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Tuesday, July 13, 2010

Meaningful Use Standards Summary


Click the link for information on Stage 2.

Rarely do I add something to a post after the fact that isn't a correction, but then few posts ever get this much attention so many days later. If you are interested in this post, there are more some more goodies you may want to look at.  I especially recommend the first.

This morning, HHS published the final rule for Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology for public display (see http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf).
This is my initial summary of the changes in the rule. John Halamka also published An analysis of the Final Standards Rule (see http://geekdoctor.blogspot.com/2010/07/analysis-of-final-standards-rule.html)
  1. While both CCD and CCR are retained as the standards for patient summaries, HHS requires the use of the HITSP C32 Version 2.5 (the version updated for the IFR) when CCD is used. This made my day, as the work I have been doing for the last 5 years is now incorporated into the final regulation text.
  2. Transport standards (SOAP and REST) have been removed from the Standards Final Rule.
  3. The requirement to use Electronic claims and eligibility transactions has been removed from the final rule, but is expected for 2013.
  4. For immunizations, the final rule now requires the CDC Implementation Guide for HL7 Version 2.3.1, or the new 1.0 guide using HL7 Version 2.5.1.
  5. For public health reporting the HL7 2.5.1 Public Health Information Network implementation guide is required to be used when HL7 2.5.1 is used (2.3.1 is also permitted and does not have a guide [thanks to Hans Buitendijk of Siemens for this catch])
  6. Standards for cross-enterprise user authentication have been removed.
  7. Rather than specifying AES for encryption, the final rule now references approved security functions found in Annex-A of FIPS 140-2. This allows most existing VPN connections and operating system encryption capabilities to continue to be used to meet the certification requirements.
  8. Accounting for disclosures is now an “optional” critieria.
  9. CPOE is no longer required for referrals, only meds, labs, and imaging/diagnostic tests.
  10. Both NCPDP SCRIPT 8.1 and 10.6 are allowed (10.6 was recently allowed under Medicare Part D rules).
  11. OMB guidelines must be followed when reporting race and ethnicity.  These guidelines do not specify code values, only the specific concepts that the codes must be able to roll up to.  The CDC Race and Ethnicity Code set is one such code set that supports this.
  12. Discharge summary requirement retained, but their inclusion in CCD/CCR not required. ONC recognized that they are not supported by the selected standards.
  13. HHS states that SNOMED-CT is allowed to report procedures.  However, this is apparently an error (see the next post), since ICD-9-CM is the alternative for procedures found in the regulation in that section.
  14. The HL7 Version 2.5.1 Electronic Laboratory Reporting implementation guide (the link only works if you are an HL7 member and logged in) is required for submission of laboratory results to public health.  This guide is available for purchase from HL7 for $50 according to Rita Altamore, and HL7 is updating their site to make it more accessible.
  15. A certified Hospital EHR must be able to record the availability of an Advance Directive.
HHS estimates the one-time costs for EHR developers to certify products will range from $750,000 to $4,800,000 depending upon whether the EHR has previously been certified or not. But also, they note that they believe the rule will not create a significant hardship on small business entities that produce EHR systems.

Thanks to Hans J. Buitendijk and David Tao of Siemens, Rob Savage (Northrup Grummund/CDC), Austin Kreisler (SAIC/CDC), Rita Altamore (Washington Deptartment of Health), and Nikolay Lipskiy (CDC) for the links to the various guides and other updates.


ONC EHR Criteria - Stage 1 Final July 2010
Don Sepulvada, Sr. Marketing Manager of GE Healthcare for our Centricity® EMR product line pulled together the following table from the standards rule. This table now includes all certification criteria and requirements for Ambulatory AND Hospital EHR products.  (Nice work Don!)

