Chapter 9 TOPS_Amend 2_05112011.docx

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S3-02-01 Baltimore, Maryland 21244-1850

Office of Clinical Standards and Quality

TOPS MEMORANDUM

QIP TOPS

CONTROL NBR: 2011-02

DATE: May 12, 2011

SUBJECT: Revisions to QIO Manual Chapter 9, Sanction and Abuse Issues, Sections 9000 – 9030 – Amendment #2 as of May 12, 2011

The purpose of this memorandum is to standardize Quality Improvement Organizations’ (QIO) processes for Sanction review responsibilities effective August 1, 2011. The Sanction review process is outlined in Sections 9000 -9030 of the QIO Manual Chapter 9.

The content of this memo supplements and supersedes the information in the October 3, 2003, version of the QIO Manual Chapter 9, any previously issued QUEST Q&A guidance, and any previously issued Transmittal Operating Policy and Procedure System (TOPS) and Standard Data Processing System (SDPS) memos related to Chapter 9 Sanction review processes. A revised version of the Chapter 9 QIO Manual is currently going through the clearance process.

Revised Section 9010: Definition of Potential Violations Step 1: The following are the three statutory obligations of practitioners and other persons that, if not met, may form the basis for the initiation of a sanction action. Also included are examples of QIO responsibilities and violations by practitioners and other persons that may occur related to the obligations:

1. Services or items ordered or furnished to Medicare patients are to be provided economically and only when, and to the extent, medically necessary.

1. Services or items ordered or furnished are supported by evidence of medical necessity and quality in the form and fashion (and at such time) that the QIO may reasonably require for review (including copies) in exercising its duties and responsibilities.

1. Items or services ordered or furnished are to be of a quality that meets professionally recognized standards of care.

Step 2: When identifying a violation, the QIO must (See 42 CFR 1004.40) indicate whether the violation is a gross and flagrant violation or is a substantial violation in three or more instances.

1. Substantial Violation in Three or More Instances: This is defined as a pattern of care that is inappropriate, unnecessary, does not meet recognized professional standards of care or is not supported by the necessary documentation of care as required by CMS.

1. Gross and Flagrant Violation: A gross and flagrant violation is a violation of an obligation which presents imminent danger to the health, safety, or well being of a Medicare beneficiary or which places the beneficiary unnecessarily in high-risk situations.

When considering the sanction process the QIO must consider the degree that the practitioner's actions were inconsistent with the professional knowledge at the time care was provided and the degree of harm that occurred to the patient. Care or services provided to or omitted from a patient that is obviously or exceptionally culpable or wrong should be considered gross and flagrant.

Revised Section 9015: QIO Sanction Panel Designation of participants needed for the QIO sanction panel and to participate in the hearing/review of a sanction case will be the responsibility of the QIO's Medical Director and appropriate Review Department staff. The QIO sanction panel must consist of a minimum of two physicians:

1. No physician member of the QIO panel may be in direct economic competition with the practitioner or other person being considered for sanction;

1. No physician member of the QIO panel may have a substantial bias for or against the practitioner or other person being considered for sanction;

1. At least one member of the QIO panel meeting with the practitioner or other person should practice in a similar area (e.g., urban or rural), and at least one member of the panel must be in the same specialty (both requirements could be met by a single individual). A dentist, optometrist, podiatrist, etc., will be included on the Sanction Panel as necessary to accomplish equitable peer/provider review.

1. Rural hospital representation will be included on Sanction Panels when appropriate, as well as representation from across the state.

1. An osteopath will be included on the sanction panel when the physician under review is a Doctor of Osteopathy.

When the sanction involves a provider/facility, health care practitioners other than physicians may be added to the Panel as necessary (e.g., Administrators, Directors of Nursing, Directors of Laboratory Services, etc.). These professionals will be from a provider similar in size as the involved provider and from the appropriate rural versus urban area.

Duties and Responsibilities of Sanction Panels:

1. The panel will ensure that the sanction process is followed according to the plan, including maintaining proper documentation and providing due process for involved parties.

1. The panel will review the case and make recommendations prior to forwarding recommendations to the CMS regarding potential sanctions.

1. The panel will ensure appropriate members participate in the sanction meeting with the provider/practitioner.

1. The panel will oversee the monitoring of the physicians and/or providers who are under CAPs.

1. The panel will review the case and make recommendation prior to forwarding recommendations to the Office of the Inspector General (OIG) regarding sanction action.

