Substance Abuse and Involuntary Commitment: Will It Work?

https://www.medpagetoday.com/meetingcoverage/aapl/75972

AUSTIN, Texas — A majority of physicians supported adult civil commitment for substance use disorder, according to a recent survey presented here.

From a national sample of 165 addiction physicians, 61% favored laws that permitted adult civil commitment for opioid and other substance use disorders, 21% were opposed, and 18% were unsure, reported Abhishek Jain, MD, of Columbia University in New York City.

Generally, respondents who spent more time with substance abuse patients were more supportive of civil commitment than those who were not, and the strongest support tended to be for opioid and alcohol use, he said at the American Academy of Psychiatry and the Law (AAPL) annual meeting.

However, the majority of physicians also reported that they were concerned with the amount of resources and facilities needed to impose this treatment, and said they generally supported having medication-assisted treatment (MAT) available if these laws were implemented.

“[The study] suggests that people oppose civil commitment for substance use more based on the lack of resources and the ability to pay for the commitment,” rather than other concerns such as losing rapport with patients, or that patients would need motivation for substance use treatment to be effective, Jain said in the talk.

Civil commitment allows family members, or others, to seek court-ordered treatment for individuals with substance abuse on the basis that they pose a substantial threat of harm to themselves or others. However, unlike being processed through a drug court, civil commitment does not require substance abusers to go through the criminal justice system, Jain explained. As of 2013, 32 states and Washington, D.C., had laws permitting civil commitment in these cases.

But he said the literature regarding civil confinement is often extrapolated from other international studies and that U.S. studies in this field tend to have small sample sizes and insufficient treatment details, making it difficult to generalize. The studies also have mixed findings. For example, in a 2007 American Psychiatric Association (APA) survey, just 22% of respondents supported alcohol or drug civil commitment, Jain added.

Those against the implementation of these programs argued that taking patients in against their will was a violation of a civil liberty, and that treatment imposed involuntarily may not be effective. Jain cited a 2017 study in which six of seven patients relapsed immediately after discharge.

For the current study, surveys were sent to addiction physicians actively practicing in the U.S. In addition to yes or no questions, the survey also asked respondents to submit their thoughts on adult civil confinement for substance abuse disorder. One respondent said involuntary treatment “treats addiction like a crime rather than a disease” and that, instead, “voluntary, low threshold treatment” should be made available. In contrast, another respondent reported, “I think all 50 states should have it.” However, it is important to note that these views do not necessarily reflect the formal position of any specific professional organization, he stated.

Part of the issue is that these commitment laws vary across states and jurisdictions, Jain said. Within some states with civil commitment legislation, for example, only certain individuals in the community are legally allowed to petition. In others, family members must submit a guarantee of payment stating they claim responsibility for the payment of treatment. Additionally, in some jurisdictions, civil commitment may only be offered for some, but not all, substances of abuse.

Debra Pinals, MD, of the University of Michigan in Ann Arbor, spoke during the session here and discussed her prior involvement in the Women’s Recovery from Addictions Program in Massachusetts, which provides women with substance use disorders who are civilly committed with a treatment program in a treatment setting instead of in a correctional setting. Although she acknowledged that the program is new so there is not yet data supporting its success, she said it has been examined as a model for similar developing institutions.

Pinals said many patients who may be subject to civil commitment for substance use disorders can have comorbid mental health disorders like depression and bipolar disorder that need to be addressed. Additionally, since substance use treatment typically utilizes strategies that focus on stages of change and aims toward engaging treatment into voluntary services, motivational interviewing can be helpful in facilitating patients to own their recovery in a personal way. In the civil commitment setting, patients are there involuntarily so there is a paradigm shift in how they get to these treatments, she stated.

Pinals said she was not presenting answers in terms of what best direction is regarding the complex issues surrounding civil commitment, but that more research is certainly needed. “I could certainly say anecdotally, I’ve seen some people do well, but I’ve also seen some people not do well,” Pinals said during her presentation.

Several policies need to be established where such civil commitment proceedings exist and where it is being established, Pinals said. For example, when a patient states their desire to leave the institution, or not adhere to the court commitment, what measures should be taken?

