1-ribbonFirst they came for the mentally ill addicts, and I did not speak out—
Because I was not a mentally ill addict.

Then they came for the empathetic prescribers, and I did not speak out—
Because I was not an empathetic prescriber.

Then they came for the Pharmacists, and I did not speak out—
Because I was not a Pharmacist.

Then they came for me—and there was no one left to speak for me

An ‘insurance warrior’ fights to get pricey therapies covered

An ‘insurance warrior’ fights to get pricey therapies covered

https://www.statnews.com/2016/04/25/insurance-warrior/

Her name is passed from one desperate family to another like an amulet.

In phone conversations and online chat rooms, she’s mentioned at moments when the devout might call on a patron saint. A baby born with a deformed skull? “Call Laurie.” An impossibly expensive cancer treatment? “Call Laurie.”

Laurie Todd isn’t a doctor, or a lawyer, or a hospital chaplain. She’s a 66-year-old former massage therapist. Most of the time, she sounds cheerful and efficient. But if someone tries to pull the wool over her eyes, her voice gets low and a little bit threatening. “Do you know what I do for a living?” she asks. “I’m known as the Insurance Warrior.”

The military metaphor is apt. When a health insurance company refuses to pay for a medical procedure, Todd goes to battle on behalf of the patient from her apartment outside Seattle.

She researches the scientific evidence behind the treatment. She parses the fine print of insurance policies. She scours the internet for the home phone numbers of the company’s top executives, and she coaches her clients on when to call and what to say. Her strategy seems to be working: By her own count, she has won 165 of the 169 cases she’s fought.

“I’m sitting here in my pajamas making decision-makers who get $20 million a year do the right thing,” she said.

There are all sorts of reasons insurers might deny coverage: They might call a treatment experimental, or say it’s not medically necessary, or insist that a local doctor in their network do the work, rather than a distant expert.

Many health economists argue that insurers are right to deny coverage of some procedures in order to reduce America’s astronomical health care costs. But even they agree with Todd about one thing: the system is so hard to navigate that the typical patient feels powerless when facing denials.

“Health insurance is completely byzantine,” said George Loewenstein, an economist at Carnegie Mellon University. “Even insurance executives themselves … have trouble making sense of the monster they’ve created.”

That’s where Todd comes in.

“I would be a widow if not for her,” said Diana Lentz.

“I am a story person. This work puts me at the epicenter of the world’s best stories”

Laurie Todd, the Insurance Warrior

 

When Lentz’s husband, Matthew, was diagnosed with cancer, their insurance company would only pay for his surgery if he went to a local surgeon who had little experience with the procedure he needed. The Lentzes wrote an appeal themselves, demanding that Matthew be treated by a true expert. It was rejected. They enlisted Todd’s help with a second version. It, too, was rejected.

Only when Todd and the Lentzes gave speeches to a board room full of insurance executives and lawyers was the coverage approved.

Todd can speak legalese and knows her way around statistics, but she attributes her success to her master’s in 18th-century French literature. Her appeals can run 55 pages, and they interweave technical arguments with vivid details that make the patient’s story come alive.

“I wouldn’t win them if I took a legal approach. I win them because I take a literary approach,” she said. “I am a story person.  This work puts me at the epicenter of the world’s best stories.”

Reversing a death sentence

Todd wrote poems as a child. She studied French, and because she was good at languages, her guidance counselor told her to become a teacher. She did. She didn’t like it much.

So she moved from state to state, taking jobs here and there, as a file clerk for a computer manufacturer, as a secretary for companies that sold everything from cookies to phones, insurance to medical devices. In California, she tried her hand at real estate, but it wasn’t her cup of tea.

Todd was working as a massage therapist in Seattle when she fell ill in October 2004. First, she noticed the exhaustion: She started feeling dog tired even before she put her hands on a patient’s back.

Then she realized her belly was getting bigger.

“I would be a widow if not for her.”

Diana Lentz, wife of cancer patient

 

She went to a doctor who said she was fine. But her symptoms kept getting worse, and in March 2005, she was diagnosed with late-stage ovarian cancer and rushed into surgery.

That diagnosis wasn’t right either. It turned out she had appendix cancer, and it had spread into her abdominal cavity, creating tumors so voluminous that there was still plenty left inside her after 15 pounds were scooped out during the emergency operation.

Her oncologist told her there was no treatment. She decided to do her own research.

“The first place I went was PubMed, where all the scientific articles reside,” she said. “What I learned was that there’s lots and lots of science about appendix cancer. And I learned that there was a certain surgeon in Washington, D.C., who stood head and shoulders above the rest.”

But her insurance company would not pay for him to operate because he was out-of-network. From an insurer’s perspective, contracting with certain hospitals allows them to keep the price for each service reasonable.

From Todd’s perspective, though, the insurance company’s decision seemed like a death sentence. She knew this surgery was as intricate as defusing a bomb, and she’d seen research showing that a surgeon only got the best outcomes after performing the surgery at least 150 times.

