A PDF version of the rule with my highlights. Click the image above to download.

I love rules and regulations, and I don’t mean that sarcastically, because a rule or a regulation isn’t a rule or regulation. It’s the way the will of the people is executed. Once I began to see rules and regulations that way, i appreciated them as windows, small puzzles, into the minds of the people who are trying to solve a problem.

The corollary to all of this is that whenever someone says to me, “The rule says X, do Y,” my response is “let’s go read it together.” My “read the regulation yourself’ approach is very important, because it’s likely that the approach to satisfying the rule depends on knowing the care process and what the problem being solved was/is. The goal is not to satisfy the rule, after all, it’s to solve the problem that created the rule.

With that in mind, I read the CMS Proposed Rule: Medicare and Medicaid Programs; Electronic Health Record Incentive Program , and my annotations are below (comments are bolded in parens). The front part is about the problems to be solved, the back part is about paying for the problems to be solved. With that in mind, I focused more on the front part.

As it says in the title of the post, the perspective I am bringing is about patient access to their health care information:

I find the rule to be encouraging in most areas (really):

• It validates the inpatient setting as the next frontier of patient access to their health care information (avoiding the 73-cents-type disasters that happen during many hospitalizations today).
• It promotes use of the After Visit Summary.
• It sets a time limit on patient access to their health data of 96 hours. Better late than never.

It’s discouraging in some areas:

• It says patient’s can’t have automated access to all of their diagnostic test results after 96 hours of finalization, just lab tests. Imaging and pathology aren’t included in the definition of lab tests. Same goes for progress notes, too. It appears that they can “request” the other testing and that these need to be delivered in 48 hours. So, maybe this is functionally equivalent? If a reader could review the pages and comment that would be helpful to me – This is somewhat confusing to me.
• It perpetuates and codifies federal discrimination against lesbian, gay, bisexual, and transgender Americans in EHR implementations. I know this is bigger than a CMS rule, however, the written word in this rule promotes practices that ensure that these Americans will continue to experience disparities that will ultimately cost them and our nation good health and productivity. A leader in the last Administration once said to me, “We know this is a problem, we are just not allowed to address it.” Well, we should be allowed to now….(and if anyone reading this has some ideas for me, let me know, I’m happy to assist)

Also, on costs, the studies that it uses to base costs of EHR implementations do not include patient portals. These have usually been funded on top of these estimates. That’s what I think. I don’t know if that changes anything about the incentive payments. It just may affect how people perceive the cost of implementation of a full meaningful use EHR.

I’m not planning on submitting this information as comments to CMS, but you are welcome to copy-pasted as you see fit if you are going to, and finally, as it says on my About page, the views expressed here are my own and not of any organization I am affiliated with.

You’ll see a stream of consciousness in my notes, keep that mind. Feel free to comment, and to follow my example, read the rule yourself, it’s worth it if you care about this.

• Highlight, page 16

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) was enacted on February 17, 2009

• Highlight, page 16

These provisions, together with Title XIII of Division A of ARRA, may be cited as the Health Information Technology for Economic and Clinical Health Act” or the “HITECH Act.”

• Highlight, page 17

CMS and ONC have been working closely to ensure that the definition of meaningful use of certified EHR technology and the standards for certified EHR technology are coordinated. “Meaningful use” is a term defined by CMS and describes the use of HIT that furthers the goals of information exchange among health care professionals. In an upcoming interim final rule, ONC will identify the initial set of standards and implementation specifications that EHR technology must implement, as well as the certification criteria that will be used to certify EHR technology, and will further define the term “certified EHR technology.”

• Highlight, page 18

in the original Medicare program or hereinafter referred to as Medicare Fee-for-Service (FFS)

• Highlight, page 20

The HITECH Act creates incentives in the Medicare Fee-for-Service (FFS), Medicare Advantage (MA), and Medicaid programs for demonstrating meaning EHR use and payment adjustments in the Medicare FFS and MA programs for not demonstrating meaningful EHR use.

• Highlight, page 23

ONC will be defining certified EHR technology in its upcoming interim final rule and we propose to use the definition of certified EHR technology adopted by ONC.

