COPS using civil asset forfeiture law to act like “wild west” robbers ?

Posted on April 14, 2019 by Pharmaciststeve

Alabama Cops Raided Their House, Seized Their Cash, and Ruined Their Lives Over $50 of Marijuana

http://https://www.reason.com/2019/04/12/alabama-cops-raided-their-house-seized-t/

Greg and Teresa Almond lost their house after a financially devastating drug raid involving civil asset forfeiture.

On January 31, 2018, a Randolph County sheriff’s deputy showed up at the home of Greg and Teresa Almond in Woodland, Alabama, to serve Greg court papers in a civil matter.

Greg, 50, wasn’t home, but his wife Teresa told the deputy he would be back before long. About two hours later, after Greg had returned home, he heard loud knocking on the door. He remembers shouting “hang on” and walking toward the door when it suddenly flew open. The next thing he knew he was on the floor—ears ringing, dazed, wondering if he’d just been shot.

Several deputies from the Randolph County Sheriff’s Department had kicked in his front door and thrown a flashbang grenade at his feet. The officers handcuffed and detained the couple at gunpoint, then started searching their house. The deputy from earlier had reportedly smelled marijuana, and so a county drug task force was descending on the Almonds’ home, looking for illegal drugs.

“I’m confused, I feel violated, I’m thinking the people who are supposed to serve and protect you basically just threw a bomb in my lap,” Greg recalls.

One may wonder what sort of dangerous criminal enterprise the Almonds were running to warrant such a display of force. The total drug haul for the Randolph County narcotics unit that day: a small amount of marijuana worth $50 or less, which the Almonds’ 27-year-old son later claimed ownership of, and one Lunesta sleeping pill found outside of a prescription bottle with Greg Almond’s name on it.

The Almonds now face misdemeanor charges for 2nd degree possession of marijuana for personal use and possession of drug paraphernalia (a glass pipe). But that’s among the least of their troubles.

The Randolph County Sheriff’s Department also seized thousands of dollars in cash and valuables from the family, through civil asset forfeiture. Greg Almond says that as a result of the raid and seizures, their business was ruined, they lost their house, their reputation was tarnished, and their ability to earn a living has been practically destroyed.

Now the Almonds are suing. A federal civil rights lawsuit filed last month alleges that the Randolph County Sheriff’s Department illegally seized roughly $8,000 in cash and dozens of firearms, some of which were antiques, from two safes. The raid, the couple argues, violated the Constitution’s protections against unreasonable search and seizures as well as their due process rights. Police took the money right out of his wallet, Almond says. According to the lawsuit, his wife’s wedding rings, his guitars, and other valuables were lost, were stolen, or do not appear on the sheriff department’s inventory of seized items.

The Almonds’ allegations against the Randolph County Sheriff’s Department, first reported by Alabama Appleseed Center for Law and Justice, exemplify the worst aspects of civil asset forfeiture—the heavy-handed use of a tool meant for major drug traffickers against petty offenders and innocent owners. Cases like these have led Alabama lawmakers to propose reining in the state’s forfeiture laws, which rank among the most aggressive and unchecked in the U.S.

It’s hard to say just how many cases like the Almonds’ are out there. Alabama currently doesn’t have any mandatory transparency or reporting requirements surrounding civil forfeiture. Although the Alabama District Attorneys Association announced earlier this year that it would begin voluntarily collecting data and publishing annual reports on the practice, Carla Crowder, executive director of Appleseed Alabama, says there should be mandatory rules in place.

“Just having the information would allow the public to know the kind of stuff that we found out in our report,” she says. “Are police just taking $1,500 from the homes of people they arrest for marijuana possession, which we documented, or are they truly going after assets that are connected to or the result of criminal activity? Our report shows they’re not.”

A 2018 report by Alabama Appleseed found that state law enforcement raked in roughly $2.2 million through civil asset forfeiture in 2015. The report revealed a widespread lack of transparency, uncovered large racial disparities, and showed that marijuana offenses, like the Almonds’ case, were a major driver of forfeiture actions.

The report highlighted the case of Royce Williams, an Alabama resident who his family says had been growing and using marijuana to manage pain from several surgeries. He wasn’t a drug dealer, they say. But that didn’t matter to local law enforcement, which initiated court proceedings to seize the 40 acres of property that had been in his family for generations.

Prosecutors continued to pursue the property even after Williams’ 2009 suicide—a last-ditch attempt to keep it in his family’s name. Williams’ wife, battling terminal cancer, continued to fight in federal court and ultimately won, but she went deep into debt in the process.

In the 2010 case of Frank Ranelli, the police department in Homewood, Alabama, seized 130 computers from his computer store, acting on a tip that he was selling stolen electronics. The sole charge against Ranelli was eventually dismissed, but he never got the computers back.

“Here I was, a man, owned this business, been coming to work every day like a good old guy for 23 years, and I show up at work that morning—I was in here doing my books from the day before—and the police just fucked my life,” he tells Al.com.

Under civil asset forfeiture laws, police can seize property—including cash, cars, and even houses—suspected of being connected to criminal activity, even in cases where no one is charged or convicted of a crime. Law enforcement groups say civil asset forfeiture is a vital tool that allows police to disrupt drug trafficking and other organized crime by targeting their illicit proceeds. But civil liberties groups say it has far too few protections for innocent property owners and too many perverse incentives for police.

Last week, an Alabama senate committee advanced a bill that would require police and prosecutors to obtain a criminal conviction before seized property could be forfeited to the state. Misdemeanor charges, like those levelled against the Almonds, wouldn’t be eligible for forfeiture either.

