David Fincher: The Bleeding Edge (The Definitive Documentary) – The Directors Series

 

BCBS takes steps to respond to opioid abuse

This article is from Aug 2017, and according to this .. their timetable for and contributing factors to opiate epidemic. Once again Congress gets a pass on their passing of the Decade of Pain Law that became law in 1999-2000. That was a significant cause of the creation of “the fifth vital sign” and the joint commission adopted that as a major standard that hospital had to address pt’s pain and most had discharge surveys that included a question if their pain was well treated. When the law expired the political party in control of Congress had flipped and it was not renewed.  The “fifth vital sign” DISAPPEARED and no longer  any concern of the Joint Commission.  Opiate Rxs peaked in 2011-2012 and have dropped every year since and now about 60% down from their peak, but the number opioid poisoning – most all from illegal “street fentanyl” has increased SEVEN TIMES in the last 10 yrs. It seems, that most all bureaucrats still believes that the “jury is still out on the matter of prescribing opiates to treat pain doesn’t cause addicts ” Since “we” don’t track suicides from untreated pain and/or premature deaths from under/untreated pain very well… “we” really don’t seem to care how many people are dying while bureaucrats are trying to satisfy their opiophobia.

BCBS takes steps to respond to opioid abuse

https://mibiz.com/sections/health-care/bcbs-takes-steps-to-respond-to-opioid-abuse

 

 

 

Jody Gembarski, pharmacy manager at Blue Cross Blue Shield of Michigan

Jody Gembarski, pharmacy manager at Blue Cross Blue Shield of MichiganNearly one in five Blue Cross Blue Shield of Michigan members had a prescription for an opioid filled in 2015. The dispensing rate nationally was higher, at 21.4 percent. Between 2010 and 2016, the 36 Blue Cross Blue Shield plans across the U.S. recorded a 493-percent spike in enrollees diagnosed with a disorder associated with opioid use. Those statistics from the Chicago-based Blue Cross Blue Shield Association reflect the opioid epidemic in America that in 2016 resulted in more than 33,000 overdose deaths. MiBiz spoke with Jody Gembarski, a pharmacy manager at Blue Cross Blue Shield of Michigan who oversees its controlled substance work group, to discuss the association’s analysis and the role the state’s largest health insurer has in responding to the epidemic.

What do you make of the Blue Cross Blue Shield Association data on opioid use?

There clearly is a problem with opioids for our members and across the nation. Michigan definitely has a problem. You can see the statistics. We have a high dispensing rate of opioids and high opioid use disorder. It’s definitely a problem and we are very invested in attacking that and seeing what we can do to improve the situation for everyone involved.

What can Blue Cross Blue Shield of Michigan do?

We try to look at it on multiple different avenues. There’s no one solution that fixes this. We look at it from the providers, our physicians and health care providers that are involved with this. We have educational webinars (and) an opioid toolkit for them to use. We encourage them to check the Michigan Automated Prescribing System that will let them see if the member and their patient has gone to a physician a week before or a month before (for an opioid prescription).

What about from the member perspective?

We have a new pilot program that focuses on overdoses and trying to get those members connected to treatment or help. My controlled substance work group, what we do is we monitor claims and if somebody has a concerning behavior, we try to connect them with appropriate resources, whether behavioral health, case management, a pain management referral, or even treatment of a substance abuse disorder that they have.Do you have a way of identifying doctors who perhaps are outside of the norm and have a higher prescribing rate for opioids?

We have a corporate and financial investigations unit. They do look at prescribers who are outliers and compare them to their peers and they investigate those prescribers. There is a whole process to evaluate physicians prescribing opioids, and we have a process to remove them from our network. A lot of times we are ahead of the state and federal government because we have our own data. We actually receive reports from the Centers for Medicare and Medicaid Services — it’s a prescriber outlier report — and we take action on that as well.

Is Blue Cross getting more aggressive in identifying outliers prescribing opioids?

We’ve definitely increased our focus there as we’re seeing how much the opioid epidemic is impacting everything. We are looking much more closely at those that are outliers and identifying what’s going on (and) why. It’s definitely a high priority for us.

Why should this be an issue for employers?

The impact of the opioid epidemic is significant. It’s raising health care costs overall with the prescribing of opioids, and then once somebody is addicted, it is very costly for the health care system. The cost for the health care system is definitely going to impact employers and everyone else involved.

What should an employer do?

Ask what type of programs are in place from the health care provider that they have. We have a list of initiatives and programs and things that we do to help identify fraud, waste and abuse. We have initiatives in providing treatment of our members. As an employer, it is worth investigating and asking the question of what’s being done from the health provider perspective? What are you doing to help improve the situation or decrease prescribing?

Is there any consensus out there on what led to the epidemic?

