House Energy and Commerce Committee grills DEA chief over free flow of opioids

https://www.washingtonpost.com/national/house-energy-and-commerce-committee-grills-dea-chief-over-free-flow-of-opioids/2018/03/20/76a79e24-2c68-11e8-b0b0-f706877db618_story.html

The acting director of the Drug Enforcement Administration said a database that monitors the flow of powerful prescription painkillers from manufacturer to distribution point was compiled manually during the height of the opioid crisis, making it a reactive, not proactive, tool.

The information contained in the drug-reporting database, known as ARCOS, is key to figuring out how many painkillers were distributed to pharmacies across the country from around 2006 to 2010. The data is confidential, but some information that has been released and analyzed is staggering: In two instances, millions of pills were shipped to pharmacies in tiny West Virginia towns.

Members of the House Energy and Commerce Committee, who spent two hours aggressively questioning acting DEA director Robert W. Patterson in Washington on Tuesday, wanted to know how so many pills flowed freely, creating conditions for the opioid crisis, and why, they said, the DEA hasn’t been forthcoming with information about how it handled opioids.

“Your agency doesn’t appear to be willing to aggressively try to help us solve, or at least deal with, this crisis,” Rep. Joe Barton (R-Tex.) said. Time, he told Patterson, is of the essence. “You just remember 80 people a day are dying because of legal prescription drugs. Remember that.”

Patterson, who has been acting director since October, said the agency has modernized how it uses the ARCOS data in recent years. It is now computerized, and the DEA has the ability to paint a fuller picture of how many pills are being shipped by also analyzing data from state prescription-drug-monitoring programs and the Department of Health and Human Services. Drug distributors are responsible for reporting their data to the DEA.

Patterson said that the modernization of the database has allowed it to be used in a “much more proactive manner” than in the past. He also said that some anomalies cannot be spotted using the database alone — it needs to be employed in concert with other data.

“I can say repeatedly in ’08, ’09, ’10, we did not use this data in the way that we are now using it, and I think that’s the key,” Patterson said. “Where we fell short, we’ll take responsibility for it.”

When asked, Patterson said that the same thing would not happen today.

“What we wish to do . . . is stop public harm,” he said.

Committee members expressed extreme frustration with the DEA, claiming that the agency dragged its feet in turning over documents and redacted many of those it did give up.

“Your agency needs to be turned upside down,” Rep. Chris Collins (R-N.Y.) said. “There is no doubt there is an abject failure in the DEA going back 10 years.”

As Rep. Raul Ruiz (D-Calif.), a medical doctor, said of the agency: “You screwed up.”

The agency also questioned Patterson as to why there was a decrease in orders preventing pharmacies or doctors that were suspected of rogue prescribing from dispensing opioids. Patterson said it was, in some cases, because U.S. attorneys asked that they complete criminal cases before shutting down the pharmacies. The names and the locations of the prosecutors were not specified.

“People continued to die, die during this period,” Rep. Greg Walden (R-Ore.) said.

The testimony came during a week when Washington is focused on the opioid crisis. The Energy and Commerce Committee will hear more than 20 bills on opioids this week. On Monday, President Trump laid out his plan to solve the opioid crisis, which was filled with tough talk but few details on how he plans to carry it out.

Trump’s plan includes executing some drug dealers, while also pledging to hold pharmaceutical companies accountable for their role in fostering addiction. He said he wants to cut the number of opioid prescriptions by one-third nationwide but did not lay out a blueprint for getting there.

When Trump called for eliminating drug dealers, he said he wants to “get tough” on them, an approach that has alarmed some public-health experts.

Trump’s administration still has not filled numerous vacant positions that deal with the opioid crisis. Patterson is the DEA’s acting director. Trump named Jim Carroll, who worked in the White House Counsel’s Office, to be director of the Office of National Drug Control Policy, but he is only in an acting capacity and his nomination has not been sent to the Senate.

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http://www.concordmonitor.com/As-Trump-calls-for-stronger-prescription-drug-monitoring-New-Hampshire-s-program-struggles-16303618

Tucked within President Donald Trump’s latest proposal to address the opioid epidemic – unveiled Monday in Manchester – is support for a somewhat obscure initiative: prescription drug monitoring programs.

The programs, administered by states, collect prescription information for patients. Pharmacists and doctors are required to participate; the resulting database allows physicians and administrators to screen for patients abusing prescriptions, “doctor shoppers” and complicit doctors.

It’s an approach with wide backing in the medical community, and Trump is hoping to expand it. A written version of the president’s plan – released by the White House on Sunday – seeks to leverage federal money to build a state-to-state, “nationally interoperable prescription drug monitoring program network.”

In New Hampshire, though, that might be easier said than done. The state’s program, approaching its sixth year, is still working to find its footing.

A critical audit by the Legislative Budget Assistant in December found a range of shortcomings from the nascent program. The program is performing its most basic function – collecting and storing prescription data – but it isn’t meeting its loftier goals of analyzing and reporting trends to guide policy, the audit found. Reports so far have been incomplete or misleading, and oversight is poor.

