QIO Communications Handbook

Updated: August 2018

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Table of Contents

Introduction ................................................................................................................................................... 4

Focus on Procedures and Processes ..................................................................................................... 4

Procedural Policies ...................................................................................................................................... 4

Beneficiary Helpline Policy/Promotion .............................................................................................. 5

Confidentiality, Disclosure, and Release of Information ................................................................ 5 Safeguarding Protected Health Information (PHI) and Personally Identifiable Information (PII) ................ 5 QIO Status under HIPAA .......................................................................................................................................................... 5 Conflict of Interest ..................................................................................................................................................................... 5 CMS Partnerships ....................................................................................................................................................................... 6 Allowed Non-QIO Partners ..................................................................................................................................................... 6 Endorsements Prohibited ....................................................................................................................................................... 6

Partnerships with Stakeholders ............................................................................................................ 6

Retaining Materials ................................................................................................................................... 6

Website Standards and Guidelines ....................................................................................................... 6 Hardware and Software Catalogs ......................................................................................................................................... 8

Gathering Information ............................................................................................................................... 8

Information Collection ............................................................................................................................. 8 Activities Requiring Clearance............................................................................................................................................... 8 Fast Track Process for Generic Clearance .......................................................................................................................... 9 Compliance with the PRA ..................................................................................................................................................... 13 Items not subject to the PRA ............................................................................................................................................... 14

CMS Information Collection Approval Process ................................................................................ 15 CMS Approval of Proposed Activity – Information Collection Proposal Submission ....................................... 16 RO Endorsement of Proposed Information Collection Intent and Concept ........................................................ 16 RCO Approval of Request for Exception to OMB Clearance ...................................................................................... 18 CMS Approval Process – Approval of Actual Activity ................................................................................................. 18 Regional Office (RO) Approval of Information Collection Documents .................................................................. 19 Additional Considerations When Medicare Beneficiaries Are Respondents ...................................................... 24 Additional Required QIO Information Collection Steps When Beneficiaries Are Respondents ................... 26 Exhibit 12-1 – Information Collection (IC) – Proposal Approval ............................................................................ 28 Exhibit 12-2 – Information Collection (IC) – Activity Approval .............................................................................. 29

Information Provider Protection ........................................................................................................ 31

Health Communication Skills................................................................................................................. 31

Communication Skill Set ........................................................................................................................ 31

Leveraging the Principles of Social Marketing ................................................................................ 31

Creating Materials ..................................................................................................................................... 32

Efficiency, Sharing, and Developing New Materials ....................................................................... 32 Sharing of Materials ............................................................................................................................................................... 32 Enabling Access: Making Materials Accessible and Easy to Read ........................................................................... 33 Cultural Competence .............................................................................................................................................................. 33 Plain Language ......................................................................................................................................................................... 33

How to Refer to CMS and Your QIO...................................................................................................... 34

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QIO Program Brand ................................................................................................................................................................ 34 CMS Proper Reference ........................................................................................................................................................... 34 QIO Proper Reference ............................................................................................................................................................ 34 Using the HHS Logo and CMS Identity Mark .................................................................................................................. 35 Avoiding Incorrect Uses of the Identity Mark................................................................................................................ 36

Impact Statement Guidelines................................................................................................................ 36

Success Stories .......................................................................................................................................... 37

Engaging Patients in Outreach Efforts ............................................................................................... 37 Disclosure of Confidential Information ........................................................................................................................... 37 Valid Authorization from Beneficiaries ........................................................................................................................... 38

Outreach Materials .................................................................................................................................. 39 Definition ................................................................................................................................................................................... 39

QIN-QIO Local Integrated Communications Plan .......................................................................... 39

Publishing and Disseminating Information .................................................................................... 40

Copyright .................................................................................................................................................... 40

Media Relations ........................................................................................................................................ 40 Responses to media inquiries that require prior CMS approval ............................................................................. 41 Written materials for distribution to the media that require prior review and approval ............................. 41

Publication Numbers, Positioning Statements, Disclaimers........................................................ 42 Publication Numbers ............................................................................................................................................................. 42 Positioning Statements and Disclaimers ......................................................................................................................... 43

Publication Review and Approval ....................................................................................................... 45

DDST Submissions ................................................................................................................................... 47

508 Compliance Policy ........................................................................................................................... 47

Digital Media Use ..................................................................................................................................... 48

Resources ....................................................................................................................................................... 49

QIO Resources ........................................................................................................................................... 49 Fact Sheets ................................................................................................................................................................................. 49 Developing Effective QIO E-Newsletters ......................................................................................................................... 49 Guide to Planning and Drafting Scientific Submissions ............................................................................................. 49 Success Story Toolkit ............................................................................................................................................................. 49

CMS Resources .......................................................................................................................................... 49 Navigating to Statement of Work Documents ............................................................................................................... 49 CMS Newsroom Page ............................................................................................................................................................. 50 CMS Press Mailing List........................................................................................................................................................... 50 CMS Product Ordering ........................................................................................................................................................... 50

QIO Program Resources ......................................................................................................................... 50 Listservs ..................................................................................................................................................................................... 50 QIOnet ......................................................................................................................................................................................... 50 Healthcare Communities ...................................................................................................................................................... 51 QualityNet.org .......................................................................................................................................................................... 51 QIOProgram.org ....................................................................................................................................................................... 51 QIO Program on Social Media ............................................................................................................................................. 51 QIO Program Commonly Used Acronyms ....................................................................................................................... 51

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Question and Answer System ............................................................................................................................................. 51 WebEx Resources .................................................................................................................................................................... 52

Contact Information ................................................................................................................................ 53 QIO Program Communications Lead ................................................................................................................................ 53 PCC-IC Contract Administration......................................................................................................................................... 53 PCC-IC Account Managers .................................................................................................................................................... 53

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Introduction The QIO Communications Handbook is designed to support Quality Improvement Organization (QIO) communication staff as they conduct their work under the QIO Program’s 11th Statement of Work (SOW) contract cycle. QIOs conduct a variety of communication activities that include positioning the organization as a resource to the general public in support of Centers for Medicare & Medicaid Services (CMS) initiatives and specific 11th SOW Tasks. The handbook is also a reference for CMS staff in the Central Office and Regional Offices (ROs) who are involved with QIO Program communication strategies and requirements. This guide serves as a resource for relevant CMS communication guidelines, policies, procedures, and other information related to QIO communication. It both quotes and sometimes (for ease of reading) paraphrases official policies and procedures and provides hyperlinks1 to original documents for reference to the exact language. The Program Collaboration Center – Integrated Communications (PCC-IC) will update this handbook periodically to include new or revised CMS communication-related policies, guidelines, or procedures.

Focus on Procedures and Processes The material in this handbook is arranged according to the procedures QIO communicators need to reference and the processes they use in their day-to-day work:

Procedural policies Gathering information Health communication skills Creating materials Publishing and disseminating information Making use of resources and contacts

An introductory paragraph prefaces each section, which is then arranged alphabetically or follows a process order relevant to the types of tasks described. Within the text, cross references provide a way to move to related sections, while the Table of Contents allows you to search for specific topics.

Procedural Policies CMS policies and procedures are contractually binding. The descriptions and summaries of key policies, procedures, and guidelines in this document are not intended to replace CMS policy directives. Questions about policy clarification should be directed to your Contracting Officer’s Representative (COR).

1 Many links in this document are directed to QIOnet. You must view this document on a Health Care

Quality Information Systems (HCQIS) computer or the links will appear to be broken. Another resource referenced frequently in this document is the Integrated Communications-PCC Community on the Healthcare Communities website. You must be a member of the Integrated Communications-PCC Community to view the content on the site.

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Beneficiary Helpline Policy/Promotion BFCC-QIOs that perform case review are required to maintain a cost-free helpline, operated according to QIO contract requirements, to handle beneficiary complaints, provide beneficiary support, and coordinate with providers and practitioners. BFCC-QIOs must publish and promote both their own helpline as well as the national 1-800-MEDICARE helpline for all information related to beneficiary rights and responsibilities, protections, and various programs and activities. BFCC-QIOs should provide information regarding Medicare beneficiary rights and responsibilities, beneficiary protections (including Hospital-Issued Notices of Non-coverage [HINNs] and Medicare notices of discharge), and appropriate health education issues related to active projects. BFCC-QIOs should make appropriate referrals when information or assistance that a beneficiary, practitioner, or provider requests are outside of the scope of its assigned QIO activities or responsibilities.

Confidentiality, Disclosure, and Release of Information Medicare beneficiaries, providers, and other individuals and entities with whom QIOs work in their health care initiatives have a right to confidentiality. The statutes that govern these rights include sections of Part B of Title XI of the Social Security Act, the Code of Federal Regulations (CFR) designated at 42 CFR Part 480, and sections of the Health Insurance Portability and Accountability Act (HIPAA). Chapter 10 of the QIO Manual provides the detailed information on confidentiality as it affects the entire QIO Program. Chapter 3 of the QIO Manual provides requirements and guidance for Memoranda of Agreement (MOAs) for QIOs under contract with CMS to perform case review functions. What follows are summaries and information about confidentiality, disclosure, and release of information that pertain to QIO communication.

Safeguarding Protected Health Information (PHI) and Personally Identifiable Information (PII) CMS released SDPS Memo 09-395-GN on November 2, 2009, to remind all users of the appropriate use of QualityNet email and the proper procedures for transmitting confidential email. PHI and PII must be safeguarded at all times by all individuals and organizations working for, or on behalf of, CMS. The disclosure or misuse of PHI or PII by an individual or organization working on behalf of CMS can cause irreparable damage to individuals whose personal records are at stake. In addition, the disclosure or misuse of PHI or PII by an individual or organization could result in legal liability from those whose information was inappropriately released. The memo further explains the proper methods for transfer of sensitive or protected data.

QIO Status under HIPAA In April 2003, CMS released SDPS Memo 03-150-GN, which provides guidance in a Questions and Answers format on supplying information to QIOs under HIPAA.

Conflict of Interest Services provided to Medicare and/or Medicaid beneficiaries under the QIN-QIO and BFCC-QIO contracts are to be free, to the greatest extent possible, of all conflicts of interest.

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Conflict of interest definition and details of the required submission of a Conflict of Interest Certificate are outlined in QIN-QIO 11th SOW Section H.3/BFCC-QIO Contract Section H.11. The following policies will help you prevent actual or apparent conflicts of interest:

CMS Partnerships Partnership activities are an integral part of the CMS mission. Developing and sustaining partnerships is central to collaborative outreach efforts, sharing information, and leveraging resources. For more information on CMS partnership communities, see the “Partner with CMS” section of the CMS website.

Allowed Non-QIO Partners QIOs are allowed, under certain specific circumstances, to cooperate with other organizations to accomplish the goals of the Medicare contract (e.g., conference sponsorship). QIOs must make sure that collaborating does not create actual or apparent conflict of interest, inadvertent endorsement of products, or contract funding issues. (TOPS Memo 2001-04).

Endorsements Prohibited When working on national campaigns, neither the QIO nor its management and staff may give the appearance that the QIO is endorsing an external entity or its products or services. If any partner or other external entity solicits an endorsement, it must be turned down. (SDPS Memo 07-096-CO)

Partnerships with Stakeholders In addition to the required collaborative activities outlined in the 11th

SOW, a QIO may coordinate activities with stakeholder organizations in its region interested in teaming with the QIO or working on comparable improvement efforts. Coordination with stakeholders may involve creating, joining, and supporting partnerships with organizations with similar goals and objectives, or facilitating ongoing discussion among the various stakeholders. The nature of the activity to facilitate coordination must be consistent with the terms of the contract and may require advance approval from the COR. QIOs shall work together with stakeholders to identify and mitigate any duplication of effort identified in its geographic area. This activity shall be reported in the QIN-QIO’s monthly COR report. (QIN-QIO Section C.4.5, 11th Statement of Work; BFCC-QIO Contract, Section C.5.5.1).

Retaining Materials In addition to SOW requirements, the Federal Acquisition Regulations require that all other documents (e.g., outreach materials) related to contracts entered into by negotiation be retained for three years after final payment under the contract. (QIO Manual, Chapter 13).

Website Standards and Guidelines The CMS website provides a complete list of CMS Contractor Website Guidelines. The QIO shall refer to this website at least every 90 days for the current standards and guidelines.

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This site and the QIN-QIO 11th Statement of Work Section 6.1.2.2 and BFCC-QIO contract Section C.5.5.5, include the following guidelines:

Your website must link to any content that is available on CMS websites rather than duplicating it.