There are a number of factors and we all ask, ‘What’s the root cause?’ Some of the national meetings that I sit on, there is discussions about how in the ’90s there was this push about the ‘fifth vital sign’ and pain management. That was kind of the focus and people shouldn’t be in pain if they’re having pain. Maybe that fueled a little. Everyone you talk to might have a different idea about that, but that is something that is on the table. There was this focus on pain management. It wasn’t being assessed appropriately and it wasn’t given enough attention. That could be the reason that partly led to this, but that’s not the reason. I don’t think there’s one reason. There are multiple things that led to this and it’s kind of hard to point to something.

Sen. Tammy Baldwin (D-Wisc.): we don’t only try to prevent people from taking up a drug

Is Sen. Tammy Baldwin (D-Wisc.) suggesting that opiates should not be prescribed to treat pain and/or all opiate prescribing creates addicts ?

Senators Press HHS Chief on Alzheimer’s Drugs, Opioids at Budget Hearing

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/103674

WASHINGTON — Alzheimer’s disease treatments, the opioid epidemic, and funding for rural healthcare were all in the spotlight during a Senate hearingopens in a new tab or window on the Biden administration’s proposed budget for the Department of Health and Human Services (HHS) in fiscal year 2024.

“It is with great disappointment that [I understand] CMS [the Centers for Medicare & Medicaid Services] is blocking and acting as a roadblock for patient access to drugs that could be very helpful to these patients,” Sen. Susan Collins (R-Maine) told HHS Secretary Xavier Becerra, the lone witness at Wednesday’s hearing held by the Senate Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies. “I just do not understand CMS’s misguided and outright unprecedented decision to not cover a whole class of Alzheimer’s drugs. It is not CMS’s job to second-guess the drug approvals of the FDA. That’s not what CMS is supposed to do.”

Collins was referring to the agency’s decision in Januaryopens in a new tab or window not to cover the Alzheimer’s disease treatment lecanemab (Leqembi) for Medicare beneficiaries unless the beneficiary is enrolled in a clinical trial of the drug. The FDA approved lecanemabopens in a new tab or window under an accelerated approval pathway, as it had done with aducanumab (Aduhelm) in 2021opens in a new tab or window. Medicare also has the same coverage requirement for aducanumabopens in a new tab or window.

“It’s not enough to say you can get it if you’re in a clinical trial,” Collins continued. “That’s so little help to states like ours where there may not be a clinical trial going on, or it may be far away from most people in the state. I’m just asking you to tell CMS to let this drug be used, and let people get access to it when the patient and the clinician agree it’s the appropriate treatment.”

But Becerra pushed back. “There’s no doubt we want to get to the type of lifesaving treatment Americans can benefit from,” he said. “The difficulty here is that we have to remember that the process that the FDA uses is different from the process that legally CMS must use to make their determinations. And while it may not make a lot of sense to folks, there is a legal distinction. And CMS has to remain consistent in the way it treats any drugs.”

Subcommittee chair Sen. Tammy Baldwin (D-Wisc.) asked Becerra to discuss the administration’s plans for tackling the mental health and substance use disorder crises, which have worsened during the pandemic. “In my state of Wisconsin, there were over 1,427 opioid-related deaths in 2021, a 16% increase over 2020 and a 70% increase over the number of deaths in 2018,” she said. “I know my colleagues are seeing similar grim statistics in their states. Of particular interest, I will want to know what the administration is doing to curb the tragic increase in overdoses and poisonings due to fentanyl. This drug is wreaking havoc across the country, and we must partner to take an ‘all of government’ approach to prevent it from coming into our communities.”

“This budget invests some $11 billion, including some $10 billion in discretionary funding for programs that try to target opioids and overdose-related activities,” Becerra said. “It is a significant increase over previous years, and it complements the work that we’ve done to establish a new strategy when it comes to drug overdose and treatment, where we don’t only try to prevent people from taking up a drug, but also … we worry about harm reduction, to make sure that we’re preventing people from harming themselves before they finally can get the treatment they need.” HHS also is investing in post-treatment services so people become productive members of society after they finish treatment, he added.

Sen. Cindy Hyde-Smith (R-Miss.) asked what HHS was doing to help keep smaller, rural hospitals open. Although hospitals are paid a set amount for each patient’s illness using the diagnosis-related group (DRG) system, “patients are staying longer and they’re exceeding those DRG payments, and hospitals are losing money hand over fist,” she said. “They’re held longer in their smaller hospitals while waiting for bed placements in a larger hospital … But how do we overcome a financial challenge that was made worse by COVID and inflation? Have you or the agency considered establishing a temporary per diem payment to the hospitals to help address this?”

Becerra agreed this was a problem. “Everyone is trying to figure out: How do we get resources and commitments into these communities?” he said. “One of the things we’re trying is [with] graduate medical education slots … Maybe we could try to get some of these into communities that haven’t always had these teaching slots available, because the evidence shows that if you locate a student in the residency program, by the time they finish that residency program in that community, they often stay there and develop their practice there.”

Hyde-Smith seemed dissatisfied with that answer. “So are you saying that a temporary per diem is not being considered?”

