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Tuesday, January 26, 2010

Meaningful Use NPRM Comments

As promised, I've been reviewing the Meaningful Use NPRM.  Below you can find some of my comments as this proposed rule relates to the use of certified EHR technology and the Meaningful Use IFR.  In the following, Roman text is quoted from the NPRM.  Text in Italics are my comments on it.  In this review I have only focused on issues of clinical content used to meet the objectives, and the measures of them, and the relationship of the NPRM to the IFR.  I have not addressed any issues related to payment, schedules, et cetera.

§495.6 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs.
(c) Stage 1 criteria for EPs and eligible hospitals or CAHs.
On each of the Measure sections of this part the text "of all unique patients seen by the EP or admitted to an eligible hospital or CAH" should be amended to include "during the EHR Reporting period". This applies to sections (c)(2)(ii), (c)(3)(ii), (c)(4)(ii), (c)(5)(ii), (c)(7)(ii), (c)(11)(ii), (c)(13)(ii) and (c)(14)(ii).  This is a minor but necessary clarification.  I don't believe that HHS intended for
the measure criteria to include all patients ever seen by an EP, eligible hospital or CAH, but it doesn't explicitely state the reporting period in the measures.


(5)(i) Objective.
(A) Preferred language.
(B) Insurance type.
(C) Gender.
(D) Race.
(E) Ethnicity.
(F) Date of birth.
(G) For eligible hospitals or CAHs, the date and cause of death in the event of mortality.
Subpart (5)(i)(B) should indicate what is meant by Insurance Type.  There are several vocabularies used to describe insurers, including those found in the 4010 and 5010 implementation guides from X12N and others found in HL7.  At the very minumum, we need to know what distinctions are important here.
Subpart (5)(i)(D) and (E) should reference OMB Guidance on the reporting of Race and Ethnicity.  It will not be helpful to report race and ethnicity if everyone does it differently and cannot role up to the OMB categories.


(5)(ii) Measure. At least 80 percent of all unique patients seen by the EP or admitted to the eligible hospital or CAH have the demographics specified in paragraphs (c)(5)(i)(A) through (G) of this section recorded as
structured data.
This section should be amended to state 'recorded as structured data or an indication that the patient declined to provide this information or does no know it.'  This change is needed because under OMB guidance and as elsewhere defined in healthcare standards (e.g., HL7), Race and Ethnicity are self declared by the person being so classified, and such classification should be voluntary.

(c)(6)(i) Objective.
(1) Height.
(2) Weight.
(3) Blood pressure.
(B) Calculate and display the body mass index (BMI) for patients 2 years and older.
(C) Plot and display growth charts for children 2 to 20 years including body mass index.
(ii) Measure. For at least 80 percent of all unique patients age 2 years or older seen by the EP or admitted to the eligible hospital, record blood pressure and BMI and plot the growth chart for children age 2 to 20 years old.
The measure in subpart (6)(ii) requires the recording of BMI, not height and weight.  However, BMI can be dynamically computed from Height and Weight as recognized in subpart (B), and the latter two have other clinical uses (e.g., weight based dosing).  I would recommend that the measure be altered to replace BMI with height and weight.  This measure would then be aligned with 42 CFR §170.302 (e) Record and chart vital signs found in the IFR, which indicates that a system should "..electronically record, modify, and retrieve a patient’s vital signs including, at a minimum, the height, weight, blood pressure, temperature, and pulse."

Also in 42 CFR §170.302 (e) (3) "Plot and display growth charts. Plot and electronically display, upon request, growth charts for patients 2-20 years old.", but (6)(ii) Requires that the growth chart be plotted for children age 2 to 20 years old.  In this case, the NPRM should be altered to state that the EP, eligible hospital or CAH has enabled functionality to plot a growth chart for children age 2 to 20 years old.

Why?  While an annual review of the patients BMI should be performed, it should not be made necessary for every visit made by the patient.  It may not be relevant for the condition for which the
patient is being treated (e.g., a referral to an ENT for an ear infection), and would require providers to engage in additional activitity in order to be a meaningful user without a specific medical benefit to the patient.


The modified section (6)(ii) appears as I suggest rewording it below:
(6)(ii) Measure. (A) For at least 80 percent of all unique patients age 2 years or older seen by the EP or admitted to the eligible hospital, record blood pressure, height and weight.and BMI and
(B) The EP, eligible hospital or CAH has enabled functionality to plot a growth chart for children age 2 to 20 years old.


(d) Additional Stage 1 criteria for EPs.
Under this section, several references are made to use of certified EHR technology to report, transmit or provide information.  However, these transmissions can be performed in a number of ways, only a few of which conform to use of the standards selected by the Meaningful Use IFR and which would be required for certification.  For example, prescriptions could be ordered by the certified product using FAX technology rather than use of the selected NCPDP SCRIPT standard.  I would like to see
clarification made to these sections to be clear what form of report, transmission or provision of this information is acceptable.
 

