Attachment G.12 - 003_TGD_QA_and_Internal_Audits_DRAFT.pdf

Appendix I: Technical Guidance for Quality Assurance and Internal Audits

DRAFT

Table of Contents

Introduction

Guidance for creating and reviewing CCE Quality Assurance Plans (QAPs) and semi-annual reports

A. QAP

B. Semi-annual Internal Audit Report

C. Purpose and Goals

D. Specific Components of QAPs and Semi-annual Internal Audit Reports

E. CCE/NPN Guidance for developing QAPs

F. COR Guidance for Reviewing QAPs and Semi-annual Internal Audit Reports

G. QA elements Mandated by the Zadroga Act and Related Metrics

H. Conclusion

Table 1 – Outline to Be Used for the Quality Assurance Plan and the Semi-annual Internal Audit Reports

Metrics to address the four Zadroga Act-mandated QA elements

Adherence to Monitoring and Treatment Protocols

Metric 1: Proportion of eligible responders and survivors who had a monitoring visit in last 18 months

Metric 2: Asthma medication ratio (AMR)

Metric 3: Asthma Emergency Department (ED) visits

Metric 4: Proportion of members who had laboratory work at most recent monitoring visit

Metric 5: Proportion of members who had Pulmonary Function Tests (PFTs) at most recent monitoring visit that met QA criteria

Metric 6: Hospital readmission within 30 days of discharge

Ensuring Appropriate Diagnostic and Treatment Referrals for Participants

Metric 7: Proportion of eligible members who obtained appropriate colorectal cancer screening in recent past

Metric 8: Proportion of eligible members who obtained appropriate lung cancer screening in recent past 39

Metric 9: Proportion of eligible members who were vaccinated against seasonal influenza in the recent past

Prompt Communication of Test Results to Participants

Metric 10: Proportion of letters with monitoring exam results that were provided/sent within 15 business days of exam

Metric 11: Proportion of lab results reviewed and provided/sent within 30 days of the blood being drawn and urine being collected

References

Appendices .................................................................................................................. Error! Bookmark not defined.

Appendix 1: Measurement Periods for the QA components and Zadroga QA elements

Appendix 2: Process required before categorizing a member as “Lost to Follow-up”

Appendix 3: Colorectal cancer screening questions

Appendix 4: Lung cancer screening questions

Appendix 5: Seasonal influenza vaccine questions

Introduction The James Zadroga 9/11 Health and Compensation Reauthorization Act (2015; Public Law 114-113) requires the development and implementation of a quality assurance (QA) program for the monitoring and treatment services delivered by Clinical Centers of Excellence (CCEs), the Nationwide Provider Network (NPN) and any other participating health care providers. This is to help ensure that the health care services provided under the World Trade Center (WTC) Health Program (or “Program”) are of the highest quality. The law requires that the QA program include an assessment of the following elements:

(1) adherence to monitoring and treatment protocols;

(2) appropriate diagnostic and treatment referrals for participants;

(3) prompt communication of test results to participants; and

(4) such other elements as the Administrator specifies in consultation with the CCE.

The Program Administrator developed 11 metrics to address these four legally mandated QA elements. Given the importance of ensuring that these mandated QA elements are addressed by the CCEs/NPN, what follows is specific guidance for measuring each QA metric. Each metric has a goal/benchmark that all CCEs should strive to achieve. When the goal/benchmark is not required by NIOSH contract language, the goal/benchmark is labeled as “aspirational.”

The contracts awarded by NIOSH to CCEs/ Nationwide Provider Network (NPN) also require the CCEs/NPN to provide NIOSH with a Quality Assurance Plan (QAP) and Semi-annual Internal Audit reports. The QAP describes the CCE/NPN’s internal QA Program and the procedures that will be used to monitor and improve all project activities. The Semi-annual Internal Audit reports provide information on QA activities conducted by the CCE/NPN during the reporting period. This Guide provides an outline that should be used when developing the QAP and Semi-annual Internal Audit report. In the future, NIOSH plans to provide detailed guidance for each of the specific QA components required by law/contract and listed in Section (D) and Table 1. For QA components without detailed Program guidance, the CCE/NPN semi-annual internal audit reports should continue to report on them as the CCE/NPN has done in the past.

The guidance provided in this document is consistent with the Federal internal control standards issued by the Comptroller General, and which took effect in fiscal year 2016 (GAO 2014). These Federal internal control standards call for agencies to define objectives in specific and measurable terms so that performance towards achieving those objectives can be assessed and monitored, and so that identified deficiencies can be remediated in a timely fashion.

Guidance for creating and reviewing CCE Quality Assurance Plans (QAPs) and semi-annual reports

A. QAP

CCEs/NPN are required to submit a “Quality Assurance Plan” (QAP) within 60 business days of contract award and which is to be updated monthly as needed (a summary of monthly updates is to be provided in the CCE monthly report). CCEs and NPN are required to annually provide NIOSH with an updated QAP. The QAP must address the specific components listed below, including how it will address the four elements mandated in the Zadroga Act. Although CCEs/NPN can report on additional metrics to address the four Zadroga Act-mandated QA elements, the CCEs/NPN are required to report on the 11 metrics provided in this Guide.