“I’d like to see it where no one else would have to go through something like this,” Greg Almond says. “It would be one thing if I had been running some kind of drug enterprise or something, but that’s just not the case.”

Following the raid, the Almonds—both of whom had no prior arrest record, according to their lawsuit—were booked overnight and much of the next day in the county jail. Their relatively brief incarceration had an enormous impact on their lives.

In addition to a tombstone engraving business they had inherited, the Almonds were raising chickens. Large poultry companies often contract with independent farmers to raise chickens, but the business, at least for the farmers, is notoriously tough. The companies provide the chicks and feed, but the contract grower has to build the chicken houses, often requiring large loans.

Prior to the raid, the Almonds were in a financially precarious spot. The poultry producer they contracted with required them to change their chicken houses before it would send them any more birds, so they lost an entire year of payments while they were making the upgrades. They had already mortgaged their house and 16 acres of property to start their farm.

The Almonds were in the process of refinancing their loans to try and stay afloat, but the deadline to refinance happened to be the same day they were stuck in jail. As a result of their incarceration, the Almonds missed the deadline. A month later, their bank foreclosed on their house.

The Almonds now live in a utility shed. According to Alabama Appleseed,

Greg insulated the shed, but the Almonds have no running water or indoor plumbing. They cook over an open fire outside their front door and keep food cool in a portable cooler. A small solar panel provides enough electricity to power their television and a floor lamp at night, but they do not have enough power to run an air conditioner. For Christmas, Greg’s boss gave them a wood-burning stove to supplement the propane heater they had been using. Some mornings, Greg wakes up to indoor temperatures in the low 50s.

Meanwhile, Greg Almond says the arrest and initial charges ruined their reputation in town.

“What I’ve been hearing since then is we were meth dealers and meth heads,” he says. “People we had been knowing for years would turn their head when they saw us and wouldn’t speak. It’s gotten where we avoid going to public places. It’s made me—I don’t how to put it in words—it’s made me not want to be out. It’s like people are whispering behind our backs.”

The Almonds’ son tried to go to the police to confess ownership of the marijuana, according to the lawsuit, but the local district attorney continued to pursue prosecution against the couple. On February 22, more than a year after the initial raid, a local grand jury returned an indictment against Greg and Teresa Almond for two misdemeanor charges: unlawful possession of marijuana for personal use and unlawful possession of drug paraphernalia, thus violating “the peace and dignity of Alabama.”

The Almonds attorney in their civil suit, Mike Segrest, says the misdemeanor charges show that the use of civil asset forfeiture, which is supposed to require law enforcement to show a “nexus” between the seized property and criminal activity, was wholly inappropriate. (The Randolph County Sheriff’s Department directed a request for comment to Webb and Ely, a law firm representing the department in the Almond lawsuit. The firm declined to comment, citing ongoing litigation.)

“If you got possession of marijuana in the second degree [i.e. for personal use], then how are you going to establish a nexus between that and the money and the guns?” Segrest says. “By definition, any crime involving drugs for personal possession, civil forfeiture shouldn’t even come into play.”

Greg has found work as a handyman. He says he has a constant roaring in one of his ears and vision problems as a result of the flashbang, and his wife constantly worries that the police will show back up to plant evidence on their property, even though she knows it’s irrational. “I don’t think she’ll ever be the same,” he says.

And it’s made him look differently at the local police, many of whom he had known for years prior to the raid.

“It’s made me distrust law enforcement on every level,” he says. “Going down the road I can see a police or state trooper, not that I’m doing anything wrong, and it’s kind of like my adrenaline goes up. My heart just pounds seeing them.”

Filed under: General Problems | 2 Comments »

Too Little, Too Late: US Government Backtracks on Opioid Discontinuation

Posted on April 14, 2019 by Pharmaciststeve

Too Little, Too Late: US Government Backtracks on Opioid Discontinuation

https://www.practicalpainmanagement.com/resources/news-and-research/too-little-too-late-us-government-backtracks-opioid-discontinuation

Three years after the CDC published its guideline on opioid prescribing for chronic pain, the FDA steps in to address the harm it may have caused patients living with chronic pain.

Jeffrey Fudin, PharmD, and Jeff Gudin, MD, PPM Co-Editors-At-Large:

Thousands of patients have been dispassionately forced into tapering their opioids, often inappropriately, due to fear from regulatory agencies following initiation of the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain. In addition to unnecessary suffering, this has resulted in opioid withdrawal due to due either rapid or misguided or inexperienced taper regimens. The sad irony here is that three years later, the FDA is saying exactly what nationally recognized pain experts have been saying all along. In a safety announcement on April 9, 2019, FDA announced that it “has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.” (Update: The next day, the CDC came out with its own follow-up, not to the full HCP community, but to one doctor in particular. See the agency’s response here which states that the CDC “does not endorse mandated or abrupt dose reduction or discontinuation” and that the CDC is “working diligently to evaluate the impact of the Guideline and clarify its recommendations.” )

The 2016 CDC guideline was born from an “expert” panel mostly consisting of addictionologists and non-pain experts, many of whom had conflicts of interest and strong partiality as anti-opioid zealots. Many of these panel members were affiliated with PROP (physicians for responsible opioid prescribing) who submitted a petition to the FDA in 2012 requesting harsh and unreasonable restrictions on opioids; this was rejected by FDA in 2013. [PPM covered FDA’s rebuttal in PROP versus PROMPT: FDA Speaks].

