POTUS Tweets Measures To Address Opioid Epidemic

In 2014, nearly 21,000 deaths in the U.S. involved prescription opioids. Here's what @POTUS is doing about it: https://t.co/M2HgnDDN6a

— The White House (@WhiteHouse) March 29, 2016

I happened to be on Twitter last night when I caught the above Tweet from POTUS.  Having a professional interest, I decided to follow the link at the White House blog to look at the proposed measures.  They were listed as:

1.  Increasing a key drug for medication assisted treatment.  That key drug is buprenorphine in a number of formulations for treating severe opioid dependence.

2.  Preventing opioid overdose deaths.  This appears to be $11 million in funding for various forms of treatment and increasing access to naloxone to reverse the effects of an acute overdose.

3.  Addressing substance use disorder parity with other medical and surgical conditions.

These are very modest and in some cases unrealistic proposals about about trying to stop a drug epidemic that is killing 20,000 people a year.  Let me tell you why:

1.  Increasing a key drug for medication assisted treatment.  That key drug is buprenorphine in a number of formulations for treating severe opioid dependence.

Buprenorphine as Suboxone and Subutex have been available for the treatment of opioid addiction in the US since 2002.  The current evidence suggests that buprenorphine has superior efficacy for abstinence from opioids and retention in treatment.  There is also evidence that patients on buprenorphine have fewer side effects and that they is a less severe neonatal abstinence syndrome in mothers maintained on buprenorphine versus methadone.   Buprenorphine is also used for acute detoxification and treatment of chronic pain.  One of the limitations of maintaining opioid addicts on buprenorphine is that a special license is required to prescribe it.  Physicians can obtain that license by by attending CME or online courses.  Even then, expansion to primary care physicians has been slow because they may have no colleagues in their practice with similar certification and that makes on call coverage problematic.  In addition, many clinics that are medically based are reluctant to provide this type of service to people who have opioid addictions.  Apart from the technical requirements of prescribing the various preparations of buprenorphine certain physician and patient characteristics may also be important.  Physicians have to be neutral and not overreact in situations where the patient exhibits expected addictive behaviors that may include relapse.  As an example, younger opioid users are frequently ambivalent about quitting and in some cases, use other opioids and reserve the buprenorphine for when their usual supply dries up.  They may sell their buprenorphine prescription and purchase opioids off the street.  It may not be obvious but physicians prescribing this drug need an interpersonal strategy on how they are going to approach these problems.    On the patient side,  there is the biology of how the opioids have affected the person.  Do they have severe withdrawal and ongoing cravings?  What is their attitude about taking a medication on an intermediate or long term basis in order to treat treat the opiate addiction?

In clinical trials, buprenorphine seems to be ideal medication for medication assisted treatment (MAT) of opioid dependence.  Like most medications, there are issues in clinical practice that are not answered and possibly may never be answered.  The issue of life-long maintenance is one.  Many people with addictions are concerned over this prospect.  Long term maintenance with buprenorphine has advantages over methadone in that it is easier to get a prescription rather than show up in a clinic every day to get a dose of methadone.  Most addicts are aware of the fact that withdrawal from both compounds can be long and painful.  This deters some people from trying it and relapse risk is high if a person attempts to taper off of it.  Despite the current consensus about use. there is still the problem of young addicts who feel that they are "not done using" and who go between using heroin and other opioids obtained from non-medical sources and buprenorphine.  

2.  Preventing opioid overdose deaths.  This appears to be $11 million in funding for various forms of treatment and increasing access to naloxone to reverse the effects of an acute overdose.