B. Semi-annual Internal Audit Report CCEs/NPN are required to submit a Semi-annual Internal Audit report. Each Semi-annual Internal Audit report must address the specific components listed below, and the 11 metrics provided in this Guidance to address each of the four Zadroga Act-mandated QA elements. Please see Appendix 1 for the measurement periods for each QA component and Zadroga Act-mandated QA element. Please label each section of the Semi-annual report utilizing the “component” name in the table below, and organize the Semi-annual Internal Audit using the same order as the table below. The Semi-annual Internal Audit report should be its own standalone document and should not contain other deliverables or reports.

C. Purpose and Goals The purpose of the QAP and Semi-annual Internal Audit reports is to both ensure alignment with WTC Health Program goals and objectives, and consistency across CCEs.

The guidance provided in this document is intended to ensure that the QAPs and Semi-annual Internal Audit reports consistently address mandated elements. It sets expectations for the content of the QAPs and Semi-annual Internal Audit reports. The Administrative Manual of the WTC Health Program specifies that NIOSH must review and approve the QAPs to ensure both consistency among them and alignment with program goals and objectives (WTCHP 2018).

D. Specific Components of QAPs and Semi-annual Internal Audit Reports The CCE/NPN contracts require that the QAPs and Semi-annual Internal Audit reports include specific components. These components are:

1. Targeted Health Care Compliance. This component shall focus on evaluating the adequacy of the procedures used by the CCE/NPN to ensure that only approved WTC health conditions and approved health care services (including provider visits, procedures, medication, and durable medical equipment) are reimbursed by the program. This includes a review of documentation justifying payment history for medically associated health conditions after approval is given by the WTC Health Program Administrator.

2. Medical Management Review. This component shall ensure that medical practice guidelines that have been developed are being followed.

3. Claims History. This component shall focus on irregularities in the claims history of any particular provider or member and shall include rejections and denied claims. This shall include members receiving provider bills or collection service threats for program services, as the CCE/NPN learns of such occasions.

4. Medical Records Review. This component shall focus on determining if appropriate procedures have been developed and are being followed for collecting, reviewing, maintaining, and securely storing medical records in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.

5. Personnel Training. This component shall focus on ensuring that all personnel who are performing work under the CCE/NPN contract are properly trained and credentialed.

6. Education and Retention. This component shall focus on the effectiveness of the activities implemented and on achieving the retention benchmarks.

7. Intensive Case Management. This component shall focus on ensuring the effectiveness of the service, quality of care, outcomes, and appropriate use of services.

8. Mandatory QA Metrics. This component shall ensure that the required QA metrics are documented, interpreted, and that action plans are developed and implemented when performance falls below mandatory performance benchmarks (where appropriate).

E. CCE/NPN Guidance for developing QAPs When developing their QAPs, CCEs/NPN should explain the methodology to be used to address each of the specific components required in the Semi-annual Internal Audit reports. This includes providing the methodology required to address the items in Table 1. This document provides detailed guidance for measuring the 11 metrics to address the four Zadroga Act-mandated QA elements. In the future, NIOSH plans to provide detailed guidance for each of the specific QA components required by law/contract and listed in Section (D) and Table 1. For QA components whose detailed guidance is unavailable from the Program, the CCE/NPN semi-annual internal audit reports should continue to report on them as the CCE/NPN has done in the past.

F. COR Guidance for Reviewing QAPs and Semi-annual Internal Audit Reports When preparing QAPs and Semi-annual Internal Audit reports, the CCE/NPN should address the items in Table 1.

The items in Table 1 are sorted by the specific components. When preparing their QAPs and Semi-annual Internal Audit reports, it is requested that CCEs/NPN follow this same topic sequence, to promote consistency in document organization and flow across the CCEs/NPN. The QAP should explain the methodology that the CCE/NPN uses to address each of the specific components required in the Semi-annual Internal Audit reports.

When reviewing the submitted QAPs and Semi-annual Internal Audit reports, the COR can use Table 1 to determine if the QAPs and Semi-annual Internal Audit reports have their topics sequenced properly and include the appropriate content. If the COR concludes that the organization and content of the QAP or Semi-annual Internal Audit report appears appropriate, the QAP or report will be distributed to WTC Health Program Subject Matter Experts (SMEs) for review and comment.

G. QA elements Mandated by the Zadroga Act and Related Metrics The Zadroga Act requires that the QA program, and therefore QAPs, include an assessment of the following elements:

(1) adherence to monitoring and treatment protocols;

(2) appropriate diagnostic and treatment referrals for participants;

(3) prompt communication of test results to participants; and

(4) such other elements as the Administrator specifies in consultation with the Clinical Centers of

Excellence.

NIOSH developed metrics to address each of the first three QA elements. A total of 11 metrics were developed:

six metrics for assessing “adherence to monitoring and treatment protocols”; three metrics for assessing “appropriate diagnostic and treatment referrals for participants”; and two metrics for assessing “prompt communication of test results to participants.” Currently, there are no “other elements as the Administrator specified in consultation with the Clinical Centers of Excellence”.

Given the importance of ensuring that these QA elements are addressed, what follows is specific guidance for measuring each QA metric.