Just recently, the article “International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering” cited forced tapering and opioid dose reductions as a large-scale humanitarian issue. The authors pointed out that “…no data exist to support forced, community-based opioid tapering to drastically low levels without exposing patients to potentially life-threatening harms.” Consensus guidelines were also publishedm, led by Kroenke and colleagues, titled “Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline.” This paper outlined a “failure to appreciate the importance of patient involvement in decisions to taper or discontinue opioids.”

A group of Pharmacy Pain Clinicians recently surveyed over 100 opioid prescribers throughout the United States to determine the level of variation within and between clinicians in opioid tapering methods (data pending presentation/ publication). Outcome analysis overseen by Amelia Persico, PharmD, suggested that although the majority of providers surveyed were pain specialists, 15% were not comfortable tapering opioids at all; morphine daily dose influenced taper confidence; and taper-motivation was largely motivated by CDC guidelines rather than medical reasons or patient specific factors.

As clinicians, we hopefully recognize the complexities of opioid prescribing. We recognize that because of tolerance, metabolic and pharmacogenetic factors, patients respond differently to different molecules of opioid and not all patients will respond to low doses. Practitioners who prescribe opioids and are comfortable assessing the benefits and potential harms should recognize the above factors and appropriately titrate analgesics the way any class of drug should be titrated to effect in the appropriate patient.  

More thoughts from PPM Editorial Advisors & Contributors:       

Jennifer Schneider MD, PhD:
As a result of the 2016 CDC guideline on opioid prescribing, which has all too often been treated as regulations rather than a guideline, a huge number of patients with chronic pain have suffered increased pain, decreased function, desperately turning to illicit opioids to treat their pain, and a large number finally committing suicide. It boggles the mind that the CDC never followed up their guideline with any information about how to appropriately taper opioids in patients on chronic opioids. Three years after publication of the guideline, the FDA (not the CDC) has now figured out that there have been significantly negative consequences. Three years! That’s 3 years too late for many patients. 

The most pertinent information from the FDA announcement for health professionals, which should be widely disseminated, includes:

“In general, for patients who are physically dependent on opioids, taper by an increment of no more than 10-25% every 2-4 weeks. It may be necessary to provide the patient with lower dosage strengths fo accomplish a successful taper.

“If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.”

Every professional who has prescribed opioids should become familiar with this Drug Safety Announcement in its entirety, as there are other important elements. A change in opioid tapering practices is the only way to prevent more patients from suffering because their prescribers did not know enough about opioids and the consequences of sudden stopping or rapid tapering.”(See Dr. Schneider’s take on tapering from 2012, even before the CDC guideline came out,  as well as and a more recent look at safe tapering practices with Courtney Kominek, PharmD.)

I’ve gone through the press release.  And the devil is in the details. There’s less here than meets the eye. I don’t want to appear ungracious in the face of “success,” but… I’m not convinced these two recent announcements actually change policy in any fundamental way.  I sense this is a political delaying action to avoid having to admit that CDC was fundamentally wrong when they bought into … fraudulent claims about dangers of opioids.  It’s  not a change of heart and there’s a long way to go before practical improvements arrive in doctor treatment of patients denied opioid therapy.  

The Director of CDC letter has doubled down on several “initiatives” which appear to assume that the original assumptions and declarations of the guidelines were correct – which they weren’t, and for which there is abundant published proof that they weren’t.  You’ve seen many of the themes in my published work, both in single-author and dual-author papers.   The myth of over-prescribing is still alive and well.  We need to kill it conclusively.

Specifically:

  • CDC claims to be doing a review with AHRQ of literature published since March 2016.  Among the areas of review are non-pharmacologic non-invasive therapies.  AHRQ published what may be the definitive systematic review of this area in June 2018 – but they tried to rig their summary level findings to put the best possible face on the very weak medical evidence behind this area of medicine.  There’s a lot of harmful quackery hiding in the many small-scale “trials” of “alternative therapies” which don’t directly compare with opioid analgesics or properly document protocols for the addition of such therapies as adjuncts to “usual therapy – namely NSAIDS and opioids.  Steve Nadeau and I have written in Practical Pain Management on this topic.
  • CDC  also claims to be doing reviews for the Quality Improvement Collaborative.  But the underlying assumption of that Collaborative is that “safety improvements” are needed in prescribing practices.  And that premise is highly debatable.

From publications that go back as far as the Cochrane review of 2010, we know that incidence of substance abuse associated with medically managed opioid analgesics is possibly as low as 0.5%.  Incidence of substance abuse or overdose diagnoses in post-surgical patients  treated with opioids for pain is on the order of a maximum of 0.6%, and incidence of chronic opioid prescribing in post-surgical patients is less than 5% in even the most failure prone surgical procedures (total knee replacement), and shows no increase above background prescribing rates in non surgical patients, in some common procedures.   With such low incidence rates, I rate the chances of “improving safety” of opioid prescribing as zero to nil.  It’s just another camouflage for discouraging opioid prescribing and threatening doctors with sanctions if they prescribe high amounts.

So my instinct is to acknowledge incremental progress, and then get busy forcing the immediate recall and repudiation of the entire guideline document and all state legislation or regulation that incorporates it.  We likely won’t be able to avoid a rewrite effort for “some” kind of guideline, because doctors won’t reenter pain management practice without a shield from sanctions;  they’ll want to be “guided”.  The HHS Task Force draft points in many of the right directions if they can translate it into actionable recommendations to Congress that allow doctors to use their judgement, and give them meaningful education to develop that judgment. 

David Cosio, PhD, ABBP:

Rather than further policing the actions of some prescribers, it may be more important to ask why they are discontinuing in this manner. It is not only the regulations that have been imposed but also the general fear that comes with using opioids that has led to this problem. So, the first thing needed is further education on appropriate opioid prescribing and reimbursement for support staff that is necessary to provide a multimodal approach.