She’d gone to see the in-network surgeon her insurance company recommended, and she wasn’t impressed: “I said, ‘How many of these surgeries have you done?’ and he goes, ‘Six.’ And I said, ‘How are your patients doing?’ He said, ‘Don’t know, don’t follow ‘em.’ And I said, ‘Thank you very much, I’m out of here.’”

Todd went ahead and booked her surgery in D.C. But she was in a bind. She was self-employed, and she was too sick to work. She had almost no money.

Even without complications, her surgery could cost hundreds of thousands of dollars.

“I wasn’t going to die because my insurance company refused to pay,” she said. And so she set about writing an appeal.

“Where do you start with a strategy game? You study your opponent,” she said.

She read the insurance company’s entire website. She created a flow chart of the organization, listing its CEO, and its vice presidents, and its board members. She went to the public library, sat on the floor, and read everything they had on insurance law. She reviewed every article she could find on appendix cancer. Then she began to write.

“Treatments are denied with words,” she said. “And denials are overturned with words.”

She estimates that her entire hospital stay cost $347,000 — and her insurance company paid for everything but $9.

A warrior in purple flannel PJs

The surgery was like getting hit by a bus, Todd said. She was in the hospital for 43 days. When she came back to Seattle, she couldn’t climb the stairs to her apartment.

“It’s like a tsunami had swept everything away: who I was before, my work, my stamina. I had no idea what was going to happen next,” she said.

What happened next was a phone call, out of the blue, from a man named Bob. He had appendix cancer, and he needed the same surgery she’d just had. His insurance company was refusing to pay for it, not because it was out-of-network, but because they said the procedure was experimental. He’d heard from an appendix cancer support group that Laurie had just won an appeal. Could she help him?

She had nothing else to do. Using her appeal as a template, she wrote a document for Bob. “He called me three days later, and he said, ‘Laurie, they are going to pay.’ And my joy was immense.”

Bob’s was the first of 20 appeals she wrote that year, mostly sitting at home in her purple flannel pajamas. At first, her clients were all appendix cancer patients, referred to Todd by other families.

As she started ringing up wins, her confidence grew. In 2007, she wrote a how-to book and traveled the nation to speak at Rotary Clubs and cancer conferences. Soon she was getting calls from other kinds of patients. She only took on the ones, she said, that had “a mountain of science” behind them.

“He said, ‘Laurie, they are going to pay.’ And my joy was immense.”

Laurie Todd

 

By then, she was charging for her services and earning a living writing appeals. Todd won’t talk about her fees, but former clients usually paid between $1,000 and $2,000.

“Best $2,000 I ever spent,” said Lisa Frank of Anaheim, Calif.

Her daughter had a severe form of Tourette’s that resisted treatment. The tics came on with such violence that when she was 13, she fractured her own hip. But the tics just kept coming, the constant spasms preventing the bone from knitting back together. The pain, Frank said, made her daughter suicidal.

The insurance company wouldn’t pay for the experimental deep-brain stimulation that some doctors recommended.

“Initially, Laurie came off kind of clinical. She’s not overly friendly,” said Frank. But Todd won her over with a single question: What do you think “experimental” means? Frank gave her a definition. “No,” Todd said, “that’s not what experimental means. It means whatever your insurance company wants it to mean.”

Frank became an acolyte on the spot. She followed all Todd’s instructions — even when Todd told her they would wait until a week before her daughter’s surgery date to start working on the appeal.

That is part of Todd’s strategy. If you file an appeal months in advance, it becomes just another pile of paper caught in bureaucratic purgatory. It’s shuffled from one desk to another. The stakes are low.

Wait until you’re down to the wire, though, and your story has drama.

Finding the 14 top targets

The first thing Todd does is to find 14 executives — the number is at once impressive, and also fits well on the cover page — that she can target with the appeal.

Some will be from the insurance company. Some will be from the patient’s employer, because most Americans have self-funded plans, which means that the employer is the one paying for the medical treatment. Then she includes a few “outside eyes”: usually members of the insurance company’s board of directors. She picks them carefully: “I’m not going to choose heads of financial institutions, money men. I like presidents of universities, because they might be a little more impartial.”

These will be the people who will receive the appeal. And the phone calls. And the follow-up phone calls.

When she sits down to write, Todd first lays out the facts of the illness, sparing little. She wrote, for instance, about the debilitating tics that wracked Frank’s daughter, from biting her mouth to losing control of her bowels.  She wrote of the social isolation caused by Tourette’s. And of the 28 prescription drugs that had been tried, many of which had powerful side effects but provided little help.

Todd then picks apart the insurer’s reason for denying coverage. In the Frank case, she mocked it for using  “the coy new insurance company phrase ‘Medical studies we have seen.’”

After scouring the research herself, she wrote, she believed the company “would be hard-pressed to produce these mysterious medical studies that show that deep brain stimulation is used to treat Tourette’s, but is not suitable for Samantha’s ‘circumstances.’”

Todd also digs through patient support chat rooms to find precedents: past cases in which the company has agreed to pay for this procedure.

She likes to send her appeals to the insurance company on Sunday afternoons. The next morning, she and her client start in on what she calls “the phone attack.”

