Meaningful Use, Standards and Certification of Electronic Health Records Implications and Applications for the caEHR P

1. Meaningful Use, Standards and Certification of Electronic Health RecordsImplications and Applications for the caEHR Project Robert Hausam, MD OntoReason, LLC September 7, 2010

2. Legislation

3. HITECH Act • HITECH = “Health InformationTechnology for Economic and Clinical Health” • Passed by Congress Feb. 17, 2009, as part (Title XIII) of ARRA (American Recovery and Reinvestment Act) • Authorizedincentive payments through Medicare and Medicaid to cliniciansand hospitals for use of Electronic Health Records (EHR’s) to achievespecified improvements in care delivery • Requires development of specific “meaningful use” objectives • Requires use of certified EHR systems

4. Why EHR’s? • Make patient’s health information available when and where it is needed • Bring patient’s total health information together in one place, and always current • Support better follow-up information for patients • Improve patient and provider convenience • Link information with patient’s computers to point to additional resources

5. Why EHR’s? (cont.) • Don’t just “contain” or transmit information, also compute with it • Improve safety through bringing all of a patient’s information together, automatically identifying potential safety issues, providing “decision support” capability to assist clinicians • Deliver more information in more directions, while reducing “paperwork” time for providers

6. Why EHR’s? (cont.) • Improve privacy and security – can be more secure than paper • Reduce costs through reduced paperwork, improved safety, reduced duplication of testing, and most of all improved health through the delivery of more effective health care

7. Why Meaningful Use? • EHR’s do not achieve these benefits merely by transferring information from paper form into digital form • EHR’s can only deliver their benefits when the information and the EHR are standardized and “structured” in uniform ways • Therefore the “meaningful use” approach requires identification of standards for EHR systems • EHR’s cannot achieve their full potential if providers don’t use the functions that deliver the most benefit • E.g. information exchange, order entry to activate “decision support” functions

8. Why Meaningful Use? (cont.) • Adoption of EHR’s in itself is not the goal • The use of EHR’s to achieve health and efficiency goals is what matters

9. Why Meaningful Use? (cont.) • Five health care goals for meaningful use of EHR’s • Improve the quality, safety, and efficiency of care while reducing disparities • Engage patients and families in their care • Promote public and population health • Improve care coordination • Promote the privacy and security of EHR’s • Demonstrating achievement of “meaningful use” objectives is the key to qualifying for EHR incentive payments

10. Why EHR Certification? • Provide assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality, and security to help them meet the meaningful use criteria established for a given phase • Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology

11. 3 Components of Meaningful Use • Use of certified EHR in a meaningful manner • e.g. e-prescribing, computerized physician order entry (CPOE), etc. • Use of certified EHR technology for electronic exchange of health information to improve quality of health care • Use of certified EHR technology to submit clinical quality measures (CQM) and other such measures selected by the Secretary of HHS

12. Regulations

13. “Medicare and Medicaid Programs; EHR Incentive Program” Final Rule (CMS) • Proposed Rule published January 13, 2010 • Final Rule issued July 13, 2010, published in Federal Register July 28, 2010 • Effective September 27, 2010

14. EHR Incentive Program Final Rule Provisions • Incentive payments available for Eligible Professionals (EP), Eligible Hospitals (EH) and Critical Access Hospitals (CAH) under Medicare and Medicaid beginning in 2011 • Estimated $9.7 to $27.4 billion total for 2011-201 • Initial incentive payments expected • Medicare – mid May 2011 • Medicaid – per individual states • Incorporates changes from the proposed rule designed to make the requirements more readily achievable while meeting HITECH goals

15. EHR Incentive Program Final Rule Provisions (cont.) • Eligible Professional (Medicare) • “Physician” = doctor of medicine or osteopathy, doctor of dental surgery or dental medicine, doctor of podiatric medicine, doctor of optometry, or a chiropractor • Legally authorized to practice their profession under state law • Eligible Professional (Medicaid) • Physician, dentist, certified nurse-midwife, nurse practitioner, physician assistant practicing in a Federally qualified health center (FQHC) led by a physician assistant, or a rural health clinic (RHC) led by a physician assistant • Consistent with the scope of practice regulations, as applicable for each professional