(4)(i) Objective. Send reminders to patients per patient preference for preventive/follow-up care.
(ii) Measure. Reminder sent to at least 50 percent of all unique patients seen by the EP that are 50 years of age and over.
The objective and measure are not coordinated.  There are a number of reminders (e.g.,
immunization) that are appropriate for patients under 50 years of age.  I would recommend removing the age constraint on the measure.  Yes, this will increase the burden on providers to remind
patients of necessary treatment, but to counter that, I would suggest that the percent be reduced to 25% of all unique patients to compensate.



(5)(i) Objective. Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, and allergies) upon request.
(ii) Measure. At least 80 percent of all patient requests for an electronic copy of their health information are provided it within 48 hours.
(6)(i) Objective. Provide patients with timely electronic access to their health information (including diagnostic test results, problem list, medication lists, and allergies) within 96 hours of the information being available to the EP.
(ii) Measure. At least 10 percent of all unique patients seen by the EP are provided timely electronic access to their health information.
I happen to like this one, as it basically gives patients the right to electronic access to their information without some of the rigamarole I've had to go through in the past.  However, these two basically state the similar things, with two different measures of performance.  I would remove one of these and alter the other to include the requirements of the first.  For example:
(6)(i) Objective. Provide patients with timely electronic access to their health information (including diagnostic test results, problem list, medication lists, and allergies) upon request within 96 hours of the information being available to the EP.
(ii) Measure. At least 80 percent of all patient requests for an electronic copy of their health information are provided it within 96 hours of the information being available to the EP.

This restatement also eliminates the issue of having to rely on patient participation to be seen as a meaningful user, as would be the case in the existing measure under (6)(ii).


(8)(i) Objective. Capability to exchange key clinical information among providers of care and patient authorized entities electronically.
(ii) Measure. Perform at least one test of certified EHR technology's capacity to electronically exchange key clinical information.
As noted under my comments on the Meaningful use IFR, the capability to communicate key
clinical information crosses the boundaries of provider type, and so this requirement should be moved up to section (c).  All provider types should be able to recieve key information regardless of the provider type that communicated it.  Definitions of "key information" produced by a provider type might be retained under section (d) and section (e) and referenced in section (c).


(e) Additional Stage 1 criteria for eligible hospitals or CAHs.
Under this section, several references are made to transmit or provide information, or to report "in the form and manner specified by CMS." However, these transmissions can be performed in a number of ways, only a few of which conform to use of the standards selected by the Meaningful Use IFR and which would be required for certification. I would like to see clarification made to these sections to be clear what form of report, transmission or provision of this information is acceptable and ensure that it is aligned with the standards selection (e.g., PQRI).


(3)(i) 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.
(ii) Measure. At least 80 percent of all patient requests for an electronic copy of their health information are provided it within 48 hours
(4)(i) Objective. Provide patients with an electronic copy of their discharge instructions and procedures at time of discharge, upon request.
(ii) Measure. At least 80 percent of all patients who are discharged from an eligible hospital or CAH and who request an electronic copy of their discharge instructions and procedures are provided it.
Again I like these, but there are repetetive and can be combined.  I would merge them into one
requirement:

(3)(i) Objective. Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, allergies, discharge summary, discharge instructions and procedures), upon request.
(ii) Measure. At least 80 percent of all patient requests for an electronic copy of their health information are provided it within 48 hours (5)(i) Objective. Capability to exchange key clinical information (for example, discharge summary, procedures, problem list, medication list, allergies, and
diagnostic test results) among providers of care and patient-authorized entities electronically.


§495.332 State Medicaid (HIT) plan requirements.
    ...
(f) Optional--proposed alternatives. A State may choose to propose any of the following, but they must be included as an element in the State Medicaid HIT Plan for review and approval:
    ...
(2) (i) Additional requirements for qualifying a Medicaid provider as a meaningful user of certified EHR technology consistent with §495.4 and §495.316(e) of this part.
(ii) A State may propose additional meaningful use objectives beyond the Federal standards at §495.6, if they do not require additional functionality beyond that of certified electronic health record technology. See also §495.316(e).
§495.8 Demonstration of meaningful use criteria.

(a) Demonstration by EPs. An EP must demonstrate that he or she satisfies each of the applicable objectives and associated measures under §495.6 of this subpart as follows:
(1) For CY 2011,
(iii) For Medicaid EPs, if, in accordance with §495.316 and §495.332, CMS has approved a State's additional criteria for meaningful use, demonstrate meeting such criteria using the method approved by CMS.
I'm not particularly in favor of adopting standards only to allow them to be altered or modified so that we wind up with 56 different requirements across the country.  While the States need to have input in how they deal with Medicaid recipients, the altering of meaningful use criteria on a state-by-state level will not be beneficial to patients or providers country wide.  I'd like to see more clarity made in §495.332 that functionality includes the selected standards.  For example, functionally the electronic transmission of prescriptions could be performed using standards other than the selected standard in the IFR.

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