ATT007_SurvivorCCE_TGD003_SemiannualReports.pdf

TGD 003: Technical Guidance for Semi-Annual Reports Published November 2018

Revised July 2024

Controlled Unclassified Information

Summary of revisions found in the July 2024 version of TGD 003

Effective date: November 15, 2024 Semi-Annual Reports

1. Updated several pharmacy-related QA components to reflect changes effective in the new

PBM contract:

a. The component, “Ensure that appropriate authorization channels are utilized for all medication dispensing events” was replaced with, “For the reporting period, review the Prior Authorization requests submitted by the CCE.”

b. The component, “Provide the proportion of generic medications vs. brand name medications filled” was replaced with an “analysis of brand prescribing patterns.”

c. The component, “Analyze the prescription patterns of individual providers at least twice per year” was replaced with, “Provide evidence that the CCE/NPN reviewed and updated their prescriber network monthly, to be reported at least twice per year.”

d. The method for analyzing the component “Analysis of controlled substance use” was updated.

2. Revised reporting requirements in QA component #18 (contact information) to reflect language in the current CCE/NPN contracts.

3. Updated QA components #19 and #20 to include language and reporting requirements on timeliness of transfers.

4. Added five new QA components: #3 (formulary assignments), #15 (HIPAA incident review), #17 (HIPAA training), #21 (translation and interpretive services), and #22 (BEAST administration) to reflect reporting requirements in the current CCE/NPN contracts.

5. “Hospital readmission within 30 days of discharge” is now listed only as Zadroga Metric 7 and not as a QA component (previously it was listed as QA component #19 and Zadroga Metric 6).

6. Updated Zadroga Metric on retention (Metric 1). New exclusions to the denominator were added for the calculation of the metric.

7. Updated the Zadroga Metric on Asthma Medication Ratio (AMR) metric (Metric 4) to remind CCEs/NPN that having attended at least one monitoring visit in the reporting year is not a requirement to be included in this metric. Also provided additional clarification on this metric (e.g., a] exclusionary conditions must be identified by the CCE/NPN by December 31 of the reporting year, otherwise members not known to have the exclusionary condition in the reporting year should be included in the AMR calculation; and b] persistent asthmatics who had no medication dispensing events in the reporting year can be excluded from the calculation).

8. Updated the spirometry Zadroga Metric (Metric 7) to reflect updated spirometry guidance from American Thoracic Society/European Respiratory Society (ATS/ERS).

9. Updated colorectal cancer screening Zadroga Metric (Metric 9). Updated figure to better explain the difference between the reporting period and the time interval for when the screening had to have occurred.

10. Updated lung cancer screening Zadroga Metric (Metric 10). Updated figure to better explain the difference between the reporting period and the time interval for when the screening had to have occurred. Also, in the Introduction, added info on shared decision-making regarding lung cancer screening.

11. Updated monitoring exam results Zadroga Metric (Metric 2). Revised the goal/benchmark to 98% (but CCEs/NPN need to explain why 100% couldn’t be achieved).

12. Added Zadroga Metrics for Initial Health Evaluation (IHE)/first monitoring exam timeliness (Metric 3), cervical cancer screening (Metric 11), and breast cancer screening (Metric 12).

13. Some QA components, Zadroga Metrics, and appendices were renumbered due to added/removed QA components and Zadroga Metrics.

14. Updated Appendix 1: Reporting periods.

15. Added new appendices that include screening questions for cervical cancer screening

(Appendix 5) and breast cancer screening (Appendix 6).

16. The benchmarks for Metrics 1 and 2 were relabeled. They are now referred to as “Required

Benchmarks” (previously, they were referred to as “Goal/Benchmark”).

