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CMS Issues Draft Regulations Mandating Disclosure by Physicians of Imaging Service Providers

On June 25, 2010, CMS proposed regulations that immediately impact physicians who provide diagnostic imaging services to their patients.  These regulations are required by the Healthcare Reform Act enacted on March 23, 2010.  A copy of the proposed regulations is available at http://www.cms.gov/.  The effective date of the final regulations is January 1, 2011.


The regulations, as proposed, require a physician or physician extender who orders a MRI, a CT scan or PET Scan, to provide the patient with a list of other suppliers of those services in the area and a statement that the patient may obtain the service from another supplier.  The required disclosures include:


  • A list of ten alternate suppliers of that service located within a 25 mile radius of the doctor’s office.



  • The address, telephone number and distance from the doctor’s office of each supplier.


The regulations require that disclosure be given to the patient at the time the test is ordered.  In addition, the patient must sign an acknowledgement of receipt of that disclosure.  This acknowledgment must be maintained in the patient’s medical record.
What if there are less than ten suppliers within a 25 mile radius of the office?

Then, all suppliers of the service must be listed.


What if there are no other suppliers within a 25 mile radius of the office?

 According to CMS, the disclosure does not need to be made.


What if the physician or extender ordering the test does not have the equipment necessary to perform the test?

The proposed rule only applies if the physician or physician extender ordering the test is able to perform the test.


Does this disclosure requirement apply to any tests other than MRI, CT Scan or PET Scans? 

At this time, no.  CMS is considering whether additional diagnostic imaging tests should be added to the disclosure requirement.


Can the disclosure be in electronic form? 

CMS does not specify that the disclosure must be in written form.  CMS is requiring the patient “to sign” an acknowledgment.  Presumably, electronic signatures are permitted.


Is a hospital a supplier?

The proposed regulations exclude hospitals and critical access hospitals from the definition of supplier.  A freestanding outpatient imaging clinic owned by a hospital is a supplier.


Is the disclosure required in emergency situations?

At this time, yes.  CMS is accepting comments on that issue.


May the patient choose another supplier who is not on the list? 

Yes.  CMS clearly states that the list of suppliers is non-exclusive.

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