After becoming law under Gov. John Lynch in 2012 and four more years under Gov. Maggie Hassan’s watch, the program was stuck in an “initial phase of maturity,” the audit concluded.

Now, leadership at the state Board of Pharmacy is scrambling to implement changes. In a compliance report presented to the legislative Fiscal Committee on Friday, the board said it was rushing to meet the budget assistant’s recommendations, 26 in all.

Policies are being rewritten. Software is being brought up to speed. “We’ve moving right along with the audit response,” said Michael Bullek, administrator of the board.

But even with a newfound focus, the program is far from up to snuff. Actually building the infrastructure to meet its statutory obligations – the analyses and reports – could take up to 18 months.

Exactly what went wrong with the program’s development has been tough to narrow down. According to operators involved, troubles for the program began early. Initiated in the final months of Gov. John Lynch’s tenure, the program was from the outset “underfunded, understaffed and overregulated,” Bullek said.

“I’ve been involved in every step of the way with the process, and there’s been a lot of pitfalls and roadblocks with the legislation,” Bullek said.

One of them was a provision preventing the program from holding prescription records longer than six months, severely hampering its abilities to analyze, he said.

A spokeswoman for Sen. Maggie Hassan – who as governor oversaw four of the program’s first six years – pointed to financial constraints.

“When the program was established in law under Governor Lynch, the Legislature failed to provide sufficient funds to implement it, setting up the program for challenges,” spokeswoman Ricki Eshman said. Eshman added that Hassan had pressed for technological upgrades for the program as governor, as well as improved prescription training for physicians.

“Over the last several years, New Hampshire’s program has been expanded a number of times, and it is clear from the report that it still has work to do to reach full maturity,” she said.

And there was a simpler problem, according to Bullek: “We didn’t buy the right software program initially. It didn’t meet the need.”

Regardless of the cause of the deficiencies, the consequences have been sharp. Presented with the audit in December, lawmakers on the Fiscal Committee were openly frustrated.

“We’re all struggling to understand why the program has not been administering data,” Sen. Andy Sanborn, R-Bedford, said at the time.

Now, Bullek says much has changed since the program began. For one, the Legislature lifted its six-month cap in 2016, freeing the Pharmacy Board to begin carrying out effective data analysis. And the program took on a new software vendor last summer, expanding its ability to process data, Bullek said.

And on Friday, the Fiscal Committee approved the addition of a new staff position: a data analyst.

Presented with the updates, Rep. Neal Kurk, chairman of the Fiscal Committee, appeared encouraged – to a point.

“I think you’re making very important strides in terms of the issues that the audit brought up,” he said Friday. “We’re looking for more, with respect.”

This just shows how “out of touch” that the Trump administration is…  back in 2005 Congress pass a bill and Bush (43) signed into law the National All Schedules Prescription Electronic Reporting (NASPER) Act  http://nasper.org/. But after Congress passed this bill .. they failed to provide funding to implement and run it… in 2016 Congress introduced the bill  S.480 – National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 and it failed to pass. This act was to provide funding for the NASPER ACT, but it failed to get passed.

Could these to failures to get a National PMP be a direct result of the 49 states — that has a state operated PMP – not wanting to give up the budgets and staffing that comes along with operating one at the state level.

Also with 48 other states operating their own PMP programs.. why did NH have to start from scratch and try to re-invent the wheel.  Surely, one of those 48 states would have a functioning and mature PMP program.

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The CDC Quietly Admits It Screwed Up Counting Opioid Pills

https://www.acsh.org/news/2018/03/19/cdc-quietly-admits-it-screwed-dishonestly-counting-pills-12717

Here’s the title of an opinion piece in the April issue of the American Journal of Public Health, which was published by four authors at the CDC:

“Quantifying the Epidemic of Prescription Opioid Overdose Death” 

I don’t like the title very much. It (intentionally, no doubt) says approximately zero about what contained within the article, which is mighty revealing. Since I’m nothing if not helpful, I thought I’d suggest a more candid title:

“We at the CDC Really F########ed Up and Here is Our Pathetic Attempt to Disguise it”

Then it gets downright hilarious. Check out this disclaimer. It’s a real beauty:

“Note. The findings and conclusions of this editorial are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.”

Really? So if I have this right, four people working for the CDC are allowed to write an opinion piece without any fear of jeopardizing their jobs. Who would have thought that federal agencies were so tolerant of employee dissent?? How about this one? Would the following opinion piece plus a disclaimer fly?

“The CDC Sucks” 

“The findings and conclusions of this editorial are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention, which may or may not suck.”

I think not. So let’s take a look at what’s really in what is, in fact, a pathetic mea culpa, with a side order of stealth. 

Halfway through the first sentence, it is clear that these guys are repeating the same old crap:

“In 2016, 63,632 persons died of a drug overdose in the United States; 66.4% (42,249) involved an opioid.”

Why do I suspect that the CDC would be absolutely gleeful if reporters read only the first sentence and then wrote their same old crap? After all, it is much easier than actually reading the paper and seeing what’s really in there. But if you bother to read it it doesn’t take long until the funny business starts.