H. Conclusion The goal of this Guide is to enhance the activities of the QA program, which is intended to help ensure that responders and survivors are receiving the highest quality care. QA allows for the identification of both common and unique problems, and can guide the implementation of health care service improvements by individual CCEs/NPN and program-wide.

Table 1 – Outline to Be Used for the Quality Assurance Plan and the Semi-annual Internal Audit Reports Component How to address in the QAP How to address in the Semi-annual Internal

Audit report Targeted Health Care Compliance

1. Ensure that appropriate authorization channels are utilized for all treatment services (i.e., that treatment was for a WTC-certified condition and those within the care suites that are considered medically necessary).

Explain how this will be assessed. During the reporting period, were appropriate authorization channels used for all treatment services? If not, please provide mitigation actions.

2. Ensure that appropriate authorization channels are utilized for all medication dispensing events (i.e., that medication was for a WTC-certified condition and those within the care suites that are considered medically necessary).

Explain how this will be assessed. During the reporting period, were appropriate authorization channels used for all pharmacy services? If not, please provide mitigation actions.

3. Describe the system used to document (and maintain record of) medical justification for services/procedures requiring Level 2 or Level 3 authorization.

Describe the system. Confirm that records are maintained on the medical justification for procedures requiring Level 2 or Level 3 authorization. If not confirmed, please provide mitigation actions.

Medical Management Review

4. Ensure that treatment services provided by the CCE/NPN are consistent with program treatment protocols.

Explain how the CCE/NPN ensures this. During the reporting period, where program treatment protocols exist, were all treatment services provided by the CCE/NPN consistent with those protocols?

If not, please provide mitigation actions.

5. Ensure that all provided treatment services were medically necessary.

Explain how the CCE/NPN ensures this. During the reporting period, were all provided treatment services considered to be medically necessary? If not, please provide mitigation actions.

6. Ensure that all provided prescriptions were medically necessary.

Explain how the CCE/NPN ensures this. During the reporting period, were all provided prescriptions considered to be medically necessary? If not, please provide mitigation actions.

Claims History

7. Provide the proportion of generic medications versus brand name medications filled.

Describe the methods to calculate this Provide the proportion for the reporting period. If there has been a 2.5% or greater decrease in the proportion of generic medications versus brand name medications, please provide rationale and potential mitigation actions.

8. Analysis of controlled substance use Describe the methods to assess this. Provide the findings for the reporting period. If there are any worrisome findings, please provide explanation and potential mitigation actions.

9. Provide evidence that the CCE/NPN analyzed the prescription patterns of individual providers at least twice per year.

Describe the methods to assess this. Was this analysis conducted for the reporting period? Please provide pertinent results. If there are any concerning findings, please provide potential mitigation actions.

10. Conduct monthly Pharmacy Claims Reviews (PCRs) on a 5% sample of approved pharmacy claims for members on the cancer formulary

Describe the methods to assess this and explain how the CCE/NPN coordinates with the WTCHP PBM. See Program Guidance on PCRs.

Provide the findings for the reporting period using the reporting template found in the latest PCR technical guidance document (TGD). If there are any concerning findings, please explain and, as necessary, provide mitigation actions.

11. Conduct monthly Pharmacy Claims Reviews (PCRs) on a 5% sample of approved pharmacy claims for members not on the cancer formulary

Describe the methods to assess this and explain how the CCE/NPN coordinates with the WTCHP PBM. See Program Guidance on PCRs.

Provide the findings for the reporting period using the reporting template found in the latest PCR TGD. If there are any concerning findings, please explain and, as necessary, provide mitigation actions.

12. Ensure that 95% of claims for internal services are submitted as clean claims within 90 calendar days of the date of service and 100% within 180 calendar days. For claims with Coordination of Benefits, 100% are submitted as clean claims within 18 months of the date of service. Per

TGD 007.

Describe the methods to assess this. During the reporting period, report how many internal claims (and %) exceeded each timely filing limit. If there was more than one such claim per month, describe the improvement plan that was implemented.

13. Review claims from external providers and make decisions on 90% of them within five business days of the claims being posted on the Claims Portal and 100% within 10 business days. Per TGD 007.

On a monthly basis, the CCE/NPN will receive a report on timely decision-making regarding claims from WTCHP external providers.

During the reporting period, if any of the benchmarks are unmet, explain why and describe the mitigation measures being undertaken.

Medical Records Review

14. Conduct a medical records review audit to ensure that appropriate procedures are being followed for collecting, reviewing, maintaining, and securely storing medical records in compliance with HIPAA law and regulations.

Explain the rationale for selecting specific metrics to track in the medical records review audit. Ensure that each metric has a benchmark and provide a justification for selecting that benchmark.

Provide findings for the medical records review audit conducted during the reporting period. Explain any mitigation actions that are taken as a result of the audit. Provide a summary of HIPAA violations during the reporting period, investigation findings, and corrective actions.

Personnel Training

15. Ensure that internal providers are properly licensed and insured.

Explain how the CCE/NPN determines that providers are properly licensed and insured

Provide results of licensure and insurance review.

Education and Retention

16. Update contact information on all enrolled members Explain how the CCE/NPN maintains up-to-date contact information on all enrolled members.

