CMS Medicare and Medicaid EHR Incentive Programs

Overview of Key Components of the Proposed Rule for Stage 2 Meaningful Use

March 8, 2012

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HITECH is Designed to Promote the Meaningful Use of Electronic Health Records

Meaningful use pertains to the specified use of certified EHR technology that is designed to improve quality, efficiency, and safety; to engage patients and families; to improve care coordination and population health; and to maintain the privacy and security of personal health information.

The Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS). The Office of the National Coordinator for Health Information Technology (ONC) is the principal Federal entity charged with coordination of nationwide efforts to implement and use HIT.

GOVERNING BODY

GOALS

The meaningful use of certified EHR technology is the foundation for a broader health IT infrastructure needed to reform the U.S. health care system.

GUIDING LEGISLATION

DEFINITION

The Health Information Technology for Economic and Clinical Health (HITECH) Act, a provision of the American Recovery and Reinvestment Act (ARRA) of 2009 which provides incentive payments for the meaningful use of certified* EHR technology for certain providers.

Source: CMS and Frost & Sullivan

PROCESS

Meaningful use sets specific objectives that will be implemented in three stages over the next five years. Over the course of these stages, eligible professionals and hospitals must meet or qualify for an exclusion to these objectives in order to qualify for incentive funds. The final rules for Stage 1 meaningful use were released in July 2010.

*EHR technology must be certified by the government to be capable of meeting meaningful use requirements

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CMS EHR Incentive Programs for Medicare and Medicaid Providers

EPs- physicians, nurse practitioners, certified nurse-midwives, dentists, physicians assistants in Federally Qualified Health Centers (FQHCs) or Rural Health Care Centers (RHCs); EHs - Acute care hospitals (including Critical Access Hospitals) with at least 10 percent Medicaid patient volume; children's hospitals.

To provide financial incentives to eligible professionals (EPs) and eligible hospitals (EHs) participating in Medicare and/or Medicaid who adopt certified electronic health records (EHRs) and attest to the meaningful use of these EHRs within specified timeframes designated by the Centers for Medicare & Medicaid Services (CMS).

PURPOSE

PAYMENTS

EPs can qualify for incentive payments totaling as much as $44,000 (over five years) through the Medicare Incentive Program, or as much as $63,750 (over six years) through the Medicaid Incentive Program. Hospitals can qualify for incentive payments totaling $2 million or higher; some hospitals are dually-eligible for Medicare and Medicaid payments.

MEDICARE PROVIDERS

MEDICAID PROVIDERS

EPs- physicians, dentists, podiatrists, optometrists, chiropractors; EHs- Subsection (d) hospitals paid under the Inpatient Prospective Payment System (IPPS); Critical Access Hospitals (CAHs); Medicare Advantage Hospitals.

Source: CMS and Frost & Sullivan

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Meaningful Use Will Evolve in Three Stages With Specific Objectives for Each Stage

Source: CMS and Frost & Sullivan

Data Capture and Sharing

• The starting point. Designed to lay the foundation for health IT; sets the baseline for electronic data capture using certified EHRs; lists requirements on how to use EHRs to track key clinical conditions, communicate and share information with patients and other providers, and initiates reporting of clinical quality measures and public health information.

Advance Clinical Processes

• Expands upon Stage 1 requirements, particularly those related to HIE including communication with public health agencies; the use of computerized provider order entry (CPOE) with clinical decision support (CDS); use of EHRs for care transitions and reporting quality measures, and patient engagement via the sharing of visit summaries.

Improve Outcomes

• Demonstrating impact. Focus on achieving improvements in quality, safety, and efficiency; access to comprehensive patient data, and improving population health outcomes. Will incorporate decision support for high priority conditions and will provide patients with access to tools to self manage their care.

STAGE 1(2011-2013)

STAGE 2(2014-2016)

STAGE 3(expected to

begin in 2016)

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Qualifying for EHR Incentive Funds Requires Meeting a Defined Number of Meaningful Use Objectives

Source: CMS and Frost & Sullivan

Meaningful use includes both a core set and a menu set of objectives specific to eligible professionals or eligible hospitals and CAHs. Providers must demonstrate that they have meet meaningful use criteria that are specific to them (e.g., Medicare or Medicaid EP, hospital, CAH) in order to receive incentive funds.

25 20 15 5

24 19 14 5

Eligible Professionals

Eligible Hospitals

Total Meaningful Use Objectives

Total Needed for Incentive Funds

Core and Menu Items Need to Qualify

MenuCore +

EPs and hospitals are also required also to report clinical quality measures (CQM) -

• EPs must report on 6 total CQMs: 3 required core measures and 3 additional measures (selected from a set of 38 clinical quality measures).