Naloxone kits that would allow for rapid reversal of opioid overdoses have been shown to be effective in partially decreasing the death rate.  At some treatment and correctional facilities opioid users are discharged with naloxone kits for administration in the event of an overdose.  Opioids are dangerous drugs in overdose because they suppress respiration and that can lead to a cardiac arrest.  There are several properties of opioids that heighten the overdose risk.  Tolerance phenomena means that the user eventually becomes tolerant to the euphorigenic and in some cases therapeutic effects of opioids and needs to take more drug.  If tolerance is lost when the user is not taking high doses for a while, using that same high dose can result in an overdose.  Taking poorly characterized powders and unlabelled pills acquired from non-medical sources compounds the problem.  The exact quantity of opioid being used is frequently unknown.  Adulterants like fentanyl - a much more potent opioid can also lead to overdoses when users do not expect a more potent drug.

In addition to the pharmacology of the drugs being used there is also a psychological aspect to overdoses.  Users often get to the point where they don't really care how much they are using in order to get high.  They will say that they are not intentionally trying to overdose, but if it happens they don't care.

The available literature on making naloxone available suggests that it is effective for reversing overdoses in a fraction of the at risk population that it is given to.  I would see at as the equivalent of an Epi-pen in that the majority of patients with anaphylactic reactions get these pens refilled from year to year but never use them.  When they are required they are life-saving.  The problem with a naloxone kit is that it assumes a user or bystander can recognize an overdose and administer naloxone fast enough to reverse the effects of opioids before the user experiences serious consequences.  Unfortunately addiction often leads to social isolation and not having a person available makes monitoring for overdoses much more problematic.  Naloxone kits should always be available opioid users, first responders, family members, and anyone involved in assisting addicts.  Detailed long term data on the outcomes over time is needed.  

3.  Addressing substance use disorder parity with other medical and surgical conditions.

The is the most critical aspect of the President's tweet.  One of the main reasons for this blog is to point out how people with addictions and severe mental illnesses have been disproportionately rationed since the very first days of managed care - now about 35 years ago.  Some of the first major changes involved moving medical detoxification out of hospitals.  So-called social detoxification was available with no medical supervision.  These non-medical detox facilities were very unevenly distributed with only a small fraction of the counties in any state running them.  Any admissions to hospitals were brief and "managed" by managed care companies.  In the case of addictions some of the management practices were absurd.  A standard practice was to determine how many days a person could be in residential treatment.  That often required a call to an insurance company nurse or doctor who had never seen the patient.  They could determine that the patient could be discharged at any time based on arbitrary criteria.  In some cases that involved just a few days and the patient was leaving with active cravings and in some cases an an active psychiatric disorder.  This practice continues today, despite party legislation that suggests that addictions and mental disorders should be treated like any other medical problem.

This is where the President's tweet is on very shaky ground.  His legislation  focuses on large systems of health care and yet these systems don't seem to be able to supply adequate treatment with either buprenorphine or naloxone kits.  The President is fully aware of the The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).  That act was supposed to provide equal treatment for mental illnesses and addictions that was on par with medical and surgical conditions.  I think it is no secret that special interests have shredded the intent of this bill to the point that it is useless.  Managed care systems still ration care for these disorders in their best financial interest.  The resources for treating these disorders are still not equal to the task. In the case of prescription painkillers the same system of care not providing adequate treatment for addiction is often where that addiction started.

All three of the President's points could be addressed by forcing health care companies to provide adequate care for addictions and mental illnesses instead of grants to provide services that they should be doing in the first place.  In an interesting recent twist the President (1) suggested that this discrimination was based on race.  He implied that as a result the police rather than doctors have been used to address the problem.

Let me be the first to say that President Obama is wrong.  There is no doubt that racial discrimination exists.  There is no doubt that it occurs in systems of health care (2,3).  There is also no doubt that all it takes is a diagnosis of addiction or mental illness to trigger highly discriminatory health care coverage - irrespective of a person's race.  It is all about how health care businesses make money in this country by rationing or denying treatment for these disorders.

To reverse that discrimination,  the government needs to take the MHPAEA seriously.  So far they have failed miserably and that is the problem on the treatment side in trying to address the opioid epidemic.  

George Dawson, MD, DLFAPA

References:

1:  Sarah Ferris.  Obama: 'We have to be honest' about race in drug addiction debate.  The Hill March 29, 2016.

