Navigating Meaningful Use : Are You Ready?

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1 Navigating Meaningful Use : Are You Ready? Brian Flood 2015 Husch Blackwell LLP Agenda For This Segment ARRA, HITECH, and Meaningful Use What is Meaningful Use? Progress to Date How providers meet Meaningful Use Meaningful Use Audits Red Flags What if I fail an Audit? Client Experiences: Things to Think About ARRA, HITECH, and Meaningful Use The Health Information Technology for Economic and Clinical Health (HITECH) Act was enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA). The HITECH Act includes more than $19 billion to help develop a robust IT infrastructure and data exchange capabilities for healthcare, as well as to assist providers in adopting and using Health Information Technology, including the implementation of Electronic Health Records (EHRs). The goal of this program is to increase EHR adoption, and support the meaningful use of EHR technology in order to improve safety, quality and reduce the cost of care. 1

2 Government Warns Physicians They Will Be Penalized For Not Using Electronic Medical Records. In a 1,500-word article, USA Today (2/2, Ungar, O'Donnell) reports that physicians are being warned by the federal government that they ll soon be penalized for not using electronic medical records, prompting a backlash from those who say the technology is fraught with problems. Recently, a group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services...saying the certification program is headed in the wrong direction, and that today s electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. The CMS responded to the criticism late last week, saying it would ease reporting burdens on doctors in a proposed rule to come this spring, but penalties would not be eliminated and Meaningful Use How does a hospital demonstrate meaningful use in order to avoid a payment adjustment? An eligible hospital demonstrates meaningful use by successfully attesting through either the CMS Medicare EHR Incentive Programs Attestation System ( or through its state s Medicaid EHR Incentive Program attestation system and Meaningful Use What is the FY 2016 EHR Eligible Hospital payment adjustment? Eligible hospitals that are not meaningful EHR users will be subject to a payment adjustment beginning on October 1, This payment adjustment is applied as a reduction to the applicable percentage increase to the Inpatient Prospective Payment System (IPPS) payment rate, thus reducing the update to the IPPS standardized amount for these hospitals. 2

3 2016 and Meaningful Use Eligible hospitals receive the payment adjustment amount that is tied to a specific fiscal year (e.g., an eligible hospital that did not successfully demonstrate meaningful use for an applicable EHR reporting period in 2014 will receive a reduction to the IPPS applicable percentage increase in FY 2016). Hospital Adjustment % Decrease 25% 50% 75% 2016 and Meaningful Use Does a hospital have to achieve meaningful use each year to avoid the payment adjustments or can it avoid the payment adjustments by achieving meaningful use only once? Hospitals must demonstrate meaningful use every year according to the timelines detailed above in order to avoid Medicare payment adjustments. For example, an eligible hospital that demonstrates meaningful use for the first time in 2013 will avoid the payment adjustment in FY 2015, but will need to demonstrate meaningful use again in 2014 in order to avoid the payment adjustment in FY The meaningful use rules are out. Here are the key details. October 07, 2015 CMS and the Office of the National Coordinator for Health IT (ONC) on Tuesday released new rules for all three stages of the meaningful use program, in addition to releasing the 2015 edition of electronic health record (EHR) certification criteria. 3

4 2-Changes to Stage 1 and Stage 2 of meaningful use A-Under the first and second stage of the meaningful use program: Eligible professionals will have only 10 reporting objectives, down from 18 in the previous two stages; and Eligible hospitals and critical access hospitals (CAHs) will have only nine reporting objectives, down from 20. The revised objectives will include reporting to public health agencies. In addition, the rules maintain the clinical quality measures for eligible professionals and hospitals. B-In regard to the reporting period, the rules say that: Providers in 2015 will be able to attest for any continuous 90-day period within calendar year 2015; and For 2016 and 2017, providers that are new to the meaningful use program will be able to attest for any 90-day period. 3-Details of Stage 3 A- CMS said that the start of Stage 3 would not be delayed, but that there would be an additional 60-day public comment period to solicit additional feedback about the meaningful use program going forward. In particular, the agency is seeking comments as it prepares to fold the program in 2019 into the Merit-Based Incentive Payment System (MIPS) called for under the law passed earlier this year that replaced the Medicare's sustainable growth rate. CMS expects to release proposed rules for MIPS by mid B- CMS CMO Patrick Conway said that the additional comment period will allow the agency "to get to a similar place" as it would have if it had delayed the rule. Conway added that the deadline for reporting in 2015 could be extended, and that providers can apply for hardship exemptions if needed. C- In the new rule, CMS said that Stage 3 will: Be optional in 2017, and providers who elect to begin Stage 3 that year will be able to attest for a 90-day reporting period; Be mandatory in 2018; Have eight reporting objections for eligible professionals, eligible hospitals, and CAHs, more than 60% of which require interoperability, compared with 33% under Stage 2. 5-Technology Challenges-Interoperability In addition, under the 2015 edition of EHR certification criteria, vendors will be required to incorporate application programming interfaces (APIs) into their EHR systems. CMS said that APIs will "enable the development of new functionalities to build bridges across systems and provide increased data access," which "will help patients have unprecedented access to their own health records, empowering individuals to make key health decisions." 4