First, the authors state that there are (at least) two ways to count opioid deaths. And the CDC has been doing it wrong (emphasis mine):

Traditionally, the Centers for Disease Control and Prevention (CDC) and others have included synthetic opioid deaths in estimates of “prescription” opioid deaths. However, with [fentanyl] likely being involved more recently, estimating prescription opioid–involved deaths with the inclusion of synthetic opioid– involved deaths could significantly inflate estimates.

Shocking! Except that I have written numerous pieces (1) which conclude exactly this: By combining fentanyl deaths with those from prescription drugs automatically skews the results. The stats from the CDC have been BS all along. They are now sheepishly admitting it, but not until the BS numbers were already used to formulate the god-awful policy which is now plaguing millions of us. All based on a bunch of lies.

It doesn’t take long to find data in the article that makes the CDC and its flunkies (2) look pretty bad. Let’s start with Table 1. The center column (green circle and arrow) represents the “traditional” method that the CDC used to count deaths. Note that the number doubled between 2013 and 2016. Those damn pills are stone cold killers, just like we’ve been told all along, right? No. Not right.

The other columns tell us why. The left column (blue) represents the number of deaths when the “conservative definition” (make that “correct definition”) is used. The data in this column no longer includes deaths from “fentanyl” (“fentanyl” in this instance meaning illicit fentanyl and its analogs – synthesized in Chinese labs, not pharmaceutical fentanyl). Once “fentanyl” (red column) is removed from a category in which it should never have been in in the first place, all of a sudden, the number of deaths drops by half. That little “a” has a big meaning. This “a” explains why fentanyl is erroneously lumped in with the others.

^a “Natural opioids include morphine and codeine, and semisynthetic opioids include drugs such as oxycodone, hydrocodone, hydromorphone, and oxymorphone. Methadone is a synthetic opioid. Synthetic opioids, other than methadone, include drugs such as tramadol and fentanyl.”

Table 1. (Left) A “new” method of categorizing opioid OD deaths includes only prescription drugs. (Center) The previous method included heroin and fentanyl, which automatically skewed the statistics. (Right) Deaths from illicit fentanyl.  Modified from American Journal of Public Health (AJPH) April 2018

WHERE IS HEROIN?

It is a bit baffling that heroin is not mentioned in footnote a. Especially since CDC data show that there were 15,469 opioid overdose deaths in 2016 (3). It is safe to assume that heroin was included in the data in the center column even though it was not specifically mentioned. It is not clear whether this omission is intentional or an oversight.

REDOING THE MATH

Now that we know that the 42,249 deaths that “involved an opioid” do not represent pain pills. If illicit fentanyl and heroin deaths are separated from the fake number we get a new number which is very different (4).

THE BIG LIE

The title of the middle column on Table 1 seems innocent enough: “Natural and Semi-Synthetic Opioids, Methadone and Other Synthetic Opioids.” But it is not. There is a nasty trick buried in a seemingly innocent definition – a false and scientifically absurd distinction between synthetic, semisynthetic (synthesized from a naturally occurring opioid) and naturally occurring opioids. This system of classifying opioids places fentanyl in the first group, heroin in the second, and morphine in the third. Ridiculous. Opioids should be classified either as pharmaceutical (legal) or non-pharmaceutical (illicit) or by their potency.

This false classification would seem to be no more than a trick. By combining legally prescribed opioids with street drugs the CDC has generated phony data that supports its doctrine – that prescription medications are killing people en masse. They are not. Once the fallacy falls away things look quite different (Table 2).

Fentanyl deaths have shot up more than 6-fold in three years while deaths from oxycodone, codeine, morphine, etc. have risen by 18%. That is a very different scenario than what the CDC has maintained and the press has parroted. Yet we continue to battle pills while the real killer isn’t pills, it’s heroin and illicit fentanyl and fentanyl analogs, most of which are far worse than fentanyl itself. Drs. Michael Schatman and Stephen Ziegler also addressed the CDC lies in their 2017 piece in the Journal of Pain Research entitled “Pain management, prescription opioid mortality, and the CDC: is the devil in the data?” The piece is, uh, rather blunt. 

Table 2. (Left) There was a 6.2-fold (520%) increase in fentanyl deaths between 2013 and 2016. (Right) By comparison, deaths from prescription opioid drugs increased by only 18%. 

WITH OPIOIDS 2+2 MAY EQUAL 5

But it gets even worse. The deaths from pills very often include other drugs, which have a synergistic effect.

It is impossible to tell how many people who died from prescribed pills would have survived had they not taken other drugs along with the opioid. But it is possible to estimate how many of them who died had taken these other drugs. This number is large. For example, in 2015 (Figure 1) about half of the people who died from prescription opioid overdoses had also taken a benzodiazepine (e.g., Valium). 