“I’m behind the scenes directing the whole thing,” said Todd.

Frank couldn’t have asked for a better general. The insurance company capitulated, covering her daughter’s brain stimulation and the subsequent courses of antibiotics and follow-up surgeries. The treatment was a success.

“I never thought my daughter would ever be able to finish school, to learn to drive, let alone to have a date,” said Frank. “Now she has a part-time job, she’s a senior, she has a boyfriend, she’s a wonderful guitar player.”

“You have the right to independent medical review, but how good are you going to be at taking advantage of it if you’ve got cancer?”

Dustin Berger, attorney

 

Families like Frank’s could go to an attorney for help crafting their appeal. But “it’s not a lucrative thing for attorneys to do,” said David Trueman, a New York lawyer who taught medical law at Columbia. “It doesn’t fall within the traditional confines of health law. There aren’t a whole lot of us out there who do this.”

Patients can also demand an external review of their case. They have a fair shot at winning: In states that tabulate such statistics, a third to a half of insurance companies’ denials get overturned by external, independent review boards. But it’s hard to navigate that system alone.

“You have the right to independent medical review, but how good are you going to be at taking advantage of it if you’ve got cancer?” said Dustin Berger, an attorney in Wyoming who has written about health insurance appeals.

Every health system rations care one way or another. And some might say that a warrior like Todd is sucking the system dry. To her, that analysis is backwards: She believes she gets patients the treatments that have the best chance of working, instead of wasting their time — and the insurers’ money — on endless rounds of less effective interventions.

“People say, ‘The insurance companies might come and torch your car,’” said Todd, laughing. “But I’m the insurance company’s best friend. I’m saving them hundreds of thousands of dollars by finding the patient the best treatment for them.”

Many of Todd’s clients — she calls them “helpees” — have become friends, and they send a steady stream of other patients her way. Now, they are encouraging her to train a successor.

“She’s an older lady,” said Frank. “She’s in her 60s, working alone, and she’s not going to be around forever.”

 

“POSTER CHILD” for PROFITS OVER PT SAFETY ?


Cadden boasted of control over federal regulators

http://www.tennessean.com/story/news/2017/01/20/cadden-boasted-control-over-federal-regulators/96806082/

Many “pain docs” that deal with implanted pumps uses these compounding pharmacies for the medications that they put in those pumps… because there is only one FDA approved opiate approved for use in those implanted pumps INFUMORPH (Morphine).. but because they can add a Lidocaine type product – which provides little/no pain relief to the pt – they can legally justify having the medication for their pumps compounded… Not to mention that they can purchase those compounded medications for 10% -25% of the cost of the commercially available product.  Also, Medtronics – the company that makes most of the implanted pumps – has tested the stability of the commercial product at SIX MONTHS – and typically the compounding pharmacy will only stand behind their stability for 30-60 days… allowing the pain doc to be able to charge for refilling pumps for frequently than would otherwise be necessary using the commercially available  product.  Medications that are infused into the spinal fluid has not only have to be STERILE …but.. must be PRESERVATIVE FREE… thus the potential issues of stability.  And how do I know all of this.. because my wife has had an implanted pain pump for TEN YEARS and I walked her out of the first pain clinic because they REFUSED to even discuss using INFUMORPH in the pump they were planning on implanting in her…  Even though they knew I was a Pharmacist… I was told that it was a “liability issue” and a “BIG BOY ISSUE” and that I didn’t understand… that they used a compounding pharmacy some 700-800 miles away and that there was no discussion to options about what they used in the pump.  After the New England Compound Center horror story… the FDA inspected 28 such compounding pharmacies and all but ONE got a NON-COMPLIANCE LETTER .. including the one that this pain clinic used.  So much for me NOT UNDERSTANDING 🙂

Barry Cadden

BOSTON – The head of a now-defunct Framingham, Mass. drug compounding firm boasted to his sales staff that state and federal regulators didn’t know what they were doing and he had to educate them so they’d stop bothering him.

That was one of the messages Barry J. Cadden delivered to the sales staff for the New England Compounding Center in a series of taped training sessions in 2011 and 2012.

The tapes were played this week in U.S. District Court during Cadden’s trial on charges of racketeering and second-degree murder. The trial, which is expected to last several months, will end its second week of testimony Friday.

Cadden was the president and part owner of the drug compounding firm that has been blamed for a deadly 2012 fungal meningitis outbreak which sickened 778 patients, killing 76 of them.

The jurors who will decide Cadden’s fate also heard from a former pharmacy technician at NECC who described the atmosphere in the company clean or sterile rooms as “a locker room on steroids.”

Joseph Connelly testified that, despite claims that it tested all of its products before shipping them out, NECC did not do so for most of the time he worked there.

And even when an end-testing policy was finally initiated in 2012, Connelly said he was told the very next day to ship out an order without testing.

The Cadden training tape excerpts, which were introduced over the objections of his lawyers, show Cadden giving instructions to sales staffers of an affiliated firm, Medical Sales Management. Dressed in blue scrubs, Cadden’s sessions included a tutorial on the attempts by state and federal regulators to place scrutiny on his operations.