• Eligible hospitals and CAHs must report on all 15 of their clinical quality measures

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Stage 1 Core Objectives for Meaningful Use EPs Must Adopt 15

Eligible Professional Core Objectives – Stage 1 Meaningful Use

(1) Use CPOE for medication orders directly entered by any licensed healthcare professional (2) Implement drug-drug and drug-allergy interaction checks(3) Maintain an up-to-date problem list of current and active diagnoses(4) Generate and transmit permissible prescriptions electronically (eRX)(5) Maintain active medication list(6) Maintain active medication allergy list(7) Record demographics (language, gender, race, ethnicity, DOB)(8) Record and chart vital sign changes (height, weight, BP, BMI, growth charts for ages 2-20)(9) Record smoking status for 13 and older(10) Report ambulatory clinical quality measures (CQM) to CMS or the states (for Medicaid)(11) Implement one clinical decision support rule relevant to specialty or high clinical priority and

track compliance with that rule(12) Provide patients with an electronic copy of their health information upon request(13) Provide clinical summaries for patients for each office visit(14) Have the capability to electronically exchange key clinical information among providers of care

and patient authorized entities (HIE)(15) Protect electronic health information in EHRs through use of appropriate technical capabilities

Source: CMS (https://www.cms.gov/EHRIncentivePrograms/Downloads/EP-MU-TOC.pdf) and Frost & Sullivan

Each core objective has specific measures that are required to meet meaningful use (e.g., must be applied to all patients; must be applied to a specific percent of patients, must be applied to certain ages, etc)

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Stage 1 Menu Objectives for Meaningful UseEPs Must Adopt Five

Source: CMS (https://www.cms.gov/EHRIncentivePrograms/Downloads/EP-MU-TOC.pdf) and Frost & Sullivan

Each menu item has specific measures that are required to meet meaningful use (e.g., must be applied to all patients; must be applied to a specific percent of patients, must be applied to certain ages, etc)

Eligible Professionals Menu Objective – Stage 1 Meaningful Use

(1) Implement drug formulary checks(2) Incorporate clinical lab-test results into the EHR as structured data

(3)Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach

(4) Send patient reminders per patient preference

(5)Provide patients with electronic access to their health information within 4 business days of the information being available

(6) Use certified EHR technology to identify patient-specific education resources and provide those resources to the patient

(7) Perform medication reconciliation when receiving patient from another care setting(8) Provide summary care record for each transition of care or referral(9) Have the capability to submit electronic data to immunization registries and actual submission

according where legally required(10) Have the capability to submit electronic syndromic surveillance data to public health agencies

and actual submission where legally required

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Stage 1 Core Objectives for Meaningful Use Eligible Hospitals and CAHs Must Adopt 14

Eligible Hospitals Core Objectives – Stage 1 Meaningful Use

(1) Use CPOE for medication orders directly entered by any licensed healthcare professional (2) Implement drug-drug and drug-allergy interaction checks(3) Maintain an up-to-date problem list of current and active diagnoses(4) Maintain active medication list(5) Main active medication allergy list(6) Record all of these demographics (language, gender, race, ethnicity, DOB, date and cause of

death in the event of mortality)(7) Record and chart vital sign changes (height, weight, BP, BMI, growth charts for ages 2-20)(8) Record smoking status for 13 and older(9) Report hospital CQM to CMS or the states for Medicaid(10) Implement one CDS rule related to a high priority hospital condition and track compliance with

that rule(11) Provide patients with an electronic copy of their health information upon request(12) Provide patients with an electronic copy of their discharge instructions at time of discharge,

upon request(13) Have the capability to electronically exchange key clinical information among providers of care

and patient authorized entities (HIE)(14) Protect electronic health information in EHRs through use of appropriate technical capabilities

Source: CMS (https://www.cms.gov/EHRIncentivePrograms/Downloads/Hosp_CAH_MU-TOC.pdf) and Frost & Sullivan

Each core objective has specific measures that are required to meet meaningful use (e.g., must be applied to all patients; must be applied to a specific percent of patients, must be applied to certain ages, etc)

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Stage 1 Menu Objectives for Meaningful UseEligible Hospitals Must Adopt Five

Source: CMS (https://www.cms.gov/EHRIncentivePrograms/Downloads/Hosp_CAH_MU-TOC.pdf) and Frost & Sullivan

Each menu item has specific measures that are required to meet meaningful use (e.g., must be applied to all patients; must be applied to a specific percent of patients, must be applied to certain ages, etc)