She also noted that licensure and funding needs to be considered where there are facilities or community-based services. Some AAPL attendees stated that in their states, programs have been designed to address treatment of pregnant women with substance use disorders, pointing out that these women, as well as other vulnerable populations, tend to require more complex treatment that would need to be built into programs that are developed.

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Medicare Rule Will Create New Challenges for Chronic Pain Patients

https://www.practicalpainmanagement.com/patient/resource-centers/chronic-pain-management-guide/medicare-rule-will-create-new-challenges

Last February, when the Trump administration announced new restrictions on opioid prescriptions covered by Medicare, the plan drew strong criticism from patients and physicians across the country. The proposed rule, which would have required insurer approval of prescriptions totaling 90 or more morphine milligram equivalents (MME) per day, generated nearly 1,400 online comments and they were overwhelmingly negative. 

“The 90 MME hard edit guidance was strongly opposed by nearly all stakeholder groups for a variety of reasons,” the Centers for Medicare and Medicaid Services (CMS) noted two months later, in April 2018. “Physician groups opposed the forcible/non-consensual dose reductions due to the risks for patients of abrupt discontinuation and rapid taper of high dose opioid use. Similarly, we received hundreds of letters from patients who have taken opioids for long periods of time and are afraid of being forced to abruptly reduce or discontinue their medication regimens with sometimes extremely adverse outcomes, including depression, loss of function, quality of life, and suicide.”

In response to the backlash, CMS changed the rule to require consultation between pharmacists and prescribers (a “soft edit”) instead of approval by insurers (a “hard edit”). That regulation, which takes effect on January 1, 2019, and does not apply to cancer patients or people in hospices or nursing homes, in theory provides more flexibility for chronic pain patients who reach or exceed the 90 MME threshold. But in practice, pain experts say, the new requirement, which CMS describes as “a tailored approach” to “address chronic opioid overuse,” is likely to further discourage prescriptions at or above 90 MME, even when they are medically justified.

The 90 MME limit, which comes from the opioid prescribing guidelines published by the US Centers for Disease Control and Prevention in 2016, is scientifically problematic for several reasons. It assumes that analgesic effect corresponds to overdose risk and that different opioids can be reliably compared to each other based on fixed ratios. It ignores numerous factors that affect how a patient responds to a given dose of a particular opioid, including obvious considerations such as the patient’s weight, treatment history, and pain intensity as well as subtler ones such as interactions with other drugs (which can suppress or amplify an opioid’s effects) and genetically determined differences in enzyme production and opioid receptors.

It is not even safe to assume that two physicians, or a physician and a pharmacist, will agree about whether a patient has reached the 90-MME threshold. Research by clinical pharmacist Jeffrey Fudin, PharmD, who specializesin pain management at the Stratton VA Medical Center in Albany, New York, and serves as PPM’s Editor-at-Large, has shown wide variation in MME estimates between medical professionals and online calculators. “There’s no consensus guideline,” says Dr. Fudin. “You can go to three different sources and get three different morphine milligram equivalents.” So the first problem patients may encounter under the new Medicare rule is that “a pharmacist’s calculation might be different from the physician’s calculation.”

The next problem is that the newly required discussion between the pharmacist and the physician may not be easy to arrange, especially if a patient is trying to fill a prescription after office hours or when the doctor is busy. “If it takes a day or two to get that prescription approved, that patient may go through withdrawal,” says Dr. Fudin. “Once the pharmacist gets approval, they don’t have to call every month. So at least the first time the patient should see if they can get the prescription early so this can all get ironed out.” Fudin says some doctors are willing to write prescriptions as many as five days early, but that practice would also have to be allowed by the pharmacy and the insurer.

Lynn Webster, MD, a former president of the American Academy of Pain Medicine and current vice president of Scientific Affairs at PRA Health Sciences, says advance notice to pharmacists also can help. If the doctor lets the pharmacist know that a patient on a higher dose will be coming in, that he considers the dose medically appropriate, and that the pharmacist can call if he has any questions, Webster says, that exchange might even qualify as the consultation required by Medicare.

