This summary is a draft-in-progress and will be updated with new information over the coming months.

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American College of Radiology

Draft Summary of Proposed Rules: CMS Stage 2 Meaningful Use

and ONC 2014 Edition HIT Certification Criteria, Standards, and

Implementation Specifications

General Overview

On March 7, 2012, the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of the National Coordinator for HIT (ONC) will publish their respective Notices of Proposed Rulemaking (NPRMs, or proposed rules) to update the user and technology requirements for the Medicare/Medicaid EHR Incentive Program

(“meaningful use,” or MU) in the Federal Register. CMS has regulatory purview over implementation of the EHR Incentive Program, including requirements for participants, incentives, and more. ONC has regulatory authority over the HIT certification program, including the certification criteria, standards, and implementation specifications for products used by program participants. Both proposed rules will have 60-day public comment periods.

Given the composition of ACR’s membership, the following summary will focus exclusively on proposed changes to the Medicare version of the EHR Incentive Program for eligible professionals (EPs) and the Certified EHR Technology (CEHRT) used by those EPs. The information herein is specific to the proposed rules and therefore subject to significant change between now and when the final rules are promulgated later this year. Aspects of the proposed rules that remain unchanged from the regulations that are currently in effect are intentionally not discussed in this summary. For a summary of the MU regulations that are currently in effect, please access the ACR MU Resource Center.

This summary is a draft-in-progress and will be updated with new information over the coming months.

Stages, Reporting Periods, Payment Years

CMS and ONC is planning for three “stages” of MU between 2011 and 2015, the requirements of will be updated on a regular basis via the rulemaking process.

CMS proposes a continuation of the existing paradigm in which an EP enters the program at Stage 1, regardless of year, and spend two years in each stage before proceeding to the next. CMS proposes that EPs who successfully participated in 2011 will spend an additional year in Stage 1 before moving into Stage 2 in 2014.

CMS proposes that the stages continue to work with the EP’s years of participation as follows: EP’s

1st Year

EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s Stage of MU Per Year of Participation EP’s 1st Year 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2011 1 1 1 2 2 3 3 TBD TBD TBD TBD 2012 1 1 2 2 3 3 TBD TBD TBD TBD 2013 1 1 2 2 3 3 TBD TBD TBD 2014 1 1 2 2 3 3 TBD TBD 2015 1 1 2 2 3 3 TBD 2016 1 1 2 2 3 3 2017 1 1 2 2 3

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Avoiding Penalties

The statute provides CMS with the authority to grant significant hardship exemptions, subject to annual review, for a maximum of 5 years. CMS is proposing 3 significant hardship exemption categories:

1. The EP does not have sufficient internet access 2 years prior. Applications for this category must be submitted before July 1 of the year prior.

2. The EP has been practicing for less than 2 years.

3. During either of the 2 prior years, the EP faced extreme and uncontrollable circumstances preventing the EP from being a meaningful EHR user. Applications for this category must be submitted before July 1 of the year prior.

CMS is requesting public comments on a prospective fourth category that would be applicable to some ACR members who find themselves unable to comply. The category would potentially be for EPs who: a) lack face-to-face or telemedicine encounters with patients, b) lack followup with patients, and c) have no influence over the technology purchasing decisions in their workplace. CMS is considering whether it would be best to limit this prospective category to a maximum 2 years instead of the full 5 allowed by the statute.

The following table shows when EPs will need to demonstrate MU or apply for the hardship exemption in order to avoid payment adjustments beginning in 2015 and beyond.

To Avoid Penalties in Payment Adjustment

Year...

You Must Comply with MU 2 Years in

Advance...

Or, For 1st Year MUsers, the 90-Day

Reporting Period Must Begin By...

Or, the EP Must Apply for the Exemption By... 2015 CY 2013 (with

submission period the 2 months following the end of the reporting period)

July 3, 2014 (with submission no later than October 1, 2014)

July 1, 2014

2016 CY 2014 (with

July 1, 2015

2017 CY 2015 (with

July 1, 2016

2018 CY 2016 (with

July 1, 2017

2019 CY 2017 (with

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Proposed Changes to Stage 1 Objectives and Measures

Many of the proposed changes to Stage 1 objectives and measures in the CMS NPRM are optional for EPs beginning in 2013 and mandatory in 2014 and beyond:

Stage 1 Objective Proposed Change(s) Effective

Use CPOE for medication orders directly entered by any licensed healthcare professional who can enter orders into the medical record per State, local and professional guidelines

Change to denominator: More than 30% of medication orders created by the EP during the EHR reporting period are recorded using CPOE

2013 (optional - can use new measure as an alternative) 2014+ (mandatory)

Record and chart changes in vital

signs Change to age limitations:than 50% of all unique patients More seen by the EP during the EHR reporting period have blood pressure (for patients age 3 and over only) and height and weight (for all ages) recorded as structured data

2013 (optional - can use new measure as an alternative) 2014+ (mandatory) Record and chart changes in vital

signs

Change to, and splitting up of, exclusions - 4 total: (1) Sees no patients 3 years or older is excluded from recording blood pressure; (2) Believes that all three vital signs of height, weight, and blood pressure have no relevance to their scope of practice is excluded from recording them;

(3) Believes that height and weight are relevant to their scope of practice, but blood pressure is not, is excluded from recording blood pressure; or

(4) Believes that blood pressure is relevant to their scope of practice, but height and weight are not, is excluded from recording height and weight.

2013 (optional - can use new measure as an alternative) 2014+ (mandatory)

Capability to exchange key clinical information (for example, problem list, medication list, medication allergies, and diagnostic test results), among providers of care and patient authorized entities electronically

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Stage 1 Objective Proposed Change(s) Effective Provide patients with an electronic

copy of their health information (including diagnostics test results, problem list, medication lists, medication allergies) upon request.

Replace with the Stage 2 objective and measure: Objective: Provide patients the ability to view online, download and transmit their health

information within 4 business days of the information being available to the EP

Measure: More than 50% of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information.

2014+

Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, medication allergies) within 4business days of the information being available to the EP.

