In case you were wondering how Pharma’s faring

money-pillsYesterday, I posted about the Joint Commission’s review of the unintended consequences of their emphasis on pain without the proper input, review and feedback systems.

The opioid crisis that this has contributed to have been a disaster for families, communities and health care professionals who are trying to navigate the standards, untrustworthy standards of care, and their medical/social consequences.

One might wonder how Pharma is faring in this crisis. Has there been regulatory, criminal, funding or popular backlash that has hurt their viability?

It would appear not.

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the unintended consequences were, in retrospect, predictable

mU8NMGqzWRQSRikWZCaTggwJAMA just published an article on the history of the Joint Commission standards on pain and the lessons learned from the opioid crisis that followed.

The article describes the impetus for the increased attention to pain.

In 1990, Max2 decried the lack of improvement in pain assessment and treatment over the previous 20 years and called for a different approach that included the following: make pain “visible”; give physicians and nurses bedside tools to guide use of analgesics; ensure patients a place in the communications loop; increase clinician accountability by developing quality assurance guidelines; improve care systems; assess patient satisfaction; and work with narcotics control authorities to encourage therapeutic opiate use. Max reiterated the conventional wisdom of the day that “therapeutic use of opiate analgesics rarely results in addiction,”2 although this was based on a single publication from 1980 that lacked detail about the study methods.3

In 2000, The Joint Commission introduced standards for pain management and began referring to pain as “the fifth vital sign.”

However . . .

The Joint Commission standards raised concerns that requiring all patients to be screened for the presence of pain and raising pain treatment to a patients’ rights issue could lead to overreliance on opioids.

What were the real world consequences?

Signals appeared suggesting that some clinicians had become overzealous in treating pain. In a 2003 survey of 250 adults who had undergone surgical procedures, almost 90% of patients reported they were satisfied with their pain medications. Nevertheless, the authors concluded that “many patients continue to experience intense pain after surgery”7 and “[a]dditional efforts are required to improve patients’ postoperative pain experience.”7 Health care organizations implemented treatment policies and algorithms based on patients’ responses to numerical pain scales. Concerns about this practice increased after a report that the incidence of opioid oversedation increased from 11.0 to 24.5 per 100 000 inpatient hospital days after the hospitals implemented a numerical pain treatment algorithm.8 The ISMP linked overaggressive pain management to a substantial increase in oversedation and fatal respiratory depression events.

Is that a little too jargon-ey for you? How about this?

Here are their lessons learned:

Several conclusions from this history could serve as lessons for addressing the current prescription opioid epidemic. First, engage all stakeholders when creating standards and not just those who passionately favor action. Advocates may be less able to see the possible unintended consequences than other stakeholders. . . .

Second, try to anticipate unintended consequences and have monitoring programs in place from the start. Many of the unintended consequences of The Joint Commission standards were, in retrospect, predictable, and the need for changes may have been identified earlier if there had been prospective monitoring of adverse consequences. . . .

Third, pay close attention to what programs and procedures organizations implement to meet new requirements. For example, the algorithms organizations used to guide treatment based on numerical pain scores should have immediately raised concern. . . .

Finally, they share a lesson that I emphasize over and over about addiction treatment research.

Fourth, carefully review the primary literature on issues of critical importance and do not simply repeat the claims of experts in previous articles. The 1980 letter to the editor by Porter and Jick3 suggesting that addiction is rare in patients treated with narcotics has been cited almost 1000 times. Yet the report is so brief, methodologically vague, and unlikely to be generalizable to recent medical practice that its finding should never have been disseminated without cautionary notes and calls for research.

The article does close with a worthwhile reminder.

Concerns about unintended consequences should not serve as a deterrent from pursuing “noble” goals.

We should work hard to not pit the problems of pain patients and people with addict against each other.

We can attentively and compassionately treat pain and be mindful of the limitations and risks of the drugs involved for the patient and the community.

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New buprenorphine study – more disappointing outcomes

Choose you evidence carefully by rocket ship

Choose you evidence carefully by rocket ship

So . . . congress recently passed $1,000,000,000 to address the opioid crisis. Much of that money is expected to be spent on medication assisted treatment.

Buprenorphine has been the most frequently touted form of medication assisted treatment. I’ve reviewed the research here and found that it does not live up to the hype.

A new study of buprenorphine was just published. It looks at prescription opioid use during and after buprenorphine treatment.

What did they find?

For their study, Alexander and his colleagues examined pharmacy claims for more than 38,000 new buprenorphine users who filled prescriptions between 2006 and 2013 in 11 states. They looked at non-buprenorphine opioid prescriptions before, during, and after each patient’s first course of buprenorphine treatment, which typically lasted between one to six months. Even though there are no universally agreed-upon guidelines regarding the optimal length of treatment, most people discontinued buprenorphine within three months.