16. Critical Access Hospital (Medicare) • A facility that meets the following criteria may be designated by CMS as a CAH: • Is located in a State that has established with CMS a Medicare rural hospital flexibility program; and • Has been designated by the State as a CAH; and • Is currently participating in Medicare as a rural public, non-profit or for-profit hospital; or was a participating hospital that ceased operation during the 10-year period from November 29, 1989 to November 29, 1999; or is a health clinic or health center that was downsized from a hospital; and • Is located in a rural area or is treated as rural; and • Is located more than a 35-mile drive from any other hospital or CAH (in mountainous terrain or in areas with only secondary roads available, the mileage criterion is 15 miles); and • Maintains no more than 25 inpatient beds; and • Maintains an annual average length of stay of 96 hours per patient for acute inpatient care; and • Complies with all CAH Conditions of Participation, including the requirement to make available 24-hour emergency care services 7 days per week.

17. EHR Incentive Program Final Rule Provisions (cont.) • Requirements begin at lower levels in Stage 1, with further requirements phased in over five years • For 2015 and later, Medicare eligible professionals who DO NOTsuccessfully demonstrate meaningful use will have a payment reduction in their Medicare reimbursement • To be considered a meaningful EHR user, at least 50 percent of an EP’s patient encounters during the EHR reporting period during the payment year must occur at a practice/location or practices/locations equipped with certified EHR technology

18. HPSA Bonus Program • Provides a 10 percent bonus to physicians who furnish Medicare covered professional services in a geographic health professional shortage area (HPSA) • Increase the limits per payment year by 10 percent for EHR-related incentive payments to EP’s who predominantly furnish covered professional services in a geographic primary medical care, dental, or mental health HPSA • For an EP to be considered as "predominantly" furnishing covered professional services in a geographic HPSA, more than 50 percent of the EP's covered professional services must be furnished in a geographic HPSA

19. Eligibility Overview • Medicare Fee-For-Service (FFS) • Eligible Professionals (EP’s) • Eligible hospitals (EH’s) and Critical Access Hospitals (CAH’s) • 11 Prospective Payment System (PPS)-exempt cancer hospitals ARE NOT included • Medicare Advantage (MA) • MA EP’s • MA-affiliated EH’s • Medicaid • EP’s • EH’s • 11 PPS-exempt cancer hospitals ARE included

20. Additional Eligibility Criteria • EP’s who qualify for both Medicare and Medicaid EHR incentive programs must CHOOSE ONE program for receiving incentive payments • Prior to 2015, an EP may switch between programs ONE TIME after the first incentive payment is initiated • EH’s who qualify for both Medicare and Medicaid EHR incentive programs may receive incentive payments from BOTH programs • Medicaid EP’s must have minimum 30% Medicaid patient volume (except pediatricians 20%, or include “needy individuals” for FQHC or RHC) • Medicaid EH’s (acute care and CAH) must have minimum 10% Medicaid patient volume (except children’s hospitals no volume requirement)

21. Hospital-based EP’s • Hospital-based EP’s DO NOT qualify for Medicare or Medicaid EHR incentive payments. • The Continuing Extension Act of 2010 modified the definition of a hospital-based EP as performing substantially all of their services in an inpatient hospital setting or emergency room. The rule has been updated to reflect this change. • A hospital-based EP furnishes 90% or more of their services in either the inpatient or emergency department of a hospital.

22. A Bit More – NPI, PECOS & NPPES • All eligible hospitals and eligible professionals must have a National Provider Identifier (NPI) • All eligible hospitals and Medicare eligible professionals must also be enrolled in the CMS Provider Enrollment, Chain and Ownership System (PECOS) to participate in the EHR incentive program • Most (which ones?) will also need an active user account in the National Plan and Provider Enumeration System (NPPES)

23. Medicaid Only: Adopt/Implement/Upgrade (A/I/U) • First participation year only for Medicaid providers • Adopted – Acquired and Installed • Example: Evidence of installation prior to incentive • Implemented – Commenced Utilization of • Example: Staff training, data entry of patient demographic information into EHR • Upgraded – Expanded • Upgraded to certified EHR technology or added new functionality to meet the definition of certified EHR technology • Must use certified EHR technology • No EHR reporting period (first year only)

24. Medicare EHR Incentive Program for EP’s • Can participate as soon as the federal program launches • Can receive up to $44,000.00 in incentives, and up to $48,400.00 if practicing in a Health Provider Shortage Area • Required to demonstrate meaningful use of certified EHR technology every year to qualify for payment • Must participate by the second year to receive the maximum incentive payment