Replace with the Stage 2 objective and measure: Objective: Provide patients the ability to view online, download and transmit their health

information within 4 business days of the information being available to the EP

Measure: More than 50% of all unique patients seen by the EP during the EHR reporting period are provided timely (within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information.

2014+

Capability to submit electronic data to immunization registries or immunization information systems and actual submission according to applicable law and practice.

Added clarification: Addition of "except where prohibited" to the objective regulation text.

2013+

Capability to submit electronic syndromic surveillance data to public health agencies and actual submission according to applicable law and practice.

Added clarification: Addition of "except where prohibited" to the objective regulation text.

2013+

Report ambulatory clinical quality

measures to CMS Deletion: separate objective, this will be Instead of being a incorporated into the definition of “meaningful EHR user.” This change is administrative only and will not be noticeable to EPs.

2013+

CMS is also proposing that, beginning in 2014, meeting exclusions from individual menu set measures will not reduce the total number of menu set set measures that need to be reported. Instead, EPs will need to report on 5 of 10 menu set measures unless they meet exclusions for more than 5 menu set measures, in which case they meet all menu set measures they can and report the remaining exclusions.

For clinical quality measures (CQMs) component, all EPs will continue to report the current CQMs in 2013, and move to the new CQMs in 2014.

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Proposed Stage 2 MU Objectives and Measures

In the proposed paradigm, objectives sometimes have 2 measures. The following table shows the proposed Stage 2 objectives, measures, and exclusions (where available). CMS proposes that EPs report on all 17 core objectives, and choose 3 of 5 menu set objectives. Meeting an exclusion for an individual objective is the same as meeting the measure(s) of the objective. Menu set objectives are highlighted in yellow.

Stage 2 Objective Measure(s) Exclusion(s)

Use computerized provider order entry (CPOE) for medication, laboratory, and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per State, local, and professional guidelines to create the first record of the order.

More than 60% of medication, laboratory, and radiology orders created by the EP during the EHR reporting period are recorded using CPOE.

Any EP who writes fewer than 100 medication, laboratory, and radiology orders during the EHR reporting period.

Generate and transmit permissible

prescriptions electronically (eRx). More than 65% of all permissible prescriptions written by the EP are compared to at least one drug formulary and transmitted

electronically using Certified EHR Technology.

Any EP who writes fewer than 100 prescriptions during the EHR reporting period or does not have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 25 miles of the EP's practice location at the start of his or her EHR reporting period.

Record all of the following demographics:

(A) Preferred language. (B) Gender.

(C) Race. (D) Ethnicity. (E) Date of birth.

More than 80% of all unique patients seen by the EP during the EHR reporting period have demographics recorded as structured data.

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Stage 2 Objective Measure(s) Exclusion(s) Record and chart changes in the

following vital signs: (A)Height/Length. (B) Weight.

(C) Blood pressure (ages 3 and over).

(D) Calculate and display body mass index (BMI).

(E) Plot and display growth charts for patients 0 - 20 years, including BMI.

More than 80% of all unique patients seen by the EP during the EHR reporting period have blood pressure (for patients age 3 and over only) and height/length and weight (for all ages) recorded as structured data.

Any EP who:

(A) Sees no patients 3 years or older is excluded from recording blood pressure;

(B) Believes that all three vital signs of height/length, weight, and blood pressure have no relevance to their scope of practice is excluded from recording them;

(C) Believes that height/length and weight are relevant to their scope of practice, but blood pressure is not, is excluded from recording blood pressure; or

(D) Believes that blood pressure is relevant to their scope of practice, but height/length and weight are not, is excluded from recording height/length and weight. Record smoking status for patients

13 years old or older. More than 80% of all unique patients 13 years old or older seen by the EP during the EHR reporting period have smoking status

recorded as structured data.

Any EP who sees no patients 13 years old or older.

Use clinical decision support to improve performance on high priority health conditions.

(A) Implement five clinical decision support interventions related to five

or more clinical quality measures, if applicable, at a relevant point in patient care for the entire EHR reporting period; and,

(B) The EP has enabled the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period.

N/A

Incorporate clinical lab-test results into Certified EHR Technology as structured data.

More than 55% of all clinical lab tests results ordered by the EP during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in Certified EHR Technology as structured data.

Any EP who orders no lab tests whose results are either in a positive/negative or numeric format during the EHR reporting period.

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

Generate at least one report listing patients of the EP with a specific condition.

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Stage 2 Objective Measure(s) Exclusion(s) Use clinically relevant information

to identify patients who should receive reminders for preventive/ follow-up care.

More than 10% of all unique patients who have had an office visit with the EP within the 24 months before the beginning of the EHR reporting period were sent a reminder, per patient preference.

Any EP who has had no office visits in the 24 months before the beginning of the EHR reporting period.

Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP.

(A) More than 50% of all unique patients seen by the EP during the EHR reporting period are provided timely (available to the patient within 4 business days after the information is available to the EP) online access to their health information subject to the EP's discretion to withhold certain information; and,

(B) More than 10 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representatives) view, download or transmit to a third party their health information.

Any EP who neither orders nor creates any of the information listed for inclusion as part of this measure is excluded from both (A) and (B) measures.

Any EP that conducts the majority (50% or more) of his or her patient encounters in a county that does not have 50% or more of its housing units with 4Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR

reporting period is excluded from (B) only.

Provide clinical summaries for

patients for each office visit. Clinical summaries provided to patients within 24 hours for more than 50% of office visits.

Any EP who has no office visits during the EHR reporting period.

Use clinically relevant information from Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient.

Patient-specific education resources identified by Certified EHR Technology are provided to patients for more than 10% of all office visits by the EP.

The EP who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliation.

The EP performs medication reconciliation for more than 65% of transitions of care in which the patient is transitioned into the care of the EP.

Any EP who was not

the recipient of any transitions of care during the EHR reporting period.

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Stage 2 Objective Measure(s) Exclusion(s) The EP who transitions their patient

to another setting of care or provider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral.