They found that 43 percent of patients who received buprenorphine filled an opioid prescription during treatment and 67 percent filled an opioid prescription during the 12 months following buprenorphine treatment. Most patients continued to receive similar amounts of opioids before and after buprenorphine treatment.

They described buprenorphine’s impact and retention like this:

Buprenorphine therapy was associated with modest declines in most measures of opioid use following the first treatment episode; however, only 33% of patients continued to fill prescriptions for buprenorphine after 3 months.

Families and people with opioid problems are NOT looking for modest declines in use and a 67% drop out rate within 3 months.

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The mechanics of hope

Ok this post is a little odd.

I’ve spent a lot of years trying to understand the transmission/kindling of hope in others.

A friend recommended the podcast, “Missing Richard Simmons.” It’s good! But, I’m not posting this to recommend it.

There’s a segment in the first episode with a person named Kathy whose life was affected by Richard Simmons. You can hear her at 16:23 of the podcast.

It’s a nice story of him kindling hope in her life that led to important, positive change for her.

What are the essential elements of the story?

  • Going beyond what’s expected?
  • Commitment and consistency?
  • Equivalence and reciprocity?
  • Kindness?
  • The indirect message of the elements above – “you are important”?

What have I missed?

It’s also worth noting what wasn’t mentioned: him being an expert, giving advice, etc. Connection seems to me much more important than any of that.

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Confused about the changes coming to publicly funded treatment in Michigan? Here’s the background.

historyI’ve gotten several questions about yesterday’s post on looming changes for publicly funded treatment in Michigan. These questions made me realize I probably needed to provide a little background. To be honest, I haven’t followed it that closely and it’s all a little confusing.

Background

Michigan is one of a shrinking number of states that “carves out” its behavior health funding. Meaning that Medicaid HMOs are not responsible for behavioral health services. (Behavioral health services refers to services for mental illness, developmental disabilities and substance use disorders.)

Instead, the state keeps about $2.4 billion dollars and distributes it to 10 regional organizations called PIHPs (Prepaid Inpatient Health Plans) that are responsible for behavioral health services in their region. The PIHPs do not deliver the services themselves, but they contract for these services and oversee them.

In February of 2016, Governor Snyder proposed that, by Sept. 2017, all behavioral health clients and money be transferred to the state Medicaid HMOs. (This is referred to as Section 298, referring to the relevant portion of the budget proposal.)

There had been no groundwork or forewarning leading up to the proposal and it caught people by surprise.

There has been a national trend away from carve-outs. There may be many reasons for this trend but the two reasons I hear are preferences for privatization and a desire to increase integration of behavioral health with physical health systems. It can also be argued that there are ways in which it seems sensible and destigmatizing to have Medicaid recipients receive services just like everyone else—through their insurer.

On the other hand, the people served by the public system often represent the most severe and complex cases. In response to this severity and complexity, public systems has developed systems of care that include things like peer support, supportive housing, employment support, and mental health club houses. They also work with local communities and first responders on things like overdose rescue, and problem solving courts. It’s hard to imagine HMOs doing this kind of work.

Providers, service recipients, families and mental health advocates organized to oppose the change. They expressed concern that this would result in cuts in services and that there would not be any financial savings for the state.

In April 2016 the outcry about the proposal resulted in the legislature creating a workgroup that is responsible for reviewing the issue and issuing a report with recommendations by February 2017. This workgroup is called the Section 298 Workgroup.

So, to this point, nothing has changed.

This brings us to yesterday’s post which was about an interim report that was released by the workgroup on Friday.

If I’m reading the report correctly, it looks like they recommend keeping the carve out and trying some pilots programs.

So, privatization looks less likely than it did a year ago, but anything could happen.

A lot depends on what the final report from the workgroup looks like and how deferent the legislature will be to the workgroup.

The new Michigan legislature is even more conservative than the last and it’s easy to imagine them deciding they want to privatize regardless of the final report’s recommendations.

 

 

Here is the statement the workgroup issued on Friday:

The Michigan Department of Health and Human Services (MDHHS) today submitted the interim report for the Section 298 Initiative to the Michigan legislature. The Section 298 Initiative is a statewide effort to improve the coordination of physical health services and behavioral health services. The interim report reflects the discussions of the 298 Facilitation Workgroup. The interim report contains a series of policy recommendations for the Michigan Legislature on improving the coordination of physical health and behavioral health services.

The MDHHS and the 298 Facilitation Workgroup also launched the next phase on the Section 298 Initiative today. The next phase of the initiative focuses on the development of recommendations on models and benchmarks for implementation.

