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

CMS Rule

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)

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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.

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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

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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

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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.

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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

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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 (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)

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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.

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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)

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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)

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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)

• Highlight, page 90

Stage 1 criteria, reliant on the electronic exchange of structured information between health care providers, we propose to set the percentage required for successful demonstration at 80 percent. (It’s only strange that this percentage is based on percentage of patients who request. As I think through this, what’s being measured is the timeliness, not the actual ability to do this, which has to be 100% from a capability perspective. The hospital then, needs to set a timer and ensure that from the moment of request that they meet the criteria. I suggest every patient and their family place the request right at admission, frankly. In other words, patients should not have to wait until discharge.)

• Highlight, page 91

Eligible Hospital Objective: Provide patients with an electronic copy of their discharge instructions and procedures at time of discharge, upon request. Eligible Hospital Measure: At least 80 percent of all patients who are discharged from an eligible hospital and who request an electronic copy of their discharge instructions and procedures are provided it. (Why not combine the two things, such that at any time, patient/family can request medical record during the admission. If they request at discharge or after, they get discharge information additionally, and if at discharge, they should get immediately since this is a fragile time)

• Highlight, page 92

EP Objective: Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, allergies) EP Measure: At least 10 percent of all unique patients seen by the EP are provided timely electronic access to their health information (frowny face. It says “lab results” here, where it says “diagnostic test results” above. This excludes imaging and path – why not just be consistent and make this section “diagnostic test results” so that whatever is shared by care providers is shared with patients [the most important care providers] )

• Highlight, page 93

We recognize that many patients may not have internet access, may not be able or interested to use a patient portal. Health systems that have actively promoted such technologies have been able to achieve active use by over 30 percent of their patients, but this may not be realistic for many practices in the short term. (This is a very low bar, I understand the rationale sort-of, however the numerator is a little squishy – it says “for example if”, doesn’t define what timely means, and what provision means. If it said “10 % of patients documented to review their diagnostic testing results online within 96 hours of transmission” that might be more supportive of this idea)

• Highlight, page 93

EP Objective: Provide clinical summaries to patients for each office visit. EP Measure: Clinical summaries provided to patients for at least 80 percent of all office visits. (Terrific. This allows organizations to compete on creating the best one. It’s important in this case that PAPER is an option, glad this is stated in the objective. Paper is very powerful in this context, this is an area where online doesn’t trump something you take away in your hand.)

• Highlight, page 94

EP Objective: Capability to exchange key clinical information (for example, problem list, medication list, allergies, and diagnostic test results), among providers of care and patient authorized entities electronically. (Again, there are two standards here, one for “care providers” who are not patients, and one for care providers who are the patients. The non-patients get more information than the patients do through the slight of a single word  – “diagnostic” vs “lab” for test results.)

• Highlight, page 95

EP/Eligible Hospital Objective: Perform medication reconciliation at relevant encounters and each transition of care. EP/Eligible Hospital Measure: Perform medication reconciliation for at least 80 percent of relevant encounters and transitions of care. (This answers my question farther up, good. And Medication reconciliation is defined above so good news there as well)

• Highlight, page 97

EP/Eligible Hospital Objective: Provide summary care record for each transition of care and referral. EP/Eligible Hospital Measure: Provide summary of care record for at least 80 percent of transitions of care and referrals. (Gosh, as I read this, it seems that there are two parallel universes – care providers who are patients themselves, and ones who are not. It almost seems redundant – why not just include patients in the care provider category and they get all the same information anyone else does during a transition. Isn’t that just easier and more accurate? This might keep the phr-ehr team competition within organizations from stopping innovation)

• Highlight, page 100

EP/Eligible Hospital Objective: Capability to provide electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice. (Kind of the same thing, whenever anything is reported that includes a specific patient’s data, it’s reported to the patient, too)

• Highlight, page 109

“Incorporate clinical lab-test results into EHR as structured data” will be expanded to include the full array of diagnostic test data used for the treatment and diagnosis of disease, where feasible, including blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear medicine tests, and pulmonary function tests; (….and let’s share all of these with patients)

• Highlight, page 111

We anticipate that for the 2012 payment year we will have completed the necessary steps to have the capacity to receive electronically information on clinical quality measures from EHRs including the promulgation of technical specifications for EHR vendors to use for obtaining certification of their systems.