1. The panel will communicate with and respond to the (OIG) regarding sanction activity.

Revised Section 9020: Extenuating Circumstances In a case where an involved practitioner relocates to another QIO area before a final determination of a violation has occurred or a final sanction recommendation has been made to the OIG, QIO will follow the procedures below:

1. If the QIO is able to make a final determination, having afforded due process, the QIO will notify the practitioner and forward a report to the OIG. In addition, the QIO will notify the QIO in the State or territory of the practitioner's new residence or where the practitioner is now practicing of the action taken.

1. If a final determination cannot be made, the original QIO will send a written notification to the practitioner, which will include the following:

1. The results/findings of the QIO's review activity and the action that could be taken based on these results/findings;

1. A statement that action cannot be taken because the practitioner has relocated or is practicing outside our review area;

1. A notice that the case is being referred to the QIO in the state where he/she is now practicing for further action as deemed appropriate; and,

1. A statement that if the practitioner again practices in original QIO's review area, the original QIO will re-evaluate the case and may reopen it depending upon the action taken by the receiving QIO.

If a QIO receives a referral from another QIO, follow the instructions below:

1. Notify the practitioner in writing of the referral received from the originating QIO;

1. Specify the action to be taken. The QIO may or may not adhere to the recommendations of the originating QIO. However, if the originating QIO's recommendation is not followed, you will document the rationale for why another course of action was chosen. The QIO’s CMS Contract Officer’s Technical Representative (COTR) will concurrently be notified of such decisions (including rationale).

1. Monitor/evaluate in accordance with our plan of action;

1. Issue an initial sanction notice based on the QIO's finding regarding the violation; and

1. Render a final determination in the sanction action with appropriate notification(s)/report(s) as would be performed for any other sanction action.

If the QIO finds additional cases related to the same G&F/Substantial concern during the corrective action plan (CAP) or the QIO finds additional quality of care concerns during the CAP, the QIO should give written notice to the practitioner or other person of any action the QIO takes as a result of additional information received (See 42 CFR 1004.60(b) and 1004.70).

Revised Section 9030: QIO Process for Developing Sanction Case

9030.1 - Initial Recommendation A QIO Sanction Committee shall receive all cases that are either gross or flagrant or have substantial violations in three or more instances. The QIO sanction committee is made up of at least three QIO staff and/or board members and must include the Review Manager and Medical Director. Except for the Review Manager and Medical Director, no members of the QIO Sanction Committee shall be a member of the QIO Sanction Panel. The QIO sanction committee receives the case upon initial referral. Two (2) additional Physician Reviewers with similar training shall review the case. The QIO Sanction Committee should make their recommendation based on all three Physician Reviewers’ determinations. In most cases, this means basing a recommendation on the majority of the determinations. The QIO Sanction Panel's recommendation regarding potential sanction activity shall be made within two business days after the two additional reviews have been completed.

If the QIO sanction committee does not recommend sanction, then the original review process continues.

If the QIO sanction committee recommends sanction, then they must notify the CMS Theme Lead and QIO’s COTR (see 9020.2).

9030.2 - Notification to CMS Notify the CMS Theme Lead and QIO’s COTR of the potential violation and review any findings with them to determine if it is appropriate to proceed with the sanction action or whether the QIO should pursue alternative measures (e.g.,.System-Wide Change (SWC), licensing board notification, or other notifications). The QIO Sanction Committee shall contact the CMS Theme Lead or COTR within one business day after making recommendation.

If the CMS Theme Lead or COTR determines that the case is not appropriate for sanction activity, then continue with your review process (i.e., quality of care, appeal or utilization review). The QIO shall pursue alternative measures at the direction of the CMS Theme Lead or COTR.

If the CMS Theme Lead or COTR determines that the case is appropriate for sanction activity, then suspends the original review process and continues with the sanction process (see 9020.3). The original review process will not be continued since correspondence with the practitioner and final determination will now be handled by the QIO sanction panel.

9030.3 - Notify Practitioner/Provider Send the practitioner or other person written notice of the identification of the violation making sure the notice contains:

1. The obligation(s) involved;

1. The situation, circumstances, or activity that resulted in the violation;

1. The authority and responsibility you have to report violations of any obligation under 1156(a) of the Act;

1. A suggested method for correcting the situation, and a time period for corrective action, if appropriate;

1. The sanction you could recommend to OIG;

1. The right of the practitioner or other person to submit to you within 30 days of receipt of the notice (the date of receipt is 5 days after the date on the notice, unless there is reasonable showing to the contrary) additional information and/or a written request for a meeting with you to review and discuss the finding; and

1. A copy of the material you used in arriving at your findings, except your deliberations, as set forth in 42 CFR 480.139.

