Today is December 15, 2013… For Indiana pain sufferers, and the physicians who care for them, it is the dawn of a new era.

Everyone has an opinion, but the only opinion that matters is that of the Medical Licensing Board of Indiana. Nevertheless, I thought it might be useful to offer the opinion of an Indiana-Kentucky licensed / interventional pain-addiction specialist / full-time Jeffersonville, Indiana-based / Greater Louisville Medical Society President / independent private practice physician (i.e., The Painful Truth).

Regulations provide boundaries. Guidelines provide guidance. As written, Indiana’s Emergency Pain Regulations are instructive as to how physicians should prescribe opioids for chronic pain and would serve as adequate guidelines. However, as regulations they are problematic due to their frequent inclusion of unclear phraseology. These “emergency” regulations are subject to revision and permanent regulations must be adopted by November 1, 2014.

When faced with unclear regulations, prescriber anxiety is heightened. This may deter physicians from prescribing the most appropriate medications, causing patients to endure avoidable pain and unnecessary suffering.

So, I guess I was wrong. If you, or anyone you care about, has been or might be touched by pain, drug abuse, or addiction – and that pretty much includes everyone;

YOUR opinion DOES matter.

 

Here we go…

The Painful Truth does not wish to over-simplify the matter, but after careful study the regulations one could say that prescribing opioids boils down to:

DRAMATIC at the start (Section 4);

FACE-TO-FACE every 2 – 4 months (Section 6);

INSPECT & DRUG SCREEN annually (Sections 7 & 8);

REVIEW, REVISE & REFER at higher doses (Section 9).

One should begin this journey by understanding the difference between a law, a regulation, and a guideline.

A law is a rule that has been passed by elected officials. Violation of a law may be viewed as a criminal act.

Indiana’s new pain law (a.k.a. additions to Senate Bill 246) is fairly concise and does not directly apply to physicians. Instead, it says the medical board must come up with regulations – which they did.

A regulation is a rule that is usually created by a government agency (i.e. a “bureaucracy”) as opposed to the legislature. Regulation determines how laws will be enforced. Violation of a regulation may not be a criminal act but can incur a wide-range of penalties.

As previously stated, Indiana’s Emergency Pain Regulations go into effect on December 15, 2013 and are subject to revision until November 1, 2014, at which time the permanent regulations are due.

A guideline, especially when endorsed by a governing body, is a set of opinions that offer insight into the manner in which regulations and laws can be properly followed. Violating a guideline may or may not be considered a wrong move, but generally will require a legitimate explanation as to the decision-making process.

The Indiana State Attorney General’s Office has published a detailed set of guidelines, called “First Do No Harm,” which offer insight as to what regulators will consider as proper medical practice, should they be called upon to investigate a controlled substances related issue.

In summary, Indiana physicians who prescribe controlled substances do not need to know details of the new law, as it does not apply directly to them.

However, physicians should clearly understand the Emergency Pain Regulations and how these regulations will affect their practice after December 15, 2013.

Also, physicians are strongly urged to become familiar with the “First Do No Harm” guidelines and to start incorporating as many of the recommended practices as possible.

SECTION-BY-SECTION BREAKDOWN (12 Sections) – The Painful Truth is my opinion.

 

SECTION 1

These REGULATIONS are from the Medical Licensing Board of Indiana and are applicable to PHYSICIANS only; and specifically with regards to OPIOIDS for CHRONIC PAIN.

The Painful Truth: In my opinion, every provider (i.e. dentists, podiatrists, nurse practitioners, physicians, etc.) should understand that the Attorney General’s Office supports the “First Do No Harm” guidelines for every provider.

SECTION 2

This section offers definitions, some of which I examine below:

* Chronic Pain “means a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.”

The Painful Truth takes this as meaning any type of pain, for whatever reason, regardless of the severity, that is a problem for two months or longer; even if it is intermittent pain. This encompasses a generous range of chronic pain scenarios.

* Morphine Equivalent Dose “means a conversion of various opioids to a standardized dose of morphine by the use of accepted conversion tables.”

The “First Do No Harm” Toolkit gives some examples of equianalgesic doses to SIXTY MGM of MORPHINE (i.e. hydrocodone 50 mg; oxycodone 40 mg; fentanyl patch 25 mcg/hr), and notes “Equianalgesic tables should only serve as a general guideline to estimate equivalent opioid doses.”