(A) The EP that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 65% of transitions of care and referrals; and,

(B) The EP that transitions or refers their patient to another setting of care or provider of care

electronically transmits using Certified EHR Technology to a recipient with no organizational affiliation and using a different Certified EHR Technology vendor than the sender a summary of care record for more than 10% of transitions of care and referrals.

Any EP who neither transfers a patient to another setting nor refers a patient to another provider during the EHR reporting period is excluded from both measures.

Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice.

Successful ongoing submission of electronic immunization data from Certified EHR Technology to an immunization registry or

immunization information system for the entire EHR reporting period.

Any EP that meets one or more of the following criteria:

(A) The EP does not administer any of the immunizations to any of the populations for

which data is collected by the jurisdiction's immunization registry or immunization information system during the EHR reporting period.

(B) The EP operates in a jurisdiction for which no immunization registry or

immunization information system is capable of receiving electronic immunization data in the specific standards required for Certified EHR Technology at the start of their EHR reporting period. (C) The EP operates in a jurisdiction for which no immunization registry or

immunization information system is capable of accepting the version of the standard that the EP's Certified EHR Technology can send at the start of their EHR reporting period.

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Stage 2 Objective Measure(s) Exclusion(s) Protect electronic health

information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities.

Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data at rest in accordance with

requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security

deficiencies as part of the EP's risk management process.

N/A

Use secure electronic messaging to communicate with patients on relevant health information.

A secure message was sent using the electronic messaging function of Certified EHR Technology by more than 10% of unique patients seen by the EP during the EHR reporting period.

Imaging results and information are accessible through Certified EHR Technology.

More than 40% of all scans and tests whose result is one or more images ordered by the EP during the EHR reporting period are accessible through Certified EHR Technology.

Any EP who does not perform diagnostic interpretation of scans or tests whose result is an image during the EHR reporting period.

Record patient family health history

as structured data. More than 20% of all unique patients seen by the EP during the EHR reporting period have a structured data entry for one or more first-degree relatives.

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Stage 2 Objective Measure(s) Exclusion(s) Capability to submit electronic

syndromic surveillance data to public health agencies, except where prohibited, and in

accordance with applicable law and practice.

Successful ongoing submission of electronic syndromic surveillance data from Certified EHR

Technology to a public health agency for the entire EHR reporting period.

Any EP that meets one or more of the following criteria:

(A) The EP is not in a category of providers who collect ambulatory syndromic surveillance information on their patients during the EHR reporting period.

(B) The EP operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data in the specific standards required for Certified EHR Technology at the start of their EHR reporting period. (C) The EP operates in a jurisdiction for which no public health agency is capable of accepting the version of the standard that the EP's Certified EHR Technology can send at the start of their EHR reporting period. Capability to identify and report

cancer cases to a State cancer registry, except where prohibited, and in accordance with applicable law and practice.

Successful ongoing submission of cancer case information from Certified EHR Technology to a cancer registry for the entire EHR reporting period.

Any EP who:

(A) Does not diagnose or directly treat cancer; or

(B) Operates in a jurisdiction for which no public health agency is capable of receiving electronic cancer case information in the specific standards required for Certified EHR Technology at the start of their EHR reporting period. Capability to identify and report

specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice.

Successful ongoing submission of specific case information from Certified EHR Technology to a specialized registry for the entire EHR reporting period.

Any EP who:

(A) Does not diagnose or directly treat any disease associated with a specialized registry; or

(B) Operates in a jurisdiction for which no registry is capable of receiving electronic specific case information in the specific

standards required under Stage 2 at the beginning of their EHR reporting period.

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Special Considerations Related to Proposed Stage 2 MU Objectives, Access

to CEHRT, and Patient Encounters

CMS proposes defining a patient encounter as any encounter where a medical treatment is provided and/or evaluation and management services are provided. This includes both individually billed events and events that are globally billed, but are separate encounters under the definition.

CMS also provides more information in the preamble of the NPRM about acceptable means of CEHRT access. Practices/locations are “equipped with CEHRT” if the record of the patient encounter that occurs at that practice/ location is created and maintained in CEHRT. This can be accomplished in three ways:

1. CEHRT could be permanently installed at the practice/location,

2. The EP could bring CEHRT to the practice/location on a portable computing device, or, 3. The EP could access CEHRT remotely using computing devices at the practice/location.

Although CMS currently allows EPs to create a record of the encounter without using CEHRT at the practice/ location and then later input that information into CEHRT that exists at a different practice/location, CMS is proposing to eliminate this ability in 2013 and beyond.

For simplification purposes, CMS proposes to eliminate the distinction between denominators that are limited to unique patients whose records are maintained using CEHRT and denominators that apply to all patients. CMS proposes to continue to allow EPs who practice in multiple practices/locations to limit the unique patient denominators to those at the practices/locations equipped with CEHRT.

Proposed Batch File Process for Attestation of MU Objectives and Measures

CMS proposes to continue the current attestation paradigm for Stage 2 objectives and measures. However, CMS is also proposing a batch file process for group practices in lieu of individual EP attestation of the MU objectives and measures beginning in 2014.

With the proposed batch file process, EPs will still be measured at the individual level (unlike the CQM group reporting options mentioned later in this summary); however, the administrative process for attesting large groups of EPs will presumably be made easier. Essentially, CMS would establish a file format in which groups would be required to submit core and menu objective information for individual Medicare EPs (including the stage of

meaningful use the individual EP is in, numerator, denominator, exclusion, and yes/no information for each core and menu objective) and also establish a process through which groups would submit this batch file for upload.

For this option, groups are 2 or more EPs, each identified with a unique NPI associated with a group practice identified under one TIN through the Provider Enrollment, Chain, and Ownership System (PECOS). Any EP who attests through this pathway would not be able to also attest as an individual or as part of an additional group. The CQM group reporting options (discussed later) are handled separately.

Proposed 2014 Clinical Quality Measures and CQM Reporting

CMS proposes to eliminate the separate objective and measure for reporting clinical quality measures (CQMs) and instead make reporting CQMs an inherent component of the definition of “meaningful EHR user.” There are 125 identified CQMs in the CMS NPRM; however, CMS intends to whittle down the list in the final rule based on readiness and feedback.

