OIG Approach To Medicare Part D Opioid Prescribing

The pharmacoepidemiology of opioids in the United States depends on a fragmented approach.  I recently posted a CDC study that used a commercial pharmacy database to look at the characteristics of opioid prescribing across individual counties in the United States.  In the past week I came across this data brief from the Office of Inspector General (OIG) of the US Department of Health & Human Services.  Their database is the 43.6 million beneficiaries of Medicare Part D.  Their stated goals are to protect beneficiaries and the community from prescription drug abuse, to prevent diversion and illegal sales, and to protect the program from fraud and unnecessary expense.

Their methodology is unique.  They look at prescription drug events (PDE) for all opioids prescribed in 2016 that are paid for by Medicare Part D.  Any prescription paid by cash or by another insurer is not counted.  Every time a prescription is dispensed and covered by the program a PDE record is sent to CMS (Centers for Medicare and Medicaid Services).  In this case they calculated total spending on opioids, total Schedule II and III opioid prescriptions, and a number of parameters that look at total cost.  They also determined the the prescriptions per beneficiary, and the average daily morphine equivalent dose (MED).  In most of the literature on opioid dosing the milligram morphine equivalents (MME) is a common measure.  MME is just the total mg of opioid multiplied by a conversion factor.  The MED is basically the same measure but it factors in the total duration of the prescription.  As an example for a one day supply of either Vicodin (hydrocodone) 10 mg tabs or Percocet (oxycodone) 5 mg tabs:

 hydrocodone:  12 tabs x 10 mg = 120 mg x 1 (conversion factor) = 120 MME or MED

oxycodone:      16 tabs x   5 mg  = 80 mg x 1.5 (conversion factor) = 120 MME or MED

In addiction practice these are common doses encountered in the low range of prescription opioid use disorders.  I used the brand names for hydrocodone and oxycodone preparations here because that is what people commonly report to me and it typically requires more investigation.  For example "Percocet" or "Perc30s" commonly refers to higher dose oxycodone without acetaminophen - a single 30 mg tablet of oxycodone or 45 MME.  The authors of this brief do not need to be concerned about those data discrepancies because they are able to get specific claims data.

In terms of outcome data, they looked at all of the prescriptions and cost variables as well.  They looked at total exposure.  One in three Medicare Part D beneficiaries received at least one opioid prescription.  That amounts to 14.4 million people out of a 2016 beneficiary base of 43.6 million people.   There were a total of 28.2 million hydrocodone-acetaminophen prescriptions, 5 million oxycodone-acetaminophen prescriptions and 14.8 million tramadol prescriptions.  Tramadol is not typically included in opioid studies even though the M1 metabolite is a mu receptor agonist.  Tramadol is a prodrug metabolized by CYP2D6, metbolism is necessary to to create M1 and slow metabolizer are less likely to experience the analgesic effect and addiction risk.

Of these beneficiaries 501,008 received high dose opioids (MED > 120 mg/day).  The indication here was for noncancer or chronic noncancer pain.  Hospice patients and cancer patients were excluded.  The most common opioid prescribed in this high dose group was oxycodone 30 mg.  The study also defined extreme amounts of opioids as an MED of 240 mg and 69,563 patients received that amount.  There were 678 patients receiving high extreme amounts a MED of 1,000 mg for an entire year.  The concern with very high levels is whether the prescriptions are indicated and whether they might be diverted.  The authors also suggested that fraud could be an issue due to stolen Medicare identification number.  They did give an example of a patient who got 62 opioid prescriptions on one year (61 from the same family physician) with an average daily MED of 3,130 mg.

The brief also estimates the degree of doctor shopping or seeking prescriptions from more than one physician and pharmacy.  The criteria used for this report was 4 prescribers and 4 pharmacies.  A total of 22,308 beneficiaries met that criteria and they also had an average daily MED > 120 mg for a period of three months.  They also identified 162 beneficiaries who got opioid prescriptions from 10 different prescribers and 10 different prescribers in the same time period.  Even larger number of prescribers and pharmacies were noted in the most extreme cases.  That number represents about 0.02% of the total number of beneficiaries using opioids and that is the same order of magnitude of a previous estimate from a large commercial prescription database (4).  

