Trump Targets Drug Middlemen With ‘Devastating’ Rebate Plan

https://www.bloomberg.com/news/articles/2019-01-31/trump-to-curb-protections-for-drug-rebates-blamed-for-high-costs

The Trump administration proposed ending a complex system of drug rebates that influence tens of billions of dollars in U.S. pharmaceutical spending, a move that could upend the relationship between drugmakers and pharmacy benefits middlemen.

The proposal, a long-awaited part of the administration’s plan to target high list prices of drugs, would ban rebates paid by drugmakers to pharmacy benefit managers, or PBMs, in government programs like Medicare.

Those rebates have been called anticompetitive by critics, who blame them for forcing many patients to pay more out of pocket. Under the administration proposal, rebates would instead be passed along directly to customers.

The proposal comes ahead of President Donald Trump’s State of the Union address scheduled for Tuesday, handing him a potential win on drug pricing — a major issue for both parties. The measure, released by the Department of Health and Human Services Thursday, would roll back so-called safe-harbor protections for such rebates, which kept them from running afoul of federal antikickback laws. The plan isn’t final and will be subject to a 60-day period for public comment.

The changes are “potentially devastating to the current pharma ecosystem,” said Eric Coldwell, an analyst with Baird Equity Research. “The U.S. health-care system is a sandcastle and the tide is coming in.”

Shares of major drug-plan providers fell. CVS Health Corp., which oversees drug benefits for more than 90 million Americans, fell 2.4 percent in late trading in New York, and Cigna Corp., which last year bought PBM giant Express Scripts, declined 1.4 percent.

Drugmakers pay rebates to insurers and PBMs in exchange for preferred status with those plans’ customers. Some of those rebates go toward insurance premiums, while the middlemen keep some for themselves. The pharmaceutical industry has said PBMs prefer higher-priced drugs so they can negotiate bigger rebates and pocket more of the money.

In a statement announcing the proposal, HHS Secretary Alex Azar blasted PBM rebates as “a hidden system of kickbacks to middlemen” that increases drug costs for Americans every day.

“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” Azar said in a statement.

Reporting by Bloomberg News over the past three years has examined a variety of pricing practices at PBMs that have been criticized by politicians and others for making it hard to tell where the money is going. In addition to the debate over rebates, PBMs also are under scrutiny over a practice known as spread pricing, a contractual arrangement that allows PBMs to pay pharmacies one price for a generic drug while charging higher prices to their health plan customers.

CVS said drugmakers were to blame for drug costs. “While PBMs have become a convenient target in the fight against skyrocketing drug costs, in reality they serve as a last line of defense for the consumer,” the company said in a statement.

Brian Henry, a spokesman for Cigna, said that rebates had helped keep premiums down overall. “It is short-sighted to look at one component of our offering as having a disproportionate impact on our business model,” Henry said in an email.

Under the proposal, safe-harbor protection would be eliminated for rebates drugmakers pay to pharmacy-benefit managers, Medicare Part D plans and Medicaid managed-care organizations. A new safe harbor would be created for rebates on drug discounts offered directly to patients, as well as fixed-fee service arrangements between drugmakers and PBMs. Without safe-harbor protections, rebate money pocketed by PBMs could be considered an illegal kickback.

Congress

While the out-of-pocket cost for many people picking up drugs at the pharmacy would decline, the premiums they pay for coverage would rise. Premiums for Medicare drug plans under the proposal could increase anywhere from 8 percent to 22 percent while average costs patients pay out of pocket would fall 9 percent to 14 percent, according to the Department of Health and Human Services.

It would be up to Congress to write new laws banning rebates in commercial plans that cover most working-age Americans, and the reception on Capitol Hill was mixed. In the Democrat-controlled House of Representatives, the chairmen of two key committees overseeing health care criticized the proposal.

“The majority of Medicare beneficiaries will see their premiums and total out-of-pocket costs increase if this proposal is finalized,” Ways & Means Committee Chairman Richard Neal of Massachusetts and Energy and Commerce Committee Chairman Frank Pallone of New Jersey said in a joint statement. “We are concerned that this is not the right approach.”

House Speaker Nancy Pelosi likewise urged Trump to work with lawmakers on drug costs.