CMS proposes 2 reporting options beginning in CY 2014 for CQMs. Option 1 includes two alternatives,(A) and (B) below, but CMS intends to finalize only one of those alternatives.

1. (A) EPs would report 12 “menu” CQMs, including at least 1 CQM from each of the 6 domains (Patient and Family Engagement, Patient Safety, Care Coordination, Population and Public Health, Efficient Use of Healthcare Resources, and Clinical Process/Effectiveness). Or, (B) EPs would report 11 core CQMs and 1 menu CQM.

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2. EPs who participate in both the Physician Quality Reporting System (PQRS) and the EHR Incentive Program may, by default, comply with MU CQM requirements by satisfying the requirements of the PQRS EHR Reporting Option.

CMS is considering an "interim submission" option for EPs who are in their first year of Stage 1 and who participate in PQRS. These EPs will submit the PQRS CQMs data for their 90-day EHR reporting period, which must be received by October 1. After that, the EP will report the remainder of his/her CQMs data by whatever deadline is specified for the PQRS.

CMS is proposing three “group reporting” options to allow EPs within a single group practice to report CQM data on a group level beginning in 2014 if all EPs in the group are beyond the first year of Stage 1:

1. Two or more EPs, each identified with a unique NPI associated with a group practice identified under one TIN may be considered an “EHR Incentive Group” and report together.

2. EPs participating in the Medicare Shared Savings Program and the testing of the Pioneer Accountable Care Organization (ACO) model who use CEHRT to submit ACO measures will satisfy the MU CQMs piece. 3. EPs who satisfactorily report PQRS clinical quality measures using CEHRT under the PQRS Group Practice

Reporting Option will satisfy the MU CQMs piece.

For the first year of Stage 1 MU compliance, EPs may report CQMs through attestation just like the current MU regulations. EPs who choose to report 12 clinical quality measures as described in Options 1(A) and (B) above will submit CQM through an aggregate reporting method, which will require the EP to log into a CMS-designated portal. Once the EP has logged into the portal, they will submit through an upload process, CQM data produced as output from their CEHRT in the XML-based format to be specified by CMS around the time the Stage 2 final rule is promulgated.

Core CQMs are listed in the below table and highlighted in blue. Core CQM No. Core CQM Title and

Description Domain

TBD Title: Closing the referral loop: receipt of specialist report

Description: Percentage of patients regardless of age with a referral from a primary care provider for whom a report from the provider to whom the patient was referred was received by the referring provider.

Care Coordination

TBD Title: Functional status assessment for complex chronic conditions Description: Percentage of patients aged 65 years and older with heart failure and two or more high impact conditions who completed initial and follow-up (patient-reported) functional status assessments.

Patient and Family Engagement

NQF 0018 Title: Controlling High Blood Pressure

Description: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled during the measurement year.

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Core CQM No. Core CQM Title and

NQF 0097 Title: Medication Reconciliation Description: Percentage of patients aged 65 years and older discharged from any inpatient facility (e.g. hospital, skilled nursing facility, or rehabilitation facility) and seen within 60 days following discharge in the office by the physician providing on-going care who had a reconciliation of the discharge medications with the current medication list in the medical record documented.

Patient Safety

NQF 0418 Title: Screening for Clinical Depression

Description: Percentage of patients aged 12 years and older screened for clinical depression using an age appropriate standardized tool and follow up plan documented.

Population/ Public Health

NQF 0028 Title: Preventive Care and

Screening: Tobacco Use: Screening and Cessation Intervention

Description: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.

TBD Title: Preventive Care and

Screening: Cholesterol – Fasting Low Density Lipoprotein (LDL) Test Performed AND Risk- Stratified Fasting LDL

Description: Percentage of patients aged 20 through 79 years whose risk factors* have been assessed and a fasting LDL test has been performed. Percentage of patients aged 20 through 79 years who had a fasting LDL test performed and whose risk- stratified* fasting LDL is at or below the recommended LDL goal.

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NQF 0068 Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic

Description: Percentage of patients 18 years of age and older who were discharged alive for acute

myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous

transluminal coronary angioplasty (PTCA) from January 1- November 1 of the year prior to the

measurement year, or who had a diagnosis of ischemic vascular disease (IVD) during the measurement year and the year prior to the measurement year and who had documentation of use of aspirin or another antithrombotic during the measurement year.

Clinical Process/ Effectiveness

NQF 0024 Title: Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents

Description: Percentage of patients 3-17 years of age who had an outpatient visit with a Primary Care Physician (PCP) or OB/GYN and who had evidence of body mass index (BMI) percentile

documentation, counseling for nutrition and counseling for physical activity during the measurement year.

NQF 0022 Title: Use of High-Risk Medications in the Elderly

Description: Percentage of patients ages 65 years and older who received at least one high-risk medication. Percentage of patients 65 years of age and older who received at least two different high-risk medications.

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TBD Title: Adverse Drug Event (ADE)

Prevention: Outpatient therapeutic drug monitoring

Description: Percentage of patients 18 years of age and older receiving outpatient chronic medication therapy who had the appropriate therapeutic drug monitoring during the measurement year.

Patient Safety

Any CQMs, including one of the aforementioned “core” CQMs, that are perceived to be relevant to ACR’s diagnostic radiology, nuclear medicine, interventional radiology, and/or radiation oncology physician membership are listed in the below table. CQMs that are not displayed above as “core” CQMs are considered “menu” CQMs for the purpose of reporting option 1(B). The following table is not comprehensive; there are 125 total CQMs for EPs listed in the CMS NPRM.

CQMs of indirect relevance to radiology (likely to be relevant to referring physicians, but not radiologists) are highlighted in red. CQMs of direct relevance to some ACR members are highlighted in green.

All CQM No. All CQM Title and

NQF 0031 Title: Breast Cancer Screening Description: Percentage of women 40-69 years

of age who had a mammogram to screen for breast cancer.