July 17, 2024

Table of Contents

Purpose

Guidance for creating Semi-annual Reports

A. Semi-annual Report

B. Purpose and Goals

C. Specific Components of Semi-annual Reports

D. COR Guidance for Reviewing Semi-annual Reports

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

F. Conclusion

Table 1: Order of Reporting Elements to Be Used for the Semi-annual Reports

Section 1: Contractually Required Elements

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

Metric 2: Proportion of letters with monitoring exam results that were provided/sent within 15 business days of exam

Section 2: Additional Metrics and QA Components

Metric 3: Proportion of new members receiving an initial health exam or initial monitoring exam (V1) within six months of CCE/NPN assignment

Metric 4: Asthma medication ratio (AMR)

Metric 5: Asthma Emergency Department (ED) visits

Metric 6: Proportion of members who had laboratory work at most recent monitoring visit

Metric 7: Proportion of members who had spirometry at most recent monitoring visit that met QA criteria . 28

Metric 8: Hospital readmission within 30 calendar days of discharge

Metric 9: Proportion of eligible members considered “current” on colorectal cancer screening

Metric 10: Proportion of eligible members considered “current” on lung cancer screening

Metric 11: Proportion of eligible members considered “current” on cervical cancer screening

Metric 12: Proportion of eligible members considered “current” on breast cancer screening

Metric 13: Proportion of members considered “current” on influenza vaccination

Metric 14: Proportion of lab results reviewed and provided/sent within 30 calendar days of the blood being drawn and urine being collected

Table 8 – Guidance for Reporting QA Components in Semi-annual Reports

References

Appendices

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

Proportion of eligible members considered “current” on colorectal cancer screening

Proportion of eligible members considered “current” on lung cancer screening

Proportion of eligible members considered “current” on cervical cancer screening

Proportion of eligible members considered “current” on breast cancer screening

Proportion of members considered “current” on influenza vaccination

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: Cervical cancer screening questions

Appendix 6: Breast cancer screening questions

Appendix 7: Seasonal influenza vaccine questions

Revision History

WTC Health Program Approval

Purpose

The James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Law 114–113, Public Law 116–59, Public Law 117–328, and Public Law 118–31) 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 CCEs.

The Administrator of the WTC Health Program (Administrator) developed 14 metrics to address these legally mandated QA elements and extended application to both the CCEs and NPN. 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 and establishes a goal/benchmark for each metric. When the goal/benchmark is required by CDC/NIOSH contract language, the goal/benchmark is labeled as “required benchmark.” When the goal/benchmark is not required by CDC/NIOSH contract language, the goal/benchmark is labeled as “aspirational goal.”

The contracts awarded by CDC/NIOSH to the CCEs/NPN require the CCEs/NPN to provide NIOSH with Semi-annual Reports.1 The Semi-annual Reports provide information on QA activities conducted by the CCE/NPN during the reporting period. This Technical Guidance Document (TGD) provides an outline that should be used when developing the Semi-annual Report.

The guidance provided in this document is consistent with the Federal internal control standards issued by the Comptroller General, 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 Semi-annual Reports

A. Semi-annual Report CCEs/NPN are required to submit a Semi-annual report. Each Semi-annual report must address the 14 metrics and specific QA components provided in this Guidance to address each of the Zadroga Act-mandated QA elements. Of the 14 metrics, Metric 1 and Metric 2 have contractually required benchmarks. Metrics 1 and 2 are outlined in Section 1. The remainder of the metrics and QA components are outlined in Section 2. Table 8 provides a description of how each QA component should be addressed in the Semi-annual Report.

Please see Appendix 1 for the reporting periods for each QA component and metric. Please organize the metrics in the Semi-annual Report using the same order as Table 1 and organize the metrics in the

1 See Section 4.1.9.1 in CCE contracts and Section 4.9 in NPN contract.

Semi-annual Report using the same order as Table 1. The Semi-annual Report should be its own standalone document and should not contain other deliverables or reports.

B. Purpose and Goals The purpose the Semi-annual Report is to ensure alignment with WTC Health Program goals and objectives, and consistency across the CCEs/NPN.

The guidance provided in this document is intended to ensure that Semi-annual Reports consistently address mandated elements. It sets expectations for the content of the Semi-annual Reports.