Your site should display a Privacy Policy.

If displaying the CMS identity mark on your website, follow the CMS Mark Identity Usage Guidelines.

Your site must comply with the accessibility requirements of Section 504 and

508 of the Rehabilitation Act of 1973.

Your site must comply with all other applicable CMS and Program requirements.

Your site must follow “Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons,” released on June 12, 2002 and by HHS on August 4, 2003.

The website must be used only for informational purposes. You must not design any applications or software unless approved in writing by the CMS Information System Security Officer (ISSO).

Either use a single web domain for your corporate and QIO web presence or

bifurcate these presences into separate websites (with different web domains). If a QIN-QIO chooses to house its QIN-QIO web presence on its corporate website, the QIN-QIO shall compartmentalize its presence so that users of the website clearly understand which parts of the website are applicable to the QIN-QIO contract (and thus funded by QIN-QIO dollars).

At minimum, the website must:

1) Provide a means for the website to be continually informed by audience analysis and situational analysis performed as part of the QIN-QIO’s Strategic Plan.

2) Host content syndicated from a centralized CMS QIO Program web presence, as required by guidance from CMS and its Coordinating Center contractors.

3) Include Really Simple Syndication (RSS) feeds (or other applicable technologies, at the COR’s discretion) that alert web users to recent updates from the QIO, including RSS feeds as applicable from CMS’ Medicare.gov website and other partner websites.

4) Conform to the QIO Program branding guidelines as articulated by CMS and its national Coordinating Center contractors.

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5) Promote national-level QIO Program communications vehicles consistent with guidance from CMS and its Coordinating Center contractors (e.g., newsletters, advertisements for nationally available conferences, and announcements of learning opportunities).

6) Post matters of national importance as directed by CMS or the Department of Health and Human Services (HHS).

QIONet, in cooperation with CMS and the HCQIS Web Strategies and Communications Workgroups, has developed 508 Compliance and Accessibility Resources along with a chronological compilation of QIO website guidance. Additional Section 508 compliance information can be found in the 508 Compliance folder under Communication Resources in the Integrated Communications section of the Healthcare Communities website. Additional information on the internet presence of QIOs can be found in QIN-QIO 11th Statement of Work, Section J. Attachment J-2; BFCC-QIO contract, Section J, Attachment J-3, B16.

Hardware and Software Catalogs Listings of HCQIS-approved software and hardware are available on QIOnet. These catalogs list the product name, model, manufacturer, details, status, and estimated cost. (SDPS Memo 04-113-GN)

Gathering Information QIO communicators gather information for conducting outreach, education, and promotion of SOW Tasks from a variety of sources: beneficiaries, partners, and other QIOs, among others. Policies relating to these information gathering activities are below.

Information Collection

Activities Requiring Clearance Any given SOW may require that certain satisfaction and other surveys be performed. If, however, a QIO wishes to collect information outside of SOW contractual requirements, CMS policies apply. Information collected using surveys or other methods can provide valuable support to the development and evaluation of interventions. The use of information collection methods to gather data that can support/facilitate the success of cooperative projects is an innovative option QIOs may consider worthwhile. However, such activities must meet all applicable CMS, statutory, and regulatory requirements before being implemented. QIOs must follow regulations outlined in the Paperwork Reduction Act (PRA) which remains to ensure federal agencies do not overburden the public with federally sponsored data collections. For detailed information on the PRA and how it applies to information collection activities, visit: https://www.opm.gov/about-us/open-government/digital-government-strategy/fitara/paperwork-reduction-act-guide.pdf

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QIOs have two options when seeking approval to collect information. Both options require review and approval through the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA):

1. A Fast Track Process for Generic Clearance is designed for a wide range of information collections that focus on the awareness, understanding, attitudes, preferences, or experiences of customers or other stakeholders relating to existing or future services, products, or communication materials.

2. Requests not meeting criteria for the Fast Track Process must go through a formal process requiring draft of the information collection instrument and publishing a Federal Register notice to solicit public comment (for 60 days) on the information collection.

NOTE: Further details for each process follow. Instructions for both types of information collection apply to all QIO projects or Special Studies when the information collection activity is directed towards 10 or more “persons” (defined in 5 CFR 1320.3k), regardless of the target audience (beneficiaries, providers of any type, organizations, etc.). This instruction does NOT apply to medical record abstraction you conduct as a part of a QI project.

Fast Track Process for Generic Clearance The Fast Track Process is designed for a wide range of information collections that focus on the awareness, understanding, attitudes, preferences, or experiences of customers or other stakeholders (e.g., delivery partners, co-regulators, and potential customers) relating to existing or future services, products, or communication materials with the objective of improvement. Work with your COR to determine if the information meets the requirements described below. Request a generic clearance submission form from your PCC-IC account manager, complete the form and the PCC-IC will submit the form for approval. Within five business days of OIRA’s receipt of the submission, OIRA will raise with your QIO any questions, concerns, or issues that OIRA has identified with the submission. If no concerns are identified, then OIRA will notify your QIO within five business days that OIRA has approved the collection, and your QIO may proceed with the collection under the OMB-issued control number for the approved Generic Clearance.

You should consider using the Fast Track Process for your data collection when the data collection meets all of the following criteria:

The purpose of the collection is to assist the agency in improving existing or future service deliveries, products, or communication materials

Participation by respondents is voluntary The collection does not impose a significant burden on respondents The collection does not require statistical rigor in order to have practical utility

for improving existing or future service deliveries, products, or communication materials

Public dissemination of results is not intended

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In general, the following kinds of collections fall under the Fast Track Process: Comment cards or complaint forms Focus groups One-time or panel discussion groups Moderated, un-moderated, in-person, and/or remote usability studies Testing of a survey or other collection to refine questions Post-transaction customer surveys (e.g., by call centers) Online surveys Customer satisfaction qualitative surveys (e.g., those designed to detect early

warning signs of dissatisfaction with QIO service delivery)

Examples of collections that would generally not fall under the Fast Track Process are:

Surveys that require statistical rigor because they will be used for making significant policy or resource allocation decisions

Collections whose results are intended to be published Collections that impose significant burden on respondents or significant costs on

the government Collections that are on potentially controversial topics or that raise issues of

significant concern to other agencies Collections that are intended for the purpose of basic research and that do not

directly benefit the QIO’s customer service delivery Collections that will be used for program evaluation and performance

measurement purposes

The Fast Track Process allows for surveying potential customers and other stakeholders (such as past customers, potential future customers, co-regulators, and delivery partners) as long as the purpose is for improving current or future service delivery, and the collection satisfies required criteria. The Fast Track Process is not for the collection of information to be used for general program evaluation.

Collections under the Fast Track Process must be low-burden for respondents based on a consideration of the total burden hours for the collection, as well as in relation to the total number of respondents and the burden-hours per respondent. The following are illustrative examples:

A 15-minute survey for 2,000 individuals would be low-burden because the total burden hours, and the burden-hours per respondent, would be small.

Two-hour focus groups, involving a total of 100 persons, would be low-burden because the total burden hours, and the total number of respondents, would be small.

A five-minute comment card filled out by 10,000 people would be low-burden because the total burden hours, and the burden-hours per respondent, would be small.

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The Fast Track Process allows for collection of Personally Identifiable Information (PII) in limited circumstances, such as when a QIO collects contact information PII in order to have follow-up contact with a respondent (e.g., in order to provide remuneration, when appropriate, for participants of focus groups). And in those limited circumstances, the QIO may collect PII only to the extent that its collection is a necessary element of the information collection request. Moreover, in such circumstances, the QIO must comply with the applicable requirements, restrictions and prohibitions of the Privacy Act and other privacy and confidentiality laws that govern the QIO's collection, retention, use, and/or disclosure of such PII.

The submission form requires you to provide summary information, including a short description of the purpose and use of the information, an estimate of the burden, information about the respondents, and a copy of the questions that will be asked in the form or format that they will be asked (e.g., if you are asking questions using a web-based application, screen shots must be provided; if you are conducting a focus group, the script for the focus group facilitator must be provided). After you have completed the form, the request for approval will be submitted to OMB by the PCC-IC through its existing processes for submitting requests to OMB. You can submit a request for approval of one proposed data collection activity at a time or you can bundle multiple eligible data collection activities together. You may bundle up to five proposed information collection activities together if they are similar in nature (e.g. five comment cards at once). If you anticipate performing multiple data collection activities and this approach will not work for you, you should contact your PCC-IC account manager to discuss possible solutions. Information Collection Not Covered by an OMB-approved Fast Track Generic Clearance For information collection not covered by an OMB-approved Generic Clearance, you will have to follow the formal PRA information collection process. In order to maintain the integrity of your information collection capabilities, it is imperative that you give careful consideration to:

The precise information you want to collect, i.e., what are the overarching questions you believe need to be answered? What are you attempting to learn through the information collection activity about characteristics or aspects of the population?

The need for the information you propose to collect, i.e., will it provide the data necessary to answer the questions that you believe need to be answered?

The quality of the instrument you propose to use to collect that information, i.e.,

will it result in data that, when analyzed, will answer the questions that drive the information collection activity?

The proposed use of the information to be collected, i.e., how exactly will the

information derived from the activity be used? Is it central or peripheral to a successful project intervention/project evaluation?

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In order to develop a successful information collection proposal, you must establish a clear relationship between:

The overarching questions for which the QIO believes it needs answers and the data the QIO proposes to collect

The data collected and the proposed analysis of the data; and

The information that will result from that analysis and the generation of answers to those “big picture” questions driving the information collection activity.

Any proposed information collection activity must meet the following CMS Center for Clinical Standards and Quality (CCSQ) requirements:

The information collection activity must be an integral part of a specific QI project (clinical or non-clinical)

You must have verified that the information you propose to collect is not available from other sources

o Other sources include peer-reviewed published literature, Medicare claims

data, Clinical Data Abstraction Center (CDAC) chart reviews, the Behavioral Risk Factor Surveillance System (BRFSS), the National Health Interview Survey (NHIS), the Medicare Current Beneficiary Survey (MCBS), the Health Plan Employer Data and Information Set (HEDIS), and other QIOs’ projects/information collection activities. The extent to which you have gone to verify this “information gap” must be documented in the materials you submit to your COR (See Exhibits 12-1 and 12-2).

Statutory and Regulatory Requirements – Paperwork Reduction Act (PRA) Paperwork Reduction Act (PRA) Definitions - The foundation for any information collection activity that a QIO might undertake is the Paperwork Reduction Act (PRA). Terms in the PRA have very specific definitions. Definitions at 5 CFR 1320 that are pertinent to QIO information collection activities are given below. See the PRA regulation text for a complete list of definitions.

Burden means “the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency.... A collection of information conducted or sponsored by a federal agency that is also conducted or sponsored by a unit of State, local, or tribal government is presumed to impose a federal burden except to the extent that the agency shows that such State, local, or tribal requirement would be imposed even in the absence of a federal requirement.” See 5 CFR 1320.3(b)(1),(3). Information means “any statement or estimate of fact or opinion, regardless of form or format, whether in numerical, graphic, or narrative form, and whether oral or maintained on paper, electronic, or other media.” See 5 CFR 1320.3(h).

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Collection of information means... “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to an agency, third parties, or the public of information by or for an agency by means of identical questions posed to, or identical reporting, record keeping, or disclosure requirements imposed on ten or more persons, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit... A 'collection of information' may be in any form or format, including the use of report forms ... questionnaires; surveys; reporting or record keeping requirements... interview guides; oral communications ... telegraphic or telephonic requests; automated, electronic, mechanical, or other technological collection techniques; standard questionnaires used to monitor compliance with agency requirements; or any other techniques or technological methods used to monitor compliance with agency requirements...” See 5 CFR 1320.3(c). Person means “an individual, partnership, association, corporation... business trust, or legal representative, an organized group of individuals, a State, territorial, tribal, or local government or branch thereof, or a political subdivision of a State, territory, tribal, or local government or a branch of a political subdivision.” See 5 CFR 1320.3(k). Practical utility means “the actual, not merely the theoretical or potential, usefulness of information to or for an agency, taking into account its accuracy, validity, adequacy, and reliability, and the agency's ability to process the information it collects (or a person's ability to receive and process that which is disclosed, in the case of a third-party or public disclosure) in a useful and timely fashion... In the case of record keeping requirements or general purpose statistics...'practical utility' means that the actual uses can be demonstrated.” See 5 CFR 1320.3(l).