Figure 1. Benzodiazepines were present in 50% of prescription opioid deaths in 2015. Source: NIH

If benzodiazepines are present in so many opioid OD deaths then surely other drugs must also be frequently found, right? The answer is, of course, yes, but the numbers may astound you. Dr. Haylea Hannah and colleagues from the California Department of Health & Human Services recently published a paper in Online Journal of Public Health Information which examined toxicology data in people in Marin County who had died from any drug poisoning. Here are the findings:

• Opioids were present 76% of the time
• Alcohol – 44% 
• Amphetamines – 24%

Perhaps more interesting:

• When an opioid was found in the tox screen, alcohol was also found 52% of the time
• The average number of drugs found all cases was 6 (!)

Once again, it is apparent that deaths from opioids occur from abuse, not use.

The more you dig the more the numbers change, and it’s always in the same direction – the number of overdose deaths from prescription opioid medications, when used properly, is far less than the bogus numbers that have been used by the CDC. Based on all these adjustments, it would not surprise me in the least if 90% of opioid overdose deaths were a result of illicit fentanyl and its analogs, heroin, and the combination of pharmaceutical opioid drugs with other drugs of abuse. Maybe more.

It should be entirely clear that pain patients who use these painkillers correctly and responsibly are not the people who are dying from overdoses. But they are dying – slowly – from having to live in misery that we wouldn’t allow for our pets as the medicines they need to (barely) function are being forcibly taken away. 

It is 2018 and this is the United States. How did we ever get here?

NOTES:
(1) See:

The Opioid Epidemic In 6 Charts Designed To Deceive You

Heads In The Sand — The Real Cause Of Today’s Opioid Deaths

How the feds are fueling America’s opioid disaster

(2) Yes, you guys. You know who I mean.

(3) Source: “Drug Overdose Deaths in the United States 1999–2016“, CDC

(4) The “new” number is not 42,249 minus (fentanyl + heroin). It is much lower but unknown (and unknowable)  because when more than one drug is found it is counted twice. A certain number of fentanyl deaths also involve heroin and the other way around. One cannot simply add or subtract columns because of multiple counting.

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In need of donations to help offset cost of hotel rooms. Please donate anything you can afford to get warriors to D.C? If your bank has Zelle you can send by using my cell number. We’re using venmo for credit cards at no cost. I’m not opposed to a check I can deposit into Bank of America on app. Any questions PM me and know we’re going to speak out for all with chronic pain. We’re not quitting or backing down. Too many lives are at stake and we’ve lost too many already. Take care and God Bless

Sherry Sherman

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Alex Azar: Trump opioid plan includes retraining physicians on pain-management options

https://www.washingtontimes.com/news/2018/mar/19/alex-azar-trump-opioid-plan-includes-retraining-ph/

Health and Human Services Secretary Alex Azar said Monday that President Trump is committed to reducing the number of prescribed opioids and retraining physicians on how to handle pain management.

“He is saying that within three years, we will reduce the prescribing of legal opioids by one-third,” Mr. Azar said on Fox News.

White House officials unveiled their plan Monday on how they intend to combat the nationwide epidemic. Mr. Trump even went so far as to suggest the death penalty for drug dealers a few weeks ago and directed the Justice Department on Monday to make this a possibility under sentencing laws.

Mr. Azar said that there needs to be “serious penalties” and “serious enforcement” for those distributing these drugs, but he did not confirm anything about the death penalty specifically.

He did say part of the plan includes retraining doctors on how to handle pain management in their patients, and to also address the issue of overprescribing both opioids and antibiotics.

“We’re doing research and development in alternative additional pain management tactics,” Mr. Azar said.

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http://kdvr.com/2018/03/19/mother-says-daughters-critical-drug-is-at-risk-because-of-dispute-between-pharmacy-and-pharmaceutical-company/

DENVER —

The mother of a child with a double lung transplant said she is worried that accessing a critical drug for her daughter’s care will be challenging if  the drug’s manufacturer and Walgreens do not reach an agreement on a contract.

Jenna Parker’s daughter Portia Opichka received a double lung transplant two years ago.

Now, Portia is on 17 medications and Parker said the most critical is immunosuppressant Prograf.

Parker said she called to request a refill at the Walgreens at Children’s Hospital Colorado and was told the prescription could not be filled after April 1.

Parker said she was told by a pharmacist that Walgreens and the drug’s manufacturer, Astellas Pharma U.S., have not been able to reach an agreement on a new contract so it’ll expire at midnight March 31.

“This is probably one of the biggest hurdles I have had to face because this is the most important drug these kids can be on,” Parker said.

Parker said the Walgreens at Children’s Hospital Colorado is the only pharmacy in the Denver area that carries Prograf and can compound it, the process of turning the pill into a liquid form that can be inserted into Portia’s feeding tube.

“This is a very serious situation,” Parker said.

If the companies can’t reach an agreement, Parker said she’ll have to have the medication flown in from out of state.

She worries about the reliability of this option as well as making sure Medicaid will cover the out-of-state medication.

“Why would I want to rely on an airplane to deliver her life-saving medicines on time? My heart can’t deal with that, that’s too stressful,” Parker said.

“Astellas cares about the patients who need our products,” Astellas Pharma U.S. said in a statement.

