Treatment Agreements and Informed Consent. If your practice prescribes opioids, you need them. But what are they and how do they differ? We dig into each and how they impact your practice and your patients.
Aren't they the same thing?
No. While Treatment Agreements and Informed Consents are often discussed in tandem (and are occasionally covered within the same document), they independently serve two distinct functions.
Informed Consent provides a framework of the risk associated with treatment. In the case of chronic opioid therapy (COT) for pain patients, the tool outlines the potential risks (e.g. potential for addiction while taking controlled substances) and benefits.
Treatment Agreements detail the framework of the doctor-patient relationship (e.g. appropriate behavior and clinician expectations). These agreements can be viewed as checklist of requirements for a patient being prescribed narcotics that sets an expectation of risk evaluation strategies.
Both tools serve a vital regulatory (check out your state's opioid prescribing guidelines) and practice management function, and both are increasingly a component of managed care requirements.
First, it's a document of many names, including:
- Controlled Substance Agreement
- Opioid Contract
- Narcotic Agreement
- Pain Contract
- Pain Treatment Agreement
- Pain Management Contract
- Medication Contract
- Opioid Form
- Patient Agreement Form
- Patient-Provider Contract
- Pain Agreement
Each of these refers to the same contractual document: a signed agreement between a prescribing physician and a patient that clearly outlines the guidelines and responsibilities between these two parties pertaining to behaviors and expectations around the prescription of opioid medications.
These contracts have developed greater importance with increased regulatory oversight and allow physicians a documented means by which to communicate to patients what they can expect when under their care for pain management. They exist to assist both the patient and the provider with compliance around controlled substance laws and regulations.
In discussion with our customers, however, we found that there is some variance in what information is included in these contracts, and what the consequences are for noncompliance.
Activities covered in a patient agreement vary but may include: expressly restricting the patient from selling their medication to other parties, requiring patients to utilize a single pharmacy, taking medications exactly as prescribed, keeping all appointments, providing a urine specimen when requested, agreeing not to drink alcohol or take illicit drugs or prescription drugs not prescribed to the patient, and agreeing to keep opioid medications in a safe and secure place. Additional provisions may include reporting activities required if the prescription medication is lost or stolen.
What happens when a patient violates an agreement? Depending on the criteria established by the physician or the practice, a patient may be weaned from their controlled substances or even dismissed from the practice.
Rhode Island provides the following guidance, “Keep in mind each patient is unique and as in the cases of other serious diseases, your clinical judgment is critical and your decision making process should be documented in the medical record. As you look at any algorithm, some violations are more serious than others and warrant an interpreted response. Keep your emotions in check. A violation of a pain agreement should never be taken as a personal attack. Keep your thoughts professional, objective and neutral and treat the matter as you would any clinical situation by taking a history and examining the facts. Violating a pain agreement could be an oversight, misunderstanding, a symptom of addiction or something else.”
The CDC has also put together a packet of sample patient agreement forms, each meant to help foster open communication between the patient and the physician.
Individual states, either state agencies or state medical societies have published sample agreements, a few we’ve found useful: Texas Minnesota Oregon. Additionally, several national medical organization have sample Treatment Agreements published as well: AAFP AAPM ASAM.
Payers have also weighed in. Blue Cross Blue Shield Anthem notes a preference for Patient Agreement/Contracts that are goal oriented and provides an example.
As the opioid epidemic continues private payers, such as Aetna Better Health - Kentucky have put requirements in place where a signed treatment agreement must be submitted as part of the opioid pre-authorization process. This trend is becoming commonplace across payers.
The use of these agreements is not just limited to Pain Management Clinics, but extends to anyone prescribing controlled substances. A long-term perspective study outlining the Long-Term Opioid Contract Use for Chronic Pain Management in Primary Care Practice: A Five Year Experience illustrates the broader needs of this type of conversation across specialty types.
Informed Consent language may be included in a Treatment Agreement or as a separate stand alone document. The risks and benefits of COT, potential side effects, purpose of treatment and an opportunity to facilitate ongoing communication regarding the goals of treatment are part of the basic standard framework.
The American Medical Association (AMA) defines Informed Consent as, “more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.”
In the context of national opioid misuse challenges, Informed Consent has become, in many cases, the document utilized to draw special attention to personal and public health risks when practitioner prescribe scheduled medications.
While it is a basic requirement for controlled substance prescribing, Informed Consent requirements vary by state. Michigan, for instance, will have a new law effective on June 1, 2018 with specific guidelines on a form prescribed by the State.
The Michigan law illustrates the changes being made across the country in regards to the ongoing fight to curb the Opioid Epidemic. As the consequences of opioid misuse and abuse continue to be front page news, the focus on a physician’s responsibility to adequately discuss the risks associated with opioids will presumably continue to be under scrutiny as well.
Here's a list of some available Informed Consent templates:
Additionally, the AMA provides an e-learning module on Informed Consent.
Where do we go from here?
In summary, a Treatment Agreement can be seen as the conversation on how patients and physicians interact, the rules of the road. Informed Consent acknowledges the risks and indicates clearly that a patient has knowledge of the possible consequences. Both are crucial steps to a meaningful patient-physician relationship. Furthermore, both are becoming a necessary component in physician documentation from a regulatory as well as payer standpoint.
To learn more about compliant prescribing check out some of our recent blog posts on the topic:
- Opioid Prescribing in 2018: Protect Your Patients. Protect Your Practice.
- Does your Practice Have Effective Opioid Prescribing Protocols?
- Are You Effectively Assessing Risk When Prescribing Opioids?
- Pain Scales: From Faces to Numbers and Everywhere In Between
- What's in the Cup: A Urine Drug Testing Primer
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