As part of the next phase of the initiative, interested stakeholders can submit potential models for consideration by the 298 Facilitation Workgroup. MDHHS will accept model proposals submitted to MDHHS-298@michigan.gov using a standardized template from January 13, 2017 to February 3, 2017 at 5:00 p.m. The model proposal template can be found on the MDHHS webpage at www.michigan.gov/stakeholder298.

The model proposal process is not a request for proposal which will result in a direct contract or other formal engagement of the submitter(s): this process is a request for information which will contribute to the development of the Section 298 Final Report for the Michigan legislature.

For more information about the interim report and the model proposal process, visit www.michigan.gov/stakeholder298 or send an email to MDHHS-298@michigan.gov.

If you have opinions on the matter, please contact the workgroup and your legislators. (There’s still plenty of time. This has not been a fast moving process.)

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Changes coming to publicly funded treatment in Michigan

historyIf you haven’t heard, there’s been serious discussion about making major changes to publicly funded mental health and substance use disorders in Michigan. The current system carves out money for those services and give it to 10 regional entities that contract for and oversee Community Mental Health services and substance use disorder services. The question is whether that should continue or whether the money and responsibility should be given to the HMOs serving Michigan Medicaid recipients.

It’s complicated.

There are ways in which it seems sensible and de-stigmatizing to have Medicaid recipients receive services just like everyone else—through their insurer.

On the other hand, the people served by the public system often represent the most severe and complex cases. In response to this severity and complexity, public systems has developed systems of care that include things like peer support, supportive housing, employment support, and mental health club houses. They also work with local communities and first responders on things like overdose rescue, and problem solving courts. It’s hard to imagine HMOs doing this kind of work.

There is a 298 workgroup and they just issued the following statement:

The Michigan Department of Health and Human Services (MDHHS) today submitted the interim report for the Section 298 Initiative to the Michigan legislature. The Section 298 Initiative is a statewide effort to improve the coordination of physical health services and behavioral health services. The interim report reflects the discussions of the 298 Facilitation Workgroup. The interim report contains a series of policy recommendations for the Michigan Legislature on improving the coordination of physical health and behavioral health services.

The MDHHS and the 298 Facilitation Workgroup also launched the next phase on the Section 298 Initiative today. The next phase of the initiative focuses on the development of recommendations on models and benchmarks for implementation.

As part of the next phase of the initiative, interested stakeholders can submit potential models for consideration by the 298 Facilitation Workgroup. MDHHS will accept model proposals submitted to MDHHS-298@michigan.gov using a standardized template from January 13, 2017 to February 3, 2017 at 5:00 p.m. The model proposal template can be found on the MDHHS webpage at www.michigan.gov/stakeholder298.

The model proposal process is not a request for proposal which will result in a direct contract or other formal engagement of the submitter(s): this process is a request for information which will contribute to the development of the Section 298 Final Report for the Michigan legislature.

For more information about the interim report and the model proposal process, visit www.michigan.gov/stakeholder298 or send an email to MDHHS-298@michigan.gov.

If you have opinions on the matter, please contact the workgroup and your legislators. (There’s still plenty of time. This has not been a fast moving process.)

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Updates to 42 CFR part 2

confidentialityNew rules have been released for 42 CFR part 2, the law that provides for confidentiality of addiction treatment records.

The changes are intended to make information sharing between providers easier, though it’s not clear how much this will actually help.

The new rules can be found here.

The federal press release can be found here.

The proposed and final rules are not loved by all:

In response to the proposed rule, Kaiser Permanente had written: “SAMHSA appears to have gone out of its way to make sharing clinical information for treatment purposes more difficult, other than nominal easing of consent form requirements for a very limited type of HIE. SAMHSA has not created a treatment exception, has not permitted patients to consent to disclosure of information to “all of my treating providers ….and has made consent forms more complicated and confusing.”

In response to the final rule, Pamela Greenberg, president and CEO of the Association for Behavioral Health and Wellness, noted that while the final rule is an improvement over current regulations and over the proposed rule, it continues to limit communication among providers, and in some cases, the ability to use existing medical information to identify members at risk for substance, such as opioid, misuse or diversion,

“ABHW applauds SAMHSA for addressing this important matter. Our hope was that the final rule would align substance use privacy protections with the Health Insurance Portability and Accountability Act (HIPAA). Unfortunately, it does not,” Greenberg said in a prepared statement. “Separation of substance use from the rest of medicine creates several problems: primary care lacks the ability to coordinate a patient’s medical and substance use treatment; substance use treatment programs lack the capability to coordinate a patient’s medical and substance use care; and patients are put at risk of unsafe, uncoordinated, and uninformed care.”

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