5 6-Comments, reaction CMS said that the regulations would "shift the paradigm so health IT becomes a tool for care improvement, not an end in itself." The College of Health Information Management Executives, which represents about 1,700 hospital CIOs, praised the regulations, and said the new requirements for vendors will "lead to greater transparency regarding vendor products, improved testing and surveillance of health IT, and an improved focus on user-centered design." Meanwhile, the American Hospital Association (AHA) said the rules are "a mixed bag for hospitals and health systems and the patients they serve." AHA praised the 90-day reporting period for 2015, but said the release at the same time of the Stage 3 rules was "too much too soon" and "deeply disappointing." AHA added, "Despite the urging of hospitals, physicians, and Congress, the Stage 3 final rule includes many new and more challenging requirements," noting that "more than 60% of hospitals and about 90% of physicians have yet to attest to Stage 2." Get peace of mind before you attest CMS has said that it plans to audit one in every 20 meaningful use attesters. Are you confident in your meaningful use plans? - See more at: Meaningful Use : The term Meaningful Use" means that providers need to show they're using certified EHR technology in ways that can be measured significantly in quality and in quantity. Stage 1 (2011) sets the baseline for electronic data capture and information sharing using EHRs. Stage 2 (2014) focuses on data sharing, patient engagement, and Health Information Exchange. Eligible Hospitals can begin reporting period in October 2013 Eligible Professionals can begin reporting period in January 2014 Stage 3 Someday-maybe/maybe not 5

6 Meaningful Use : What do EP s and EH s have to do? It s not enough just to own a certified EHR. Providers have to show CMS that they are using their EHRs in ways that can positively affect the care of their patients. To do this, providers must meet objectives established by CMS. Then they will be able to demonstrate, or attest that they met the applicable measures. EPs and EHs must meet all Core Set Objectives to successfully attest to Meaningful Use. Some core objectives have exclusions that can be taken, which indicates that the EP or EH does not have to actually meet that objective, based on a particular circumstance or exception. EPs and EHs must also meet a specified number of Menu Set Objectives (varies by EP/EH and MU stage). Meaningful Use : Common questions on what do EP s and EH s have to do? Meet the Objectives. Most objectives are based on how the EHR is used for patient care: E.g., More than 30% of unique patients with at least one medication in their medication list seen by the EP or admitted to the eligible hospital s or CAH s inpatient or emergency department have at least one medication order entered using CPOE. However there are other measures related to data sharing: E.g., Public Health objectives where EPs/EHs have to prove they have the ability to send data to various Public Health agencies (e.g., immunization data to state immunization registries) One measure is related to security of patient information: Conduct or review a security risk analysis in accordance with the requirements under 45 CFR (a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process. Measures are generally Yes/No or Percentage-based In For A Penny In For A Pound Any provider attesting to receive an EHR incentive payment for either the Medicare or Medicaid EHR Incentive Program potentially can be subject to an audit. Here's what you need to know to make sure you're prepared: = 6

7 Meaningful Use Audits Audits In early 2012, the U.S. Government Accountability Office (GAO) looked at steps taken by the federal government and the states to verify participants meet criteria for receiving payments and are putting computerized information to meaningful use. The EHR programs may be at greater risk of improper payments than other, more established CMS programs because they are new programs with complex requirements that providers must meet to qualify for incentive payments. Robert Anthony deputy director of CMS's Health IT Initiatives Group said that CMS aims to audit about 5% of all meaningful use program participants CMS will look to conduct the same amount of pre-payment audits and post-payment audits A majority of these will be via "desk audits," but that on-site audits could occur Other sources have this number as high as 10% for EHs and 20% for EPs! Meaningful Use Audits March, 2013: CMS Issues FAQ #7711 Re-asserts that any single shortfall results in recoupment To ensure you are prepared for a potential audit, save the electronic or paper documentation that supports your attestation. An audit may include a review of any of the documentation needed support the information that was entered in the attestation. The level of the audit review may depend on a number of factors, and it is not possible to include an all-inclusive list of supporting documents. Meaningful Use Audits The same CMS guidance also stated: The accounting firm Figliozzi & Company will be the designated contractor performing audits on behalf of CMS, and will perform audits on Medicare EPs and eligible hospitals, as well as on hospitals that are dually-eligible for both the Medicare and Medicaid EHR Incentive Programs. The individual states and their contractors will perform audits on Medicaid providers. 7