Compliance with the PRA Surveys and any other information collection activity must comply with the provisions of the PRA of 1995 (Public Law 104-13). These provisions generally prohibit an agency from conducting or sponsoring a collection of information (as that term is defined in the PRA) unless, in advance thereof, the agency: (1) reviews the collection of information, (2) publishes a 60-day notice in the “Federal Register”, (3) evaluates comments received pursuant to such notice, and (4) receives approval and a control number from the Office of Management and Budget (OMB). Applicability of Statutory/Regulatory Requirements in QIO Program QIOs should always remember that information collection is a valuable tool applicable to both clinical and non-clinical quality improvement work. Since there are legal issues for both CMS and QIOs if information collection is undertaken without having appropriate approval, it is also a tool that could lead to litigation or be taken away, if misused. CMS believes it is better for a QIO to err on the side of caution and consult its RO on all information collection activities than it is to make mistakes.

The key issues for the utilization of information collection in the QIO Program are: (1) what qualifies as “information” under the PRA, and (2) what information collection activity requires or is excepted from OMB clearance. Items that are not considered “information” would not, in general, be subject to review by OMB (or CMS). Activities that are excepted

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from OMB clearance (see page 15) are still subject to CMS review (i.e. the Division of Quality Improvement (DQI)). Differentiating between what is and is not subject to the PRA: Whether an information collection activity is subject to the PRA rests, in general, on the following criteria: number of “persons” from whom information is being collected, type of question(s) being used to collect that information, if identical questions are being asked of all entities, and if the information is being collected within a consecutive 12-month period.

Number of persons = nine or fewer: If information is being collected from nine or fewer “persons" (as defined in the PRA), the approval process is not required. Therefore, the information collection activity would not be subject to OMB clearance or CMS review.

Number of persons = 10 or more: If information is being collected from more than nine “persons,” in general, the approval process would be required. Therefore, the information collection activity would be subject to OMB clearance and CMS review.

CMS guidance regarding (1) open-ended questions asked of (2) more than nine “persons”: While the CMS Reports Clearance Officer (RCO) has indicated that information collection activities meeting those two criteria would not be subject to the PRA, CMS requires RO involvement (review/approval) of any collection involving more than nine “persons.” This is required no matter what type of queries, questions, or probes are used. CMS also encourages QIOs to inform their ROs when undertaking information collection activities that do not require RO review and approval, i.e., activities not considered information collection under the PRA.

Items not subject to the PRA The following is a list of things that are, in general, not subject to the Paperwork Reduction Act:

Consents Acknowledgments Receipts Publication order forms Reader response cards/feedback forms if questions are open-ended Website feedback (suggestion box format only) and publication, etc., order

forms Evaluation forms for meetings Follow-up contact lists for meetings Discussion guides/prompts with open-ended discussion topics Open-ended phone scripts Continuing intermittent feedback from physicians A closed-ended question survey that goes to nine or fewer "persons" A subcontract if CMS is not sponsoring the collection

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Statutory and Regulatory Requirements – Office of Management and Budget (OMB) Role Activities that are considered “information collection” under the PRA must receive OMB clearance. The implementing regulations require OMB approval for any collection of information that gathers data from 10 or more “persons” (public respondents) using a standardized format and identical or similar questions. (Regulations at 5 CFR 1320 implement the provisions of the PRA.) These provisions apply to information collected by any method (e.g., oral interviews or self-administered questionnaire). OMB clearance must occur prior to the conduct of the data collection activity.

Information Not Subject to OMB Clearance - The federal government has specified at 5 CFR 1320.3(h) certain categories of items that generally do not constitute “information” for purposes of the PRA and, as such, are not subject to the general OMB clearance requirement, although OMB may determine that any specific item constitutes “information.” In planning a project, discuss with your COR the potential applicability of these categories to your project and any information collection activities planned for the project. OMB Clearance - Unless a survey or other data collection activity would not be subject to the PRA under the regulations as discussed above, you must have prior OMB approval to conduct, or engage someone else to conduct, the survey or other information collection activity that is performed as part of your Medicare contract. If the proposed activity requires OMB approval, you must submit Form 83 Parts I and II. Please note that every information collection request must have one Form 83 Part I; however, it is possible for an information collection request to have multiple Part II forms. Provide the Request for OMB Review, Supporting Statement Parts A and B, if applicable, and related materials to your COR. Your COR will then submit the Request to OMB through CMS' Reports Clearance Officer (RCO). You may initiate the information collection activity only after you have secured proper approval from OMB through the RCO. You can contact your COR for Form OMB 83-I, the supporting statement outline, and the checklist of related materials.

CMS Information Collection Approval Process Role of the RCO - While OMB retains the ultimate authority to determine if a QI project (clinical or non-clinical) includes an information collection activity(ies) subject to the PRA, the authority within CMS to decide whether any aspect of your QI project falls outside the definition of “information,” or is otherwise not subject to the requirements of the PRA, resides with CMS’ RCO in the Central Office.

NOTE: “Project” refers to the overall QI project, whether it is clinical or non-clinical. “Project” is never used in the narrower sense to refer to the proposed collection activity. The RCO will consider whether the QI project under which the information collection activity will be carried out is exempt from OMB clearance under 5 CFR 1320.3 or 5 CFR 1320.4. The RCO determination will be made only after the proposed activity has first been endorsed by the RO. If the RCO judges a QI project/topic not subject to 5 CFR 1320, then any information collection activities that you conduct to support that project would be exempt from OMB review. It will, however, be subject to the CMS review process described below. If, however, the RCO determines that the project is not exempt from OMB review,

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the information collection activity is, therefore, subject to formal OMB clearance. You will need to work with your COR to submit the appropriate documentation to apply for formal OMB clearance. Documentation will be submitted through the RCO. This process requires approximately 6–9 months from the time of submission.

Review Process Developed by CMS - Based on the provisions in the PRA, CMS has developed a two-part process that covers all OMB clearance requirements.

Proposal Approval - Approval of the proposed information collection activity is the first component of the CMS process. This involves endorsement of the idea/concept by the RO and a decision by the RCO whether the project is exempt from OMB clearance. While these two reviews focus on very different things, a single document, the Proposal Submission (Exhibit 12-1), is used for both purposes. The RO reviews the document to determine if the activity described in a QIO’s write-up will add value to the associated QI project (step one). If this decision is positive, the RO forwards the Proposal Submission to the RCO for his/her decision as to whether OMB clearance is necessary (step two).

The national exemption applies only to RCO/OMB review - The rest of the

information collection approval process must be completed. This second component of CMS’ review process is described briefly below. Complete requirements follow.

Activity Approval - The second component of the approval process is the RO

approval of the information collection activity itself. This stage requires, for all proposed information collections, submission of three documents: a justification for the proposed information collection, a description of the methodology to be used, and the final draft information collection instrument.

If the target respondent audience(s) includes Medicare beneficiaries then an additional document, the “Beneficiary Notification Letter,” is required as explained in the Additional Consideration for Medicare Beneficiary Respondents section below.

CMS Approval of Proposed Activity – Information Collection Proposal Submission

RO Endorsement of Proposed Information Collection Intent and Concept Proposal Submission document - The proposal submission includes the information necessary for the RO to make a decision about endorsing the proposed information collection. All proposal submissions must include the following information:

Exemption-related Information - For possible “clinical” exemptions, the clinical topic or the patient care outcome which is the focus of quality improvement needs to be described. For possible “audit” exemptions, evidence of, or results from, previous audit activities must be provided.

Information Collection Intent - Briefly describe the general purpose of the information collection activity, including the key questions that the activity is intended to answer. This section must also indicate whether: (1) the information obtained through the activity will be used to design and/or implement

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interventions/intervention strategies, and if so, how; and/or (2) if you plan to use the activity as a part of an evaluation process, how the collected information will be used. Also, you must name the population of interest.

Opportunity for Improvement - Describe the opportunity, including the numbers that demonstrate the presence of the opportunity and information on the data source(s) used to identify the opportunity’s existence (e.g., CMS claims data, Clinical Data Abstraction Center chart abstraction).

NOTE: An information collection activity cannot be used solely to identify an opportunity for improvement (i.e., to establish an initial project baseline). Rather, information collection activities can only be used to provide useful information to assist you in designing and implementing effective interventions and/or to evaluate the impact of an intervention (i.e., to measure improvement). If initial baseline or re-measurement baseline data are collected in conjunction with the aforementioned utilities, it is allowable.

Format/submission - The QIO should submit the required information using the Information Collection Proposal Approval Template (Exhibit 12-1). The information submitted should cover all requirements described above, so that RO staff and the COR can determine whether the value added to the QI project by the proposed information collection activity will justify the resources required. CMS is looking for well thought out and thorough content, presented clearly and concisely, that should require no more than one-half (½) page. The Information Collection Proposal Approval document must be submitted electronically to your COR, unless the COR approves another mechanism for submission. Timeline - Once your COR receives your Information Collection Proposal Submission, the COR, in consultation with the RO, has 15 business days to review this document and provide comments to you. You may be asked to submit additional information. The RO will then have an additional 15 business days from the date of resubmission of the paper for review/approval. NOTE: The times allowed for review of all documents that are part of the CMS information collection review process are taken directly from the OMB clearance process. While you can discuss expediting the review with your COR, it is the QIO’s responsibility to take these response times into its planning and proposed timeline for any information collection activity it wants to do. This means that no such activity can be done as a spur of the moment or “spontaneous” action.

Conflict resolution - The Division of Quality Improvement (DQI) Associate Regional Administrator will resolve any disagreements between you and the COR on the proposed concept/idea and/or its approval. Next step for all projects - If your COR and RO agree with the intent and concept of the project, the COR will inform you electronically. You can then move to the next action

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required of you by the information collection approval process, submission of documents related to the actual activity.

RCO Approval of Request for Exception to OMB Clearance Following RO endorsement of the proposed activity’s intent/concept (as documented in the information collection proposal submission), the COR will transmit the information collection proposal to the RCO. This second step of the approval process provides the RCO with information adequate to allow a determination of whether the QI project (clinical/non-clinical) meets one of the exemptions to OMB clearance. The following information needed by the RCO is also provided in the information collection proposal:

The QI project topic (i.e., the clinical topic and focus for quality improvement/patient care outcomes (clinical exemption) or evidence/results of previous audit activities (audit exemption, under which any information collection activity related to payment error surveillance may fall).

How the information will be used (i.e., for intervention development and design and/or assessment of intervention/project impact).

Both pieces of information are necessary in order for the RCO to decide whether: (1) a proposed project falls into an exemption category, and (2) the information collected will be used solely to establish a baseline or opportunity for improvement.

Format/submission - See “Format/submission” requirements above. The same document, the Information Collection Proposal Submission, is used to submit information to the RCO. Timeline - The RCO has 15 business days from the date the COR submits your proposal to decide whether the proposed project/information collection is subject to OMB review. The RCO will convey his/her decision via email to your COR, who will in turn notify you electronically of the RCO’s decision. If for any reason the RCO needs additional documentation to assist in making his/her determination, you will be notified by your COR. If additional documentation is required, the RCO will again have 15 business days to make his/her determination from the date that this additional documentation is submitted to the RCO by your COR. The same process described above for informing you of the RCO’s decision will be followed once a determination is made subsequent to the review of additional information.

Conflict resolution - There is no appeal of the RCO’s decision. When his/her decision is that the proposed information collection activity is subject to OMB clearance, you must provide the documentation described in CMS Information Collection Documentation Process if you want to proceed with the proposed information collection activity. Your COR will help you with this documentation and with the OMB clearance process. CMS Approval Process – Approval of Actual Activity – Information Collection Justification, Methods, and Instrument The next component in the information collection approval process is approval of documents related to the actual information collection activity. The QIO must submit the

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following for RO review and approval: a document justifying the information collection activity, a description of the methods/methodology the QIO intends to use, and the proposed instrument. If Medicare beneficiaries will be included in the respondent sample, you must also submit a Beneficiary Notification Letter described below in the Additional Considerations for Medicare Beneficiaries section. You can work with your COR and RO in developing the survey justification and in designing the survey methodology and information collection instrument(s) to be used in the project. However, whether or not you choose to use/work with your COR and RO staff, you are required to complete this part of the approval process. Once you consider both the contents and formatting of the documents described below in final draft form, submit them to your COR. CMS has two expectations related to these documents:

The draft submitted must be a final draft, that is, complete, thorough and, in the case of the instrument, ready in both content and format to be pilot-tested or fielded, once RO review and approval have been completed.