“We are unaware of any business dispute with this retailer. Retailers make their own decisions about which products to carry.”

Walgreens could not be reached for comment.

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Class-Action Lawsuit Against Cigna Advances

www.legalscoops.com/class-action-lawsuit-against-cigna-advances/

A federal judge in Connecticut has denied most of Cigna Health and Life Insurance’s claims in the company’s request to dismiss a lawsuit claiming it artificially inflated prescription drug costs. The move, they claim, violates its clients’ health insurance policies.

The ruling by U.S. District Judge Warren Eginton means that the class-action lawsuit against Cigna and OptumRX Inc. will advance. The insurer hired OptumRX as its benefits manager to negotiate drug prices on behalf of the Cigna network.

Eginton wrote in the ruling, “The court finds the plaintiffs have plausibly alleged more than an entitlement to lower-cost prescription drugs or breach of contract. … The complaint plausibly alleges the defendant CIGNA acted with scienter by alleging that it intentionally sought to charge excess amounts for prescription drugs and that it required the pharmacies to conceal from the insureds the amounts of the prescription drug costs.”

The lawsuit was filed in October 2016 on behalf of five individuals covered by Cigna. The suit alleges both companies conspired over several years to make policyholders pay higher prices for prescription drugs. The plaintiffs allege that the companies misrepresented the costs of the drugs through higher charges to patients and efforts to get a larger portion of patient payments.

Eginton denied the motion to dismiss most of the claims, but the RICO claim against OptumRX was dismissed. The RICO claim against Cigna was not dismissed.

The lawsuit notes numerous examples of the defendants and agents of the defendants taking clawback or spread payments from pharmacies across the country thousands of times per day.

One example cited in the suit showed that a class member paid a $20 co-payment for a prescription drug, which was 1,043% more than the actual $1.75 fee that is paid to the pharmacist. The lawsuit claims that the defendants, without disclosing to the consumer, clawed back the $18.25 overcharge.

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www.ohio.com/akron/news/local/pharmacists-say-corporate-greed-is-pushing-up-prescription-drug-prices-and-them-out-of-business

At 62 years old, Rod Kalbus was looking for a reason to retire. Firing a barrage of bullets, a couple hitting their mark, at three robbers who jumped behind his drugstore counter in December seemed as good reason as any.

But that was just “the final straw,” as Kalbus put it last week. His business — the last independent pharmacy in Akron’s Highland Square neighborhood — closed its doors forever on Tuesday. It was a business decision, and not necessarily one made out of fear.

In the final months of his 27 years filling prescriptions, what state lawmakers now call an “oligopoly” of health management companies, which fellow pharmacists call “too big to fail,” had proved far more effective than masked thieves at skimming profits from Kalbus’ Highland Square Pharmacy cash register.

“It’s a very shady, nontransparent business,” Kalbus said of the companies, known as pharmacy benefit managers, whose success is allegedly built on killing competition and inflating Ohio’s prescriptions drug costs for pharmacies and customers.

Kalbus and other pharmacists interviewed by the Beacon Journal/Ohio.com say corporate greed is the best explanation for why 164 pharmacies, many of them small and locally owned, have closed in Ohio over the past two years.

PBMs at work

Pharmacy benefit managers, or PBMs, have been a mainstay in the prescription drug industry for decades. They were first introduced to haggle with drug manufacturers to get better prices for pharmacies, insurers, health plan providers, business, workers, the government and — ultimately — patients.

Over time, though, the companies have become integral to the drug prescription industry. Now middlemen in the supply chain, PBMs operate in negotiation between insurance claims, pill prices, which drugs make the cut and what pharmacies get to bottle them up.

This is where pharmacists and lawmakers say the free market can be abused for financial gain. PBMs can push more expensive drugs if they get a bigger cut on the negotiated price. “In any other industry you would call that a kickback,” said Ernest Boyd, executive director of the Ohio Pharmacists Association. “In our industry, they call it a rebate.”

Today, five PBMs are estimated to have a hand in filling half the nation’s prescriptions. Every company authorized to accept state Medicaid dollars for prescriptions uses a PBM, which negotiates drug costs, what insurance covers and how much from state funding or private insurance payouts should trickle to pharmacies.

Pharmacists, and now some pro-business Republicans at the Statehouse, argue that PBMs have unfairly cornered the market. For example, CVS Caremark, which is contracted by four of Ohio’s five Medicaid providers, can charge less for services provided to its CVS-branded pharmacies.

Parent company CVS Health, which responded by email Friday, said a “stringent firewall” keeps the influence of its PBM from unduly benefiting its pharmacies. “We reimburse our participating network pharmacies, including the many independent pharmacies that are valued participants in our network, at competitive rates that balance the need to fairly compensate pharmacies while providing a cost-effective benefit for our clients,” wrote Christine Cramer, the company’s senior director of corporate communications.

But pharmacists, who now have the attention of lawmakers, allege that recently PBMs have had more than just a thumb on the free market scale.

Price setting

In the fall, PBMs slashed reimbursements for Medicaid-approved prescriptions, cutting 80 percent of revenue in the most egregious cases reported by pharmacists and lawmakers.