The FDA does seem to offer some guidance, but it is confusing and incomplete. They first say, for example, there are no standard opioid tapering schedules, but then propose a general 10 to 25% reduction every 2 to 4 weeks? They also suggest that a multimodal approach to pain management, including mental health support, be in place prior to initiating an opioid analgesic taper. If about 50% of patients who suffer from chronic pain obtain their care from a primary care provider, then a multimodal approach may not be accessible due to insurance regulations or may not be available in the clinic where they seek their care. Furthermore, many patients may not embrace this approach and thus this holds the prescriber hostage.

The FDA also recommends frequent follow-up appointments, again not recognizing that in some clinics there is a wait of up to three months to see a general practitioner.

Norm Shealy MD, PhD:
“t is becoming more and more clear that the FDA is responsible for the opioid epidemic. Any physician who is not caught up in pharmaceutical ties knows to withdraw their patients from opioids slowly.

Srinivas R. Nalamachu, MD:
Typical FDA, nothing new and very generic with no guidance.

Add your thoughts on our LinkedIn conversation or email the editors at ppmeditorial@verticalhealth.com

Filed under: General Problems | 3 Comments »

When did people’s feelings start mattering more than patient safety?

Posted on April 14, 2019 by Pharmaciststeve

When did people’s feelings start mattering more than patient safety?

www.kevinmd.com/blog/2019/04/when-did-peoples-feelings-start-mattering-more-than-patient-safety.html

As an elder millennial physician, I’ve been straddling two worlds, that of the “old-school” mentality of training and this newer one of “wellness.” I’ve become disheartened with new physicians being increasingly unable to tolerate any criticism by teaching faculty, even when patient harm is at risk. However, it wasn’t until I was accused of bullying and bullying exclusionary by a group of colleagues — not trainees — that I grew completely fed up.

Merriam Webster defines bullying as the abuse and mistreatment of someone vulnerable by someone more powerful. By definition, there is no power differential between my colleagues and myself. I am in no position of power — purely clinical physician at a community-based teaching program. I have been told that while there is no “factual evidence” to base these claims off of that it is, perhaps, the “perception of my tone” and my “intimidating nature” that are to blame.

It is known to most of my colleagues that I have exceptionally high standards when it comes to patient care, my signouts are very detailed, I pose lots of questions and ask about exam findings, etc. This style of signout is not only targeted at those who have been known to miss things or have cases go before our performance-improvement committee but extends to my close friends and physicians I would trust with my family’s lives. Patient handoff is the most dangerous time for the patients, and I take it seriously. My intent is not to intimidate others, and there is no subtext of criticism. At what point am I in control of the perceptions of others and at what point are others projecting their own insecurities onto my clinical questions? I welcome all clinical questions about my patients as I want to ensure the same focused care for them after I leave. If residents ask about changes I suggest to their management, I let them know if things they were doing could or did cause patient harm — because that is a paramount part of their education.

When did people’s feelings start mattering more than patient safety? If the goal is to create a work environment where everyone feels safe, including patients, where does that leave me?

I have been told many that I am intimidating, but never before in a negative light. I have exemplary blinded resident evaluations. I have been told that my high expectations push residents to be better, more thorough and efficient clinicians. Many a female resident has told me what an inspiration I have been to them as a strong female role model. Many a colleague, as well as nursing and support staff, have told me they would entrust or have entrusted me with the care of their loved ones to me, so I have to assume I’m not that intimidating — right?

People would also not describe me as a social butterfly. I have a small group of friends at work I socialize with outside the hospital. I have courteous professional relationships with the other faculty. I work similar shifts as these close friends, does that mean we exclude others? I would argue that by a group of us working a similar typically undesirable shift, we have developed excellent teamwork and ways to support each other as we work with limited resources. When people who do not typically work these shifts join us occasionally, they are welcomed and sit with us and enjoy this same support. Does my special bond with a few attendings really cause distress for others?

Does being demanding now equate with me being a bully? I would argue not. Does that give the others I work with the right to associate this HR terminable phrase with my name without any evidence — definitely not. The same people claiming I am contributing to their “toxic work environment” are essentially creating that for me. What recourse do I have? It seems that everyone’s feelings about this matter except mine. I have asked for ways to improve perceptions of others and my superiors had nothing to offer.

Interestingly, now I am the one who feels targeted, under a microscope and unsure how to proceed. If I were in extremis, I’d hope the doctors taking care of me cared more about my care and less about their feelings towards each other.

Filed under: General Problems | 2 Comments »

CDC Issues Key Clarification On Guideline For Prescribing Opioids For Chronic Pain

Posted on April 14, 2019 by Pharmaciststeve

CDC Issues Key Clarification On Guideline For Prescribing Opioids For Chronic Pain

https://www.news-line.com/PH_news28551_enews

The American Society of Clinical Oncology (ASCO), the American Society of Hematology (ASH), and the National Comprehensive Cancer Network® (NCCN®) are pleased to acknowledge receipt of a key clarification from the Centers for Disease Control and Prevention (CDC) on prescribing opioids to manage pain from certain conditions. The clarification regarding CDC’s Guideline for Prescribing Opioids for Chronic Pain—issued in a letter from the agency to ASCO, ASH, and NCCN—comes as a result of a collaborative effort by these organizations to clarify CDC’s opioid prescribing guideline in order to ensure safe and appropriate access for cancer patients, cancer survivors, and individuals with sickle cell disease.