C. Specific Components of Semi-annual Reports The CCE/NPN contracts require that Semi-annual Reports include specific components. These components are:

1. Utilization Management. This component shall focus on evaluating the adequacy of the procedures used by the CCE/NPN to ensure that only approved, medically necessary health care services (including provider visits, procedures, medication, and durable medical equipment) to treat certified WTC-related and medically associated health conditions are reimbursed by the Program. It also includes validating the necessity of inpatient hospitalizations and a review of alternatives to inpatient care.

2. Medical Management Review. This component shall ensure that medical practice guidelines are being followed, in alignment with Program procedures.

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 bills from providers or collection services 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, receiving, maintaining, transmitting, 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 education and retention activities implemented and on achieving the retention benchmarks.

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

D. COR Guidance for Reviewing Semi-annual Reports When preparing Semi-annual Reports, the CCE/NPN should address all metrics and QA components in Table 1. When preparing their Semi-annual Reports, it is requested that CCEs/NPN follow this same topic sequence, to promote consistency in document organization and flow across the CCEs/NPN.

When reviewing the submitted Semi-annual Reports, the Contracting Officer’s Representative (COR) can use Table 1 to determine if Semi-annual Reports have their topics sequenced properly and include the appropriate content. If the COR concludes that the organization and content of the Semi-annual Report appears appropriate, the Report will be distributed to WTC Health Program Subject Matter Experts (SMEs) for review and comment.

E. QA elements Mandated by the Zadroga Act and Related Metrics The Zadroga Act (sec. 3301(e)) 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 CCEs.

The Administrator has extended application of these QA elements to both the CCEs and the NPN.

NIOSH developed metrics to address each of the first three QA elements. A total of 14 metrics were developed: seven metrics for assessing “adherence to monitoring and treatment protocols”; five 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.

F. Conclusion The goal of this guidance is to enhance the activities of the QA program, which is intended to help ensure that Program members receive 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 both program-wide and by individual CCEs/NPN.

Table 1: Order of Reporting Elements to Be Used for the Semi-annual Reports

2 Metric 1 and Metric 2 have contractually required benchmarks. See Section 1 for details on calculations.

3 “Current” for Metrics 9–13 refers to being in compliance with at least one screening strategy at any point in the reporting period.

4 See Section 4.3.8.6 in CCE contracts and Section 4.6.4 in NPN contract for Cancer Screening.

Component Metrics to address the Zadroga Act-mandated elements Metric 1: Proportion of eligible responders and survivors who had a monitoring visit in last 18 months2 Metric 2: Proportion of letters with monitoring exam results that were provided/sent within 15 business days of exam Metric 3: Proportion of new members receiving an initial health exam or first monitoring exam (V1) within 6 months of CCE/NPN assignment Metric 4: Asthma medication ratio (AMR) Metric 5: Asthma Emergency Department (ED) visits Metric 6: Proportion of members who had laboratory work at most recent monitoring visit Metric 7: Proportion of members who had spirometry at most recent monitoring visit that met QA criteria Metric 8: Hospital readmission within 30 calendar days of discharge Metric 9: Proportion of eligible members considered “current”3 on colorectal cancer screening4

Metric 10: Proportion of eligible members considered “current” on lung cancer screening Metric 11: Proportion of eligible members considered “current” on cervical cancer screening Metric 12: Proportion of eligible members considered “current” on breast cancer screening Metric 13: Proportion of members considered “current” on influenza vaccination Metric 14: Proportion of lab results reviewed and provided/send within 30 calendar days of the blood being drawn and urine being collected QA Components

Utilization Management

1. Ensure that appropriate authorization channels are utilized for all medical treatment services (e.g., that treatment services were for a certified WTC-related health condition, within the appropriate care suite, and considered medically necessary).

2. For the reporting period, review the Prior Authorization (PA) requests submitted by the

CCE/NPN.

3. Ensure that appropriate formulary assignments are utilized for all membership.

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

Medical Management Review

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

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

Claims History

7. Analysis of brand prescribing patterns.

8. Analysis of controlled substance use.

9. Provide evidence that the CCE/NPN reviewed and updated their prescriber network monthly, to be reported at least twice per year.