“I have to get back to you — I’m not sure if that is one of the considerations,” said Becerra. “I would suspect that one of the issues with a temporary per diem would be the cost. Where would the money come from to do that?”

Sen. Jeanne Shaheen (D-N.H.) wanted to know how well the $35-per-month cap on insulin copayments for Medicare beneficiaries — passed as part of the Inflation Reduction Act — was working. “Do we have any data that shows what the impact of that has been?”

“We’re beginning to collect the data,” Becerra said. “And the anecdotal stories I’m hearing from actual insulin users is perhaps the best evidence.” He cited a North Carolina woman he had spoken to who was shocked when she was only charged $35 for her monthly supply of insulin after previously paying $117. “She went back to the insurer and said, ‘I think I owe some money.’ She had to be told, ‘No, that’s the cost now.'”

A conversation with Kristen Ogden, patient advocate for Dr. David Bockoff

A conversation with Kristen Ogden, patient advocate for Dr. David Bockoff

 

Watch Cops Seize Combat Vet’s Life Savings [RARE FOOTAGE]

Civil Asset Forfeiture: “Take-now, explain-never forfeiture”

The FBI took her life savings. Now she’s fighting to help others get theirs back

https://www.foxnews.com/us/fbi-took-life-savings-now-fighting-help-others-get-back

Linda Martin feels ‘misled’ and ‘angry’ after the FBI seized her life savings

Linda Martin thought she was being responsible by putting her nest egg in a safe deposit box where she wouldn’t be tempted to touch it. 

She never imagined the FBI would seize her life savings.

“They didn’t tell us why they took our money. They haven’t told us anything as far as what we did wrong,” Martin, 58, told Fox News. “We haven’t done anything wrong. We work and we saved our money because we were trying to save and buy a house.”

Two years later, Martin still doesn’t know why her money was taken or if she’ll ever get it back. 

THE FBI TOOK HER LIFE SAVINGS, BUT SHE HASN’T BEEN CHARGED. HEAR HER STORY BELOW:

“The FBI, they feel like they can get away with anything,” she said. “I just feel like it’s unfair.”

On March 22, 2021, the FBI seized Martin’s and 1,400 other customers’ safe deposit boxes from U.S. Private Vaults, a Beverly Hills–based company. The FBI took the $40,200 Linda was saving for a down payment on a home in addition to another $86 million in cash and tens of millions more in gold, silver, jewelry and other valuables from other safe deposit box renters. 

Martin found out about the raid while watching the local news with her husband. 

“I just couldn’t believe it,” Martin said. “I really didn’t believe it. I sat down to start watching the news with him, and the FBI was raiding our private vault place.”

Several months later, she received a notice stating that the FBI wanted to keep her money through a process known as civil forfeiture. Confused by the legal jargon, Martin chose to file a petition with the bureau, the first option listed on their notice, without realizing doing so conceded that her property could be forfeited and, consequently, allowing the FBI to determine if she could get her money back.

Martin told Fox News she hasn’t received a determination.

She also said that to her knowledge, no one who had their assets taken have been charged with or even suspect of any crime. Rather, the FBI had been investigating U.S. Private Vaults, which shut down following the raid and pleaded guilty to conspiracy to launder drug money. 

Linda Martin is filing a class-action lawsuit to recover her life-savings which were seized from her safe deposit box by the FBI in a 2021 raid. 

Linda Martin is filing a class-action lawsuit to recover her life-savings which were seized from her safe deposit box by the FBI in a 2021 raid. 

“Unfortunately, this is legal,” Institute for Justice attorney Bob Belden told Fox News. “Civil forfeiture is a process in the United States where law enforcement can take property from people who have never been charged with a crime.” 

Last week, Martin and Institute for Justice filed a putative nationwide class action lawsuit seeking to help anyone who has had property taken by a government agency in the last six years and received a deficient forfeiture notice. 

FORMER FBI AGENT CONVICTED OF ACCEPTING $150K IN BRIBES TO PROVIDE CONFIDENTIAL INFORMATION

According to the FBI notice Martin received, her life savings were taken under administrative forfeiture, an action under the Tariff Act of 1930 that allows federal agencies to seize property without judicial involvement.  

“It’s really a system where the agency is the not only the prosecutor, judge and jury,” Belden said, “but also, a governor or a president thinking about giving a pardon.” 

He said that in these types of forfeitures, law enforcement only needs probable cause that property is somehow connected to a crime in order to seize it. 

“Linda’s case is a very good example of how that standard in real life is somewhat meaningless,” he said. 

The FBI applied for a seizure warrant against U.S. Private Vaults in March 2021, but both the FBI and the United States Attorney’s Office said in the application that agents would merely “inventory” box renters’ property and that the warrant would “authorize the seizure of the nests of the boxes themselves, not their contents,” according to Institute for Justice’s review of the court documents. 

Using federal forfeiture records, the Institute for Justice calculated that from 2017 to 2021, Department of Justice agencies took in over $8 billion through forfeitures, with the FBI receiving $1.19 billion of that.