NQF 0034 Title: Colorectal Cancer Screening Description: Percentage of adults 50-75 years of age who had appropriate screening for colorectal cancer.

NQF 0045 Title: Osteoporosis:

Communication with the Physician Managing Ongoing Care Post-Fracture

Description: Percentage of patients aged 50 years and older treated for a hip, spine, or distal radial fracture with documentation of

communication with the physician managing the patient's on-going care that a fracture occurred and that the patient was or should be tested or treated for osteoporosis.

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NQF 0048 Title: Osteoporosis: Management Following Fracture of Hip, Spine or Distal radius for Men and Women Aged 50 Years and Older

Description: Percentage of patients aged 50 years or older with fracture of the hip, spine or distal radius that had a central dual-energy X-ray absorptiometry measurement ordered or performed or

pharmacologic therapy prescribed.

NQF 0052 Title: Use of Imaging Studies for Low Back Pain

Description: Percentage of patients with a primary diagnosis of low back pain who did not have an imaging study (plain x-ray, MRI, CT scan) within 28 days of diagnosis.

Efficient Use of Healthcare Resources

NQF 0239 Title: Venous Thromboembolism (VTE) Prophylaxis

Description: Percentage of patients aged 18 years and older undergoing procedures for which VTE

prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin

(LMWH), Low-Dose

Unfractionated Heparin (LDUH), adjusted-dose warfarin,

fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time.

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formerly NQF 0246 (no longer endorsed, but will be resubmitted for endorsement later in 2012)

Title: Stroke and Stroke

Rehabilitation: CT or MRI Reports Description: Percentage of final reports for CT or MRI studies of the brain performed either:

- In the hospital within 24 hours of arrival, OR

- In an outpatient imaging center to confirm initial diagnosis of stroke, transient ischemic attack (TIA) or intracranial hemorrhage.

For patients aged 18 years and older with either a diagnosis of ischemic stroke, TIA or intracranial hemorrhage OR at least one documented symptom consistent with ischemic stroke, TIA or intracranial hemorrhage that includes documentation of the presence or absence of each of the following: hemorrhage, mass lesion and acute infarction.

NQF 0271 Title: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures)

Description: Percentage of non-cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic antibiotics AND who received a prophylactic antibiotic, who have an order for

discontinuation of prophylactic antibiotics within 24 hours of surgical end time

Patient Safety

NQF 0312 Title: Lower Back Pain: Repeat Imaging Studies

Description: Percentage of patients with back pain who received inappropriate imaging studies in the absence of red flags or progressive symptoms (overuse measure, lower performance is better).

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NQF 0382 Title: Oncology: Radiation Dose Limits to Normal Tissues

Description: Percentage of patients, regardless of age, with a diagnosis of pancreatic or lung cancer receiving 3D conformal radiation therapy with documentation in medical record that radiation dose limits to normal tissues were established prior to the initiation of a course of 3D conformal radiation for a minimum of two tissues.

Patient Safety

NQF 0383 (paired with 0384) Title: Oncology: Plan of Care for Pain - Medical Oncology and Radiation Oncology

Description: Percentage of visits for patients with a diagnosis of cancer currently receiving intravenous chemotherapy or radiation therapy who report having pain with a documented plan of care to address pain

NQF 0384 (paired with 0383) Title: Oncology: Pain Intensity Quantified - Medical Oncology and Radiation Oncology

Description: Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or

radiation therapy in which pain intensity is quantified.

NQF 0387 Title: Breast Cancer: Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer Description: 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

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NQF 0388 Title: Prostate Cancer: Three-Dimensional Radiotherapy

Description: Percentage of patients with prostate cancer receiving external beam radiotherapy to the prostate only who receive 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiation therapy)

Patient Safety

NQF 0389 Title: Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients Description: Percentage of patients, regardless of age, with a diagnosis of prostate cancer at low risk of recurrence receiving interstitial prostate

brachytherapy, OR external beam radiotherapy to the prostate, OR radical prostatectomy, OR cryotherapy who did not have a bone scan performed at any time since diagnosis of prostate cancer.

Efficient Use of Healthcare Resource

NQF 0507 Title: Stenosis measurement in carotid imaging studies

Description: Percentage of final reports for carotid imaging studies (neck MR angiography [MRA], neck CT angiography [CTA], neck duplex ultrasound, carotid

angiogram) performed that include direct or indirect reference to measurements of distal internal carotid diameter as the denominator for stenosis measurement

NQF 0508 Title: Inappropriate use of “probably benign” assessment category in mammography screening

Description: Percentage of final reports for screening mammograms that are classified as ”probably benign”

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NQF 0510 Title: Exposure time reported for procedures using fluoroscopy Description: Percentage of final reports for procedures using fluoroscopy that include documentation of radiation exposure or exposure time

Patient Safety

NQF 0513 Title: Thorax CT: Use of Contrast Material

Description: This measure calculates the percentage of thorax studies that are performed with and without contrast out of all thorax studies performed (those with contrast, those without contrast, and those with both).

NQF 0562 Title: Over Utilization of Imaging Studies in Stage 0-IA Melanoma Description: Percentage of patients with stage 0 or IA melanoma, without signs or symptoms, for whom no diagnostic imaging studies were ordered

TBD Title: Closing the referral loop: receipt of specialist report

Description: Percentage of patients regardless of age with a referral from a primary care provider for whom a report from the provider to whom the patient was referred was received by the referring provider.

Care Coordination

Proposed CMS Appeals Processes

The CMS NPRM proposes processes and timelines for 3 types of appeals related to the EHR Incentive Program: 1. Eligibility appeals: Must be filed no later than 30 days after the 2-month period following the payment year; 2. MU appeals: Must be filed no later than 30 days from the date of the demand letter or other finding that could

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3. Incentive payment appeals: Must be filed no later than 60 days from the date the payment was issued, or 60 days from any federal determination that the incentive payment calculation was incorrect or duplicative.