And there’s no verifiable evidence that PBMs are setting cost and reimbursement rates according to basic supply-and-demand economics. The rates, instead, are established privately and, critics say, can fluctuate widely from one pharmacy to another, or from one month to the next.

As they allegedly withheld Medicaid dollars, CVS Health sent letters and emails to Ohio pharmacies asking if they would sell their businesses, citing the lower reimbursement rates they controlled “as a reason [the pharmacies] should get out of the market,” state Rep. Scott Lipps, a Franklin County Republican, said at a news conference Wednesday.

“Our retail business’ acquisition activity is completely unrelated to, separated from, and not coordinated with in any way the PBM business’ management of its pharmacy network,” Cramer said.

Dan Jones, a pharmacist and vice president of operations at Klein’s Pharmacy in Cuyahoga Falls, said the buyout request arriving amid lower reimbursement rates sent a clear, coordinated message. “Basically, to me, it seems they are trying to drive out competition.”

Before he closed up shop last week, Kaldus said he was making less than $2 to fill up to 40 percent of his customers’ prescriptions. For some transactions, Kaldus pocketed as little as 57 cents.

Revenues that low are unsustainable, though other area pharmacists, who have closed branch locations, say they refuse to turn away customers just because they’re losing money.

A 2016 study by Mercer Government Human Services Consulting, which was paid by the Ohio Department of Medicaid to investigate the cost of filling prescriptions, found that pharmacists spent between $9 and $10 on average to fill a prescription. That includes on-site consultation, state reporting requirements, monitoring to ensure drugs are used properly, salaries for employees and more.

Pharmacy deserts

Beyond the threat of higher prescription drug costs, shuttering pharmacies has a few other potentially negative consequences for customers and communities.

“The biggest concern that we have had is that, as pharmacies have closed their doors, patients are losing access to health care,” said Jones, who attributed market pressure from PBMs for the closing of a downtown Akron location last year, which was open to the public for 40 years. “These are patients that were already disadvantaged and now have to find access to transportation to fill their prescriptions.”

Similar concerns face rural communities, Boyd of the Ohio Pharmacists Association said. “Pharmacists provide services,” he said of one-stop shops for insulin, heart medication, flu shots and more. “If you check with rural health associations, in many counties we are the only health care provider there.”

Independent pharmacies are more likely to compound drugs on site. As they close, Boyd said customers with — for example — newborn babies may be forced to drive further for drugs requiring special blending and not typically stocked on shelves.

Boyd also warned that PBMs’ influence with drug manufacturers could put profits over patient choice. PBMs negotiate prices with manufacturers. But that doesn’t mean the lowest price prevails.

The PBM is then in the position to steer pharmacies, through variable pricing, toward more expensive drugs even if cheaper generics are available.

“We get a manufacturer’s drug on your formulary, your list” of what satisfies a doctor’s order, Boyd alleged of how PBMs negotiate in their own best interests. “We [the PBMs] win, you [the manufacturers] win. And the only one who gets screwed is the buyer.”

Reach Doug Livingston at 330-996-3792 or dlivingston@thebeaconjournal.com. Follow him @ABJDoug on Twitter or http://www.facebook.com/doug.livingston.92 on Facebook.

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“We feel like we have to keep proving we are disabled just to get some level of care to keep making it day to day,” Janet Zureki says.

http://www.monroenews.com/news/20180319/opioid-epidemic-patients-who-are-caught-in-middle

As the country confronts an ongoing opioid epidemic, law enforcement officials are cracking down on healthcare providers they deem as overprescribing medicines — a practice many say contributes to an increase in drug abuse and overdose deaths.

It’s a problem that deeply affects Monroe County: 44 people died from drug-related overdoses in 2015, with 31 of those deaths tied to opioids. It’s a stark increase compared to earlier years — in 2010 there were 18 drug overdoses, with nine of those deaths caused by opioids.

While officials confront the health crisis, however, patients who suffer from chronic pain or have debilitating illnesses have found themselves caught in the middle.

They are patients who are prescribed opioids; they neither abuse their medications nor distribute them to others. Instead, they rely on them as part of their treatment plans.

Many of those patients feel like they’re the invisible victims in the response to the public health crisis.

LIVING WITH THE PAIN

Janet Zureki will never know a day without pain.

From the moment the 49-year-old Monroe resident wakes up, she grapples with managing pain stemming from a traumatic injury she endured after a botched operation.

Zureki had to have her tailbone surgically removed after it was broken. The injury also resulted in her spine leaking fluid and damaged muscle tissue in her lower back and hips, causing her severe pain.

“My kids would have to watch me crawl around the house,” she said. “There were times I couldn’t even crawl — I would have to stop and wait for it to subside.”

Zureki takes prescribed opioids throughout the day, combining it with physical therapy and exercise to address her pain. A patient of Dr. Lesly Pompy of Monroe, she worked with the doctor for several years to develop a treatment plan to give her “back a quality of life.”

