Attachment_J.3-A_TO_0002_Case_Review_SOW.docx

Attachment J.3-A Case Review SOW

Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) 12th Scope of Work (SoW)

Centers for Medicare & Medicaid Services

Center for Clinical Standards & Quality Quality Improvement & Innovation Group

Beneficiary Protection: Case Review Services

Contract No. _____________________

Task Order No. __________________

Table of Contents

ATTACHMENTS

Attachment J.3-B, Schedule of Deliverables Attachment J.3-C, Evaluation Measures Table Attachment J.3-H, BFCC-QIO Estimated Level of Effort (LOE) by Case Type

Introduction The Centers for Medicare & Medicaid Services (CMS) requires expert healthcare quality improvement (QI) services for the statutory Case Review services. This Task Order (TO) is issued under the terms and conditions of the BFCC Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Independently, and not as an agent of the Government (except if noted herein), the BFCC-QIO shall furnish all the necessary services, qualified personnel, material, equipment, and workspace facilities, not otherwise provided by the Government, as needed to perform the requirements of this TO.

Personnel Requirements The BFCC-QIO shall provide personnel for this TO in accordance with Section C.3 BFCC-QIO IDIQ Services of the IDIQ SOW. Qualifications for Key Personnel will be provided in this TO.

2.1. Designation of Key and/or Other Recommended Personnel

Certain positions may be designated as “Key Personnel”, within the meaning of Health and Human Services Acquisition Regulation 352.270-5. For this TO, the following positions are determined as Key or Other Recommended Personnel:

Key Personnel A. Medical Director (Clinical MD) (1 FTE)

1. Demonstrated experience overseeing the medical care and other designated care and services in a health care organization or facility.

2. Demonstrated experience and responsibility for coordinating medical care and helping to develop, implement and evaluate resident care policies and procedures that reflect current standards of practice and new or proposed treatments, practices, and approaches to care.

3. Demonstrated knowledge of existing and emerging healthcare industry trends, practices and requirements that impact all domains of quality.

4. Proven ability to provide input to surveyors on physician issues, individual clinical issues, and clinical practices.

5. Proven ability to ensure that appropriate systems exist to facilitate sound medical care, establish and apply capable monitoring systems and effective documentation and follow up of findings, and help improve physician compliance with regulations, including required visits.

6. Ability to influence, facilitate, coach and mentor others to affect positive change.

7. Demonstrated experience and skills in excellent oral and written communication spanning executives to the general public.

B. Project Coordinator (1 FTE)

1. Demonstrated experience in healthcare quality improvement and the ability to provide quality services and deliverables in a timely manner.

2. Demonstrated experience with process improvement and PDSA approach in developing, implementing and revising QI initiatives.

3. Demonstrated skill and experience working closely with project management leadership team, project managers, liaise with cross functional teams to complete a variety of tasks integral to the timely and successful launch and completion of both internal and external projects.

4. Proven skill and experience in project management, managing people, project planning and coordination of daily activities, data analysis, constructive reporting, project management techniques and tools.

5. Proven skill and experience in critical-thinking, innovation, and problem-solving, recommending successful solutions, including the spread and implementation of such solutions for large scale change.

6. Proven skill and experience in excellent oral and written communication spanning executives to the general public.

C. Case/Claims Review Lead (1 FTE)

1. Demonstrated experience in healthcare QI and the ability to motivate and lead a Task team to provide quality services and deliverables in a timely manner

2. Demonstrated experience within the specific task domain is preferred

3. Proven skill and experience in project management, managing people, project planning and coordination of daily activities, data analysis, constructive reporting, project management techniques and tools

4. Proven skill and experience in critical-thinking, innovation, and problem-solving, recommending successful solutions, including the spread and implementation of such solutions for large scale change

5. Proven skill and experience in excellent oral and written communication spanning executives to the general public Other Recommended Personnel A. Quality Improvement (QI) Coordinator (1 FTE)

1. Specific healthcare work experience in quality improvement, systems design, or project management and analysis

2. Proven skill in design, direction and oversight of implementation of clinical quality improvement programs

3. Demonstrated experience supporting the accomplishment of quality improvement strategic plans that achieve high impact and significant improvements in performance

4. Demonstrated experience in program evaluation and extensive knowledge of industry-leading quality improvement methods and tools

5. Proven skill and experience in excellent oral and written communication spanning executives to the general public B. Data Analyst (1 FTE)

1. Demonstrated experience in conducting literature searches for background information on the latest trends in health policy affecting pharma, insurers and the health care delivery system

2. Proven skill in analyzing state and federal reports on the health care industry and translating and synthesizing this information for industry reports, policy papers, presentations, as well as legislative and regulatory testimony using data, statistics and analysis to support the industry’s position

3. Proven skill in utilizing statistical and other data modeling; financial and actuarial analysis and discipline; integrate clinical data including social determinants of disease to inform opportunities

4. Demonstrated experience interfacing with leaders and experts and stakeholder groups (e.g., clinical operations, consultants, employer groups, government agencies, payers)

5. Demonstrated experience identifying opportunities and actionable solutions from data; effective partnering with quality, finance, operations, and other population health stakeholders to identify/implement improvement programs; and monitor associated process and outcomes

6. Proven analytic skills that include risk adjustment, new and ongoing product evaluation, Return on Investment (ROI) calculations, business development and financial modeling, process and technology/tool development, forecasting, and cost management and revenue maximization strategies

7. Demonstrated experience in establishing and maintaining a formal discipline for population health IT initiatives, including electronic health record (EHR) solutions such as population health registries, reporting, analytics, clinical decision support, and other levers to improve care processes, as well as care coordinator technology solutions around populations

Definitions See Attachment J.6, Glossary of Terms & Acronyms of the IDIQ Contract for definitions of terms and the list of acronyms associated with this contract and all TOs.