Stating that the Massachusetts Board of Pharmacy had issued NECC its first license, Cadden told the staffers, who were employed by Medical Sales Management, an affiliated firm, they are the ones who “hold my life in their hands.”

“They don’t want to deal with us,” Cadden said, adding “They don’t know what they are looking at. They were coming down here all the time. I had to educate them. Then they got to understand.”

He boasted that when complaints came in from other states, the Massachusetts Pharmacy Board just says, “Go away.”

He also boasted of turning back efforts by the U.S. Food and Drug Administration to inspect and regulate NECC.

“The FDA was trying to take over drug compounding,” he said, adding that they were calling compounders “the wolf in sheep’s clothing.”

The lack of either state or federal oversight of NECC prompted investigations both in Massachusetts and Washington, D.C. Ultimately, tighter regulation was imposed in the wake of the deadly outbreak.

Cadden told the staffers that NECC went way beyond regulatory requirements in the compounding of drugs.

“A lot of what we do is way above the standard,” Cadden said. He added, “As far as quality goes, we do it. We’re not selling jelly beans. We need to bat one thousand.”

He instructed the sales staffers to “drop those names” of NECC’s big customers when soliciting new business and to stress to potential hospital customers that buying from NECC would eliminate the risk of something going wrong in in-house operations.”

In his testimony, Connolly, the pharmacy technician, said it was difficult to raise safety concerns because any efforts would be rebuffed by his boss Glenn Chin.

Chin, like Cadden, is facing racketeering and second-degree murder charges. His trial will be held when Cadden’s is completed.

Connolly said when he raised concerns, they went nowhere.

With photos displayed by prosecutors, Connolly described rusted equipment, floor defects covered with plastic and tape, and a wide opening to non-sterile areas, all in the rooms that were supposed to be perfectly sterile.

He said that when spiders, flies and other insects appeared, he and other workers would spray them with alcohol.

Connolly said the air conditioning in the clean room area frequently failed, sending temperatures soaring especially in summer months. This, despite the fact that the some of the chemicals they were using were temperature-sensitive. He said one co-worker had to leave the area because he was getting faint.

He said that when the company’s regulatory problems heated up in 2012, they were ordered to stop making drugs and clean up the area because inspectors were coming.

On another occasion, he said a worker from a sister company, Ameridose, came into the clean room area with some drugs from that firm.

“You don’t see this,” Connolly said the Ameridose worker told him.

Connolly said there was a big increase in product being produced at NECC in the Spring of 2012. He said he warned that “something’s going to happen,” and that the company would get shut down.

NECC shuttered its doors for good in October of 2012, just a month after the deadly outbreak became public.

People who abuse substances… will always find something to abuse

Opioid alternative linked to spike in WV overdose deaths

Aug 6, 2016… I posted this: Gabapentin the next medication to become a “controlled substance” ?

I nothing else… bureaucrats/politicians are fairly predictable

A drug being touted as a safer alternative for treating pain than more powerful prescription opioids is contributing to an increasing number of overdose deaths in West Virginia.

The number of fatal overdoses related to the nerve-pain drug gabapentin — sold by Pfizer under the brand name Neurontin — jumped from three in 2010 to 109 in 2015.

The increase has prompted a West Virginia Board of Pharmacy committee to recommend making gabapentin a controlled substance in the state. That would allow the pharmacy board to track prescriptions for gabapentin.

“It’s showing up in cocktails of drugs that are showing up in overdose deaths,” said Mike Goff, a pharmacy board administrator who oversees the state’s drug-monitoring database.

Addicts mix the drug with opioids or muscle-relaxants and anti-anxiety medications. The combination creates a euphoric high and can cause an unintentional overdose.

“Sometimes, they have prescriptions for all of them,” Goff said.

Last year’s gabapentin-related overdose deaths are expected to eclipse the 2015 total. The fatalities are still being counted. Gabapentin overdoses have increased each year since 2010.

If state lawmakers pass a bill that makes gabapentin a controlled substance, pharmacies would have to report prescriptions for the drug, and the state could monitor the number of pills prescribed each year.

“Right now, we don’t know the volume of the drug,” Goff said.

Ohio started requiring pharmacies to report sales of gabapentin on Dec. 1.

The U.S. Food and Drug Administration has approved gabapentin to treat seizures and pain caused by shingles. Some veterinarians also use it to treat epilepsy and seizures in dogs and cats.

But a recent study — first reported by Pain News Network — found one out of five people taking the drug are using it illegally. More than half took it with an opioid and about a quarter with an opioid and a muscle-relaxant or anxiety medication such as Xanax, according to researchers at ARIA Diagnostics.

 

A separate report by IMS Health found prescriptions for gabapentin increased 42 percent over the past five years nationwide. The U.S. Centers for Disease Control and Prevention has promoted the drug as a safer alternative to prescription opioids.

The West Virginia pharmacy board spotlighted the increase in gabapentin-related overdose deaths in the agency’s annual report released last week.