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Despite the statutory limitation prohibiting the Secretary from requiring the electronic submission of clinical quality measures if HHS does not have the capacity to accept this information electronically, as previously discussed, the Secretary has broad discretion to establish requirements for meaningful use of certified EHR technology and for the demonstration of such use by EPs and eligible hospitals. (So the spotlight will be on meaningful use, which includes patient access, it’s good that this is up front and not later on)

• Highlight, page 119

• Clinical quality measures that promote CMS and HHS policy priorities related to improved quality and efficiency of care for the Medicare and Medicaid populations that would allow us to track improvement in care over time. These current and long term priority topics include: prevention; management of chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved efficiency; improved patient and family experience of care; improved end-of-life/palliative care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT. (Good reminder that elimination of health disparities and patient and family experience of care are important considerations for CMS so this area is an available one to influence change as well)

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TABLE 3: Proposed Clinical Quality Measures for Electronic Submission by Medicare or Medicaid Eligible Professionals for the 2011 and 2012 Payment Year

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Title: Controlling High Blood Pressure Description: Percentage of patients with last BP < 140/80 mm Hg. (This should include home measurement with validated cuff. Office blood pressure measurement is often inaccurate)

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The second required measure set for each EP is to submit information on at least one of the sets listed in Tables 5 and 19 as specialty groups. The specialty groups are Cardiology, Pulmonology, Endocrinology, Oncology, Proceduralist/Surgery, Primary Care Physicians, Pediatrics, Obstetrics and Gynecology, Neurology, Psychiatry, Ophthalmology, Podiatry, Radiology, Gastroenterology, and Nephrology. (Lots of tables follow. These are the kind of things that are very amenable to clinical decision support rules/ alerts, and again, because acting on these reduces much more severe problems [or they wouldn’t be included], they should not cause alert fatigue. The most leading edge providers will find a way to involve patients in understanding why these are important, so maybe an alert won’t be needed because the studies will be ordered by the patients themselves)

• Highlight, page 154

Stroke-4 Title: Ischemic stroke – Thrombolytic therapy for patients http://www.hitsp.org/ arriving within 2 hours of symptom onset ConstructSet_Details.a NQF 0437 Description: Acute ischemic stroke patients who arrive at this spx?&PrefixAlpha=5 hospital within 2 hours of time last known well and for whom IV &PrefixNumeric=906 t-PA was initiated at this hospital within 3 hours of time last known well. Measure Developer: The Joint Commission

• Highlight, page 172

We are proposing at §495.8 that for CY 2011 and FY 2011, EPs and eligible hospitals demonstrate that they satisfy each of the proposed meaningful use objectives specified in §495.6 through attestation

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As HIT advances we expect to move more of the objectives away from being demonstrated through attestation.

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As described below, the HITECH Act requires the Secretary to post online the names of Medicare EPs and eligible hospitals and CAHs who are meaningful EHR users for the relevant payment year.

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Section 1848(o)(3)(D) of the Act requires the Secretary to list in an easily understandable format the names, business addresses, and business phone numbers of the Medicare EPs and, as determined appropriate by the Secretary, of group practices receiving incentive payments for being meaningful EHR users under the Medicare FFS program on our internet web site. We do not propose to post information on group practices because we do not propose to base incentive payments at the group practice level.

• Highlight, page 179

Section 1848(o)(1)(C , states that hospital-based EPs are not eligible for the Medicare incentive payments.

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(Based on preliminary claims data from the first 9 months of 2009, CMS currently estimates that, under this proposed definition, about 27 percent of Medicare EPs CMS-0033-P 187 (physicians) would be considered hospital-based and thus not eligible to receive any incentive payments. We do not have any data on Medicaid practitioners.)

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(physicians) would be considered hospital-based and thus not eligible to receive any incentive payments. We do not have any data on Medicaid practitioners.)

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Some primary care EPs who provide services to Medicare and Medicaid beneficiaries would be ineligible for the incentive payments. For example, we currently estimate that under this proposal, 12-13 percent of family practitioners under Medicare would be considered hospital-based under our proposed definition of hospital-based EP, and therefore would not be eligible for the EHR incentive payments.