1. Seek consent to disclose findings to the beneficiary.

1. Refer to Chapter 5 [5250.3], Preparation and Mailing of Final Decision Letter to Beneficiary, for content of the letter when consent or not consent is obtained from the practitioner.

The QIO Sanction panel shall send the letter within two business days of receiving determination from CMS Theme Lead or Project Officer.

9030.4 - Meeting with Practitioner/Provider If the practitioner or other person requests a meeting with the QIO Sanction Panel (See 42 CFR 1004.50), conduct a meeting following the conditions specified at 42 CFR 1004.40(6)(i)-(iii).

1. The meeting must be held within 30 days of receipt of the request by you, but may be extended for good cause;

1. The practitioner or other person may have an attorney present; and the attorney, if present, will be permitted to make opening and closing remarks, ask clarifying questions, and assist the practitioner or other person in presenting testimony of expert witnesses, who may appear on behalf of the practitioner or other person.

1. The QIO may also have an attorney present at the sanction meeting, but it is not required and often is not necessary. The meeting is not a legal hearing, but instead a chance for the involved practitioner to present additional information and seek clarification.

1. Three physicians from the QIO sanction panel must be present.

1. The QIO may allow the practitioner or other person five working days after the meeting to provide you with additional relevant information that may affect your finding; and

1. A verbatim record must be made of the meeting and made available to the practitioner or other person promptly.

9030.5 - Initial Sanction Recommendation The decision will be reached by a majority vote. (NOTE: The Chairperson is a nonvoting party.) The (PR) who was solely or primarily responsible for making medical judgments and developing the record and initial findings to be used at the discussion will not vote on the QIO's final determination.

Upon completion of the Physician Reviewer Assessment Format (PRAF) or by recommendation of the panel, the panel needs to make a final determination based on all of the facts contained in the case file.

The sanction panel will notify the practitioner/provider in writing of any action taken as a result of the additional information received.

1. Deferment of Decision: The sanction panel may accept a proposed method of corrective action and time frame for completion. Should this occur, a final sanction decision will not be made until the appropriate amount of time has elapsed for revaluation of the physician or provider.

If the corrective action is not taken within the specified time frame, if a time frame and/or corrective action cannot be agreed upon or if previous Quality Improvement Plan (QIPs) have been unsuccessful, the QIO will send a report and recommendation to the OIG.

1. Reversal of decision: If the sanction panel members believe the additional information presented is sufficient and a sanction recommendation is no longer warranted, the original decision will be reversed. An alternate method of corrective action and follow up may be determined by the panel should problems remain evident which do not meet the definitions of gross and flagrant or substantial.

1. Affirmation of decision: The sanction panel may decide to uphold the original sanction recommendation.

The final sanction recommendation, if made, will be forwarded to the QIO's Quality Improvement Committee.

If the QIO affirms the findings, the QIO may suggest that a written method of correction is in order for the situation (See 42 CFR 1004.60).The QIO has the flexibility and may use its discretion in working with the practitioner or other person when a CAP is appropriate. When providing the written CAP, the QIO must specify a time period within which the QIO expects the situation to be corrected. This CAP may be in conjunction with or a continuation of a prior CAP, or may be a new proposal based on additional information received. If the QIO determines after careful consideration that implementation of a CAP would not be appropriate, the QIO must document the rationale for the decision. Include this documentation in your report to OIG. However, if the findings are resolved to the QIO's satisfaction, the QIO may modify the initial finding or recommend that the case be closed.

9030.6 - Request a CAP Request a written CAP from the provider/practitioner as appropriate. CAPs should be submitted to the QIO Sanction Panel within 30 days of request. The panel must review and approve the CAP and/or request modifications. Should the panel recommend an alternative form of or additions to the corrective action, it will include time frames and a method of follow-up evaluation. The QIO Sanction Panel must also provide clear instructions on what constitutes successful completion of the CAP. All CAPs will be communicated to the practitioner/provider in writing. The practitioner/provider must sign and return a copy of the CAP to the QIO for documentation purposes, and must submit periodic reports.