Report the status of efforts to update contact information on all enrolled members assigned to the CCE/NPN during the reporting period. For the 12-month reporting period, all enrolled members should be placed in one of three categories:

1) Contact information was verified/updated; 2) Member failed to respond; or, 3) No effort was made to contact member (no more than 1 % of members should fall into this last category).

Please report on the number of members who fall into each category. If no effort was made to contact more than 1% of all members during the 12-month reporting period, please provide a mitigation plan.

17. Number of members who transferred out of the CCE.

Describe the methods to assess this. Report the number of members who transferred out of your clinical center and document the destination clinical center.

18. Incoming transfers. Ensure timely and smooth transition of services for incoming transfers. Report the number of members who transferred into the CCE.

Describe the methods to assess this. Report the number of members who transferred into the CCE during the reporting period and the proportion who were contacted within 3 calendar days of transfer completion to initiate services. If members were not contacted within 3 calendar days of transfer completion, describe improvement plan.

Case Management

19. Hospital readmissions within 30 days of discharge Provide the methods used to investigate any hospital readmission rates that are higher than expected, as well as any currently implemented strategies to prevent hospital readmissions.

Not applicable. See Metric #6.

Metrics to address the four Zadroga Act-mandated elements

20. Report findings for each of the following metrics. Include an action plan when performance falls below the goal/benchmark. Detailed guidance for each of these metrics can be found in this document.

Metric 1: Proportion of eligible responders and survivors who had a monitoring visit in last 18 months Metric 2: Asthma medication ratio (AMR) Metric 3: Asthma Emergency Department (ED) visits Metric 4: Proportion of members who had laboratory work at most recent monitoring visit Metric 5: Proportion of members who had Pulmonary Function Tests (PFTs) at most recent monitoring visit that met QA criteria Metric 6: Hospital readmission within 30 days of discharge Metric 7: Proportion of eligible members who obtained appropriate colorectal cancer screening in recent past Metric 8: Proportion of eligible members who obtained appropriate lung cancer screening in recent past

Metric 9: Proportion of eligible members who were vaccinated against seasonal influenza in recent past Metric 10: Proportion of letters with monitoring exam results that were provided/sent within 15 business days of exam Metric 11: Proportion of lab results reviewed and provided/send within 30 days of the blood being drawn and urine being collected

Metrics to address the four Zadroga Act-mandated QA elements

Detailed Guidance

Quality Assurance (QA) Metric

James Zadroga 9/11 Health and Compensation Reauthorization Act (2015)

Adherence to Monitoring and Treatment Protocols

I. Metric Title:

Metric 1: Proportion of eligible responders and survivors who had a monitoring visit in last 18 months

II. Zadroga Act QA Category: Adherence to monitoring and treatment protocols

III. Goal/Benchmark: 65% or more of eligible members received a monitoring exam in the previous 18 months (e.g., if measuring this metric for “2020”, the 18-month lookback period is from July 1, 2019 through December 31, 202020). When the rate of retention is greater than 65%, the benchmark for change in the retention rate is no decline greater than 2.5%, in absolute terms, between reports submitted every 6-months.

IV. Background: Enrolled responders are eligible to receive an annual monitoring exam administered by their assigned CCE/NPN. Survivors with certified conditions are also eligible to receive an annual monitoring exam. The monitoring exam consists of a medical history (including screening tools for PTSD, depression, and alcohol abuse), a physical exam, pulmonary function tests, blood and urine testing, and a chest X-ray (every two years). Electrocardiograms and immunizations may also be administered. The monitoring exam serves several purposes, including: 1) To find cases of disease related to 9/11 exposures, and refer them as necessary for clinical follow-up; 2) track the natural history of these diseases related to 9/11 exposures; 3) to identify research gaps, such as emerging evidence for an association between 9/11 exposures and a disease not currently included on the covered conditions list; and 4) to inform emergency preparedness efforts for future disasters.

Maintaining member participation in the Program is a high priority. Participation can be defined as: 1) receiving periodic monitoring exams;

2) receiving Program-covered treatment for a WTC-certified condition; or 3) both. For the purposes of this retention metric, we are interested only in participation in the periodic monitoring exam.

WTC Health Program members are classified as “active” or “inactive” based on when the member received their most recent monitoring exam. The Retention Workgroup of the WTC Health Program uses an 18-month time interval to determine “active” or “inactive” status. This time interval is also referred to as the retention period. A WTC Health Program member is considered “active” if their most recent monitoring exam was within the previous 18 months. A member who hasn’t received a monitoring exam within the previous 18 months is considered “inactive.”

Given that members can receive a monitoring exam every 12 months, the 18-month interval is the desired time between exams. The 18-month interval represents the required 1-year quiescent period between exams along with a 6-month accommodation for scheduling exams after the 1-year quiescent period.

V. Source of data: The DCs. This metric will be calculated by the relevant DC. LHI will calculate this for the NPN and WSC. The NPN will be stratified into responder and survivor populations.

