Toshiba protests alleged low-field restrictionsFed up with paying top dollar for what it says are inferior MRIservices, Blue Shield of Pennsylvania has implemented an accreditationprogram that will soon determine which freestanding and mobileMRI
Fed up with paying top dollar for what it says are inferior MRIservices, Blue Shield of Pennsylvania has implemented an accreditationprogram that will soon determine which freestanding and mobileMRI facilities are good enough to participate in HMO and PPO programscovered by the 6.2-million-member payor.
The initiative is the first effort of its kind to be implementedcovering MRI equipment. An equipment accreditation program sponsoredby the American College of Radiology has inched its way towardimplementation over the last three years (SCAN 3/15/95). ACR officialshope to begin their voluntary program in November.
Detailed questionnaires were mailed April 1 to about 110 MRIfacilities services covered by Blue Shield, according to Dr. AndrewBloschichak, medical director of provider programs. The programdoes not apply to hospital-based services covered by Pennsylvania'sfour Blue Cross insurers. About half the surveys were completedand returned to Blue Shield by May 15, Bloschichak said.
The results will help officials write criteria for inspectingeach imaging site and reviewing selected MRI films, he said. BlueShield nurse or physician reviewers will perform site inspectionsbeginning in July. A peer-review committee organized in consultationwith the Pennsylvania chapter of the American College of Radiologywill examine films acquired during site visits. Bloschichak expectsthe accreditation process to be completed in late 1996 or early1997.
Accreditation standards distributed with the survey immediatelyprovoked controversy, mainly stemming from a recommendation favoringmagnetic field strengths of 0.6 tesla or stronger. Scanners performingbelow that threshold are subject to a focused review, accordingto the 13-page program description. Systems that perform fewerthan 150 scans per month will also be reviewed more closely thanhigher volume systems, the report said.
Toshiba America Medical Systems was first in line to protestBlue Shield's field-strength restrictions. Lawyers for the manufacturerof the 0.064-tesla Access and 0.5-tesla Flexart made their concernsknown to Blue Shield, claiming that the program would create anillegal restraint of trade.
In a written statement submitted to SCAN, Fredric Friedberg,TAMS senior vice president and general counsel, stated that theBlue Shield program sets criteria that have not been clinicallyproven.
"The program announced, as we understand it, would resultin significant likelihood of the creation of credentialing criteriageared toward non-accreditation of certain MRI equipment for anti-competitivereasons, including bias in favor of high-field MRI equipment againstcost-effective equipment," he wrote.
Blue Shield's Bloschichak contends that the standards are notas restrictive as they seem. He stresses that his group is examiningnumerous factors bearing on quality. Facilities failing to meetthe standards will be given several opportunities to make thegrade.
Differences in quality. The field-strength recommendation itselfwas inspired by a 1990 quality assessment of 33 Philadelphia-areaMRI services conducted by Dr. David Friedman and colleagues atThomas Jefferson University in Philadelphia (Radiology 1995;196(1):219-225).
Friedman found statistically significant differences in qualitybetween facilities equipped with scanners having field strengthsof 0.6 tesla or less and facilities equipped with higher field-strengthsystems. Findings relating to patient volume and physician experiencealso influenced Blue Shield's recommendations, Bloschichak said.
At the urging of the ACR and other advisers, Bloschichak toneddown provocative language that appeared in earlier versions ofthe criteria. For example, recommendations concerning field strengthwere originally requirements. Although the final protocols haveyet to be written, focused review reserved for lower field strengthswill involve reviewing more films than at other facilities, hesaid. What is meant by a closer review for sites that performfewer than 150 scans per month has yet to be defined. Also pendingis the policy for dealing with facilities that don't respond tothe survey.
Restrictions that apply to facilities that don't make the gradeapply only to participation in Blue Shield's HMO, PPO, and point-of-servicenetworks. They account for roughly 40% to 60% of PennsylvaniaBlue Shield business, Bloschichak said. Blue Shield is legallyobligated to reimburse all physicians who qualify for participationin its indemnity plans, he said.
Blue Shield's questionnaire poses about 40 questions that canbe answered in two hours, according to James Stuppino, MRI supervisorand chief technologist at MRI of Easton in Easton, PA, which receivedand completed one of the questionnaires. The center has a 1.5-teslascanner.
Most of the 75 possible points that can be scored from correctresponses are distributed among several areas contributing toimage quality. They include quality control issues, such as routineQC tests of a scanner's magnet and printers, contrast and sedativeadministrative protocols, biohazardous waste disposal procedures,and physician and technologist credentials, Stuppino said.
Only two points were set aside for magnet strength and type,while five points could be scored for timely report delivery,he noted. MRI of Easton was chosen for the first pilot site inspection,which was performed May 13.
The site visit took three and one-half hours. Points of emphasisincluded enforcement of rules to restrict personnel access insidethe 5-gauss line, ambulance entrance design, gurneys and wheelchairaccess, crash cart and defibrillator equipment status, claustrophobicpatient procedures, RF coil inventories, and quality control/qualityassurance procedures, Stuppino said.
Before leaving, inspectors selected films covering two spinalstudies and a study of the brain and extremities. Film notationswere masked to hide the magnet model and type, the facility name,and patient identification, Stuppino said.
Patrice Nelson, director of Langhorne MRI Center in Langhorne,PA, which would be affected by the policy, sees nothing wrongwith certifying imaging centers when the criteria are objectivelybased on image quality and staff credentials, rather than on magnetfield strength.
"MRI should not be judged on field strength," she said."
The merits of the services should be based on the quality of theimages and the qualifications of its personnel."