Other trends cited in the report:

The number of controlled substances dispensed in West Virginia decreased by 12.7 million last year — and by 30 million over five years. The number of hydrocodone pills dispensed statewide dropped by nearly 4 million last year, while oxycodone doses decreased by 4.5 million.

The opioid painkiller tramadol has increased from less than 1 million pills in 2011 to 35.7 million last year. Tramadol has fewer federal restrictions than hydrocodone and oxycodone.

“It’s way less potential for abuse, way less diversion,” Goff said.

West Virginians seeing multiple doctors and frequenting multiple pharmacies over a short period of time — a practice called “doctor shopping” — decreased 75 percent during the past two years.

The pharmacy board sends letters to pharmacists and physicians about suspected doctor-shoppers.

“It’s not an accusatory letter,” Goff said. “It’s an informational letter.”

The number of health professionals who use the state’s controlled substance database has doubled during the past two years. Doctors tap the database to check patients’ past prescriptions.

In West Virginia, 731 people — a record number — fatally overdosed on drugs in 2015. The state Medical Examiner’s Office has counted 717 drug overdose deaths so far in 2016, but the number is expected to increase — and likely surpass the 2015 total — after the office finishes tallying last year’s overdose deaths. The official count should be completed by March.

Fentanyl and heroin are the leading causes of overdose deaths. Hydrocodone- and oxycodone-related overdoses were highest between 2007 and 2014.

Addicts… how many is just dependence left untreated ?

I am sure that there is some truth to the statement that “their addiction started with a prescription for some opiate pain medication “

Recently there was a article by F. Perry Wilson, MD  http://www.medpagetoday.com/PainManagement/PainManagement/62462  who claims that 1.3% of addicts started with a prescription.  When you consider that there are abt 230 million adults out of our population of 330 million and there are an estimated 2.1 million serious opiate addicts… or about 1% of our adult population.

After 1-2 yrs, a addict finds it more difficult to “get high” because of their tolerance to “getting high” from a opiate… they continue using because of withdrawal issues what they refer to as “dope sick”.

Just think how many people get pain medication for an acute issue and after several weeks or so … they are told to stop the medication because the source of their pain is – or should be – resolved… Whoever prescribe the medication does not concern themselves with the potential withdrawal the pt is going to experience and does nothing to help them wean themselves off the dependency of the opiate.

All the person knows is that they feel like hell and can’t function and their prescriber just “cuts them off” and left them to deal with the withdrawal issues.

The once pt is now left in withdrawal and without any support…  all they know is that taking some opiate – any opiate – they resolved the withdrawal symptoms.  We have all to often heard of the path they end up on … stealing opiates from medicine cabinets from family and friends, buying on the street and when they run short on cash… first they start selling their positions and buying the least expensive opiate – normally Heroin on the streets.. and the downward spiral into a “addicts hell” begins.

These people don’t suffer from the mental health issue of an addictive personality.  Perhaps these are the same people that we see the addiction rehab facilities promoting as their “success stories”, and their success stories may be just the failures of our medical system… of making sure that those who are prescribed opiates for acute pain… are allowed to properly treat the known withdrawals that some may not be able to deal with on their own.

We know that we have an estimated 45 million alcoholics, 35 million nicotine addicts, 150,000 addicted to gambling and untold numbers that are addicted to some activity or thing that we don’t track.

It would seem that most homo sapiens have some degree of an “addiction gene” in them… in some individuals they are not able to suppress its influence on their behavior and they are totally out of control, others need a little extra support to know how to manage their “addiction issues”.

It has been proven time and again… abstinence does not work to control or prevent addiction. Apparently we keep electing politicians that after 240 yrs have still not got that figured out ?

The right to LIFE, LIBERTY, PURSUIT OF HAPPINESS… unless the DEA objects ?

From my INBOX:

Heroin use does not “usually begin with the use of legally prescribed opioid pain killers” and studies bear this out. The rate of addiction (3-6% of the population) and misuse of prescription medications by Chronic Pain Patients (CCPs = 30-34% of the population) is no greater than all forms of addictions in the general population. Drug seeking behavior / addiction is a mental illness and very few addicts obtain their abused substances through legal means. They obtain the prescription meds from illicit sources and while an argument can be made that greater legitimate prescribing / dispensing can result in greater diversion and hence abuse the link of addiction to legitimate prescribing/ supply use can not be made.  Continued focus on the addiction side of the story rather than the CPP population leads to denied access to those in need.