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• As will be explained in the next section of this proposed rule, the hospital’s total incentive payment is based on total inpatient services. As result, a hospital with a large outpatient department will not receive a higher incentive payment as a result of their outpatient services. • Finally, as previously discussed, we are proposing that the Stage 1 meaningful use criteria for eligible hospitals apply only to a hospital’s inpatient setting. Because of these factors, we are concerned that hospital investment in their outpatient primary care sites is likely to lag behind their investment in their inpatient EHR systems. To address these concerns, as part of future rulemaking, we plan to consider ways to realign the meaningful use objectives and criteria to include a broader definition of hospital care to include outpatient services. (Right)

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In accordance with section 1848(o)(5)(C) of the Act, we propose to add a definition of the term “eligible professional” in our regulations at §495.100 to mean a physician as defined under section 1861(r) of the Act. Section 1861(r) of the Act defines the term “physician” to mean the following five types of professionals, each of which must be legally authorized to practice their profession under state law: a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of

• Highlight, page 192

podiatric medicine, a doctor of optometry, or a chiropractor. (Dentists and Podatrists and Chiropractors, too. I don’t know much about how these professionals bill Medicare or not, it would be interesting and useful to see patient access to their work as well – I hadn’t thought of a Chiropractic PHR before now….)

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TABLE 22: Maximum Total Amount of EHR Incentive Payments for a Medicare EP who does not Predominantly Furnish Services in a HPSA

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Increase in Incentive Payment for EPs who Predominantly Furnish Services in a Geographic Health Professional Shortage Area (HPSA) Section 1848(o)(1)(B)(iv) of the Act provides that the amount of the annual incentive payment limit for each payment year be increased by 10 percent

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Section 1848(a)(7) of the Act, as amended by section 4101(b) of the HITECH Act, provides for payment adjustments effective for CY 2015 and subsequent years for EPs who are not meaningful EHR users during the relevant EHR reporting period for the year

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The term ‘applicable percent’ means: “(I) for 2015, 99 percent (or, in the case of an EP who was subject to the application of the payment adjustment if the EP is not a successful electronic prescriber under section 1848(a)(5) for 2014, 98 percent);” “(II) for 2016, 98 percent; and (III) for 2017 and each subsequent year, 97 percent.

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but in no case shall the applicable percent be less than 95 percent.

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In addition to the base amount, the discharge related amount provides an additional $200 for each hospital discharge during a payment year, beginning with a hospital’s 1,150th discharge of the payment year, and ending with a hospital’s 23,000th discharge of the payment year. (More discharges = more $$$ , up to 23,000 per year)

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Medicare Share

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We propose to determine the numbers of Medicare Part A and Part C inpatient-bed-days using the same data sources and methods for counting those days that we employ in determining Medicare’s share for purposes of making payments for direct graduate medical education costs, as provided under section 1886(h) of the Act and §413.75 of our regulations.

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The exclusion of charges attributable to charity care has the effect of decreasing the denominator of the Medicare share fraction as the proportion of charity care (charity care charge ratio) provided by a hospital increases.

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Figure 1–Incentive Payment Calculation for Subsection D Hospitals

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In other words, the Secretary is required to subject eligible hospitals who are not meaningful users to one-quarter, one-half, and three-quarters reductions of their market basket updates in FY 2015, FY 2016, and FY 2017 and subsequent years respectively.

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A hospital that fails to report quality data and does not qualify as a meaningful EHR user would receive an update of 1.0 percent, which represents the full 2.0 percent update minus the reduction of one-quarter (0.5 percentage point) for failing to report

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quality data, and a further reduction of 0.5 percentage point (33 1/3 percent of three- quarters of the full update: 1/3 times 1.5 equals 0.5).

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qualifying EPs who do not have individual TINs (that is, a qualifying EP who works solely in a group practice) will be paid at the group practice level’s TIN.

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are proposing that qualifying EPs select one TIN for disbursement of their Medicare EHR incentive payment.

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We will conduct selected compliance reviews of EPs, eligible hospitals, and qualified CAHs who register for the incentive programs and of recipients of incentive payments for the meaningful use of certified EHR technology. The reviews will validate provider eligibility their meaningful use attestations including verification of meaningful use and would also review components of the payment formulas.