VI. Calculation Methods

a. Numerator: Number of enrolled members who received a monitoring exam during the measurement period.

b. Denominator: Number of enrolled members assigned to the CCE/NPN during the measurement period. Exclude from the denominator those members enrolled within the final 6 months of the measurement period who did not have a monitoring exam. So, if the end date of the reporting period is December 31, 2020, exclude members who were enrolled between July 1, 2020 and December 31, 2020 if they didn’t receive a monitoring exam. This accounts for the fact that it may take more than 6 months for newly enrolled members to receive their initial monitoring exam. Also exclude those who are deceased, who stated that they no longer want to participate in any aspect of the WTC Health Program (i.e., the member has told the CCE in no uncertain terms that they want to permanently cease any and all participation in the Program), and those lost to follow-up (see Appendix 2 for the process to determine “lost to follow-up”).

c. Stratification: None.

d. Trend: Provide “annual” trends using the 18-month measurement period. In 2021,

i. the 18-month measurement period should be defined as:

• from July 1, 2019 through December 31, 2020,

• from January 1, 2020 through June 30, 2021

e. How to handle members whose sole purpose for joining the Program is to file a September 11th Victim Compensation Fund (VCF) claim:

It is possible that such members will have no interest in participating in post-V1 monitoring exams. However, NIOSH recommends retaining these members in the denominator until these folks are contacted to schedule a V2 exam. If at that time the member informs the CCE/NPN that he/she no longer wants to participate in any aspect of the WTC Health Program, that member can be excluded from the group of members eligible for a monitoring exam (i.e., excluded from the metric’s denominator).

VII. Reporting Frequency

a. Generate findings for each Semi-annual Internal Audit report (see measurement periods defined in VI.d). For example, for the semi-annual internal audit report due on May 15, 2021, report findings for the measurement period of July 1, 2019 through December 31, 2020 (18-month period). For the semi-annual internal audit report due on November 15, 2021, report findings for the measurement period of January 1, 2020 through June 30, 2021 (18-month period).

b. Please include the breakdown of numbers used in section VI. Calculation Methods. For example, include the number of members used to determine the denominator (including counts of exclusions due to recent enrollment, death, no longer participating, and lost to follow-up.)

Metric 2: Asthma medication ratio (AMR)

III. Aspirational Goal/Benchmark: A total of 78% or more of members with persistent asthma will have an appropriate AMR (i.e., ≥0.50,) which is a benchmark established by the State of Health Care Quality Report (National Committee for Quality Assurance, 2017).

IV. Background: The Asthma Medication Ratio (AMR) is an important indicator of the quality of asthma care received by a patient. The AMR metric assesses the percentage of persistent asthmatic members 5 to 85 years of age who have a ratio of asthma controller medications to total asthma medications ≥0.50 in the measurement year. Controller medications better manage persistent asthma and reduce reliance on rescue medications. Relevant literature notes that an AMR below the 0.50 threshold is a predictor of acute asthma exacerbations and subsequent emergency medical care (Schatz et al., 2005). The AMR is based on Healthcare Effectiveness Data and Information Set (HEDIS®) 2017 specifications (National Committee for Quality Assurance, 2016). The utilization of industry-standard methodologies creates opportunities to assess care, identify quality improvement initiatives, and compare the Program’s performance against national benchmarks.

Note that the HEDIS measure undergoes revisions every year; however, these revisions are generally minor. Nonetheless, when examining trends, it is important that for the years included in the trend, all data are calculated using the same version/specification of the AMR metric.

V. Source of data: To be calculated by each DC based on data provided by the CCEs. LHI will calculate this for NPN and WSC. The HPE can also provide assistance, if needed.

VI. Calculation Methods (based on HEDIS® 2017 specifications. When more up-to-date HEDIS® specifications are used, be sure when examining trends to use the same version/specification for all years included in the trend. Also include members between the ages of 5 years and 85 years.)

Asthma Medication Ratio

a. Numerator: For a given member with persistent asthma AND who is certified for an obstructive airways disease (OAD), the number of controller asthma medication dispensing events in the year of interest (i.e., measurement year). Controller medications include methylxanthines, long-acting beta-agonists, long-acting anticholinergic drugs, mast cell stabilizers, omalizumab, anti-interleukin-5 therapy, leukotriene modifiers, and corticosteroids.

b. Denominator: For a given member with persistent asthma AND who is certified for an obstructive airways disease (OAD), the number of total asthma medication dispensing events in the year of interest. This includes rescue (i.e., short-acting beta-2-agonists) and controller medications.

c. Members to be excluded from the AMR calculation: Exclude members with any of the following conditions: Emphysema; COPD;

Obstructive Chronic Bronchitis; Other Emphysema; Chronic Respiratory Condition due to fumes/vapors; Cystic Fibrosis; and Acute

Respiratory Failure. Also exclude any members without an obstructive airway disease certification. Exclude members who were in hospice care during the measurement year. Finally, exclude members whose age is less than 5 years or greater than 85 years.

d. Proportion of members with an appropriate AMR (i.e., ≥0.50) in the measurement year:

i. Numerator: Following steps VI.a through VI.c, the total number of members with an AMR ≥0.50.

ii. Denominator: Total number of members with persistent asthma, excluding those from steps VI.c.

e. Stratification: By age (i.e., 12-18 years, 19-50 years, 51-64 years, 65-85 years, and all ages combined), as the benchmark varies by age

(National Committee for Quality Assurance, 2017).

f. Trend: Annual trend.