Dr. Fudin suggests that doctors prepare for possible gaps in medication by prescribing clonidine or lofexidine, which “will prevent, or significantly lessen, the withdrawal symptoms,” when taken as directed. Patients may be able to avoid that problem by forgoing Medicare coverage and paying for their medication out of pocket, assuming the pharmacist is willing to fill the prescription. That could cost as much as $800 for a month’s supply of a brand-name drug that’s still under patent, although the price could be less than $100 for something like generic hydrocodone.

The expense might be reimbursed by the insurer once the pharmacist has talked to the prescriber. Then again, insurers may impose their own requirements for opioid prescriptions, as they are permitted to do under Medicare regulations. Patients also should be cognizant of limits set by state law. For example, see the information provided by the National Conference for State Legislatures, or refer to pharmacy policies shared online by drugstore chains like CVS and Walmart.

Drs. Fudin and Webster both think the new CMS rule will have a noticeable impact on prescribing practices. Doctors undeterred by the soft edit may nevertheless switch to less expensive medications, which may be less effective or more easily abused, to reduce the burden on patients who end up paying out of pocket. Other doctors may decide to taper patients down below 90 MME, something that is already happening in response to the CDC guidelines, which are officially optional but have become increasingly mandatory as they are incorporated into laws, regulations, and insurance rules.

“This is such a hassle for both the prescriber and for the pharmacist,” says Dr. Webster, “that they don’t want to trigger some event that’s going to cost them money and time, so they’ll just keep the patients below 90 MME. It places the physician and the pharmacist in a confrontational position, and the patient is going to be the real loser, because neither of them wants to be in a confrontationtoo many chiefs and not enough Indians. They’ll basically abandon the patient’s needs. As with most of the policies to date, the people in pain who really suffer are the ones who are paying the price for the illegal use of the drugs that have been diverted.”

There is this old idiom … “too many chiefs and not enough Indians”  which boils down to … ” in an organization, there are too many people in charge and not enough people doing the work”  In the new Medicare opiate guidelines that take effect Jan 1, 2019… we have too many people who perceive that they have some sort of “professional discretion” and/or some “professional obligation”

Their decisions may be based on personal opinions or biases. Corporate policies created that may have more to do with protecting the corporation from a legal perspective (fear of the DEA) , actions taken to enhance or protect the corporate bottom line or state edicts/laws that may or may not have certain exceptions for certain pts (cancer, hospice, nursing home).

The pt may be dealing with a multiple of subjective diseases (pain, anxiety, depression) where there is no objective test to have a bench mark to reach or maintain which is considered some sort of presumed “normal level”.

We have already seen where individual healthcare professionals, corporations, states have taken the 90 odd pages of the CDC opiate dosing guidelines and find one sentence or paragraph that they are found of and make it their entire policy when dosing opiates for pts in chronic pain.

As pointed out in this article, most of the opiate conversion programs may or may not agree with each other and at best these conversion programs are “CRUDE ESTIMATES AT BEST” and apparently with the likes of the DEA who seem to believe that these conversion programs are accurate and irrefutable.  What else would you expect out of agency that is made up of LAW ENFORCEMENT ?

Our country is a country of LAWS and our laws are out there with numerous INTERPRETATIONS, but opiate conversion programs and the appropriate opiate dosing to meet the needs of a pt.. should be done via a “cookie cutter formula” ?

My recommendations to pts is that it is legal by federal law – some states may have different limitations – for the prescriber to write for a 90 days supply of the pt’s opiates in December 2018 so to allow all the dust to settle before the pt needs their next new  order filled.  The last thing that a chronic pain pt needs is to need a fill their next controlled med Rx the first week of Jan 2019… the system is going to be full of unanswered questions and that means that when that happens.. the pt gets told – NO NOT TODAY !

Just ask any pharmacist that was around when the Part D program began in Jan 1, 2006.  All too many pts timed their refills so that they would be due the first week of Jan 2006 and the Part D billing system literately FELL APART and a lot of pts were told that their new Part D insurance would not approve the payment of their meds.  Personally, back then… I timed Barb’s refills for no earlier than Jan 15th, 2006 hoping that if/when the system didn’t perform as promised that there would be such an uproar by Medicare folks not getting their meds promptly paid for … that within 2 weeks … things would be straightened out… and when I went to fill Barb’s Rxs after Jan 15, 2006… the system was functioning as designed. 