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C. Medicare Advantage (MA) Organization Incentive Payments

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Therefore, over the EHR reporting period, the qualifying EP must provide on average 20 hours per week of patient care services.

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Section 1853(m)(3)(B)(i) of the Act, as added by section 4101(c) of the HITECH Act, provides that if for a payment year at least one-third (33 percent) of a MA eligible hospital’s discharges (or bed-days) of Medicare patients are covered under Part A (rather than under Part C), the hospital may only receive an incentive payment under section 1886(n) of the Act – the Medicare FFS incentive program.

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So, the maximum cumulative incentive payment over 5 years to a qualifying MA organization for each of its qualifying MA EPs that meaningfully use certified EHRs beginning on or before 2012 would be $44,000 per qualifying MA EP.

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We estimated the national average FFS allowed amounts for the 5 levels of office visit codes (CPT codes 99211 – 99215) in 2009 to be: $20, $39, $63, $95, $129, respectively. We contemplated allowing, but not requiring, qualifying MA organizations to report consultation codes for specialist physicians (CPT codes 99241 – 99245) estimated to have national average FFS allowed amounts of $50, $94, $129, $190, and $234, respectively. (There it is, what a doctor can bill for each type of an office visit. A primary care physician seeing a patient for a cold is likely to bill at 99212 or 3, so $39 or $63 – no wonder primary care is in crisis)

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Meaningful User Attestation We propose meaningful user attestation requirements in §495.210. For each MA EP and MA-affiliated hospital for which a qualified MA organization seeks an incentive payment, the organization must attest, in a form and manner specified by us, that its MA EPs and MA-affiliated eligible hospitals are meaningful EHR users, as required by sections 1853(l)(6) and 1853(m)(1) of the Act.

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we note that qualifying MA organizations sponsoring coordinated care MA plans are already required to submit Healthcare Effectiveness Data and Information Set (HEDIS), Health Outcomes Survey (HOS), and Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures per §422.152 and §422.516. Coordinated care MA plans include HMO, PPO and RPPO (Regional PPO) plans. Beginning with CY 2010, PFFS and MSA plans will also be required to begin collecting and submitting administrative HEDIS measures.

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Sections 1853(l)(7) and 1853(m)(5) of the Act, require us to post information on an Internet website related to the receipt of incentive payments under the MA EHR incentive program. Information would include the names, business addresses, and business phone numbers of each qualifying MA organization receiving an incentive payment under this section for qualifying MA EPs and hospitals. A list of the names of

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each qualifying MA EP and qualifying MA-affiliated eligible hospital for which an incentive payment has been made would also be posted. Since this requirement is applicable to other Medicare EPs and eligible hospitals, we have included this requirement in proposed §495.108. (Translation – you’ll be able to tell if your doctor uses a meaningful EHR before you go to see them, imagine how this will change the landscape of quality rating on the Web)

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In future rulemaking we will develop standards related to payment adjustments to qualifying MA organizations related to MA EPs and MA-affiliated eligible hospitals that are not meaningful users of certified EHR technology.

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Robert Miller and Christopher West report that initial EHR costs per full-time-equivalent (FTE) billing provider averaged almost $54,000, with much variation across CHCs and within each cost category, including hardware, software, installation, training, etc. and ongoing costs per FTE provider, per year, averaged $20,6105.

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The CBO paper goes further to say that few detailed studies available report that total costs for office-based EHRs are about $25,000 – $45,000 per physician6 and estimates for annual costs for operating and maintaining the system, which include software licensing fees, technical support, and updating and replacing used equipment range between $3,000 to $9,000 per physician per year7.

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An article written by the Agency for Healthcare Research and Quality (AHRQ), Research Activities, September 2005, Health Information Technology, adoption rates of electronic health records are low among physician groups — indicates that the average purchase and implementation cost of an EHR was $32,606 per FTE physician. The article indicates that maintenance costs were an additional $1,500 per physician, per month and smaller practices had the highest implementation costs per physician at $37,2048.

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However, based on the information reviewed, we determined that the average costs for initial EHR systems currently can range from $25,000 to $54,000 in the implementation year, per professional. Since the average costs of EHR technology in the first year can be as much as $54,000 and no less than $25,000, and since we believe the costs of such technology will be increasing we are proposing to set the average allowable cost at $54,000.