The draft submitted must represent the best work of the QIO. That is, it should not be simply the best that the person in charge of the related project can do but the best that the organization as a whole can do. This means that relevant internal expertise should be applied to the development and review of the contents of the information collection justification, methods, instrument, and, when necessary, beneficiary notification letter. If such expertise/experience does not exist within the QIO, then CMS expects that the QIO will engage appropriate outside consultation to ensure that the documents sent to the RO for review meet or exceed RO expectations.

Regional Office (RO) Approval of Information Collection Documents – Justification, Methods, and Instrument Information Collection Justification - The justification for the information collection activity has two objectives: first, to provide a clear statement of the purpose of the activity, and second, to demonstrate the need for the information collection. No information collection activity will be approved unless these two objectives are met. The Statement of Purpose should show why it is important/necessary to do the proposed information collection activity, that is, what value will be added to the project and why perceived returns justify the investment in/resources used by collecting this information. The justification should provide:

A brief statement of the purpose of the project and explanation of the circumstances that make the survey necessary/integral to the successful completion of the project. This statement should also clearly address why collection of new information related to your targeted population is necessary. It should also include relevant characteristics and aspects, relative to the population/project that the results of this activity help you understand.

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A description/summary of the overarching questions that the information collection activity is designed to address. Include the QIO’s conceptual-/design-type purpose/thinking that is driving the proposed collection activity. DO NOT include the specific inquiries or probes that are proposed for the instrument.

A discussion of the purpose for which the information gained from the activity will be used, including how and by whom the information will be used. This should also describe situations in which your project and/or information collection results may be used at an aggregate level (e.g., regional, national, etc.). Make clear how responses to each of the above questions will be used relative to improving health care/health outcomes for Medicare beneficiaries.

A description of the population that will be the subject of the information collection activity.

Information about the source of the proposed activity’s concept/design, if it has been imported from another organization, agency, etc.

If applicable, justification for any questions of a sensitive nature, such as questions regarding sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Follow the guidelines outlined in OMB Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting, and the subsequent revisions to that Directive, when asking questions related to race and ethnicity. You can obtain these documents from: https://www.federalregister.gov/documents/2016/09/30/2016-23672/standards-for-maintaining-collecting-and-presenting-federal-data-on-race-and-ethnicity

The demonstration of need should show why the QIO cannot get the information elsewhere or in some other way. This part of the justification should:

Describe the process you used to verify that the information to be collected is not available through any other source (peer-reviewed published literature, Medicare claims data, CDAC chart reviews, Behavioral Risk Factor Surveillance Survey, National Health Information Survey, Medicare Current Beneficiary Survey, Health Plan Employer Data and Information Set, other QIOs’ projects/surveys, etc.).

Describe your efforts to identify similar information collection activities previously conducted by you or by another association, organization, or agency. If any similar information is available, show specifically why it cannot be used or modified in order to fulfill the objectives described above. List resources searched.

Provide estimates of the cost to the federal government for the survey (Annualize the cost, if applicable). This means actual costs, not just labor hours, but should include, as best you can, components of costs (e.g., labor hours in developing and testing the instrument, cost of any consultant involvement, cost of analyzing data and writing up reports, etc.).

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Information Collection Methods - The methods to be used in different aspects of designing, administering, and analyzing the information collection activity, such as the sampling strategy, development of questions/queries, maximizing response rates, administering the instrument, and analyzing the collection data, need to be clearly and thoroughly documented. At minimum, this documentation should address instrument design and administration and data analysis. NOTE: You are encouraged to consult with individuals or organizations with specialties in designing, collecting, and analyzing data that can be collected through the information collection activity you propose. Design/Development

Sampling strategy - Describe the type of sampling to be done (e.g., non-probability sampling such as convenience sampling, purposive or purposeful selection, etc.; probability sampling such as simple random sample, stratified random sample, cluster sample, etc.).

o Provide sample size calculations based on population size (sampling frame), prevalence of the study variable(s), confidence levels/intervals, and estimated non-response rates. Include the sampling accuracy (sample size and associated power) needed for the purpose described in your information collection justification and describe any unusual problems requiring specialized sampling procedures.

o Provide a description of the sampling methodology, including how interviewees will be selected. Address whether proxies will be interviewed and any exclusion criteria used for interviewees.

o If a sampling strategy will be used that does not allow for generalization, the rationale needs to be provided as does how the utility of the data collected will be affected.

Questions - Include a description of any tests of procedures or methods to be

undertaken to assess the reliability and validity of questions to be developed.

NOTE: You are strongly encouraged to use measures that have already been developed and tested and are in the public domain, rather than creating new measures. You are also encouraged to use an experienced consultant when developing new questions. The RO may request the resumes of any consultants you use.

Accuracy/validity - Show that the accuracy and reliability of the data being collected are expected to be adequate for the intended uses. Describe how the instrument will be pre-tested for reliability and validity.

o Describe possible sources of bias and how you will deal with them. Provide justification for any collection that will not yield reliable and valid data that can be generalized to the units studied.

Field-testing - Describe how the information collection instrument has been or will be field-tested. If the instrument has not been or will not be piloted, provide a rationale for this approach.

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Response rates - Describe expected response rates for the collection as a whole, and upon what evidence you base this estimate. Include the actual response rates if any entity has previously conducted a similar collection.

o Describe methods to maximize response rates and to deal with issues of non-response.

Implementation/administration Use of technology - Describe any use of automated, electronic, mechanical, or

other technological collection techniques or other forms of information technology that may reduce the burden on the respondent.

Instrument administration - Describe the process by which the instrument will be administered (e.g., mail, in-person, telephone). Describe who will be conducting the survey. If a subcontractor will be used, provide a resume or description of the subcontractor, including survey experience.

o If the survey is to be self-administered, possible biases should be

included above in the accuracy/validity discussion. If the instrument is to be administered by telephone or some other technological method (see immediately above), possible biases related to the method of administration must also be included in the accuracy/validity discussion.

o Give an estimate of how long it will take for the respondent to provide his/her responses to the instrument, if a questionnaire is used, or time that participation will take for activities such as focus groups.

o Honoraria or other types of compensation for participants’ time are not permissible. Meals are only permissible if the participants are required to work through lunch. It is recommended that all instruments, including those administered to focus groups, be of a reasonable length.

Confidentiality - Describe the procedures you, your subcontractors, and your consultants will employ to maintain respondents’ confidentiality and the confidentiality of all data collected, including hard copy and computer files.

Data Analysis Data analysis strategy/plan - Briefly discuss how you plan to analyze the data,

including use of statistical methods, statistical testing, adjusting for possible biases, etc. This discussion should also include which tests you anticipate using for which objectives of the analysis.

o The plan should address both qualitative and quantitative analyses, as appropriate, and include any plans for interim analyses (e.g., process or implementation evaluations).

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o If applicable, describe how information collected in the survey will be used to account/adjust for confounders in multivariate regression models.

o The connections between questions driving the need for this information collection activity, the data the QIO wants to collect, and the analysis of that data should be clearly and logically laid out. You should also describe the use of the information to be developed from the collected data.

Information Collection Instrument - Provide an exact copy of the entire proposed survey questionnaire and any related instructions for completing the questionnaire. The instrument should be the final draft version. Certain information in the introduction to the instrument is mandated (see below) and must be provided to the respondent before the instrument is administered. This language lets respondents know that opting out of participating will have no effect on the respondent or responding institution. If a cover letter is sent to possible respondents and includes the language below, it must be repeated in the introduction to the survey instrument when the instrument is to be self-administered by the respondent. If the instrument is administered during a telephone interview, the introductory language must be repeated when the actual administration takes place, even if the language has been provided previously (e.g., when calling the respondent to set an interview time). We suggest using some form of preliminary notification in all information collection activities, both as an advisory and possible means of increasing participation and getting better data.

Required Language Introducing Information Collection - When providing the required information to the respondent, you should adhere to the following language as closely as possible (as appropriate and makes sense):

The information provided by the respondent is voluntary.

The identification of the respondent and the information provided by the respondent are confidential.

The respondent's decision whether to participate in the survey will not affect his or her Medicare (or Medicaid, where applicable) benefits or reimbursements. (It is less confusing if this language is adapted to the type of respondent: if a beneficiary, use “his/her benefits;” if a respondent is responding on behalf of a provider, practitioner, etc. (i.e., has some institutional relationship), use “the institution’s reimbursements.”)

An estimate of the total time it will take the respondent to answer the questions.

The name of the QIO collecting data.

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Information to enable the respondent to contact the requestor (toll-free/collect phone number, or name and address), if he/she has questions or wants further information about the survey. Depending on the medium through which the respondent provides answers to the instrument, contact information could include electronic media such as an email or web address or web site.

Format/submission - Use the Information Collection – Activity Approval template (See Exhibit 12-2). The information submitted must be sufficient that RO staff can understand the justification for the information collection activity, the methods to be used, and the data analysis(es) to be performed. CMS is looking for well thought out and thorough content, presented clearly and concisely; there is, however, no suggested page length for these documents. The submitted instrument must be the final draft version, with all formatting complete. The supporting documentation must be submitted electronically to your COR, unless the COR approves another mechanism. Your COR, in consultation with the RO, must approve the information collection instrument(s) and all supporting documentation prior to your implementation of the actual information collection activity. You may, therefore, want to consult with RO staff as you are developing these documents. Timeline - Your COR will have 15 business days from receipt to review the justification and methods documents and the instrument(s) and to provide a decision to you. The RO may ask you to submit additional information. The RO will then have another 15 business days from the date of resubmission to review your documentation and to provide a decision. Conflict resolution - The DQI Associate Regional Administrator will resolve any disagreements between you and the COR on the documentation provided to support the information collection activity and the actual instrument(s). NOTE: If you have discussed your proposed activity with your COR and expect your concept/idea to be endorsed by the RO, you can begin work on the required documents (justification, methods, instrument) at the same time that your proposed activity’s concept/idea paper is under review by the RO and your Request for Exception, if required, by the RCO. If the RCO determines that the project is subject to the requirements of 5 CFR 1320, and you choose to submit your project to OMB for formal review, you will be required to include the information described in the CMS Approval Process section of this handbook with your submission to OMB. Work with the RO and the RCO to prepare a Request for OMB Review, supporting statement, and related materials.

Additional Considerations When Medicare Beneficiaries Are Respondents The CMS approval process involves one more mandatory step and submission of one more document if the targeted respondents include any Medicare beneficiaries. The QIO’s implementation of the information collection activity involves two more steps. CMS Approval - If beneficiaries are proposed as respondents, you must notify each potential beneficiary respondent in advance of contacting him/her to administer the

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instrument. The purpose of the notification is to give the beneficiary advance warning of the activity and the opportunity to opt out of participating.

Beneficiary Notification Letter - The letter that you propose sending to the beneficiary must be approved by the RO and must go out under the signature of your CMS Regional or Consortium Administrator.

RO review of the Beneficiary Notification Letter may occur simultaneously with the RCO's review of your request. It must be submitted to your COR in final draft form and must include the following information:

o Identification of your organization as the Medicare Quality Improvement Organization for your region.

o Description of the survey (the purpose of the survey, how the instrument will be administered, e.g., by mail or telephone, etc.).

o Assurance of the voluntary nature of the beneficiary’s participation (i.e., informing the beneficiary that he/she is under no obligation to respond to the survey).

o Assurance that the decision to respond or not to respond will in no way affect the beneficiary’s Medicare (or Medicaid, where applicable) benefits.

o Assurance that the beneficiary’s identity and the responses provided by him/her are confidential and that all information provided is protected by the Privacy Act, the QIO confidentiality statute at §1160 of the Social Security Act, and the QIO confidentiality regulations at 42 CFR Part 480. Copies must be provided upon request.

o Contact information: a toll-free or collect telephone number with the name of a contact person at the QIO whom the beneficiary can call if he/she has additional questions about the survey or wants to exercise his/her right not to participate in the survey (see §12670.B of the Social Security Act).

o Date letter is to be sent to the beneficiary.

o (Optional) You may also want to include the tentative timeframe in which the beneficiary can expect to receive a mailed instrument or be called for a telephone interview. For example, if the notification letter is received by the beneficiary the first week of October, then the letter might inform him/her to expect to be contacted or receive a mailing no later than the middle of November.