This time, since controlled meds are involved.. I suspect that there will be no “I will lend you a few to get you by” like there was done in 2006.  You try to get your next controlled med Rx… the pt will either be told YES or NO…   Consequences to the pts being told NO… will not be a concern to all those involved… they will not FEEL YOUR PAIN !

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Florida sues Walgreens, CVS alleging they added to state’s opioid crisis

CVS says Florida’s opioid claim ‘without merit’

https://www.clickorlando.com/health/florida-sues-walgreens-cvs-alleging-they-added-to-states-opioid-crisis

FORT LAUDERDALE, Fla. – Florida is suing the nation’s two largest drugstore chains, alleging they added to the state’s opioid crisis.

Attorney General Pam Bondi announced late Friday that she has added Walgreens and CVS to a state-court lawsuit filed last spring against Purdue Pharma, the maker of oxycontin, and several opioid distributors.

Bondi said in a press release that CVS and Walgreens “played a role in creating the opioid crisis.” She said the companies failed to stop “suspicious orders of opioids” and “dispensed unreasonable quantities of opioids from their pharmacies.”

CVS spokesman Mike DeAngelis issued a statement Saturday saying the company is “dedicated to helping reduce prescription drug abuse and diversion.” That includes training pharmacists and their assistants and public education efforts.

The nation’s second-largest drugstore chain says Florida’s lawsuit alleging that it helped fuel the state’s opioid crisis “is without merit.”

Walgreens declined to comment for this story.

The federal government says about 45 people die daily because of opioid overdoses.

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Despite state warning, CVS Caremark has not reversed cuts to pharmacists

https://www.dispatch.com/news/20181114/despite-state-warning-cvs-caremark-has-not-reversed-cuts-to-pharmacists

Two weeks after CVS Caremark promised to reverse cuts in payments to Ohio pharmacists, many pharmacies report that they are still losing money on Medicaid prescriptions.

That means that CVS Caremark, a pharmacy benefit manager and middleman in the pharmacy supply chain, continues to charge taxpayers who fund Medicaid more than it pays pharmacists to fill prescriptions for the poor and disabled.

“Nothing has changed. It’s gotten worse,” said Wilmington pharmacist Mark Kratzer of Kratzer’s Hometown Pharmacy.

Kratzer said his reimbursements have gone from an average loss of 66 cents per prescription in October, to a loss of $2.37 in November. In September, he was reimbursed about $2.10 on average for each Medicaid prescription.

The Ohio Department of Medicaid launched an investigation two weeks ago after The Dispatch presented state officials with evidence that CVS Caremark had cut its payments to pharmacists.

When told that the practice is continuing, Medicaid spokesman Tom Betti said: “This is why we are moving to a transparent pass-through model effective Jan. 1, so the state has full knowledge of prescription-drug pricing. Any attempt by CVS to take advantage of the spread-model contract over these last few months is completely unacceptable.”

As of Thursday, CVS has not responded to Medicaid’s request for information about pricing changes, Betti said.

Reportedly angered by the news of again-slashed reimbursements, legislative leaders on Wednesday scheduled another hearing before the House Health Committee on House Bill 465, which would cut CVS Caremark and other pharmacy benefit managers out of Ohio Medicaid.

The bill didn’t come to a vote previously after Medicaid officials projected that such a “fee for service” arrangement would cost more than the present one. Assistant Director Jim Tassie also said his department is working to implement a more-transparent system on Jan. 1 and take further steps from there.

Even though the committee didn’t vote, Thursday’s hearing is a sign of growing impatience with CVS’ Medicaid practices.

“You have a very broken system,” Antonio Ciaccia of the Ohio Pharmacists Association told the committee. “It’s been outsourced to for-profit entities.”

Michael DeAngelis, CVS Caremark’s spokesman, said reimbursements were adjusted on Nov. 8 after complaints were raised, and pharmacists should see the change by now.