“President Trump must work with Congress to deliver the real, tough legislation needed to actually drive down the price of prescription drugs for seniors and families across America.” she said in a statement criticizing the plan.

The Pharmaceutical Care Management Association, an industry group for PBMs, said it was reviewing the proposed rule.

“We stand ready to work with the administration to achieve our shared goal to reduce high drug costs,” PCMA Chief Executive Officer JC Scott said in a statement.

The Pharmaceutical Research and Manufacturers of America, the main drug industry trade group, applauded the move. The proposal would “fix the misaligned incentives in the system” that now result in insurers and PBMs favoring medicines with high list prices, PhRMA CEO Stephen Ubl said in a statement.

A few days ago I made this post Saving Money For Medicaid in WV      where WV got rid of their middlemen on their state Medicaid program in 2017  and saved 30 million dollars. WV is not all that large a state ..population about 1.8 million.

The PBM industry started when I was in my last year of Pharmacy school and have watched the industry grow from a nuisance to Pharmacists to a entity that is controlling of the price and approval to pay about 80%-90% of all the prescriptions filled in the country.

They have gained so much control from their beginning that they can now demand discounts/rebates/kickbacks from the pharmas in exchange for the PBM’s to put their medications of the PBM’s approved list of “paid medications”

We have had for years Silver Scripts which is part of CVS Health and last year they started charging higher copays for having prescriptions filled at non-preferred pharmacies and last year there was only two independent pharmacies that were preferred pharmacies.  As of Jan 2019, in three adjacent counties the only PREFERRED PHARMACIES are CVS pharmacies and if a pt with Silver Scripts uses a non-preferred pharmacy the copays they are charged will be 50%-100% higher.

All of these PBM’s are licensed insurance companies and they have fought every attempt to regulate how they run their business by parts of our bureaucracy.  Basically they have fought not to be forced to operate in a TRANSPARENT WAY.  Also the insurance industry has one of the top funded lobbyist funds.  If this gets much traction in Congress i suspect that there will be a whole herd of lobbyists descending on Congress to see if they can get this proposal greatly modified to cause less financial harm to the PBM industry.

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5 police officers injured in Houston shooting, 2 suspects dead, officials say

https://www.foxnews.com/us/5-police-officers-injured-in-houston-shooting-officials-say

Did anyone pay attention to this raid on a suspected drug house in Houston…  Apparently all the police involved in this raid was from the city of Houston and/or Harris county.

Does it seem strange to anyone but me, but the DEA has a district office in Houston , TX but apparently they were no where to be found or involved in this raid.

Maybe because there were probably no real assets to seize/confiscate and/or there was a high probability of a fire fight… ?

If this had been a prescriber’s office… where there is little/no change of getting shot and high probability of sizeable assets to be seized and a high profile court case to be sending out endless stream of press releases on their BUSTING A PILL MILL DOC ?

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Civil Rights Case Gives Hope to Pain Patients

https://www.painnewsnetwork.org/stories/2019/2/1/civil-rights-case-gives-hope-to-pain-patients

Selma Medical refused to schedule a new patient appointment for a man who was taking the addiction treatment drug Suboxone. He filed a civil rights complaint asserting that his rights were violated because has a disability.

According to the complaint, Selma Medical “regularly turns away prospective new patients who are treated with narcotic controlled substances such as Suboxone.”

The DOJ and Selma Medical settled the complaint out-of-court. The full agreement can be read here.

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Jan. 31, 2019 – 2:00 – Investigation by the California State Board of Pharmacy finds that a Walgreens employee in the Bay Area who worked as a pharmacist for nearly 11 years and wrote 745,00 prescriptions never had a license

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Pharmacies can make deadly mistakes while keeping the public in the dark

http://www.weny.com/story/39891507/pharmacies-can-make-deadly-mistakes-while-keeping-the-public-in-the-dark

Ohio (WEWS) — A secret crisis is unfolding inside pharmacies in the state and across the country. The struggle to fill an increasing number of prescriptions has fueled growing concerns over harmful and sometimes deadly prescription mistakes.