Using the estimates of high dose opioids and degree of doctor shopping allowed for an estimate of serious risk of opioid overuse or overdose.  The number estimate in that category was 89,843 or about 0.6% of the entire group taking opioids.

The brief also looks at the issue of who is prescribing the opioids.  For the 89,843 there were an estimated 115,851 prescribers who wrote at least one of those prescriptions.  A total of 401 prescribers were determined to be "far outside the norm".  One hundred and ninety eight ordered opioids for patients getting extreme amounts of opioids (MED of 240 mg), 264 ordered opioids for patients who appeared to be doctor shopping, and 61 ordered opioids for patients who were members of both groups.  The total number of prescriptions written by prescribers in this group was 256,260 opioid prescriptions.  There were 15 prescribers who ordered opioids for > 98 beneficiaries receiving extreme amounts (MED of 240 mg).   Of the 401 prescribers with questionable prescribing 1/3 or 133 were nurse practitioners (N=81) or physicians assistants (N=52).

Are there any conclusions possible from this administrative look at opioid prescribing in a subset of Medicare patients?  I think that there are a few.  My conclusions assume that generalizations from this data are possible:    

1.  Opioids are commonly prescribed to Medicare recipients - and the vast number of these prescriptions appear to be appropriately managed.

2.  A small number of prescribers appear to be responsible for most of the inappropriate prescriptions - and there are some outliers practicing at the extremes in terms of prescribing patterns.  Very extreme prescribing described in a few cases would appear to be a function of unnecessary use rather than patients with special needs who require extremely high doses of opioids (MED > 375 mg).  That is an important point because concentrations of high dose opioid prescribing is often attributed to the special needs of patients or referral patterns resulting in concentrations of these patients and the need for the prescriber to write prescriptions for these amounts.  If this was a case of biological variability - a much larger fraction of the patients who require extreme amounts of opioids.

3.  The problem of inappropriate prescriber appears to be easy to follow on the CMS data base - the standard political approach to the opioid epidemic is to blame all doctors and mandate various education programs about opioid prescribing.  It should be clear that a minority of physicians or in this case prescribers are problem and there should be a targeted approach.  At the very minimum the prescribers in the top 1% of all prescribers or the group who is prescribing extreme amounts of opioids, to people who are probably doctor shopping, or both should be receiving active feedback from CMS.

4.  Not counting opioids prescribed for cancer or hospice care is an important omission -  This is a problem with very little research or policy making.  Patients undergoing end-of-life care are  prescribed liberal amounts of opioids for pain relief.  There is no question that these patients should have adequate pain relief by whatever medication is necessary.  The question is what happens when there are opioids from these prescriptions that the patient never uses?  One palliative care study (3) noted that of the hospice care agencies responding to their poll, over a third noted that substance use and diversion were a problem for their agency.  Diversion of drugs is known to occur in health care systems where there is monitoring and checks and balances.  There are large amounts of opioids out in in-home hospice care settings with much less accountability.  A similar study looking at the amounts of opioids prescribed in these settings and what happens to that medication is needed.

5.  Opioids are not prescribed in isolation - CMS and the OIG are not medical research organizations.  A more comprehensive approach to the problem would look at all of the medications that these patients are receiving and not opioids in isolation.  Benzodiazepines frequently accompany opioid prescriptions and in some cases with sedative hypnotics for sleep.  Prescribing both compounds can lead to serious and in some cases fatal drug interactions.  That would result in an additional category of inappropriate prescribing of opioids.

Although this is an administrative database, it does illustrate how this data can be used for pharmacosurveillance purposes.  There was emphasis about the cost of opioid prescribing and the need to prevent fraud from a CMS perspective.  The data could also be used to provide valuable feedback to physicians and other prescribers as well as politicians and regulators.

It can be used to counter some myths that seem to exist on both sides.


George Dawson, MD, DFAPA




References:



1:  US Department of Health and Human Services: Office of the Inspector General.  Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing.  HHS OIG Data Brief OEI-02-17-00250.