2:   Eddie L. Greene, MD and Charles R. Thomas, Jr, MD.  Minority Health and Disparities-Related Issues: Part I.  Medical Clinics of North America July 2005; 89(4).

3:   Eddie L. Greene, MD and Charles R. Thomas, Jr, MD.  Minority Health and Disparities-Related Issues: Part II.  Medical Clinics of North America July 2005; 89(5).

  

Is Mental Health Legislation Really The Joke That I Think It Is?

The above graphic is a headline search of mental health parity going back to 2004.  I was in the thick of things from 2009-2012 as the transitioning President of a District Branch of the American Psychiatric Association - the Minnesota Psychiatric Society.  Not that it gave me the inside track on anything.  I think officers in district branches spend most of their time trying to get members motivated to do something.  My strategy was basically to approach things in the way I do on this blog.  I don't think that is was any more or less successful than the dialogue promoters, but at one point some people became uncomfortable when I suggested that one of the hospitals could have been managed better.  It was apparent to me at that time that professional organizations do not tolerate disagreement very well.  As far as I can tell, there can be no real changes in organizations without disagreement and disagreement should be expected anytime there are people who want to talk endlessly and people who want action.  On the other hand nobody has to take it personally.  That may not be possible in Minnesota or in professional organizations.  I have previously referred to it here as the "big tent" approach where multiple goals are tolerated even some that conflict with the overall goals and ethics  of the organization.  An example would be prior authorization of medications.  The vast majority of members find it extremely intrusive and a waste of their time, but the members who are executives in managed care organizations do not.  Accepting both of those positions is a tacit acceptance of prior authorization while working with the members to change it.  How do you think that will work out?

Parity or equal coverage for mental illness and physical illness was a legislative initiative of two U.S. Senators Paul Wellstone and Peter Domenici.  Both had personal experience with the problem having family members with severe mental illness.    That personal experience remains critical in the political and cultural landscape.  There are still plenty of people pushing the "myth of mental illness" fallacies.  Some have moved on to just blame psychiatrists.  People with experience recognize those arguments for what they really are and can try to proceed with real solutions.  I never met Paul Wellstone, but I liked him a lot.  He was one of a handful of US Senators who voted against authorizing the invasion of Iraq based on the flawed weapons of mass destruction argument.  He was vilified by some for the vote and referred to as an ultra-liberal.  That is a glib characterization during an era where there are no liberals.  In Minnesota he was widely known as a populist.  People perceived him as a common man who cared about the common people.  He was tragically killed in a in a plane crash in northern Minnesota in 2002 while campaigning for his fourth term in the Senate.  Senator Domenici retired from the Senate in 2009, after the longest tenure at that position by anyone from the state of New Mexico.  My guess is that the final form of this bill and the way it is implemented was not the intent of either of these Senators.

I read through several iterations of their bill until it became The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).  All of those versions are available on the Congressional web sites, but the factsheet is available from CMS.  It should be fairly obvious by any casual read of the factsheet that there are so many exceptions and vagaries associated with this law that it would not take the insurance industry and their government affiliates long to shred it.  I pointed this out at the APA 2011 Annual Meeting in Hawaii.  There was a meeting about how the MHPAEA was going to revolutionize the care of people with addictions.  A prominent psychiatrist and government official was scheduled to be there to explain how this was going to happen.  At the time, the impact of the law was not apparent on any of the acute care services where I was working.  At the meeting after listening to an overenthusiastic presenter explain how funding all of these programs were going to greatly increase bed capacity and services for all, I asked the simple question: "What would prevent any managed care company from providing a screening test and calling that assessment and treatment?"  The answer was "Nothing would prevent that."  No elaboration.  No discussion of how employers can just opt out of mental health and substance use treatment.