• Highlight, page 26

For these sections, the EHR reporting period may be any continuous 90-day period within the first payment year and the entire payment year for all subsequent payment years.

• Highlight, page 27

For example, for payment year 2011, an EHR reporting period of March 13, 2011 to June 11, 2011 would be just as valid as an EHR reporting period of January 1, 2011 to April 1, 2011. An example of an unallowable EHR reporting period would be for an EP to begin on November 1, 2011 and finish on January 31, 2012.

• Highlight, page 28

Moreover, as discussed later in this proposed rule, we will require EPs and hospitals to demonstrate meaningful use by meeting certain performance thresholds (for example, EPs will need to use CPOE for 80 percent of all orders, and hospitals for 10 percent of all orders)

• Highlight, page 29

For the first payment year, therefore, we propose that the EHR reporting period will be any continuous 90-day period within the first payment year. However, beginning in the second payment year we see no compelling reason not to seek the most robust verification possible. Therefore for the second payment year and all subsequent payment years we propose the EHR reporting period be the entire payment year.

• Highlight, page 29

For example, allowing an EHR reporting period to begin as early as July 3, 2010 would allow an eligible hospital to successfully CMS-0033-P 30 demonstrate meaningful use on October 1, 2010, the first day of FY 201

• Highlight, page 30

Due to the operational challenges presented and the statutory requirement to avoid duplication of payments to the extent possible, we are proposing that the earliest start date for EHR reporting period be the first day of the payment year.

• Highlight, page 32

We propose to define at §495.4 the term “meaningful EHR user” as an EP or eligible hospital who, for an EHR reporting period for a payment year, demonstrates meaningful use of certified EHR technology in the form and manner consistent with our standards (discussed below).

• Highlight, page 34

In developing its recommendations, the HIT Policy Committee considered a report entitled “National Priorities and Goals” (http://www.nationalprioritiespartnership.org/uploadedFiles/NPP/08-253- NQF%20ReportLo%5b6%5d.pdf) generated by the National Priorities Partnership, convened by the National Quality Forum (NQF). Of the national health care priorities set forward by the NQF report, the HIT Policy Committee chose as priority areas patient engagement; reduction of racial disparities; improved safety; increased efficiency; CMS-0033-P 35 coordination of care; and improved population health to drive their recommendations. Those recommendations are available electronically at http://healthit.hhs.gov.

• Highlight, page 35

coordination of care; and improved population health to drive their recommendations

• Highlight, page 35

Section V. of this proposed rule discusses the current adoption rates of HIT

• Highlight, page 37

Therefore, we propose to create a common definition of meaningful use that would serve as the definition for providers participating in the Medicare FFS and MA EHR incentive program, and the minimum standard for EPs and eligible hospitals participating in the Medicaid EHR incentive program.

• Highlight, page 40

meaningful use of certified EHR technology should result in health care that is patient-centered, evidence-based, prevention-oriented, efficient, and equitable.

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We are considering updating the meaningful use criteria on a biennial basis, with the Stage 2 criteria proposed by the end of 2011 and the Stage 3 definition proposed by the end of 2013.

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Stage 1: The Stage 1 meaningful use criteria focuses on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes

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Stage 2: Our goals for the Stage 2 meaningful use criteria

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encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized

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Stage 3: Our goals for the Stage 3 meaningful use criteria are, consistent with other provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety and efficiency, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data and improving population health.

• Highlight, page 42

We intend that Medicaid EPs and eligible hospitals who qualify for an incentive payment for adopting, implementing, or upgrading in their first payment year would follow the same meaningful use progression outlined below as if their second payment year was their first payment year.

• Highlight, page 46

Table 1 outlines our proposal to apply the respective criteria of meaningful use for each payment year (1st, 2nd, 3rd, etc.) for EPs and eligible hospitals that become meaningful EHR users before 2015. Please note that nothing in this discussion limits us to proposed changes to meaningful use beyond Stage 3 through future rulemaking. TABLE 1: Stage of Meaningful Use Criteria by Payment Year * Avoids payment adjustments only for EPs in the Medicare EHR Incentive Program. ** Stage 3 criteria of meaningful use or a subsequent update to the criteria if one is established through rulemaking.