10. Conduct monthly Prescription Claims Reviews (PCRs) on a 5% sample of approved prescription claims for members on the Cancer Formulary.

11. Conduct monthly Prescription Claims Reviews (PCRs) on a 5% sample of approved prescription claims for members on all other formularies (i.e., NOT on the Cancer Formulary).

12. Ensure that 95% of claims for internal services are submitted as clean claims (see TGD 010 for Clean Claim definition) within 90 calendar days of the date of service and 100% within 180 calendar days. For claims for internal services with Coordination of Benefits, ensure 100% are submitted as clean claims within 18 months of the date of service. Per TGD 007.

13. Review claims from external providers and make decisions (i.e., approve, deny, or pend) 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.

Regulatory Compliance

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

15. Conduct a HIPAA incident review to ensure that appropriate reporting and mitigation efforts were performed and were in compliance with contract and business associate agreement with the WTCHP.

Personnel Training

16. Ensure that internal health professionals are properly licensed and insured.

17. Ensure all CCE/NPN staff receive annual security awareness and HIPAA training.

Reporting on this QA component commences in 2024.

Education and Retention

18. Update contact information on all enrolled members

19. Number of members who transferred out of the CCE/NPN. Ensure outgoing transfers are timely and processed according to the Transfer Handbook.

20. Incoming transfers. Ensure incoming transfers are timely and processed according to the Transfer Handbook. Report the number of members who transferred into the CCE/NPN, and proportion who were contacted within three business days of transfer completion.

21. Translation and interpretive services.

22. Benefits Eligibility Assessment and Screening Tool (BEAST) implementation.

Reporting on this QA component commences in 2024.

Section 1: Contractually Required Elements

Quality Assurance (QA) Metric

James Zadroga 9/11 Health and Compensation Act of 2010 (P.L. 111–347, as amended by P.L. 114–113, P.L. 116–59, P.L. 117–328, and P.L. 118–31)

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. Required Benchmark: 65% of eligible members (see VI.a; excluding all members described in VII.b.i-vi) received a monitoring exam in the previous 18 months (i.e., if measuring this metric for 2021, the 18-month lookback period is from July 1, 2020 through December 31, 2021). The previously reported percentage of eligible members receiving monitoring exams over a given period should not decline more than 2.0%, in absolute terms, in six months, or more than 0.5%, in absolute terms, in 12 months.5

Aspirational Goal: Excluding only members that fall into VII.b.i., VII.b.ii, or VII.b.iii. below, 65% or more of eligible members (see VI.a) received a monitoring exam in the previous 18 months (i.e., if measuring this metric for 2021, the 18-month lookback period is from July 1, 2020 through December 31, 2021). Note that this is similar to the calculation that was used in TGD 003 versions prior to July 2024, but adding the exclusion in VII.b.iii. The previously reported percentage of eligible members receiving monitoring exams over a given period should not decline more than 2.0%, in absolute terms, in six months, or more than 0.5%, in absolute terms, in 12 months.

IV. Background: Enrolled responders are eligible to receive an annual monitoring exam (AME) administered by their assigned CCE/NPN; survivors with certified conditions are also eligible to receive an annual monitoring exam; enrolled screening-eligible survivors are eligible to receive an initial health exam (screening-eligible survivors are included as “eligible members” for purposes of this metric; see VI.a). 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 members 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 List of WTC-Related Health Conditions (List); and 4) to inform emergency preparedness efforts for future disasters.

5 See Section 4.3.3 in CCE contracts and Section 4.3.4 in NPN contract.

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 certified health condition; or 3) both. For the purposes of this metric, the Program is interested 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 WTC Health Program uses an 18-month interval to determine “active” or “inactive” status. 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 encompasses the desired time between exams. The 18-month interval represents the required one-year quiescent period between exams plus a six-month accommodation for scheduling exams after the one-year quiescent period.

V. Source of data: The Data Centers (DCs). This metric will be calculated by the relevant DC.

The NPN will be stratified into responder and survivor populations. Until the relevant DCs are able to calculate this metric for NPN and the William Streat Clinic (WSC) CCE, NPN and WSC are responsible for the calculation.