Using federal forfeiture records, the Institute for Justice calculated that from 2017 to 2021, Department of Justice agencies took in over $8 billion through forfeitures, with the FBI receiving $1.19 billion of that. (Irfan Khan / Los Angeles Times via Getty Images)

The FBI and the United States Attorney’s Office didn’t tell the judge that months prior, they had already planned to use civil forfeiture to seize all assets in customers’ boxes worth over $5,000, the FBI’s minimum monetary threshold for forfeitures, according to findings from Institute for Justice. 

“They had developed probable cause in their own mind before they knew anything about a single box owner,” Belden told Fox News. 

An FBI spokeswoman previously said that the bureau broadly seized safe deposit boxes at U.S. Private Vault “based on allegations of widespread criminal wrongdoing” and that the seizure fell within the bounds of their warrant. But Martin said she never received an explanation.

Additionally, government agencies stand to gain from these types of raids, according to Belden. After an agency submits seized property to the Department of Justice’s Assets Forfeiture Fund, the money is then returned to the agency to pay for “costs associated with accomplishing the legal forfeiture of the property,” according to the DOJ. 

Belden said that just means more money in the agency’s pocket. 

“It is a big incentive,” he told Fox News. “It’s a big incentive to forfeit property.”

Using federal forfeiture records, the Institute for Justice calculated that from 2017 to 2021, Department of Justice agencies took in over $8 billion through forfeitures, with the FBI receiving $1.19 billion of that.

In a previous class-action lawsuit the Institute for Justice filed, a judge ruled in favor of a group of safe deposit box holders and found that the notices of administrative forfeiture sent by the FBI did not provide enough information to the plaintiffs about why and how their property was seized. The judge ordered the FBI to return the property to those named in the lawsuit or send a more detailed notice about the administrative forfeitures. The FBI returned the property. 

DOJ SUED FOR REFUSING TO EXPLAIN WHY IT IGNORED PROTESTS AT SUPREME COURT JUSTICES’ HOMES

“We’ve taken to calling this, ‘Take-now, explain-never forfeiture,’” Belden said. 

The FBI seized an estimated $86 million in cash from hundreds of safe deposit boxes at U.S. Private Vaults in a March 2021 raid. 

The FBI seized an estimated $86 million in cash from hundreds of safe deposit boxes at U.S. Private Vaults in a March 2021 raid.  (Al Seib / Los Angeles Times via Getty Images)

“Linda has no idea what they think she did wrong,” Belden said. “It just illustrates what we think is happening to hundreds or thousands of people in other states throughout the country.”

Martin chose to file a class action lawsuit in hope of retrieving not only her property, but the property of anyone who has fallen victim to administrative forfeiture. 

“I felt misled. I felt angry,” Martin told Fox News. “I’m advocating for just not myself, but for everyone, because there’s a lot of people that don’t know what to do.”

“We’re just trying to get justice,” she added.

Neither the FBI nor the U.S. Attorney for the Central District of California returned Fox News’ request for comment. 

To watch the full interview with Martin and Belden, click here

UAB among first in Alabama to offer new treatment for chronic pain

This unit appears to be just a “re-invented” T.E.N.S. unit or SCS.  We stocked T.E.N.S. units when we had our pharmacy and Home Medical Equipment (HME) business… and a T.E.N.S. unit that uses topical electrodes and some sort of gel on the electrodes to transfer the electrical impulses thru the skin in an attempt to interrupt the nerves impulses to the brain and hopefully the brain will not get a “pain signal” from some area in the body.  The pts that we provided T.E.N.S. units to did not have all that good a long term experience.  We have also read many a horror story about pts and their experiences with implanted SCS. On top of all this, this device/treatment is recommended to be used for 60 days.

UAB among first in Alabama to offer new treatment for chronic pain

https://www.uab.edu/news/health/item/13475-uab-among-first-in-alabama-to-offer-new-treatment-for-chronic-pain#.ZBRkDiE1o7w.facebook

Stream UAB pain clinicThe temporary PNS device can be used to treat chronic nerve pain, as well as joint pain and back pain, for patients for whom oral medications are not effective, or who wish to minimize the use of medications or more invasive procedures.Pain can be debilitating with frustrations that reach well beyond the physical pain. According to the National Institutes of Health, pain affects more Americans than diabetes, heart disease and cancer combined.

For patients with chronic pain who wish to minimize the use of medications or more invasive procedures, physicians at the University of Alabama at Birmingham Pain Treatment Clinic at UAB Hospital-Highlands are offering a new alternative — peripheral nerve stimulation, or PNS, that serves as a minimally invasive treatment option for patients with chronic pain.

“We are proud to be among the first sites in Alabama to utilize this technology,” said Prentiss Lawson Jr., M.D., assistant professor at the UAB Marnix E. Heersink School of Medicine Department of Anesthesiology and Perioperative Medicine. “It offers patients the ability to treat their pain without over-reliance on medications that can have side effects and is an alternative treatment option when other conservative treatments have failed.”

