• Health Care Reform Act Requires Patient Notices for In-Office MRI, CT, or PET Scan Referrals; Hasty Drafting Leads to Effective Date Questions
  • May 4, 2010 | Author: Thomas R. Neal
  • Law Firm: Krieg DeVault LLP - Carmel Office
  • Section 6003 of the 2010 Health Care Reform Act (the "Act") amends the Stark Law's statutory In-Office Ancillary Services Exception, which protects physicians' referrals for certain designated health services ("DHS") furnished in the physicians' offices.  Specifically, the Act requires that, at the time of referral, a referring physician inform, in writing, the patient that he or she may obtain MRI, CT, or PET imagining services (or other DHS that the Secretary of HHS may identify at a future date), from a person other than the referring physician, a physician in the same group practice as the referring physician, or an individual directly supervised by the physician or by another physician in the group practice.  This is targeted at physicians other than radiologists who own their own imaging equipment, especially the high-priced service models.  In addition, the Act requires the referring physician to provide the patient with a written list of suppliers "who furnish such services in the area in which the patient resides."  The effective date for this change as set forth in the Reform Act is January 1, 2010, and is to apply to all such services as of that date.  Clearly, the publication of the Act as adopted on March 23, 2010, with a mandate like this for January 1, 2010, leaves some questions as to the practical effect of such legislation.  Retroactive notices are not appropriate and not intended.  Notices for ongoing services are likely intended, but a lack of explanation of how this should be done will inhibit compliance.  The Act requires the HHS Secretary (CMS) to promulgate rules for these interpretations and procedures.

    A technical reading of the Act's notice provision leads some to conclude the mandate will only be effective upon the adoption of these rules.  The impossible date of January 1, 2010, the specific directive to CMS for rules and the practical unanswered questions supports this approach.  For example, a large provider with in-office imaging may serve patients from a wide geographic area.  How is this provider to know where all the MRIs to be covered by the notice are if the patient is from a metropolitan area in another state?  The almost impossibility of performance and the lack of clear drafting of this part of this hurried legislation can lead to the conclusion that the practical approach here, without verbal or written guidance from CMS in the meantime, is to wait for the rules.  We believe this is a risk management assessment for the providers.

    If a provider covered by these provisions prepares a list of known imaging providers in its own vicinity to give to patients along with the statement that the patient may get the imaging done there or elsewhere, it will have established a good faith effort at minimal compliance.  The provider may also list and suggest its own location, as it has done historically.  The provider can wait for CMS rules on these notices, but given the enormous stress on that office with all the other reform agenda, the agency may not get around to these rules for months.  Then, if the rules provide for some minimum compliance effort beginning March 23, 2010, the wait-and-see provider will be unable to comply.  The likelihood of that occurring may be small, but some providers are not risk tolerant when Stark rules are involved.

    The more conservative approach should be to attempt to comply with the supposed intent of the Act with some notice of alternative suppliers now, and if the rules require modification later, the provider will at least have a record of good faith compliance.

    The covered provider, such as a physician practice, is only required by the Act to provide the notice to patients being referred for MRI, CT, or PET services in its offices.  It is possible that CMS will expand the scope of the notice requirement to include other DHS, such as labs or other imaging studies at a later time.  The Act also requires that the notice be provided "at the time of referral."  This would imply that the notice could be included on an order form (assuming the appointment has not already been made with the imaging supplier).  Providing alternative locations or suppliers of imaging on the provider's website or with the initial visit paperwork would not comply with the "at the time of referral" requirement, as such notices would be too detached from the actual referral.  There is no provision of the Act that requires the patient to sign the notice.  A provider will want to ensure that its policies and procedures relative to delivery of the notices are simple but specific, and are followed.  There is literally no guidance available on how a provider is to learn what services are available "where the patient lives," and especially if the patient is not local. A number of providers are contacting CMS for guidance on this immediately. Until then, the good faith effort at compliance seems to be a consensus response.