But in 2016, Pompy’s offices were raided by local law officials after a year-long investigation levied accusations of illegal pill distribution and healthcare fraud. His license later was suspended and his case referred to a federal court.

The charges left several of his patients with chronic conditions and severe illnesses adrift, many scrambling to find new pain management specialists, she says.

An Air Force veteran, Zureki worked as an asset collector for the Internal Revenue Service before her injury prompted her to take an early retirement. A wife and mother of two, she says addressing her pain is a part of her daily life, often making it hard to take part in social and family events.

“It’s hard sitting at an event for your kids,” Zureki said. “You don’t get butterflies when your kids are doing good because you want to go home because of the pain.”

Lyn Herrmann, an auto factory worker who lives in Monroe, can relate.

Herrmann suffers from bulging discs and degenerative disc disease. She also has another serious disease that causes her pain. Her job, which she has had for 21 years, requires strenuous physical labor and has long hours, sometimes averaging 10 to 12 hour days.

Herrmann is not a viable candidate for corrective surgery. Instead, she has to rely on a treatment plan that addresses her condition, which includes opioid pain medicine. In addition to complicating her work life, her conditions impact life at home with her husband and 4-year-old daughter.

“Some days my daughter wants me to play with her on the floor and I don’t know if I’ll be able to get back up if I get down there,” she said. “I want to play with my kid, but sometimes I just can’t. It makes me feel like a bad mother.”

EFFECTS ON PATIENTS

A routine operation gone awry resulted in the injury to Zureki’s tailbone. For nine months, her pain grew until it became unbearable. At first, doctors were unable to identify the source of her discomfort.

But as her condition worsened, her primary physician referred her to Pompy, who specialized in pain management. He was the first doctor to find her broken tailbone and helped her come up with a plan on how to address it.

After the raid, Zureki was unable to receive her medications for several months. She tried to find another physician quickly, but many doctors who worked in pain management were leaving the field or weren’t accepting new patients.

Her own primary doctor refused to prescribe her pain medicines and others in the area were wary of taking Pompy’s patients, she said, adding that some doctors even had signs in their windows saying they wouldn’t prescribe opioids.

“We feel like we have to keep proving we are disabled just to get some level of care to keep making it day to day,” Zureki said. “We were treated like we did something wrong. No one would even see us.”

Zureki eventually experienced the effects of withdrawal and the return of her pain. The muscles in her back contracted again and she struggled to breathe while sitting up.

“The vomiting, the pain, the crying — you can’t feel like yourself. To be taken off medication you’ve been on for years isn’t safe,” she said. “Even when you’re back on the medicine, it’s like you have to start all over.”

Herrmann, also a former patient of Pompy, had similar experiences.

Her primary care physician refused to treat her pain and referred her to another doctor, a practice many pain patients face, she said, adding that doctors would rather transfer responsibility of their patients’ pain care to another physician than risk scrutiny.

“Family doctors in Monroe are all afraid to give anyone any pain medicine,” Herrmann said.

It took several months for Herrmann to find a new pain management doctor. During that time she lowered her dosages and rationed her medication as she looked to bridge the gap in care, an act that she says shows she doesn’t abuse her medication.

Even now doctors are reluctant to prescribe pain medicine, often reducing or adjusting her dosages.

“Every month it decreases like I’m magically going to get better,” she said. “I’m not going to get better. I’m going to get worse.”

FIGHTING A STIGMA

Zureki said pain management patients face stigmatization for taking medications, sometimes even from their own doctors. Pain patients will minimize the depth of their pain out of fear of being accused of drug seeking, she said.

“You tell your pain doctor about your pain, but you don’t want to tell them the worst of it because they may think you’re trying to get more drugs,” she said. “You’re always walking on egg shells. What if you lose this pain doctor? Where do you turn next?”

Herrmann said people make assumptions about pain patients and patients of Pompy without trying to understand the severity of patients’ pain or conditions.

“They think you’re a druggie or just making it up,” she said.

Zureki says it’s easy to became resentful of having to take medications. Her life is regimented around it, often having to plan days in advance what she will do so she can be prepared.

It also takes a mental toll, she said, adding that she sometimes battles depression and anxiety that stems from her condition.

“It’s a constant battle. If the pain would be better, the depression would be better. They feed off of each other,” she said. ” You end up in a vicious cycle.”

LOOKING TO THE FUTURE

Herrmann’s plant is slated to begin production on a new vehicle soon. She is worried about how she will manage her pain as the car parts she works with at the factory will be much heavier. Not working is not an option for her, she says, so she’ll have to work through the pain.

She said a lot of people aren’t abusing their medication and need it to function, which she hopes law enforcement and doctor will better understand in the future.

“Overdose death numbers seem to be rising even though prescriptions are more rare,” she said. “Who do they have to blame now?”

Zureki understands the need to address the opioid problem in Monroe. She supports stricter prescribing guidelines, but she also hopes law enforcement will work more closely with doctors to ensure patients with legitimate needs for medication don’t lose access to care.

“They’re creating a vacuum by just cutting off the doctors,” Zureki said. “They’re potentially making people go from getting the legal medication they need to turn to the streets.”