The temporary PNS device can be used to treat chronic nerve pain, as well as joint pain and back pain. With the PNS treatment, physicians use imaging guidance to insert a very fine wire, or lead, not much larger than the size of a hair, into the skin close enough to stimulate a target nerve and interrupt the pain signal. The stimulating lead connects to an external battery power supply.

The small PNS device sends gentle pulses, which feel like a small vibration, through the lead to stimulate the nerve. Patients will work with a team to determine the best stimulation level for their condition and use a simple hand-held remote to control stimulation level and turn the device on and off. After 60 days, the lead is removed, and treatment is complete.

“I am excited to offer patients this new treatment option,” Lawson said. “Because it is a minimally invasive option, it can be introduced early in the treatment continuum, and often, earlier intervention leads to better outcomes.”

Studies suggest that some patients experience prolonged relief even after the removal of the temporary device. If results are not prolonged, some people may be candidates for placement of this device periodically.

“Our goal at the UAB Pain Treatment Clinic is to help our patients with chronic pain have the highest quality of life,” Lawson said. “This can help patients who have had repeat surgeries or patients who do not have the option of injections feel better without relying on medications.”

Physicians administering this treatment at UAB include Lawson; Peter Nagi, M.D.; Chris Paul, M.D.; Alethia Sellers, M.D.; and Roland Short, M.D. Patients interested in learning more can schedule an appointment today at the UAB Pain Treatment Clinic at uabmedicine.org.

 

FDA warns pharmacy benefit company for distributing unapproved foreign drugs

FDA warns pharmacy benefit company for distributing unapproved foreign drugs

https://www.raps.org/news-and-articles/news-articles/2023/3/fda-warns-pharmacy-benefit-company-for-distributin

The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced from foreign pharmacies that have not been approved by the agency.
 
The company, which contracts with public and private employers in the US, states on its invoices that recipients “may have noticed that the medication which has been shipped to you is different in name or presentation to that which you may have received in the past. IF YOU HAVE ORDERED A BRANDED DRUG the name may appear different to the one you are used to. The reason for this is that you have been supplied internationally branded product and for various reasons drug companies market their products under different names and packaging in different countries.”
 
FDA said that this practice violates the Federal Food, Drug, and Cosmetic Act, and is “particularly concerning, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer’s ‘insurance’ plan and may not question their legitimacy.”
 
“The substitution of FDA-approved prescription drugs with unapproved drugs poses significant health risks to U.S. consumers,” FDA added. “Substituting an unapproved drug for the FDA-approved drug prescribed by a patient’s healthcare practitioner can negatively affect patient outcomes because the healthcare practitioner may unknowingly make subsequent treatment decisions based on the patient’s response to the unapproved drug.”
 
The warning letter goes on to cite other dangers to patients, including drug interactions with other medications, and the presence of drugs with a narrow therapeutic index (NTI), products subject to a risk evaluation and mitigation strategy (REMS), controlled substances and drugs to treat serious conditions.
 
FDA explains that ElectRx acts as a broker between foreign pharmacies and employee-sponsored health insurance plans to supply patients with medications.
 
While ElectRx notifies the patient that the drug they have received may have a different name than what is in the prescription, they fail to tell them that the drug isn’t FDA-approved.
 
FDA notes that drugs approved by the agency have a level of assurance that they have been reviewed by its staff for safety, effectiveness and quality. The manufacturers of those drugs must follow certain manufacturing controls and their facilities are inspected by the regulatory agency.
 
“Unapproved foreign drugs circumvent these safeguards, which are designed to protect patients,” FDA warned. “Unapproved drugs do not have the same assurance of safety and efficacy as drugs subject to FDA oversight and may be subpotent, superpotent, or adulterated with unknown active ingredients.”
“Treatment with drugs that may be subpotent, superpotent, or adulterated can lead to drug resistance and/or therapeutic failures, and jeopardize the effectiveness of alternative drug therapies on patient outcomes,” the agency added.
 
FDA has asked ElectRx to respond to its warning letter within 15 working days with details on what steps it has taken or plans to take to address the regulatory violations raised by the agency and what it plans to do to prevent such violations in the future. If the company does not respond within that time frame, FDA warns that it may have to take legal actions such as a seizure, injunction or temporary restraining order.


FDA Response

Dear Valued Clients and Participants:

ElectRx and Health Solutions LLC (“ElectRx”) recently received a letter from the United States Food and Drug Administration (“FDA”) regarding the importation of medication to the United States. It is apparent by the content of this form letter that the FDA is unaware of the type of personal importation programs supported by ElectRx and the extensive care, custody, and control procedures that exist for you and your plan sponsors.