VI. Definitions:

a. Eligible Member: Members who are eligible to receive an annual monitoring exam. This includes:

i. Enrolled responders

ii. Enrolled certified-eligible survivors

iii. Enrolled screening-eligible survivors who had not yet received an IHE before the beginning of the reporting period

b. Transfer-out member: This is a member who transferred to another CCE/NPN and whose transfer request was approved in the Member Transfer Module by the destination clinic during the metric reporting period.

VII. Calculation Methods

a. Numerator: Number of enrolled members who received a monitoring exam (including initial monitoring exam) or initial health evaluation during the reporting period. For purposes of calculating this metric, a member is considered to have received a monitoring exam if they completed the office visit/physical exam portion of the monitoring visit.

b. Denominator: Number of enrolled members assigned to the CCE/NPN during the reporting period. Exclude from the denominator:

i. Those members enrolled within the final six months of the reporting period who did not have a monitoring exam. For example, if the end date of the reporting period is December 31, 2021, exclude members who were enrolled between July 1, 2021 and December 31, 2021 if they didn’t receive a monitoring exam. This accounts for the fact that it may take more than six months for newly enrolled members to receive their initial monitoring exam. Reporting on these members can be found in Metric 3.

ii. Those who are deceased; members 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/NPN in no uncertain terms that they want to permanently cease any and all participation in the Program – “Refusal to Participate”6), and those lost to follow-up (see Appendix 2 for the process to determine “lost to follow-up”).

iii. “Transfer-Out Members”: Those members who have transferred out (see VI.b) during the reporting period, as they will be included in the retention statistic of the receiving CCE/NPN. Note that members who transferred into the CCE/NPN at any time during the reporting period, and who were members of that CCE/NPN on the last day of the reporting period, are to be included in the denominator.

iv. “Enrolled but Received No Program Services for 3 Years”: Those members who were enrolled for more than three years as of the end date of the reporting period but have not received any Program-covered monitoring, treatment, or medications since enrollment. For example, if the end date of the reporting period is December 31, 2021, exclude members who have never been seen and were enrolled and assigned to the CCE/NPN prior to December 31, 2018. Note that these members are not classified as “lost to follow-up,” and the CCE/NPN continues to be responsible for ongoing member outreach efforts for these members (e.g., maintaining contact information).

v. “Received No Program Services for Previous 6 Years”: Those members who were enrolled and previously received Program services, but have not received any Program-covered treatment, medications, or monitoring within the 6 years that precedes the end date of the reporting period. For example, if the end date of the reporting period is December 31, 2021, exclude members who have not been seen nor received any Program-covered services after December 31, 2015.

However, the CCE/NPN continues to be responsible for ongoing member outreach efforts for these members (e.g., maintaining contact information).

vi. (Survivor Population Only) Survivor members who completed an initial health evaluation before the start date of the reporting period but who are not certified-eligible for a WTC-related condition and are therefore not eligible for annual monitoring.

c. Stratification: None. However, please include the breakdown of numbers used in section VII. That is, indicate the the number of members excluded from the denominator within each category (including counts of exclusions due to recent enrollment, death, no longer participating, and lost to follow-up).

Note on Impact of September 11th Victim Compensation Fund (VCF): It is possible that some members are only joining the Program for purposes of filing a VCF claim and will have no interest in participating in post-V1 monitoring exams. However, these members need to be retained in the denominator unless they fall into one of the listed exclusions (e.g., Refusal to Participate or Certified but Received No Program Services for 6 Years).

VIII. Reporting Frequency

a. Generate findings for each Semi-annual Report using the 18-month reporting period

(see reporting periods defined in VII.b.i). For example, for the Semi-annual Report due on May 15, 2024, report findings for the reporting period of July 1, 2022 through December 31, 2023 (18-month period). For the Semi-annual Report due on November

6 Note that the “Refusal to Participate” category is distinct from voluntarily opting out of the Program, which is a formal process.