8 Document Retention For Audit What information should an eligible professional, eligible hospital, or critical access hospital participating in the Medicare or Medicaid Electronic Health Record (EHR) Incentive Programs maintain in case of an audit? When Selected for Audit For Medicare eligible professionals and for hospitals that are eligible for both Medicare and Medicaid EHR incentive payments - When a provider is selected for an audit, they will receive an initial request letter from the audit contractor. The request letter will be sent electronically by the audit contractor from a CMS address and will include the audit contractor s contact information. The address provided during registration for the EHR Incentive Program will be used for the initial request letter. The initial review process will be conducted at the audit contractor s location, using the information received as a result of the initial request letter. Additional information might be needed during or after this initial review process, and in some cases an on-site review at the provider s location could follow. A demonstration of the EHR system could be requested during the on-site review. A secure communication process has been established by the contractor, which will assist the provider to send any information that could be considered sensitive. Any questions pertaining to the information request should be directed to the audit contractor. States will have separate audit processes for their Medicaid EHR Incentive Program. For more information about these audit processes, please contact your State Medicaid Agency. Overview of the CMS EHR Incentive Programs Audits All providers attesting to receive an EHR incentive payment for either the Medicare or Medicaid EHR Incentive Programs should retain ALL relevant supporting documentation (in either paper or electronic format) used in the completion of the Attestation Module responses. Documentation to support the attestation should be retained for six years postattestation. Documentation to support payment calculations (such as cost report data) should continue to follow the current documentation retention processes. CMS, and its contractors, will perform audits on Medicare and dually-eligible (Medicare and Medicaid) providers. States, and their contractors, will perform audits on Medicaid providers. CMS and states will also manage appeals processes. 8

9 Overview of the CMS EHR Incentive Programs Audits Preparing for an audit: To ensure you are prepared for a potential audit, save the electronic or paper documentation that supports your attestation. Also save the documentation that supports the values you entered in the Attestation Module for Clinical Quality Measures (CQMs). Hospitals should also maintain documentation that supports their payment calculations. Upon audit, the documentation will be used to validate that the provider accurately attested and submitted CQMs, as well as to verify that the incentive payment was accurate. Documentation An audit may include a review of any of the documentation needed to support the information that was entered in the attestation. The level of the audit review may depend on a number of factors, and it is not possible to include an all-inclusive list of supporting documents. The primary documentation that will be requested in all reviews is the source document(s) that the provider used when completing the attestation. This document should provide a summary of the data that supports the information entered during attestation. Ideally, this would be a report from the certified EHR system, but other documentation may be used if a report is not available or the information entered differs from the report. Summary Documentation This summary document will be the starting point of most reviews and should include, at minimum: The numerators and denominators for the measures The time period the report covers Evidence to support that it was generated for that eligible professional, eligible hospital, or critical access hospital. Although the summary document is the primary review step, there could be additional and more detailed reviews of any of the measures, including review of medical records and patient records. The provider should be able to provide documentation to support each measure to which he or she attested, including any exclusions claimed by the provider. 9

10 A Few Examples of Additional Support are as Follows: Drug-Drug/Drug-Allergy Interaction Checks and Clinical Decision Support Proof that the functionality is available, enabled, and active in the system for the duration of the EHR reporting period. Electronic Exchange of Clinical Information Screenshots from the EHR system or other documentation that document a test exchange of key clinical information (successful or unsuccessful) with another provider of care. Alternately, a letter or from the receiving provider confirming the exchange, including specific information such as the date of the exchange, name of providers, and whether the test was successful. Protect Electronic Health Information Proof that a security risk analysis of the certified EHR technology was performed prior to the end of the reporting period (e.g., report which documents the procedures performed during the analysis and the results). Drug Formulary Checks Proof that the functionality is available, enabled, and active in the system for the duration of the EHR reporting period. Immunization Registries Data Submission, Reportable Lab Results to Public Health Agencies, and Syndromic Surveillance Data Submission Screenshots from the EHR system or other documentation that document a test submission to the registry or public health agency (successful or unsuccessful). Alternately, a letter or from registry or public health agency confirming the receipt (or failure of receipt) of the submitted data, including the date of the submission, name of parties involved, and whether the test was successful. Exclusions Documentation to support each exclusion to a measure claimed by the provider. Red Flags Elements of provider attestation Inconsistency between numerator / denominators that should be related Exclusions that may be inconsistent with other measures CMS Data supplemental to attestations Measures or exclusions inconsistent with patient mix (both hospital and EP specialty) Peer group comparisons State and local public health capabilities EHR Vendor characteristics Providers who indicated use of multiple EHR products to meet requirements EHR s with capability of collecting data for only a few CQM s (ambulatory only) Representative sample of Certified EHR vendors What Happens if I Fail an Audit? Appeal? What caused the fail? E.g., audit logs EHR certification process did not require this for specific functionality Core Objective 2: Drug-drug and drug-allergy interaction checks Core Objective 11: Clinical decision support rule Menu Objective 1: Drug formulary checks or Learn from mistakes, return the incentive money or prepare for future losses! 10

11 Review, Withdrawal and Appeal To date the review standard is Pass/Fail Documentation for attestation and core measures are reviewed. All measures must be accomplished and documented to pass. A properly performed and documented risk assessment must be presented to the auditor. You cannot pay them back during an audit. You can appeal the audit but you must have sufficient documentation to support your appeal. Client Experiences: Best Practices Designate a person to be in charge in the event of an audit, and to own the Book of Evidence Keep internal teams informed, and aware of procedures Establish contact with auditor Monitor the deadlines established by the auditor Seek the EHR vendor for support Seek counsel if needed! Client Experiences: Lessons Learned Recommended Book of Evidence includes, but is not limited to: EHR vendor purchase agreements EHR implementation documents (project plans, configuration documents, etc.) Attestation reports generated from the EHR which reconciles exactly to the attestations made for each Core and Quality measure Documentation for Public Health measures with confirmation s from contacts at the Public Health Agencies (where applicable) A statement about change control and source code control systems which documents that functionality such as Drug/Allergy Interaction Checking, Drug Formularies and Clinical Decision Support Rules were enabled for the entire reporting period Documentation that explains the interpretations made by management for measures where exclusions were taken Complete Security Risk Analysis documentation including identified threats and mitigation plans (as per OCR guidance) Screenshots, screenshots, screenshots 11