In addition to complying with the exemptions surrounding personal importation, ElectRx goes even further to ensure compliance with international standards for prescriptions obtained by you from Canadian based pharmacies. As you may know, the former Commissioner of the FDA (Dr. Scott Gottlieb) said “Canadians have safe drugs” and “if you are going into a brick-and-mortar pharmacy you are getting a safe and effective drug.” Each prescription filled as part of your plan is done by a Canadian “brick-and-mortar” pharmacy. Dr. Gottlieb’s statement came long after the FDA was required to create regulations to fully allow personal importation of Canadian filled prescriptions under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“Medicare Modernization Act”). The FDA’s failure to put in place the procedures under the Medicare Modernization Act and those required by both former President Trump’s 2019 and President Biden’s 2021 executive orders further establishing Canadian drug importation programs, has resulted in a lawsuit by the State of Florida against the FDA.

Your personal importation of medications directly from a Canadian pharmacy are within the permissive acts established under the proposed regulations and the intent of the numerous executive orders, postal regulations, and language of the Medicare Modernization Act. You are receiving, as Dr. Gottlieb professed, safe and effective drugs from Canadian pharmacies. We will continue to work with the FDA on this matter and, as always, please feel free to contact us if you have any further questions or concerns.

Thank you for your continued belief in the benefits of personal importation, and its effectiveness.

Sincerely,
Your Friends at ElectRx and Health Solutions LLC

Dr. Gottlieb’s Statement

Forbes Report: Ron DeSantis Touts Drug Importation Program from Canada

Video Player

 

US sues Rite Aid for allegedly missing ‘red flags’ in unlawful prescriptions

US sues Rite Aid for allegedly missing ‘red flags’ in unlawful prescriptions

 

Here is a quote from this article:  Associate attorney general Vanita Gupta said that the pharmacy chain’s prescribing practices had “opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores”.  Maybe this is why this attorney is working for the Feds, because apparently believes that Rite Aid PRESCRIBES PRESCRIPTIONS.  Neither Rite Aid nor Pharmacist have prescriptive authority. That is the statutory  function of  physicians and mid-levels practitioners.

The whistleblower lawsuit said that federal and state laws require pharmacies to review prescriptions to ensure they are being prescribed legally and for the right reasons. The complaint comes after three former employees of Rite Aid – Andrew White, Mark Rosenberg and Ann Wegelin – brought a lawsuit against the chain.

Under whistler blower lawsuits https://kkc.com/frequently-asked-questions/whistleblower-rewards-programs-payouts-guide/  Each program requires the government to pay a minimum reward to the whistleblower of between 10 and 15 percent. Under some laws, the reward can be as much as 30 percent of the money recovered.

I just wonder if the DOJ sought out these three pharmacists to file a law suit or they pursued a lawsuit in opens of $$$ they could get from such a lawsuit ?  Since all three of these Pharmacists FORMER EMPLOYERS…it would not be hard for the DOJ to search some databases to find Pharmacists that were employed by Rite Aid during 2014 -2019 time frame, but no longer employed by Rite Aid.

Here is another example of who ever wrote this article has no idea of the proper context of what they wrote Over-prescription of opioids is estimated to have been responsible for 500,000 deaths since 2000.  I have never heard the term “Over-prescription”

US sues Rite Aid for allegedly missing ‘red flags’ in unlawful prescriptions

https://www.theguardian.com/us-news/2023/mar/14/rite-aid-lawsuit-opioids-fentanyl-prescriptions

DoJ alleges pharmacy chain knowingly filled prescriptions that were ‘medically unnecessary’, including opioids

The US government has sued Rite Aid, one of the nation’s largest pharmacy chains, for allegedly missing “red flags” when it knowingly filled unlawful drug prescriptions – including opioids and fentanyl – and ignored internal controls on its practices.

In a complaint filed on Monday, the federal justice department asserted that Rite Aid “filled at least hundreds of thousands of unlawful prescriptions for controlled substances that were medically unnecessary, lacked a medically accepted indication, or were not issued in the usual course of professional practice” between 2014 and 2019.

Rite Aid pharmacists are accused of ignoring obvious signs of misuse, including filling prescriptions for “trinities” – a combination of opioids, benzodiazepine and muscle relaxants.

So-called drug trinities are considered particularly euphoric for substance abusers – but also especially dangerous. Opioids such as oxycodone slow breathing, benzodiazepines like Xanax slow the heart, and muscle relaxants compound both effects, leading to fatal overdoses.

There is really no substantial clinical trials that those three meds prescribed to pts in appropriate doses for particular medical health issues and the pt taking those meds as prescribed, puts these pts at any adverse medical health issues.  Of course, when you are dealing with people who have addictive mental health issues, they could be abusing Nicotine, Alcohol, Caffeine, sex, gambling, opioids, amphetamines, cocaine, etc..etc… can lead to the personal abuse of those particular items.  We have some 30-40 million people using/abusing the two drugs Nicotine & Alcohol and that contributes to abt 550,000/yr deaths.  Maybe because those two drugs have a very health “six tax” revenue stream going to various bureaucracies.  Does that suggest that those deaths are considered “socially acceptable” ?