Data from Kratzer and other pharmacists raise questions about that claim. One pharmacist reported that his reimbursements went from 51 cents a prescription during the period of Oct. 15 to Oct. 31 to minus 69 cents in the past week.

That same pharmacist was reimbursed about $2.40 per prescription in September.

Another pharmacist in the Dayton area reported a reimbursement of minus $1.85 in the first week of November.

And a Cleveland-area pharmacist said he was making about 35 cents on average for a Medicaid prescription in October, far less than the $9.43 he was paid on average for non-Medicaid prescriptions and not nearly enough to cover his cost to buy the drug and to fill the prescription.

Drug costs vary, but it generally costs $10 in overhead — pill bottlles, salaries — to fill a prescription.

“Nothing changed at all. Everyone says they are going to do something, but they don’t do anything,” he said. “I sold one for $100 under cost, but the woman needed it.”

Why this matters to the public is that the state is paying a flat rate for medications, meaning that CVS Caremark is pocketing more taxpayer money when the pharmacy benefit manager slashes reimbursements to Ohio pharmacists.

There is growing concern within Medicaid and at the Statehouse that CVS Caremark is reaping as much as possible from Ohio before the new contracts are in place by Jan. 1.

Last week, DeAngelis said in an e-mail that “we plan to continue providing PBM services to our Ohio MCO clients in 2019 under the new pass-through model requirement.” He also said last week that CVS Caremark would correct some of the drastic cuts in reimbursements.

Earlier, DeAngelis said the company uses several lists, which it doesn’t make public, to set drug prices and reimbursements to pharmacists.

Ciaccia said, “Medicaid and (Ohio) Auditor (Dave) Yost’s reports caught CVS/Caremark with their hand in the cookie jar. Now everyone is watching the jar, and CVS is still grabbing cookies.

“I continue to be amazed at the obscene level of control CVS appears to have over the economic fates of their competitor pharmacies and our state budget. We had this same conversation one year ago, and we are right back where we started. When will regulators actually end Medicaid’s all-you-can-eat buffet for the PBM industry?”

For three weeks, pharmacists have been providing The Dispatch with data that shows CVS Caremark cut what it paid pharmacists for drugs they provided to Medicaid patients.

The drop in reimbursements mirrors what CVS Caremark did in the fourth quarter of 2017. Then, pharmacists across Ohio launched several complaints with the state’s Department of Insurance and with legislators, asking for an explanation.

CVS Caremark raised the rates in 2017 after The Dispatch and lawmakers made public what was happening.

State Rep. Scott Lipps, R-Franklin, is the sponsor of the bill that would cut out pharmacy benefit managers if the five companies that oversee care for Medicaid patients don’t take action.

“We are no longer going to accept the tail wagging the dog,” he said.

Lipps said he is holding the five managed-care companies responsible for reeling in CVS Caremark. The five manage care for the more than 3 million poor Ohioans on Medicaid. CVS Caremark is the pharmacy benefit manager hired by four of the five managed-care plans to keep drug costs in check.

Dispatch Reporter Marty Schladen contributed to this story.

ccandisky@dispatch.com

@ccandisky

lsullivan@dispatch.com

@dispatchsully

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Of all the lame brain BS mess….. My insurance carrier is now claiming that MSContin is “not cost effective enough for ongoing treatment“….yet they have recommended either Duragesic or Opana ER as a possible replacement medicine. And as you know those two are highly more expensive than generic versions of MSCONTIN. None of it makes sense really ya know

We have always suspected that the cost of a pt’s therapy is more important than the appropriateness of the therapy. As far as I know, Opana ER has been removed from the market by FDA/DEA and there may – or may not – be a generic available.

Moving a pt from one opiate to another can be a very bumpy ride for the chronic pain pt.. if the new opiate works and getting to a dose that provides equal or better pain management than what the original med provided. Plus the pt may be forced to have multiple office visits and office visit charges out of his pocket while the “new” correct dose is determined.

All so the insurance company MIGHT BE ABLE to save some money in hopes that the pt will eventually be able to gain a adequate pain management.

Since one of the basics of the practice of medicine… is the starting, stopping or changing the pt’s therapy – which includes medications. So does it sound like in the particular situation this insurance company – or PBM – may be attempting to practice medicine without a license ?

