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Source: CMS Interpretive Guidlines for Ambulatory Surgery Centers Conditions of Coverage (CfC) - Revised - Effective 5/18/2009

CMS Conditions for Coverage for Ambulatory Surgery Centers - §416.50 - Patient Rights

Effective 5/18/2009

Q-0220

§416.50 Condition for Coverage - Patient Rights

The ASC must inform the patient or the patient’s representative of the patient’s rights, and must protect and promote the exercise of such rights.
Interpretive Guidelines §416.50

The ASC must inform each of its patients, or the patient’s representative in the case of minor patients or other situations where there is a designated representative for the patient, of their rights as an ASC patient. Further, all of the ASC’s policies, procedures and actions must be consistent with the protection of the patients’ rights articulated in this Condition. Finally, the ASC must actively promote the exercise by patients of their rights.

Survey Procedures §416.50
When there is a team surveying the ASC, survey of the Patients’ Rights Condition should be coordinated by one surveyor. However, each surveyor, as he or she conducts his/her survey assignments, should assess the ASC’s compliance with the Patient’s Rights regulatory requirements. It is particularly important for the surveyor who will be following one or more patients from start of their case to discharge to be observing how the ASC’s actions protect and promote those patients’ exercise of their rights.

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Q-0221

§416.50(a)(1) Standard: Notice of Rights

(1) The ASC must 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, in a language and manner that the patient or the patient’s representative understands […]

Interpretive Guidelines §416.50(a)(1)
The ASC must inform each patient, or the patient’s representative, of the patient’s rights. This notice must be provided both verbally and in writing prior to the date of procedure, i.e., prior to the patient’s registration or admission to the ASC. It would be acceptable, for example, at the time the patient’s procedure is being scheduled, for the ASC to advise the patient verbally that, as a patient of the ASC, he/she enjoys certain rights, and that the ASC will be sending a written notice explaining these rights prior to the scheduled procedure date. The written notice must be delivered in a manner that reasonably assures its receipt by the patient prior to the scheduled procedure date. For example, it would not be acceptable for the ASC to mail such a notice the day prior to the scheduled procedure, since it is unlikely that the patient would receive the notice prior to the procedure date. On the other hand, if the ASC has obtained an e-mail address from the patient, it would be acceptable for the ASC to e-mail a written notice on the day prior to the scheduled procedure.

It is not acceptable for the ASC to provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless:

• the referral to the ASC for surgery is made on that same date; and

• 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.

In such situations the ASC must provide the required notice prior to obtaining the patient’s informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance notice requirement. Notice must be provided regardless of the type of procedure scheduled to be performed. The regulation does not mandate a specific form or wording for the written notice, so it is acceptable for the ASC to develop a generic, pre-printed notice for use with all of its patients. The notice must:

• Address all of the patient’s rights under this 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. For example, if there are State licensure requirements that include a more expansive set of patients’ rights, as well as advance written notice of those requirements, the ASC is expected to advise the patient of all of his or her rights under both the Medicare and State licensure requirements.

• 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. It may not be practical for an ASC to have a printed patients’ rights information document in each language that a patient may understand, but it is expected that, where a written document is not practical, the ASC would make certain that its verbal explanation is clear, thorough and understandable. The ASC may need to make use of translation services in order to accomplish this. The Department of Health and Human Services has published guidance on providing service to individuals with limited English proficiency at 67 FR 4968, , February 1, 2002, and every ASC is expected to comply with this guidance.(73 FR 68717-68718)

Survey Procedures §416.50(a)(1)

• Determine what the ASC’s policy and procedures are for notifying all patients and/or their representatives of their rights in advance of the scheduled procedure date. Are the policies and procedures consistent with the regulatory requirements?

• Determine whether the information provided in the written notice to the patients and/or their representatives by the ASC addresses all of the patients’ rights listed in this Condition; if there is also applicable State law requirements for advance written notice, determine whether these requirements are also met.

• Are staff responsible for advising patients of their rights aware of the ASC’s policies and procedures for providing such notice, including to those patients with special communication needs?

• Review records, interview staff, and observe staff/patient interaction to examine how the ASC communicates information about patient rights to diverse patients, including patients who need assistive devices or translation services. - Does the ASC provide all patients with verbal and written notice of their rights prior to the date of the procedure? How does the ASC document the timing of provision of notice? If there are cases where notice is provided on the same day as the surgery, is there documentation in the file that the patient was referred to the ASC for same-day surgery by a physician who indicated it was medically necessary for the patient to have the procedure on the same day? If there are cases where surgery is scheduled and performed on the same date, how frequent are they? - Does the ASC have a significant number of patients with limited English proficiency? If so, are there written notice materials available for patients who have a primary language other than English? If not, does the ASC have translators available to provide verbal notice of their rights to ASC patients?

• Ask patients to tell you how, when and what the ASC has told them about their rights.

