise and likely to create confusion.

II. Various Considerations

HGSA's proposal to require something other than general physician supervision for the majority of the diagnostic ultrasound procedures will be expensive, with no appreciable improvement on the quality of patient care services. Patient quality concerns may only be addressed effectively by ensuring that the technologists and sonographers who perform studies are well qualified, as established by nationally recognized credentialing programs. In fact, as of January 1, 1999, the local medical review policy in Pennsylvania has authorized payment for studies only when performed or directly supervised by Registered Vascular Technologists ("RVT") or Registered Vascular Specialists ("RVS"). Because we believe so strongly in credentialing and its ability to affect quality, we urge HGSA to introduce a standard that requires all ultrasound technologists and sonographers (whether practicing in an IDTF or otherwise) to be credentialed, and not just supervised by such a person. This is how strongly we are committed to ensuring quality. We believe that a three-year phase-in of the credentialing requirement would be sufficient for transition purposes.
Mandating more than general supervision for most diagnostic ultrasound procedures would greatly increase the expense when studies are performed by mobile units, for example, at nursing homes. Physicians would have to accompany nonphysician personnel to all locations. In an era where every Medicare dollar is precious, cost effective methods of delivering safe, quality care must be utilized. Appropriately credentialed nonphysician personnel are trained and qualified to perform most diagnostic ultrasound procedures under general supervision. To require that a physician be present in the room or at a mobile location would be unnecessary and unworkable.

Our concern is that HGSA will unintentionally create an access problem if physicians must provide more than the general supervision in mobile locations. The physician will have to be available to accompany the technologist or sonographer, either preventing or causing a delay in obtaining the study for the patient.

Nor can the physician availability problem be addressed by transporting the patient to a physician's office or other location. In the case of most nursing home and other patients, this approach would lead to higher costs because of the necessity to transport the patients by ambulance, the time spent preparing the patient for transport and for staff members who will have to accompany some patients. Some patients also will experience discomfort in transport.

For the reasons set forth above, SVT and SDMS believe that the supervision requirement for all diagnostic ultrasound code should be general supervision except for a small number of Current Procedural Terminology ("CPT") codes, including CPT code 76936 (ultrasound guided compression repair of arterial pseudo-aneurysm or arteriovenous fistulae).

III. Comments Regarding Specific Provisions

SVT and SDMS would like to suggest some specific changes to the proposed draft policy concerning IDTFs. The comments will follow the outline and order of the draft policy to assist the reader.

Table I

Diagnostic Ultrasound

In the Head and Neck table, SVT and SDMS suggest deleting COA and COT as appropriately qualified nonphysicians to perform CPT codes 76511-76529 (various ophthalmic ultrasounds). We believe that the appropriately qualified nonphysician to perform CPT codes 76516-76519 (ophthalmic biometry by ultrasound echography, A-scan) is an ROUB and for CPT codes 76511-76513 (ophthalmic ultrasound, echography) and 76529 (ophthalmic ultrasonic foreign body localization) is an RDMS in ophthalmology.

In the Pelvis table, SVT and SDMS suggest adding RDMS in OB/GYN to the appropriately qualified nonphysicians to perform CPT codes 76825-76828 (fetal echocardiography codes) and 76856-76857 (echography, pelvic (nonobstetric)). An RDMS is well qualified to perform these examinations.

For CPT codes 76856-76857, also found in the Pelvis table, we believe that an obstetrician-gynecologist is a qualified physician to supervise these tests. These physicians regularly perform and evaluate ultrasound images in their clinical practices. For CPT code 76831 (hysterosonography, with or without color flow Doppler), SVT and SDMS support HGSA's determination to require personal supervision.

In the Genitalia table, for CPT code 76872 (echography, transrectal), SVT and SDMS suggest adding RDMS in OB/GYN to the appropriately qualified nonphysicians to perform this procedure. Certain portions of the female reproductive tract and pelvic structures may best be visualized using a transrectal approach, such as possible lacerations to the rectum after a delivery or possible vaginal-rectal fistulae; therefore, we believe that adding an RDMS in OB/GYN is appropriate.

Medicine

In the Echocardiography Table, SVT and SDMS suggest that a general supervision requirement be imposed for all echocardiography, except for CPT codes 93312-93317 (echocardiography, transesophageal) and CPT code 93350 (echocardiography, transthoracic, during rest and cardiovascular stress test). We support HGSA's determination to require personal supervision for CPT codes 93312-93317.

CPT codes 93303-93308 (echocardiography, transthoracic) and CPT codes 93320-93325 (Doppler echocardiography) are not invasive, nor do they require physical exertion on the part of the patient, which might precipitate a major cardiac event. Appropriately certified nonphysicians are trained and competent to perform these studies in the absence of a physician. Therefore, we propose that these codes be performed under general supervision.

In the Cerebrovascular Studies table, for CPT codes 93886-93888 (transcranial Doppler study of the intracranial arteries), SVT and SDMS suggest adding vascular surgeons as qualified physicians. Vascular surgeons have training in interpreting and utilizing these studies in clinical practice and have developed specific expertise in this area. Therefore, we believe that they should clearly be included as physicians who are qualified to supervise CPT codes 93886-93888.

SVT and SDMS believe that general supervision is the appropriate supervision level for all peripheral vascular ultrasound studies contained in the Extremity Arterial, Venous, and Arterial-Venous and Visceral and Penile Vascular Studies tables. CPT codes 93922-93931 (non-invasive physiologic studies and duplex scans of extremity arteries), CPT codes 93965-93971 (non-invasive physiologic studies and duplex scans of extremity veins), CPT codes 93975-93981 (duplex scans of visceral and penile arteries and veins), and CPT code 93990 (duplex scan of hemodialysis access) are noninvasive procedures and are well within the capabilities of appropriately qualified nonphysicians to perform.

Other Comments

The alternative of real-time ultrasound does not adequately respond to the access concerns we have articulated, as such transmissions are expensive, not practical for most of our members and not cost effective for the Medicare program. There has been no demonstrated increased safety utilizing real-time ultrasound transmissions. HCFA, based on critical comments by the American Medical Association and many other societies attending the HCFA meeting discussed above, rejected this approach in its consideration of the issue following the October 31, 1997 final rule. The University of Tennessee, Memphis, has estimated that the cost for a network (which consists of two municipal area networks, the ethernet and the video), even based upon sharing the fiber among different users, is approximately $20,000 per year for just the first remote site.

Thank you, once again, for the opportunity to comment on this important policy.

Sincerely,

Patricia Marques, RN, RVT, FSVU
President
Society of Vascular Technology

Anne Jones, BSN, RN, RVT, RDMS, FSVU
Legislative Chair
Society of Vascular Technology

Stephen McLaughlin, BS, RT, RDMS
President
Society of Diagnostic Medical Sonographers

Laurinda Andrist, BS, RDMS, RDCS
Legislative Chair
Society of Diagnostic Medical Sonographers