• Highlight, page 48

CMS and ONC have carefully reviewed the objectives and measures proposed by the HIT Policy Committee. We found many objectives to be well suited to meaningful use, while others we found to require modification or clarification. In our discussion we will focus on those areas where our proposal is a modification of the recommendation of the HIT Policy Committee.

• Highlight, page 49

We also removed the phrase “etc.” We believe that the level of ambiguity created by “etc” is not appropriate for Federal regulations.

• Highlight, page 49

For Stage 1 criteria, we propose that it will not include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic imaging center.

• Anchored Note, page 49

CPOE

Wow, no electronic transmittal required of the order?

• Highlight, page 50

We describe a “problem list” as a list of current and active diagnoses as well as past diagnoses relevant to the current care of the patient. (The first official definition of an electronic problem list I have seen)

• Highlight, page 50

emographics: preferred language, insurance type, gender, race and ethnicity, and date of birth

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Record the following demographics: preferred language, insurance type, gender, race and ethnicity, and date of birth. We note that race and ethnicity codes should follow current federal standards published by the Office of Management and Budget

• Highlight, page 50

Record the following demographics: preferred language, insurance type, gender, race and ethnicity, and date of birth. We note that race and ethnicity codes should follow current federal standards published by the Office of Management and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr).

• Highlight, page 50

We do not propose to include the objective “Record Advance directives.” (Looking at the rationale, I wonder if this decision is politically driven, based on events of the summer of 2009. I think it’s reasonable to ask that an EHR store a patient’s wishes for life sustaining care, and unforunately a lot of EHRs do this very poorly, resulting in lots of confusion and poor outcomes when they are least needed by stressed patients and families.)

• Highlight, page 51

plot and display growth charts for children 2 – 20 years, including BMI. This is a modification to the HIT Policy Committee recommendation to require eligible professionals to record vital signs: height, weight, blood pressure and calculate BMI. We added “plot and display growth charts for children 2 – 20 years, including BMI” to the objective recommended by the HIT Policy Committee, as BMI itself does not provide adequate information for children. (Interesting example of CMS going beyond what was recommended; I understand the rationale – meaningful use looks like a back door for guideline implementation)

• Highlight, page 52

Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, and outreach. (unfortunately, LGBT status is not respected as a vulnerable population in the rule due to well-described federal discrimination against this group, so this group will be completely passed over in benefitting, even though the data shows clearly that they suffer disparities in the health care system – this should be changed)

• Highlight, page 52

Send reminders to patients per patient preference for preventive/follow-up care. Patient preference refers to the patient’s choice of delivery method between internet based delivery or delivery not requiring internet access. (First mention of patient access! Noted, page 52)

• Highlight, page 54

It does not include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic imaging center in 2011 or 2012. (So, basically, the EHR is a typewriter for these types of orders in 2010)

• Highlight, page 55

We note that race and ethnicity codes should follow current federal standards published by the Office of Management and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr).. (Note exclusion of lesbian, gay, bisexual, transgender Americans in the group of people experiencing disparities)

• Highlight, page 57

We believe greater clarification is required around the term clinical decision support. We propose to describe clinical decision support as health information technology functionality that builds upon the foundation of an EHR to provide persons involved in care processes with general and person-specific information, intelligently filtered and organized, at appropriate times, to enhance health and health care. (Okay, this definition as operationalized in health care typically means “not including the patient” when “persons involved in care processes” are discussed. Not sure if this is a huge deal, but in the future, perhaps a clinical decision support rule might be one aimed at patients rather than doctors/nurses)

• Highlight, page 58

The second health outcomes policy priority identified by the HIT Policy Committee is to engage patients and families in their healthcare. The following care goal for meaningful use addresses this priority: ( smile )

• Highlight, page 58

For purposes of all objectives of the Stage 1 criteria of meaningful use involving the disclosure of information to a patient, a disclosure made to a family member or a patient’s guardian consistent with Federal and State law may substitute for a disclosure to the patient.