Format/submission - The draft submitted to the COR must be in letter format and must be a final draft version. The COR and DQI Associate Regional Administrator will review and

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approve the content and format of the Beneficiary Notification Letter prior to its being submitted for the Regional or Consortium Administrator’s signoff. Work with your COR to secure the proper CMS authorization and signature for the letter. The letter must be written on CMS letterhead, but may be mailed in an envelope using your return address. RO staff will make sure the letter is properly formatted according to CMS standards and will return the signed original to you. Timeline - Your COR will have 15 business days from receipt of the letter for review. If there are suggestions, changes, etc. that need to be made, the COR will return the letter to you for modification. You are encouraged to model your Beneficiary Notification Letter after previously approved letters, to expedite the review and clearance processes. Once the COR has received a revised letter, he/she has 15 business days again for DQI review and to get the letter reviewed and signed by the Regional or Consortium Administrator. As with other documents that must be submitted as part of the CMS information collection approval process, you should consider the time required for this letter’s review and clearance when planning your information collection activity. Also, once your COR has endorsed the information collection proposal, the notification letter can be submitted for review when submitting the documents supporting the activity or when the Request for Exception is sent to the RCO. Conflict resolution - The DQI Associate Regional Administrator will resolve any disagreements between you and the COR related to the Beneficiary Notification Letter. Decisions made by the DQI Associate Regional Administrator about the letter content, editing, formatting, etc., are final.

Additional Required QIO Information Collection Steps When Beneficiaries Are Respondents

Pre-notification of Beneficiaries - A Beneficiary Notification Letter must be sent to every beneficiary who could possibly be contacted to participate in the information collection activity. These letters must be sent in such a manner that they are received by the beneficiary at least 15 calendar days prior to the implementation of the activity. This timeframe is necessary in order to allow the beneficiary time to contact the QIO if he/she chooses not to participate and/or does not choose to be contacted for this or any other similar activity.

Beneficiary No-Contact List - Any beneficiary who informs the QIO that he/she does not want to participate in this activity must be entered onto a No-Contact List. This list must be maintained by the QIO at all times, since in the course of your work, you may encounter beneficiaries who indicate that they prefer not to participate in activities that would require you contacting the beneficiary. The list must include each beneficiary’s name, health insurance claim (HIC) number, address, and date of birth.

Before any activity that would require direct contact with identified beneficiaries, including activities that require a Beneficiary Notification Letter, this list must be

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reviewed and any listed beneficiary removed from the sample/outreach mailing, etc. No beneficiary who is on the list should ever be contacted.

Upon request from CMS, you must provide to CMS the name, HIC number, address, and date of birth of all beneficiaries on your Beneficiary No-Contact List. Personal information in the possession of CMS is protected from disclosure to third parties by the Privacy Act.

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Exhibit 12-1 – Information Collection (IC) – Proposal Approval

Exhibit 12-1 Information Collection (IC): Proposal Approval

IC Proposal Submission

Organization: Type of IC Activity: Date Submitted:

(e.g., survey, focus groups, etc.) IC Title:_____________________ Quality Improvement: Task #________ Project

Title:_______________

PROPOSAL SUBMISSION

(intent/concept/request for exception) Provide the following information clearly

and concisely (one-half page).

The QIO is responsible for ensuring that all requirements included in the QIO

Communication Handbook are addressed

below.

Information Required Information Provided by QIO 1a. For possible “clinical” exemptions (See page 14 of the QIO Communication Handbook

for more information on items not subject to

OMB clearance), provide the clinical topic or

the patient care outcome which is the focus of quality improvement.

1b. For possible “audit” exemptions (See page 15 of the QIO Communication Handbook for

more information on items not subject to OMB

clearance), provide evidence of, or results from, previous audit activities.

2. General intent/purpose of proposed IC

activity, including:

Key questions QIO wants to answer

Role of information in intervention

design/implementation and/or evaluation

Population of interest

3. Opportunity for improvement identified in

the quality improvement project (Required for

all proposed IC activities not targeting Task 1

quality indicators)

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Exhibit 12-2 – Information Collection (IC) – Activity Approval

Exhibit 12-2 Information Collection (IC): Activity Approval

IC Justification and Methods Submission

Organization: Type of IC Activity: Date

Submitted:

(e.g., survey, focus group, etc.)

IC Title:_________________________ Quality Improvement: Task #________

Title:_____________________

Information Collection Justification Provide the following information

clearly and concisely.

Information Required Information Provided by QIO

The QIO is responsible for ensuring that

all information collection requirements are

addressed below.

1. Statement of Purpose

a. Purpose of clinical/audit project,

including:

Circumstances that necessitate

information collection (IC) activity

b. Questions IC activity is designed to

address

c. Purpose for which information resulting

from IC activity will be used, including:

How information will be used

By whom information will be used

Use of information at aggregate levels

d. Population that will be subject of IC

activity (i.e., respondents)

Also address what the IC activity will

help QIO understand about the

population

e. Source of proposed activity’s

concept/design, if imported from other

entity

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f. Justification for any questions of sensitive

nature, if applicable

2. Demonstration of Need

a. Process used to verify that desired

information is not elsewhere available

b. Efforts made to identify similar IC

activities previously done by your QIO or

another entity

If existing, explain why information

cannot be used or modified to fulfill

purposes described in 1 above.

c. Estimated actual cost to government of

proposed IC activity

Annualize, if applicable

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Information Provider Protection No person or provider supplying information to a QIO will be held, by reason of having provided such information, to have violated any criminal law or to be civilly liable under any state or federal law, unless the information provided is unrelated to the performance of the contract of the QIO or the information is false and the individual knew or had reason to believe that the information was false (SDPS Memo 03-106-GN).

Health Communication Skills Outreach is a primary function of QIOs, necessary for educating beneficiaries, practitioners, and provider staff about QIO Program services and for conducting QI interventions according to the Tasks of a given SOW. In addition to customer knowledge-building, QIO communicators are engaged in intervention planning, message design, and tracking and measurement. QIO communicators assist in managing public recognition and press relations, and work not only with their own QIO’s clinical staff, but also with local, statewide, and national stakeholders in social marketing interventions. Other types of outreach communication include crafting success stories and preparing scientific articles and presentations. Some of the primary skills and methods used by QIO communicators are described in the following sections.

Communication Skill Set CMS recommends that each QIN-QIO has on staff an Integrated Communications Lead with:

Proven ability to build and maintain awareness of a program by using a variety of communications tools (including social media) and tactical methods to spread information about a program and its work within local communities.

Proven ability to conduct a communications health initiative that uses change management principles to move intended audiences from a current to a future state in ways that are efficient, sustainable, memorable, and actionable.

Demonstrated exceptional oral and written communication skills with the ability to leverage research and analysis.

Demonstrated advanced writing, public relations, and technology skills to plan and execute professional communications.

(QIN-QIO 11th Statement of Work, Section C.6.3.4). The BFCC contract classifies a Communication Director as Key Personnel (BFCC-QIO Contract, Section G.12).

Leveraging the Principles of Social Marketing In performing the tasks of the SOW, QIOs incorporate various tactics to stimulate widespread positive changes in the attitudes and behavior of various target audiences. QIOs are encouraged to engage in health promotion campaigns using their own creative strategies.

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Effective communications work in support of SOW Tasks ensures access to the right information and services in the right form at the right time, to the right people, in the right place. Communication plans will focus the QIO’s energy such that each policy, action, and decision is made with an educated and strategic consideration of the impacts they have on stakeholders (QIN-QIO 11th SOW, Section A.1.3). The QIO must effectively adhere to CMS policy requirements and agency and departmental directives. In addition, QIOs are encouraged to use social marketing theories (systematic approaches to achieve behavioral change) in developing strategies and products to ensure that content, design, and dissemination appropriately conform to target audience(s). Measuring the effectiveness of communication tactics helps identify which tactics are effective for getting an audience to take action (and worth repeating), and which tactics are not effective (and should be discontinued). The Integrated Communications section on the Healthcare Communities website houses multiple training resources on social marketing.

To the maximum extent practicable, the QIO shall measure and evaluate the effectiveness of its communication and outreach work. That is, the QIO shall use systematic, communication industry standard methods to assess how well communication activities meet their intended objectives and how these communication objectives ultimately help the QIO meet its contractual objectives. CMS will not assess QIO performance on the success or failure of particular communication tactics; however, the QIO shall ensure that it uses the information gathered from communication evaluations to determine whether certain communication techniques are effective and worth repeating or sharing with other QIOs.

The QIO shall not use contract resources to repeat communication activities/tactics/techniques that the QIO finds unsuccessful, unless the QIO tweaks its approach for communication through a “test of change” as part of the Plan-Do-Study-Act cycle. That is, the QIO shall not repeat its known mistakes and errors; rather, the QIO shall learn from mistakes and errors and change its approaches to avoid them in the future. (QIN-QIO 11th Statement of Work Section C.4.6). (BFCC-QIO Contract, Section C.5.5.4).

Creating Materials

Efficiency, Sharing, and Developing New Materials QIOs should manage their resources as efficiently and effectively as possible. CMS recognizes three major sources from which QIOs can obtain already-prepared marketing materials and resources:

Other CMS contractors ESRD Networks Other external sources that provide non-copyrighted materials and resources

QIOs may also develop their own materials.

Sharing of Materials QIOs are encouraged to share materials with the general QIO community. QIOs can share their materials in the Integrated Communications section of the Healthcare Communities

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website. Any member of the communications community can post their materials directly to the QIO sharing site or they can forward resources to their PCC-IC account manager for posting.

Enabling Access: Making Materials Accessible and Easy to Read QIO communicators are called upon to consider how all members of their audience might best access the materials they create, disseminate, and/or publish; this section reviews cultural competence and plain language guidelines. For information on Section 508 compliance (access to electronic information by people with disabilities), please see the 508 Compliance Policy section.

Cultural Competence Cultural competence is the ability of the individual and organization to function effectively in cross-cultural situations. Achieving cultural competence is one step along the path to reducing the disparities gap in health care. From the HHS website: “Quite simply, health care services that are respectful of and responsive to the health beliefs, practices and cultural and linguistic needs of diverse patients can help bring about positive health outcomes.” QIO communication must reflect the heterogeneity of the beneficiary population at large with respect to race, color, age, sex, physical handicaps, and national origin. Cultural competence includes not only the choice of language, but also the images and illustrations used. Sometimes separate ethnic or cultural versions of a communications product may be required. Your communication, in whatever medium, whether it directly portrays or identifies a group or groups of people, or whether it does so by implication, must not reflect adversely on that group or groups. You may not portray stereotyped behavior unless it serves the purpose of the communications product. HHS has developed a website of resources about cultural competence, www.ThinkCulturalHealth.hhs.gov. The site offers links to training materials, articles, and toolkits for addressing cultural competence issues. The website also includes cultural competence training modules eligible for CE credits for a variety of health care professionals.

Plain Language Federal government contractors must use plain language (or “plain English”) in all written communication. By using plain language, we send a clear message about what the Program is doing, Program requirements, and what services it offers. Plain language documents are logically organized, use easy-to-read design, and feature:

1. Common, everyday words, except for necessary technical terms 2. “You” and other pronouns 3. Active voice (see active voice) 4. Short sentences

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Several plain language resources are available online, including the Federal Plain Language website. In particular, review the Federal Plain Language Guidelines. There are also several resources available in the Integrated Communications section of the Healthcare Communities website, including a QualityNet Conference presentation by Jessica Ridpath from Group Health Research Institute, “It Takes a Village to Build a CRISP Strategy.” Jessica’s presentation can be found in the Training folder under Patient-Centered Communication. Other plain language resources, including information on the Program for Readability in Science and Medicine (PRISM) can be found in the Writing Help folder. While most of us have heard the expression “the active voice,” we may not know exactly what it means, nor how to find and remove its opposite (the passive voice) from our prose. The Federal Plain Language Guidelines include a brief explanation of how to revise passive language into active language. Consult a writing handbook for a more in-depth explanation of the attributes of passive language and how to avoid them, for example, Style: Ten Lessons in Clarity and Grace, by Joseph Williams.

How to Refer to CMS and Your QIO

QIO Program Brand The QIO Program brand provides the building blocks for clearly articulating the Program’s goals and priorities to external audiences. It consists of various brand and messaging elements that are essential for ensuring consistent communications. The elements are not typically used at the same time, but rather form a hierarchy of information for communicating the QIO Program’s value and benefits to all stakeholders. These building blocks define the brand positioning and include brand attributes and brand pillars.

The brand positioning is the internal expression of what our brand represents to key stakeholders. It answers the question of who we are and why, and describes the promise of value to be delivered to external target audiences. At the same time, it informs internal audiences about the Program’s purpose and impact. It guides strategy and creative (tone and content) for all assets. It provides an outline for telling a more compelling QIO Program story and is not meant as external messaging, but rather provides a compass to guide decisions and messaging about the brand. The Brand Guidelines Manual provides tools for QIOs to project a consistent image and use a common vocabulary. The manual includes information on co-branding, messaging, logo use, color palettes, typography, photo use, templates and more. The QIO Program Brand Guidelines Manual and resources can be found in the Integrated Communications section of the Healthcare Communities website in the Branding folder.