2011 Edition and 2014 Edition Certification Criteria

Instead of implementing technology requirements that would be specific to a given stage of MU, ONC is proposing a certification paradigm that would feature “2011 Edition EHR certification criteria” (what exists now) and “2014 Edition certification criteria” (what is being proposed in the ONC NPRM). When finalized, the 2014 Edition certification criteria will ensure products can enable EPs to do the revised Stage 1 and Stage 2 MU objectives and measures. EPs will be allowed to implement products certified for the 2014 Edition certification criteria prior to 2014 provided their product(s) have the 2011 Edition criteria covered by equivalent criteria.

2011 2012 2013 2014

Stage 1 Stage 1 Stage 1 Stage 1 or Stage 2

All EPs must have EHR technology that has been certified to all applicable 2011 Edition EHR certification criteria or equivalent 2014 Edition EHR certification criteria.

All EPs must have EHR technology (including a Base EHR) that has been certified to the 2014 Edition EHR certification criteria that would support the objectives and measures, and their ability to

successfully report the CQMs, for the MU stage that they seek to achieve.

Proposed Redefining of “Certified EHR Technology”

ONC is proposing to redefine CEHRT in a way that is significantly more flexible for EPs. Beginning in 2014, CEHRT must have all “Base EHR” certification criteria covered and any additional certification criteria that correspond with CMS objectives and measures the EP complies with to meet MU. In other words, objectives from which an EP is excluded do not need to have corresponding capabilities in the certified system(s) the EP uses in order to meet the regulatory definition of CEHRT, unless a given capability falls under the purview of a “Base EHR.”

The concept of Complete EHRs and EHR Modules remains in the ONC NPRM; however, because of the increased flexibility in the the definition of CEHRT for 2014 and beyond, EPs can possibly meet the definition of CEHRT using one EHR Module (or, they can use a Complete EHR or combination of certified EHR Modules).

Note that ONC is not proposing to implement this increased flexibility until 2014. If EPs choose to implement products certified for equivalent 2014 Edition certification criteria, those criteria must still comprehensively equate to all mandatory 2011 Edition certification criteria.

Proposed 2014 Edition EHR Certification Criteria, Standards, and

Implementation Specifications

The following table provides a comprehensive list of all proposed 2014 Edition certification criteria, standards, and implementation specifications. ONC proposes to include all certification criteria in one list instead of splitting by “general,” “inpatient,” and “ambulatory;” however, some of the criteria and some items within certain criteria are specific to a given setting. Inpatient setting-only criteria or inpatient-specific items within criteria are not shown here. “Base EHR” criteria are highlighted in blue.

Proposed Criteria with Corresponding Standards and Implementation Specifications

Clinical: CPOE Enable a user to electronically record, change, and access the following order types, at a minimum: Medications; Laboratory; and Radiology/imaging.

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Clinical: Drug-drug,

drug-allergy interaction checks Interventions. Before a medication order is placed during computerized provider order entry (CPOE), interventions must automatically and electronically indicate to a user at the point of care of drug-drug and drug-allergy contraindications based on medication list and medication allergy list.

Adjustments. (A) Enable the severity level of interventions provided for drug-drug interaction checks to be adjusted. (B) Limit the ability to adjust severity levels to an identified set of users or available as a system administrative function.

Clinical: Demographics Enable a user to electronically record, change, and access patient demographic data including preferred language, gender, race, ethnicity, and date of birth. (A) Enable race and ethnicity to be recorded in accordance with The Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997 and whether a patient declines to specify race and/or ethnicity. (B) Enable preferred language to be recorded in accordance with ISO 639-1:2002 and whether a patient declines to specify a preferred language.

Clinical: Vital signs, body mass index, and growth charts

Vital signs. Enable a user to electronically record and change, and access

recordings of a patient’s vital signs including, at a minimum, height/length, weight, and blood pressure.

Calculate body mass index. Automatically calculate and electronically display body mass index based on a patient’s height and weight.

(Optional) Plot and display growth charts. Plot and electronically display, upon request, growth charts for patients.

Clinical: Problem list Enable a user to electronically record, change, and access a patient’s problem list for longitudinal care in accordance with, at a minimum, IHTSDO SNOMED CT® International Release January 2012.

Clinical: Medication list Enable a user to electronically record, change, and access a patient’s active medication list as well as medication history for longitudinal care.

Clinical: Medication

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Clinical: Clinical decision

support Evidence-based decision support interventions. Enable a user to select (or activate) one or more electronic clinical decision support interventions (in addition to drug-drug and drug-drug- allergy contraindication checking) based on the data elements included in each one or any combination of the following:(A) Problem list; (B) Medication list; (C) Medication allergy list; (D) Demographics; (E) Laboratory tests and values/results; and (F) Vital signs.

Linked referential clinical decision support. (A) Enable a user to retrieve diagnostic or therapeutic reference information in accordance with HL7 Context-Aware Knowledge Retrieval (“Infobutton”) Standard, International Normative Edition 2010. (B) Enable a user to access the reference information specified above relevant to patient context based on the data elements included in each one or any combination of the following: (1) Problem list; (2) Medication list; (3) Medication allergy list; (4) Demographics; (5) Laboratory tests and values/results; and (6) Vital signs.

Configure clinical decision support. (A) Enable interventions and reference resources specified in the previous two paragraphs to be configured by an identified set of users (e.g., system administrator) based on each one of the following: (1) A user’s role; (2) Clinical setting; and (3) Identified points in the clinical workflow. (B) Enable interventions to be triggered, based on the data elements specified in the above first paragraph, when a summary care record is incorporated pursuant to the “summary care record” certification criterion. Automatically and electronically interact. Interventions selected and configured in accordance with the above three paragraphs must automatically and electronically occur when a user is interacting with EHR technology.

Source attributes. Enable a user to review the attributes for each intervention or reference source for all clinical decision support resources including: (A) Bibliographic citation (clinical research/guideline) including publication; (B) Developer of the intervention (translation from clinical research/guideline); (C) Funding source of intervention development technical implementation; and (D) Release and, if applicable, revision date of the intervention.

Clinical: Electronic notes Enable a user to electronically record, change, access, and search electronic notes.