RuleMeaningful Use Stage 1 ObjectiveMeaningful Use Stage 1 MeasureInterim Final Certification CriterionFinal Certification Criterion
§170.302(a) - Drug-drug, drug-allergy, drug-formulary checksImplement drug-drug and drug-allergy interaction checksThe EP/eligible hospital/CAH has enabled this functionality for the entire EHR reporting periodInterim Final Rule Text:
(1)Alerts. Automatically and electronically generate and indicate in real-time, alerts at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, age, and computerized provider order entry (CPOE).
(3)Customization. Provide certain users with administrator rights to deactivate, modify, and add rules for drug-drug and drug-allergy checking.
(4)Alert statistics. Automatically and electronically track, record, and generate reports on the number of alerts responded
Final Rule Text:
§170.302(a)
(1) Notifications. Automatically and electronically generate and indicate in real-time, notifications at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, and computerized provider order entry (CPOE).
(2) Adjustments. Provide certain users with the ability to adjust notifications provided for drug-drug and drug-allergy interaction checks.
§170.302(a) - Drug-drug, drug-allergy, drug-formulary checksImplement drug-formulary checksThe EP/eligible hospital/CAH has enabled this functionality and has access to at least one internal or external drug formulary for the entire EHR reporting periodInterim Final Rule Text:
(2)Formulary checks. Enable a user to electronically check if drugs are in a formulary or preferred drug list in accordance with the standard specified in §170.205(b).
Final Rule Text:
§170.302(b)
Drug-formulary checks. Enable a user to electronically check if drugs are in a formulary or preferred drug list.
§170.302(b) - Maintain up-to-date problem listMaintain an up-to-date problem list of current and active diagnosesMore than 80% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one entry or an indication that no problems are known for the patient recorded as structured dataInterim Final Rule Text:
Maintain up-to-date problem list. Enable a user to electronically record, modify, and retrieve a patient’s problem list for longitudinal care in accordance with:
(1) The standard specified in §170.205(a)(2)(i)(A); or
(2) At a minimum, the version of the
Final Rule Text:
§170.302(c)
Final rule text remains the same as Interim Final Rule text, except for references to adopted standards, which have been changed.
§170.302(c) - Maintain active medication listMaintain active medication listMore than 80% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one entry (or an indication that the patient is not currently prescribed any medication) recorded as structured dataInterim Final Rule Text:
Maintain active medication list. Enable a user to electronically record, modify, and retrieve a patient’s active medication list as well as medication history for longitudinal care in accordance with the standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.302(d)
Maintain active medication list. Enable a user to electronically record, modify, and retrieve a patient’s active medication list as well as medication history for longitudinal care.
§170.302(d) - Maintain active medication allergy listMaintain active medication allergy listMore than 80% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21or 23) have at least one entry (or an indication that the patient has no known medication allergies) recorded as structured dataInterim Final Rule Text:
Maintain active medication allergy list. Enable a user to electronically record, modify, and retrieve a patient’s active medication allergy list as well as medication allergy history for longitudinal care.
Final Rule Text:
Unchanged
Now §170.302(e)
§170.302(e) - Record and chart vital signsRecord and chart changes in vital signs:
•          Height
•          Weight
•          Blood pressure
•          Calculate and display BMI
•          Plot and display growth charts for children 2-20 years, including BMI
For more than 50% of all unique patients age 2 and over seen by the EP or admitted to eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23), height, weight and blood pressure are recorded as structured dataInterim Final Rule Text:
(1)Vital signs. Enable a user to electronically record, modify, and retrieve a patient’s vital signs including, at a minimum, the height, weight, blood pressure, temperature, and pulse.
(2)Calculate body mass index. Automatically calculate and display body mass index (BMI) based on a patient’s height and weight.
(3) Plot and display growth charts. Plot and electronically display, upon request, growth charts for patients 2-20 years old.
Final Rule Text:
§170.302(f)
(1)Vital signs. Enable a user to electronically record, modify, and retrieve a patient’s vital signs including, at a minimum, height, weight, and blood pressure.
(2) Unchanged
(3) Unchanged
§170.302(f) - Smoking statusRecord smoking status for patients 13 years old or olderMore than 50% of all unique patients 13 years old or older seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or Emergency department (POS 21 or 23) have smoking status recorded as structured dataInterim Final Rule Text:
Smoking status. Enable a user to electronically record, modify, and retrieve the smoking status of a patient. Smoking status types must include: current smoker, former smoker, or never smoked.
Final Rule Text:
§170.302(g)
Smoking status. Enable a user to electronically record, modify, and retrieve the smoking status of a patient. Smoking status types must include: current every day smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; and unknown if ever smoked
§170.302(g) - Incorporate laboratory test resultsIncorporate clinical lab-test results into
certified EHR technology as structured data
More than 40% of all clinical lab tests
results ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period whose results are eitEHR in a positive/negative or numerical format are incorporated in certified EHR technology as structured data
Interim Final Rule Text:
(1) Receive results. Electronically receive clinical laboratory test results in a structured format and display such results in human eadable format.
(2) Display codes in readable format. Electronically display in human readable format any clinical laboratory tests that have been received with LOINC® codes.
(3) Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).
(4) Update. Enable a user to electronically update a patient’s record based upon received laboratory test results.
Final Rule Text:
§170.302(h)
(1) Unchanged
(2) Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).
(3) Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record.
§170.302(h) - Generate patient listsGenerate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research or outreachGenerate at least one report listing patients of the EP, eligible hospital or CAH with a specific conditionInterim Final Rule Text:
Generate patient lists. Enable a user to electronically select, sort, retrieve, and output a list of patients and patients’ clinical information, based on user-defined demographic data, medication list, and specific conditions.
Final Rule Text:
§170.302(i)
Generate patient lists. Enable a user to electronically select, sort, retrieve, and generate lists of patients according to, at a minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
(3) Demographics; and
(4) Laboratory test results.
§170.302(i) - Report quality measuresEligible
Professionals: Report ambulatory clinical quality measures to CMS or the States