Comprehensive Task Order Work Plan The BFCC-QIO shall provide a comprehensive task order work plan which includes the Contract Start-Up Plan, Comprehensive Contract Management Plan and the Beneficiary Protection: Case Review Services Comprehensive Work Plan as attachments.

Task Order Requirements The BFCC-QIO shall perform the following tasks as described below.

Contract Start-Up The BFCC-QIO must perform contract start-up activities including but, not limited to the following:

a. Contract Start-Up Plan: Develop a comprehensive Contract Start-Up Plan that includes all activities necessary to establish contract operations to ensure all processes are operational to start full performance of Case Review Services on May 8, 2019.

Full performance will begin on May 8, 2019 with Case Review services. There may be some start-up activities that will not be completed prior to the start of Case Review services. Any contract start-up activities that impact the provision of Case Review services to beneficiaries must be completed timely as there will be no lapse in service to beneficiaries.

b. Comprehensive Contract Management Plan: Develop and maintain a results-oriented Comprehensive Contract Management Plan for overall contract operations as required in Section C.3, BFCC-QIO IDIQ Services which at a minimum, includes effective lines of communication, budget and cost controls, Internal Quality Improvement Program (IQIP), project schedule management, development of comprehensive task order work plans, call center operations, resource management to include staffing matrices by task/subtask, progress reviews and performance monitoring, risk management, change management, timely delivery and reporting, and clearly defined roles, responsibilities, lines of authority, resources appropriately aligned to services and deliverables, and compliance with IDIQ SOW Sections on Collaboration, Accountability, and Transparency; Contractor Performance Measurement; Transition Requirements; Technical Considerations; and General Requirements.

c. Contract Start-Up Meetings: Within 5 calendar days of task order award, the BFCC-QIO shall participate in a CMS Contract Kick-Off/Planning Meeting to confer with the COR/SME by conference call to discuss the award. This will include a discussion of the BFCC-QIO’s proposal and CMS’s expectations for project objectives and goals, the project design, expected timeframes, project staff, and the project tasks. The discussion shall also include the transition process between SOWs, if applicable for the BFCC-QIO. For this meeting, the BFCC-QIO shall prepare discussion materials for its Comprehensive Task Order Work Plan which includes Contract Start-Up Plan, Comprehensive Contract Management Plan (includes the IQIP), and Beneficiary Protection: Case Review Services Comprehensive Work Plan.

d. Internal Quality Control Plan: Develop and maintain an IQIP, also known as an Internal Quality Control (IQC) program or a Continuous Internal Quality Improvement Program (CIQIP), which complies with provisions in Chapter 13 of the QIO Manual. The purpose of the IQIP requirement is to support and foster an environment of continuous quality improvement within the QIO through ongoing assessment and improvement in areas that are critical for successful contract performance. The IQIP should be included in the Comprehensive Contract Management Plan.

The IQIP must have a:

1) Focus on Beneficiaries - An important measure of quality is the extent to which beneficiaries’ needs and expectations are met. The IQIP shall seek improvements that include:

· Systems that affect beneficiary access

· Insuring that health care is evidence-based

· Patient safety

· Support for patient engagement

· Coordination of care with other parts of the larger health care system

· Cultural competence, including assessing health literacy of patients, patient-centered communication, and linguistically appropriate care

2) Focus on the Use of the Data - Data is the cornerstone of QI. The IQIP must use data to describe how well current BFCC-QIO systems are working; what happens when changes are applied, and to document successful performance.

3) Inter-rater Study – The BFCC-QIO shall use an independent 3rd party to conduct an inter-rater reliability study within the organization to:

· Minimize variation in the application of clinical guidelines;

· Evaluate the staff ’s ability to identify potentially avoidable utilization;

· Evaluate staff ’s ability to identify quality-of-care issues;

· Target specific areas most in need of improvement; and

· Target staff needing additional training.

4) The IQIP will be updated annually.

e. Task Order Work Plan: Establish operational requirements for development of Comprehensive Task Order Work Plan(s) which at a minimum, will include the following:

· Resource planning activities, key milestones (including due dates), risk mitigation strategies to ensure success, plan to avoid duplication of effort, and task descriptions including a detailed description of activities necessary to complete each task;

· The identification of the appropriate personnel resources available to ensure completion of the work outlined in the task order. Consultants may be utilized only upon receiving permission from the COR/SME and Contracting Officer;

· The integrated communication plan, which will include names of potential partners/stakeholders, dates, and timeframes for the task order work;

· Task Order Work Plan Timetable that details the schedule for completion of each task;

· Strategies for Person/Patient and Family Engagement; and

· Any additional strategies or plans required under an individual task order.

f. Call Center: The purpose of the beneficiary helpline is to provide callers with information and necessary services concerning Medicare beneficiary rights and responsibilities, beneficiary protections and the performance of various BFCC-QIO programs and or activities detailed in this task order.