12 Medicare Eps: Reminder: Important Payment Adjustment Information for Eligible professionals (EPs) participating in the Medicare EHR Incentive Program may be subject to payment adjustments beginning on January 1, CMS will determine the payment adjustment based on meaningful use data submitted prior to the 2015 calendar year. EPs must demonstrate meaningful use prior to 2015 to avoid payment adjustments. Determine how your EHR Incentive Program participation start year will affect the 2015 payment adjustments: If you began in 2011 or 2012 If you first demonstrated meaningful use in 2011 or 2012, you must demonstrate meaningful use for a full year in 2013 to avoid the payment adjustment in If you began in 2013 If you first demonstrate meaningful use in 2013, you must demonstrate meaningful use for a 90-day reporting period in 2013 to avoid the payment adjustment in If you plan to begin in 2014 If you first demonstrate meaningful use in 2014, you must demonstrate meaningful use for a 90-day reporting period in 2014 to avoid the payment adjustment in This reporting period must occur in the first 9 months of calendar year 2014, and EPs must attest to meaningful use no later than October 1, 2014, to avoid the payment adjustment. Avoiding Payment Adjustments in the Future You must continue to demonstrate meaningful use every year to avoid payment adjustments in subsequent years. If you are eligible to participate in both the Medicare and Medicaid EHR Incentive Programs, you MUST demonstrate meaningful use to avoid the payment adjustments. You may demonstrate meaningful use under either Medicare or Medicaid. If you are only eligible to participate in the Medicaid EHR Incentive Program, you are not subject to these payment adjustments. Things to Think About Law360, New York (January 26, 2015, 6:11 PM ET) -- The U.S. Department of Health and Human Services on Monday announced a timeline for moving doctors and hospitals into new payment systems and tying Medicare reimbursement to quality of care, the first time regulators have laid out specific goals for such reforms HHS described its announcement as a historic development in the country s ongoing efforts to base payments on the efficiency with which health care providers operate and the extent to which they are successful in healing patients Under one element of Monday s announcement, HHS said it will try to link 85 percent of payments in Medicare Parts A and B to quality or value by 2016 and to link 90 percent of payments by 2018, compared with about 80 percent of payments that currently have some sort of link New Medicare Demands Spell Doom For Old Payment System Law360, New York (January 27, 2015, 6:08 PM ET) -- Medicare s newly announced plans to condition more payments on quality and value is another nail in the coffin of traditional reimbursement, What is virtually certain is that Medicare's move will spur similar changes in how private insurance plans structure their payments. According to the nonprofit Catalyst for Payment Reform, 40 percent of private insurance reimbursements last year were linked to quality, compared with about 10 percent the year prior, an increase that dovetails with Medicare's rising quality requirements. And CMS explicitly says it wants private plans to copy its approach. The agency on Monday announced it's creating a task force of sorts formally called the Health Care Payment Learning and Action Network to bring together government officials, private insurers, large employers, providers and other stakeholders to get in sync on quality-based payments. 12

13 BEGINNING IN 2015, MEDICARE ELIGIBLE PROFESSIONALS WHO DO NOT SUCCESSFULLY DEMONSTRATE MEANINGFUL USE WILL BE SUBJECT TO A PAYMENT ADJUSTMENT. THE PAYMENT REDUCTION STARTS AT 1% AND INCREASES EACH YEAR THAT A MEDICARE ELIGIBLE PROFESSIONAL DOES NOT DEMONSTRATE MEANINGFUL USE, TO A MAXIMUM OF 5%. QRURs (Quality and Resource Use Reports) and the Value Modifier Medicare s version of physician profiling and P4P First QRURs went to large physician groups in Physicians in practices of 1-10 about to get first QRURs VM applies to entire Medicare revenue- 9% swing? 100 or more physicians- subject to the VM in 2015, based on CY 2013 performance 10 or more physicians- subject to the VM in 2016, based on CY 2014 performance. VM does not apply to groups where any physician member in an ACO or CPPI in CY 2013 and 2014 All physicians in Fee-For-Service Medicare will be affected by the VM starting in 2017, based on CY 2015 performance 38 Value Modifier: Quality composite and cost composite 39 13

14 CY 2017 Value-Based Payment Modifier Amounts Groups and solo practitioners eligible for an additional +1.0Å~ if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25% of all beneficiary risk scores 40 What Information Is Included on the Performance Highlights Page? 1. Your Quality Composite Score 2. Your Cost Composite Score 3. Your Beneficiaries Average Risk Score 4. Your Quality Tiering Performance Graph 5. Your Payment Adjustment Based on Quality Tiering 2014 Incentives Payment Adjustments 14