Eligible Hospitals and CAHs: Report hospital clinical quality measures to CMS or the States
For 2011, provide aggregate numerator, denominator, and exclusions through attestation as discussed in section II(A)(3) of [the Medicare and Medicaid EHR Incentive Programs final rule]

For 2012, electronically submit the clinical quality measures as discussed in section II(A)(3) of [the Medicare and Medicaid EHR Incentive Programs final rule]
Interim Final Rule Text:
(1) Display. Calculate and electronically display quality measures as specified by CMS or states.
(2) Submission. Enable a user to electronically submit calculated quality measures in accordance with the standard and implementation
specifications specified in §170.205(e).
Final Rule Text:
§170.304(j)
(1) Calculate.
(i) Electronically calculate all of the core clinical measures specified by CMS for eligible professionals.
(ii) Electronically calculate, at a minimum, three clinical quality measures specified by CMS for eligible professionals, in addition to those clinical quality measures specified in paragraph (1)(i).
(2) Submission. Enable a user to electronically submit calculated clinical quality measures in accordance with the standard and implementation specifications specified in §170.205(f).
§170.302(j) - Check insurance eligibility and §170.302(k) - Submit claims§170.302(j) - Check insurance eligibility
Removed from
final rule
Removed from final ruleInterim Final Rule Text:
Enable a user to electronically record and display patients’ insurance eligibility, and submit insurance eligibility queries to public or private payers and receive an eligibility response in accordance with the applicable standards and implementation specifications specified in §170.205(d)(1) or (2).
Final Rule Text:
Removed
§170.302(j) - Check insurance eligibility and §170.302(k) - Submit claimseligibility and §170.302(k) - Submit claims
Removed from
final rule
Removed from final ruleInterim Final Rule Text:
Enable a user to electronically submit claims to public or private payers in accordance with the standard and implementation specifications specified in §170.205(d)(3).
Final Rule Text:
Removed
§170.302(l) - Medication reconciliationThe EP, eligible hospital or CAH who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliationThe EP, eligible hospital or CAH performs medication reconciliation for more than 50% of transitions of care in which the patient is transitioned into the care of the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23)Interim Final Rule Text:
Medication reconciliation. Electronically complete medication reconciliation of two or more medication lists by comparing and merging into a single medication list that can be electronically displayed in real-time.
Final Rule Text:
§170.302(j)
Medication reconciliation. Enable a user to electronically compare two or more medication lists.
§170.302(m) - Submission to immunization registriesCapability to submit electronic data to immunization registries or Immunization Information Systems and actual submission in accordance with applicable law and practicePerformed at least one test of certified EHR technology's capacity to submit electronic data to immunization registries and follow up submission if the test is successful (unless none of the immunization registries to which the EP, eligible hospital or CAH submits such information have the capacity to receive the information electronically)Interim Final Rule Text:
Submission to immunization registries.
Electronically record, retrieve, and transmit immunization information to immunization registries in accordance with:
(1) One of the standards specified in §170.205(h)(1) and, at a minimum, the version of the standard specified in §170.205(h)(2); or
(2) The applicable state-designated standard format.
Final Rule Text:
§170.302(k)
Submission to immunization registries.
Electronically record, modify, retrieve, and submit immunization information in accordance with: (1) The standard (and applicable implementation specifications) specified in §170.205(e)(1) or
§170.205(e)(2); and
(2) At a minimum, the version of the standard specified in §170.207(e).
§170.302(n) - Public health surveillanceCapability to submit electronic syndromic surveillance data to public health agencies and actual submission in accordance with applicable law and practicePerformed at least one test of certified EHR technology's capacity to provide electronic syndromic surveillance data to public health agencies and follow-up submission if the test is successful (unless none of the public health agencies to which an EP, eligible hospital or CAH submits such information have the capacity to receive the information electronically)Interim Final Rule Text:
Public health surveillance. Electronically record, retrieve, and transmit syndrome-based public health surveillance information to public health
agencies in accordance with one of the standards specified in §170.205(g).
Final Rule Text:
§170.302(l)
Public health surveillance. Electronically record, modify, retrieve, and submit syndrome-based public health surveillance information in
accordance with the standard (and applicable implementation specifications) specified in §170.205(d)(1) or §170.205(d)(2).
§170.302(o) - Access controlProtect electronic health information created or maintained by the certified EHR technology through the implementation of appropriate technical capabilitiesConduct or review a security risk analysis per 45 CFR 164.308 (a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management processInterim Final Rule Text:
Access control. Assign a unique name and/or number for identifying and tracking user identity and establish controls that permit only authorized users to access electronic health information.
Final Rule Text:
§170.302(o)
Unchanged
§170.302(p) - Emergency accessInterim Final Rule Text:
Emergency access. Permit authorized users (who are authorized for emergency situations) to access electronic health information during an emergency.
Final Rule Text:
§170.302(p)
Unchanged
§170.302(q) - Automatic log-offInterim Final Rule Text:
