Meaningful Use Rules Finalized!

July 13, 2010 was, at least for those of us in the informatics field, a historic day: the release of the Stage 1 meaningful use rules by the Office of the National Coordinator for Health IT (ONC) and the Center for Medicare and Medicaid Services (CMS). These rules define explicitly what healthcare professionals and hospitals must do to quality for the incentive funding under the HITECH Act. As I have written before, the meaningful use framework is an excellent construct, enshrining the notion that HITECH is not just about adopting technology, but rather insuring it gets used in ways that benefit human health. As much as we love technology, we can never lose sight of the notion that, at least in healthcare, the goal of its use is to improve the care that people get. We do not always succeed at that, but it should always be what motivates us.

The final rules also demonstrate some other positive attributes about people, organizations, and governments. Most critical of these was that ONC and CMS listened, recognizing that the initial proposed rules were a little too much, too soon. So they dialed back, but not to the point of making the criteria too easy, which could have effectively turned the program into a government boondoggle, i.e., a subsidy for healthcare organizations. The whole ONC process has been very open and deliberate, involving many thoughtful people and organizations.

So what do the rules actually say? Before we get into the details, let's step back and look at the big picture. It is estimated that if every eligible professional and hospital meets the criteria, the cost of the program will be about $27 billion. When you add in the additional $2 billion invested in infrastructure (regional extension centers, HIE funding for the states, SHARP research projects, Beacon demonstration projects, and workforce development), the total cost will be $29 billion. That is no small sum of money, but is one of the those situations where the market would be unlikely to bring about this change. True to the American Recovery and Reinvestment Act (ARRA) from where it was legislated, the program certainly has created jobs and will likely create more.

As always with health IT, you can find a great deal information about the rules on the Web. One place to start, especially if you have a lot of time on your hands, is the full text of the final meaningful use rule (officially called the CMS Electronic Health Record Incentive Program, which also has an official Web site) and the final standards rule (officially called the Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology). However, for those of us with other things to do than read federal rules documents hundreds of pages long, concise early summaries are available from a number of places, including:

• An article in New England Journal of Medicine (NEJM) by Dr. David Blumenthal, National Coordinator
  
• Postings by Dr. John Halamka (Geek Doctor) on the meaningful use and standards rules, along with the beginnings of a frequently asked questions (FAQ) list
  
• A succinct overview from the Mr. HISTalk blog

The overall requirements from the ARRA legislation are of course still intact. The overall requirements for meaningful use involve:

• Use certified EHR technology in a meaningful manner
• Use certified EHR technology connected in a manner that provides for health information exchange to improve the quality of care
• Using certified EHR technology, the provider submits information on clinical quality measures

A certified EHR is a qualified EHR approved by an ONC- recognized certifying body. A qualified EHR is an electronic record of health-related information on an individual that includes patient demographic and clinical health information, such as medical history and problem lists and has the capacity to:

• Provide clinical decision support
• Support physician order entry
• Capture and query information relevant to healthcare quality
• Exchange electronic health information with, and integrate such information from, other sources

The incentives will be provided through increased Medicare or Medicaid reimbursement to eligible professionals (EPs), who include:

• Medicare: Physicians, Osteopathic Physicians, Dentists, Podiatrists, Optometrists, Chiropractors
• Medicaid: Physicians, Pediatricians, Dentists, Certified Nurse Midwives, Nurse Practitioners, Physician Assistants operating at an FQHC/RHC

As well as to eligible hospitals (EHs), which include:

• Medicare: hospitals paid under inpatient prospective payment system, critical acess hospitals; within the 50 states or DC
• Medicaid: acute care hospitals, childrens' hospitals

What follows is an overview of the criteria required to achieve meaningful use in Stage 1. The text that follows is gleaned most verbatim from Dr. Blumenthal's NEJM article as well as two PDF tables sent by email (can't find them on the Web) by ONC from the final regulations with the criteria sorted by core and menu items and by method of measure. An additional table from ONC compares the preliminary and final rules.

The rules are now organized so that in order to achieve meaningful use, an EP or EH must achieve 14 (EH) or 15 (EP) core rules and then five additional menu rules. There are also some additional twists on the menu rule. For example, some of them apply only to EPs while others apply only to EHs. In addition, one of the menu items selected must be a public health measure. This means that EPs must submit data to an immunization registry or syndromic surveillance registry, while EHs must submit to either of these or a reportable lab registry. However, if a state or regional public health agency is not prepared to accept such data, the EP or EH will not be penalized.