• Highlight, page 58

Provide patients with an electronic copy of their health information (including diagnostics test results, problem list, medication lists, allergies) upon request. CMS-0033-P 59 Consistent with the HIT Policy Committee’s recommendations, we propose the following additional clarification of this objective. Electronic copies may be provided through a number of secure electronic methods (for example, personal health record (PHR), patient portal, CD, USB drive).

• Highlight, page 59

Consistent with the HIT Policy Committee’s recommendations, we propose the following additional clarification of this objective. Electronic copies may be provided through a number of secure electronic methods (for example, personal health record (PHR), patient portal, CD, USB drive). (The so-called “PDF is okay” clause)

• Highlight, page 59

Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, allergies) within 96 hours of the information being available to the EP. Also, consistent with the HIT Policy Committee recommendations, we propose the following additional clarification of this objective. Electronic access may be provided by a number of secure electronic methods (for example, PHR, patient portal, CD, USB drive). Timely is defined as within 96 hours of the information being available to the EP either through the receipt of final lab results or a patient interaction that updates the EP’s knowledge of the patient’s health. We judge 96 hours to be a reasonable amount of time to ensure that certified EHR technology is up to date. We welcome comment on if a shorter or longer time is advantageous. (Hmmm…4 days. It’s certainly better than never. Where does imaging and pathology fall into this time frame?)

• Highlight, page 59

We do not propose to include the objective “Provide access to patient-specific education resources upon request.” (This seemed confusing to me from the start, I understand the rationale – I think providing the raw information is going to drive this happening, that’s where the focus should be anyway, in my opinion)

• Highlight, page 60

Provide clinical summaries for patients for each office visit. Changed from encounter to office visit. The HIT Policy Committee recommended the objective “ Provide clinical summaries for patients for each encounter.” We believe this objective requires further clarification in order make the distinction that it is not meant to apply to alternative encounters such as telephone or web visits. As a result, we propose to revise this objective to “Provide clinical summaries for patients for each office visit.”

• Highlight, page 60

As a result, we propose

• Highlight, page 60

Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, allergies, discharge summary, procedures), upon request. Consistent with the HIT Policy Committee’s recommendations, we propose the following additional clarification of this objective. Electronic copies may be provided through a number of secure electronic methods (for example, Personal Health Record (PHR), patient portal, CD, USB drive). (PHR in the inpatient setting is made possible by this – excellent)

• Highlight, page 60

Provide patients with an electronic copy of their discharge instructions and procedures at time of discharge, upon request.

• Highlight, page 61

By “diagnostic test results” we mean all data needed to diagnose and treat disease, such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear medicine tests, and pulmonary function tests. (Excellent, this means that imaging and pathology are included in the definition of diagnostic testing. They are currently not considered the same as “test results” in many organizations for the purpose of sharing. This ends that distinction – however further down, we go back to “lab tests” for patient sharing, excluding imaging and path. Let’s not do that.)

• Highlight, page 62

Examples would include an insurance company that covers the patient or a personal health record vendor identified by the patient. (This hints at interoperability in Stage 1 – “personal health record vendor” identified by the patient – does this override the 96 hour delay discussed above?)

• Highlight, page 62

We propose to describe medication reconciliation as the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency and route, by comparing the medical record to an externally list of medications obtained from a patient, hospital or other provider. (Wow, a single definition for medication reconciliation. This is significant)

• Highlight, page 63

Provide summary care record for each transition of care or referral. (A net add by CMS , was not in the initial HIT Pol objectives explicitly, just referred to)

• Highlight, page 63

The patient’s health care team communicates with public health agencies. The goal as recommended by the HIT Policy Committee is “communicate with public health agencies.” We found this goal to be somewhat ambiguous, as it does not specify who must communicate with public health agencies. We propose to specify “the patient’s health care team” as who would communicate with public health agencies. (Below this there are some specifics – this looks like a lot to accomplish)

• Highlight, page 64

The fifth health outcomes policy priority is to ensure adequate privacy and security protections for personal health information. The following care goals for meaningful use address this priority: Ensure privacy and security protections for confidential information through operating policies, procedures, and technologies and compliance with applicable law. Provide transparency of data sharing to patient. (What will the objective be for the last bullet point? Reading with anticipation. I read further down and couldn’t find the measurable objective spelled out, unless “provide transparency” is referring to the items above in patient access)