Automatic log-off. Terminate an electronic session after a re-determined time of inactivity.
Final Rule Text:
§170.302(q)
Unchanged
§170.302(r) - Audit logInterim Final Rule Text:
(1) Record actions. Record actions related to electronic health information in accordance with the standard specified in §170.210(b).
(2) Alerts. Provide alerts based on user-defined events.
(3) Display and print. Electronically display and print all or a specified set of recorded information upon request or at a set period of time.
Final Rule Text:
§170.302(r)
(1) Record actions. Record actions related to electronic health information in accordance with the standard specified in §170.210(b).
(2) Generate audit log. Enable a user to generate an audit log for a specific time period and to sort entries in the audit log according to any of the elements specified in the standard at 170.210(b).
§170.302(s) - IntegrityInterim Final Rule Text:
(1)In transit. Verify that electronic health information has not been altered in transit in accordance with the standard specified in §170.210(c).
(2) Detection. Detect the alteration and deletion of electronic health information and audit logs, in accordance with the standard specified in §170.210(c).
Final Rule Text:
§170.302(s)
(1) Create a message digest in accordance with the standard specified in 170.210(c).
(2) Verify in accordance with the standard specified in 170.210(c) upon receipt of electronically exchanged health information that such information has not been altered.
(3) Detection. Detect the alteration of audit logs.
§170.302(t) - AuthenticationInterim Final Rule Text:
(1)Local. Verify that a person or entity seeking access to electronic health information is the one claimed and is authorized to access such information.
(2)Cross network. Verify that a person or entity seeking access to electronic health information across a network is the one claimed and is authorized to access such information in accordance with the standard specified in §170.210(d).
Final Rule Text:
§170.302(t)
Authentication. Verify that a person or entity seeking access to electronic health information is the one claimed and is authorized to access such information.
§170.302(u) - EncryptionInterim Final Rule Text:
(1) General. Encrypt and decrypt electronic health information according to user-defined preferences in accordance with the standard specified in §170.210(a)(1).
(2) Exchange. Encrypt and decrypt electronic health information when exchanged in accordance with the standard specified in §170.210(a)(2).
Final Rule Text:
§170.302(u)
General encryption. Encrypt and decrypt electronic health information in accordance with the standard specified in §170.210(a)(1), unless the Secretary determines that the use of such algorithm would pose a significant security risk for Certified EHR Technology.
§170.302(v)
Encryption when exchanging electronic health information. Encrypt and decrypt electronic health information when exchanged in accordance with the standard specified in §170.210(a)(2).
§170.302(v) - Accounting of disclosuresInterim Final Rule Text:
Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in §170.210(e).
Final Rule Text:
§170.302(w)
Certification criterion made optional, while the text of this certification criterion remains unchanged
§170.304(a) - Computerized provider order entryUse CPOE for medication orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelinesMore 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 (POS 21 or 23) have at least one medication order entered using CPOEInterim Final Rule Text:
Enable a user to electronically record, store, retrieve, and manage, at a minimum, the following order types:
(1) Medications;
(2) Laboratory;
(3) Radiology/imaging; and
(4) Provider referrals.
Final Rule Text:
§170.304(a)
Computerized provider order entry. Enable a user to electronically record, store, retrieve, and modify, at a minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
§170.304(b) - Electronically exchange prescription informationGenerate and Transmit permissible prescriptions electronically (eRx)More than 40% of all permissible prescriptions written by the EP are transmitted electronically using certified EHR technologyInterim Final Rule Text:
Enable a user to electronically transmit medication orders (prescriptions) for patients in accordance with the standards specified in §170.205(c).
Final Rule Text:
§170.304(b)
Electronic prescribing. Enable a user to electronically generate and transmit prescriptions and prescription-related information in accordance with:
(1) The standard specified in §170.205(b)(1) or §170.205(b)(2); and
(2) The standard specified in 170.207(d).
§170.304(c) - Record demographicsRecord demographics
• preferred language
• gender
• race
• ethnicity
• date of birth
More than 50% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or Emergency department (POS 21 or 23) have Demographics recorded as structured dataInterim Final Rule Text:
Enable a user to electronically record, modify, and retrieve patient demographic data including preferred language, insurance type, gender, race, ethnicity, and date of birth.
Final Rule Text:
§170.304(c)
Record demographics. Enable a user to electronically record, modify, and retrieve patient demographic data including preferred language, gender, race, ethnicity, and date of birth. Enable race and ethnicity to be recorded in accordance with the standard specified at 170.207(f).
§170.304(d) - Generate patient reminder listSend reminders to
patients per patient
preference for
preventive/ follow
up care
More than 20% of
all unique patients
65 years or older or
5 years old or
younger were sent
an appropriate
reminder during
the EHR reporting
period
Interim Final Rule Text:
Electronically generate, upon request, a patient reminder list for preventive or follow-up care according to patient preferences based on demographic data, specific conditions, and/or medication list.
Final Rule Text:
§170.304(d)
Patient reminders. Enable a user to electronically generate a patient reminder list for preventive or follow-up care according to patient preferences based on, at a minimum, the data elements included in:
(1) Problem list;