VII. Definitions:

Members with “persistent asthma”:

Those with persistent asthma must meet at least one of the following criteria during both the measurement year and the year prior to the measurement year. Criteria can be different in the two years:

i. Had at least one emergency department visit with a principal diagnosis of asthma

ii. Had at least one acute inpatient encounter with a principal diagnosis of asthma

iii. Had at least four outpatient visits or observation visits on different dates of service with any diagnosis of asthma and at least two asthma medication dispensing events.

iv. Had at least four asthma medication dispensing events (NOTE: When leukotriene modifiers or antibody inhibitors are the sole asthma medications dispensed then there also must be least one diagnosis of asthma in any setting during the measurement year.)

Asthma medication dispensing event:

i. Oral medication dispensing event. An oral medication dispensing event is one prescription lasting 30 days or less. Dispensing events lasting longer than 30 days are calculating by dividing the total days’ supply by 30 and then rounding down to the nearest whole number (e.g., a supply for 75 days = 75/30 = 2.5 and is rounded down to 2). Dispensing events are based on the year that the prescriptions are filled (vs. written).

ii. Inhaler dispensing events.

a. All inhalers of the same medication dispensed on the same day are counted as one dispensing event.

b. Inhalers with different drug IDs dispensed on the same day are counted as different dispensing events.

c. Dispensing events are based on the year that the prescriptions are filled (vs. written).

iii. Injection counts. Each injection counts as a separate dispensing event. For example, if a member receives two injections of medication A and one injection of medication B then they are counted as three dispensing events.

VIII. Reporting Frequency

a. Generate findings annually for a calendar year. In each Semi-annual Internal Audit report, report findings from the previous calendar year (i.e., the CCE can report the same findings in the two internal audit reports due in a calendar year). For example, the semi-annual internal audit reports due on May 15 and Nov 15, 2021 should provide the AMR for calendar year 2020.

Metric 3: Asthma Emergency Department (ED) visits

III. Aspirational Goal/Benchmark: A total of < 3% of members with persistent asthma will have an ED visit with a principal diagnosis of asthma during the measurement year (Cantrell et al. 2011).

IV. Background: Asthma ED visits is an important indicator of the quality of asthma care received by a patient. This metric assesses the percentage of persistent asthmatic members 5 to 85 years of age who have had an ED visit in the measurement year. The Asthma ED visit metric is based on Healthcare Effectiveness Data and Information Set (HEDIS®) 2017 specifications (National Committee for Quality Assurance, 2016b). The HEDIS® 2017 specifications provide standardized definitions for persistent asthmatics (denominator) and asthma ED visits (numerator). This methodology was also used by Health Research and Analysis, LLC (HRA 2017). Note that HEDIS measures generally undergo revision every year; however, these revisions are usually minor. Nonetheless, when examining trends, it is important that for the years included in the trend, all data are calculated using the same version/specification of the Asthma ED visit metric.

The benchmark was derived from the Ingenix Impact National Managed Care Benchmark Database and described in Cantrell et al. (2011).

Data from 2007 were used to determine the benchmark. The benchmark database included data from more than 45 commercial managed care organizations covering 9 census regions and contained the complete medical and pharmacy claims records for more than 65 million patients seen in the commercial setting. It is considered representative of the US commercially insured population younger than 65 years of age; but is not representative of those 65 years of age or older. Although those who are 65 years of age or older have the lowest incidence of asthma ED visits, Cantrell et al. did not explain if those 65 years of age or older were over- or under-represented in the Benchmark database.

Furthermore, the Cantrell et al. definition for persistent asthma was more inclusive than the definition used in this metric. Cantrell et al.

defined a persistent asthmatic as someone who was at least 4 years of age and had at least one medical encounter with asthma as the primary diagnosis OR at least two outpatient encounters with asthma as a secondary diagnosis OR had an asthma diagnosis and an asthma medication fill.

An alternative benchmark is also available. According to data from the National Health Interview Survey (NHIS), in 2015 there were 16.6 million individuals in the US with asthma (i.e., those who reported currently having asthma and were ever told by a health care professional that they have asthma) (CDC 2017). And according to the 2014 National Hospital Ambulatory Medical Care survey (NHAMCS), among those 15-64 years of age, there were 1.1 million ED visits with asthma as the principal reason for the visit (Rui and Kang, no date). These NHIS and NHAMCS data suggest that ~7% of current asthmatics experience an ED visit where the principal diagnosis was asthma.

V. Source of data: This metric is based on claims data. The metric can be calculated by the DCs, CCEs/NPN or the HPE contractor.

VI. Calculation Methods (based on HEDIS® 2017 specifications. When more up-to-date HEDIS® specifications are used, be sure when examining trends to use the same version/specification for all years included in the trend. Also include members between the ages of 5 years and 85 years.)

Asthma ED visits

a. Numerator: Among members who have persistent asthma AND are certified for an obstructive airways disease (OAD), the number who had ED visits in the measurement year for asthma.