1) Call Center Operation: The BFCC-QIO shall establish and maintain a Call Center and Beneficiary Helpline with a toll-free beneficiary helpline seven (7) days a week.

2) Staffing: The beneficiary helpline must be staffed during the BFCC-QIO’s business hours set forth below, and must be equipped with voicemail capability to record calls after hours or in the event of unexpectedly high call volume. CMS encourages the BFCC-QIO to utilize flexibility in staffing the call center to accommodate call volume.

3) Hours of Operation:

· The intake of cases shall occur seven (7) days per week. On Monday through Friday, the BFCC-QIO shall be staffed during core business hours from 9:00 a.m. to 5:00 p.m. and on weekends and holidays from 11:00 a.m. to 3:00 p.m.

· The call center may be open before or after core business hours to effectively manage business operations.

· The hours of operation shall be prominently included on the BFCC-QIO's web site and included on the recorded message for callers contacting the BFCC-QIO outside of the core hours of operation.

· The BFCC-QIO shall staff for effective operations in each time zone within the BFCC-QIO’s contract area.

4) BFCC-QIO Experience Survey:

· The BFCC-QIO shall use an automated telephone messaging and call transfer process (with opt out), to direct beneficiaries and providers who contact the BFCC-QIO regarding case/claims reviews to the QIO Experience Survey administered by the BFCC-SC.

5) Report of Helpline Service: The report will be provided in the Quarterly Progress Report and include:

· Total number of calls received by month

· Total number of answered calls by month

· Total number of abandoned calls by month

· Calls average waiting times by month

· Percentage of calls answered within 30 seconds by month

· Average length time of calls by month

· Number of calls transferred from 1-800-Medicare

g. BFCC- QIO Website: Establish and maintain a QIO section 508/504 compliant website in accordance with CMS communications requirements

1) Follow the CMS Contractor Website Guidelines located at https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/contractorwebguidlines.html. The BFCC-QIO shall refer to this website at least every 90 calendar days for the current standards and guidelines.

2) The website is NOT intended to be accredited or maintained within a CMS FISMA ATO’d system boundary. However, in addition to the Contractor Website guidelines, the BFCC-QIO website shall follow general industry security standards and practices while maintaining the website.

· Refrain from allowing user login or maintain unique identifiers for end users (static content ONLY)

· Ensure the website and supporting servers are patched against vulnerabilities and threats.

· Ensure the website is configured to follow standard industry practices for security outlined in the Open Web Application Security Project (OWASP) guide.

· Ensure proper industry standard cryptography is utilized when applicable (SSL/TLS, PKI or HTTPS)

3) The Website must have the following functional elements:

· Provide communication and instructions on Electronic Submission for Task 1.1 and Task 1.3;

· Include Provider Related Information;

· Include Information about Person and Family Engagement Programs;

· Include a link to the BFCC-QIO Experience Survey administered by the BFCC-SC; and

· Assist CMS’ public health efforts by disseminating information and messages as directed by the COR/SME.

h. Compliance with Technical Considerations: as specified in Section C.4 of the IDIQ SOW which covers requirements such as:

1) Appoint a Security Point of Contact (SPOC) within 90 calendar days of Task Order award.

2) Conduct Security Awareness Training (SAT) for all employees utilizing or accessing CMS data within the Health Care Quality Information System (HCQIS) environment on an annual basis. Security Awareness Training for employees will be tracked and logged locally by the BFCC-QIO SPOC as identified by the CMS ISSO. A QNET SAT Certification Letter shall be provided to CMS 90 calendar days after Task Order award and annually thereafter in accordance with the Task Order Schedule of Deliverables.

3) Visit the CMS security website http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html and the QualityNet security website http://qionet.sdps.org at least every 30 calendar days for updates. [Note: The QualityNet security website is an Intranet website; thus, access is restricted to only active users within the QualityNet Enterprise.]

4) Provide upon request, all related artifacts, in the format and method prescribed by CMS, resulting from compliance with CMS, FISMA, OIG, and other relevant audits, reviews, evaluations, tests, and assessments of BFCC-QIO systems, processes, and facilities as it relates to program security and compliance.

5) Provide a BFCC-QIO System Security Plan (SSP) and Information Security (IS) Risk Assessment (RA) within 90 calendar days of after task order award, annually thereafter, and updates 30 calendar days after any major changes.

6) Develop, in conjunction with CMS, Corrective Action Plans (CAP) for all identified weaknesses, findings, gaps, or other deficiencies in the IS Program (e.g., those items identified during a FISMA audit or similar activity) in accordance with IOM Pub. 100-17 (BPSSM) or as otherwise directed by CMS. Submit CAPs within 30 calendar days after the audit or finding in accordance with the Task Order Schedule of Deliverables.