15, 2024, report findings for the reporting period of January 1, 2023 through June 30, 2024 (18-month period).

(P.L. 111–347, as amended by P.L. 114–113, P. L. 116–59, and P. L. 117–328)

I. Metric Title:

Metric 2: Proportion of letters with monitoring exam results that were provided/sent within 15 business days of exam

II. Zadroga Act QA Category: Prompt communication of test results to participants.

III. Required Benchmark: Results in the form of electronic or hard copy letters will be provided within 15 business days of completing the monitoring exam 100% of the time.7 The electronic letter can explain to the member that exam results can be retrieved remotely by the member from their electronic medical record (e.g., MyChart). The results letter for this metric might exclude PFT, chest X-ray and laboratory results as those tests are often not performed on the same day as the monitoring exam, and the results for these tests may not be available at the time the letter is prepared. Achieving a benchmark of 98% or higher with explanations when monitoring exam results were provided more than 15 days after exam completion and proposing responsive mitigation efforts could satisfy the aspirational goal for this metric, at the discretion of NIOSH.

IV. Background: Enrolled responders and certified survivors are eligible to receive an annual monitoring exam administered by their assigned CCE/NPN. 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; 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.

It is vital that members are promptly notified of the findings from their annual monitoring exam. Some CCEs/NPN provide a letter to the member at the end of their monitoring exam visit. Such a letter provides a summary of findings from their exam and any tests performed during the same monitoring exam visit. PFTs, chest X-ray and laboratory work are often not performed on the same day as the monitoring exam and therefore the results for that testing are not required for this metric (note that there is a separate metric for reporting laboratory results).

Other CCEs/NPN use “MyChart” or other similar online portals, which allow members to log into their account and see their exam and test results. Exam and test results are uploaded to “MyChart” within three days of the results being available to the CCE/NPN. If a member

7 See Section 4.3.8.3.3 in CCE contracts and Section 4.6.1 in NPN contract.

doesn’t use “MyChart”, then a single letter is sent that provides the results for all exams and tests. EPIC tracks the dates that exams and tests were performed, and the date(s) that the exam/test results were available to be retrieved by the member in “MyChart.” For members who don’t use “MyChart,” the date that their notification letter was generated for mail out is available in Epic.

Additionally, some CCEs/NPN send a letter to the member only after the monitoring exam and all related testing are complete. They do not provide a letter to the member at the end of their monitoring exam visit. However, members are promptly called if any abnormalities are found on testing (note that the dates are not recorded for these phone calls).

Once they are prepared by the CCE/NPN, the hard copy letters containing exam/test results generally are promptly sent to the CCE/NPN mailroom. The CCEs/NPN record the date that the letters are sent to the mailroom but have no information on the exact date that the mailroom provided the letter to USPS.

V. Source of data: To be calculated by each CCE/NPN, or by the DC based on data provided by the CCE/NPN.

VI. Definitions: N/A

VII. Calculation Methods:

a. Numerator: During the six-month reporting period, the number of enrolled members who received their monitoring exam results at the end of their monitoring exam visit or whose results were reviewed and generated for mail out within 15 business days of receiving their monitoring exam or whose results were reviewed and saved in a member’s electronic medical record (e.g., MyChart) and the member was notified of the availability of these results within 15 business days of receiving their monitoring exam.

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

c. Stratification: None

VIII. Reporting Frequency:

a. Generate findings for each Semi-annual Report using the six-month reporting period (i.e., for monitoring exams conducted between January 1 and June 30, include findings in the report due on November 15; for monitoring exams conducted between July 1 and December 31, include findings in the report due on May 15 of the following year).