15 Access to accurate, comprehensive data is increasingly key Only way to manage new payment models economic results depend on the variation between projected and actual experience, rather than on maximizing volume Only way to respond effectively to profiling to ensure publicly reported practice profiles are accurate, to use the data to improve practice quality and efficiency Only way to eliminate the currently inexplicable variation in treatment patterns 43 Former CFO indicted over fraudulent meaningful use claims- February 11, 2014 White faces up to seven years in prison.- CFO of now-closed Shelby Regional Medical Center in Texas, has been indicted for allegedly defrauding the federal government of nearly $800,000. Shelby was among thousands of providers that received payments through the government's meaningful use program, Under the program, health care providers who demonstrate meaningful use of certified electronic health record (EHR) systems can qualify for Medicaid and Medicare incentive payments. The indictment states that Shelby was granted $785,655 in January 2013 for successful demonstration of meaningful use during the 2012 full-year reporting period. In addition, the hospital had received $1.17 million in meaningful use payments from CMS in November He pled guilty November 12, 2014 The indictment alleges that he: Submitted the attestation while knowing the hospital did not meet the program's requirements and "only minimally used the EHR platform and continued to use paper records and charts as well as older, uncertified technology"; Directed the hospital's EHR vendor to input data into the system manually from paper records and other sources, even after the FY 2012 reporting period; and "[K]nowingly and willingly made materially false, fictitious and fraudulent statements and representations, and made and used false writings and documents" to defraud the EHR incentive program. Interesting FAQs 15

16 CMS has created a new webpage on the EHR Incentive Programs website that contains all the program requirements and resources for previous years of the EHR Incentive Programs. The webpage includes information on: 2014 Definition of Stage Definition of Stage Certified EHR Technology flexibility reporting 2014 Clinical Quality Measures (CQMs) reporting 2013 Definition of Stage CQM reporting 2011 and 2012 Definition of Stage 1 Please note: The corresponding pages for the programs above have been removed from the site; all respective resources can be found on the new webpage. The webpage also has FAQs and additional guidance for previous years of the EHR Incentive Programs. Coming Soon CMS will make further updates to the EHR Incentive Programs website to include new information and resources on the latest requirements for the EHR Incentive Programs, including information on program participation in What does it mean to possess EHR technology as mentioned in FAQ ? Answer: We consider possession of EHR technology certified to an edition of EHR certification criteria to be either the physical possession of the medium on which a certified Complete EHR, or certified EHR Module resides, or a legally enforceable right by an eligible health care provider to access and use, at its discretion, the capabilities of a certified Complete EHR or certified EHR Module. An eligible health care provider may determine the extent to which it will implement or use these capabilities, which will not affect the provider s possession of the certified Complete EHR or certified EHR Module. An EP, EH, or CAH must possess all of a certified Complete EHR or certified EHR Module (i.e., the capabilities for which certification is required) in order to receive the benefit of such certification. An EP, EH, or CAH cannot purchase or possess only components of a certified Complete EHR or certified EHR Module for the purposes of meeting the CEHRT definition. That is, unless independently certified, those components could not be used to meet the CEHRT definition. We further explain this policy in FAQ 5 and in the 2014 Edition EHR certification criteria final rule (77 FR 54266). In the final rule, we also note that the possession policy does not apply to those capabilities that an EHR technology developer may include with those that constitute a certified Complete EHR or certified EHR Module but for which certification is not required. In those instances, because these other included capabilities are not required for certification, an EP, EH, or CAH, would not necessarily need to possess them if the EHR technology developer would separately sell them. [EHR Incentive Programs] If an eligible professional (EP) sees a patient in a setting that does not have certified electronic health record (EHR) technology but enters all of the patient's information into certified EHR technology at another practice location, can the patient be counted in the numerators and denominators of meaningful use measures for the Medicare and Medicaid EHR Incentive Programs? Starting in 2013, an EP must have access to Certified EHR Technology at a location in order to include patients seen in locations in the determination of whether they meet the threshold of 50% of patient encounters at locations equipped with Certified EHR Technology to be eligible for the EHR Incentive Program. However, if the EP meets this threshold and also includes information on patient encounters at locations where they do not have access to Certified EHR Technology, information about those encounters can be included when calculating the numerators and denominators for the meaningful use measures. For information about the patient encounters threshold, please visit FAQ For more information about the Medicare and Medicaid EHR Incentive Program, please visit 16