2: CDC, “Increases in Drug and Opioid-Involved Overdose Deaths: United States, 2010–2015.” MMWR Morb Mortal Wkly Rep, December 30, 2016, pp. 1445–52. Accessed at https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm on July 16, 2017

3: Blackhall LJ, Alfson ED, Barclay JS. Screening for substance abuse and diversion in Virginia hospices. J Palliat Med. 2013 Mar;16(3):237-42. doi: 10.1089/jpm.2012.0263. Epub 2013 Jan 5. PubMed PMID: 23289944

4: McDonald DC, Carlson KE. Estimating the prevalence of opioid diversion by"doctor shoppers" in the United States. PLoS One. 2013 Jul 17;8(7):e69241. doi: 10.1371/journal.pone.0069241. Print 2013. PubMed PMID: 23874923.

The CMS Investigation Of Anoka Metro Regional Treatment Center

In a previous post I discussed a recent local news article that pointed out the increase in incidents of aggression at one of the state's major psychiatric facilities and a threatened loss of Medicare funding unless certain deficiencies were corrected.  The deficiencies were determined by an investigation of the facility by the Centers for Medicare & Medicaid Services (CMS).  No specifies from the report were available from the news article or the Minnesota Department of Human Services.  They did provide me with a contact person at CMS and after another forwarded e-mail, I was sent 4 attachments detailing the results of the investigation.   I will report on those reports in this post.  The documents were all typed on a standard government form as noted in the graphic below.  The entire CMS report is written in the column labelled "Summary Statement of deficiencies...".  No comments were written in the column labelled "Provider's Plan of Correction...":

I have coded them AMRTC 1-4 for convenience and will refer to them that way in the summaries below.

AMRTC-1 is a 34 page document that states the visits was done to see if the hospital was in compliance with 42 CFR Part 482 for acute care hospitals.  The survey was conducted from 10/19 to 10/23/2015.  The report indicates that there is a 108 patient capacity at the facility and that 30 records were reviewed as the basis for the report.  Problems were found in 2/30 cases with regard to patient care.  There were additional administrative problems that also resulted in noncompliance with the federal standard.  There were problems noted  It was determined that the hospital was not in compliance with the Conditions of Participation of 42 CFR Part 482.  The main finding of the first report is that The Governing Body of the hospital failed to ensure that services provided by staff or contracted staff were proved in a safe and effective manner.  The highlighted areas include failure to assure that quality processes were in pace to minimize or prevent medical errors, failure to assure that comprehensive nursing plans were developed, and a patient's rights condition that occurred when a patient was given forced medications that were prohibited by a court order.

The Quality Assessment Performance Improvement (QAPI) programs extended across a number of clinical and nonclinical disciplines.  In some cases,  they involved the administration not doing what they stated they would do in their descriptions of quality improvement.  The best example I can think of is the reference to Six Sigma.  I have always found it a questionable practice to apply engineering management processes to any medical field.  I sat through a presentation of this paradigm in a previous job and it just seemed like the standard management buzzwords that we hear in different iterations by people who think they are inventing management every 5-10 years of so.  At that job we suffered through a couple of presentations and printed Powerpoints and it faded as soon as it came up.  We moved on to a different paradigm.  Since it was widely promoted, the Six Sigma approach has been shown to not be uniformly effective in business and manufacturing models.  What the proponents of Six Sigma to medical fields don't seem to understand is that measurement is a limiting factor and it has nowhere near the precision or accuracy of measuring products in electronics or automobiles.  At the philosophical level the administration probably made the common error of espousing a philosophy that they could not live up to.  I am not aware of any major healthcare corporation that uses the Six Sigma management model and they probably have many more resources than a state hospital. 

One of the case examples cited was an agitated patient who was physically aggressive and received olanzapine and then intramuscular haloperidol despite a court order excluding haloperidol and risperidone.  The psychiatrist and nurse involved were questioned and said they were unaware of the order at the time the medication was administered.  The patient got this medication for a period of 3 days before it was discontinued.  CMS investigators comment how the physician in this case could be held in contempt of court for ignoring a District Court judge's order.  There was a question of whether or not there were two different orders and the one barring the medications showed up later.  As a physician who has worked with different court orders in these cases for over 20 years, I can attest to the fact that they are not necessarily clear.  In many cases there is a temporary order until the final document can be typed up.  It would seem that the quality process here would be to appoint a person to make sure the latest order is in the chart and read by the attending physician before any medication orders are written.  There is also a question of how paper documents from the court are placed in an electronic record and how easily they can be read in that record.