7) Submit the Plan of Action & Milestones (POA&M) within 15 calendar days of approval of a CAP and monthly thereafter until the CAP is closed.

8) Maintain a list of all purchased and leased equipment in a HHS 565 submission Final Report.

9) Comply with all CMS system and software maintenance procedures. All digital media must be encrypted before physically leaving the BFCC-QIO. The BFCC-QIO shall perform maintenance of systems and software in compliance with applicable configuration requirements. BFCC-QIO IT staffs are responsible for completion of IT tasks as assigned to the CMS designated IT service manager for BFCC-QIO local systems.

· Comply with CMS Incident Handling Standards and Procedures (RMH Vol III Standard 7-1 Incident Handling, RMH Vol II Procedure 7-2 Incident Handling Procedure) located at http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html and report suspected security breaches within the designated time periods. The BFCC-QIO shall assist the CMS ISSO on active investigations and provide requested documentation as needed for all security incidents.

i. Compliance with General Requirements:

1) Adhere to the privacy, confidentiality, and disclosure requirements set forth in Section 1160 of the Act, and in Title 42 of the Code of Federal Regulations (CFR) Part 480, and be prepared to document adherence to these privacy, confidential and disclosure requirements. http://www.access.gpo.gov/nara/cfr/waisidx_02/42cfr480_02.html

2) Be prepared, if required to provide a copy of training materials developed or used to meet the confidentiality training requirement specified in 42 CFR 480.115. CMS may request documentation that users of the QIO review system have been trained in the proper handling of confidential information prior to being given access to that information and review system.

3) Obtain all Data Use Agreements (DUAs) necessary to comply with contract requirements and to execute required services.

4) Execute a data abstraction subcontract with the Clinical Data Abstraction Centers (CDACs).

5) Copy the COR/SME on all communication between the BFCC-QIO and the CDAC related to these subcontracting arrangements.

6) At a minimum, participate annually in collaborative activities that are sponsored by the applicable CMS Regional Office and focus on CMS-identified priority initiatives.

7) Develop and provide to CMS two different plans to address emergency preparedness: (1) a Continuity of Operations Plan (COOP) and (2) Contingency Plan (CP), which includes a Disaster Recovery (DR) Plan.

8) Conduct periodic national emergency exercises and natural disaster drills.

9) Prepare a “Table Top” test to evaluate the effectiveness of the COOP/CP/DR Plans, annually. At a minimum, this test shall include a structured walk-thru of each Plan with all BFCC-QIO and CMS staff needed for CMS to evaluate each Plan.

10) Fully cooperate with and provide, subject to the QIO confidentiality provisions in Section 1160 of the Social Security Act and 42 CFR Part 480, requested data for any evaluation of the QIO program that the Secretary, or CMS on behalf of the Secretary, chooses to conduct. Such evaluations may be conducted by a CMS contractor.

11) Fully comply with all conflict of interest requirements as outlined in Section H of the IDIQ Contract.

j. Compliance with Contractor Performance Measurement: as specified in Section C.3 of the IDIQ SOW.

k. Compliance with Contract Phase-Out: as specified in Section C.3 of the IDIQ SOW which covers requirements such as:

1) The incumbent BFCC-QIO will provide transition/ phase-out support to the successor BFCC-QIO Contractor selected by CMS (refer to FAR 52.237-3 Continuity of Services).

2) Transition will begin no more than 120 days before the end of the 12th SoW QIO contract and the aim will be for it to end at the incumbent BFCC-QIO contract’s end date. During this period, the incumbent BFCC-QIO shall work with the successor BFCC-QIO, CMS Staff, and other identified CMS contractors to assure continued operation of the BFCC-QIO program.

3) Before the transition begins, the incumbent BFCC-QIO will provide CMS with a transition plan. The transition plan will provide adequate coverage to assure uninterrupted service of BFCC-QIO services for the BFCC-QIO program. The BFCC-QIO Contractor’s Transition Plan shall provide detailed methods that will be used to ensure a smooth transition from the incumbent BFCC-QIO’s operation to operation by the successor BFCC-QIO. At a minimum, the Transition Plan shall include the following:

· Organizational Chart that

1. Displays internal and external organizational relationships

2. Identifies the individuals (at all organizational levels) who will be responsible for the transition and their respective roles; detail the lines of communication and how the incumbent BFCC-QIO will interface with CMS during this phase of contract performance.

· A milestone chart detailing the timelines and stages of transition

· Phase-Out

1. A plan to transition (without any lag time), receipt and processing of all expedited and fast-track appeals.

2. A list of all pending case reviews with points of contact that the successor contractor will be required to complete.

4) Prior to the 60th day before the last day of the incumbent BFCC-QIO’s contract, the incumbent BFCC-QIO will follow all actions identified within the current QualityNet Startup and Shutdown Procedures. The incumbent BFCC-QIO will transition information systems activities as directed by CMS.