(2) Medication list;
(3) Medication allergy list;
(4) Demographics; and
(5) Laboratory test results.
§170.304(e) - Clinical decision supportImplement one clinical decision support rule relevant to specialty or high clinical priority along with the ability to track compliance that ruleImplement one clinical decision support ruleInterim Final Rule Text:
(1) Implement rules. Implement automated, electronic clinical decision support rules (in addition to drug-drug and drugallergy contraindication checking) according to specialty or clinical priorities that use demographic data, specific patient diagnoses, conditions, diagnostic test results and/or patient medication list.
(2) Alerts. Automatically and electronically generate and indicate in real-time, alerts and care suggestions based upon clinical decision support rules and evidence grade.
(3) Alert statistics. Automatically and electronically track, record, and generate reports on the number of alerts responded to by a user.
Final Rule Text:
§170.304(e)
(1) Implement rules. Implement automated, electronic clinical decision support rules (in addition to drug-drug and drugallergy contraindication checking) based on the data elements included in: problem list; medication list; demographics; and laboratory test results.
(2) Notifications. Automatically and electronically generate and indicate in real-time, notifications and care suggestions based upon clinical decision support rules.
§170.304(f) - Electronic copy of health informationProvide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, medication allergies), upon requestMore than 50% of all patients of the EP or the inpatient or emergency departments of the eligible hospital or CAH (POS 21 or 23) who request an electronic copy of their health information are provided it within 3 business daysInterim Final Rule Text:
Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, and procedures in:
(1) Human readable format; and
(2) On electronic media or through some other electronic means in accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(f)
Electronic copy of health information. Enable a user to create an electronic copy of a patient’s clinical information,
including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in:
(1) Human readable format; and
(2) On electronic media or through some other electronic means in accordance with:
(i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2);
(B)Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
§170.304(g) - Timely accessProvide patients with timely electronic access to their health information (including lab results, problem list, medication lists, medication allergies) within four business days of the information being available to the EPMore than 10% of all unique
patients seen by the EP are
provided timely (available to
the patient within four
business days of being
updated in the certified EHR
technology) electronic access
to their health information
subject to the EP’s discretion
to withhold certain
information
Interim Final Rule Text:
Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list,
medication list, medication allergy list, immunizations, and procedures.
Final Rule Text:
§170.304(g)
Timely access. Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list, medication list, and medication allergy list.
§170.304(h) - Clinical summariesProvide clinical summaries for patients for each office visitClinical summaries provided to patients for more than 50% of all office visits within 3 business daysInterim Final Rule Text:
(1) Provision. Enable a user to provide clinical summaries to patients for each office visit that include, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations and procedures.
(2) Provided electronically. If the clinical summary is provided electronically it must be:
(i) Provided in human readable format; and
(ii) On electronic media or through some other electronic means in accordance with:
(A) One of the standards specified in §170.205(a)(1);
(B) The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);
(C) One of the standards specified in §170.205(a)(2)(ii);
(D) At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and
(E) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(h)
Clinical summaries. Enable a user to provide clinical summaries to patients for each office visit that include, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list. If the clinical summary is provided electronically it must be:
(1) Provided in human readable format; and
(2) Provided on electronic media or through some other electronic means in accordance with:
(i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2);
(B)Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
§170.304(i) - Exchange clinical information and patient summary recordCapability to exchange key clinical information (for example, problem list, medication list, medication allergies, diagnostic test results), among providers of care and patient authorized entities electronically
-----------------------The EP, eligible hospital or CAH 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 of care record for each transition of care or referral
Performed at least one test of certified EHR technology's capacity to electronically exchange key clinical information
----------------------
The EP, eligible hospital or CAH who transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 50% of transitions of care and referrals
Interim Final Rule Text:
(1) Electronically receive and display. Electronically receive a patient’s summary record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, medication allergy list, immunizations, and procedures in accordance with §170.205(a) and upon receipt of a patient summary record formatted in an alternate standard specified in §170.205(a)(1),
display it in human readable format.
(2) Electronically transmit. Enable a user to electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, and procedures in accordance with:
(i)One of the standards specified in §170.205(a)(1);
(ii)The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);
(iii)One of the standards specified in §170.205(a)(2)(ii);