Institutional and professional claims data should be used to identify relevant ED visits. For institutional claims (UB-04), the “principal diagnosis” (form locator [FL] field=FL67) is the condition established after study to be chiefly responsible for admission or ED visit (see page 21 at this link). As such, “principal diagnosis” is the field that should be searched, not admit diagnosis. Professional claims (CMS- 1500) codes can also be used to identify ED visits (see pages 32 and 398 at this link). The relevant variable on the CMS-1500 is the “diagnosis or nature of illness or injury” (FL21). On the CMS-1500, the primary reason (primary diagnosis) for the service (i.e., ED visit) must be the first diagnosis pointer listed in the field (FL24e).

HRA uses the codes that are supplied by HEDIS to identify ED visits. These include the following CPT and revenue codes:

CPT®: 99281, 99282, 99283, 99284, 99285

UBREV: 0450, 0451, 0452, 0456, 0459,0981

Note that this metric includes all ED visits, regardless of whether or not they progressed to an inpatient stay.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c25.pdf https://www.nucc.org/images/stories/PDF/1500_claim_form_instruction_manual_2019_07-v7.pdf

b. Denominator: Number of members who had persistent asthma in the measurement year AND who are certified for an obstructive airways disease (OAD).

c. Members to be excluded from the asthma ED visit calculation: Exclude members with any of the following conditions: Emphysema;

COPD; Obstructive Chronic Bronchitis; Other Emphysema; Chronic Respiratory Condition due to fumes/vapors; Cystic Fibrosis; and Acute Respiratory Failure. Also exclude any members without an obstructive airway disease certification. Exclude members who were in hospice care during the measurement year. Finally, exclude members whose age is less than 5 years or greater than 85 years.

d. Stratification: None.

e. Trend: Annual trend.

VII. Definitions:

Members with “persistent asthma”:

Those with persistent asthma must meet at least one of the following criteria during both the measurement year and the year prior to the measurement year. Criteria can be different in the two years:

i. Had at least one emergency department visit with a principal diagnosis of asthma

ii. Had at least one acute inpatient encounter with a principal diagnosis of asthma

iii. Had at least four outpatient visits or observation visits on different dates of service with any diagnosis of asthma and at least two asthma medication dispensing events.

iv. Had at least four asthma medication dispensing events (NOTE: When leukotriene modifiers or antibody inhibitors are the sole asthma medications dispensed then there also must be least one diagnosis of asthma in any setting during the measurement year.)

Asthma medication dispensing event:

i. Oral medication dispensing event. An oral medication dispensing event is one prescription lasting 30 days or less. Dispensing events lasting longer than 30 days are calculating by dividing the total days’ supply by 30 and then rounding down to the nearest whole number (e.g., a supply for 75 days = 75/30 = 2.5 and is rounded down to 2). Dispensing events are based on the year that the prescriptions are filled (vs. written).

ii. Inhaler dispensing events.

a. All inhalers of the same medication dispensed on the same day are counted as one dispensing event.

b. Inhalers with different drug IDs dispensed on the same day are counted as different dispensing events.

c. Dispensing events are based on the year that the prescriptions are filled (vs. written).

iii. Injection counts. Each injection counts as a separate dispensing event. For example, if a member receives two injections of medication A and one injection of medication B then they are counted as three dispensing events.

a. Generate findings annually for a calendar year. In each Semi-annual Internal Audit report, report findings from the previous calendar year (i.e., the CCE can report the same findings in the two internal audit reports due in a calendar year). For example, the semi-annual internal audit reports due on May 15 and Nov 15, 2021 should provide the asthma ED visit metric for calendar year 2020.

IX. Questions

a. CCEs may not have complete data. For H+H, this is because H+H/WTCHP is the secondary payor and may never see ER claims paid by the primary insurer. Data for members assigned to other CCEs/NPN may also be incomplete if the member has ED visits paid by their health insurer and not the WTCHP. A limitation of this metric is that when a CCE/NPN achieves the metric goal (i.e., < 3% of members with persistent asthma will have an asthma ED visit during the measurement year), it might be because responders and survivors are receiving high quality asthma or because of incomplete access to all relevant ED claims data. Despite this limitation, the CCEs/NPN should calculate this metric.

Metric 4: Proportion of members who had laboratory work at most recent monitoring visit

III. Aspirational Goal/Benchmark: 95% or more of members should have had laboratory work at their most recent monitoring visit

IV. Background: Enrolled responders and certified survivors are eligible to receive an annual monitoring exam administered by their assigned CCE. The monitoring exam consists of a medical history (including screening tools for PTSD, depression, and alcohol abuse), a physical exam, pulmonary function tests, blood and urine testing, and a chest X-ray (every two years). The monitoring exam serves several purposes, including: 1) To find cases of disease related to 9/11 exposures, and refer them as necessary for clinical follow-up; 2) track the natural history of these diseases related to 9/11 exposures; and 3) to identify research gaps, such as emerging evidence for an association between 9/11 exposures and a disease not currently included on the covered conditions list.