Eligible Hospitals Menu Objective – Stage 1 Meaningful Use

(1) Implement drug formulary checks(2) Record advance directives for 65 years or older(3) Incorporate clinical lab-test results into the EHR as structured data

(4)Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach

(4) Send patient reminders per patient preference

(5)Use certified EHR technology to identify patient-specific education resources and provide those resources to the patient

(6) Perform medication reconciliation when receiving patient from another care setting(7) Provide summary care record for each transition of care or referral(8) Have the capability to submit electronic data to immunization registries and actual submission

according where legally required(9) Have the capability to submit electronic data to public health agencies and actual submission

according where legally required(10) Have the capability to submit electronic syndromic surveillance data to public health agencies

and actual submission where legally required

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Stage 1 Requirements for Meaningful Use - Core Objectives are Aligned with Patient-Driven Domains

Source: CMS and Frost & Sullivan

text

Core Objectives• Protect Electronic

Health Information

Menu Objectives• Immunization

Registries Data Submission

• Syndromic Surveillance Data Submission

Core Objectives• Electronic Exchange

of Clinical Information

Menu Objectives• Medication

Reconciliation• Transition of Care

Summary

Core Objectives• Electronic Copy of

Health Information• Clinical Summaries

Menu Objectives• Patient Electronic

Access• Patient-specific

Education Resources

Core Objectives• CPOE for Medication

Orders• Drug Interaction Checks• Maintain Problem List• E-prescribing• Active Medication List• Medication Allergy List• Record Demographics• Record Vital Signs• Record Smoking Status• Clinical Quality

Measures (CQMs)• Clinical Decision

Support (CDS)

Menu Objectives• Drug Formulary Checks• Clinical Lab Test Results• Patient List• Patient Reminders

Improve Quality, Safety, & Efficiency

Engage Patients & Family

Improve Care Coordination

Ensure Privacy & Security of PHI

Improve Public & Population Health

STAGE 1 (2011-2013)Patient-Driven Domains for Meaningful Use

CORE AND MENU OBJECTIVES BY PATIENT-DRIVEN DOMAIN

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Stage 2 Meaningful Use Proposed Rules Released in February 2012

On February 24, 2012, the Department of Health and Human Services (HHS) issued two Notices of Proposed Rulemaking (NPRMs) related to Stage 2 Meaningful Use –

o the Medicare and Medicaid EHR Incentive Programs that detail proposed expectations for providers (Notice of Proposed Rule Making: 42 CFR 412, 413, and 495. Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2);

o the Standards & Certification Criteria (S&CC) that specify the proposed requirements for the certification of EHR technology (Notice of Proposed Rule Making: 45 CFR 170. Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology)

The 455-page proposed rule for Stage 2 will open to public comment for 60 days (until May 7, 2012) after which CMS will finalize the regulation, expected around July 2012. Stage 2 will begin on October 1, 2013 for hospitals and on January 1, 2014 for eligible professionals.

CMS will not adopt all of the new proposed measures and thus seeks comments and feedback on the following -

o 125 potential measures for EPs and 49 potential measures for eligible hospitals and CAHso mechanisms for electronic CQM reporting o proposed rules related to state Medicaid agencies Source: CMS and Frost & Sullivan

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Stage 2 Proposed Rules are a Logical Continuation of Stage 1 Including More Emphasis on CQM

The proposed Stage 2 rule is applicable to eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs) and delineates criteria that must be met in order to qualify for CMS EHR incentive payments. Stage 2 criteria are designed to provide incremental advancement towards the Meaningful Use goals as laid out in Stage 1. All Stage 1 measures have been reevaluated and refined. Almost all objectives considered optional for Stage 1 are proposed as requirements in Stage 2. While the actual number of required core and menu measures has not changed much, clinical quality measures (CQM) have been doubled for EPs and almost doubled for hospitals as illustrated below.

Source: CMS and Frost & Sullivan

Measure Eligible Professionals Eligible Hospitals and CAHs

Stage 1Stage 2 (Proposed) Stage 1

Stage 2 (Proposed)

Core 15 17 14 16

Menu5 (of 10) 3 (of 5) 5 (of 10) 2 (of 4)

CQM Alternative 16 (of 38) 12 15 24

CQM Alternative 2 Physician Quality Reporting System Program

Hospital Inpatient Quality Reporting Program

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New Timeline for Incentive Funds for Providers Who Attested in 2011

Source: CMS , HIMSS, and Frost & Sullivan

Attestation for EHR incentive funds began in 2011. Stage 2 requires changes that cannot reasonably be completed in the time between publication of the final rule (approximately July 2012) and the start of the next EHR reporting periods. Thus, CMS has proposed that providers who first successfully demonstrated Meaningful Use in 2011 now have until 2014 to meet Stage 2 criteria and until 2016 to meet all rules.