The 14-15 core measures must be achieved by all EPs and EHs in order to qualify for incentive payments. These include:

• Record patient demographics (sex, race, ethnicity, date of birth, preferred language, and in the case of hospitals, date and preliminary cause of death in the event of mortality) data - More than 50% of patients’ demographic data recorded as structured
• Record vital signs and chart changes (height, weight, blood pressure, body - mass index, growth charts for children) - More than 50% of patients 2 years of age or older have height, weight, and blood pressure recorded as structured data
• Maintain up-to-date problem list of current and active diagnoses - More than 80% of patients have at least one entry recorded as structured data
• Maintain active medication list - More than 80% of patients have at least one entry recorded as structured data
• Maintain active medication allergy list - More than 80% of patients have at least one entry recorded as structured data
• Record smoking status for patients 13 years of age or older - More than 50% of patients 13 years of age or older have smoking status recorded as structured data
• For individual professionals, provide patients with clinical summaries for each office visit; for hospitals, provide an electronic copy of hospital discharge instructions on request - Clinical summaries provided to patients for more than 50% of all office visits within 3 business days; more than 50% of all patients who are discharged from the inpatient department or emergency department of an eligible hospital or critical access hospital and who request an electronic copy of their discharge instructions are provided with it
• On request, provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, medication allergies, and for hospitals, discharge summary and procedures) - More than 50% of requesting patients receive electronic copy within 3 business days
• Generate and transmit permissible prescriptions electronically (does not apply to hospitals) - More than 40% are transmitted electronically using certified EHR technology
• Computer provider order entry (CPOE) for medication orders - More than 30% of patients with at least one medication in their medication list have at least one medication ordered through CPOE
• Implement drug-drug and drug-allergy interaction checks - Functionality is enabled for these checks for the entire reporting period
• Implement capability to electronically exchange key clinical information among providers and patient-authorized entities - Perform at least one test of EHR’s capacity to electronically exchange information
• Implement one clinical decision support rule and ability to track compliance with the rule - One clinical decision support rule implemented
• Implement systems to protect privacy and security of patient data in the EHR - Conduct or review a security risk analysis, implement security updates as necessary, and correct identified security deficiencies
• Report clinical quality measures to CMS or states - For 2011, provide aggregate numerator and denominator through attestation; for 2012, electronically submit measures

EPs and EHs must then select any five choices from the menu set. Criteria applicable to both EPs and EHs include:

• Implement drug formulary checks - Drug formulary check system is implemented and has access to at least one internal or external drug formulary for the entire reporting period
• Incorporate clinical laboratory test results into EHRs as structured data - More than 40% of clinical laboratory test results whose results are in positive/negative or numerical format are incorporated into EHRs as structured data
• Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach - Generate at least one listing of patients with a specific condition
• Use EHR technology to identify patient-specific education resources and provide those to the patient as appropriate - More than 10% of patients are provided patient-specific education resources
• Perform medication reconciliation between care settings - Medication reconciliation is performed for more than 50% of transitions of care
• Provide summary of care record for patients referred or transitioned to another provider or setting - Summary of care record is provided for more than 50% of patient transitions or referrals
• Submit electronic immunization data to immunization registries or immunization information systems - Perform at least one test of data submission and follow-up submission (where registries can accept electronic submissions)
• Submit electronic syndromic surveillance data to public health agencies - Perform at least one test of data submission and follow-up submission (where public health agencies can accept electronic data)

Additional menu criteria for EHs include:

• Record advance directives for patients 65 years of age or older - More than 50% of patients 65 years of age or older have an indication of an advance directive status recorded
• Submit of electronic data on reportable laboratory results to public health agencies - Perform at least one test of data submission and follow-up submission (where public health agencies can accept electronic data)

Additional criteria for EPs include:

• Send reminders to patients (per patient preference) for preventive and follow - up care - More than 20% or patients 65 years of age or older or 5 years of age or younger are sent appropriate reminders
• Provide patients with timely electronic access to their health information (including laboratory results, problem list, medication lists, medication allergies) - More than 10% of patients are provided electronic access to information within 4 days of its being updated in the EHR

In my postings ahead, I will explore the meaningful use criteria in more detail, especially from the standpoint of the competencies requires of informatics users, organizations, and systems.