The justice department’s complaint said that Rite Aid had “early fills” of fentanyl and oxycodone prescriptions before a prior prescription for the same drug had run out, which is “a clear sign of over-utilization”.

In a statement, the US attorney general, Merrick Garland, said: “The justice department is using every tool at our disposal to confront the opioid epidemic that is killing Americans and shattering communities across the country.”

Associate attorney general Vanita Gupta said that the pharmacy chain’s prescribing practices had “opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores”.

The justice department also accused Rite Aid of intentionally deleting some pharmacists’ internal notes about suspicious prescribers, such as “cash only pill mill???”, “writing excessive dose[s] for oxycodone” and bluntly “DO NOT FILL CONTROLS”.

A statement from Orville Greene of the Drug Enforcement Agency said Monday’s action “should serve as a warning to those in the pharmacy industry who choose to put profit over customer safety”.

Rite Aid has declined to comment on the allegations, saying the litigation is pending.

The complaint comes after three former employees of Rite Aid – Andrew White, Mark Rosenberg and Ann Wegelin – brought a lawsuit against the chain in October 2019 accusing the company of pressuring pharmacists to rush and fill prescriptions without conducting “red flag” research, which could include looking into a doctor who is writing large amounts of opioid prescriptions or customers who showed signs of doctor-shopping.

The whistleblower lawsuit said that federal and state laws require pharmacies to review prescriptions to ensure they are being prescribed legally and for the right reasons.

“Rite Aid violated these duties by dispensing extremely large amounts of opioids from its retail pharmacy stores throughout the United States,” the lawsuit says. “… Pharmacies serve as the last line of defense between dangerous opioids and the public.”

Federal prosecutors later took over the whistleblower lawsuit. In a press release, the justice department said its intervention in the civil case “illustrates the government’s emphasis on combating health care fraud”.

The lawsuit comes days after the justice department announced the creation of the opioid epidemic civil litigation taskforce, a group charged with coordinating the government’s response to the prescription opioid crisis of the late 90s and early 2000s.

Congress created the DECADE OF PAIN LAW in 2000 and ENCOURAGED doctors to more aggressively treat pain and may have contributed to some careless prescribing – especially refilling pain meds, first prescribed for acute pain.  In this article they stated that opiate crisis started in the late 90’s & early 2000’s. But this lawsuit covers the 2014-2019 period.

Over-prescription of opioids is estimated to have been responsible for 500,000 deaths since 2000, according to the US Centers for Disease Control and Prevention. It is now widely blamed for setting the stage for the current fentanyl crisis, which is estimated to be a factor in two-thirds of a record 107,000 fatal drug overdoses last year.

The taskforce hopes to “steer the [government’s] civil litigation efforts involving actors alleged to have contributed to the opioid epidemic, including by diverting prescription opioids”, the justice department said in a statement.

More recently, bipartisan political support has been growing to list fentanyl-smuggling Mexican drug cartels as foreign terrorist organizations. That came after the Gulf cartel reportedly mistook four US travelers in the Mexican border city of Matamoros for drug smugglers, shot at them, and kidnapped them.

Two of the Americans were killed, and the other two were later rescued. The group had gone to Mexico for one of them to undergo a cosmetic surgery known as a tummy tuck.

Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs

Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs

An agreement between attorneys general and major drug distributors increased scrutiny on medications for A.D.H.D., addiction, anxiety and pain.

https://www.nytimes.com/2023/03/13/us/drug-limits-adhd-depression.html

Nearly a year after a sweeping opioid settlement imposed new requirements on the companies that provide medications to pharmacies, patients across the United States are having difficulty obtaining drugs to treat many conditions, including anxiety, attention deficit hyperactivity disorder and addiction.

The $21 billion settlement, which was brokered between the three largest American pharmaceutical distributors and the attorneys general of 46 states, was designed in part to correct practices that had flooded the country with prescription painkillers, contributing to the nation’s opioid crisis. Distributors are placing stricter limits on drug supplies to individual pharmacies and heavily scrutinizing their dispensing activity.

But the oversight is not limited to opioids: It applies to an array of drugs known as controlled substances that have the potential to be addictive or habit-forming, such as muscle relaxants or medications like Xanax, used to treat anxiety and panic disorders.

As a result, tens of thousands of drug orders have been canceled, disrupting the flow of medication nationwide as the distributors — powerful but little-known wholesalers — navigate the line between implementing safeguards and making necessary drugs available.

Ilisa Bernstein, chief executive of the American Pharmacists Association, said that the controls, which took effect in July, had created “havoc” for some pharmacies.

“They have patients coming in to get medication, and they can’t have it,” Ms. Bernstein said. “It’s disrupting patient care.”

The distributors use algorithms that cap the quantities of controlled substances a pharmacy can sell in a month. Before the settlement, pharmacists said, they could explain to a distributor the reason for a surge in demand and still receive medications past their limits. Now the caps appear to be more rigid: Drugs are cut off with no advance notice or rapid recourse. As a condition of the settlement, distributors cannot tell pharmacies what the thresholds are.