• Highlight, page 66

For each of these measures utilizing a percentage and the reporting of clinical quality measures, we propose at §495.10 that EPs and eligible hospitals submit numerator and denominator information to CMS. We invite comment on our burden estimates associated with reporting these measures (see section III. of this proposed rule). (This is where we get into numbers)

• Highlight, page 68

we are proposing all measures be limited to actions taken at practices/locations equipped with certified EHR technology. (So if part of the practice is not using an EHR, that doesn’t go into the count)

• Highlight, page 68

We are proposing that to be a meaningful EHR user an EP must have 50 percent or more of their patient encounters during the EHR reporting period at a practice/location or practices/locations equipped with certified EHR technology. (But practices can’t limit EHR use to a subset of their organization to collect the incentive based on percentages, let’s see how this plays out with patient access)

• Highlight, page 72

EP/Eligible Hospital Objective: Maintain an up-to-date problem list of current and active diagnoses based on ICD-9-CM or SNOMED CT® EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the EP or admitted to the eligible hospital have at least one entry or an indication of none recorded as structured data. (This is good for patients – there are many products out there that create crosswalks between these codes and searchable terms on the Internet, and in the future, the actual codes themselves will be the best search terms – let’s get away from “patient friendly” conversions)

• Highlight, page 74

EP/Eligible Hospital Objective: Maintain active medication list. EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the EP or admitted by the eligible hospital have at least one entry (or an indication (I don’t see how this supports maintaining the list accurately or having the patient confirm its accuracy, I’ll keep reading – and sure enough, reconciliation events are discussed later on)

• Highlight, page 78

The numerator for this objective is the number of unique patients seen by the EP or admitted to an inpatient facility/department (POS 21) that falls under the eligible hospital’s CCN during the EHR reporting period who have all required demographic elements (preferred language, insurance type, gender, race, and ethnicity, date of birth and, for hospitals, date and cause of death in the case of mortality) recorded as structured data in their electronic record.(I’m going to say this because I have a feeling no one else will, sadly, and that is that sexual minority status should also be recorded as a demographic – all of the concerns/fears that go with recording this have already been addressed in getting us to the place where we record ethnicity and race, if there’s disagreement on this point, I’d like to hear it)

• Highlight, page 83

EP/Eligible Hospital Objective: Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, and outreach. EP/Eligible Hospital Measure: Generate at least one report listing patients of the EP or eligible hospital with a specific condition. (Not very robust – “create a list of patients once” – I’ll keep reading, this is Stage 1)

• Highlight, page 84

EP Objective: Send reminders to patients per patient preference for preventive/ follow-up care EP Measure: Reminder sent to at least 50 percent of all unique patients seen by the EP or admitted to the eligible hospital that are 50 and over (Messy – the hospital would send preventive care reminders? What about the patient’s primary physician? This one seems a little un-supportive if not threatening to good primary care. I have a feeling that hospitals would rather not be accountable for this task, but I could be wrong…) (Corrected 1/12/10 – this is an EP measure, not a hospital measure, this is clarified in the IFR document – I am still confused about the insertion of ‘eligible hospital’ in the requirement)

• Highlight, page 86

Research has shown that decision support must be targeted and actionable to be effective, and that “alert fatigue” must be avoided. (Actually, Research has not shown that “alert fatigue” must be avoided – the alert fatigue part of this sentence has been thrown in, but it has no basis in evidence that I know of, e.g. that alert fatigue exists when the alerts are accurate. Feel free to correct me on this point.)

• Highlight, page 89

EP Objective: Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, and allergies) upon request Eligible Hospital Objective: Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, allergies, discharge summary, and procedures), upon request. EP/Eligible Hospital Measure: At least 80 percent of all patients who request an electronic copy of their health information are provided it within 48 hours. (Great. This will prevent another 73 cents disaster. Diagnostic tests does include radiology and path as discussed above. Progress notes are not included, though, why not? They should be)

» Read more: Now Reading: Proposed CMS Rule for EHR Incentives (from a patient access perspective)