(iv)At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and
(v)The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.304(i)
(1) Electronically receive and display. Electronically receive and display a patient’s summary record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, and medication allergy list in accordance with the standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient summary record formatted according to the alternative standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in accordance with:
(i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and
(ii) For the following data elements the applicable standard must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2);
(B) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(C) Medications. The standard specified in §170.207(d).
Patient EducationUse certified EHR technology to identify patient-specific education resources and provide those resources to the patient if appropriateMore than 10% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) are provided patient-specific education
resources
N/AFinal Rule Text:
§170.302(m)
Patient-specific education resources. Enable a user to electronically identify and provide patient-specific education resources according to, at a minimum, the data elements included in the patient’s: problem list; medication list; and laboratory test results; as well as provide such resources to the patient.
Measure CalculationN/AN/AN/AFinal Rule Text:
§170.302(n)
Automated measure calculation. For each meaningful use objective with a percentage-based measure, electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage associated with each applicable meaningful use measure.
HOSPITAL ONLY CRITERIA
§170.306(a) - Computerized provider order entryUse 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
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 (POS
21 or 23) have at
least one
medication order
entered using
CPOE
Interim Final Rule Text:
Enable a user to electronically record, store, retrieve, and
manage, at a minimum, the following order types:
(1) Medications;
(2) Laboratory;
(3) Radiology/imaging;
(4) Blood bank;
(5) Physical therapy;
(6) Occupational therapy;
(7) Respiratory therapy;
(8) Rehabilitation therapy;
(9) Dialysis;
(10) Provider consults; and
(11) Discharge and transfer.
Final Rule Text:
§170.306(a)
Computerized provider order entry. Enable a user to electronically record, store, retrieve, and modify, at a
minimum, the following order types:
(1) Medications;
(2) Laboratory; and
(3) Radiology/imaging.
§170.306(b) - Record demographicsRecord demographics
• preferred language
• gender
• race
• ethnicity
• date of birth
• date and
preliminary cause
of death in the
event of mortality
in the eligible
hospital or CAH
More than 50% of
all unique patients
seen by the EP or
admitted to the
eligible hospital’s
or CAH’s inpatient
or emergency
department (POS
21 or 23) have
demographics
recorded as
structured data
Interim Final Rule Text:
Enable a user to electronically record, modify, and retrieve
patient demographic data including preferred language,
insurance type, gender, race, ethnicity, date of birth, and
date and cause of death in the event of mortality.
Final Rule Text:
§170.306(b)
Record demographics. Enable a user to electronically
record, modify, and retrieve patient demographic data
including preferred language, gender, race, ethnicity, date of
birth, and date and preliminary cause of death in the event
of mortality. Enable race and ethnicity to be recorded in
accordance with the standard specified at §170.207(f).
§170.306(c) - Clinical decision supportImplement one
clinical decision
support rule related
to a high priority
hospital condition
along with the
ability to track
compliance with
that rule
Implement one
clinical decision
support rule
Interim Final Rule Text:
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drugallergy
contraindication checking) according to a high priority
hospital condition that use demographic data, specific patient
diagnoses, conditions, diagnostic test results and/or patient
medication list.
(2) Alerts. Automatically and electronically generate and
indicate in real-time, alerts and care suggestions based upon
clinical decision support rules and evidence grade.
(3) Alert statistics. Automatically and electronically track,
record, and generate reports on the number of alerts responded
to by a user.
Final Rule Text:
§170.306(c)
(1) Implement rules. Implement automated, electronic clinical
decision support rules (in addition to drug-drug and drugallergy
contraindication checking) based on the data elements
included in: problem list; medication list; demographics; and
laboratory test results.
(2) Notifications. Automatically and electronically generate
and indicate in real-time, notifications and care suggestions
based upon clinical decision support rules.
§170.306(d) - Electronic copy of health informationProvide patients
with an electronic
copy of their health
information
(including
diagnostic test
results, problem
list, medication
lists, medication
allergies, discharge
summary,
procedures), upon
request
More than 50% of
all patients of the
EP or the inpatient
or emergency
departments of the
eligible hospital or
CAH (POS 21 or
23) who request an
electronic copy of
their health
information are
provided it within 3
business days
Interim Final Rule Text:
Enable a user to create an electronic copy of a patient’s
clinical information, including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in:
(1) Human readable format; and
(2) On electronic media or through some other electronic
means in accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.306(d)
(1) Enable a user to create an electronic copy of a patient’s
clinical information, including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
and procedures:
(i) In human readable format; and
(ii) On electronic media or through some other electronic
means in accordance with:
(A) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(B) For the following data elements the applicable standard
must be used:
(1) Problems. The standard specified in §170.207(a)(1) or, at a