CMS Proper Reference The proper reference to CMS is “Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services.” The reference to HHS is only required the first time CMS is mentioned in the document. Note that the full name of the agency includes an ampersand (&) and not the word “and.” More information on the proper way to reference CMS can be found in the CMS Brand Strategy and Graphics Guide.

QIO Proper Reference

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A QIO serving people with Medicare and their caregivers by reviewing quality of care concerns and appeals of denied medical services is called a Beneficiary and Family Centered Care-QIO (BFCC-QIO). A QIO working directly with providers in all health care settings to improve the quality and safety of care delivered to patients is called a Quality Innovation Network-QIO (QIN-QIO).

An organization subcontracting with a QIN-QIO to provide services in a designated state/jurisdiction should identify its organization using the QIN-QIO name and logo; they are considered one entity. If designation of a specific state/jurisdiction needs to be made, it can be done by using the QIN-QIO name with the description “in [state/jurisdiction]” or “serving [state/jurisdiction].”

Using the HHS Logo and CMS Identity Mark The HHS logo and CMS identity mark (logo) cannot be used by QIOs without CMS clearance. Materials including the HHS logo and CMS identity mark should be numbered using the QIO’s internal publication numbering system (See “Publication Numbers, Positioning Statements, Disclaimers”). A disclaimer is not required if clearance is obtained to use the HHS logo or CMS identity mark. When planning to use the CMS identity mark, QIOs, National Coordinating Centers, Program Collaboration Centers, and the Strategic Innovation Engine should use the following process. Please note that Section 1140 of the Social Security Act governs the use of the CMS identity mark, and penalizes unauthorized use with a fine.

Send the product to the appropriate National Coordinating Center (NCC) for a clinical review, if applicable.

Ensure the content clearly and accurately reflects CMS-approved messages, correct placement of the CMS identity mark, and correct references to CMS and/or HHS. Use the CMS Brand Strategy and Graphics Standard Guide as your primary resource to ensure appropriate use of the mark and logo.

Submit a request for approval to use the CMS identity mark and/or HHS logo to your COR, copied to the Communications SME/COR and the QIO’s point of contact at the PCC-IC. Include a contact name, telephone number, and FAX number.

Include the final draft of your material and as much information as possible in your request (e.g., why you need to use the logo, what format the final product will be in [digital vs. print], what file format you need the logo in, duplication quantity, distribution, who will see it, a timeline, etc.).

You may retain the logo and identity mark on materials without further clearance if you do not modify these materials or if you modify them only as follows. You may:

Add the logo and contact information including name, address, etc., of your organization (note that the HHS logo must be larger and more prominently placed than the CMS identity mark or any other logo);

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Select document color(s) to fit your corporate brand;

Add the names of local partners;

Delete any text and references (but not author acknowledgments if included in the CMS document) that you select to shorten the materials, without altering the message of the original document. In this instance, you must include the following disclaimer on the materials:

o “This is an edited version of a document prepared by the Centers for Medicare & Medicaid Services and/or its contractors. You can find the original, unedited version of the document at (fill in the cms.gov website address here).” (TOPS Memo 99-30)

If the logo and identity mark appear on materials used to contain/present other information (folders, binders, covers, etc.) the cover should bear the following disclaimer:

o “The enclosed material was prepared and assembled by (name of QIO) under contract with the Centers for Medicare & Medicaid Services (CMS). The contents presented do not necessarily reflect CMS policy.” (TOPS Memo 99-23)

Avoiding Incorrect Uses of the Identity Mark

Do not alter the position of the identity mark elements. Do not alter or change the typeface. Do not rotate any of the identity mark elements. Do not combine the mark with other elements to create a new mark, symbol, etc. Do not stretch, distort, or otherwise alter the aspect ratio of the identity mark. Do not position the identity mark too close to other items or images. Do not alter the color of any of the identity mark elements. Do not position the identity mark on colors that do not complement the mark’s

colors. Do not position the identity mark on a photographic background where there is

insufficient contrast between the photographic image and the identity mark and typography.

(From the CMS Brand Strategy and Graphics Standard Guide)

Impact Statement Guidelines An impact statement is defined as a written document (or a section of a written document) for an external audience that presents state/jurisdiction-level data and attributes improvements demonstrated by the data to the work of the QIO. An external audience is defined as any audience other than CMS employees and contractors including, but not limited to, providers, state legislators, media, stakeholders, and the general public. Use the following guidelines when developing impact statements:

Include information that provides context for the QIO Program and the data presented.

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When appropriate, articulate differences between those practitioners or providers that work with the QIO and those who do not.

Identify data source(s) and methodology(ies) for all data presented. Outline specific measurable achievement by setting rather than as a cross-

setting aggregate. Use CMS separate, specific guidance for reporting on the following three topics:

lives improved, cost savings, and project impact. Refer to TOPS Memo 2007-01 for each of these topics.

Promote activities that are CMS and QIO Program priorities, such as (a) adoption and use of health information technology, (b) beneficiary protection, and (c) other topics that may be identified by CMS.

Follow the guidelines in TOPS Memo 2007-01 if including one or more local success stories as examples of impact.

Include a publication number and disclaimer.

Please note: None of the data or other content provided by the QIO in impact statements can be used in lieu of the contractual evaluation criteria specified in the SOW contract and its supporting documents to determine eligibility for interim award fees, final award fees, or group award fees or to determine if the QIO has met the SOW contract performance criteria. (TOPS Memo 2007-01)

Success Stories A story can be defined as a narrative designed to interest, amuse, or instruct. Yet, when the word “success” is added before the word “story,” expectations of the narrative heighten. In the context of the QIO Program, success stories can draw attention to the effectiveness of QIO interventions and technical assistance in improving health care for real people. Success stories can inspire other providers or beneficiaries to make similar improvements in health quality or personal health behavior. Well-written success stories can also help readers understand the value of the QIO Program by making it less abstract; they demonstrate its concrete benefits. Often QIOs gather success stories at the point in the contract when meaningful data that can demonstrate success have become available. A Success Story Toolkit is located under Communication Resources in the Writing Help folder in the Integrated Communications section of the Healthcare Communities website. The toolkit, in addition to defining and explaining success stories, offers several examples, describes applicable policies, and provides a success story template. This toolkit and others are also listed in the “Resources” section of this handbook.

Engaging Patients in Outreach Efforts

Disclosure of Confidential Information Effective January 1, 2013, CMS promulgated new QIO regulations at 42 CFR 480.145 that govern a beneficiary’s right to authorize a QIO to use or disclose the beneficiary’s

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confidential information, including his or her name.2 CMS made these regulatory changes as part of its commitment to patient-centered care; allowing beneficiaries to share their “real-world” experiences can help QIOs demonstrate the importance of health care quality. This, along with the fact that Medicare beneficiaries have asked to participate in QIO work in a meaningful way, provided an impetus for revising previous regulations. Under these regulations, QIOs may disclose confidential information about a beneficiary if the QIO has that beneficiary’s informed consent, as the term is defined by HIPAA.

The regulations do not limit a QIO’s ability to use patient information in a particular medium; however, several other provisions of the regulation apply when a QIO seeks to identify a beneficiary by name and/or likeness in a communique (whether through explicit or implicit identification).

Valid Authorization from Beneficiaries The regulation states that a QIO may not use or disclose a beneficiary’s confidential information without a valid authorization from the beneficiary. The following requirements must be met in order for an authorization to be valid:

A specific and meaningful description of the confidential information to be included The name of the QIO(s) and QIO point(s) of contact making the request to use or

disclose the information The name or other specific identification of the person whose PHI will be used in the

story A description of the purpose(s) for using the PHI The date or event upon which the authorization will expire A dated beneficiary signature authorizing the use and/or disclosure of the PHI A statement that the QIO may be unable to protect the information from re-

disclosure A statement that the beneficiary retains the right to revoke his or her authorization

in writing, a description of any exceptions to the right to revoke, and a description of the process a beneficiary must use to revoke the authorization.

Further stipulations of the written authorization state that a beneficiary may revoke, in writing, an authorization at any time, except when the QIO has taken action in reliance upon the authorization. The regulation also requires that the authorization must be written in plain language, and that a signed copy of the authorization must be provided to the beneficiary.

2 This regulation was published as part of the Calendar Year 2013 Outpatient Prospective Payment System (OPPS) final rule, notice CMS-1589-FC. The regulation was also published at 77 FR 68209 on November 15, 2012. See the regulation text online at http://www.gpo.gov/fdsys/pkg/FR-2012-11-15/pdf/2012-26902.pdf. The confidentiality regulation in question is discussed on pages 68508 through 68523, with the new 42 CFR 480.145 language at page 68564.

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Finally, the rule states that each QIO is responsible for developing an authorization form that meets the new regulations. Sample release forms are provided at the end of the QIO Success Story Toolkit; these forms are provided as a convenience and no representations are made as to their “validity.” QIOs are advised to have any forms or modifications thereof reviewed by legal counsel prior to use.

Outreach Materials

Definition An outreach item is defined as any item that is given to a target audience at no cost in order to reinforce messages delivered in print, online, or in verbal communications. Outreach items may include a nominal giveaway that a QIO uses to supplement its integrated communications activities and that is used to promote behavior changes or to address barriers to behavior change associated with an intervention the QIO seeks to perform as part of the work of the contract. An outreach item differs from a promotional item in that the item itself has an inherent and clear connection to the interventions the QIO is attempting to implement, has meaning to a target audience that can influence the outcome of an intervention (i.e., not targeted to the general public at large), and delivers some message or value to the user that encourages them to change behavior or remove barriers to behavior change. All outreach items must conform to CMS and QIO Program branding guidelines. Furthermore, outreach items must achieve at least one of the three objectives of communications for behavior change: 1) initiation and “will building;” 2) engagement and maintenance; and 3) retention and sustainment throughout the life of the QIO task. Outreach items may or may not be allowable contract costs, per COR discretion.

QIN-QIO Local Integrated Communications Plan The Local Integrated Communications Plan (ICP), Deliverable A.1#23, is a quarterly deliverable that provides CMS the opportunity to collect data about QIN-QIO communication activities at a national level and spot trends over the course of the 11th SOW. QIN-QIOs are also expected to update their Local ICP for any new Tasks or Special Innovation Projects awarded by CMS within 21 days of the start date or of any other change event. (HCQIS Memo #16-029-CO) An ICP template provides the opportunity to place communication tactics in a single document that spans all Tasks. QIN-QIOs are encouraged, though not required, to use the template, which has three components:

1. Communications Planning & Measurement Worksheet – The Communications Planning & Measurement worksheet is organized by Task and captures three tactics you have implemented or plan to implement, your target audience(s), the desired audience behavior, the key message, and your measurement plan and results. The template serves as a tool when planning communications and social marketing techniques with improvement teams. This worksheet should be updated every

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quarter and include communication tactics for new Tasks or Special Innovation Projects awarded by CMS. Report your measurement results and indicate if you plan to continue the tactic in the next quarter; if applicable, adjust your key message and measurement plan. If you do not plan to continue the tactic in the next quarter, propose a new tactic and measurement plan, and remove the old tactic in your next update. Regardless of whether you plan to continue using a tactic, you should always report measurement results for three tactics per Task every quarter.

2. Situational Analysis – You only need to complete one Situational Analysis for each quarterly ICP. List only three issues; you are not required to include an issue for every Task and sub-Task.

3. Bright Idea Worksheet – Communication Best Practices Sharing (Optional) – If you have a successful communication tactic you would like to have considered as a Bright Idea, please share it on this worksheet. To complete this section:

Indicate the primary audience and Task Briefly describe your tactic/strategy Describe the objective or purpose of the tactic Describe the tactic: Explain how it was implemented, how you determined it was

successful, and why you think others can benefit from replication.

Publishing and Disseminating Information

Copyright Information and artwork created and published by the federal government is in the public domain, whether authored by government employees or under contract. In the case of peer-reviewed journals, no copyright transfer agreement is needed between a QIO or its employee(s) and the journal, as work done on behalf of CMS should not be copyrighted. A copyright compliance toolkit is available in the Training folder in the Integrated Communications section of the Healthcare Communities website.

Media Relations CMS recognizes that many QIOs have longstanding working relationships with members of the media and it is the intention of these guidelines to support those relationships. Definitions:

Local media include but are not limited to: local newspapers, local affiliates of national networks, and local trade publications such as a publication for a state provider association or state affiliate of a national advocacy organization.