Zureki hopes to get her doctor back one day. She continues to work on retraining her muscles by going to the gym and hopes to resume the treatment plan she and Pompy created together.

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https://gizmodo.com/experts-arent-buying-into-trumps-proposed-opioid-plan-1823815123

Earlier today, Politico provided a preview of what’s believed to be the broad contours of Trump’s grand plan for addressing the opioid crisis. But while some of the details include common sense measures embraced by public health and opioid experts, others are setting their nerves on edge.

The proposal, which might be fully revealed as soon as Monday, according to Politico, is expected to be a mix of law enforcement and health care policy changes.

On the health side of things, Trump reportedly proposes repealing a Medicaid rule that bars it from being used to pay for addiction treatment at large facilities, will ask the majority of Medicaid and Medicare providers to revamp how they decide to pay for opioid prescriptions to fit “best practices” within three years, and will call for the mandatory screening of new federal prisoners for opioid use along with providing avenues for treatment at halfway houses. Following the lead of many state agencies, Trump would also make it a priority to expand the access first responders have to naloxone, the medication used to rapidly reverse overdoses.

Ideas like expanding naloxone availability and giving Medicaid patients access to more treatment centers have received almost universal support from opioid researchers and doctors. But Stefan Kertesz, a clinical researcher in addiction at the University of Alabama at Birmingham, is suspicious of the proposed changes to Medicare and Medicaid prescription payment criteria.

“What is ‘best practices?’” he said in a email to Gizmodo. “Based on the last few years, I am worried that this expression is code for strict adherence to certain dose and duration thresholds for patients with pain, in violation of the CDC Guideline.”

Kertesz and many of his colleagues have already harshly criticized a proposal by the Centers for Medicare and Medicaid Services to impose mandatory restrictions on opioid prescriptions that would come into effect in 2019. These restrictions, while intended to prevent misuse, would also affect stable chronic pain patients on long-term opioid therapy, Kerterz says, and depend on a disingenuous reading of the CDC Guideline on prescribing opioids that was released in 2016.

“The CDC Guideline does NOT say to reduce such patients’ doses against their will, but legislators, health systems, and quality metric agencies have read it that way,” Kertesz said. “What it did say was to reduce our tendency to rely on opioids as first or second line responses to chronic pain and to be very cautious with dose escalation. That’s wise, and doctors had been making that shift since 2010.”

Kertesz is similarly worried about the White House’s claim that their plan will reduce opioid prescriptions by one-third within three years.

“I really do fear that the only way to reduce prescribing by one-third in a few years is forced dose reductions in currently stable patients,” he says. “Forced dose reductions have no data to support them whatsoever and in a number of instances they result in the death of the patient, sometimes due to suicide, sometimes due to overdose as the patient goes into crisis, sometimes due to medical deterioration.”

Kertesz himself has met with and studied some of these patients.

When it comes to law enforcement, Trump’s proposal is said to contain language that would call for the increased use of the death penalty in “certain cases where opioid, including Fentanyl-related, drug dealing and trafficking are directly responsible for death,” according to Politico. The policy reflects rhetoric Trump had spouted earlier this month during an White House Summit on opioid abuse. Another policy would try to make it easier to hand out mandatory minimum sentences for drug traffickers who are believed to knowingly distribute potent, synthetic opioids like fentanyl.

These ideas are unlikely to win much support from those like David Herzberg, a historian at the University at Buffalo who has studied past US drug policy.

“It would be hard to overstate how misguided and destructive the death penalty (and mandatory minimum sentences) idea is,” he told Gizmodo via email. “We’ve tried harsh punishments (including mandatory minimums and, at least on paper, the death penalty) repeatedly over the past century—in the 1920s, in the 1950s, in the 1970s/80s/90s—and every time, they have wreaked more harm rather than helping the communities they were supposed to serve/protect. Total disasters all.”

While some other ideas would be a step in the right direction, Herzberg says it’s unlikely Trump and his administration are capable of pulling them off.

“We clearly need supply-side clampdowns to rein in an out-of-control pharmaceutical industry and to repair medical and pharmacy institutions warped by their influence,” he said. “However, blunt, broad, one-size-fits-all versions of these policies could be incredibly damaging in a variety of ways, and very little that Trump has said makes me think he is interested in careful, nuanced policy implementation.”

And for those living with addiction who lose their suppliers or prescription drugs, Herzberg says, they’ll need more than just expanded access to naloxone or screenings at prisons.

“Even more important would be dramatic (yet careful) expansions of buprenorphine treatment, safe injection sites, etc. Putting more money into treatment is great—but we need to make sure those resources go towards public health approaches proven to save lives and protect health rather than pursuing abstinence (becoming ‘clean’) at any cost,” he said. “A lot of terrible things are done to drug users in the name of ‘treatment’—not just ineffective but, in some cases, tantamount to torture. It matters a lot what kinds of treatment they will make available.”

“And again, Trump does not inspire confidence that he is ready to set aside macho moralism and follow where the public health evidence leads,” he added.

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