Beneficiary Protection: Case Review Services Section A. Overview/Background A BFCC-QIO’s work is derived from provisions in the QIO statute in Part B of Title XI of the Act and the QIO regulations in 42 CFR Parts 475, 476 and 480. The BFCC-QIO must be familiar with these provisions. The scope of this BFCC SOW includes numerous review functions that include, but are not limited to the following:

· Quality of care reviews, including beneficiary complaint reviews, general quality of care reviews and Immediate Advocacy;

· Referrals for Quality Improvement Initiatives (QIIs)

· Beneficiary appeals of denials of hospital admissions, discharge and terminations of services decisions, commonly referred to as Grijalva, BIPA, and Weichardt appeals, etc.;

· Medical necessity reviews;

· Appropriateness of setting reviews;

· Discrimination Reviews

· Focused Reviews

· Reviews of Emergency Medical Treatment and Labor Act (EMTALA);

· Sanctions; and

· Monitoring of Physician Acknowledgement Statements under section 1156(a) of the Act and 42 CFR § 412.46.

For the 12th SoW, BFCC-QIO Case Review service areas align to the 10 CMS Regions as follows:

Attachment J.3-H, BFCC-QIO Level of Effort by Case provides historical data on case review volume and estimated level of effort per case.

The BFCC SOW includes four core functions:

1) Beneficiary Oversight;

2) Beneficiary Protection;

3) Beneficiary and Stakeholder Engagement; and

4) BFCC Data Analytics and Management.

These core functions incorporate analytics, data driven improvements, innovation, and collaboration to measurably improve the quality of health care for Medicare beneficiaries and ensure proper implementation of Medicare coverage requirements for payment purposes. In addition to the BFCC-QIO’s review activities, the BFCC-QIO will be responsible for using the results of all activities to make recommendations to the BFCC SC, QIN NCC, QIN-QIOs, QIO Independent Evaluation Center, End Stage Renal Disease (ESRD) Networks, Hospital Improvement & Innovation Networks (HIINs), Transforming Clinical Practice Initiative (TCPI), and other Network of Quality Improvement and Innovation Contractors (NQIIC) on quality improvement initiatives, develop recommendations to CMS for focused reviews, and engage beneficiaries and stakeholders in quality improvements and outreach.

Section B. Desired Outcomes The BFCC-QIO work is an effort to measurably improve the quality of health care for Medicare beneficiaries as well as all individuals protected under EMTALA and to provide peer review for purposes of determining the appropriateness of payment under Medicare.

The results of all case review activities shall also be used to identify and recommend quality improvement efforts and make recommendations to CMS for approval of focused reviews to be conducted by the BFCC-QIO.

The four BFCC Program Core Functions and the Strategic Goals listed below are aligned with nine AIMs to reflect the desired outcomes. Performance under this task order may span across all of the listed BFCC core functions and AIMs. See Attachment J.3-C, Evaluation Measures Table for specific performance measures aligned to the BFCC Core Functions and Strategic Goals.

1) Beneficiary Oversight

· Strategic Goal - Protect the Medicare Trust Fund

· BFCC AIM 1 - Achieve 95% accuracy of BFCC-QIO reviews of Medicare claims (Short Stay, HWDRG, Readmission) during contract period of performance.

· BFCC AIM 2 - Achieve 95% compliance with CMS requirements for Memorandums of Agreement and Physician Acknowledgement Statements over the contract period of performance.

2) Beneficiary Protection

· Strategic Goal – Support an improved quality healthcare system

· BFCC AIM 3 - Generate a baseline measure for provider satisfaction with the BFCC-QIOs and establish an AIM for improvement, after the first year of contract period of performance.

· BFCC AIM 4 - Achieve 85% Medicare beneficiary satisfaction with BFCC-QIOs case review process over the contract period of performance.

3) Beneficiary and Stakeholder Engagement

· Strategic Goal – Improve beneficiary experience

· BFCC AIM 5 - Achieve 85% Medicare beneficiary satisfaction with BFCC-QIOs Patient and Family Engagement (PFE) process over the contract period of performance.

· BFCC AIM 6 - Improve the appropriate utilization of health care facilities/services among beneficiaries participating in health care navigation by (15%) over the contract period of performance.

4) BFCC Data Analytics and Management

· Strategic Goal – Support an improved quality healthcare system

· BFCC AIM 7 - Utilize state-based BFCC program data to identify trends and patterns to propose at least three improvements per year, for each contracted region over the contract period of performance.

· BFCC AIM 8 - Utilize QII data to identify trends and patterns to propose at least three improvements per year, for each contracted region, over the contract period of performance.

· BFCC AIM 9 - Utilize BFCC program data and analytics to propose at least three focused reviews per year, for each contracted region, over the contract period of performance.

Section C. Task Requirements Task 1 Beneficiary Protection: Case Review Services Comprehensive Work Plan

The BFCC-QIO shall provide a comprehensive work plan for Case Review services under the Beneficiary Protection, that at a minimum will include the following:

1) Resource planning activities, key milestones (including due dates), risk mitigation strategies to ensure success, plan to avoid duplication of effort, and task descriptions including a detailed description of activities necessary to complete each task;

2) The identification of the appropriate personnel resources available to ensure completion of the work outlined in the task order. Consultants may be utilized only upon receiving permission from the COR/SME and Contracting Officer;

3) The integrated communication plan, which will include names of potential partners/stakeholders, dates, and timeframes for the task order work;

4) Task Order Work Plan Timetable that details the schedule for completion of each task;

5) Strategies for Person/Patient and Family Engagement; and

6) Any additional strategies or plans required under an individual task order.