Section 2: Additional Metrics and QA Components

(P.L. 111–347, as amended by P.L. 114–113, P.L. 116–59, P.L. 117–328, and P.L. 118–31)

I. Metric Title:

Metric 3: Proportion of new members receiving an initial health exam or initial monitoring exam (V1) within six months of CCE/NPN assignment

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

III. Aspirational Goal: 75% of new members received/completed V1 within six months of clinic assignment.

IV. Background: The initial health exam (IHE) or initial monitoring exam (IME), together referred to as “V1,” is an essential prerequisite to initiating care, documenting and monitoring symptoms, certifying eligible conditions for coverage, and connecting members with follow-up medical services or specialists as needed. The V1 consists of a medical and exposure history (including screening tools for PTSD, depression, and alcohol abuse), a physical examination, spirometry, blood and urine testing, and a chest X-ray. Findings from the V1 are used to evaluate whether the member has a WTC-related or medically associated health condition. The V1 must be completed in a timely manner to ensure that new members have appropriate access to the level of care required to treat their WTC-related conditions. For new members joining the program who are asymptomatic (primarily responders), a timely initial exam is still essential to provide a baseline of health with which further monitoring can be compared, so that any conditions that may develop can be promptly identified and treated. The purpose of this metric is to assess V1 timeliness after program enrollment.

V. Source of Data: The DCs. This metric will be calculated by the relevant DC. The NPN will be stratified into responder and survivor populations. Until the relevant DCs are able to calculate this metric for NPN and WSC, NPN and WSC are responsible for the calculation.

VI. Definitions:

a. Completed initial health exam date: This is the V1 date of service (DOS). For a member enrolled in a CCE/NPN, this is defined as the DOS in which the roll-up code (See Technical Guidance Document #006 for roll-up code details) is utilized on a claim. The V1 DOS for a member enrolled in the NPN is defined as the DOS in which CPT code 99205 (i.e., V1 code) is utilized on a claim.

b. Newly enrolled CCE/NPN member: This is a member who was recently determined to have met Program enrollment eligibility criteria and was either auto-assigned, or in the case of General Responders, chose to be assigned to the CCE/NPN. This assignment occurred during the metric reporting period.

c. Newly enrolled transfer member: This is a member whose transfer request was approved in the Member Transfer Module by the destination clinic during the metric reporting period, and the approval occurred within six months of when the member was assigned to their initial CCE/NPN; the member did not receive a V1 pre-transfer.

d. V1: The initial monitoring examination (IME) or initial health evaluation (IHE). The V1 consists of a medical and 9/11 exposure history (including screening tools for PTSD, depression, and alcohol abuse), a physical examination, spirometry, blood and urine testing, and a chest X-ray.

VII. Calculation Methods

a. Numerator: Members from the denominator who had a V1 within six months of CCE/NPN assignment. The member has up to six months from their CCE/NPN assignment date to be counted in the numerator; thus, the period for inclusion in the numerator may extend up to six months beyond the metric reporting period (e.g., for a 12-month metric reporting period of July 1, 2022 through June 30, 2023, if a member is assigned to the CCE/NPN on June 30, 2023, the CCE/NPN has until December 31, 2023 to complete the V1 for that member and be included in the numerator).

b. Denominator: During the 12-month reporting period, the number of newly enrolled members and “newly enrolled transfer members” (defined in VI) assigned to the CCE/NPN during the reporting period. Exclude from the denominator:

i. Newly enrolled members who transferred out of the CCE/NPN within six months of CCE/NPN assignment and did not receive their V1. Such transferring members should be included in the V1 metric for the destination CCE/NPN. For the destination CCE/NPN, the calculation should be based on six months from the transfer effective date.

ii. Newly enrolled transfer members who transferred into the CCE/NPN but completed their V1 with the originating CCE/NPN.

iii. Those who are deceased and those members 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/NPN in no uncertain terms that they want to permanently cease any and all participation in the Program – “Refusal to Participate”).

c. Stratification: Stratify members in the denominator into two groups based on IHE timeliness.

One group will consist of members who received a timely IHE, and the other group will consist of members who did not receive a timely IHE (this group includes members who received an IHE more than six months after their CCE/NPN assignment date and those who have not yet received an IHE).

VIII. Reporting Frequency

a. Generate findings for each Semi-annual Report using the 12-month reporting period (see reporting periods defined in VI.d). For example, for the Semi-annual Report due on May 15, 2024, report findings for the reporting period of July 1, 2022, through June 30, 2023 (12-month period). For the Semi-annual Report due on November 15, 2024, report findings for the reporting period of January 1, 2023, through December 31, 2023 (12-month period).