CDC’s clarification letter notes that the agency’s guideline was developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

The letter conveys that CDC’s guideline is not intended to deny clinically-appropriate opioid therapy to any patients who suffer acute or chronic pain from conditions such as cancer and sickle cell disease, but rather to ensure that physicians and patients consider all safe and effective treatment options for pain management with the goal of reducing inappropriate use.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” said ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO.

The CDC’s clarification further notes that clinical practice guidelines addressing pain control for survivors of cancer, such as the American Society of Clinical Oncology Clinical Practice Guideline on Management of Chronic Pain in Survivors of Adult Cancers and the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Adult Cancer Pain, which were published and/or updated more recently than CDC’s guideline, provide important guidance on the unique considerations when using opioids to control pain in cancer survivors without worsening the current opioid crisis.

“Pragmatic approaches for pain management exist at the intersection of multiple health concerns,” said NCCN Chief Executive Officer Robert W. Carlson, MD. “Our guidelines help clinicians to assess the risk of inappropriate substance use, while still ensuring people with cancer don’t suffer unnecessary, severe pain. CDC’s acknowledgement that clinical decision-making should be based on the relationship between physicians and their patients is important and in the best interest of people with cancer and sickle cell disease.”

In November 2018, ASCO, ASH, CDC, and NCCN representatives met in-person to discuss concordance and variation among current guidelines for chronic pain management and develop a strategy to resolve inconsistencies as well as improve communication of existing recommendations. External reviews had previously identified perceived inconsistencies among existing guidelines and had noted concern that such inconsistencies may be causing inadvertent confusion in the healthcare community.[1] The organizations also discussed issues related to the CDC guidelines and agreed jointly to seek clarification of the guidelines regarding their applicability to patients with cancer and sickle cell disease. Following the meeting, ASCO, ASH, and NCCN sent a letter to CDC urging the clarification.

“People with sickle cell disease suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied,” said ASH President Roy Silverstein, MD. “We appreciate CDC’s acknowledgement that the challenges of managing severe and chronic pain in conditions such as sickle cell disease require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered.

Filed under: General Problems | 2 Comments »

CDC: More people are overdosing on this legal drug

Posted on April 12, 2019 by Pharmaciststeve

CDC: More people are overdosing on this legal drug

https://www.daytondailynews.com/news/national/cdc-more-people-are-overdosing-this-legal-drug/SYJXTs2CGveCULnKFa0acO/

An herbal over-the-counter drug was a cause in the overdose deaths of 91 people from July 2016 to December 2017, according to the Centers for Disease Control. 

That’s more than double what was earlier reported.

The CDC also noted that in about 60 of those kratom-related deaths, fentanyl was a co-cause.

A clinic worker at Northside Forsyth Hospital in Cumming, Georgia, said they’ve treated several kratom overdose cases.

“When we have seen them coming in, they have some kind of psychotic episode where they are hallucinating. Some are unconscious,” said Antwan Brownlee, behavioral health clinician at Northside Forsyth Hospital. “From this EMS report, they had given the patient Narcan, and the person was responsive when we started to do the evaluation.” 

The DEA is considering criminalizing kratom, saying it has a high potential for abuse and no currently accepted medical use in treatment.

But a Cobb County, Georgia, woman doesn’t agree.

Christy Garner said kratom has helped her battle chronic pain, while stopping her addiction to opiates.

“It’s given me a new life. When it’s used responsibly, it’s a miracle supplement,” Garner said.

Poison centers have noted a spike in calls related to kratom.

The FDA and DEA have solicited public comment on a proposal to criminalize the possession and sale of kratom.

More than 100,000 have signed petitions opposing plans to make kratom illegal.

Just read the WORDS that they use … “Kratom WAS A CAUSE” and ILLEGAL FENTANYL WAS ALSO IN TOXICOLOGY

Hospital has TREATED SEVERAL KRATOM OVERDOSE CASES — NO ONE DIED ?

Kratom HAS A HIGH POTENTIAL FOR ABUSE  – based on what clinical data ?

Poison Centers have NOTICED A SPIKE in calls related to Kratom – a spike could be a increase from TWO to FOUR ?

In a 550 day period – 90 deaths where KRATOM WAS “A CAUSE”  – NOT THE ONLY CAUSE ?

The DEA is playing “magician” with the numbers… they can turn “small numbers” into seemingly “LARGE NUMBERS”

In the same time frame the two drugs ( Alcohol & Nicotine) would be involved in 825,000 deaths… just 9000 PERCENT MORE PER DAY

Filed under: General Problems | 7 Comments »

Fed mandate to use opioid data-sharing technology angers states

Posted on April 12, 2019 by Pharmaciststeve

Fed mandate to use opioid data-sharing technology angers states

https://www.politico.com/story/2019/04/12/opioid-data-sharing-angers-states-1320532

The Trump administration is forcing states that want millions in federal grants to use relatively untested technology to share prescription data that is key to combating the opioid crisis.

Using the software, many state officials worry, could mean turning over patient data to law enforcement and invading patients’ privacy. And it would override an already proven system used by doctors in 46 states plus Washington, D.C., and Puerto Rico.

The dispute is over prescription drug monitoring programs, which track all the drugs dispensed in a given state. While handy for doctors seeing whether patients might be receiving too many opioids, or for law enforcement looking for pill mills, it’s inherently limited: An affected patient might easily receive prescriptions from multiple states. Hence the need to share data across state lines. If states use competing systems that don’t communicate, the data-sharing work falls apart.

The dispute is particularly acute given the overdose crisis that’s claiming tens of thousands of lives each year in the U.S. Getting the data-sharing right could help doctors detect patients’ problems sooner and solve them faster.