Specific Tasks

BFCC-QIOs are required to perform individual case review to fulfill mandatory review requirements. BFCC-QIOs must conduct individual case review in accordance with applicable law, instructions in the QIO Manual, and other administrative directives. Individual case review will also include a number of ancillary activities such as post-review activities, communication with beneficiaries and/or providers, referral of cases to other entities and other routine responsibilities.

The CMS system of record for BFCC-QIO case reviews is the Quality Management and Review System (QMARS)[footnoteRef:2]. BFCC-QIOs shall enter all case review activities into the CMS designated case review system on an ongoing basis. All data must be entered into the review system no later than four (4) calendar days from the date a case review is completed. [2: CMS will not provide reimbursement of expenditures for contractor owned information systems in the performance of these tasks]

Task 1.1 Quality of Care Reviews The BFCC-QIO shall complete quality of care reviews in compliance with the regulations at 42 CFR Part 476 and the appropriate chapter of the QIO Manual. Quality of care reviews may be in the Medicare FFS program or from the Part C and Part D Medicare plans.

A Quality of Care Review focuses on whether the quality of services provided to beneficiaries is consistent with professionally recognized standards of health care. In conducting a Quality of Care Review, the QIO is responsible for reviewing actual care and services to determine where the provided care and services fall within the range of professionally recognized standards of health care.

The BFCC-QIO is responsible, among other things, for performing reviews in the following situations:

a) In response to written Beneficiary Complaints.

b) In response to oral Beneficiary Complaints where appropriate,

1) NOTE: Immediate Advocacy (Task 1.2) is to be used as an informal process to quickly resolve an oral complaint or when the nature of the complaint is not likely to be part of medical record documentation.

c) In response to potential quality of care concerns identified from sources other than beneficiaries, including:

1) As a result of referrals from other entities, e.g., other QIOs, the Office of Inspector General, the Office for Civil Rights, MACs, RACs, SSAs, etc.;

2) In conjunction with other specified activities and tasks of the BFCC-QIO, e.g., readmission reviews, and in any situation where the BFCC-QIO identifies a potential quality of care concern in the course of completing other tasks under this BFCC-QIO SOW, the BFCC-QIO shall conduct a quality of care review;

3) As a result of tracking trends identified in aggregate data which the BFCC-QIO obtains; and

4) As a result of CMS-directed focused reviews.

Task 1.2 Person and Family Engagement: Immediate Advocacy Purpose: Immediate Advocacy is an informal alternative dispute resolution process used to quickly resolve an oral complaint a Medicare beneficiary or his/her representative has regarding the quality of Medicare-covered health care received. This process involves a QIO representative's direct contact with the practitioner and/or provider. See 42 CFR §476.1.

Process: Once oral consent is obtained for all parties, the BFCC-QIO may either use conference call/three-way call or make a call on behalf of the beneficiary to obtain resolution of the beneficiary’s oral complaint. The focus of the call should be to provide a quick and amicable resolution of these complaints within a short time frame, Objective: The objective of this BFCC-QIO activity is to:

· Provide flexibility in resolving complaints in situations when the traditional Peer Review process alone is likely not going to reach complete resolution—for example, if the complaint includes issues that would not be documented in the medical information, or the specific time constraints related to the complaint render the Peer Review process and review of the medical information inappropriate;

· Increase beneficiary, practitioner, and/or provider satisfaction throughout the process by resolving complaints in a more expeditious and effective fashion; and

· Resolve complaints in a more cost-effective manner.

Reporting: The BFCC-QIO will provide a report of Person and Family Engagement activities on a quarterly basis in the Quarterly Progress Report.

Task 1.3 Reviews of Beneficiary Appeals of Provider Discharges/Service Terminations and Denials of Hospital Admissions Beneficiaries may appeal provider discharges, service terminations, and denials of hospital admissions. The BFCC-QIO shall review:

a) BIPA Appeals - Beneficiary appeals of discharge decisions related to the Medicare FFS expedited appeals process for home health, SNF, hospice, and CORF services, commonly referred to as Benefits Improvement and Protection Act (BIPA) of 2000 appeals.

b) Grijalva Appeals - Beneficiary appeals of discharge decisions related to the Medicare Advantage (MA) fast-track appeals process for skilled nursing facility (SNF), home health (HH), and CORF services, commonly referred to as Grijalva appeals.

c) Weichardt Appeals - Beneficiary appeals of discharge decisions in the hospital setting (FFS and MA), commonly referred to as the Weichardt appeals.

d) Notice of Hospital Requested Review (HRR) - Discharge decisions when the hospital issues a Notice of Hospital Requested Review (HRR) to the beneficiary. The hospital requests the QIO to review discharge decisions when the hospital and physician disagree about the decision to discharge a beneficiary.

e) Hospital Issued Notices of Non-Coverage Reviews (HINN) - Beneficiary appeals of denials of hospital admissions in response to the issuance of both preadmission and admission Hospital Issued Notices of Non-Coverage (HINN).

