September 30, 2002
Lynn E. Hickman, MD
Medicare Carrier Medical Director
BC/BS of Arkansas
8687 United Plaza Blvd., Bldg 9
P.O. Box 98501
Baton Rouge, LA 70884-9501
RE: Noninvasive Vascular Studies LMRP
Dear Dr. Hickman:
On behalf of the Society for Vascular Surgery ("SVS") and the American Association for Vascular Surgery ("AAVS"), the Society for Vascular Ultrasound ("SVU") - formerly the Society of Vascular Technology (“SVT”), the Society of Diagnostic Medical Sonography ("SDMS"), the Intersocietal Commission for the Accreditation of Vascular Laboratories (“ICAVL”), the American Society of Neuroimaging ("ASN"), and the American Society of Echocardiography (“ASE”) (hereinafter referred to as "the Societies"), we want to thank you for the dedication and leadership you have demonstrated in serving the Medicare beneficiaries of Louisiana. We want you to know that our societies share your commitment to controlling utilization and ensuring that services are both reasonable and necessary. It is because of our mutual goal to serve Medicare patients' best interests and to protect the fiscal stability of the program that we are writing to express our unanimous support for the inclusion of a credentialing or accreditation standard as part of local medical review policies for noninvasive vascular services. We believe strongly that both the Medicare Program and Medicare beneficiaries will be better served if an LMRP which provides a choice for either credentialing of technologists or accreditation of vascular laboratories is developed.
We agree strongly with the call to carrier medical directors from Congress, the Center for Medicare and Medicaid Services (“CMS”), and MedPAC to improve the consistency of local policies. With more than 30 Medicare carrier jurisdictions having adopted the very same kind of LMRP that we request today, we believe that both the value of credentialing and accreditation and the need for LMRP consistency dictate that the current Louisiana policy be adopted in the four other states covered by your carrier.
We know that you and your fellow carrier medical directors are eager to develop medical review policy that will reflect the current medical standards for facilities and personnel qualified to perform noninvasive vascular diagnostic studies and ensure that Medicare beneficiaries receive reasonable and necessary medical care. In an era where every Medicare dollar is precious, cost effective methods of delivering safe, quality care must be utilized.
By way of background, AAVS focuses on issues important to all vascular surgeons, while SVS concentrates on issues that pertain primarily to academic vascular surgeons. AAVS represents more than 1,800 vascular surgeons and has the major responsibility for interdisciplinary relations, practice issues such as retraining, quality of care, and government relations. SVS, on the other hand, assumes responsibility for training and education, accreditation and credentialing.
SVU (formerly SVT), founded in 1977, is the only professional organization that is dedicated exclusively to the advancement of noninvasive vascular technology used for diagnostic purposes. SVU has a diverse membership of vascular ultrasound professionals that includes vascular surgeons, nurses, vascular technologists, sonographers, and other health care professionals. Of SVU's 3,800 members, nearly 900 are physicians from a variety of specialties.
Founded in 1970, SDMS is the largest professional sonography organization in the country, with approximately 13,000 sonographer and physician members. SDMS promotes the delivery of high quality abdominal and obstetrical ultrasound, echocardiography and vascular ultrasound services.
ICAVL is an intersocietal organization, sponsored by eleven medical societies, that was incorporated in 1990 for the purpose of ensuring the quality of patient care through a process of voluntary accreditation and peer review of noninvasive vascular testing. Since 1991 ICAVL has accredited over 2100 vascular laboratories in the United States, Canada and Puerto Rico.
ASN is a professional society comprised of over 800 neurologists, neurosurgeons, neuroradiologists and other neuroscientists. ASN is dedicated to the advancement of techniques used to evaluate the nervous system, including the delivery of cerebrovascular ultrasound services, magnetic resonance imaging ("MRI") and computerized tomography ("CT") testing.
ASE represents the full cardiovascular team including physicians, lab directors, nurses and sonographers who are involved in the cardiovascular care of patients including in-patient and out-patient vascular imaging. Established in 1975, ASE is a professional organization with a membership of 7,800 physicians, scientists, sonographers, nurses and other healthcare professionals. The ASE is an organization of professionals committed to excellence in cardiovascular ultrasound and its application to patient care through education, advocacy, research, innovation and service.