But opioid prescribing data is already being shared across most of the U.S. That adds to states’ puzzlement that the CDC and Department of Justice’s Bureau of Justice Assistance are requiring grant applicants to provide patient information through a competing data hub called RxCheck, funded by the Bureau.

RxCheck helps pass requests from doctors and pharmacists for prescription history across state lines. The government says RxCheck, which is managed by member states’ prescription drug monitoring boards, will introduce competition in the market.

Officials in 14 states said in a series of letters last fall that the RxCheck hub is being foisted upon them to solve a problem they don’t have. The hub, with its relatively untested technical capacity, could lead to privacy invasions and incapacitate the established data-sharing system most use now, some worry.

“When you have a good thing going, to go and jump into a system that isn’t widely used — it’s kind of like, nonsense,” said Joe Fontenot, assistant executive director of the Louisiana Board of Pharmacy.

The Bureau’s grants, worth hundreds of thousands of dollars to each winning state, were awarded in September. In order to use the money, states had to connect to RxCheck. But the bigger prize is the upcoming CDC grants, worth as much as $9.1 million per state, which also come with the requirement that states use RxCheck. States need to decide on the CDC grants by a May 4 deadline.

A competing technology, backed by a firm called Appriss, has dominated the prescription drug monitoring program market since its entry in 2014. Since 2011, Appriss has also led interstate data-sharing through a system called PMP InterConnect, developed with the nonprofit National Association of Boards of Pharmacy. The federal government thinks that Appriss’ twin dominance puts RxCheck at an unfair disadvantage.

The federal government has been trying to encourage the use of RxCheck since at least May 2012, but only with this latest round of grants has it required the use of the technology.

For affected states, the preference for PMP InterConnect reflects its superiority — and a reason not to dabble with RxCheck.

“We may move from a system that works extremely well to one that has a lot of unknowns and is of uncertain capability,” said David Brown, director of Virginia’s Department of Health Professions.

Brown’s concerns about RxCheck and the grant requirements are shared by many other states. They say the language in the Bureau’s grant requirements opens the door for access by law enforcement contrary to state law. The grant requires software, data, “or other intangible property … designed, developed, acquired, or produced under this award” to be provided upon request.

That leaves open the possibility that state prescription data “owned” by the participating states will be subject to sharing without a review process, New Jersey’s attorney general wrote in an Oct. 31 letter.

Michigan won’t accept the grant money if it requires the state to “violate its own laws,” said Pardeep Toor, spokesperson for the Department of Licensing and Regulatory Affairs. North Dakota may follow suit, although Sen. John Hoeven’s office said he is working to address the state’s concerns.

The CDC grants pose slightly different concerns, mandating that states have archiving plans for their data. That requirement, some states say, would clash with their privacy laws, which require them to scrub old data.

The CDC’s money is perceived as a powerful form of leverage, because it doesn’t specifically flow to drug monitoring programs but rather to state departments of health. A monitoring program director’s concerns might not override a state’s broader interest in the money.

“They’re basically strong-arming the states to say if you want this money for the state, the whole state overall, not just the PDMP, you need to accept this condition,” said Mark Hardy, executive director of the North Dakota Board of Pharmacy.

Only four states use RxCheck, a state of affairs the agencies blame on Appriss, which blocks access through “influence over both the cost and timing of connections that are made at the state level,” said Tara Kunkel, an adviser to the Department of Justice’s Bureau of Justice Assistance.

Kunkel said the federal government had received complaints from 11 states who say the vendor has abused its market position. The states said they’d been unable to access their data without paying extra fees and faced prohibitively high costs to connect providers serving poor or rural areas to PDMPs through their electronic health records, she said.

But not all states agree with the complaint. Cost “has not been a barrier at all,” said North Dakota’s Hardy.

States aren’t sure they can afford to maintain RxCheck and InterConnect at the same time. The National Association of Boards of Pharmacy’s director, Carmen Catizone, says his organization may have to close InterConnect if the government continues to push RxCheck.

Justice and the CDC have attempted to calm such concerns with letters, webinars and FAQs. They say they don’t intend to circumvent relevant laws and that the provisions are methods of combating competitive abuses.

But states also worry that the RxCheck hub may be incapable of handling the demands of data-sharing. Some 20 million transactions per month pass through PMP Gateway, the EHR integration tool, the National Association of Boards of Pharmacy says. RxCheck’s EHR integration only moved out of the pilot phase last fall.

Kunkel also claimed Appriss is using its competitive position to block RxCheck and to choke off provider and government use of prescription data for things like analyses to detect over-prescribing “hot spots.”

Rob Cohen, president of Appriss’ health division, denied the government’s complaints. He said Appriss provides several tools to analyze state data, and only has minimal charges in rare circumstances.

The federal government said RxCheck enables doctors to cheaply access PDMP information directly through their computer systems. In Kentucky, state officials can provide RxCheck to doctors who want a low-cost option, according to Dave Hopkins, a program manager at Kentucky’s PDMP. The Gateway alternative has more features but costs more, he said.

But only a tiny number of doctors have connected their EHRs to PDMPs through RxCheck, Cohen said, while Appriss has connected hundreds of thousands in the state.

RxCheck, he claimed, lacks important features such as robust audit trails that allow administrators to see what user accessed data. While RxCheck may not charge for the integrations, he said, maintenance functions like call centers will get “pushed out to the states, or the vendors to the states, or the EHRs.”