That introduction allows me to flash forward to the current time.  I was recently interested in referral for an acute psychiatric hospitalization in the Twin Cities - a metropolitan area of 3.8 million people.  According to a 2007 state report there were a total of 563 acute care beds for that area or 14.8 beds per 100,000 population.  According to the Organisation for Economic Co-operation and Development (OECD), the US ranks about 30th of 35 ranked industrial countries in terms of psychiatric beds per 100,000 population and the Minnesota metro is significantly below the US average of 25/100,000.   Based on those factors it should not be surprising that I was advised that there were no available beds and that the emergency department we could refer to had a 30 hour wait for assessments.

Compare that to Cardiology services in the same area.  Any middle-aged person (or younger) with chest pain would be immediately admitted to a coronary care unit or telemetry and have a standard evaluation completed even if they were discharged or undergo emergency catheterization and angioplasty/stenting.   I have never heard of a wait for acute Cardiology services.  I have never heard of a 30 hour wait in the emergency department for Cardiology services.   My point here is that the MHPAEA or parity legislation has done exactly nothing for the availability of acute psychiatric services.  These same numbers and waiting times in the ED have been there for the past 15 years.  There is no parity as long as there is no equal funding, and mental health services are funded at a fraction of what Cardiology services are.  Walk through any modern Cardiology Department or Heart Hospital and ask yourself: "Where are the equivalent psychiatric or mental health services?"  There are a few exceptions but generally not many and even then, a new facility is still managed by rationing strategies that result in people being discharged with inadequate plans and before their problems are completely addressed.  Inpatient psychiatric services are in effect behind a firewall and accessible only through the bottleneck in the ED.

The grim picture of acute care mental health services is only exceeded by the state of acute care addiction services.  As early as 1988, I was being advised by managed care companies that I could not detoxify patients with alcohol dependence on inpatient psychiatric units,  even if they had significant psychiatric comorbidity like suicidal ideation and depression.  The picture has gotten progressively worse since then.  It is common practice these days to send alcohol dependent people home with benzodiazepines and expect them to manage their own detox.  The lack of functional detoxification services keeps many people in the cycle of addiction to benzodiazepines, opioids and alcohol.

Confirmation of my skepticism about parity came in the form of the Mental Health Reform Act of 2015.  It is also a bipartisan bill introduced by Senators Bill Cassidy (R-Louisiana) and Chris Murphy (D-Connecticut).   There are House and Senate versions.  Both establish a new assistant secretary position for mental health and substance use disorders under the Department of Health and Human Services (HHS).   The fate of the Substance Abuse and Mental Health Services Administration (SAMHSA) hangs in the balance and getting rid of this highly flawed agency should be a priority.  SAMHSA has been the lead agency for mental health during this time of no parity and has not said anything about it.  The remaining description of the bill has to do with education people about HIPAA (do we really need that?) and insurance company accountability for a lack of parity.  The fanfare for this bill including praise from the APA is the exact same way the parity legislation started.  It should be evidence to every American by now that Congress is really interested in appearing to do something and appearing to want reform rather than getting the job done.

I don't think that there is anyone in Washington who knows the meaning of the word reform.  Until politicians everywhere realize that mental health services and substance use services have been an easy way for health care companies to make money by denying reasonable services nothing will happen.   It would help legislators to realize that they also have the highly flawed idea that managed care actually saves money and it is a conflict of interest for them to continue to promote this middle man on that basis.  I am not holding my breath, but it should be obvious that when a reform bill happens every 7 years, and there are still 30 hour emergency department waits and no acute care beds for admissions - there is no parity and there has been no reform.

George Dawson, MD, DFAPA





         

The New York Times Editorial Board on Parity

The New York Times Editorial Board came out with a comment on mental health parity entitled Equal Coverage for the Mentally Ill.  Like most sources with no knowledge of how mental health treatment works in this country - their outlook was very rosy.  I am  sure that is what the authors of the original bill - the late Senator Paul Wellstone and Senator Pete Domenici were hoping for.  Let me tell you why that is not going to happen.  As I followed the link to who is actually on the Editorial Board it is probably significant that there is nobody with health care expertise.  Even if there was the national press has a naive approach to health care and seems to present a distinctly politicized and business friendly viewpoint.  I would generally characterize that as a view that is very short on quality and long on cost effectiveness rhetoric.  The press seems to uncritically accept that "high quality cost effective" health care is the goal of businesses and governments.  Nothing could be farther from the truth.