The Painful Truth believes this is an inexact science, and there are many “accepted” morphine equivalent conversion tables from which to choose – none of which are perfect. The Toolkit references an online calculator from GlobalRPH. I also like the one from Practical Pain Management. The state of Washington has a nice one as well. When making these conversions try to err on the low side. Better to underestimate than overestimate (i.e. Once someone takes a medicine it is impossible to get it back). Murphy’s laws:  (1) Start low and go slow; (2) Every dose is a test dose.

* “Outset of an opioid treatment plan” refers only to a patient who has been prescribed: (1) more than sixty opioid-containing pills a month; or (2) a morphine equivalent dose of more than fifteen (15) milligrams per day; for more than three consecutive months.

The Painful Truth believes this is very important, somewhat confusing, and will be discussed again later in SECTIONS THREE & NINE. For now, just realize that there is a definitely a threshold where these regulations become relevant.

SECTION 3

 

This section explains which patients are exempt from the regulations.

(1) With a terminal condition

(2) Living in a licensed health facility

(3) Enrolled in a licensed hospice program

(4) Enrolled in a palliative care program of a licensed hospital

Note: If a non-terminal patient eventually leaves the health, hospice, or palliative facility the opioid use during that time still counts in the threshold calculation (see below).

This section also establishes thresholds that trigger the requirements of the Emergency Regulations.

 

(1) “More than sixty (60) opioid-containing pills a month.”

(For more than three consecutive months*)

OR

(2) “A morphine equivalent dose of more than fifteen (15) milligrams per day;

for more than three (3) consecutive months.”

 

The Painful Truth believes with a little creativity and a literal interpretation, these thresholds allow a wide range of unintended prescribing options.

For example: You could prescribe 60 pills for the month and tell the patient to break each pill in half – effectively offering FOUR doses per day without exceeding the 60 pill per month threshold.

You could even prescribe a drug as potent as Oxycontin twice per day for 89 consecutive days and avoid the THREE CONSECUTIVE MONTH threshold.

In contrast, prescribing a relatively benign sixty-one codeine pills for three consecutive months**  exceeds the threshold and triggers all of the requirements spelled out in the regulations.

This should not encourage anyone to “game the system.” It only illustrates how difficult it is to establish dosing thresholds that are clinically relevant and enforceable.

I addressed dosing thresholds in a letter (and blog post) from October of this year. Hopefully there will be some changes to the thresholds when the final regulations are enacted in 2014.

Be advised that the Attorney General’s “First Do No Harm” provider Toolkit does not explore these initial thresholds or the concept of exempted patients in any detail.  The Toolkit seems to imply that any use of opioids carries enough danger to warrant risk stratification, surveillance, and a cautious approach when prescribing.

The Painful Truth advises prescribers to conservatively interpret the measures outlined in the Emergency Regulations.

And stay tuned, because a 60 mgm morphine equivalent dose threshold becomes an important issue in Section NINE (to be discussed later by The Painful Truth).

Note:

*  On December 17, 2013 at 2:40 p.m. I spoke by telephone with Michael Minglin, J.D. (Board Director, Medical Licensing Board of Indiana). Regarding the sixty-pills-per-month threshold and the fifteen mgm morphine-equivalents-per-day threshold, he told me: “It is clear; the three consecutive months interval applies to both.”

**  This sentence was updated on 12/17/2013 to reflect the above mentioned clarification (*) by the Board Director.

SECTION 4 

This section deals with the Physician’s responsibility for performing the initial evaluation, including determination of level of risk.

It is clearly stated that the physician shall do the physician’s OWN evaluation and risk stratification of the patient by doing the following:

1. Perform an APPROPRIATELY focused history and physical exam
2. Obtain or order APPROPRIATE tests “as indicated”
3. Make a DILIGENT effort to obtain and review records & document the effort.
4. ASK the patient to complete an OBJECTIVE pain assessment tool
5. Use a VALIDATED screening tool for mental health and substance abuse
6. Establish a “working diagnosis”
7. Tailor a plan with MEANINGFUL and FUNCTIONAL goals (to be reviewed “from time to time”)
8. WHERE MEDICALLY APPROPRIATE use non-opioid options instead of or IN ADDITION TO prescribing opioids.

The Painful Truth believes the requirements of Section Four lend themselves to creation of a checklist. Therefore, at the initial evaluation a Hoosier physician must be DRAMATIC

o          D         diagnosis made (“working diagnosis”)

o          R         records obtained (a diligent effort made to obtain & review)

o          A          assessment of pain

o          M         mental health (and substance abuse) screen

o          A          activity goals established

o          T          tests ordered if indicated

o          I           instead of opioids, use non-opioid options

o          C         conduct focused history and physical

The Painful Truth notes that the terms “appropriate,” “as indicated,” “diligent,” “meaningful,” and “from time to time” are subjective. Physicians are advised to be able to defend his or her interpretation of these terms.