The laboratory testing that is performed as part of the routine monitoring exam consists of a complete blood count (CBC), a comprehensive metabolic panel, and a urinalysis. The complete blood count screens for anemia, infection, and hematologic cancers. The comprehensive metabolic panel (sometimes referred to as Chem 12, chemistry panel, SMA12 and SMA 20) is performed on blood drawn at the monitoring exam. It is useful for screening for liver disease, kidney disease and lipid disorders The comprehensive metabolic panel generally consists of the following tests: serum glucose, calcium, blood urea nitrogen, creatinine, electrolytes (sodium, potassium, chloride, and carbon dioxide), protein (total serum protein and albumin), and liver function assessment (bilirubin, alkaline phosphatase, aspartate amino transferase [AST], and alanine amino transferase [ALT]) and lipids (total cholesterol, triglycerides, and HDL cholesterol). The urinalysis is useful for screening for urinary tract or kidney disease.

V. Source of data: This metric can be calculated based on data held by the CCEs/NPN. Alternatively, the metric can be calculated by the DCs, using claims data for the numerator and retention data for the denominator.

a. Numerator: Number of enrolled members who received laboratory work at their most recent monitoring visit during the reporting period. The CCE can also include members who refused laboratory work but for whom the clinic obtained results on laboratory work that the member received within 12 months of their monitoring visit (this concession excludes laboratory work received at the previous monitoring visit).

b. Denominator: Number of enrolled members who received a monitoring exam during the reporting period.

c. Stratification: None

d. Trend: Provide trends using data from each 6-month reporting period.

a. Generate findings for each Semi-annual Internal Audit report (i.e., for monitoring exams conducted between Jan 1 and June 30, include findings in the internal audit report due on November 15; for monitoring exams conducted between July 1-December 31, include findings in the internal audit report due on May 15 of the following year).

Metric 5: Proportion of members who had Pulmonary Function Tests (PFTs) at most recent monitoring visit that met QA criteria

III. Aspirational Goal/Benchmark: 85% or more of members should have had PFTs that met QA criteria at their most recent monitoring visit (see section VII.e of this metric)

IV. Background: Enrolled responders are eligible to receive an annual monitoring exam administered by their assigned CCE. The monitoring exam consists of a medical history (including screening tools for PTSD, depression, and alcohol abuse), a physical exam, pulmonary function tests, clinical chemistry laboratory tests, and a chest X-ray (every two years). The monitoring exam serves several purposes, including: 1) To find cases of disease related to 9/11 exposures, and refer them as necessary for clinical follow-up; 2) track the natural history of these diseases related to 9/11 exposures; and 3) to identify research gaps, such as emerging evidence for an association between 9/11 exposures and a disease not currently included on the covered conditions list.

Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. It is useful for tracking lung function over time to detect and evaluate changes. Spirometry testing completed for the WTC Health Program must meet American Thoracic Society (ATS) standards. A brief overview of what is required to obtain an acceptable PFT is provided in section VI.

Additional information regarding ATS standards is available at Miller et al 2005. The aspects of spirometry that should be captured include the forced vital capacity (FVC), the forced expiratory volume in one second (FEV1) and the mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75) (at a minimum).

V. Source of data: To be calculated by each DC based on data provided by the CCEs.

a. Numerator: Number of enrolled members who received PFTs that met QA criteria at their most recent monitoring visit during the reporting period (i.e., spirometry test sessions that comply with the requirements provided in section VII.e).

b. Denominator: Number of enrolled members who received a monitoring exam during the reporting period.

d. Trend: Provide trends using data from each 6-month reporting period.

VII. Spirometry Guidance (adapted from guidance provided by LHI, dated January 9, 2017, and American Thoracic society [ATS] standards [Miller et al 2005])

This section provides a brief overview of what is required to obtain an acceptable PFT. Additional information regarding ATS standards is available at Miller et al 2005.

a. Training and supervision

i. Technicians who perform testing should have successfully completed a National Institute for Occupational Safety and Health (NIOSH) course, or equivalent, within the past five years. In-house training by a staff member who has completed NIOSH training is also acceptable.

ii. Testing should be supervised by a health care professional that is knowledgeable about spirometry accuracy and test validity.

b. Spirometer

i. The spirometer must be calibrated each day of testing using a 3L syringe.

ii. The spirometer must be able to print numeric results for FVC, FEV1, and FEF25-75 (at minimum) for the three best maneuvers.

iii. The spirometer must be able to print the volume flow graph and volume time graph with the three best maneuvers.

c. Prepare the member

i. Ask the member about smoking, recent illness, medication use, etc. The spirometry test should be postponed if the member is acutely ill, has eaten a heavy meal, smoked, or used a bronchodilator within two hours prior to the test.

ii. Measure the member’s height and weight without shoes.

iii. Take the member’s blood pressure and pulse. Postpone the test if the member’s blood pressure is elevated above 170/100.

iv. For safety reasons, testing should be preferably done in the sitting position, using a chair with arms and without wheels. However, if it is thought that the member can give much better results while standing, then standing is acceptable (be sure to place a solid chair directly behind standing members). Note the member’s position during the test.

d. Instruct and demonstrate

i. Demonstrate proper technique to the member including:

• Correct posture – sitting straight (this is preferable to standing)

• Inhale rapidly and completely

• Positioning of the mouthpiece

• Exhaling with maximal force for at least 6 seconds or a plateau is reached in the volume-time curve or the subject can no longer continue

ii. It is recommended that a nose clip be utilized to prevent extra breathes from being taken through the nose. If the nose clip falls off or is uncomfortable, the member may hold their nose during the maneuver.

iii. Instruct the member to…