Note that because members have six months to obtain a V1, V1 completions for members assigned during the reporting period may continue six months past the reporting period. For example, for a member assigned to a CCE/NPN on December 31, 2023 (i.e., the last day of the January 1, 2023 through December 31, 2023 reporting period), that member has until

June 30, 2024 to complete their V1 in order to be included in the numerator for the reporting period.

(P.L. 111–347, as amended by P.L. 114–113, P.L. 116–59, P.L. 117–328, and P.L. 118–31)

I. Metric Title:

Metric 4: Asthma medication ratio (AMR) II. Zadroga Act QA Category: Adherence to monitoring and treatment protocols

III. Aspirational Goal: A total of 78% or more of members with persistent asthma will have an appropriate AMR (i.e., ≥0.50).8 NOTE: Having attended at least one monitoring visit in the reporting year is not a requirement to be included in this metric.

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 up to 85 years of age who have a ratio of asthma controller medications to total asthma medications ≥0.50 in the reporting 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. Until the relevant DCs are able to calculate this metric for NPN and WSC, NPN and WSC are responsible for the calculation. The HPE can also provide assistance, if needed.

VI. Definitions:

a. Members with “persistent asthma”: Those with persistent asthma must meet at least one of the following criteria during both the reporting year and the year prior to the reporting 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

8 This is a benchmark established by the State of Health Care Quality Report (National Committee for Quality Assurance, 2017)

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, there also must be least one diagnosis of asthma in any setting during the reporting year.)

NOTE: If a member has an exclusionary condition (e.g., COPD), do not determine if that member has persistent asthma.

b. Asthma medication dispensing event: A dispensing event is defined as one of the following:

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 calculated 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 (i.e., not the year they were 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 (i.e., not the year they were 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.

VII. Calculation Methods: (based on HEDIS 2017 specifications. When more up-to-date HEDIS specifications are used, be sure to use the same version/specification for all years included in the trend. Also include all members up to age 85.)

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., reporting 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 OAD, the number of total asthma medication dispensing events in the year of interest.

This includes rescue (e.g., short-acting beta-2-agonists) and controller medications.

Exclude from the denominator:

i. 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.

ii. Any members without an OAD certification. The exclusionary condition must be identified by the CCE/NPN by December 31 of the reporting year. That is, include members in the metric who were not known to have the exclusionary condition in the reporting year (e.g., if a member with persistent asthma is diagnosed with COPD on July 1, 2022, that member can be included in the AMR metric in the 2021 reporting year).

iii. Members who were in hospice care during the reporting year.

iv. Members whose age is greater than 85 years.

v. Persistent asthmatics who had no medication dispensing events in the reporting year.

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

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

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

d. Stratification: By age (e.g., up to 50 years, 51–64 years, 65–85 years, and all ages combined), as the benchmark varies by age (National Committee for Quality Assurance, 2017).

e. Trend: Provide annual trends using the 12-month reporting period. In 2024, the 12-month reporting period should be defined as from January 1, 2023 through December 31, 2023.

VIII. Reporting Frequency

a. Generate findings annually for a calendar year. In each Semi-annual Report, report findings from the previous calendar year (i.e., the CCE/NPN can report the same findings in the two reports due in a calendar year). For example, the Semi-annual Reports due on May 15 and November 15, 2024 should provide the AMR for calendar year 2023.

(P.L. 111–347, as amended by P.L. 114–113, P. L. 116–59, P. L. 117–328, and P.L. 118–31)

I. Metric Title:

Metric 5: Asthma Emergency Department (ED) visits II. Zadroga Act QA Category: Adherence to monitoring and treatment protocols

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

IV. Background: Asthma ED visits are an important indicator of the quality of asthma care received by a patient. This metric assesses the percentage of persistent asthmatic members up to 85 years of age who have had an ED visit in the reporting 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 nine 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 four 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…