1. Carrier LMRP Implementation
A clear and growing majority of Medicare carrier jurisdictions have implemented LMRPs (see enclosure), like the one in Louisiana, in order to address concerns about duplicate services, inappropriate studies, and utilization concerns, as well as to ensure a minimum
level of quality of care. The information included within this report was found via Internet searches. As you will find, a link to the policy published on each carrier’s web site is provided within the report. We support these requirements and believe that they indicate a clear recognition that credentialing and accreditation go hand in hand with appropriate utilization and quality care.
2. Concerns when LMRPs Like These Are Not Used
In the absence of LMRPs like the one that Louisiana has adopted, there are a number of specific problems that have emerged in state after state. The most critical concerns that result from the absence of a credentialing or accreditation policy are discrepancies in carotid duplex results between qualified (accredited labs and credentialed vascular technologists) and unqualified providers; the need to repeat studies and its impact on patient management, and the overall failure of non-accredited facilities and personnel to establish and follow appropriate protocols. Even if we disregard the obvious impact on quality of care, the issue of appropriate utilization cannot be ignored. Our members tell us that these inequities occur frequently, and they strongly support a credentialing and accreditation standard. A recent survey (see enclosure) conducted of a sample of vascular ultrasound providers revealed that an average of about 12% of all carotid studies were repeated because of deficiencies attributable to the absence of credentialing and accreditation requirements. This figure does not include all of those situations where defective studies were performed and were relied upon in the treatment of the patient, though we know that this number is also disturbingly high.
3. Uses of Credentialing and Accreditation in the Medicare Program
There are many examples throughout the Medicare program where the Centers for 1 or its contractor carriers require or permit either Medicare and Medicaid Services (CMS)
the accreditation or credentialing of providers as a prerequisite to participating in the Medicare program.
For example, CMS recognizes the effectiveness of these measures to control inappropriate utilization in diagnostic services, including ultrasound. Independent diagnostic testing facilities (IDTF's) are required to ensure that non-physician personnel who perform tests be certified by an appropriate national credentialing body in the 2absence of state licensure. Many carriers have been motivated to adopt the LMRP that
we seek here precisely because they recognize that CMS has strongly supported these kinds of measures in this regulation.
This use of a credentialing or accreditation program is by no means unusual in the Medicare program. For the services of a physician assistant to be covered by the Medicare program, the physician assistant must have passed the national certification examination that is administered by the National Commission on Certification of
1 Formerly the Health Care Financing Administration (HCFA). 2 42 C.F.R. 410.33(c).
3 Another example is the requirement that Clinical Nurse Physician Assistants (NCCPA).4Specialists be certified by the American Nurses Credentialing Center. Further,
throughout the regulations, there are requirements for completion of provider training 5programs that must be accredited by a national accreditation.
4. Accreditation and Credentialing: Impact on Determining Reasonable and
The Social Security Act states that no payment may be made for services that are not 6“reasonable” and “necessary” for the diagnosis and treatment of illness or injury. CMS
has very broad authority in determining what qualifies as “reasonable” and “necessary,” and, has used this authority in many situations that are analogous to the accreditation or credentialing standards that have been issued by carriers in connection with vascular ultrasound and other ultrasound services.
Further, CMS has explicitly stated that, in the absence of a specific national coverage 7decision, coverage decisions are to be made at the discretion of the local contractors. As
such, where CMS has not decided the issue as to whether accreditation or credentialing should be required under the “reasonable” and “necessary” standard, that determination falls to the Carriers. In connection with this, we note that the contract between the Medicare program and the Carriers requires that Carriers institute safeguards that include 8methods of assuring that payments are for covered services that are medically necessary.
