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

CVS says Florida’s opioid claim ‘without merit’

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

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

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

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

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

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

Walgreens declined to comment for this story.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dispatch Reporter Marty Schladen contributed to this story.

ccandisky@dispatch.com

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lsullivan@dispatch.com

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

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

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

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

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

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

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

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

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

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

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

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https://youtu.be/_GI3FexQgDk

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Meningitis trial: Massachusetts board let NECC off with warnings

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Indiana Pain Warriors Asked to Share Experience with Forced Medication Switches

Dear U.S. Pain Foundation volunteers,

U.S. Pain Foundation belongs to the Indiana Stable Patient Protection Coalition. Together, we oppose the unfair practice called non-medical switching, or NMS. NMS occurs when insurance companies make changes to coverage that ultimately force patients to switch medication.

These coverage changes take place during the plan year, long after open enrollment. NMS locks consumers into a plan that no longer meets their needs–all for the profit of insurers.

If you believe you have been a victim of non-medical switching, we encourage you to share your experiences by taking this survey.

We, along with 12 patient and provider groups which make up the state-based coalition share the same goal: make stakeholders aware of the need to change NMS practices. In the coming months, we plan to propose a common-sense bill that will eliminate non-medical switching by private health plans. The survey data will be used to better inform legislators about the impact of NMS.

Thank you for your interest in helping to end this unfair and dangerous practice.

With gratitude,

Shaina Smith
Director of State Advocacy & Alliance Development

Take the survey

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Middletown, CT 06457

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FDA Warns Against Using Unapproved Meds in Implanted Pain Pumps

https://www.medscape.com/viewarticle/904885

The US Food and Drug Administration (FDA) is alerting healthcare providers about the risk for complications with intrathecal administration of pain medications that are not approved for use with implanted intrathecal pumps.

These complications may include dosing errors, pump failure, opioid withdrawal, and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.

“The treatment of pain has become increasingly complex,” FDA Commissioner Scott Gottlieb, MD, said in a news release.

Implanted pumps that deliver medication directly into the spinal fluid can play an important role in treating pain, but their use must be “judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” said Gottlieb.

In a safety communication, the FDA reminds providers that the only approved medicines identified in FDA-approved implanted pump labeling for intrathecal infusion to treat or manage pain are morphine sulfate preservative-free injectable solution (Infumorph, West-Ward Pharmaceuticals) and preservative-free ziconotide sterile solution (Prialt, TerSera Therapeutics).

The FDA advises providers to review current labeling (ie, instructions for use) of the implanted pump, because not all pumps are currently approved for use with Prialt.

In reviewing medical device reports and other information, the FDA discovered that patients are sometimes treated with medications that are not approved for use with an intrathecal implanted pump. Such drugs include compounded medicines, hydromorphone, bupivacaine, fentanyl, and clonidine.

Any mixture of two or more different kinds of medicines and any compounded medicine (eg, to achieve higher concentration or different formulation of an FDA-approved medicine) are not approved for use, the FDA said.

Using drugs not approved for use with these pumps “may lead to serious risks to patients due to pump failure or dosage errors,” the FDA said.

The FDA has determined that implantable intrathecal pump failure is more common with the use of medicines not approved for use with the pump. Some medicines or fluids may contain preservatives or other characteristics that can damage the pump tubing or lead to corrosion of the pumping mechanism, it points out.

Dosing errors are also a risk with unapproved medicines. Programmable implanted pumps employ dose calculation software, and the accuracy of calculations depends on use of the approved medicine, approved medicine concentration, and approved medicine characteristics. A problem may arise, for example, if there is more than one medicine in the pump reservoir. In such cases, the pump software can calculate the dose only on the basis of the infusion rate of a single medicine, the FDA said.

Healthcare providers are encouraged to report problems with implanted pumps to the FDA’s MedWatch Adverse Event Reporting Program.

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