Sunday, January 3, 2010

Electronic Medical Records: HHS Releases a Proposal

HHS released its proposal for EMR this past week. Dr Blumenthal the leader of the effort summarized the work, somewhat, in NEJM and he states:

"On December 30, the government took several critical steps toward a nationwide, interoperable, private, and secure electronic health information system. The Department of Health and Human Services (DHHS) released two proposed regulations affecting HIT . The first, a notice of proposed rule-making (NPRM), describes how hospitals, physicians, and other health care professionals can qualify for billions of dollars of extra Medicare and Medicaid payments through the meaningful use of electronic health records (EHRs). The second, an interim final regulation, describes the standards and certification criteria that those EHRs must meet for their users to collect the payments. "

We comment here on the second.

First the definition is as follows:

"4. Definition of Qualified Electronic Health Record (EHR)

Qualified EHR is defined at section 3000(13) of the PHSA as “an electronic record of health-related information on an individual that:

(A) includes patient demographic and clinical health information, such as medical history and problem lists; and

(B) has the capacity:

(i) to provide clinical decision support;

(ii) to support physician order entry;

(iii) to capture and query information relevant to health care quality; and

(iv) to exchange electronic health information with, and integrate such information from other sources.” We have adopted the statutory definition of Qualified EHR without modification."

The second part of the definition is rant with issues. As we have argued for the past year, and in fact for over two decades now, the complexity of an EMR is significant. Also as we have argued having the Federal Government define it is totally bassakwards. After all these are the same people who run TSA, the Treasury Department and the like. Not overly comforting. Let me take a closer look. What does "provide clinical decision support" really mean. Let us look at an example.

A 60 year old man comes in with lower back pain. Should we do an MRI, perhaps a herniated disc, yet many men have these with no symptoms. He may have prostate cancer mets, he may have multiple myeloma. Should not the physician using his or her standard differential diagnosis, based upon knowledge of the patient, make a judgment? Or are we using the EMR as the camel's nose in the tent regarding the Comparative Clinical Effectiveness scam which is rationing is Government clothes.

Let us go to the health care quality element. Again, what is quality, and are we then developing a system to monitor the health care provider and assessing his or her quality. If so then we may have increased the level of defensive medicine.

Finally exchanging information with whom and for what purpose. This is a massive task if we take this literally and also manage to stay within the bounds of HIPPA.

Let me continue from the HHS document:

"5. Definition of EHR Module

We have defined the term EHR Module to mean any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

Examples of EHR Modules include, but are not limited to, the following:

• an interface or other software program that provides the capability to exchange electronic health information;

• an open source software program that enables individuals online access to certain health information maintained by EHR technology;

• a clinical decision support rules engine;

• a software program used to submit public health information to public health authorities; and

• a quality measure reporting service or software program.

While the use of EHR Modules may enable an eligible professional or eligible hospital to create a combination of products and services that, taken together, meets the definition of Certified EHR Technology, this approach carries with it a responsibility on the part of the eligible professional or eligible hospital to perform additional diligence to ensure that the certified EHR Modules selected are capable of working together to support the may provide the additional capabilities necessary to meet the definition of Certified EHR Technology, but may not integrate well with each other or with the other EHR technology they were added to. As a result, eligible professionals and eligible hospitals that elect to adopt and implement certified EHR Modules should take care to ensure that the certified EHR Modules they select are interoperable and can properly perform in their expected operational environment."

Thus HHS is not only "choosing winners" but it has made itself the "winner". Unlike the Internet IETF approach of having the users and user groups holistically evolve the standards, HHS has taken the approach of having some group of GS 12s decide what is best. They will become the Certification agent for all EMRs.

Specifically a Certified EHR is defined as:

"Certified EHR Technology is defined at section 3000(1) of the PHSA as “a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are applicable to the type of record involved.”

In this interim final rule, we have slightly revised the definition of Certified EHR Technology to make it more consistent with the initial standards, implementation specifications, and certification criteria that are being adopted. Certification criteria focus on the capabilities of Complete EHRs or EHR Modules and consequently, Certified EHR Technology should be defined in accordance with that approach.

We believe defining Certified EHR Technology in that manner will provide greater clarity and
meaning for this interim final rule.

We have defined Certified EHR Technology to mean:

A Complete EHR or a combination of EHR Modules, each of which:

1) meets the requirements included in the definition of a Qualified EHR; and

2) has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary.

To clarify the meaning of “applicable certification criteria” in this definition’s second part, we note that Congress indicated their expectation that different types of HIT would be certified. Congress elaborated on this expectation with a parenthetical in the statutory definition, which references two examples, “an ambulatory electronic health record for office-based physicians” and “an inpatient hospital electronic health record for hospitals.”

For a variety of reasons, including that certain proposed meaningful use Stage 1 objectives only apply to an eligible professional or eligible hospital and that these two types of health care providers require different capabilities from Certified EHR Technology, we have adopted specific certification criteria that are only “applicable” to Complete EHRs or EHR Modules designed for use in an ambulatory setting (e.g., by eligible professionals) or an inpatient setting (e.g., by eligible hospitals).

We indicate in Table 1, and in the regulation text below, which certification criteria apply solely to Complete EHRs..."

Yes, this means that HHS will create standards and certify against their standards and if you do not comply then there will be penalties. Frankly what Government standard has ever made sense. Just look at HIPPA, despite the fact that when it was promulgated the Internet was blossoming, they demanded faxes.

The regulation outline is shown below. It is useful to see the extent of this regulation and then to read the specifics. It is this which will control and we believe will destroy any creativity in EMRs.



Subpart A – General Provisions


170.100 Statutory basis and purpose.

170.101 Applicability.

170.102 Definitions.

Subpart B – Standards and Implementation Specifications for Health Information Technology


170.200 Applicability.

170.202 Transport standards for exchanging electronic health information.

170.205 Content exchange and vocabulary standards for exchanging electronic health information.

170.210 Standards for health information technology to protect electronic health information created, maintained, and exchanged.

170.299 Incorporation by reference.

Subpart C – Certification Criteria for Health Information Technology


170.300 Applicability.

170.302 General certification criteria for Complete EHRs or EHR Modules.

170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting.

170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting.

This is worth the read.

Now the real issue is that the Government never does anything itself. It in almost all cases contracts the work out to some beltway bandit. In particular to the lowest bidder. If you liked the mess at Newark Airport this weekend imagine that the team at HHS will do with EMRs and their Certification. A Government designed, Government Certified, Government paid for, and Government controlled system, with penalties for non compliance will truly be a disaster. There is no known example of this ever working. Industry does a better job. I come back to the IETF and the development of the Internet.

EMR are truly required if we ever hope to gain control over health care but placing the Government smack dab in the middle with cause just the opposite. Having spent many years in that environment I know from first hand experience what happens. One must be truly ignorant of all reality to assume that such a major system can be designed and controlled by the Government without a TSA type of outcome. The lowest priced bidder solution.