Determine Risk and Demonstrate Medical Necessity When Prescribing Opioids

By: Jody Lutz

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Defining Patient Risk and the Challenges of EHR Integration

How does your practice define patient risk to decide the services you may provide, the laboratory tests you may order and/or the prescriptions you may write? Another important question in today’s environment--How do you document these multi-layered facets within your EHR system?

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What is "Medical Necessity?"

The AMA defines medical necessity as: “Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the patient, treating physician, or other health care provider. 

The “prudent physician” standard of medical necessity ensures that physicians are able to use their expertise and exercise discretion, consistent with good medical care, in determining the medical necessity for care to be provided each individual patient.

It’s important to note in light of this discussion that Medical Necessity as defined by CMS and the AMA are not the same and payer policies are not united under a national umbrella.

And while a “prudent” physician utilizes their best judgement in patient care, the opioid epidemic brings about additional questions, concerns and paradigms, namely:

  • Ensuring appropriate pain management for the individual needs of the patient in your care
  • Monitoring risk for addiction, misuse and abuse
  • Administrative requirements pertaining to pain management

Pain policies may be influenced by a variety of factors and vary by state as well as by specific payers’ plans. It is a complex and multi-sided question: patient history (in both a medical and life events context), as well as demographic and even geographical implications can help a physician define risk. The underlying statement of clinical assessment of individual’s risk potential for abuse and diversion as a guiding principle is multi-faceted and can change within a single patient over time.

Barriers to Therapeutic Success

LR Webster summarizes that, “Therapeutic success depends on proper candidate selection, assessment before administering opioid therapy, and close monitoring throughout the course of treatment. Risk assessment and prevention include knowledge of patient factors that may contribute to misuse, abuse, addiction, suicide, and respiratory depression. Risk factors for opioid misuse or addiction include past or current substance abuse, untreated psychiatric disorders, younger age, and social or family environments that encourage misuse.”

Add in guidelines and recommendations from State Medical Boards, regional Local Coverage Determinations (LCDs), professional organizations, state pain societies and the CDC and pain management practices can get very complex.

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It’s a complicated equation, one that can overwhelm any practice. However, advanced data driven technology can guide your practice into a streamlined and clinically based approached. Enter AffirmHealth’s Shield, a customer and patient centric approach to enabling physicians to categorically assess risk via aggregated relevant data and aligned with your customized prescribing protocols to form a robust risk profile for each patient.

When clinical resources such as Prescription Monitoring Reports, Functional Assessments, Opioid Risk Tool (ORT), Patient Health Questionnaire (PHQ), Current Opioid Misuse Measure (COMM), Urine Drug Screen (UDS) results, Pill Counts, Aberrant Drug-Related Behavior Checklists are all at your fingertips and customized to your practice protocols, documented and analyzed risk assessment becomes a targeted component of patient management.


Targeted data allows you, the physician to clinically document outcomes and assess changing patient needs while providing the long term care many chronic pain patients require. For continuing anaylsis on this topic and more subscribe to the blog at the link below:




Jody Lutz is the owner of Globe Street Holdings, a boutique consulting firm with an interest in disruptive healthcare start ups. Jody has worked in both the US and the UK healthcare markets and has extensive project management experience. She is a Certified Representative of the American Society of Pain Educators, holds a Project Management Certificate from Project Management International as well as completing the Regulatory Affairs for Laboratory Compliance Certificate from the American Association for Clinical Chemistry. She is also a member of the American Academy of Professional Coders. Jody currently serves as President-Elect of the Texas Biomedical Research Forum. She received her undergraduate degrees from the University of Texas at Austin and her graduate degree from St. Mary's University. 

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