 Here is a link to an NIH study with sub-links related to this subject:

 

https://www.ncbi.nlm.nih.gov/pubmed/18489635

  What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-rela… – PubMed – NCBI

www.ncbi.nlm.nih.gov

Pain Med. 2008 May-Jun;9(4):444-59. doi: 10.1111/j.1526-4637.2007.00370.x. Meta-Analysis; Review

The irony in the Florida DOH letter titled ” Emerging Health Threat” indicates that the DOH views restricted supply and access to needed medications, in this case Hydromorphone, as a “threat’ to public safety yet they turn a blind eye and ignore aggressive and overzealous big pharmacy corporate policy making decisions that deny access to needed medications to patients with legitimate medical needs. CVS, Walgreens, and Walmarts blacklist certain prescribers as “inappropriate” and their computer systems prevent the filling of any prescriptions from these prescribers even if the patient has legitimate medical need for the medications. The prescribers are usually first blacklisted simply by the number of controlled prescriptions written as a percentage of the whole. The DEA scrutinizes any doctor who writes a high number of controlled prescriptions even if that doctor is specialized in pain management and in due course would in fact write a high number of controlled prescriptions in the specialty practice. The same applies to pharmacies that fill a high number of controlled prescriptions and once the percentage reaches 20-30% red lights go off at the DEA for scrutiny. This leads to irrational fear of DEA sanctions by the corporations and implementation of the policies that “threaten” public health and safety for the CPPs in need. It is bit of a”Catch 22″ scenario.

 

The implementation of corporate policies to protect company interests that limit access do so by usurping and interfering with the individual Pharmacist’s Professional Judgment. Even if this highly educated professional, trained to critically access and vet each individual controlled prescription for validity and medical necessity, deems the unique patient and the patient’s health status / diagnosis as legitimate the Pharmacist is coerced to refuse that valid prescription and refuse access to needed care. This coerced refusal is done by fear of retribution and loss of employment. The conflict of interest between corporate protectionism and the ethics of the profession of pharmacy in which Pharmacists are sworn by oath to “relieve pain and suffering” only does disservice to those patients in need.

 

The interference with a Pharmacist’s professional judgment is an act disallowed by any entity in Florida Pharmacy Laws and Rules. https://www.flrules.org/gateway/readFile.asp?sid=0&tid=16866377&type=1&file=64B16-27.831.doc. Several more points of  Florida Pharmacy law prohibit any interference as well. Interference with the professional judgment of a Pharmacist’s professional judgment is subject to disciplinary action and fines but the DOH and MQA take no action against the corporations even when the residents of Florida are inappropriately denied access to care. The mission of the DOH is to protect the people and the integrity of the various professions but it fails miserably. 

 

The coerced refusal to fill valid and legitimate prescriptions mandated by corporate policy has the consequence of violating Patient Rights’ as spelled out in State and Federal guidelines for Medicare, Medicaid and American Disabilities Act. The corporations force the Pharmacists to violate Patient Rights and violate these laws which has potential personal liability for the Pharmacists who can be sued individually for those violations by the patients. If that were to occur, and it has, I am certain the corporation would deny all responsibility. The Centers for Medicare/Medicaid Services (CMS) and Florida Medicaid are aware of these practices by the corporations yet while charged with protection of the people and their Rights also fail to take any action to do so.

 

The heroin epidemic regardless of why it is occurring and having reach the current level of attention has done great harm to the CPP population. These patients are treated like criminals in their attempts to gain access to needed medications. Sometimes good people with legitimate needs end up at the office of a “dirty” doctor as that’s their last resort.  In their situation they have often lost their jobs and insurances and lack adequate transportation to get to better and needed care. They spend an inordinate amount of time doing the “pharmacy crawl” trying to find a pharmacist / pharmacy that will help them. These patients lack the resources to reach the best care of certified pain management clinics, physical therapy, psychological care, surgical care and addiction treatment if needed. Obtaining some medication that affords them some quality of life is all they have.

 

The pharmacist in fear of retribution from employers and unwarranted scrutiny by the DEA refuse to maintain adequate inventory to help the patients. The corporations don’t count the controlled prescriptions in calculating pharmacists work so many pharmacist feel why bother if they don’t get credit for the work. The Chronic Pain Patient story is the story that should be told.

 

“Suspicious” painkiller orders, DEA suspends a FL drug distribution center’s sales

 

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“Suspicious” painkiller orders, DEA suspends a FL drug distribution center’s sales

http://www.fox4now.com/news/suspicious-painkiller-orders-fl-pharmaceutical-drug-distribution-sales-suspended

Pharmaceutical drug supplier McKesson Corporation has been fined and suspended from sales of certain controlled substances in several states, including Florida, after failing to flag a series of “suspicious orders,” according the Drug Enforcement Administration (DEA). 

Mckesson has been fined $150 million and must suspend sales of controlled substances from distribution centers in Florida, Colorado, Ohio, and Michigan.

The DEA says Mckesson fulfilled a series of “suspicious orders” for controlled substances such as oxycodone and Hydrocodone which are often abused. The opioid painkillers have also fueled the current heroin epidemic which in 2015 caused more deaths than gun-related homicides, according to the Centers for Disease Control and Prevention. 

Addiction Psychiatrist at Nextep Treatment Center in Fort Myers, Brandon Short, says the penalty Mckesson received is a sign of a greater problem. 

“This is a supply and demand issue,” said Short. 

He provides rehabilitation treatment and therapy to patients battling addiction, and says recently most of them have been seeking help for opiate addiction. 