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TABLE 27: Maximum Incentive Payment Amount for Medicaid Professionals

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TABLE 28: Payment Scenarios For Medicaid EPs Who Begin Adoption in the First Y ear

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TABLE 33: Burden and Capital Costs associated with Meaningful Use Objectives and Associated Measures

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Send reminders to patients per patient preference for preventive/ follow up care Reminder sent to at least 50% of all unique patients seen by the EP that are age 50 or over Reporting requirement: numerator and denominator data The burden associated with this measures is included in the 0.5 hour attestation burden estimate TBD – cost of having functionality to send reminders to patients

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Estimated Total Burden and Total Capital Cost per Respondent for attestation to EHR technology, Set A Set B measures, and attestation and reporting of quality measures (I don’t think these numbers, based on the studies above, include costs for patient portals, so this may be low)

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To estimate capital costs, we assume a certified EHR will cost roughly $54,000 as explained in section V.G.4 of this proposed rule. (This does not includes costs for patient portals, remember, so this is artificially low)

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TABLE 34: Burden and Cost Estimates Associated with Information Collection Requirements ( I don’t think there are good estimates of the capital costs of patient portals )

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Overall, we expect spending under the EHR incentive program for transfer payments to Medicare and Medicaid providers to be between $14 and $27 billion over 10 years

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In total, we estimate that there are approximately 624,000 healthcare organizations (EPs or eligible hospitals) that will be affected by the incentive program.

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About 553,200 original Medicare FFS EPs in 2011 (some of which will also be Medicaid EPs).  About 27 percent of the total EPs are hospital-based Medicare EPs, and are not eligible for the program. This leaves approximately 404,400 nonhospital-based Medicare EPs in 2011.  Twenty percent of the nonhospital-based Medicare EPs (approximately 80,900 Medicare EPs in 2011) are also eligible for Medicaid (meet the 30 percent Medicaid patient volume criteria) but can only be paid under one program. Any EP in this situation will choose to receive the Medicaid incentive payment, because it is larger.

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About 38,200 non-Medicare eligible EPs (such as dentists, pediatricians, and eligible non-physicians such as certified nurse-midwives, nurse practitioners and physicians assistants) will be eligible to receive the Medicaid incentive payments.  5,011 eligible hospitals, comprised of the following: ++ 3,620 acute care hospitals. ++ 1,302 CAHs (Medicare only). ++ 78 children’s hospitals (Medicaid only). ++ 11 cancer hospitals (Medicaid only).

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12 MA Organizations (about 28,000 EPs, and 29 hospitals) would be eligible for incentive payments.  Payments can begin as early as FY 2011.

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Based on these studies, we estimate for EPs, the average adopt/implement/upgrade cost is $54,000 per physician FTE, while annual maintenance costs average $10,000 per physician FTE. (Again, these studies typically do not include costs to provide patient electronic access, open to correction on this point)

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The CBO estimated a cost range of $25,000 to $45,000 per physician. (I don’t think this includes patient access services)

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TABLE 35: Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology, High and Low Scenario

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We estimate that there are 12 MA plans that might be eligible to participate in the EHR incentive program. Those plans have about 28,000 EPs.

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TABLE 36: Estimated Costs (+) and Savings (–) for Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology, Low Scenario (in billions)

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TABLE 38: Hospital IT Capabilities By Hospital Size

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TABLE 47: Assumed Number of Nonhospital Based Medicaid EPs Who Will Be Meaningful Users of Certified EHR Technology, High Scenario

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ario

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Qualified EHR means 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 meet all of the following: (1) Provide clinical decision support. (2) Support physician order entry. (3) Capture and query information relevant to health care quality. (4) To exchange electronic health information with, and integrate such information from other sources.

26 Comments

Thank you so so much! I've dreaded plowing through it.

First question – this is unclear to me: "It says patient’s can’t have access to all of their diagnostic test results, just lab tests. Imaging and pathology. Same goes for progress notes, too."

Do you mean not imaging, pathology, and progress notes?

(If so, that'll be really disappointing, as you say, because among other things Regina Holliday still would be unable to see the reports that nobody on her husband's care team had acted upon, causing him much pain and harm.)

