Quality Improvement Organization Manual (Pub. 100-10), Ch. 5 § 5030.2
Initial Information Collection
5030.2 – Initial Information Collection
(Rev. 28, Issued: 10-21-16, Effective: 10-21-16, Implementation: 10-21-16)
After receiving a call from a beneficiary or during the review of a complaint received via
correspondence, the QIO should collect and record basic information about the potential
complaint in the CMS-designated case review system on an ongoing basis during the course of a
review, including completion of the initial contact.
In addition, the QIO must determine whether the complaint is eligible for Immediate Advocacy,
or if Peer Review as part of a Beneficiary Complaint Review (under 476.130), or a General
Quality of Care Review (under 42 CFR §476.160)) is required during the initial call or contact
with the beneficiary.
NOTE: Written beneficiary complaints are not eligible for Immediate Advocacy. These steps
apply only to telephonic or face-to-face encounters with a beneficiary who is making or has
made a complaint about a quality of care concern.
To meet the deadlines and timeframes imposed by 42 CFR §476 for Quality of Care Reviews,
QIOs should respond to messages received after normal business hours by close of the next
business day.
The following list contains information deemed necessary for the completion of intake process of
a beneficiary complaint. The QIO should attempt to collect this information during the initial
contact from the beneficiary. Much of the information might already be accessible using the
CMS-designated case review system. (See §5030.4.) If specific information is not readily
available, the QIO should ensure appropriate follow-up is completed to obtain the information
from the beneficiary.
The following information is the minimum necessary for the QIO to perform the initial screening
of a beneficiary complaint and must be collected. The QIO should obtain or note the following
information:
1. The beneficiary’s name, age, date of birth, sex, Healthcare insurance identification
number, and race/ethnicity (if willing to provide).
2. The beneficiary’s phone number, address, and email address.
3. The name of the caller if other than the beneficiary, including phone number, address,
and email address; this person should be e.g. the beneficiary representative.
NOTE: If the caller is other than the beneficiary (e.g., beneficiary representative) the
QIO must obtain a completed Authorization of Representative Form included in
Appendix 5-1.2), prior to continuing with specifics about health care issues and the
detailed complaint.
4. The date and time the complaint was received.
5. General information about the health care issue(s) surrounding the complaint. The focus
of the information collected must be on the general circumstances related to the episode
of care. The beneficiary’s assumptions and/or conclusions about the care received,
including statements regarding a single problematic aspect associated with an episode of
care or why the beneficiary believes the care did not meet professionally recognized
standards of care, are not necessary to process the complaint.
NOTE: QIOs should avoid narrowly focusing the scope of a review based on the
beneficiary’s statements about why care was problematic because most beneficiaries are
not health care practitioners or providers, and thus they are not likely to have sufficient
knowledge and/or experience to render such judgments about the care received. See
§5030.1, “Scope of Complaint” for additional instructions regarding the nature of the
complaint.
6. The QIO must request the beneficiary’s permission to disclose to the
practitioner/provider the beneficiary’s name and the reason for any medical information
requested and document the beneficiary’s response. A QIO is required to inform the
practitioner and/or provider that the medical information is being requested due to a
beneficiary complaint. See 42 CFR §476.130(b) (2).
NOTE – The QIO must explain to the beneficiary that if he/she chooses not to disclose
his/her name as part of the complaint process, the complaint may be processed as a General
Quality of Care Review, if the QIO deems appropriate. (See §5100 General Quality of Care
Review.)
Any additional information that may be helpful in processing the complaint should also be
documented in the CMS case review system -- e.g., notes related to the conversation with the
beneficiary, any discussions with internal staff about the complaint.
In order to properly conduct screening, the QIO must be able to identify the following from the
information the beneficiary provides in the complaint:
1. The State in which the complaint originates.
NOTE: The QIO for the area that includes the State in which the care was received is the
QIO that has authority to conduct the review.
2. The name of the practitioner(s) or provider(s) who is/are the subject of the complaint.
3. The setting in which the care that is the subject of the complaint took place/originates—
e.g., during a physician’s office visit, hospital admission, skilled nursing facility stay, or
other.
4. Whether the beneficiary:
•
Has been discharged from the facility or is no longer receiving services;
• Is still in the facility or is still receiving the services in question; and
• Intends to file a written complaint.
5. The overall severity of the Quality of Care Concerns involved in the complaint to
determine whether Immediate Advocacy can be offered and if any concern could be
deemed “gross and flagrant,” “substantial,” or “significant.” (See §5035). The QIO
staff member who identifies the potential “gross and flagrant”, “substantial”, or
“significant” concern should consult with the QIO as needed in making such
determinations.
If any concerns the beneficiary raised could be designated “gross and flagrant,”
“substantial,” or “significant,” the complaint is NOT eligible for Immediate Advocacy.
See §5035 for information and process requirements for Immediate Advocacy. The QIO
may consult with the QIO as needed in making such determinations.
The QIO is responsible for coordination and implementation of the medical record review
process through the application of established written criteria based on typical patterns of
practice in the QIO area, or use of national criteria where appropriate. See 42 CFR §476.100
(c)(1). The QIO assesses medical necessity, appropriate level of care and quality of services
provided. The QIO is responsible for timely and accurate completion of all medical record
review including data entry into the CMS-designated case review system in accordance with
CMS contract requirements.
Any additional information that may be helpful in processing the complaint should also be
collected and documented (e.g., notes related to the conversation, any discussions with internal
staff about the complaint.
In situations where the beneficiary states that he/she may cause harm to self or others or where
the beneficiary indicates other patients may be at risk of potential harm, the QIO should
immediately contact the QIO to discuss the circumstances.
The beneficiary must provide permission to disclose to the practitioner/provider the
beneficiary’s name and the reason for any medical information requested. A QIO is required to
inform the practitioner and/or provider that the medical information is being requested due to a
beneficiary complaint. See 42 CFR §476.130(b)(2).
The QIO is expected to explain to the beneficiary that if he/she chooses not to disclose his/her
name as part of the complaint process, the complaint may be processed as a General Quality of
Care Review, if the QIO deems appropriate. (See §5100 General Quality of Care Review.)
NOTE: Once a written complaint is received, Immediate Advocacy may not be offered.
NOTE: If it is determined at any point during the intake of a complaint that the matter is not
within the QIO’s review responsibility (e.g., inappropriate referral for a billing issue, the matter
occurred outside the QIO’s service area), but is the responsibility of another CMS component or
contractor such as the Medicare Administrative Contractor (MAC), the caller should be
provided with sufficient information to contact the appropriate entity. The QIO may offer to refer
the matter to the other entity after obtaining the beneficiary’s oral agreement (Written consent is
not required).
• Alternatively, if it is determined that the call is not a Beneficiary Complaint but does
relate to an issue for which the QIO is responsible (e.g., an expedited discharge appeal),
the QIO must follow the procedures in place for those types of reviews.