17 [EHR Incentive Programs] When eligible professionals work at more than one clinical site of practice, are they required to use data from all sites of practice to support their demonstration of meaningful use and the minimum patient volume thresholds for the Medicaid EHR Incentive Program? CMS considers these two separate, but related issues. Meaningful use: Any eligible professional demonstrating meaningful use must have at least 50% of their patient encounters during the EHR reporting period at a practice/location or practices/locations equipped with certified EHR technology capable of meeting all of the meaningful use objectives. Therefore, States should collect information on meaningful users' practice locations in order to validate this requirement in an audit. Patient volume: Eligible professionals may choose one (or more) clinical sites of practice in order to calculate their patient volume. This calculation does not need to be across all of an eligible professional's sites of practice. However, at least one of the locations where the eligible professional is adopting or meaningfully using certified EHR technology should be included in the patient volume. In other words, if an eligible professional practices in two locations, one with certified EHR technology and one without, the eligible professional should include the patient volume at least at the site that includes the certified EHR technology. When making an individual patient volume calculation (i.e., not using the group/clinic proxy option), a professional may calculate across all practice sites, or just at the one site. For more information on applying the group/clinic proxy option, see FAQ #10362 or click here. For more information about the Medicare and Medicaid EHR Incentive Program, please visit EHR Incentive Programs] Do specialty providers have to meet all of the meaningful use objectives for the Medicare and Medicaid EHR Incentive Programs, or can they ignore the objectives that are not relevant to their scope of practice? For eligible professionals (EPs) who participate in the Medicare and Medicaid EHR Incentive Programs, there are a total of 25 meaningful use objectives. To qualify for an incentive payment, 20 of these 25 objectives must be met. There are 15 required core objectives. The remaining 5 objectives may be chosen from the list of 10 menu set objectives. Certain objectives do provide exclusions. If an EP meets the criteria for that exclusion, then the EP can claim that exclusion during attestation. However, if an exclusion is not provided, or if the EP does not meet the criteria for an existing exclusion, then the EP must meet the measure of the objective in order to successfully demonstrate meaningful use and receive an EHR incentive payment. Failure to meet the measure of an objective or to qualify for an exclusion for the objective will prevent an EP from successfully demonstrating meaningful use and receiving an incentive payment. For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] Is the physician the only person who can enter information in the electronic health record (EHR) in order to qualify for the Medicare and Medicaid EHR Incentive Programs? No. The Final Rule for the Medicare and Medicaid EHR incentive programs, specifies that in order to meet the meaningful use objective for computerized provider order entry (CPOE) for medication orders, any licensed healthcare professional can enter orders into the medical record per state, local, and professional guidelines. The remaining meaningful use objectives do not specify any requirement for who must enter information. For more information about the Medicare and Medicaid EHR Incentive Program, please visit 17

18 [EHR Incentive Programs] If data is captured using certified electronic health record (EHR) technology, can an eligible professional or eligible hospital use a different system to generate reports used to demonstrate meaningful use for the Medicare and Medicaid EHR Incentive Programs? By definition, certified EHR technology must include the capability to electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage for all percentagebased meaningful use measures (specified in the certification criterion adopted at 45 CFR (n)). However, the meaningful use measures do not specify that this capability must be used to calculate the numerators and denominators. Eligible professionals and eligible hospitals may use a separate, non-certified system to calculate numerators and denominators and to generate reports on the measures of the core and menu set meaningful use objectives. Eligible professionals and eligible hospitals will then enter this information in CMS' web-based Medicare and Medicaid EHR Incentive Program Registration and Attestation System. Eligible professionals and eligible hospitals will fill in numerators and denominators for meaningful use objectives, indicate if they qualify for exclusions to specific objectives, report on clinical quality measures, and legally attest that they have successfully demonstrated meaningful use. Please note that eligible professionals and eligible hospitals cannot use a non-certified system to calculate the numerators, denominators, and exclusion information for clinical quality measures. Numerator, denominator, and exclusion information for clinical quality measures must be reported directly from certified EHR technology. For additional clarification about this, please refer to the following FAQ from the Office of the National Coordinator of Health Information Technology: For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] What information must an eligible professional provide in order to meet the measure of the meaningful use objective for provide a clinical summary for patients for each office visit under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs? [In our final rule, we defined "clinical summary" as: an after-visit summary that provides a patient with relevant and actionable information and instructions containing, but not limited to, the patient name, provider s office contact information, date and location of visit, an updated medication list, updated vitals, reason(s) for visit, procedures and other instructions based on clinical discussions that took place during the office visit, any updates to a problem list, immunizations or medications administered during visit, summary of topics covered/considered during visit, time and location of next appointment/testing if scheduled, or a recommended appointment time if not scheduled, list of other appointments and tests that the patient needs to schedule with contact information, recommended patient decision aids, laboratory and other diagnostic test orders, test/laboratory results (if received before 24 hours after visit), and symptoms. The EP must include all of the above that can be populated into the clinical summary by certified EHR technology. If the EP s certified EHR technology cannot populate all of the above fields, then at a minimum the EP must provide in a clinical summary the data elements for which all EHR technology is certified for the purposes of this program (according to (h)): Problem List Diagnostic Test Results Medication List Medication Allergy List This answer applies to clinical summaries generated by certified EHR technology for electronic or paper dissemination. Also, if one form of dissemination (paper or electronic) has a more limited set of fields than the other, this does not serve as a limit on the other form. For example, certified EHR technology may be capable of populating a clinical summary with a greater number of data elements when the clinical summary is provided to the patient electronically than when the clinical summary is printed on paper. When the clinical summary in this example is provided electronically, it should include all of the above elements that can be populated by the certified EHR technology. The clinical summary would not be limited by the data elements that are capable of being displayed on a paper printout. [EHR Incentive Programs] Can an eligible professional (EP) use EHR technology certified for an inpatient setting to meet a meaningful use objective and measure? Yes. For objectives and measures where the capabilities and standards of EHR technology designed and certified for an inpatient setting are equivalent to or require more information than EHR technology designed and certified for an ambulatory setting, an EP can use the EHR technology designed and certified for an inpatient setting to meet an objective and measure. There are some EP objectives, however, that have no corollary on the inpatient side. As a result, an EP must possess Certified EHR Technology designed for an ambulatory setting for such objectives. Please reference ONC FAQ and and CMS FAQ for discussions on what it means to possess Certified EHR Technology, ONC FAQ for a list of affected capabilities and standards, and how that relates to the exclusion and deferral options of meaningful use. To view the ONC FAQs, please visit: 18