But Ohio pharmacies and others nationwide can make these mistakes and the public can be kept in the dark, a 5 On Your Side investigation has found, because they are not required to report these errors to state regulators.

Our findingsState regulators do not maintain comprehensive data on how many people have been harmed or killed as a result of prescription mistakes made by pharmacies.

In an effort to piece together how often these mistakes occur, our team reviewed four years of Ohio Pharmacy Board minutes, court dockets and autopsy reports.

We found there have been at least 491 complaints — filed largely be consumers involving prescription mistakes. In addition, we uncovered two people were killed and 31 people were harmed as a result of being given the wrong medication at local pharmacies across the state.

Alarmingly, industry experts are convinced those numbers are likely much higher. Our investigation found no one is certain just how many are harmed because pharmacies in Ohio are not required to report those complaints.

‘Try your best not to kill anyone’At the same time, demand and workload for Ohio’s 20,349 pharmacists and 20,649 pharmacy technicians is growing, according to Ohio Pharmacy Board records.

The Ohio Pharmacists Association , which represents pharmacists and pharmacy technicians, is concerned that 150 local pharmacies have closed their doors and small pharmacies are being bought out by large chains that the association believes fail to adequately staff pharmacies.

“It’s fill as fast as you can — try your best not to kill anyone,” said Antonio Ciaccia, the association’s Director of Government and Public Affairs.

Our investigation found heartbreaking and tragic mistakes:

Michael James Carmack was just 25 years old when he died in April of 2015 as a result of being given the wrong medication at his local pharmacy, according to the lawsuit that was settled and dismissed, as well as pharmacy board disciplinary reports . Court records reveal Carmack “ingested the wrong medication,” and an autopsy report confirmed “the pills in the prescription bottle did not match the prescription on the prescription label.” The pharmacist “neither admits nor denies the allegations,” according to the disciplinary records. However the pharmacy board said it has “evidence sufficient to sustain the allegations” and levied a $3,000 fine that the pharmacist agreed to pay.

In another case, a lawsuit alleged that 68-year-old Johnny Shepherd died as a “result of pharmacy negligence” after dispensing medication that was “mislabeled.” His wife Molly Shepherd is convinced “the medication killed him.”

“I loved him, and he loved me,” Shepherd said. “[His death] caused me to be miserable, living by myself.”

Tabatha Gonzalez said she was five months pregnant when she discovered she had been taking prescription medicine belonging to someone else. But fortunately, it turned out to be the identical medication and dosage. Even so, she remembers worrying, “Is my baby going to be OK?” she said.

The mother of a now 20-year-old remembers how a pharmacy mistake hospitalized her son when he was just 5 years old. Carrie Klein said her son, Freddie, suffered from a rare brain disorder since birth and required medication to control his seizures. “I got a magnifying glass and looked at the pill and sure enough, it was double the dosage,” she said. “They could have killed him.” The mistake was never reported until Klein filed a complaint on her own.

Doing ‘more with less’Last year, more than 171 million prescriptions were filled at pharmacies across Ohio, according to the Henry J Kaiser Family Foundation . The Ohio Pharmacy Association said, “that number is skyrocketing” while pharmacies are “being forced to do more with less.”

“That is incredibly dangerous,” Ciaccia said. “We should not be sitting around waiting for the next error or the next death to occur.”

Even longtime pharmacists like Ray Carlson are taking the highly unusual step of voluntarily becoming “whistleblowers” to bring conditions inside pharmacies to the public attention. Carlson owns a successful compounding pharmacy in Poland, Ohio that provides specialized prescriptions for patients and hospitals in Northeast Ohio.

“This is very unusual for a pharmacist to not have his face blocked out or his voice garbled,” Carlson said in an interview.

For example, in a highly public move, Carlson took the Ohio Pharmacy Board to court in order to compel the board to survey Ohio’s pharmacies to ensure they were following both state and federal laws governing dispensing.

With Ohio’s growing opioid crisis, Carlson grew concerned over workplace conditions that may be leading pharmacists to be too busy to ask consumers a comprehensive list of questions regarding their medication and drug reactions, among others.

Carlson’s goal was to warn the public of the “impact and danger” if safe dispensing practices were not adhered to, including the potential for errors.