National media include but are not limited to: major television networks; major metropolitan newspapers, including but not limited to USA Today, The Wall Street Journal, the Los Angeles Times, The Washington Post, The Baltimore Sun (given proximity to CMS headquarters), The New York Times, the Chicago Tribune, The Miami Herald, and The Boston Globe; and major wire services such

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as the Associated Press, United Press International, Reuters, and Scripps Howard; and major online news organizations.

National trade publications include but are not limited to: Modern Healthcare, The Remington Report, Family Practice Management, American Medical News, Healthcare Informatics, and Government HealthIT.

Responses to media inquiries that require prior CMS approval In general, QIOs are encouraged to be proactive in working with the media. However, prior to responding to inquiries from local media, national media, or national trade publications, a QIO must obtain CMS approval via its COR and any other designated CMS contact if the topic:

Is a CMS issue not specific to the QIO Program Addresses CMS agency policy in general Relates to a beneficiary complaint Relates to the evaluation or critique of the operation or impact of a QIO or of the

QIO Program Is national in scope

For topics other than those bulleted above, a QIO may share factual information about a local issue or initiative or about the QIO Program with a national media organization or national trade publication but must provide courtesy notification to its COR and any other designated CMS contact. A QIO with national media in its state/jurisdiction may provide factual information about a local issue or initiative, or about the QIO Program, to reporters, but must also direct them to CMS’ available information resources and must provide prompt notification to the COR and any other designated CMS contact prior to accepting a formal interview. CMS recognizes that many QIOs have staff considered as national experts who may receive inquiries from national media and national trade publications on health care quality issues. When the topic is not among those bulleted above, staff may respond directly to these media calls but must provide courtesy notification to the COR and any other designated CMS contact.

Written materials for distribution to the media that require prior review and approval: QIOs are strongly encouraged to use products with approved key messages when working to place materials with the media. Key messages help to present a unified Program to the public and help in fostering a “brand” messaging platform for the Program, its efforts, and the related CMS vision. Any written material for any audience (local or national) must be submitted to CMS for review and approval prior to final layout and distribution if the material:

References or quotes the HHS Secretary, CMS Administrator, or CMS Chief Medical Officer (unless the quote has previously been released publicly by CMS)

Includes the HHS logo or CMS identity mark

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All newly developed or substantially modified materials intended for national media or national trade publications must be submitted to CMS for review and approval prior to final layout and distribution.

Materials for placement with local media do not require CMS review unless the material references or quotes the HHS Secretary, CMS Administrator, or CMS Chief Medical Officer, or includes the HHS logo or CMS identity mark. Such materials include but are not limited to articles, press releases, fact sheets, impact statements, educational ads, and letters to the editor (except letters for peer-reviewed publications that include QIO Program data that have not previously been published). When crafting press releases or other communication products that present data and attribute improvements demonstrated by the data to the impact of a QIO or the QIO Program, QIOs should exercise good judgment and, as applicable, follow the Impact Statement Guidelines. Requests for review and approval must be submitted by email to the QIO’s COR with a CC to the Communications SME/COR; include the requested deadline for review, the target media and audience, the type of product, and the QIO contact name, email, and telephone number. The QIO shall provide a copy of the final version of the material to the COR and Communications SME/COR.

Publication Numbers, Positioning Statements, Disclaimers This guidance for QIOs, national support contractors, and Special Project QIOs (and those who monitor their performance) supersedes language from SDPS Memo #07-067-GN dated 2/15/07. QIO outreach materials, certain types of publications, and materials intended for the media require publication numbers and positioning statements or disclaimers as outlined below. See special requirements for using the HHS logo and CMS identity mark. Outreach materials are non-peer-reviewed products (electronic or hard copy) that will be distributed outside the QIO to any audience, including health professionals, stakeholders, information intermediaries, Medicare beneficiaries, and media organizations or their representatives. In the case of national support contractors and Special Project QIOs, this also includes materials prepared for distribution to QIOs. Outreach materials include but are not limited to CDs, newsletters, brochures, pamphlets, folders, posters, audiovisual materials, meeting/conference handouts, promotional materials, and clinical intervention materials. The requirements do not apply to correspondence, or to individualized provider performance feedback reports.

Publication Numbers QIO outreach materials, media materials, articles for peer-reviewed journals, letters to the editor, conference and journal abstracts, and articles for trade publications must be assigned a unique number for internal tracking purposes, even if the material does not require a disclaimer or positioning statement. This includes materials that have been approved to display the HHS logo and/or CMS identity mark.

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CMS requests that, for ease of reference, QIOs use a numbering system that identifies the year of production, contract theme task, and the state/jurisdiction for which the QIO is producing the item. If the QIO determines that a publication number is impossible to display on a specific item due to design, size or other factors, a number should be assigned but is not required to appear on the item. In this case, the QIO should be prepared to explain, upon CMS request, why the publication number does not appear on the item.

Positioning Statements and Disclaimers QIOs, national support contractors and special project QIOs must follow the requirements detailed below for each type of product. To use an alternative positioning statement or disclaimer as necessitated by the content, format, or authorship of the material in question, the QIO must obtain approval from its COR.

Materials containing the HHS logo and/or CMS identity mark: Following the official approval process outlined in the “Using the HHS Logo and CMS Identity Mark” section of this handbook, use the appropriate publication number and positioning statement/disclaimer as required below for the material, with the exception that the statement, “The content presented does not necessarily reflect CMS policy” should not be included.

Articles for peer-reviewed journals, letters to the editor of peer-reviewed journals (if the letter includes QIO Program data that have not previously been published); book chapters; books: These materials must display the following disclaimer: “[The analyses upon which this article/letter/book is based/The activities described in this article/letter/book] were performed under [contract number] titled Medicare [Quality Innovation Network - Quality Improvement Organization/ Beneficiary and Family Centered Care - Quality Improvement Organization] for [region], funded by the Centers for Medicare & Medicaid Services, an agency of the U.S. Department of Health and Human Services. The content of this [article/letter/book] does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.”

“[The author assumes/The authors assume] full responsibility for the accuracy and completeness of the ideas presented. This [article, letter, book] is a direct result of the Quality Improvement Organization Program initiated by the Centers for Medicare & Medicaid Services, which has encouraged identification of quality improvement projects derived from analysis of patterns of care, and therefore required no special funding on the part of this contractor. Feedback to the [author/authors] concerning the issues presented is welcomed.”

Any deviation from the above must be approved in writing by the COR.

Conference abstracts or scientific poster/storyboard presentations submitted for publication or presentation at professional meetings (excluding CMS-, QIO-, or American Health Quality Association–sponsored meetings) require the following

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disclaimer, if possible: “This material was prepared by [QIN/BFCC-QIO name] the Medicare [Quality Innovation Network - Quality Improvement Organization/Beneficiary and Family Centered Care - Quality Improvement Organization] for [region], under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The content presented does not necessarily reflect CMS policy.”

Media materials that require prior CMS review and approval (see “Media Relations”) must display the following disclaimer: “This material was prepared by [QIN/BFCC-QIO name], the Medicare [Quality Innovation Network - Quality Improvement Organization/Beneficiary and Family Centered Care - Quality Improvement Organization] for [region], under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services.”

Radio advertisements: Radio ads must include the following disclaimer: “Paid for

by [QIN/BFCC-QIO name] under contract with the Centers for Medicare & Medicaid Services.”

Print and television advertisements: Print and TV ads must include the following

disclaimer: “Paid for by [QIN/BFCC-QIO name] under contract with the Centers for Medicare & Medicaid Services, an agency of the U.S. Department of Health and Human Services.”

Promotional items: The QIO’s name (with or without logo) may be included on a

promotional item as a secondary message when the primary message supports a CMS program, initiative, or quality care message. The QIN/BFCC-QIO’s name must be immediately followed by the positioning statement: “The Medicare [Quality Innovation Network - Quality Improvement Organization/Beneficiary and Family Centered Care - Quality Improvement Organization] for [region].” No QIO name or logo on an item should compete in size or placement with the primary CMS message.

Materials developed by a national support contractor or Special Project QIO: The

national support contractor or Special Project QIO should include a publication number and the following positioning statement: “This material was prepared by [corporate name and title of national support contractor or Special Project QIO], under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services.”

Minor modifications to a national support contractor or Special Project QIO

product: Minor modifications may include the addition of the QIO corporate logo and contact information with no changes to content. The QIO must replace the national support contractor’s or Special Project QIO’s publication number with its own unique QIO publication number. The QIO must also replace the national

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support contractor’s or Special Project QIO’s positioning statement with the following: “This material is distributed by [QIN/BFCC QIO name], the Medicare Quality Innovation Network-Quality Improvement Organization OR Beneficiary and Family Centered Care-Quality Improvement Organization for [region], an agency of the U.S. Department of Health and Human Services.” Note: This positioning statement does not require the disclaimer sentence, “The contents presented do not necessarily reflect CMS policy” because content would have been CMS-approved by the national support contractor or Special Project QIO’s SME.

Substantial modifications to a national support contractor or Special Project QIO

product: The QIO must replace the national support contractor or Special Project QIO publication number and positioning statement with the appropriate QIO publication number and disclaimer sentence. Products modified substantially may not be consistent with CMS messages or its views or policies, and therefore, strict adherence to disclaimer requirements is required. National support contractor or Special Project QIO template products that are substantially modified by a QIO will also require the QIO’s disclaimer sentence.

Products developed by other QIOs: The QIO may either distribute the publication

as is or, to maintain the QIO’s name recognition, replace the authoring QIO’s publication number, disclaimer, and logo with its own. The distributing QIO may also want to recognize the authoring organization with the following positioning statement: “Reprinted with permission from [name of originating QIO].”

All other QIO outreach materials: All materials not included in the above

categories must include the following disclaimer: “This material was prepared by [QIN/BFCC-QIO name], the Medicare [Quality Innovation Network - Quality Improvement Organization/Beneficiary and Family Centered Care - Quality Improvement Organization] for [region], under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy.”

Publication Review and Approval CMS supports the development of articles for publication to the extent they describe documented results of QIO Program activities and contribute to achieving the Program’s mission. Authors should consult the Impact Statement Guidelines for guidance on appropriate ways of presenting QIO Program data and/or attributing improvements demonstrated by the data to the impact of a QIO or the QIO Program. Articles considered for the review and approval process are those articles submitted by a QIO on its own behalf to a professional or trade journal, and which results from a CMS-funded quality improvement activity. Procedures for QIOs to follow in submitting documents for pre-publication review apply to the following materials:

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Abstracts for national professional meetings/conferences targeting external audiences, defined as any audience other than CMS employees and contractors

Articles for a peer-reviewed journal (for example, JAMA, Annals of Internal Medicine) or national trade journal (for example, The Remington Report or Modern Healthcare)

Letters to the editor of a peer-reviewed journal or national trade journal if the letter includes QIO Program data that have not previously been published

Book chapters

Books

The guidelines do not apply to: QIO outreach materials, such as newsletters, fact sheets, brochures, pamphlets,

flyers, posters, conference handouts, promotional materials, and clinical intervention materials

Articles for local trade publications that do not include research-based results from a CMS-funded QI activity

Letters to the editor, unless the letter includes Program data that have not previously been published

Press releases and other written materials intended for the media (see “Media Relations” guidance)

Review and Approval Process CMS supports and encourages research articles and national presentations by QIOs. The purpose of CMS’ review process for abstracts for national external audiences, journal articles, letters to the editor (if review is required), book chapters, and books is not to restrict authorship activities, but to ensure accuracy and appropriateness and to ensure that adequate notification is provided to QIO Program leadership. A QIO’s COR is the first point of contact for initiating review. The COR will determine whether consultation with Program leadership is required. At minimum, the COR must consult with Program leadership when a document includes a stated or implied assessment of the effectiveness or value of a federal program or federally supported activity. If you are unsure whether a document falls under the review and approval process, consult with your COR, who has the discretion to decide whether a document requires CMS review. As the first step in the process, a QIO submits the final draft of a document (abstract for a national external audience, peer-reviewed journal article, trade publication [if review is required], letter to the editor [if review is required], book chapter, or book) to the COR

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before submitting it to the conference planning committee, journal, or publisher. The COR has 10 calendar days to notify the QIO of acceptance or rejection of an abstract or letter to the editor (if review is required), and 30 calendar days for an article, book chapter, or book. The QIO may negotiate for an expedited review; the COR has the discretion to honor or reject such requests. For all documents, the COR determines whether data are presented in a way that is consistent with CMS confidentiality rules as specified in 42 CFR Part 480, §1160 of the Social Security Act, and Chapter 10 of the QIO Manual. For abstracts, articles, letters to the editor (if review is required), book chapters, or books, the COR also determines whether the material includes the appropriate disclaimer. The COR or other RO staff may provide the QIO with substantive changes to the manuscript. Consider these substantive changes similar to changes suggested by other peer reviewers. The QIO must address any confidentiality and/or disclaimer issues raised by the COR. Once these issues have been addressed and the COR has certified that they have been adequately addressed, the QIO may submit the manuscript for publication. Disagreements with the COR’s determination regarding the manuscript will be resolved by the RO. If revisions to a manuscript are made between the time it is first submitted to a journal or other publication and when it is actually published, the QIO is responsible for informing the COR of any changes to the manuscript that relate to QIO data and/or CMS policy. The COR may decide to review revisions of the manuscript but is not required to do so. Ultimately, the QIO is responsible for the manuscript as published. The QIO is liable for any breaches of confidentiality or misrepresentation of CMS policy that result from publication of a revision of the original manuscript and will be subject to any penalties that may be imposed for doing so. Once a document is published, the QIO must provide a PDF file (if a book: title page and table of contents only) to the COR.