25. Medicaid EHR Incentive Program for EP’s • Can participate once the EP’s state offers the program (check with the state for expected launch date) • Can receive up to $63,750.00 in incentives • Can qualify for payment for adopting, implementing, upgrading or demonstrating meaningful use of certified EHR technology in first participation year. Required to demonstrate meaningful use in each subsequent year to qualify for payment • Must participate by 2016 to receive the maximum incentive payment

26. Medicare and Medicaid EHR Incentive Programs for Hospitals • Medicare eligible hospitals • "Subsection (d) hospitals" in the 50 states or DC that are paid under the hospital inpatient prospective payment system • Critical Access Hospitals (CAH’s) • Medicare Advantage (MA) Hospitals • Medicaid eligible hospitals • Acute care hospitals (including Critical Access Hospitals • At least 10% Medicaid patient volume • Children's hospitals • No Medicaid volume requirements • Amount of the incentives for each year is based on a number of factors, beginning with a $2 million base payment

27. Medicare Advantage (MA) • Qualifying MA Organization • MA organization that is organized as a health maintenance organization (HMO) as defined in section 2791(b)(3) of the PHS Act • Qualifying MA EP • Must furnish at least 80 percent of his or her professional services covered under Title XVIII (Medicare) to enrollees of the qualifying MA organization • Must furnish, on average, at least 20 hours per week of patient care services

28. Medicare Advantage (MA) • Qualifying MA-Affiliated Eligible Hospital • Must be under common corporate governance with a qualifying MA organization that serves individuals enrolled under MA plans offered by such organization where more than two-thirds of the Medicare hospitals discharges (or bed-days) are Medicare individuals enrolled under MA plans offered by such organization

29. Stage 1 (2011-2012) Health Outcome Priorities • Improve quality, safety, efficiency and reduce health disparities • Engage patients and families in their health care • Improve care coordination • Improve population and public health • Ensure adequate privacy and security protections for personal health information

30. Stage 1 Strategy • Focus on electronically capturing health information in a coded format • Use that information to track key clinical conditions • Communicate that information for care coordination purposes • Initiate the reporting of clinical quality measures and public health information

31. Stage 1 Final Rule Overview • To meet certain objectives/measures, 80% of patients must have records in the certified EHR technology • EP’s have to report on 20 of 25 Meaningful Use objectives • Eligible hospitals have to report on 19 of 24 Meaningful Use objectives • Reporting Period • 90 days for first year • 1 year for subsequent years

32. Stage 1 Objectives “Two-Track” Approach • Change from Proposed Rule • Ensures that basic elements of meaningful EHR use are met by all providers qualifying for incentive payments • Allows latitude in other areas to reflect providers’ varying needs and their individual paths to full EHR use • Objectives now divided into • Core Set (15 for EP’s, 14 for EH’s) • Menu Set (10) • Pick 5 of 10 • Include one population/public health measure

33. Stage 1 Reporting Mechanism • For 2011, CMS will accept provider attestations for demonstration of ALL meaningful use measures, including clinical quality measures • Starting in 2012, CMS will continue attestation for most of the meaningful use objectives but plans to initiate the electronic submission of the clinical quality measures

34. Meaningful Use for Hospitals that Qualify for Both Medicare & Medicaid Payments • Applicable for subsection (d) hospitals that are also Medicaid acute care hospitals (including CAH’s) • Attest/Report on Meaningful Use to CMS for the Medicare EHR Incentive Program • Will be deemed meaningful users for Medicaid (even if the State has CMS approval for the Meaningful Use flexibility around public health objectives)

35. Clinical Quality Measures (CQM) Overview • 2011 – EP’s, eligible hospitals, and CAH’s seeking to demonstrate Meaningful Use are required to submit aggregate CQM numerator, denominator, and exclusion data to CMS or the States by attestation • 2012 – EP’s, eligible hospitals, and CAH’s seeking to demonstrate Meaningful Use are required to electronically submit aggregate CQM numerator, denominator, and exclusion data to CMS or the States

36. CQM: Eligible Professionals • Core, Alternate Core, and Additional CQM sets for EP’s • EP’s must report on 3 required Core CQM, and if the denominator of 1 or more of the required core measures is 0, then EPs are required to report results for up to 3 Alternate Core measures • EP’s also must select 3 additional CQM from a set of 38 CQM (other than the Core/Alternate Core measures) • In sum, EP’s must report on 6 total measures: 3 required core measures (substituting alternate core measures where necessary) and 3 additional measures