In carrying out these appeal responsibilities, the BFCC-QIO shall review the sufficiency of the notices (for example, the content and timeliness of delivery to the beneficiary), issued for each appeal process as well as the pertinent Medicare coverage policies. Standards used for these reviews will include, as applicable, those in the Medicare Benefit Policy Manual chapters and regulations on inpatient services, SNF services, home health, and outpatient therapies.

BFCC-QIOs are required to have a mechanism in place to accept appeal requests 24 hours a day 7 days a week. Unless specified to do otherwise by CMS instructions, the BFCC-QIO must follow-up on all voicemails received within one calendar day. A report on appeal requests will be provided in the Quarterly Progress Report and include:

Task 1.4 Medical Necessity Reviews Authority: The BFCC-QIO shall complete medical necessity reviews based on the pertinent Medicare coverage policies. Such reviews must also address the following elements of review: whether services and/or items for which payment may be made (whole or in part) under Medicare are or were reasonable and medically necessary in accordance with Section 1862(a)(1) or (a)(9). See § 1154(a)(1)(A). These reasonable and medically necessary reviews can include determinations about whether services and items proposed to be provided in a hospital or other health care facility on an inpatient basis could be effectively provided more economically on an outpatient basis or in an inpatient health care facility of a different type.

Process: Medical necessity review shall be conducted on all cases reviewed by the BFCC-QIO for any purpose, unless otherwise directed by CMS. The BFCC-QIO shall undertake medical necessity reviews in accordance with the appropriate chapter of the QIO Manual.

Task 1.5 Reconsideration Reviews Authority: A Medicare beneficiary, and a provider, or an attending practitioner (when applicable) and in accordance 42 CFR Sections 475, 476 and 478, who is dissatisfied with an initial denial determination is entitled to a reconsideration by the QIO that made that determination. The types of reviews eligible for reconsideration include:

· Quality of Care Reviews, including:

· Beneficiary complaint reviews;

· General quality of care reviews (Providers and Practitioners only);

· Beneficiary appeals of denials of hospital admissions, discharge and terminations of services decisions, commonly referred to as Grijalva, BIPA, and Weichardt appeals, etc.;

· Medical Necessity Reviews; and

· Diagnostic Related Grouping (DRG) Reviews

· Appropriateness of Setting Reviews Task 1.6 Emergency Medical Treatment and Labor Act (EMTALA) Reviews Authority: Section 1866 of the Act enacted provisions to prevent hospitals from refusing to treat individuals requiring emergency care or inappropriately transferring or discharging individuals with unstabilized emergency conditions.

Patients who are not stable must either be treated until stabilized or transferred in accordance with the transfer requirements. The transfer requirements apply only to unstabilized patients. Appropriate transfers must be effected through qualified persons and transportation equipment (if medically necessary) to a receiving hospital that has available space and qualified personnel to treat the individual and that has agreed to accept the individual. The medical record must accompany the individual.

Process: When requested by the CMS Survey and Certification Group Regional Office, BFCC-QIOs shall provide timely, complete, and clinically sound physician opinions for 5-day and 60-day reviews described in EMTALA Section 1867(d)(3) for cases involving potential violations. The Regional Office may consult with the QIO before determining whether the hospital has violated EMTALA, unless a delay in obtaining a QIO review would jeopardize the health or safety of individuals. Clinical aspects of the case may include questions such as whether the individual had an emergency medical condition, whether there was an appropriate medical screening examination, whether a hospital had the capability to provide stabilizing treatment, whether an individual’s emergency medical condition was stabilized, whether a transfer was appropriate, whether a recipient hospital had the required capability and capacity to provide stabilizing treatment, and any other questions as necessary.

Task 1.7 Sanction Activities

The BFCC-QIO plays a key role in identifying quality of care issues that warrant a referral for sanction activity, preparing the case for CMS and OIG, and coordinating and communicating with the practitioner or other persons of concern. Sanction means an exclusion or monetary penalty that the Department of Health & Human Services (HHS) Secretary may impose on a practitioner or other person as a result of a recommendation from a QIO.

Authority: The BFCC-QIO shall carry out sanction and sanction-related activities described in this section in accordance with Section 1156(b) and 42 CFR part 1004. Sanction-related activities include:

a) Coordinating with the Office of Inspector General regarding potential sanctionable conduct;

b) Providing providers and practitioners with an opportunity for discussion; and

c) Developing and imposing corrective action plans, if appropriate.

In accordance with 42 CFR 1004, subpart B, the BFCC-QIO must provide a report and make sanction recommendations to the OIG for those cases that continue to involve a particular level of seriousness.

These activities shall be carried out when the BFCC-QIO identifies care which either:

a) Grossly and flagrantly violates any obligation in Section 1156(a) of the Act in one or more instances, or

b) Fails in a substantial number of cases substantially to comply with an obligation imposed in Section 1156(a) of the Act.

Process: The BFCC-QIO may identify a potential violation for peer review through individual case reviews, including, but not limited to, beneficiary complaints and other general quality of care reviews. Quality of care issues may also be referred from other QIOs and other agencies for review by a BFCC-QIO physician peer reviewer.