First Payment Year New Proposed Meaningful Use Timeline for Providers Who Attest in 2011

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

2011 Stage 1 Stage 2 Stage 3 TBD

2012 Stage 1 Stage 2 Stage 3 TBD

2013 Stage 1 Stage 2 Stage 3 TBD

2014 Stage 1 Stage 2 Stage 3 TBD

2015 Stage 1 Stage 2 Stage 3 TBD

2016 Stage 1 Stage 2 Stage 3

2017 Stage 1 Stage 2 Stage 3

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Key Focus Areas for Stage 2 Proposed Rules

Requirements for CPOE use have been increased; now a majority of provider orders must be done electronically

CMS is making a major move to tie quality reporting to meaningful use; many quality measures may become requirements for reporting through an EHR

Stage 2 goes beyond demonstrating the ability to exchange information to requiring that providers actually demonstrate that information exchange has occurred.

Stage 2 places a heightened emphasis on interoperability and clarity of standards that enable interoperability, e.g., problem lists coded in SNOMED, medications in RxNorm, care summaries in Consolidated CDA (clinical document architecture, an HL7 markup standard)

More than half of a given organization’s patients must be provided timely online access to their health information, and ten percent must actually access that information

Source: Frost & Sullivan

COMPUTERIZED PROVIDER ORDER

ENTRY

QUALITY REPORTING

HEALTH INFORMATION EXCHANGE

STANDARDS

PATIENT ENGAGEMENT

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Summary of Stage 2 Proposed Changes For Select Meaningful Use Criteria

Source: CMS and Frost & Sullivan

Meaningful Use Criteria Summary of Stage 2 Proposed Changes

Care Transitions/Summary of Care

• EPs and EHs will provide a summary of care record for more than 65 percent of transitions of care and referrals

• EPs and EHs will record care plan goals and patient instructions in the care plan for• more than 10 percent of patients

Clinical Decision Support (CDS)

• CDS will now be called clinical decision intervention (CDI)• Providers will enable and implement the functionality for drug-drug and drug allergy

interaction checks• Increased alignment with existing quality programs and National Quality Strategy - at

least five CDI rules must coincide with five CQM measures

Computerized Provider Order Entry (CPOE)

• More than 60 percent of medication, laboratory, and radiology orders created by an EP or authorized providers of the eligible hospital's or CAH's inpatient or ED will be recorded using CPOE

• The CPOE requirement is up from 30 percent required in Stage 1

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Source: CMS and Frost & Sullivan

Meaningful Use Criteria

Summary of Stage 2 Proposed Changes

Clinical Lab Tests • EPs and EHs must incorporate more than 55 percent of all clinical lab tests results into EHR as structured data

Clinical Quality Measures (CQM)

• EPs will report 12 CQMs out of 125 potential CQMs and EHs and CAHs will report 24 CQMs out of 49 potential clinical quality measures

• Quality reporting will become part of the definition of meaningful use rather than a separate designation

• In an effort to make reporting of quality measures easier for providers, CQM will align with existing quality programs, such as those used for the Physician Quality Reporting System and CMS’ Shared Savings Program for EPs and the Hospital Inpatient Quality Reporting and the Joint Commission’s hospital quality measures for EHs and CAHs

ePrescribing (eRX) • EPs will use EHRs for more than 65 percent of all permissible prescriptions, comparing to at least one drug formulary and transmitting electronically

Health Information Exchange (HIE)

• The Stage 1 “exchange of key clinical information” core objective will be replaced with a more robust “transitions of care” core objective that requires electronic exchange of summary of care documents

• Direct will join CONNECT as a required communication protocol; all EHRs must implement the Direct Project (protocol for encrypted email)

• Providers will exchange data across organizational boundaries with other providers that use disparate EHRs

Summary of Stage 2 Proposed Changes For Select Meaningful Use Criteria (continued)

17

Source: CMS and Frost & Sullivan

Meaningful Use Criteria

Summary of Stage 2 Proposed Changes

Electronic Medication Administration (eMAR)

• eMAR is required for 10 percent of all medication orders for hospital patients

Imaging • More than 40 percent of all scans and tests whose result is an image must be accessible through the EHR

Medication Reconciliation

• EPs and EHs will perform medication reconciliation during 65 percent of transitions of care in which patient moves into care of physician or is admitted to hospital or ED

Patient Engagement/Patient Access to Information

• The Stage 1 objective to provide patients with an electronic copy of their health information would be removed and replaced by an "electronic/online access" core objective – e.g., more than 10 percent of patients seen by EPs or discharged from hospitals or EDs must "view, download or transmit to a third party" their health information

• EPs will provide online access to health information to at least 50 percent of their patients within four business days of the visit. EPs will use EHRs to provide clinical summaries to patients within 24 hours of the visit for more than half of office visits. EPs will send preventive care reminders to 10 percent of patients. EPs will enable secure messaging for communication with patients via email, patient portals, PHRs or stand-alone applications

• EHs will give 50 percent of patients access to data about an ED visit or hospitalization within 36 hours of discharge.