“Absolutely, it leads to errors,” Carlson said. “We know it’s being under reported if not reported at all.”

The case was ultimately dismissed, but Carlson continues to stress that pharmacies appear to be failing to spend adequate time with consumers simply because they are overworked and too busy.

In fact, he said the next time consumers pick up their prescriptions, they should notice the box they check that seems to indicate only that they have picked up their medication. By checking it, he said, consumers are also surrendering their rights to counseling and questions from the pharmacist.

“I can remember when it once took five pharmacies to fill just 100 prescriptions a day,” Carlson said. “Now, you got one pharmacy with two pharmacists doing 500 a day.”

“If I make you do more with less time and less resources—will you do better?” Ciaccia asked. “I don’t think anybody wouldI think everybody would actually say they would do worse.”

Pharmacies respondIn a statement to News 5, the National Association of Chain Drug Stores (NACDS), which represents 40,000 pharmacies nationwide, said “while some have attempted to link” prescription errors “with pharmacist’s current responsibilities,” the NACDS warns against a “rush to judgment” or “assume a causal relationship.”

The NACDS also supports “voluntary reporting of medical and prescription errors in a non-punitive forum” as opposed to mandatory reporting without fear of being subjected to lawsuits. You can read NACDS’ full statement here.

NACDS also points to a report by the Institute for Safe Medication Practices that “emphasize strongly the importance of voluntary reporting rather than mandatory as well as findings by the Agency for Healthcare Research and Quality within the U.S. Department of Health and Human Services.

The nation’s two largest pharmacies provided written statements to News 5 but declined on-camera interviews.

A spokesperson for Walgreens responded saying, “Prescription errors are rare and we take them very seriously. In the event there is an error with a prescription, our first concern is always for the patient’s well-being.” You can read Walgreens’ full statement here .

A CVS spokesperson also insisted “errors are rare,” saying the pharmacy “has comprehensive policies and procedures in place” to ensure safety. You can read CVS’ full statement here .

Walmart, the nation’s fourth largest retail pharmacy, said only, “We don’t have anything to add to your story.”

We shared our findings with the Ohio Pharmacy Board that is now promising to move forward with proposed rules that would require mandatory reporting of pharmacy errors.

Pharmacy Board Executive Director Steven Schierholt said the debate has long been that if pharmacist and technicians were fearful of possible criminal charges, it would have the opposite effect and encourage less reporting — not more.

He said the board has been working toward mandatory reporting that would encourage more accurate and full reporting without criminalizing pharmacists.

“The board is in the process of promulgating rules that would require a pharmacist to report instances of reckless behavior that resulted in a dispensing error, or unprofessional conduct that resulted in a dispensing error,” Schierholt said.

New rules regarding mandatory reporting of pharmacy errors will be proposed and released in the next few months.

There are some 4 + Billion prescriptions filled each year in the USA. I don’t know what the definition of “rare error ” is that is used by the chains.. But if 99.9 percent of prescriptions are filled without a ERROR… that means that FOUR MILLION PRESCRIPTION ERRORS are happening EVERY YEAR…  ABOUT ELEVEN THOUSAND A DAY – 7 days a week

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Last Sunday Barb and I decided to go out to Brunch at O’Charlie’s… by Monday neither one of us was feeling all that well…

but about 6PM Monday evening we both started taking turns over the next 18-24 hrs..  There could not have been more than 10 minutes between each of us starting…. Normally we don’t eat the same foods but this day – for some odd reason we both ordered a scrambled egg mess of potatoes, green peppers and a couple of meats.  Apparently, while not being able to taste/smell anything wrong with the meal… THERE APPARENTLY WAS  !!!

It is probably going to take me most of the weekend to go thru all the backlog of emails – some 600 already … FB messages and other things that have “piled up ” …

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So it would appear that Walmart has created a corporate edict for their pharmacists to not only cut the days supplies of opiate Rxs for acute pain but to also reduce the dose to 50 MME/day.

Here is just one of the MME conversion programs out there https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/  and a footnote off of this one particular program which all have – or should have a similar WARNING to not use these conversion numbers as ABSOLUTE

Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring. 

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user’s use of or reliance upon this material.  

wasn’t it Nero playing his fiddle while Rome burned ” ?