NOTE: When a document has both QIO and CMS employee authors, the COR and the CMS employee’s supervisor coordinate all review responsibilities.

DDST Submissions DDST is a web application that allows QIOs to upload their deliverables and to track other required information (SDPS Memo 11-373-DD). The application allows the COR to acknowledge, reject, or approve the QIO-submitted deliverables. More information on how to register for DDST can be found in SDPS Memo 11-334-ID.

508 Compliance Policy Section 508 of the Rehabilitation Act requires federal agencies to make all of their electronic and information technology (EIT) accessible to people with disabilities. The HHS.gov website explains the policy, provides tools and resources listed by federal agency, and includes helpful information about all areas of 508 compliance. CMS also provides information on Section 508 - Policies for Accessibility.

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Additional information on 508 compliance is available at Usability.gov. This is the primary government resource for information on usability and user-centered design. It provides guidance and tools on how to make websites and other communication systems more usable and useful. A number of 508 compliance training sessions and related information are available in the 508 Compliance folder in the Integrated Communications section of the Healthcare Communities website.

Digital Media Use A strategic digital media program (also known as “social media” in some contexts) can help individual QIOs increase awareness of the QIO Program brand; rapidly communicate and spread ideas, Program news and successes; inspire the will to change behavior; build relationships with local stakeholders; and engage with improvement initiative participants to sustain their involvement. If a QIO engages Medicare beneficiaries in its digital media outreach, it is imperative to follow valid authorization guidance detailed in the “Engaging Patients in Outreach Efforts” section of this handbook.

In accordance with Section C.6.1.2.3 of the QIN-QIO 11th SOW and Section C.5.5.8 of the BFCC-QIO contract:

Before the QIO begins to use social media tactics as part of its projects, the QIO shall submit a business case to CMS using the QIO Program Digital Media Business Case template. No costs for social media shall be allowable under this contract without approval of the business case by the COR. The Digital Media Business Case template is available in the Integrated Communications section of the Healthcare Communities website in two separate folders under Communication Resources: CMS Resources & Guidance under CMS Guidance and in the Social Media Help folder.

The QIO shall compartmentalize its social media presences so that users of the social media tools clearly understand which tools are applicable to the QIO contract (and thus funded by QIO dollars) and which are not.

No QIO shall use contract funds to support a social media presence that strays from the uses outlined in the CMS-approved business case or that does not adhere to CMS-defined QIO Program brand principles.

The intent of the Digital Media Business Case template is to give QIOs a framework to engage in digital media use responsibly and in conformance with CMS requirements and QIO Program brand principles. Your business case will include information about your QIO’s digital media policy. If your QIO does not have a corporate digital media policy that conforms to CMS’ digital media contract requirements found in Section C.6.1.2.3 of the QIN-QIO 11th SOW or Section C.5.5.8 of the BFCC-QIO contract, you must create one before submitting your business case. Costs associated with digital media use that do not comply with the terms a QIO has outlined in its COR-approved Digital Media Business Case are not allowable under the 11th SOW. For more details, see TOPS Memo QIO-2013-06, including the memo’s attachments.

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Resources

QIO Resources

Fact Sheets Fact sheets for current SOW Tasks are available in the QIO Program Basics folder in the Integrated Communications section of the Healthcare Communities website.

Developing Effective QIO E-Newsletters A well-planned, well-written, and well-designed e-newsletter can be a strategic tool that supports the work of QIO QI teams, motivates behavior change among practitioners, and ultimately helps improve care for Medicare beneficiaries.

An e-newsletter is an interactive HTML publication that you email to subscribers, typically via a web-based email marketing service provider such as Constant Contact, Vertical Response, or Mail Chimp. A guide on “Developing Effective QIO E-Newsletters,” offers best practices that will help you create electronic publications that get read and get results. The guide is posted in the Writing Help folder in the Integrated Communications section of the Healthcare Communities website.

Guide to Planning and Drafting Scientific Submissions Scientific publications are effective channels for educating clinicians and the health quality community about QIO improvement projects and demonstrating their impact. While getting published can be arduous, it is achievable. A set of resources to guide QIO authors as they define their topic, identify a target journal, write the article, and navigate the review processes titled, “Putting Pen to Paper,” is posted in the Writing Help folder in the Integrated Communications section of the Healthcare Communities website.

Success Story Toolkit The impact of success stories has been discussed in the “Success Stories” section of “Creating Materials.” A Success Story Toolkit, providing definitions, examples of success stories, applicable policies, and a success story template is located in the Writing Help folder in the Integrated Communications section of the Healthcare Communities website. Training by Richard Stone titled, “How to Use Storytelling to Powerfully Communicate,” is also available in the Strategic Communications folder within the Training folder in the Integrated Communications section of the Healthcare Communities website.

CMS Resources

Navigating to Statement of Work Documents Hyperlinks in this document will take you to the sources referenced. Some documents are not available by direct hyperlink but can be downloaded by following the parenthetical instructions to the download page. It can be useful to know how to navigate to certain

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primary reference sources. Instructions for navigating to the QIO Manual and 11th Statement of Work documents are as follows:

QIO Manual: Located here on the CMS website.

11th Statement of Work Documents: To access Statement of Work documents for QIN-QIOs visit the contract page on the FedBizOpps website. To view documents for BFCC QIOs visit the contract page on the FedBizOpps website. The files relating to the Statement of Work are available in the green box on the right. Modifications may be made to these contracts. Please refer to the HCQIS Memo system on QIONet for information about updates to the QIN-QIO 11th Statement of Work and BFCC-QIO Statement of Work.

CMS Newsroom Page The CMS Newsroom page contains links to press releases, fact sheets, podcasts, and more. The sign-up link for the Press Mailing List noted below also originates from this page.

CMS Press Mailing List You can sign up for the CMS press mailing list and receive CMS media releases via email. Enter your email address and name, indicate any list preferences and select “Join the list.”

CMS Product Ordering CMS publications are free of charge to QIOs. Delivery takes approximately two to four weeks from the day the publication is ordered. If there is a limit on quantity, it will be noted beside the publication. To place an order, visit the CMS Product Ordering website. You will be asked to create an account. You may also email CMS at Mailpubs@cms.hhs.gov for more assistance with ordering publications.

QIO Program Resources

Listservs To sign up for HCQIS discussion and notify lists, go to the listserv link on the QIOnet home page and click to access the sign-up form.

Complete the User Information section; Select the lists to which you wish to subscribe; and Click “Subscribe.”

To post a message to the Integrated Communications discussion list, address an email to icpcc-poc-discuss@lists.qualitynet.org. For additional instructions, visit http://qionet.sdps.org/listserve/listhelp.shtml. Anyone on the HCQIS network can sign up for any topic on the open discussion lists.

QIOnet

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QIOnet is an intranet site available only to those on the HCQIS network. It provides the home page and web resources for QIOs, the ESRD Networks, and CMS staff, and is a centralized resource for all operational aspects of the current SOW. Resources posted on QIOnet include all HCQIS and TOPS Memos.

Healthcare Communities Healthcare Communities is a public-private website that provides a collaborative platform for the health care quality improvement community to share knowledge and contribute to each other’s’ QI work. The site includes a searchable resource library and document archive, forums, and a blog. Depending on the permissions set by individual community managers, these features can be made available to the public or made private via a password-protected portal.

QualityNet.org QualityNet.org is a website that gives providers, practitioners, and QIOs the latest information on data exchange and reporting for CMS health care quality initiatives. QualityNet.org is also the gateway to the only CMS-approved website for secure communication and exchange of health care quality data. Click on “My QualityNet” to access that section of the site.

QIOProgram.org QIOProgram.org is a public-facing website administered by the PCC-IC that provides general information and resources about the QIO Program. It defines the QIO Program’s structure, priorities, and patient-centered approach to improving care, and contains contact information for the QIOs; it is the face of the QIO Program brand. It includes videos, industry news headlines, webinars, fact sheets, and links to outside resources. The site is not intended to serve as official policy guidance and is separate and distinct from CMS.gov.

QIO Program on Social Media On Twitter: @QIOProgram, sharing healthcare quality improvement news and resources.

On YouTube: http://www.youtube.com/c/QIOProgramVideos sharing videos highlighting QIO successes and quality improvement processes.

QIO Program Commonly Used Acronyms A nine-page comprehensive list of QIO Program Commonly-Used Acronyms is posted in the Writing Help folder in the Integrated Communications section of the Healthcare Communities website.

Question and Answer System The official process to submit questions and receive answers regarding 11th SOW contract activities and expectations is through the QIO Q&A Tool The purpose of the Q&A System is to provide you with a consistent, timely, primary resource for obtaining answers to topic-specific questions. It serves as a search engine for existing 11th SOW Q&As in order to provide you with immediate answers to questions. If

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you are unable to find an existing Q&A that answers your question, the system enables you to submit a question within one of the identified topics. By default, anyone who has access to QIOnet can access the search interface of the Q&A system and its database. The user is able to view posted Q&As and submit a search to query the system. Before submitting a question, users must complete a simple registration process to access this secure website. To register for an account and submit a question:

Go to the Q&A tool On the Log In screen, select create an account Select the Ask a Question tab

WebEx Resources WebEx support for several CMS programs is provided by Ventech Solutions, Inc., the HCQIS Infrastructure Contractor, whose staff provide online meeting services via WebEx for QIOs, CMS Regional and Central Office employees, ESRD Networks, and external vendors and partners as needed. The QualityNet Help Desk uses the WebEx Support Center to assist callers. For detailed information on how to request and reserve a time slot for a WebEx meeting and for presenter training opportunities, see SDPS Memo (SDPS Memo # 10-336-GN – CMS WebEx Support). The HCQIS Infrastructure Contractor WebEx support team can be reached via qnet_webex_support@hcqis.org or at 571-598-1988. Please notify your information technology point of contact if you have any questions. He or she may contact the QualityNet Help Desk if additional information and/or assistance are needed.

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Contact Information

QIO Program Communications Lead Monique Ndenecho Phone: 410-786-4712 Email: Monique.Ndenecho@cms.hhs.gov

PCC-IC Contract Administration Sage Communications Erika Christ, PCC-IC Director Phone: 703-207-1076 Email: echrist@aboutsage.com

PCC-IC Account Managers Paulette Strader PCC-IC Director, Technical Assistance Phone: 573-230-4700 Email: Paulette.Strader@area-K.hcqis.org Accounts: QIN-QIO: Alliant Quality; HSAG; Telligen; and QIN NCC. BFCC QIO: KEPRO; Livanta; and BFCC NCC. Amy Steinmann PCC-IC Public Affairs Specialist Phone: 804-287-6212 Email: Amy.Steinmann@area-K.hcqis.org Accounts: Atlantic Quality Innovation Network; Health Quality Innovators; New England Quality Innovation Network; Mountain-Pacific Quality Health; and TMF. Chris Burkey PCC-IC Public Affairs Specialist Phone: 804-287-6214 Email: Christopher.Burkey@area-K.hcqis.org Accounts: atom Alliance; Great Plains Quality Innovation Network; Health Insight; Lake Superior Quality Innovation Network; Qualis Health; and Quality Insights Quality Innovation Network.

QIO Directory See the Related Links section of the CMS website.

U.S. Department of Health and Human Services See the HHS Employee Directory.