The actual Rule that was published yesterday is a 205 page document.  It is written in a style that defies comprehension by anyone who is not a Congressional insider or an attorney.  Despite being highly acclaimed by a number of organizations including the American Psychiatric Association (APA) there is a surprising lack of details in why this is some sort of advance.  I go into this with thirty years of experience battling managed care in its various forms and needless to say I am no friend to that approach.  I know that the real goal is for managed care companies to make money and they make money by denying care and providing low quality care.  I also know that governments at all levels are very friendly to the managed care cartel and have bought their theology.  Practically all health care legislation is managed care friendly and the PPACA (Obamacare) facilitates super managed care organizations called Accountable Care Organizations.  With that backdrop and realizing that like most other people, I lack the legal qualifications to read this document, here are a few of my impressions:

1.  Medical necessity - there are 44 references to medical necessity in the document.  There is some concern about transparency.  It is quite easy for a managed care company to tell a person or their physician, pharmacy, or hospital that they are not covering a service because it is not "medically necessary."  This generally means that the company can employ doctors who can arbitrarily deny services.  In Minnesota in the 1990s, several psychiatrists were concerned that these companies were discharging people from hospitals prematurely and they insisted on seeing the actual criteria for these decisions.  They were advised that they were "proprietary" and not available.  The new Rule seems to demand adequate disclosure of these criteria.  Even if it did, the disclosure of this information is irrelevant.  In fact, there are criteria in use right now that are essentially made up on financial information and they have nothing to do with psychiatric treatment.  Unless there is an actual appeal process to a neutral party who has the power to overturn these decisions, managed care companies will continue to do whatever they want.

2.  Utilization review - there is one reference to utilization review (UR), a managed care tactic that is basically designed to harass physicians into discharging patients from a hospital based on the financial demands of the managed care company.  An example would be serial calls to a physician treating a patient with suicidal ideation.  The attending physician who sees the patient every day is concerned that the patient has a significant suicide risk and wants to continue to treat them on an inpatient basis.  The reviewer who is an employee of the managed care company, is sitting in a room several states away, and has never seen the patient and has no professional responsibility to them decides the patient is not at high risk and that they should be discharged from the hospital.  This leads to a series of unproductive conversations and forces the physician working with the patient to call him every day to justify keeping the patient in the hospital.  In many ways dealing with this process is like dealing with a bill collector.  The only difference is that you are paying a penalty for doing  your work and being responsible to a patient.

The rule seems to suggest that the amount of UR done is not a problem as long as it is equally applied across both mental health and general medical surgical services.  There are major problems with that idea.  The first is a decade long initiative by the managed care industry to internalize utilization review by case managers.  They claim these case managers are part of some kind of imaginary patient care team.   In fact they are there applying business standards to force physicians to discharge patients.  The second problem is that UR is completely unnecessary.  Managed care companies have huge financial leverage.  They reimburse a set amount per admission/discharge diagnosis that is a discounted rate.  The only conceivable uses for UR today are to pressure inpatient physicians and to create an incentive through internal UR to increase profits by managing discounted rates.  That happens when a hospital receives a fixed payment for what is probably a 5 day hospitalization and they now have UR by case managers to get physicians to discharge these patients in 3 days instead of 5.  There is no major psychiatric condition requiring hospitalization that  responds to three days of treatment.

3.  Small employer exemption - the Mental Health Parity And Addiction Equity Act (MHPAEA) does not apply to small employers:

 "MHPAEA and the regulations under it do not apply to employers with 50 or fewer employees (although, separately, the EHB regulations adopt MHPAEA)."   