minimum, the version of the standard specified in
§170.207(a)(2);
(2) Procedures. The standard specified in §170.207(b)(1) or
§170.207(b)(2);
(3) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(4) Medications. The standard specified in §170.207(d).
(2) Enable a user to create an electronic copy of a patient’s
discharge summary in human readable format and on
electronic media or through some other electronic means.
§170.306(e) - Electronic copy of discharge informationProvide patients
with an electronic
copy of their
discharge
instructions at time of discharge, upon
request
More than 50% of
all patients who are
discharged from an
eligible hospital or
CAH’s inpatient department or
emergency
department (POS
21 or 23) and who
request an
electronic copy of
their discharge
instructions are
provided it
Interim Final Rule Text:
Enable a user to create an electronic copy of the discharge
instructions and procedures for a patient, in human readable
format, at the time of discharge on electronic media or
through some other electronic means.
Final Rule Text:
§170.306(e)
Electronic copy of discharge instructions. Enable a user to
create an electronic copy of the discharge instructions for a
patient, in human readable format, at the time of discharge on
electronic media or through some other electronic means.
§170.306(f) - Exchange clinical information and summary record.Capability to
exchange key
clinical information
(for example,
discharge
summary,
procedures,
problem list,
medication list,
medication
allergies, diagnostic
test results), among
providers of care
and patient
authorized entities
electronically
----------------------
The EP, eligible
hospital or CAH
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 of care
record for each
transition of care or
referral
Performed at least
one test of certified
EHR technology's
capacity to
electronically
exchange key
clinical information
----------------------
The EP, eligible
hospital or CAH
who transitions or
refers their patient
to another setting
of care or provider
of care provides a
summary of care
record for more
than 50% of
transitions of care
and referrals
Interim Final Rule Text:
(1) Electronically receive and display. Electronically receive a
patient’s summary record from other providers and
organizations including, at a minimum, diagnostic test results,
problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in
accordance with §170.205(a) and upon receipt of a patient
summary record formatted in an alternate standard specified in
§170.205(a)(1), display it in human readable format.
(2) Electronically transmit. Enable a user to electronically
transmit a patient’s summary record to other providers and
organizations including, at a minimum, diagnostic results,
problem list, medication list, medication allergy list,
immunizations, procedures, and discharge summary in
accordance with:
(i) One of the standards specified in §170.205(a)(1);
(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a
minimum, the version of the standard specified in
§170.205(a)(2)(i)(B);
(iii) One of the standards specified in §170.205(a)(2)(ii);
(iv) At a minimum, the version of the standard specified in
§170.205(a)(2)(iii); and
(v) The standard specified in §170.205(a)(2)(iv).
Final Rule Text:
§170.306(f)
(1) Electronically receive and display. Electronically receive
and display a patient’s summary record from other providers
and organizations including, at a minimum, diagnostic test
results, problem list, medication list, medication allergy list,
and procedures in accordance with the standard (and
applicable implementation specifications) specified in
§170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient
summary record formatted according to the alternative
standard, display it in human readable format.
(2) Electronically transmit. Enable a user to electronically
transmit a patient’s summary record to other providers and
organizations including, at a minimum, diagnostic results,
problem list, medication list, medication allergy list, and
procedures in accordance with:
(i) The standard (and applicable implementation
specifications) specified in §170.205(a)(1) or §170.205(a)(2);
and
(ii) For the following data elements the applicable standard
must be used:
(A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in
§170.207(a)(2);
(B) Procedures. The standard specified in §170.207(b)(1) or
§170.207(b)(2);
(C) Laboratory test results. At a minimum, the version of the
standard specified in §170.207(c); and
(D) Medications. The standard specified in §170.207(d).
§170.306(g) - Reportable lab resultsCapability to
submit electronic
data on reportable
(as required by
state or local law)
lab results to public
health agencies and
actual submission
in accordance with
applicable law and
practice
Performed at least one test of
certified EHR technology’s
capacity to provide electronic
submission of reportable lab
results to public health agencies
and follow-up submission if the
test is successful (unless none of
the public health agencies to
which eligible hospital or CAH
submits such information have
the capacity to receive the
information electronically)
Interim Final Rule Text:
Electronically record, retrieve, and transmit
reportable clinical lab results to public health
agencies in accordance with the standard
specified in §170.205(f)(1) and, at a minimum,
the version of the standard specified in
§170.205(f)(2).
Final Rule Text:
§170.306(g)
Reportable lab results. Electronically record,
modify, retrieve, and submit reportable clinical
lab results in accordance with the standard (and
applicable implementation specifications)
specified in §170.205(c) and, at a minimum, the
version of the standard specified in
§170.207(c).
Record Advance DirectivesRecord advance
directives for
patients 65 years
old or older
More than 50% of all unique
patients 65 years old or older
admitted to the eligible
hospital’s or CAH’s inpatient
department (POS 21) have an
indication of an advance
directive status recorded
N/AFinal Rule Text:
§170.306(h)
Advance directives. Enable a user to
electronically record whether a patient has an
advance directive.