9030.7 - Monitor CAP Monitor and review the outcome of the CAP and determine if it was acceptable. The practitioner must demonstrate improvement using quantifiable measures over a 12 month period. The QIO Sanction Panel must, at minimum, evaluate the practitioner's results on a quarterly basis. If at any time the QIO Sanction Panel identifies additional gross and flagrant or a substantial number of substantial concerns, the QIO Sanction Panel must refer the new concern(s) to the QIO Sanction Committee (see 9020.1). The QIO Sanction Panel may end the CAP before 12 months and pursue a sanction recommendation to the OIG if the QIO Sanction Panel determines patients are in imminent danger.

If after 12 months the QIO Sanction Panel determines the results were acceptable, then case will be closed.

If the QIO Sanction Panel determines the results to be unacceptable, go to section 9020.7. The QIO Sanction Panel's determination shall be based on majority vote.

9030.8 - Report of Recommendation A. Manner of Reporting - If the violation(s) identified have not been resolved, the QIO must submit a report and recommendations to OIG at the field office with jurisdiction (See 42 CFR 1004.80).

NOTE: The QIO shall also report the violation to the state licensing board at this time.

B. Content of Report - The report must include the following information:

1. Identification of the practitioner or other person and, when applicable, the name of the director, administrator, or owner of the entity involved;

1. The type of health care services involved;

1. A description of each failure to comply with an obligation, including specific dates, places, circumstances and other relevant facts;

1. Pertinent documentary evidence;

1. Copies of written correspondence, including reports of conversations with the practitioner or other person regarding the violation and, if applicable, a copy of the verbatim transcript of the meeting with the practitioner or other person;

1. The QIO's finding that an obligation under 1156(a) of the Act has been violated, that the violation is a substantial violation in three or more instances, or is gross and flagrant;

1. A case-by-case analysis and evaluation of any additional information provided by the practitioner or other person in response to your initial finding;

1. A copy of the CAP that you developed, and documentation of the results of the plan;

1. The number of admissions by the practitioner or other person reviewed by you during the period in which the violation(s) were identified;

1. The professional qualifications of QIO reviewers; and

1. The QIO's sanction recommendation.

C. QIO Recommendation - The report must specify:

· The sanction recommended;

· The amount of monetary penalty recommended, if applicable;

· The period of exclusion recommended, if applicable;

· The availability of alternative sources of services in the community, with supporting information; and

· The county or counties in which the practitioner or other person furnishes services.

NOTE: The QIO's recommendation to OIG must be based on documentation of the type of offense involved, the severity of the offense, the deterrent value, a consideration of the practitioner's or other person's previous sanction record, the availability of alternative sources of services in the community, and any other factors that the QIO considers relevant such as the duration of the problem (See 42 CFR 1004.90).

D. Rejection of QIO Recommendation -- OIG will inform the QIO of the date it received the QIO's report and recommendation, will review the report to determine whether the QIO has followed the regulatory requirements, and will determine if a violation has occurred (42 CFR 1004.100). If OIG decides that a sanction is not warranted, it notifies the QIO and the affected practitioner or other person and the licensing board that the recommendation to sanction is rejected (See 42 CFR 1004.100(c)).

E. Decision to Sanction -- If OIG decides that a violation of an obligation has occurred; it determines the appropriate sanction by considering (See 42 CFR 1004.100(d)):

1. The QIO's recommendation;

1. The type of offense;

1. The severity of the offense;

1. The practitioner's or other person's previous sanction record;

1. The availability of alternative sources of services in the community;

1. Any prior problems the Medicare or State health care programs have had with the practitioner or other person; and

1. Any other matters relevant to the particular case.

9030.9 - Notification of Final Outcome If the findings are not resolved satisfactorily as specified in 9015, the QIO must (See 42 CFR 1004.70):

1. Submit a report and your recommendation to OIG;

1. Send the affected practitioner or other person a concurrent final notice, with a copy of all the material that is being forwarded to OIG, advising that:

1. The QIO has submitted its recommendation to OIG;

1. The practitioner or other person has 30 days from receipt of the final notice to submit any additional written material or documentary evidence to OIG at its headquarters location. The date of receipt is presumed to be 5 days after the date on the notice, unless there is a reasonable showing to the contrary; and

1. Due to the 120-day statutory requirement specified in 42 CFR 1004.100(e), the period for submitting additional information will not be extended and any material received by OIG after the 30-day period will not be considered.

The QIO must provide notice to the State medical board or to other appropriate licensing boards for other practitioner types when you submit your report and recommendations to OIG with respect to a physician or other person whom the board is responsible for licensing.

If you have questions regarding this memorandum, please contact Linda D. Smith by e-mail at Linda.Smith@cms.hhs.gov or by telephone at 410-786-5650.

image1.png oleObject1.bin