“There is a direct correlation between the amount of availability in this country of oxycodone, [and other] opiates that is killing Americans, which is turning Americans into opiate addicts [and] into heroin addicts,” said Short.

The Florida Department of Health, sent an email to pharmacist across the state this week warning them of a pending drug shortage. The statement was later retracted because DOH officials said it was “found to be confusing,” and the suspension would “only impact one distribution center in Florida and impacts only the handling of hydromorphone.” 

According to DOH, the the distribution center affected by the suspension is located in Lakeland. However, Mckesson can still supply Florida pharmacies with hydromorphone by routing the orders through out-of-state distribution centers. Fort Myers Pharmacist T.J. Depaola says simply disrupting the supplier isn’t helpful because it places a burden on pharmacist treating patients with legitimate chronic pain issues. 

“It’s a terrible way of policing, essentially what they’re going to try do is, rather than go in and physically shut down what they call ‘pill mill physicians’ or ‘dirty doctors’ they cut the supply,” said Depaola. He also says it can have an opposite effect and turn more people to illicit drugs. 

“You have patients that were being treated for chronic pain; all of a sudden they couldn’t get meds, they went to heroin because that’s the closest thing to what they were on before,” said Depaola. 

It’s not clear how long Mckesson will be banned from processing sales from its Florida distribution center. 

According to the DEA, the settlement also impose new and enhanced compliance regulations on Mckesson’s distribution system. 

Trump Signs Order to ‘Ease the Burden of Obamacare’

Trump Signs Order to ‘Ease the Burden of Obamacare’

http://www.medscape.com/viewarticle/874779?

Soon after he was sworn in, President Donald Trump signed a series of executive orders, including one to “ease the burden” of the Affordable Care Act (ACA), according to news reports.

The executive order was not yet on the White House website as of press time. But in a version posted on Twitter, the order first notes the President’s intention to seek the “prompt repeal” of the ACA, and says that in the meantime, it was seeking to offer flexibility to states to create a more “free and open healthcare market.”

The order grants authority to the heads of all federal agencies, including the Secretary of Health and Human Services to “waive, defer, grant exemptions from or delay the implementation of any provision or requirement of the Act that would impose a financial burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.”

Essentially, this means that any tax imposed by the ACA would be overturned.

The executive order also directs federal agencies to grant states maximum flexibility in implementing “healthcare programs,” and to encourage the development of “a free and open market in interstate commerce for the offering of healthcare services and healthcare insurance with the goal of achieving and preserving maximum options for patients and consumers.”

During the campaign, President Trump said that he wanted to make it possible for insurers to sell policies across state lines.

FL Healthcare providers… BEWARE… your pts might not have access to their pain meds

Not sure if just Pharmacists or all licensed medical healthcare providers got this email in Florida… warning them that the actions of the DEA against Mc Kesson drug wholesaler may compromise their pt’s ability to obtain their necessary controlled medications.

This warning is a result of actions by the DEA 

McKesson said it would pay $150 million settles investigation on controlled substances

in which – as usually – the DEA took actions based on “HARD FACTS” that the DEA came to based on their opinions, beliefs, and suspicions.  Of course, the collateral damage to pts that have a valid medical necessity for taking controlled substances… is just not really the problem of the DEA…

ACLU to the rescue …discriminatory practice on women health issues

Walgreens again in hot water over refusal to fill prescription

https://www.abqjournal.com/931967/yt.html

ALBUQUERQUE, N.M. — The two women had never met, but it took only a few moments for them to connect over a singular act that still makes them shudder – first with shock, then with anger – just like it did when they each walked into a Walgreens pharmacy and felt as if they were hurled back into the Dark Ages.

“It’s just hard to believe this is still happening,” says Susanne Koestner, a married woman in her 30s who made headlines when she fought back after a pharmacist refused to refill her prescription for birth control pills in June 2012 because of his religious beliefs. “It freaks people out when I tell them the story.”

That story led to a January 2013 agreement from the nationwide drugstore chain to affirm its policy of filling prescriptions, including birth control medications, “as efficiently as other prescriptions without imposing any burden on the customer.”

But four years later and in spite of that agreement, here we are again with another case alleging that a prescription was not filled because of a Walgreens pharmacist’s refusal to do so – a violation of the state Human Rights Act, the American Civil Liberties Union of New Mexico contends.

And so here we are with the two women in the offices of the ACLU, which supported Koestner and now plans to do the same for the latest Albuquerque woman to accuse a Walgreens pharmacist of denying her service.

As a reminder, it is 2017.

In a letter submitted Jan. 12 by the ACLU to Walgreens corporate honchos in Deerfield, Ill., the woman in the latest story is listed as Jane Doe. In this conference room, she is a longtime Albuquerque Public Schools teacher in her 40s and the mother of a teenage daughter. It is the latter role that leads her to ask not to be named so as not to identify her daughter.

She says that because of struggles with difficult menstrual cycles and birth control medications, her daughter, in consultation with her gynecologist, opted to try an intrauterine device. In preparation for the procedure in August 2016, Doe said, she went to a Walgreens at Coors and Montaño NW to fill her daughter’s three prescriptions – a mild pain reliever, an anti-anxiety medication and misoprostol, a synthetic hormone used to soften the cervix in preparation for the insertion of the IUD.