Will the Medical/Pharmacy boards doing anything while pts suffer ?

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Clampdown on opioids is hurting pain patients

https://starledger-nj.newsmemory.com/?publink=09353ea64

In the summer of 1994, I was working at my desk at the Department of Justice when my back started to burn. Moments later, my body seized up and I fell to the floor. Suddenly, at the age of 30, I was no longer able to sit or stand. I could barely walk short distances. These limitations, related to a surgical mishap, would continue for almost 20 years.

After dozens of failed treatments, I reluctantly tried prescription opioids. The pain medication enabled me to work despite my condition. I argued cases in federal court from a foldable reclining chair, negotiated settlements by video teleconference and, working remotely, managed litigation in U.S. attorney’s offices across the country.

When medical advancements led to an improvement of my health, I went off opioids without incident.

I was, as it turns out, incredibly lucky. A report released last month by Human Rights Watch paints a cautionary and at times harrowing picture of what pain patients are experiencing today.

Because of well-intended efforts to address the overdose crisis, many doctors are severely limiting opioid prescriptions. Patients who rely on opioid analgesics are being forcibly weaned off the medication or seeing their prescriptions significantly reduced. Other patients are unable to find doctors willing to treat them at all.

One such patient, Maria Higginbotham, has had more than a dozen surgeries to correct the collapse of her spine. She suffers from a painful condition in which the spinal cord fuses with adjacent membranes. Last year, her physician cut her pain medication by 75 percent, explaining that the reduction was to comply with federal guidelines.

In the past, Higginbotham could function. Now she needs assistance just to get out of bed and go to the bathroom.

The federal guidelines Higginbotham’s doctor cited were issued in 2016 by the U.S. Centers for Disease Control and Prevention. They were intended as nonmandatory recommendations for primary care physicians.

Increasingly, the guidelines are treated not as recommendations but as one-size-fits-all mandates. They are being misapplied by physicians, state legislatures, insurers and Medicaid programs.

Some physicians told Human Rights Watch researchers that they had taken patients off opioids, or reduced patients’ prescriptions, against their better clinical judgment.

“You set yourself up for a liability, even when you know they’re not addicted and they’re benefiting from opioids,” one physician said.

Other doctors said they had stopped treating pain patients altogether — even patients who don’t use prescription opioids.

It’s true that opioids were prescribed liberally in recent decades. Doctors began doing this in the 1990s. There were some bad actors, such as “pill mills” and wayward pharmacies. Opioid medication too often fell into the wrong hands.

Moreover, opioids are not the magic bullet we once believed them to be. The evidence about their efficacy across a broad population is limited. Even when their use is appropriate, opioids carry risks, and the risks increase at higher doses. The CDC was right to encourage judicious, responsible prescribing. But chronic pain is a large umbrella category, encompassing a wide range of injuries and diseases, some of which are incurable. A one-size-fits-all approach to treatment does not work.

The recent clampdown has had harmful consequences. Some patients told researchers that they were forced to quit working or go on disability when their medication was denied. Others are now homebound. Many mentioned the possibility of suicide.

Patients also said that they were turning to alcohol or illegal substances to treat their pain.

What began as an effort to protect patients may be morphing into one that is harming them. The CDC’s National Center for Health Statistics estimates that 50 million Americans have pain every day and nearly 20 million have pain that limits major life activities. If the experiences that patients described to Human Rights Watch are common, the harm to patients could be widespread.

The CDC’s own data show that fatal overdoses are driven largely by illegally produced fentanyl, its analogs and heroin, not by medically prescribed opioids.

For all these reasons, the CDC should address the misapplication of its guidelines, as the American Medical Association recently did. The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in “forced tapering.”

The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do.

Tackling the overdose crisis is a vital public policy goal. But chronic pain patients should not become casualties in that fight. Kate M. Nicholson is a civil rights and health policy attorney. She served for 20 years in the Justice Department’s civil rights division, where she drafted current regulations under the Americans with Disabilities Act. She gave a TEDx talk about chronic pain, “What We Lose When We Undertreat Pain.”

What began as an effort to protect patients may be morphing into one that is harming them.

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