19 [EHR Incentive Programs] To meet the meaningful use objective "use computerized provider order entry (CPOE)" for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, should eligible professionals (EPs) include hospital-based observation patients (billed under POS 22) whose records are maintained using the hospital's certified EHR system in the numerator and denominator calculation for this measure? If the patient has records that are maintained in both the hospital's certified EHR system and the EP's certified EHR system, the EP should include those patients seen in locations billed under POS 22 in the numerator and denominator calculation for this measure. If the patient's records are maintained only in a hospital certified EHR system, the EP does not need to include those patients in the numerator and denominator calculation to meet the measure of the "use computerized provider order entry (CPOE)" objective. For more information about the Medicare and Medicaid EHR Incentive Program, please visithttp:// [EHR Incentive Programs] Does a provider have to record all clinical data in their certified EHR technology in order to accurately report complete clinical quality measure data for the Medicare and Medicaid EHR Incentive Programs? We recognize that providers are continuing to implement new workflow processes to accurately capture clinical data in their certified EHR technology, but many providers are not able to capture all data at this time. Although we encourage providers to capture complete clinical data in order to provide the best care possible for their patients, for the purpose of reporting clinical quality measure data, CMS does not require providers to record all clinical data in their certified EHR technology at this time. CMS recognizes that this may yield numerator, denominator, and exclusion values for clinical quality measures in the certified EHR technology that are not identical to the values generated from other methods (such as record extraction). However, at this time CMS requires providers to report the clinical quality measure data exactly as it is generated as output from the certified EHR technology in order to successfully demonstrate meaningful use. We will continue to collaborate with our partners in the Office of the National Coordinator for Health Information Technology and with industry stakeholders to make further headways in system interoperability, standards for EHR data, as well as certification of vendor products. For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] Does a provider have to record all clinical data in their certified EHR technology in order to accurately report complete clinical quality measure data for the Medicare and Medicaid EHR Incentive Programs? To be a meaningful EHR user a provider must do three things: Have complete certified EHR technology for all meaningful use objectives either through a complete EHR or a combination of modules; and Meet 20 measures (19 for eligible hospitals and CAHs), including all of the core and five (5) menu-set measures associated with the objectives (unless excluded). Core measures include reporting clinical quality measures. Use the capabilities and standards of certified EHR technology in meeting the measure of each objective If the conditions above are met and data is transferred from the certified EHR technology to a data warehouse, the provider can use information from the data warehouse to report on Meaningful Use objectives and clinical quality measures. However, in order to report calculated clinical quality measures, the data warehouse may need to be certified. The Office of the National Coordinator of Health Information Technology has addressed the issue of certification of a data warehouse in the following Frequently Asked Question: For more information about certification, you can contact ONC directly at onc.certification@hhs.gov. For more information about the Medicare and Medicaid EHR Incentive Program, please visit 19

20 [EHR Incentive Programs] For the meaningful use objective of "capability to exchange key clinical information" for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, does exchange of electronic information using physical media, such as USB, CD- ROM, or other formats, meet the measure of this objective? No, the use of physical media such as a CD-ROM, a USB or hard drive, or other formats to exchange key clinical information would not utilize the certification capability of certified EHR technology to electronically transmit the information, and therefore would not meet the measure of this objective. For the purposes of the Stage 1 "capability to exchange key clinical information" measure, exchange is defined as electronic transmission and acceptance of key clinical information using the capabilities and standards of certified EHR technology (as specified at 45 CFR (i) for EPs and 45 CFR (f) for eligible hospitals and CAHs). We expect that this information would be exchanged in structured electronic format when available (e.g., drug or clinical lab data); however, where the information is available only in unstructured electronic formats (e.g., free text or scanned images), the exchange of unstructured information would satisfy this measure. For more information about electronic exchange of key clinical information, please refer to the following FAQ: Please note that this objective is distinct from objectives such as "provide a summary of care record for each transition of care," where electronic exchange of the summary of care record is not a requirement but an option. To satisfy the measure of the "provide a summary of care record for each transition of care" objective, a provider is permitted to send an electronic or paper copy of the summary care record directly to the next provider or can provide it to the patient to deliver. In this case, the use of physical media such as a CD-ROM, a USB or hard drive, or other formats could satisfy the measure of this objective. Effective 2013, this objective and measure are no longer required. For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] Can eligible professionals (EPs) allow another person to register or attest for them? Yes. Users registering or attesting on behalf of an EP must have an Identity and Access Management System (I&A) web user account (User ID/Password) and be associated to the EP's NPI. If you are working on behalf of an EP(s) and do not have an I&A web user account, please visit to create one. For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] To meet the meaningful use objective capability to exchange key clinical information for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, can different providers of care (e.g., physicians, hospitals, etc.) share EHR technology and successfully meet this objective? In order to meet this objective, clinical information must be sent between different legal entities with distinct certified EHR technology and not between organizations that share a certified EHR technology or organizations that are part of the same legal entity, since no actual exchange of clinical information would take place in these latter instances. Distinct certified EHR technologies are those that can achieve certification and operate independently of other certified EHR technologies. It is possible for different legal entities to meet this objective by using separate instances of the same certified EHR technology (e.g. both entities using separate license of the same program), subject to the following limitations: A different legal entity is an entity that has its own separate legal existence. Indications that two entities are legally separate would include (1) they are each separately incorporated; (2) they have separate Boards of Directors; and (3) neither entity is owned or controlled by the other. In order to be distinct certified EHR technology, each instance of certified EHR technology must be able to be certified and operate independently from all others. Separate instances of certified EHR technology that must link to a common database in order to gain certification would not be considered distinct. However, instances of certified EHR technology that link to a common, uncertified system or component would be considered distinct. Instances of certified EHR technology can be from the same vendor and still be considered distinct. The exchange of key clinical information requires that the eligible professional, eligible hospital, or critical access hospital (CAH) must use the standards of certified EHR technology as specified by the Office of the National Coordinator for Health IT, not the capabilities of uncertified or other vendor-specific alternative methods for exchanging clinical information. 20