At the end of the document problems with the care of 10 different patients with different diagnoses and problems are reviewed.   These clinical examples were given to illustrate that that patient with varied problems were all given treatment plans that were not comprehensive, even in the case of patients with aggressive or self injurious behavior.  The reports describes this as: 

"Interventions on the Patient Treatment Plan were generic and were normal functions of the professional disciplines involved in the patient's care and were not individualized to the patient."  

What does all of this mean?  A recent article in the StarTribune (1) had quotes from several mental health experts and advocates about the state of affairs at AMRTC.  The commentary seemed to vary in the level of outrage expressed as "egregious" and "appalling" and "no excuse."  As an expert - when I read the report it seems to scratch the surface.  Would correcting the deficiencies in the report right the ship out at AMRTC?  Possibly - but the previous news report suggests there is a much bigger problem.  That report was about incidents  of aggression, how they were increasing, and there was an opinion that aggressive inmates transferred based on new legislation was the main reason.  A union representative was quoted as saying that some of the inmates transferred from correctional facilities had "taken over" and that they were more aggressive than non-correctional patients.  None of those problems are specifically addressed in the report.  The report comments on problems in the care of specific individuals, only one of whom seem to be as aggressive as two of the patients mentioned in the original article (2).  The errors in the report may be largely documentation and reading errors, but administrators always emphasize "if it isn't documented it did not happen."  Some of the problems at AMRTC have been decades in the making.

For a long time the message given to most professionals in the state is that the state hospital system including AMRTC (like practically all other hospitals in the state system) was going to be shut down. Only the practical fact that there is always a backlog of committed patients waiting to get in to AMRTC prevents it from being shut down.  But the key question remains - is this really the attitude of managers at the level of the State of Minnesota?

The second problematic attitude that I have heard about constantly is written about in the recent article (1):

"Nearly half of the 101 patients currently there no longer meet the hospital-level criteria for care but are kept at the hospital because they have nowhere to go in the community. In 2013 alone, patients spent a total of 13,800 unnecessary days at Anoka-Metro after they were treated — enough to care for another 140 patients, according to a state legislative report."

This is a good example of circular reasoning.  The reason why patients spend so-called "unnecessary days" at AMRTC is that there are no other facilities that can manage their behavior.  I am aware of programs where very aggressive individuals are managed in very small settings (2 to 4 resident group homes) and the staff is taught to physically restrain them when they become very aggressive.  That is really an unacceptable long term solution to the problem for many reasons.  It is time to stop pretending that long term hospitals are acute care hospitals and that they should be managed like acute care community hospitals.  A transient reduction in symptoms does not mean that a patient at AMRTC is spending "unnecessary days" at the hospital.  If they cannot successfully transition to a community placement - they probably need to be there.

The real and unaddressed issues (beyond the CMS report):

1. The effect of the message that state hospitals should all be closed: As a psychiatrist in the state, this is what I have been hearing for a long time. It is really not possible to develop a quality of care focus or have the necessary stable staffing patterns of experienced staff, when those same staff are hearing that the state is trying to close down the facility and that many people at the facility don't need to be there. Instead - the facility should be managed as one that can provide state-of-the-art care to patients with complex problems including violence and aggression. Another aspect of that is eliminating the positions of experienced staff to save money. You will never have a high quality program using this approach and yet the state has used this approach.

2. The effect of management from higher levels: This seemed to stand out as I read the issue of "generic treatment plans" from the CMS report. At some level all treatment plans become "generic treatment plan". The evidence is that you can purchase treatment planning texts for nursing, psychotherapy and to a lesser degree psychiatry that will show you generic treatment plans for an entire list of problems. Is the problem really a generic treatment plan that covers most interaction or the lack of a treatment plan that addresses a high degree of aggression? I would contend that it is the latter.