Hey Dave,

Thanks so much for picking up on that un-clarity. I/the world need you to review those pages carefully and provide your comment so we can understand this together. It appears that:

"Diagnostic test results" = lab + imaging + path

"Lab results" = lab only

There's a requirement that "diagnostic test results" be provided electronically, on request, within 48 hours

There's a requirement that "lab results" be provided and accessible, by 96 hours of being finalized

I don't see any mention of providing progress notes at all.

First, can you double check my accuracy?

Second, if this is accurate, it seems that the rule is saying that imaging and path are not required to provided routinely, only on request.

Third, what are some alternatives in your mind –

A. Replace all mention of "lab results" with "diagnostic test results"

B. More general – define patient as a care provider with the same standing as any other care provider such that any information that is exchanged to another doctor (during care transitions, etc), is routinely available to the patient online, too.

C. Other?

Thanks, glad you, CMS, HIT Policy Committee, ONC, and "the crowds" are here. I neglected to mention above that 4-5 years ago, we couldn't imagine that this kind of support for electronic health records and patients' access to them would exist. It does, and I for one am grateful. Glass 3/4 full,

Ted

Ted, Dave,

although this is a typical US discussion, allow me to say that I would go for option B, having the patient with the same standing as any other provider. That's in my view one of the things you need to create that partnership of trust we at ICMCC are talking about for quite a while.

Lodewijk

Hi Lodewijk,

Thanks for commenting – I realize that I have neglected to find any feedback from leaders such as yourself from other countries – how does all of this strike you and your colleagues? Do you think the U.S. is on the right track? Are you impressed with our progress or do you think we could be/should be doing more? Where are you at in your journey – what areas do you lead / lag us? Comparisons are helpful…

I didn't do a thorough investigation of how the rule would be different if it was restructured the way I suggested (eliminating the patient / care provider distinction), but maybe as others look at it they can see if it makes sense.

Power of the crowd,

Ted

Hi Ted —

Many thanks for publishing your annotated reading.

One of the requirements that interests me is on page 89 — "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."

What bothers me is that this is contingent upon patient request. How many patients actually think of requesting an electronic copy of their info? The proportion must be pretty small. I often don't think of it myself with all the other things I'm trying to remember at a doctor's visit. While I agree that the time (48 hours) for fulfilling such a request is important (and this seems to be the emphasis of this "objective"), what's even more relevant is HAVING THE CAPABILITY to provide patients an electronic copy of their info in the first place–regardless of the specific time frame.

I think patients would be better served if the requirement were to proactively OFFER patients (or some proportion of patients) an electronic copy of their health info. As a prerequisite of offering it, providers would have to have the capability to actually do so. Just that simple act–getting providers to ask people if they want an electronic copy–would help drive patient awareness and demand for HIT as effectively as a major education campaign.

In the following objective (p. 92-93) the regs go on to discuss how 10% of patients should have access to their health info electronically via means such as a patient portal. I would assume that offering a patient portal is a big undertaking relative to giving people an electronic copy of their info and letting them do with it what they wish — including taking advantage of major independent PHRs such as Health Vault, Google, and Dossia offer. So go with the low hanging fruit. I'm not saying providers shouldn't also be encouraged to build a patient potal, etc, but realistically not all can or will, especially in the short term.

Ever been in a store or restaurant that has a sign posted at the cash registers: "If we don't offer you a copy of your receipt, your meal is on us…"? Signs like that encourage employees and customers alike to think about the information they are transacting and share more. I'm not saying that providers should have to pony up a lunch if they forget to offer, but making the offer of electronic health info to patients standard is a great opportunity to drive awareness–as well as use–of HIT.

– Lygeia

Hi Ted,

allow me to get back on this in the next couple of days, as I want to go through the details before giving you an answer. In a general sense I can already say that I know of no other country where this discussion is being held so extensively and so publicly, if at all.

Lodewijk

Thanks to the several people who picked up on, and suggested ideas regarding unequal treatment for lesbian, gay, bisexual, and transgender Americans. I received this comment from Danny Rosenthal, MD, from National Quality Forum and am reposting it here:

"In regards to your post on the 10th regarding, what sounds like a call to standardize collection of sexual identity – I asked around to some disparities folks at NQF about prior work on this. Couldn’t find too much – I would suggest staying tuned to the disparities work at NQF (see our website for more info) and insert feedback at the right time… may be a good forum."

Ted Eytan, MD