Summary of Stage 2 Proposed Changes For Select Meaningful Use Criteria (continued)

18

Source: CMS and Frost & Sullivan

Meaningful Use Criteria Summary of Stage 2 Proposed Changes

Privacy/Security • Providers will conduct or review security risk analysis, address encryption or security of data at rest and execute security updates as necessary, and correct identified security deficiencies

Public Health Reporting • Electronic submission of data to immunization registries becomes a core requirement; submission of information to cancer and other specialized registries is a menu item. Reporting of syndromic surveillance and reportable lab data moves forward from testing to actual submission of data.

Standards • EHR vendors will be required to imbed standard vocabularies such as Systematized Nomenclature of Medicine (SNOMED), Logical Observation Identifiers Names and Codes (LOINC), and RxNORM

• Stage 2 calls for the adoption of the Consolidated CDA standard for summary of care records, which is a revised version of the Continuity of Care Document (CCD). This standard includes several metadata elements, including two that are proposed for use--data provenance and the Confidentiality Code.

Summary of Stage 2 Proposed Changes For Select Meaningful Use Criteria (continued)

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What to Expect in the Final Rules

Written or electronic comments on the proposed rules must be received no later than 5 p.m. on May 7, 2012. ONC and CMS have been very clear that they are soliciting active and robust input – both positive and negative - from all stakeholders. In many areas, CMS has given itself plenty of room to maneuver by proposing a variety of requirements around top priorities like patient engagement.

The final rule for CPOE and HIE will likely remain similar to the preliminary ones as they are the logical follow-on to the Stage 1 criteria. Expect significant trimming between the preliminary and final rule for the CQM reporting.

Expect significant pushback on patient engagement requirements - many providers are not ready or willing to comply with the proposed rules and it is not clear that 10 percent of patients will even want to view, download or transmit their health data.

Source: Frost & Sullivan

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Appendices

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Appendix: List of Abbreviations

ACO Accountable Care OrganizationARRA American Recovery and Reinvestment Act of 2009

CAH Critical Access HospitalCDS Clinical Decision SupportCMS Centers for Medicare & Medicaid ServicesCPOE Computerized Provider Order EntryCQM Clinical Quality MeasuresED Emergency DepartmentEH Eligible HospitalEHR Electronic Health RecordEP Eligible ProfessionalHHS United States Department of Health and Human ServicesHIE Health Information ExchangeHIPAA Health Insurance Portability and Accountability Act HIT Health Information TechnologyHITECH Health Information Technology for Economic and Clinical Health ActHITPC Health Information Technology Policy CommitteeNPRM Notice of Proposed RulemakingONC Office of the National Coordinator for Health Information TechnologyPCMH Patient Centered Medical HomePHI Personal Health InformationPQRS Physician Quality Reporting System

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Appendix: Useful Resources

The CMS website for the Electronic Health Records (EHR) Incentive Program. Available at http://www.cms.gov/EHRIncentivePrograms/01_Overview.asp

"Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule," 75 Federal Register 144 (28 July 2010), pp. 44314-44588. Available at http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

Medicare and Medicaid Programs; Electronic Health Record Incentive Program-- Stage 2 Proposed Rule. (February 23, 2012). Available at http://www.ofr.gov/OFRUpload/OFRData/2012-04443_PI.pdf

ONC Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Proposed Rule. (February 24, 2012). Available at http://www.ofr.gov/OFRUpload/OFRData/2012-04430_PI.pdf

Posnack, S. Proposed Rule Standards & Certification Criteria, 2014 Edition. Office of the National Coordinator for Heath Information Technology. Available at http://www.healthit.gov/sites/default/files/pdf/2014_SCCEdition2014.pdf

HIMSS Meaningful Use OneSource. Available at http://www.himss.org/ASP/topics_meaningfuluse.asp

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Contacts

Nancy FabozziSenior Industry AnalystHealthcare & Life Sciences(720) 328-1227nancy.fabozzi@frost.com

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