Final In-Office Ancillary Service Exception Disclosure Requirements to Take Effect January 1, 2011
December 22, 2010
New disclosure requirements to the In-Office Ancillary Services (IOAS) exception, issued as part of the final 2011 Physician Fee Schedule (the “PFS,” a Final Rule with a Comment Period [PDF]), call for physicians to meet minimal, but essential requirements. Section 6003 of the Patient Protection and Affordable Care Act of 2010 (PPACA) amended the IOAS exception to require referring physicians to provide written notice to patients being referred for CT, MRI or PET that the imaging services can be purchased from suppliers other than the physician. Although there was initially confusion regarding the provision’s effective date, CMS clarified in its proposed version of the rule that the additional criteria added by PPACA was not self-implementing and that compliance by physicians would not be required until after the issuance of a final rule.
The Final Rule takes a much more measured approach than the rule as originally proposed. The Final Rule dispenses with the proposed requirement that the required disclosures be signed by the patient and retained by the physician. It also significantly decreases the amount of information physicians are required to provide to patients with regard to alternate suppliers. The net result is a Final Rule that reduces or eliminates many of the more burdensome provisions that had been proposed. Providers should remember, however, that a failure to comply with the Final Rule’s requirements will prevent compliance with the In-Office Ancillary Services exception to the Stark law.
The Final Rule, as part of the 2011 PFS, takes effect January 1, 2011 (meaning that it will apply to all services provided on or after that date). Physicians should begin the preparations necessary to provide the required disclosures to ensure that their forms and internal processes are patient-ready on the first of the year.
Changes to the Proposed Rule
When the proposed version of the Rule was issued, we wrote about it here. CMS received approximately 45 comments to the proposed rule, and the final version of the Rule reflects many of the concerns expressed by commenters. In short:
While the remainder of the Proposed Rule’s provisions was finalized as proposed, CMS’s response to comments in the preamble of the Final Rule provides additional guidance as to how CMS will interpret certain provisions. The preamble to the Final Rule noted the following:
Statutory requirements mandate disclosures for CT, MRI and PET referrals. Given the statutory requirements, the Final Rule has provided physicians a fairly flexible means of compliance with a minimum of “paperwork.” Physicians who rely on the In-Office Ancillary Services exception to the Stark law, however, must be careful to maintain strict compliance with the new requirements beginning on the first of the year. Failing to properly document a disclosure or to make reasonable efforts to include viable suppliers within the Final Rule’s 25 mile limit may subject otherwise compliant self-referrals to scrutiny and the substantial penalties that come with non-compliance.
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