CMS Issues Interpretive Guidelines for Ambulatory Surgery Centers' Patient Rights Condition of Participation

26 May 2009 Publication
Authors: Kevin J. Egan Shirley P. Morrigan J. Mark Waxman

Legal News Alert: Health Care

On May 15, 2009, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum providing interpretive guidelines (Guidelines) for complying with a recently enacted patient rights Condition of Participation (COP) for ambulatory surgery centers (ASCs). The new patient rights COP was published in the Federal Register on November 18, 2008, along with other COPs for ASCs. Among other things, the COP requires ASCs to “provide the patient or the patient’s representative with verbal and written notice of the patient’s rights in advance of the date of the procedure …” The Guidelines in the May 15 memorandum, which was addressed to State Survey Agency Directors, clarify what is and is not acceptable notice to patients and patient representatives under the patient rights COP.

In summary, the Guidelines provide:

  • The notice must be provided both verbally and in writing, regardless of the type of procedure.
  • It is acceptable to advise the patient verbally at the time the procedure is being scheduled and to follow up with the written notification by mail prior to the procedure date.
  • Delivery of the notice must occur in a manner “that reasonably assures its receipt by the patient prior to the date of the procedure.” Mailing the notice the day before the procedure is unacceptable, as it is unlikely the patient would receive the notice prior to the procedure date. It would be acceptable, however, for the ASC to e-mail the written notice on the day prior to the scheduled procedure if the ASC has obtained an e-mail address from the patient.
  • An ASC may not provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur unless: (1) the referral to the ASC for surgery is made on that same date; and (2) the referring physician indicates in writing that it is medically necessary for the patient to have the surgery on the same day and that surgery in an ASC setting is suitable for that patient. The ASC must provide the notice prior to obtaining the patient’s consent for the procedure.
  • The notice must be “provided and explained in a language and manner that the patient or the patient’s representative understands, including patients who do not speak English or with limited communication skills.” CMS acknowledged that it might not be practical for an ASC to have a printed patients’ rights information document in each language that a patient may understand. However, when a written document is not practical, CMS expects the ASC to make certain that its verbal explanation is clear, thorough, and understandable and may need to make use of translation services in order to accomplish this.

In the Guidelines, CMS did not mandate that a specific form or wording be used in the notice and indicated that a generic, pre-printed notice would be acceptable. The Guidelines do require, however, that the notice “address all of the patient’s rights under the Condition, as well as any other patient-related rights for which advance written notice is required under State or other Federal law for ASC patients.”

The full text of the Conditions for Coverage — Patient Rights appears in Title 42 of the Code of Federal Regulations at Section 416.50 (42 C.F.R. § 416.50). 


Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and our colleagues. If you have any questions about this update or would like to discuss this topic further, please contact your Foley attorney or the following:

Rachelle (Shelly) R. Hart
Milwaukee, Wisconsin
414.297.5656
rhart@foley.com

Shirley P. Morrigan
Los Angeles, California
213.972.4668
smorrigan@foley.com

Robert E. Slavkin
Orlando, Florida
407.244.7135
rslavkin@foley.com

J. Mark Waxman
Boston, Massachusetts
617.342.4055
jwaxman@foley.com

Kevin J. Egan
Chicago, Illinois
312.832.4361
kegan@foley.com

Michael Scarano
San Diego, California
858.847.6712
mscarano@foley.com

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