Regardless if it is the insurance company or a PBM, both/each has a medical director… and if anyone is responsible within these organizations for the decision to change a pt’s therapy… who else has the legal authority and education within that organization but their medical director ?

Under the controlled substance act, no prescriber can legally prescribe a controlled substance for a person that they have not done a in person exam.. so is this organization causing the pt’s therapy to be changed… even if the pt’s own doctor does in fact prescribe the medication ?

It is also illegal for a prescriber to treat a pt in a state in which the prescriber is not licensed in and illegal to prescribe ANY MEDICATION in which they have not done a in person physical exam.

Is it just me, or does this appear to be a case of the company’s profits are more important that optimizing the pt’s quality of life ?  Also who believes that this is the only pt out of their hundreds or thousands of chronic pain pts that they are doing the same thing to… to make more profits for the company ?

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This is the CDC info. please email them your story or call them.
cdc.gov/info
800-232-4636 then press 9 then 7
I emailed mine.

https://wwwn.cdc.gov/dcs/ContactUs/Form

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https://youtu.be/_GI3FexQgDk

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Meningitis trial: Massachusetts board let NECC off with warnings

https://www.tennessean.com/story/news/2018/11/14/meningitis-trial-board-necc-drugs-warnings/2006029002/

BOSTON – The Massachusetts Pharmacy Board got multiple notifications that a drug compounding company it licensed was violating state law but let the firm off with advisory letters that imposed no discipline. 

Eight years later, that same company was identified as the cause of a deadly meningitis outbreak that killed 76 patients. The early warnings were detailed today by a state board official who testified in the trial of six former employees of the New England Compounding Center. They are charged with racketeering and mail fraud, but the state board official reported today that five of the six still have their pharmacist licenses. 

The sixth defendant, Gregory Conigliaro, was an officer and part owner of the company but was never a licensed pharmacist.

Samuel Penta, executive director of the pharmacy board, testified that his agency received complaints from three other states that NECC was selling drugs without patient-specific prescriptions, a requirement under state law. 

Penta said the complaints that NECC was selling prescription drugs out-of-state without prescriptions came in 2004 from pharmacists and health providers in South Dakota, Idaho and Wisconsin.

Penta said the board also learned a year later that NECC was attempting to sell drugs in bulk and without prescriptions to Partners Health, a Massachusetts health care firm.
In yet a fifth instance, a board inspector, after reviewing company records, cited NECC for selling a prescription drug with invalid patient names.

All of the three out-of-state violations were dealt with in a Sept. 21, 2004, meeting of the state board, according to records entered into the court record by federal prosecutors.

That meeting came just three months after Sophia Pasedis was named to the pharmacy board. Pasedis was an officer of Ameridose, another drug company with common ownership with NECC. Her name has surfaced in prior court testimony about an unlicensed pharmacy technician at NECC who was trying to get his state credentials restored.

Massachusetts officials initially stated that Pasedis abstained from any votes involving NECC or Ameridose. They later said some board records were unclear. When the outbreak became public, state officials — including then Gov. Deval Patrick — called on Pasedis to resign. She refused and remained on the board until her term expired just weeks later.

Penta, under questioning Wednesday by Assistant U.S. Attorney George Varghese, said NECC had told Partners Health that they could sell up to 5 percent of their drugs in bulk without prescriptions.

Though some states do have a so-called 5 percent rule, Penta said that was not the case in Massachusetts and individual prescriptions are required. He said he advised Health Partners of that fact.

In other testimony, Kristina Donohue, an official of the U.S. Food and Drug Administration, recounted her visit to NECC in response to an adverse event complaint registered against the company in 2002. She said that NECC President Barry Cadden was cordial and cooperative the first day she went to the company’s Framingham, Massachusetts, offices, but the next day she said Cadden refused to answer questions or provide any documents.

Cadden was convicted of racketeering and mail fraud charges and is now serving a nine-year federal prison sentence.

Donohue said that when she returned to NECC a year later, the company had grown from eight to 12 employees. She said that reviews of NECC’s operations raised concerns about the sterility of its products. The FDA, however, deferred to the state board for any further action.

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