The Painful Truth believes it is acceptable for a prescribing physician to use historical information obtained by sources other than the prescribing physician (i.e., office staff) as long as the physician personally verifies the information with the patient.

The Painful Truth points out that the initial physical exam must be done by the prescribing physician and cannot be delegated.

The Painful Truth notes that a truly “objective pain assessment tool” does not exist, as pain is personal and subjective. Nevertheless, at minimum, a visual analog scale (i.e., 0 to 10) or similar documentation aid should be employed in order to satisfy the regulatory requirement.

 

The Painful Truth believes that only in rare circumstances would a non-opioid treatment option fail to exist.

SECTION FIVE

 

This section deals with treatment agreements and informed consent.

 

Although the term “Informed Consent” (IC) is not mentioned, Section Five clearly deals with elements of informed consent in discussing the requirement for a treatment agreement (TA).

Both the PATIENT and the PHYSICIAN must sign the “agreement.” A copy must be kept in the patient’s chart.

 

The document(s) must attest to a “simple and clear” explanation of:

1. Risks and benefits (IC)
2. Alternatives to opioid treatment (IC)
3. Consent to drug monitoring and random pill counts (TA)
4. The requirement to take the drugs as prescribed (TA)
5. Prohibition of the sharing of drugs (TA)
6. “That the patient inform the physician about any other controlled substances prescribed or taken”
7. Treatment goals
8. Reasons opioid therapy may be changed or discontinued.
9. COUNSELING FOR WOMEN: Particular attention must be given to “women between the ages of 14 and 55 with child bearing potential” (e.g., has not had a hysterectomy). They must be counseled regarding RISKS TO THE FETUS, specifically including the risks of “fetal opioid dependency and neonatal abstinence syndrome.”

The Painful Truth recommends combining the treatment agreement and the informed consent into one document.

SECTION SIX

 

This section deals with periodic scheduled visits – PROGRESS, COMPLIANCE & EXPECTATIONS.

 

1. “Stable” regimens need a “face to face” at least once every 4 months.
2. “If changes are prescribed by the physician” – face to face at least every 2 months.

At the visit:

1. Evaluate progress
2. Evaluate compliance
3. “Set clear expectations”

– “such as: attending physical therapy, counseling or other treatment options”

 

SECTION SEVEN

 

This section deals with INSPECT reports, which must be obtained at the beginning and annually. One must document in the chart if the INSPECT is “consistent with the physician’s knowledge of the patient’s controlled substance use history.”

SECTION EIGHT

 

This section deals with drug monitoring tests, which must be obtained at the beginning and annually.

 

There must also be a “confirmatory” test for these drug-monitoring tests.

If a test shows “inconsistent medication use” or “illicit substances” there must be documented a discussion, review, and revision of the treatment plan.

The Painful Truth notes that “confirmatory” is not defined in these regulations. However, this probably means that the specimen must be submitted for a more specific evaluation (e.g. gas chromatography – Still, one could argue that repeating the initial drug screen is a type of “confirmation.”).  Note that the regulations do not specify that every drug-monitoring test have a confirmatory test – rather, only the one at the “outset” and at the “annual” screen.

The Painful Truth submitted an opinion on drug-monitoring tests (October 2013).

SECTION NINE

 

This section deals with requirements when the morphine equivalent dose (MED) is greater than 60 mgm/day.

 

When the MED is greater than 60 mgm/day, one must REVIEW, REVISE, & REFER

 

Note: MED was defined in Section TWO of the regulations.

When the 60 mgm per day MED threshold is exceeded, the following must be done:

1. A face-to-face REVIEW of the treatment plan.
2. Document a REVISED ASSESSMENT & PLAN  – including risk of DEATH.
3. Consideration of REFERRAL to a “specialist.”

 

The Painful Truth notes that the main goal of the “revised” plan seems to be mitigation of risks (especially DEATH) associated with higher opioid dose regimens.

The Painful Truth notes that while the non-specific wording (i.e., “revised,” “consideration,” and “specialist”) allows application of a physician’s clinical judgment, it remains important that documentation adequately justify therapeutic decisions.

 

The Painful Truth recommends addressing the increased risks (including death) associated with MED greater than 60 mgm/day in a combined opioid INFORMED CONSENT & TREATMENT AGREEMENT (see section FIVE).

SECTION TEN

 

This section deals with Physician Assistants (PA) and Advanced Practice Registered Nurses (APRN).

