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New "Stark Law" CMS Regulations Final

by Astrid Fiano, DOTmed News Writer | August 20, 2008

8) Where parties have failed to obtain a signature necessary to satisfy the requirements of an exception to the physician self-referral law, CMS provides for alternative compliance with the exception if the financial relationship between the entity and the referring physician otherwise fully complied with an applicable exception and: (1) If failure to comply with the signature requirement was inadvertent, the entity rectifies the failure to comply with the signature requirement within 90 days after the commencement of the financial relationship; or (2) If the failure to comply with the signature requirement was not inadvertent, the entity rectifies the failure to comply with the signature requirement within 30 days after the commencement of the financial relationship. This provision may be used by an entity only once every three years with respect to the same referring physician.

9) The Final Rule modifies the definition of ''entity'' at CFR 411.351 to clarify that a person or entity is considered to be ''furnishing'' DHS (and thus subject to physician self-referral rules) if it is the person or entity that has performed the DHS, (notwithstanding that another person or entity actually billed the services as DHS) or presented a claim for Medicare benefits for the DHS. CMS is delaying the effective date of the amendment to the definition of ''entity'' at CFR 411.351 until October 1, 2009 in order to afford parties an adequate time to restructure arrangements.
The Stark laws can be found at 42 U.S.C.S. 1395nn, and regulations to further define and carry out procedures of the law may be found in 42 C.F.R. 411.350 through 411.389.
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The 2009 Final Rules may be accessed at:
http://www.cms.hhs.gov/AcuteInpatientPPS/downloads/CMS-1390-F.pdf

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