Clinical: Drug-formulary

checks Enable a user to electronically check if drugs are in a formulary or preferred drug list. Clinical: Smoking status Enable a user to electronically record, change, and access the smoking status of a

patient in accordance with the standard that says smoking status types must include: current everyday smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown;

and unknown if ever smoked.

Clinical: Imaging Electronically indicate to a user the availability of a patient’s images and/or narrative interpretations (relating to the radiographic or other diagnostic test(s)) and enable immediate electronic access to such images and narrative interpretations. Clinical: Family health

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Clinical: Patient lists Enable a user to electronically select, sort, access, and create lists of patients according to, at a minimum, the data elements included in the problem list, medication list, demographics, and laboratory tests and values/results. Clinical: Patient reminders Enable a user to electronically create a patient reminder list for preventive or

follow-up care according to patient preferences based on, at a minimum, the data elements included in the problem list, medication list, medication allergy list, demographics, and laboratory tests and values/results.

Clinical: Patient-specific

educational resources Enable a user to electronically identify and provide patient-specific education resources according to: (i) At a minimum, each one of the data elements included in the patient's: problem list; medication list; and laboratory tests and values/ results; and (ii) HL7 Context-Aware Knowledge Retrieval (“Infobutton”) Standard, International Normative Edition 2010.

Care Coordination: Transitions of care - incorporate summary care record

Upon receipt of a summary care record formatted according to HL7 Implementation Guide for Clinical Document Architecture, Release 2.0 (Consolidated CDA) (US Realm), Draft, September 2011, electronically incorporate, at a minimum, the following data elements: Patient name; gender; race; ethnicity; preferred language; date of birth; smoking status; vital signs; medications; medication allergies; problems; procedures; laboratory tests and values/results; the referring or transitioning provider’s name and contact information; hospital admission and discharge dates and locations; discharge instructions; reason(s) for hospitalization; care plan, including goals and instructions; names of providers of care during hospitalizations; and names and contact information of any additional known care team members beyond the referring or transitioning provider and the receiving provider.

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Care Coordination: Transitions of care - create and transmit summary care record

Enable a user to electronically create a summary care record formatted according to HL7 Implementation Guide for Clinical Document Architecture, Release 2.0 (Consolidated CDA) (US Realm), Draft, September 2011 and that includes, at a minimum, the following data elements expressed, where applicable, according to the specified standard(s): (A) Patient name; gender; date of birth; medication allergies; vital signs; laboratory tests and values/results; the referring or transitioning provider’s name and contact information; names and contact information of any additional care team members beyond the referring or transitioning provider and the receiving provider; care plan, including goals and instructions; (B) Race and ethnicity in accordance with OMB Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997;(C) Preferred language in accordance with ISO 639-1:2002; (D) Smoking status - Smoking status types must include: current everyday smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; and unknown if ever smoked; (E) Problems - at a minimum, IHTSDO SNOMED CT® International Release January 2012; (F) Encounter diagnoses - The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions; (G) Procedures - the code set specified at 45 CFR 162.1002(a)(5) or the code set specified at 45 CFR 162.1002(c)(3); (H) Laboratory test(s). At a minimum, LOINC® version 2.38; (I) Laboratory value(s)/ result(s). The value(s)/results of the laboratory test(s) performed; and (J)

Medications. At a minimum, RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, February 6, 2012 Release.

Transmit. Enable a user to electronically transmit the summary care record created in the above paragraph in accordance with: (A) Applicability Statement for Secure Health Transport and External Data Representation and Cross-Enterprise

Document Media Interchange for Direct Messaging; (B) Optional. SOAP-Based Secure Transport RTM version 1.0.

Care Coordination:

Electronic Prescribing Enable a user to electronically create prescriptions and prescription-related information for electronic transmission in accordance with: (i) NCPDP SCRIPT Standard, Implementation Guide, Version 10.6; and (ii) At a minimum, RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, February 6, 2012 Release.

Care Coordination: Clinical information reconciliation

Enable a user to electronically reconcile the data elements that represent a patient’s active medication, problem, and medication allergy list as follows. For each list type: (i) Electronically display the data elements from two or more sources in a manner that allows a user to view the data elements and their attributes, which must include, at a minimum, the source and last modification date. (ii) Enable a user to merge and remove individual data elements. (iii) Enable a user to review and validate the accuracy of a final set of data elements and, upon a user’s confirmation, automatically update the list.

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Care Coordination: Incorporate laboratory tests and values/results

Receive results. (1) Electronically receive clinical laboratory tests and values/ results in accordance with HL7 2.5.1 and HL7 Version 2.5.1 Implementation Guide: Standards and Interoperability Framework Lab Results Interface, Release 1 (US Realm) and, at a minimum, LOINC® version 2.38. (2) Electronically display the tests and values/results received in human readable format.

Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).

Incorporate tests and values/results. Electronically incorporate a laboratory test and value/result with a laboratory order or patient record.

CQMs: Clinical quality measures - capture and export

Electronically record all of the data elements that are represented in NQF Quality Data Model, Version 2011.

CQMs: Clinical quality measures - incorporate and calculate

Incorporate. Electronically incorporate all of the data elements necessary to calculate each of the clinical quality measures that are included in the EHR technology.

Calculate. Electronically calculate each clinical quality measure that is included in the EHR technology.

CQMs: Clinical quality

measures - reporting Enable a user to electronically create for transmission clinical quality measurement results in a data file defined by CMS. Privacy and security:

Authentication, access control, and authorization

(i) Verify against a unique identifier(s) (e.g., username or number) that a person seeking access to electronic health information is the one claimed; and (ii) Establish the type of access to electronic health information a user is permitted based on the unique identifier(s) provided in the above paragraph, and the actions the user is permitted to perform with the EHR technology.

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Privacy and security: Auditable events and tamper-resistance.

Enabled by default. The capability specified in the next paragraph must be enabled by default (i.e., turned on) and must only be permitted to be disabled (and re-enabled) by a limited set of identified users.