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Florida Attorney General announces fight against opioid abuse in Tampa Bay

Posted on April 12, 2019 by Pharmaciststeve

http://www.fox13news.com/news/local-news/florida-attorney-general-to-announce-fight-against-opioid-abuse-in-tampa-bay

TAMPA, Fla. (FOX 13) – Last year, there were over 1,300 overdose deaths specifically in the Bay Area. The statistics bring to light the local intensity of the opioid epidemic, a reality that far too many families are forced to face.This lies next to the number of people consuming alcohol who often consult DUI attorney for the legal issues caused by it. 

“I lost my brother two years ago to a carfentanil overdose,” said Ellen Snelling with the Hillsborough County Anti-drug Alliance.

Continue reading below

Today, and every day, 17 people throughout Florida will die from overdoses of opioids or heroin, a staggering statistic that Attorney General Ashley Moody says needs to change.

JD Injury Law, AP explains motorcycle accident cases and other accidents “In order to make meaningful strides against this opioid epidemic, we must not let up on our efforts against going after aggressively those who are trafficking in opioids.”

In an effort to tackle the crisis head-on, local, state and federal officials are introducing a strategy calling ‘DEA 360.’

“DEA 360 attacks the drug epidemic from every angle, all sides. We go after the bad guys, and we educate the good guys,” said Mike Furgason with the DEA Tampa District.

They’re calling it a three-pronged approach combining law enforcement, diversion control, and community outreach to address the root issues.　

“A law enforcement solution alone is inefficient, it is instead an integral part of a multi-prong strategy that has to be implemented in unison in order to be as effective as possible,” said Cpt. Mike Jenkins with the Pasco County Sheriff’s Office.

While this won’t be an overnight fix, the future seems promising.

“I believe those numbers will go down with this multi-faceted approach. We cannot arrest our way out of this, it has to be fully engaged from all community members,” said Mark Brutnell, with FDLE.

It’s a new game plan to tackle a problem that kills more than 500 Floridians every month.

DEA 360 has already been successfully implemented in communities across the United States.

Locally, the DEA 360 program will be put in place in 10 counties surrounding the Tampa Bay Area including Hillsborough, Pinellas, Pasco, Manatee, Desoto, Sarasota, Polk, Hernando, Citrus and Hardee. It’s a new game plan to tackle a problem that kills more than 500 Floridians every month.

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Trump Administration Plans To Bail Out Insurers To Hide Higher Drug Costs

Posted on April 12, 2019 by Pharmaciststeve

Trump Administration Plans To Bail Out Insurers To Hide Higher Drug Costs

www.thefederalist.com/2019/04/12/trump-administration-plans-bail-insurers-hide-higher-drug-costs/

This is not a government agency sharing risk, it’s a government agency assuming virtually all of the risk associated with the higher premium costs due to the rebate rule. In other words, a bailout.
Christopher Jacobs

By

April 12, 2019

The more things change, the more they stay the same. On a Friday, the Trump administration issued a little-noticed three paragraph statement that used seemingly innocuous language to outline a forthcoming bailout of health insurers—this one designed to avoid political controversy prior to the president’s re-election campaign.

Republicans like Sen. Marco Rubio (R-FL) quite rightly criticized President Obama for wanting to bail out health insurers via a crony capitalist boondoggle. They should do the same now that Trump wants to waste billions more on a similar tactic that has all the stench of the typical Washington “Swamp.”

Explaining the President’s Drug Pricing Proposal

The announcement from the Centers for Medicare and Medicaid Services (CMS) involves the president’s efforts on drug pricing. As part of that campaign, the administration released a proposed rule—comments on which were due April 8—that would change the system of rebates handled by pharmaceutical benefit managers (PBMs).

At present, drug manufacturers pay rebates to PBMs in exchange for preferred placement on an insurer’s pharmacy formulary. PBMs then share (most of) these rebates with insurers, who pass them on to beneficiaries. But historically, PBMs have passed those rebates on via lower premiums, rather than via lower drug prices to consumers.

For instance, Drug X may have a $100 list price (the “sticker” price that Manufacturer Y publicly advertises), but Manufacturer Y will pay a PBM a $60 rebate to get Drug X on the PBM’s formulary list. It sounds like a great deal, one in which patients get the drug for less than half price—except that’s not how it works at present.

Instead, the PBM uses the $60 rebate to lower premiums for everyone covered by Insurer A. And the patient’s cost-sharing is based on the list price (i.e., $100) rather than the lower price net of rebates (i.e., $40). This current policy hurts people whose insurance requires them to pay co-insurance, or who have yet to meet their annual deductible—because in both cases, their cost-sharing will be based on the (higher) list price.

The proposed rule would require PBMs operating within Medicare and Medicaid to pass any rebates they receive directly through to customers at the point of sale. (Extending this proposed change to other forms of insurance would require Congress to pass legislation.) For the reasons explained above, the change would lower out-of-pocket costs for seniors—particularly for those with very high drug costs. But prohibiting PBMs from applying rebates to premiums means that the latter by definition will rise.

The Policy and Political Problems

The administration’s proposed rule conceded that the proposed change could raise Medicare Part D premiums. The CMS Office of the Actuary estimated the rule would raise premiums anywhere from $3.20 to $5.64 per month. (Some administration officials have argued that premiums may stay flat, if greater pricing transparency prompts more competition among drug manufacturers.)

The rule presents intertwined practical and political problems. From a practical perspective, the administration wants the rule to take effect in 2020. But the comment period on the proposed rule just closed, and the review of those comments could last well beyond the June 3 date for plans to submit bids to offer Part D coverage next year.

