Beware of Using Blunt Instruments for Patient Care

Courtesy of Google Search:
Blunt in·stru·ment (noun)
A heavy object without a sharp edge or point, used as a weapon.
• An imprecise or heavy-handed way of doing something.

I came across a broadcast recently geared towards making a case for the use of a “binary” drug formulary in the Workers’ Compensation system, stating that a formulary is “a blunt instrument”. The broadcast announced that the weapon’s simplistic design is due to the perception that diagnosis information is unavailable to the process’ “most important” user – the pharmacist. The broadcast indicates that the information is unavailable to this stakeholder due to HIPAA protected Personal Health Information (PHI). The heavy-handed tool was presented as being evidence-based as users can link directly to single study abstracts published in PubMed.

In the interest of patient safety, preserving the integrity of true evidence-based-medicine, and ushering the aspect of quality patient care in Workers’ Compensation back to the founding spirit of the Grand Bargain – to protect injured workers’ well-being and compensation – I am compelled to address several concerns with the broadcast’s message.

HIPAA, PHI, and Workers’ Compensation (WC)

The issue of diagnosis being unavailable to pharmacists due to PHI implications is not entirely accurate. I posed the question about PHI and HIPAA, as it relates to Workers’ Compensation, to our in-house compliance attorneys. They pointed me to the following and confirmed that diagnosis information (along with the patient’s name and drug prescription information), while considered PHI, may be used and disclosed by a covered entity (such as a doctor) to comply with the law for WC purposes:

45 C.F.R. § 164.512(l)

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section… (l) Standard: Disclosures for workers’ compensation. A covered entity may disclose protected health information as authorized by and to the extent necessary to comply with laws relating to workers’ compensation or other similar programs, established by law, that provide benefits for work-related injuries or illness without regard to fault.

Additional guidance from the National Council for Prescription Drug Program (NCPDP) on the ICD-9/ICD-10 transition and how it relates to the e-prescribing, e-billing & DUR e-Prior authorization standards states (Page 11-12):

6: In what situations are diagnosis codes required on a prescription? 

Diagnosis codes are always required on prescriptions for Medicare Part B claims. In addition some Prior Authorizations will require the submission of a diagnosis code. Even though it is not a covered HIPAA transaction, a Workers Compensation claim might also require a diagnosis code based on the injury of the patient.

Most Important User

A fundamental difference between the patient-centric, condition-based drug formulary founded in true EBM and a binary drug list, is who is qualified and should drive medical decisions, including drug prescriptions. All matters pertaining to the medical care of an injured worker should be driven by the treating physician – not bureaucrats, not the payer, and not pharmacists. These stakeholders are important in their own functions and are in place to verify a physician’s recommendations to ensure that the injured worker’s well-being remains the center of focus and over-utilization of care is avoided; they do not have sufficient information about the patient to make critical decisions regarding clinical care.

To state that the user who potentially has the least amount of information is the most important part of the process is, frankly, dangerous and irresponsible. We must restore focus to quality patient care in Workers’ Compensation over simplicity by empowering treating physicians to make sound decisions on diagnosis-specific drug prescriptions supported by true EBM.

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Blunt Instruments and Evidence-Based Medicine (EBM)

Using a drug formulary as a “blunt instrument” is counter-intuitive to the spirit of the Grand Bargain, designed to protect the injured worker’s well-being and compensation. Oversimplifying prescription drug decisions in the interest of every stakeholder except the injured worker is pulling Workers’ Compensation further away from its original intent and ignores considerations for quality patient care.

Group Health has successfully utilized drug formularies for years with the primary purpose of cutting costs.  However, every Workers’ Compensation drug formulary discussion that I’ve been a part of at the State level has been initiated by sincere concerns of the health and well-being of injured workers, with cost savings being viewed a byproduct of improved care.

The broadcast pointed users of the binary drug formulary to link directly to PubMed to view single article abstracts published through the site. Supporting drug recommendations, or any other guideline recommendation, with a single source of evidence is not EBM. True EBM requires that the process take into account the preponderance of evidence (the greater weight of the evidence) combined with expert opinion/consensus. Pointing users to a single source of information assumes the person referencing the information will be able to appropriately interpret, rank, and grade the quality of the information (i.e., was there a conflict of interest, does the recommendation of the information make sense, etc.). As a general practice, EBM content developers/publishers should provide an analysis of the evidence and summarize why it receives the grade it does as part of a transparent and reproducible process.

So What

A recent blog post from a highly esteemed colleague reminded me that we have the privilege, and the malison, of living during The Age of Information, The Digital Age, The Computer Age, or The New Media Age. Society has effectively shifted from traditional industry that the Industrial Revolution brought through industrialization, to an economy based on the computerization, and thecommoditization of information.

With users of search engines launching more than 54,000 searches each second, it is not surprising how vast the amount of unqualified, errant information is disseminated through various outlets (e.g., websites, blogs, social media, etc). The senders of such poorly scrutinized data are as unqualified to interpret the information as the information itself.

In my simple mind, quality patient care should be restored as the center of every medical, administrative, and judicial decision in Workers’ Compensation. All medical care decisions should be driven by a qualified medical professional, taking into account all aspects (including diagnosis) of the patient’s needs, using highly scrutinized and reproducible evidence-based data to support their expertise and opinions. The care should be delivered, not as a “blunt instrument”, rather in a manner that is consistent with the modern version of theHippocratic Oath.

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug…

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