21 [EHR Incentive Programs] To what attestation statements must an eligible professional (EP), eligible hospital, or critical access hospital (CAH) agree in order to submit an attestation, successfully demonstrate meaningful use, and receive an incentive payment under the Medicare Electronic Health Record (EHR) Incentive Program? Currently, the attestation process requires EPs, eligible hospitals, and CAHs to indicate that they agree with the following attestation statements: The information submitted for clinical quality measures (CQMs) was generated as output from an identified certified EHR technology. The information submitted is accurate to the knowledge and belief of the EP or the person submitting on behalf of the EP, eligible hospital, or CAH. The information submitted is accurate and complete for numerators, denominators, exclusions, and measures applicable to the EP, eligible hospital, or CAH. The information submitted includes information on all patients to whom the measure applies. For CQMs, a zero was reported in the denominator of a measure when an EP, eligible hospital or CAH did not care for any patients in the denominator population during the EHR Reporting Period. CMS considers information to be accurate and complete for CQMs insofar as it is identical to the output that was generated from certified EHR technology. Numerator, denominator, and exclusion information for CQMs must be reported directly from information generated by certified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting that the information for CQMs entered into the Registration and Attestation System is identical to the information generated from certified EHR technology. CMS does not require EPs, eligible hospitals, or CAHs to provide any additional information beyond what is generated from certified EHR technology in order to satisfy the requirement for submitting CQM information. Please note that quality performance results for CQMs are not being assessed at this time under the EHR Incentive Programs. Complete and accurate information for the remaining meaningful use core and menu set measures does not necessarily have to be entered directly from information generated by certified EHR technology. By definition, for each meaningful use objective with a percentage-based measure, certified EHR technology must include the capability to electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage for these measures. However, with the exception of CQMs, meaningful use measures do not specify that this capability must be used to calculate the numerators and denominators. EPs, eligible hospitals, and CAHs can use a separate, uncertified system to calculate numerators and denominators and to generate reports on all measures of the core and menu set meaningful use objectives except CQMs. In order to provide complete and accurate information for certain of these measures, they may also have to include information from paper-based patient records or from records maintained in uncertified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting to providing all of the information necessary from certified EHR technology, uncertified EHR technology, and/or paper-based records in order to render complete and accurate information for all meaningful use core and menu set measures except CQMs. For more information about the Medicare and Medicaid EHR Incentive Program, please visit [EHR Incentive Programs] Who can enter medication orders in order to meet the measure for the computerized provider order entry (CPOE) meaningful use objective under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs and when must these medication orders be entered? Any licensed healthcare professional can enter orders into the medical record for purposes of including the order in the numerator for the measure of the CPOE objective if they can enter the order per state, local, and professional guidelines. The order must be entered by someone who could exercise clinical judgment in the case that the entry generates any alerts about possible interactions or other clinical decision support aides. This necessitates that CPOE occurs when the order first becomes part of the patient's medical record and before any action can be taken on the order. Each provider will have to evaluate on a case-by-case basis whether a given situation is entered according to state, local, and professional guidelines, allows for clinical judgment before the medication is given, and is the first time the order becomes part of the patient's medical record. For more information about the Medicare and Medicaid EHR Incentive Program, please visit Questions? 21

22 Brian Flood Partner Austin, Texas Thank You Husch Blackwell LLP Post-Pay Audit Engagement Letter & Information Request 22

23 Post-Pay Audit Engagement Letter & Information Request (Continued) HITECH Incentive Payment HITECH Incentive Payment -(Continued) 23

24 Hospital Appeal Filing Request Hospital Appeal Filing Request (Cont'd) Hospital Appeal Filing Request (Cont'd) 24

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