Record actions. Record actions related to electronic health information, audit log status and, as applicable, encryption of end-user devices in accordance with the below standard:

Record actions related to electronic health information, audit log status, and encryption of end-user devices. (1) When EHR technology is used to create, change, access, or delete electronic health information, the following information must be recorded:

(i) The electronic health information affected by the action(s); (ii) The date and time each action occurs in accordance with the standard specified at RFC 1305 NTPv3 or RFC 5905 NTPv4; (iii)The action(s) that occurred; (iv)Patient identification; and (v) User identification.

(2) When the audit log is enabled or disabled, the following must be recorded: (i) The date and time each action occurs in accordance with RFC 1305 NTPv3 or RFC 5905 NTPv4); and (ii) User identification.

(3) As applicable, when encryption of electronic health information managed by EHR technology on end-user devices is enabled or disabled, the following must be recorded: (i) The date and time each action occurs in accordance with the standard specified at RFC 1305 NTPv3 or RFC 5905 NTPv4; and (ii) User identification. Audit log protection. Actions recorded in accordance with the above second paragraph must not be capable of being changed, overwritten, or deleted. Detection. Detect the alteration of audit logs.

Privacy and security: Audit

report(s) Enable a user to create an audit report for a specific time period and to sort entries in the audit log according to each of the elements specified in the below standard. Record actions related to electronic health information, audit log status, and encryption of end-user devices.

(1) When EHR technology is used to create, change, access, or delete electronic health information, the following information must be recorded: (i) The electronic health information affected by the action(s); (ii) The date and time each action occurs in accordance with the standard specified at RFC 1305 NTPv3 or RFC 5905 NTPv4; (iii)The action(s) that occurred; (iv)Patient identification; and (v) User identification.

(2) When the audit log is enabled or disabled, the following must be recorded: (i) The date and time each action occurs in accordance with RFC 1305 NTPv3 or RFC 5905 NTPv4); and (ii) User identification.

(3) As applicable, when encryption of electronic health information managed by EHR technology on end-user devices is enabled or disabled, the following must be recorded: (i) The date and time each action occurs in accordance with the standard specified at RFC 1305 NTPv3 or RFC 5905 NTPv4; and (ii) User identification.

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Privacy and security:

Amendments Enable a user to electronically amend a patient’s health record to: (A) Replace existing information in a way that preserves the original information; and (B) Append patient supplied information, in free text or scanned, directly to a patient’s health record or by embedding an electronic link to the location of the content of the amendment.

Enable a user to electronically append a response to patient supplied information in a patient’s health record.

Privacy and security:

Automatic log-off Terminate an electronic session after a predetermined time of inactivity. Privacy and security:

Emergency access. Permit an identified set of users to access electronic health information during an emergency. Privacy and security:

Encryption of data at rest If EHR technology manages electronic health information on an end-user device and the electronic health information remains stored on the device after use of the EHR technology on that device has stopped, the electronic health information must be encrypted in accordance with any encryption algorithm identified by the National Institute of Standards and Technology (NIST) as an approved security function in Annex A of the Federal Information Processing Standards (FIPS) Publication 140-2. This capability must be enabled by default (i.e., turned on) and must only be permitted to be disabled (and re-enabled) by a limited set of identified users.

or,

Electronic health information managed by EHR technology never remains stored on end-user devices after use of the EHR technology on those devices has stopped. Privacy and security:

Integrity Create a message digest in accordance with the standard for electronic health information has not been altered in transit. Standard. A hashing Verification that algorithm with a security strength equal to or greater than SHA–1 (Secure Hash Algorithm (SHA–1) as specified by the National Institute of Standards and Technology (NIST) in FIPS PUB 180–3 (October, 2008)) must be used to verify that electronic health information has not been altered.

Verify in accordance with the above standard upon receipt of electronically exchanged health information that such information has not been altered. Privacy and security:

Optional - accounting of disclosures

Record disclosures made for treatment, payment, and health care operations in accordance with the standard for Record treatment, payment, and health care operations disclosures. The date, time, patient identification, user identification, and a description of the disclosure must be recorded for disclosures for treatment, payment, and health care operations, as these terms are defined at 45 CFR 164.501.

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Patient engagement: View, download, and transmit to 3rd party

Enable a user to provide patients (and their authorized representatives) with online access to do all of the following:

(A) View. Electronically view in accordance with Web Content Accessibility Guidelines (WCAG) 2.0, Level AA Conformance, at a minimum, the following data elements: patient name; gender; date of birth; race; ethnicity; preferred language; smoking status; problem list; medication list; medication allergy list; procedures; vital signs; laboratory tests and values/results; provider’s name and contact information; names and contact information of any additional care team members beyond the referring or transitioning provider and the receiving provider; and care plan, including goals and instructions.

Patient engagement: View, download, and transmit to 3rd party

(B) Download. Electronically download:

(1) A file in human readable format that includes, at a minimum, all of the data elements specified above.

(2) A summary care record formatted according to HL7 Implementation Guide for Clinical Document Architecture, Release 2.0 (Consolidated CDA) (US Realm), Draft, September 2011, that includes, at a minimum, the following data elements expressed, where applicable, according to the specified standard(s): (i) Patient name; gender; date of birth; medication allergies; vital signs; laboratory tests and values/results; the referring or transitioning provider’s name and contact

information; names and contact information of any additional care team members beyond the referring or transitioning provider and the receiving provider; care plan, including goals and instructions; (ii) Race and ethnicity in accordance with OMB Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997;(iii) Preferred language in accordance with ISO 639-1:2002; (iv) Smoking status - Smoking status types must include: current everyday smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; and unknown if ever smoked; (v) Problems - at a minimum, IHTSDO SNOMED CT® International Release January 2012; (vi) Encounter diagnoses - The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions; (vii) Procedures - the code set specified at 45 CFR 162.1002(a)(5) or the code set specified at 45 CFR 162.1002(c)(3); (H) Laboratory test(s). At a minimum, LOINC® version 2.38; (viii) Laboratory value(s)/result(s). The value(s)/results of the laboratory test(s) performed; and (ix) Medications. At a minimum, RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, February 6, 2012 Release.