11 comments:

  1. Keith,
    Wonderful work (and public service) as usual. BTW, the one Implementation Guide that came as rather a surprise (and hard to find on the web) was the one for syndromic surveillance from CDC. The FR references HL7 2.5.1: Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and the Errata and Clarifications National Notification Message Structural Specification. However, digging through the Internet to the CDC site, there is only a Version 2.0 out there. So if you have a direct link to the right IG, that would be wonderful.
    David

    ReplyDelete
  2. I think I found the guide I asked about. Here's the link
    http://www.cdc.gov/phin/library/documents/pdf/PHIN_NotifiableConditionMessageORUSpecification%20Final%20V1.0.pdf

    David

    ReplyDelete
  3. Excellent summary Keith! Your colleague Don Sepulvada deserves kudos as well for his outstanding work...

    ReplyDelete
  4. Thanks for posting, Keith! Now we need to add some columns that include the standards that match up to the references and an indicator of the ones that are optional versus core.

    Great work!

    ReplyDelete
  5. Excellent work to get the summary of Rules

    Thanks

    ReplyDelete
  6. Keith, re C32 v2.5, it points to HITSP C83 and C80. I THINK that v2.0 of those documents (published January 2010) is appropriate to use, but the FR is not specific about that, and I know that some people assume that C83/C80 v1.1 (published July 2009) are the appropriate versions. I hope NIST will clarify this soon, but do you have a recommendation and have you had any conversations with ONC or NIST about that?
    Thanks,
    David

    ReplyDelete
  7. Has anyone located the Errata document yet?

    ReplyDelete
  8. Keith,
    A slight suggested change on the item you have marked as "For public health reporting the HL7 2.5.1 Public Health Information Network implementation guide is required to be used when HL7 2.5.1".
    §170.205(d)(1) states "Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification". Notice the Errata and Clarifications part.
    I found another document that seems to be for the Errata and Clarifications. It seems like this should be used in addition to the document you have linked to.
    http://www.cdc.gov/phin/library/documents/pdf/errata_clarification/Msg%20Structure%20Spec%20v%201.0%20Errata%20and%20Clarifications%2005222008.pdf

    ReplyDelete
  9. Keith, I would like to know if in rule "170.302(o) - Access control", the differents area that the user will be access is defined, or just it means login or not login to the EHR System?

    Thanks

    ReplyDelete
  10. Thanks a lot Keith. This blog was very helpful.

    ReplyDelete