Misoprostol is also often prescribed to treat stomach ulcers. But it also can be used to induce an abortion.

That last usage is believed to be the conclusion the pharmacist erroneously jumped to – as if he should have jumped at all.

The teen’s mother was told the first two prescriptions would be filled but the misoprostol would have to be picked up at another Walgreens, even though the medication was in stock. When she asked the pharmacist why he could not fill the misoprostol prescription, she says, he told her that it was against his “personal beliefs.”

Like Koestner had been years ago, the teen’s mother says she, too, was confused at first. Stunned. Ashamed, though she didn’t know why.

But as she made her way through rush-hour traffic to another Walgreens about 3 miles away, anger and indignation set in.

Koestner knew those feelings too.

“It’s like someone else takes power over your life, your choices,” Koestner says. “It’s like you are being judged.”

Doe says she turned around and went back to the first Walgreens, confronted an assistant manager and then the pharmacist.

“I told him he was discriminating against me, that he should be ashamed for judging us, that he didn’t know my daughter’s medical history or her complications or conversation with her doctor. That he didn’t know what the medication was for,” she says. “And he just looks at me and says, ‘Oh, I have a pretty good idea.’ ”

Like Koestner, she started making calls to Walgreens officials. She contacted the Southwest Women’s Law Center, which in turn helped her contact the ACLU of New Mexico.

The ACLU letter to Walgreens points out that forcing customers to travel to another pharmacy after being denied service places a significant burden on the woman – especially if the woman relies on public transportation or has limited time or if that woman lives in a rural area where Walgreens pharmacies are few and far between.

As it did in the letter written on Koestner’s behalf, the ACLU also asked the company to immediately address the discriminatory practice and specify what steps the company planned to take to prevent a similar occurrence – and a lawsuit contending a violation of the state Human Rights Act, which protects from discrimination, including on the basis of gender.

“Religious liberty does not mean the right to discriminate against others,” attorney Erin Armstrong wrote. “Walgreens should take reasonable steps to accommodate employees’ religious beliefs and practices, but it cannot do so by imposing additional discriminatory burdens on women.”

Walgreens issued the following statement late Tuesday:

“We take very seriously our responsibility to serve the prescription needs of our patients. While we cannot comment on the specifics of this incident, we can tell you that our policy is intended to meet the needs of our patients while also respecting the sincerely held views of our pharmacists. We believe our policy has been very effective in doing that.”

After our meeting, the two women hugged, happy to have found some solace in knowing they were not alone, troubled by not knowing how many other women had been similarly denied and how many more might still be in the future.

UpFront is a daily front-page news and opinion column. Comment directly to Joline at 823-3603, jkrueger@abqjournal.com or follow her on Twitter @jolinegkg. Go to www.abqjournal.com/letters/new to submit a letter to the editor.

FDA says investigations underway into counterfeit medications

FDA says investigations underway into counterfeit medications

http://www.walb.com/story/34304503/fda-says-investigations-underway-into-counterfeit-medications

DEA now getting involved in ILLEGALLY IMPORTED medications that ARE NOT CONTROLLED SUBSTANCES… The question has to be asked is where did they get the statutory authority under the CONTROLLED SUBSTANCE ACT to do this…  the medications that they are referring to in this article are not controlled substances ?

ALBANY, GA (WALB) – Justice Department officials say they are concerned that more Americans are buying medication illegally from foreign pharmacies, and investigations into the growing problem are underway.  The Feds tell me that counterfeit medicines could be a prescription for disaster.

Justice Department officials say they are seeing an increase in Americans using the Internet to buy medications from foreign pharmacies, and they say they see an increase of counterfeit drugs being sent instead.
Drug Enforcement Administration Diversion Program Manager David Hargroder said “And we are starting to look at those.  And we are starting to do investigations against these types of imports of controlled substances.”

DEA agents say across the nation more Americans are buying prescription pills and medications from foreign sources, but warn that customers more and more are getting counterfeit medicine, not what they want.
Hargroder said “There is no FDA approval on them.  There is no over site on these types o of drugs. And a lot of them are synthetic made.”
Instead of being what the Doctor ordered, Pharmacists warn that buying  from unknown sources could really hurt your health.

U-Save-It Pharmacist Betsy Urick said “You are thinking you are taking a medication that’s going to lower your blood pressure, but in fact it’s just inert or inactive ingredients, you are not going to be getting any benefit from that.”

The reason more people are buying medications from foreign sources is lower prices.  Pharmacists say instead you should talk to them about cutting costs.
Urick said “We can work with anyone who has, say a high cost medication, to look into finding something that may be less expensive for them, but equally effective. “

The DEA warns besides the counterfeit concerns, it’s illegal to get prescription medications from foreign sources, and they are cracking down.
DEA officials say they have investigators in some of the countries where these counterfeit medications are coming from, trying to combat the problem from the source.
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