Complicating that issue are previous stories about how plans were implemented by state administrators with no psychiatric experience to address patient aggression. I sat in on one of these sessions that suggested that a focus on the aggressive person as a psychologically traumatized individual was the best way to proceed, but not much specifics after that. Is at least part of the problem that state hospital staff have inadequate guidance on what to do about aggression? Are they reluctant to intervene early or clearly document what happened and their response because the response from administrators is inconsistent? Are they being advised to use interventions that are ineffective?

3. The lack of teamwork and possibly a split staff: One of the most dangerous problems in any inpatient psychiatric environment is staff splitting - some of the staff are praised and well liked and other are criticized and disliked. This emotional environment in inpatient care leads to problems in patient care. Splitting needs to be minimized or eliminated largely by recognizing that professionalism and the objective analysis and treatment of problems is the real priority. I have been in treatment environments where staff were disliked or falsely accused and that lead to major problems in patient care and episodes of aggression. It also leads to staff turnover.  The attitude of administrators can be particularly insidious and create an immediate rift among the staff.

4. The influx of inmates into AMRTC that is caused by the current public policy of rationing community psychiatric care and the resulting shift in the cost of care to the correctional system: Instead of addressing the widespread problem of rationing psychiatric care for the severely mentally ill - the solution is currently to dump at least some of them from law enforcement facilities to a rationed long term care facility. How is that a solution to anything?

These are the real problems at AMRTC and within the state system as far as I can tell. This is all based on what I read in the papers, the CMS report, and my extensive inpatient and out patient experience as well as experience treating aggressive people. The CMS report while noting significant problems does not come close to addressing these issues and makes it seem that addressing problems in patient care or documentation will correct the problem with aggression within this system.

I doubt it is that easy.



George Dawson, MD, DFAPA


1:  Chris Serres.  Anoka state mental hospital violated basic rules for patient care, feds say generic treatment plans, other issues put mental hospital's federal funding at risk. StarTribune January 16, 2016.

2: Chris Serres. State psychiatric hospital in Anoka threatened with loss of federal funding. Minneapolis StarTribune January 4, 2016.

Accountability - The Last Refuge of a Scoundrel

On April 7, 1775, Samuel Johnson said:  "Patriotism is the last refuge of a scoundrel."  His biographer had to clarify that Dr. Johnson was not talking about love of country but "pretend patriotism which so many have made a cloak for self interest".  We see the rhetorical application in American elections where politicians spend more time on discussions of their military records rather than issues relevant to any kind of plan that they have for the nation or solving any real problems.  Nunberg makes the observation that that the term can also mean an irrational bias favoring one's country and that Americans have applied the term indiscriminately at times. He also points out that it can be a word designed to put people on the defensive.  

If I had to pick a word in the medical field that has similar uses - it would be "accountability".  There has probably been no single word more responsible for facilitating managed care and recent government intrusions into the practice of medicine.  If you think about the premise of physicians being "accountable" to politicians and businesses - it is absurd on the face of it.  Taking a professional who has been trained to be accountable to an individual patient and who operates in a professional environment that specifies behavior toward that person and telling them that they are now going to be monitored by businesses with a goal of maximizing profits or politicians with numerous conflicts of interest and a clear interest in getting re-elected - is an ongoing disaster.  So  how has it happened?  I would suggest that most of it has to do with rhetoric.

Before I point out the medical applications of the accountability rhetoric let me say that I don't consider this to be specifically applied to medicine.  Accountability rhetoric is broadly applied by any person or group seeking some kind of political advantage.  An obvious example is education and teaching.  Politicians everywhere get a lot of mileage out of the idea that they are going to hold teachers accountable usually through standardized test scores.  It has become a pat answer to taxpayers concerns about the money being spent on education and low graduation rates.  In some states, the test scores are marched out every year and used to rank schools and teachers.  Never mind the fact that the school system that produces the top international performance scores does not work that way.  In Finland, a professional teaching culture is by far and away the most significant factor in their academic excellence.  In the book written about this the teachers say they would not tolerate the kinds of intrusions that are common in the United States.  These intrusions are all based on accountability rhetoric.  