The political implications seem obvious. The administration doesn’t want to anger seniors with Part D premium increases heading into the president’s re-election bid. And while the administration could have asked insurers to submit two sets of plan bids for 2020—one assuming the rebate rule goes into effect next year, and one assuming that it doesn’t—doing so would have made very explicit how much the change will raise premiums, handing Democrats a political cudgel on a hot-button issue.

Here Comes the Bailout

That dynamic led to the Friday announcement from CMS:

If there is a change in the safe harbor rules effective in 2020, CMS will conduct a demonstration that would test an efficient transition for beneficiaries and plans to such a change in the Part D program. The demonstration would consist of a modification to the Part D risk corridors for plans for which a bid is submitted. For CY2020, under the demonstration, the government would bear or retain 95% of the deviation between the target amount, as defined in section 1860D-15(e)(3)(B) of the Social Security Act (the Act) and the actual incurred costs, as defined in section 1860D-15(e)(1) of the Act, beyond the first 0.5%. Participation in the two-year demonstration would be voluntary and plans choosing to participate would do so for both years. Under the demonstration, further guidance regarding the application process would be provided at a later date.

To translate the jargon: Risk corridors are a program in which the federal government subsidizes insurers who incur large losses, and in exchange insurers agree to give back any large gains. I explained how they worked in the Obamacare context here. However, unlike Obamacare—which had a risk corridor program that lasted only from 2014-2016—Congress created a permanent risk corridor program for Medicare Part D.

It all sounds well and good—until you look more closely at the announcement. CMS says it will “bear or retain 95% of the deviation…beyond the first 0.5%.” That’s not a government agency sharing risk—that’s a government agency assuming virtually all of the risk associated with the higher premium costs due to the rebate rule. In other words, a bailout.

Déjà Vu All Over Again

The use of a supposed “demonstration project” to implement this bailout echoes back to the Obama administration. In November 2010, the Obama administration announced it would create a “demonstration project” regarding Medicare Advantage, and Republicans—rightfully—screamed bloody murder.

They had justifiable outrage, because the added spending from the project, which lasted from years 2012 through 2014, seemed purposefully designed to delay the effects of Obamacare’s cuts to Medicare Advantage. Put simply, the Obama administration didn’t want stories of angry seniors losing their coverage due to Obamacare during the president’s re-election campaign, so they used a “demonstration project” to buy everyone’s silence.

In response to requests from outraged Republicans, the Government Accountability Office (GAO) conducted multiple reviews of the Medicare Advantage “demonstration project.” Not only did GAO note that the $8 billion cost of the project “dwarfs all other Medicare demonstrations…in its estimated budgetary impact and is larger in size and scope than many of them,” it also questioned “the agency’s legal authority to undertake the demonstration.” In other words, the Obama administration did not just undertake a massive insurer bailout, it undertook an illegal one as well.

The current administration has yet to release official details about what it proposes to study in its “demonstration project,” but, in some respects, those details matter little. The real points of inquiry are as follows: Whether buying off insurance companies and seniors will aid Trump’s re-election; and whether any enterprising journalists, fiscal conservatives, or other good government types will catch on, and raise enough objections to nix the bailout.

Congress Should Stop the Insanity

On the latter count, Congress has multiple options open to it. It can obtain request audits and rulings from GAO regarding the legality of the “demonstration,” once those details become public. It can explore passing a resolution of disapproval under the Congressional Review Act, which would nullify Friday afternoon’s memo.

It can also use its appropriations power to defund the “demonstration project,” preventing the waste of taxpayer funds on slush funds and giveaways to insurers. Best of all, they can do all three.

Republicans objected to crony capitalism under Democrats—Rubio famously helped block a taxpayer bailout of Obamacare’s risk corridor program back in 2014. Here’s hoping they will do the same thing when it comes to the latest illegal insurer bailout proposed by CMS.

Mr. Jacobs is founder and CEO of Juniper Research Group, a policy consulting firm based in Washington. He is on Twitter: @chrisjacobsHC.

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AG Barr believes that CONTINUED OVER PRESCRIBING has to be CUT BACK ?

Posted on April 12, 2019 by Pharmaciststeve

Start listening at about 4:00 as AG Barr is going to “put pressure” on the over prescribing of legal opiates that have been over prescribed and diverted

Filed under: General Problems | 5 Comments »

Veteran who killed himself outside of VA center in Decatur identified

Posted on April 11, 2019 by Pharmaciststeve

Veteran who killed himself outside of VA center in Decatur identified

https://www.ajc.com/news/breaking-news/veteran-who-killed-himself-outside-center-decatur-identified/NMqi3pO2DjCWu7KqOiXtbN/

Victim was 68-year-old Alpharetta man who shot himself

The veteran who killed himself outside the main entrance to the Atlanta VA Medical Center in Decatur Saturday has been identified as Olen Hancock, 68, of Alpharetta, according to the DeKalb County Medical Examiner’s Office.

“After Mr. Hancock shot himself, the staff at the VA immediately assisted him and called 911 for an ambulance,” Mark Anglin, the chief investigator for the DeKalb Medical Examiner’s Office told The Atlanta Journal-Constitution. He said Hancock was transported to Grady Memorial Hospital and pronounced dead at the emergency department.

Another Georgia veteran died by suicide in a parking lot at the Carl Vinson VA Medical Center in Dublin Friday. Veterans Affairs Department officials have declined to identify the victim, citing privacy reasons.

More than 6,000 veterans killed themselves each year between 2008 and 2016, VA figures show. In 2016, 202 veterans died by suicide in Georgia. And between 2015 and 2016, the suicide rate per 100,000 people for veterans ages 18 to 34 increased from 40.4 to 45 nationwide, despite the VA’s efforts to tackle the problem.

 

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