According to the Census that eliminates about 34 million people or about the same number of uninsured that the PPACA purports to cover for the first time.  It also defeats the concept of parity.  But it turns out there are a lot of exceptions.  So who knows the total number of people who will be not even be covered:

"MHPAEA requirements do not apply to:

• Non-Federal governmental plans that have 100 or fewer  employees;
• Small private employers who have 50 or fewer employees;
• Large group health plans that are exempt from MHPAEA based on their increased cost.  Large group health plan sponsors that make changes to comply with MHPAEA and incur an increased cost of at least two percent in the first year that MHPAEA applies to the plan (the first plan year beginning after October 3, 2009) or at least one percent in any subsequent plan year (generally, plan years beginning after October 3, 2010) may apply for an exemption from MHPAEA based on their increased cost. If such a cost is incurred, the plan is exempt from MHPAEA requirements for the plan year following the year the cost was incurred. Subsequently, the plan sponsors must notify the plan beneficiaries that MHPAEA does not apply to their coverage.  These exemptions last one year. After that, the plan is required to comply again; however, if the plan incurs an increased cost of at least one percent in that plan year, the plan could claim the exemption for the following plan year. The following set of FAQ’s provide additional information related to the application of MHPAEA. In particular, see Q. 11 for a discussion of the processes by which plans may claim a cost exemptionhttp://cms.gov/cciio/resources/factsheets/aca_implementation_faqs5.html); and
• Self-funded non-Federal governmental employers that opt-out of the requirements of MHPAEA.  Non-Federal governmental employers that provide self-funded group health plan coverage to their employees (coverage that is not provided through an insurer) may elect to exempt their plan (opt-out) from the requirements of MHPAEA by following the Procedures & Requirements for HIPAA Exemption Election posted on the Self-Funded Non-Federal Governmental Plans webpage (Seehttp://cms.gov/cciio/resources/files/hipaa_exemption_election_instructions_04072011.html), then issuing a notice of opt-out to enrollees at the time of enrollment and on an annual basis. Thereafter, the employer must also file the opt-out notification with CMS"

4.  This bill will have no impact on gun violence.  You can't assess and treat potentially violent and aggressive people in a rationed, low quality system of care that is run by case managers bent on getting people out of the hospital.  There are many better suggestions on this blog but they require a system of quality care and professionalism.

5.  The bill will not save any money.  It should be painfully apparent that delegating the management of health care in the United States to a profit motivated middleman is a recipe for health care inflation.  That point is routinely lost on politicians and journalists.  The other point that these folks never seem to get is that managed care companies have in many cases acquired the means of production that they had sought to control.  This creates an additional conflict of interest.  If you now own all of the MRI scanners, you have an interest in seeing them run 24/7 especially when they might be covering a significant part of your hospital costs.  That might explain what an MRI of the C-spine is $1,500 in the US and $150 in Japan.

6.  The rule is doomed if the Editorial Board is serious about it depending on enforcement by state insurance commissioners.  The members of the Board must not have ever filed a complaint with a state insurance commission.  In many states it is difficult to find the state agency responsible for taking complaints against managed care companies.  Unlike Medical Boards, insurance complaints are often a well kept secret.  There are often pro-insurance and pro-managed care statutes in state law and industry insiders on the commission.  In my experience, the only hope state residents have against the managed care industry is an activist Attorney General.  Activist AGs happen about once a decade.    

These are all huge deficiencies in a Rule that is supposed to assure parity between mental health and substance use disorders and general medical surgical treatment.  Combined with pressure for collaborative care in primary care clinics, it is very easy to imagine that this Rule will not make any difference at all.  That is my preliminary take on the Rule with my previously stated qualifiers.

I fully expect a business friendly government to continue to be an obstacle to the provision of quality mental health and addiction services largely due to the conflict of interest it creates when it uses private businesses to make money by denying care at several levels.  But the New York Times won't be telling you that.

George Dawson, MD, DFAPA

Final Rule on Mental Health Parity.  Federal Register.  November 13, 2013.