In preparing for this post, I searched my e-mails from the past three years and found 1800 e-mails containing the word accountability.  Most of those hits were due to the Health Insurance Portability and Accountability Act (HIPAA).  If you read the long title of this act it was clearly doomed out of the box.  The major impetus for the PPACA (Obamacare) was health insurance portability suggesting that HIPPA was already a failure.  That did not deter legislators from including a Privacy Rule under HIPAA to supposedly crack down on privacy violations.  My read of the bill is that is actually broadens the use of anyone's medical information among all "covered entities" affiliated with your health plan.  In the meantime,  the Privacy Rule was so threatening that it almost immediately made it more difficult for the doctors doing the work to get access to data.  Was it necessary for physicians?  Absolutely not - physicians are trained in medical privacy and all broad breaches of medical privacy have been due to either hacking or business people losing computers with significant amounts of data.  Make no mistake about it - politicians will be there to make the most accountable people accountable and greatly decrease their efficiency.   A great example of the title of this post.

I have recently posted a number of examples of accountability rhetoric being used for political leverage against physicians.   It can be used by medical boards, advocacy organizations, state agencies, federal agencies, and specialty boards in addition to politicians.  I am going to focus on a single example and that is Medicare.  All of the information that follows is public and can be accessed through the Medicare link on the American Psychiatric Association's web site.  I picked it up on my Facebook feed but it disappeared and I had to call APA staff to figure out where it went.  I am very familiar with the history of Medicare quality initiatives because I was one of their quality reviewers for inpatient hospitalizations in Minnesota and Wisconsin in the late 1980s and 1990s.  If you look for inpatient psychiatry measures you will find that many of them (polypharmacy, multiple drugs from the same class, discharge planning) are unchanged from that era, despite the fact that the review organization was disbanded because it did not find enough quality or utilization problems to justify its ongoing existence.

The APA points out that Medicare now has a fee scale that takes into account "quality of care measures instead of just paying a standard fee for every procedure (CPT) code".  They have a Physician Quality Reporting System (PQRS) that requires psychiatrists to report on one measure in order to avoid a 1.5% penalty.  For 2013 that report has to be made on one Medicare patient.  This is described as an "incentive" to report on quality performance measures and of course a "penalty" for those who fail to report.   A managed care company would call it a "holdback" in that it is technically work that has been done, but the no cost way to turn it into an "incentive" is just to take it from the people doing the work and make it seem like they are rewarded with it later.

The document goes on to document "measures identified as pertinent to psychiatrists (along with their designated codes)".  If you are a psychiatrist read through these reporting measures and marvel at the morass of initial codes that I am sure are going to grow as this administrative nightmare continues.  The further problem is that Medicare/CMS clearly has the goal of comparing physicians and holding them accountable based on the fantasy that these measures actually mean something in clinical practice or even the world.  And if this list of measures is not enough, there are also 50+ page guidelines online like: "The American Medical Association-convened Physician Consortium for Performance Improvement - Adult Major Depressive Disorder Performance Measurement Set" that describes an additional set of performance measures.  The AMA is involved and if you click the link 2013 PQRS Quality Measures you can search on Major Depressive Disorder and find the following links.  You can download the 50+ page document from the top link.

Most people realize that physicians currently have some of the highest burnout rates of any group of professionals.  Those burnout rates are directly related to micromanagement even before we get to the level I just described in the above paragraphs.  The paradox that every physician is aware of is that these reportable measures are not valid objective markers and they are being promoted by bureaucrats who not only have no accountability but in the case of the mental health system of care are some of the same people who destroyed it in the first place.  Don't forget that Congress skewed insurance coverage of mental illness and addictions so badly that Senators Wellstone and Domenici had to write legislation in an attempt to correct that.  At this time the final form of their legislation is still pending.

So accountability has become the last refuge of scoundrels.  Be very skeptical of any politician or bureaucrat waving that flag.  It has little to do with reality and more to do with promoting their own self interests while creating a tremendous and unnecessary burden for the doctors they regulate.

George Dawson, MD, DFAPA

Nunberg G.  Going Nucular: language, politics, and culture in confrontational times.  Cambridge: MA Perseus Books Group, 2004.

For a complete analysis of political doublespeak as applied to medicine see:

Robert W. Geist:  Hot Air Index: Political/Commercial Double-speak Lexicon for Medicine