The Painful Truth notes the EMERGENCY REGULATIONS are from the Medical Licensing Board of Indiana, which only has jurisdiction over PHYSICIANS. Physician Assistants and Advanced Practice Registered Nurses each have separate licensing boards.

Regarding Physician Assistants, Section 10 notes that PA duties and responsibilities must be “within the supervising physician’s scope of practice.”

The Painful Truth believes the Regulations could be interpreted as delineating a physician’s scope of practice. By this interpretation, physician assistants would be required to follow the Board of Medical Licensure’s Regulations.

 

The Painful Truth also believes that, since they do not place limits on opioid prescribing, the Regulations could be interpreted as not delineating a physician’s scope of practice. By this interpretation, physician assistants would not be required to follow the Board of Medical Licensure’s Regulations.

 

Regarding Advanced Practice Registered Nurses, Section 10 does not mention “scope of practice.” Thus, APRNs (considered more independent of physician supervision than PAs) would not be required to follow the Board of Medical Licensure’s Regulations.

Lending more credence to the concept that the Regulations do not apply to PAs and APRNs is language from Senate Bill 246 that was passed in this year’s Indiana State Legislature:

The state board of pharmacy or any licensing board, commission, or agency that controls, authorizes, or oversees controlled substance registrations under IC 35-48-3 shall adopt rules necessary to complement the rules adopted by the medical licensing board under this chapter.

 

If PAs and APRNs were subject to the rules of the Medical Licensing Board, there would be no need for a law requiring their boards to adopt complementary rules. Note: As of today – December 12, 2013 – no other boards have adopted any complementary rules.

The Indiana Board of Pharmacy will consider emergency rules at its meeting in January 2014.

The Painful Truth reminds physicians that requisite supervisory agreements allow PHYSICIANS to place limits on prescriptive practices for the PA’s and APRN’s they supervise. To illustrate this point, The Painful Truth received an email on December 12, 2013 sent by the Indiana Professional Licensing Agency stating:

 

“Professionals that hold a license to practice should review all collaborative agreements with Advance Practice Nurses and Physician’s Assistants to assure that they are in compliance with the new rule.”

SECTION ELEVEN

 

This section describes circumstances allowing waivers of the initial INSPECT and initial drug monitoring test.

 

The Painful Truth believes Section Eleven was included to ease transition to regulatory compliance for patients currently receiving chronic opioid therapy.

 

The requirement for an initial INSPECT is waived if, prior to December 15, 2013, a patient has reached the thresholds described in SECTION 3

i.e., prescribed more than sixty opioid-containing pills a month; or a morphine equivalent dose of more than fifteen milligrams per day; for more than three consecutive months.

Regardless, an INSPECT must be done by November 1, 2014.

The requirement for an INITIAL drug monitoring test at the outset of an opioid treatment plan (SECTION 8) is waived if, prior to January 1, 2015, a patient has reached the threshold described in SECTION 3

i.e., prescribed more than sixty opioid-containing pills a month; or a morphine equivalent dose of more than fifteen milligrams per day; for more than three consecutive months.

 

The Painful Truth believes INSPECT reports and drug screens should be done “early and often.” Include reports from border states (e.g. Kentucky’s KASPER) when available. Also note that (as stated in section THREE) if a physicians does a dug screen or INSPECT… “any subsequent requirements are determined by when the initial evaluation would have been required and not at the earlier date it actually was conducted.”

SECTION TWELVE – These Regulations are effective December 15, 2013.

 

 

In Conclusion…

 

The Painful Truth reminds physicians that there are three vital elements to success when prescribing opioids for chronic pain.

1. The wellness of the patient
2. The safety of the community
3. The security of your practice

If any of these three “balls” are dropped, the outcome can be disastrous. Thorough knowledge of these Emergency Regulations and diligent adherence to their conservative interpretation will make the juggling easier.

Remember…

DRAMATIC at the start (Section 4);

FACE-TO-FACE every 2 – 4 months (Section 6);

INSPECT & DRUG SCREEN annually (Sections 7 & 8);

REVIEW, REVISE & REFER at higher doses (Section 9).

Now go treat some pain.

You may contact the Medical Licensing Board of Indiana by phone at 317-234-2060 or email at pla3@pla.in.gov.

Disclaimer: I represent no organization. All opinions, unless specifically referenced, are my own. This webpage is intended to be a resource. It is NOT intended to be comprehensive or to be legal advice or medical advice. Physicians should always consult with their medical malpractice insurance company for risk management advice and with their private health care attorney for legal advice. If you have a medical condition please seek advice from your personal physician. Every patient, practitioner, and facility should consult its own counsel for advice and guidance. If you rely upon information from this website, you do so at your own risk.