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Q - 0222

§416.50(a) Standard: Notice of rights (1)[…]

In addition, the ASC must –

(i) Post written notice of patient rights in a place or places within the ASC likely to be noticed by patients (or their representatives, if applicable) waiting for treatment. The ASC’s notice of rights must include the name, address, and telephone number of a representative in the State agency to whom patients can report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman. Interpretive Guidelines §416.50(a)(1)(i)

The ASC must ensure that a written notice of patient rights is posted in one or more places where they are likely to be noticed. This would include waiting rooms, recovery rooms, or any other areas where patients and/or their representatives are likely to be. Notices must be posted in at least one area. Posting in more than one area increases the likelihood that patients will see the notice, but an ASC may post only one notice and comply with the requirement, so long as the notice is posted in an area used by every ASC patient and where it is likely to be noticed. The notice must include the name, address, and telephone number of a representative in the State survey agency to whom patients and/or their representatives can report complaints. Because there can be staff turnover in the State survey agency, creating a burden for both States and ASCs to keep current the names of State staff, it is sufficient if the notice provides the title of the individual in the State survey agency to whom complaints may be reported, as well as the address and telephone number. The notice must also include, with respect to ASC patients who are Medicare beneficiaries, the Web site for the Office of the Medicare Beneficiary Ombudsman: http://www.cms.hhs.gov/ombudsman/resources.asp. Patients who are Medicare beneficiaries, or their representative, should be informed that the role of the Medicare Beneficiary Ombudsman is to ensure that Medicare beneficiaries receive the information and help they need to understand their Medicare options and to apply their Medicare rights and protections. These Medicare rights are in addition to the rights available to all ASC patients under this CfC.

Survey Procedures §416.50(a)(1)(i)

• Observe waiting rooms, recovery rooms, and other common areas used by patients to see if one or more notices of patient rights are posted. Ensure that the notices are posted in conspicuous locations in the waiting rooms, recovery rooms, or other common areas. If only one notice is posted, verify that it is conspicuously located in an area used by every ASC patient.

• Observe notices to see that each notice contains all required information.

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Q-0223
§416.50(a) Standard: Notice of rights

(1) […In addition, the ASC must –]

(ii) The ASC must also disclose, where applicable, physician financial interests or ownership in the ASC facility in accordance with the intent of Part 420 of this subchapter. Disclosure of information must be in writing and furnished to the patient in advance of the date of the procedure.

Interpretive Guidelines §416.50(a)(1)(ii)
An ASC that has physician owners or investors must provide written notice to the patient, or the patient’s representative, in advance of the date scheduled for the patient’s procedure, that the ASC has physician-owners or physicians with a financial interest in the ASC. 42 CFR Part 420 provides definitions and requirements concerning ownership and control of Medicare-participating providers and suppliers. Surveyors are not expected to have expert knowledge of what constitutes ownership and control, but ASCs are required to comply with the provisions of Part 420. ASCs that meet the physician ownership and control threshold specified in 42 CFR Part 420 must disclose their physician ownership to patients. The intent of this disclosure requirement is to assist the patient in making an informed decision about his or her care by making the patient, or the patient’s representative, aware when physicians who refer their patients to the ASC for procedures, or physicians who perform procedures in an ASC also have an ownership or financial interest in the ASC.

The written notice must disclose, in a manner designed to be understood by all patients, that physicians have an ownership or financial interest in the ASC. Information should be provided in a manner that is not only technically correct, but also easily understood by persons not familiar with financial statements, legal documents or technical language. The ASC should also be aware of the age and the cognitive abilities of its patients in developing its written notice. (72 FR 50475, August 31, 2007) Although the regulation does not require provision of the list of physician owners or investors to patients, ASCs should consider making it available upon request.

The written notice must be delivered in a manner that reasonably assures its receipt by the patient prior to the scheduled procedure date. For example, it would not be acceptable for the ASC to mail such a notice the day prior to the scheduled procedure, since it is unlikely that the patient would receive the notice prior to the procedure date. On the other hand, if the ASC has obtained an e-mail address from the patient, it would be acceptable for the ASC to e-mail a written notice on the day prior to the scheduled procedure.

Survey Procedures §416.50(a)(1)(ii)

• Ask the ASC whether it is has reported in accordance with 42 CFR Part 420 to the Medicare program whether the ASC has any physicians with ownership/financial interests. (Surveyors are not required to make an independent determination regarding whether an ASC has physicians with ownership or financial interests.) If the answer is yes, then the ASC is required to comply with the requirement for disclosure to patients. If the ASC’s response is no, then the ASC has no disclosure requirement and the surveyor does not have to investigate further.

• If the ASC indicates it has physicians with ownership/financial interests in the ASC: - Does the ASC have policies and procedures in place to make the required disclosures to patients? Are the policies and procedures consistent with the regulatory requirements? - Does the ASC provide a written notice of disclosure to all patients in advance of the date of the procedure? How does the ASC document the timing of provision of notice?

• Interview ASC staff to assess their knowledge and understanding of the physician ownership notice requirements, including the ASC’s process for delivering the notice.

• Interview patients to ask them whether they were aware that the ASC has physician owners/investors. Ask them if they recall getting a written notice about this prior to the date of their surgery.

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Source: CMS Interpretive Guidlines for Ambulatory Surgery Centers Conditions of Coverage (CfC) - Revised - Effective 5/18/2009 - Patient Rights, Pages 108-113