The BFCC-QIO must copy the CMS Contracting Officer Representative/Subject Matter Expert (COR /SME) on the sanction recommendation report the BFCC-QIO prepares for the OIG. The BFCC-QIO, upon direction from CMS, must cooperate with investigative agencies, including the Office of the Inspector General (OIG), by making disclosures to these agencies regarding the data it has acquired in the course of performing case reviews and other activities (in accordance with procedures and safeguards established by the regulations at 42 CFR 480). The data and information at issue is that which may identify specific providers or practitioners as may be necessary to assist in investigating cases.

Task 1.8 Discrimination Referrals The BFCC-QIO shall refer cases for investigation to the HHS Office for Civil Rights (OCR) if it is suspected that care is being delayed or denied due to discrimination on the basis of race, color, national origin, age, disability, religion or sex.

Task 1.9 Focused Reviews Focused Reviews will be one of the primary sources for the BFCC-QIO to identify the need for general quality of care, medical necessity and readmission reviews. A focused review process will allow BFCC-QIOs to target areas of possible concern. The BFCC-QIO shall initiate at least one focused review per year in each contracted region:

a) The Focused Review request must be submitted to the COR/SME for approval which includes the topic and data supported justification to initiate the Focused Review.

1) The Focused Review must be determined from Case Review data mining and analytics;

2) The Focused Review is to be limited to a review of up to 50 medical records; and

3) The Focused review design must be able to identify an opportunity for a state-based innovation and improvement project.

4) A report of the Focused Review results and BFCC-QIO recommendations are to be submitted to the COR/SME within 60 calendar days of completion.

b) The BFCC-QIO may be required to perform focused reviews as determined by CMS.

Task 1.10 Quality Improvement Initiatives (QIIs) As defined in 42 CFR 476.1, a Quality Improvement Initiative (QII) is any formal plan designed to assist a provider(s) and/or practitioner(s) in identifying the root cause of a confirmed quality of care concern, develop a framework in which to address the concern and improve a process or system. The improvements may relate to safety, healthcare, health and value and involve providers, practitioners, beneficiaries, and/or communities. QIIs may consist of system-wide (organization-based) and/or non-system-wide (practitioner-based) activities. System-wide QIIs are improvement activities that may require technical assistance and interventions as defined in 42 CFR 476.1. Non-system-wide QIIs may not warrant technical assistance or interventions, but the BFCC-QIO shall propose recommendations regarding the quality of care concern.

1. The BFCC-QIO must make recommendations to QIN-QIOs or other CMS-designated contractor(s) for consideration of conducting quality improvement initiatives (QIIs) associated with quality of care issues within 4 calendar days of the QIO final determination. QIIs may be the result of any BFCC function and could include system-wide change QIIs and non-system-wide change QIIs.

0. QIN-QIO Referrals - The BFCC-QIO must make QII referrals to the QIN-QIOs for those confirmed quality of care concerns that warrant QIN-QIO technical assistance and interventions such as conducting a root cause analysis (RCA), developing an improvement plan, establishing baseline data, and monitoring data to ensure improvement plans are successful and improvements are sustained.

Note: The QIN-QIOs will provide technical assistance and work with the provider and/or practitioner in conducting these types of quality improvement interventions. QIIs that are referred to the QIN-QIO are documented into the CMS-designated system as appropriate.

0. The BFCC-QIO will routinely follow-up with the QIN-QIO and document the status/outcome of QII in the CMS designated system.

1. BFCC-QIO Technical Assistance – The BFCC-QIO must make recommendations to the provider and/or practitioner for quality improvement activities for those confirmed quality of care concerns that do not warrant QIN-QIO technical assistance or for provider interventions that involve RCAs and monitoring of data. These BFCC-QIO technical assistance activities may include notification of concern, offering advice, or a continuing education course, or conducting an informal teleconference to a provider.

1. The BFCC-QIO must analyze findings from the CMS-designated case review system, other information from review activities, and information from providers to:

1. Identify trends and patterns of referral;

1. Identify trends and patterns of referral that end in discontinuation or abandonment;

1. Identify needs for technical assistance related to CMS quality measures across provider settings to help providers and practitioners meet standards (an example of a CMS quality measure is a measure found in the National Hospital Inpatient Quality Measures set); and

1. QIIs that require BFCC-QIO technical assistance are to be submitted into the CMS-designated system as appropriate.

1. BFCC-QIO-identified trends and patterns are to be addressed in coordination with the BFCC National Coordinating & Oversight Review Center (NCORC). Recommendations must be provided to the BFCC NCORC before being communicated to the applicable QIN-QIO.

1. BFCC-QIO shall adhere to the CMS standard operating procedure for the entry of QII referrals into the CMS-designated system as appropriate.

1. The BFCC-QIO shall provide a report of these activities in the Quarterly Progress Report. This QII report is an aggregate report and not the actual QII referral(s).

Task 1.11 Monitoring of Physician Acknowledgement Statements Hospitals that are paid under the prospective payment system (PPS) are required to obtain a signed acknowledgement from physicians who have admitting privileges at a particular hospital.