This, obviously, was a strong factor in the emergence of so many accreditation and credentialing LMRPs, involving a clear majority of all Medicare carriers. There are also many other instances of carriers requiring accreditation and credentialing of providers and provider entities by national accrediting or credentialing organizations. For instance, the North Carolina carrier requires that all centers performing stress echocardiograms be accredited by the Intersocietal Commission for the Accreditation of 9Echocardiographic Laboratories (ICAEL) by January 1, 2003; HGSAdminstrators
(Northeast Region) requires certification of sonographers and also requires facility 10accreditation for procedures such as bladder capacity ultrasounds; HGSAdminstrators
Pennsylvania requires physician assistants to have passed the national certification 11examination administered by NCCPA. Nationwide Medicare (Ohio and West Virginia)
requires that freestanding facilities that perform sleep studies be certified by the American Sleep Disorders Association and have an accredited Clinical 12Polysomnographer on staff.. Cahaba GBA requires that non-physician professionals
3 42 C.F.R. 410.74(C)(2) 4 42 C.F.R. 410.76. 5 See eg. 42 C.F.R. 485.70 (respiratory therapist, respiratory therapy technician); 42 C.F.R. 460.64 (physical therapist, occupational therapist); 42 C.F.R. 486.104 (portable X-ray technologist). 6 Section 1862(a)(1)(A). 7 See Federal Register Vol. 64, No. 80, Tuesday, April 27, 1999, pg 22621. 8 Article XII, Part B Medicare Contract 9 Policy # 00-11-M001. 10. Policy # X-38A. 11 Policy # Z-10F. 12 LMRP Polysomnography.
providing low vision rehabilitation services be certified by the Joint Commission on Allied Health Personnel in Ophthalmology or the Academy for the Certification of Vision 13 Rehabilitation and Education Professionals.
5. Policies of Professional Ultrasound Societies
The Societies believe that the language of the local medical review policy ("LMRP") concerning technologists who may perform noninvasive vascular diagnostic studies should require that all vascular technical component ultrasound services be performed by or under the direct supervision of persons credentialed as either a Registered Vascular Technologist (RVT) by the American Registry of Diagnostic Medical Sonographers ("ARDMS") or as a Registered Vascular Specialist (RVS) by Cardiovascular Credentialing International ("CCI"). Personnel credentialing and appropriate educational pathways are an appropriate and well-accepted mechanism to insure appropriate examination performance. Appropriate utilization and quality concerns can be and have been addressed effectively in carrier jurisdiction after jurisdiction by ensuring that the technologists and sonographers who perform studies are well qualified, as established by nationally recognized credentialing programs in the relevant area.
A document that reflects the input and review of leading professional societies in this 14area of health care, the Scope of Practice for the Diagnostic Ultrasound Professional
discusses the nature of the work undertaken by ultrasound professionals providing technical component services and stresses the need for appropriately credentialed individuals to administer diagnostic ultrasound studies. Completed in 2000, The Scope
was created by the Sonography Coalition, and unanimously endorsed by all of the
professional ultrasound organizations, including SVT (now SVU), SDMS, the American Institute for Ultrasound in Medicine ("AIUM"), the American Society of Echocardiography ("ASE") and the Canadian Society of Diagnostic Medical Sonographers ("CSDMS"). We have enclosed the Scope of Practice for your review and consideration.
The ICAVL accreditation program was created in 1990 by first developing the written standards for noninvasive vascular testing through the input of all of the major medical specialties involved in vascular testing. The Essentials and Standards and the application
for accreditation are periodically revised to reflect current practices. The application consists of documentation submitted by laboratories that reflect all aspects of their operation from the qualifications of the medical and technical staff through written policies and procedures for test performance. The key component of the accreditation process is the review of actual case studies and their final reports performed and interpreted by the laboratory for compliance with the standards. These reviews are conducted by physicians and technologists/sonographers that have been through the accreditation process and are trained for this purpose. The ICAVL Essentials and
Standards are available for review and printing on the ICAVL website www.icavl.org.
13 Policy # 317. 14 Scope of Practice for the Diagnostic Medical Sonographer, copyright 2000, Society of Diagnostic Medical Sonography
6. Implementation of LMRP and Transition Period
Although our members are eager for adoption of local medical review policies requiring accreditation or credentialing under the “reasonable” and “necessary” standard, we
anticipate and welcome a reasonable transition period. We propose that there be a two to three-year period to insure adequate opportunity to comply with the LMRP. Because so many of our members are already in compliance, we do not foresee a significant problem with implementation, and transitions in other jurisdictions, even shorter ones than what we propose here, have not resulted in any problems affecting access or any other concern to the program.
We would be happy to meet with you and the other carrier medical directors to discuss this issue further. Thank you for your service to the program and its beneficiaries.