37. CQM: Eligible Hospitals and CAH’s • Must report on all15 CQM

38. Stages 2 (~2013) and 3 (~2015) • Intend to propose 2 additional Stages through future rulemaking • Future Stages will expand upon Stage 1 criteria • Stage 1 menu set will be transitioned into core set for Stage 2 • Will reevaluate measures – possibly higher thresholds • Will include greater emphasis on health information exchange across institutional boundaries

39. “HIT: Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR” Final Rule (ONC) • Interim Final Rule published December 30, 2009 • Final Rule issued July 13, 2010, published in Federal Register July 28, 2010 • Effective August 27, 2010 • “Companion” to the Meaningful Use Rule

40. ONC Goals for Standards and Certification Criteria • Focus criteria on achievement of meaningful use • Promote interoperability • Support the evolution and timely maintenance of adopted standards • Promote technical innovation using adopted standards • Encourage participation and adoption by all vendors, including small businesses • Keep implementation costs to a minimum

41. Standards, Specifications, and Certification Criteria Final Rule Key Points • Establishes the required capabilities and related standards and implementation specifications that Certified EHR Technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible health careprofessionals and hospitals under the Medicare and Medicaid EHR Incentive Program regulations • Developers of EHR technology who design their EHR technology in accordance with this final rule and subsequently get their EHR technology tested and certified by an ONC-ATCB are assured that their EHR technology can be adopted by eligible health care professionals and hospitals who seek to achieve meaningful use Stage 1

42. “Complete EHR” vs. “EHR Module” • Complete EHR • Meets all applicable certification criteria adopted by the Secretary (HHS) • Criteria represent the minimum capabilities EHR technology needs to include and have properly implemented in order to achieve certification • Complete EHR developers may include additional capabilities not required for the purposes of certification • EHR Module • Any service, component, or combination thereof that meets at least one certification criterion adopted by the Secretary

43. Certified EHR Technology • A Complete EHR that meets the requirements included in the definition of a Qualified EHR and has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary • A combination of EHR Modules in which each constituent EHR Module of the combination has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary, and the resultant combination also meets the requirements included in the definition of a Qualified EHR

44. Can I use multiple software applications to achieve Meaningful Use? • Meaningful Use can be achieved using any combination of systems. However, every application and module used to achieve meaningful use must be certified (or the combination of systems in use at the site must achieve site certification). • Commercial vendors will certify their products, but in my opinion, many hospitals will end up doing site certification because they have numerous built and bought applications that will be used to achieve Meaningful Use. • (Answer courtesy of John D. Halamka, MD - http://geekdoctor.blogspot.com)

45. Certification CQM Requirements • A Complete EHR or EHR Module designed for an ambulatory setting must be tested and certified as including at least nine clinical quality measures specified by CMS • All 6 core and alternate core • At least 3 additional measures • A Complete EHR or EHR Module designed for an inpatient setting must include and will be required to be tested and certified to all 15 of the clinical quality measures specified by CMS

46. “Establishment of the Temporary Certification Program for HIT” Final Rule (ONC) • Proposed Rule published March 10, 2010 • Both temporary and permanent certification programs • Final Rule for temporary program published June 24, 2010 • Effective June 24, 2010 • ONC anticipates that the permanent certification program will begin in 2012

47. Temporary Certification Program Key Points • Provides process by which organization(s) may become an ONC-Authorized Testing and Certification Body (ONC-ATCB) • ONC-ATCB’s authorized to perform the testing and certification of Complete EHRs and/or EHR Modules. • CCHIT (the prior certification authority) must apply to become an ONC-ATCB • EHR systems that have previously been CCHIT certified WILL NOT automatically be granted Certified EHR Technology status under the temporary certification program and must be re-certified by an ONC-ATCB

48. What Are Some Implications and Applications for the caEHR Project and NCCCP Sites?

49. Can caEHR Assist an NCCCP Site in Achieving Meaningful Use? • caEHR is an AMBULATORY project, so related incentive payments will be directly toEligible Professionals, not to the institution itself • But incentive payments MAY be eligible for reassignment to the institution depending on contractual arrangements • Depends to a significant degree on what EHR capability a site already has • Most likely EHR systems from major vendors will be or will become certified for most or all Meaningful Use objectives

50. Oncology-specific “Additional” CQM’s for EP’s • Therapy • Oncology Breast Cancer: Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer • Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period • NQF 0387, PQRI 71