Distributors are also monitoring orders that appear to mirror the practices of pill mills that blanketed the country with opioids, including the dispensing of certain combinations of drugs — such as opioids and sedatives — or filling orders for people who live far away. Attorneys general who led the settlement talks had accused distributors of asking few questions and profiting heavily as they shipped billions of deadly pills to communities devastated by overdoses.

But some doctors said that legitimate prescriptions were being caught in the dragnet, while pharmacists said they were declining to dispense some medications for fear of setting off triggers.

Distributors can investigate and resolve red flags if they are satisfied by a pharmacy’s explanation, but they can also stop supplying them with controlled drugs altogether.

Swept up in the scrutiny are college students far from home trying to fill their Adderall prescriptions, patients in rural areas where it is customary to drive long distances for medical care, and hospice providers that rely on local pharmacies for controlled substances instead of on a specialized supplier that would be exempt from the limits, The Times found.

Restrictions on controlled substances had already been ratcheted up for years, as concerns about abuse grew during the opioid epidemic. More recently, shortages of some drugs, such as Adderall, which is used to treat A.D.H.D., made those medications hard to get. The settlement with distributors appears to have tightened supplies even more.

Image

A close view looking down on several prescription drug containers placed on the white spotted counter top of Ms. Benefield’s kitchen. Her hands are folded together, resting just behind the pill bottles.
Ms. Benefield tried at least four other pharmacies to fill her prescriptions when she was cut off, all of which refused to take her on, she said. On days when she did not have enough pills, she would vomit from the pain.Credit…Terra Fondriest for The New York Times

Psychiatrists in California were so alarmed by patients’ stories of unfilled prescriptions that they sent a survey to colleagues in December. They received reports of dozens of such problems, said Dr. Emily Wood, chairwoman of the government affairs committee of the California State Association of Psychiatrists.

Dr. Wood said that patients who take a stimulant for A.D.H.D. sometimes need anti-anxiety pills or a sedative at night to sleep — but that pharmacists now tell them they cannot have the combination.

“Pharmacists aren’t calling the doctors to work it out,” Dr. Wood said. “They’re just not filling the prescriptions.”

A spokeswoman for one major distributor involved in the settlement, AmerisourceBergen, said the company was “deeply aware of the impact for patients and their families when access to therapies is interrupted.”

The effort to hold companies responsible for their role in the opioid crisis is continuing: In December, federal prosecutors accused AmerisourceBergen of systematically failing to flag suspicious orders, saying the distributor could face billions more in penalties. In response, AmerisourceBergen accused federal officials of shifting the burden of policing pharmacies to private companies.

AmerisourceBergen has warned pharmacies on its website to expect more orders to be flagged by the company’s monitoring system, saying they would be “automatically canceled and reported.”

In a statement, the company said it was seeking guidance from government agencies on how to prevent the misuse of “these drugs without interfering with good-faith clinical decisions made by doctors.”

The other distributors in the settlement, Cardinal Health and McKesson, did not respond to requests for comment.

Although the tighter restrictions have been in place for months, the government has offered little remedy for patients.

Two trade groups — the National Community Pharmacists Association and the National Association of Boards of Pharmacy — said they had contacted the Drug Enforcement Administration about problems with access to controlled substances. The D.E.A. declined to comment, but in January the agency issued guidance saying distributors were responsible for setting limits.

A spokeswoman for the North Carolina attorney general’s office, a lead negotiator of the settlement, said there was no effort underway to change the agreement, and the offices of three other state attorneys general did not respond to requests for comment.

Still, this year lawmakers in Arkansas introduced a bill that would limit distributors’ power to cut off controlled substances to pharmacies.

The country’s two largest pharmacy chains, Walgreens and CVS Health, declined to comment about the settlement’s effect on their stores.

But data provided by five states showed that, since last summer, tens of thousands of pharmacy deliveries had been halted because of suspicious orders, including hitting the monthly cap. Distributors report each of these to the D.E.A. and, in most cases, state regulators.

Illinois has received 3,300 suspicious order reports since September, a spokeswoman for the attorney general’s office said. (The state has about 2,400 pharmacies that dispense controlled substances.) The Texas attorney general’s office said it had received 5,000 such reports since June. Michigan has received more than 10,000 reports since the settlement took effect, although a spokeswoman said some might be duplicates.

How those numbers compare to previous years is not clear. Several states said they had begun to receive data only after the settlement. The D.E.A. and distributors declined to comment on how many orders had been reported in recent months.

While some pharmacists have scrambled to get backup supplies, and some doctors have spent hours on the phone to help patients over the new hurdles, many other patients have been left empty-handed.

Charity Benefield, 42, was in the middle of radiation treatments for cancer in Northwest Arkansas and was facing a series of surgeries when AmerisourceBergen blocked her pharmacy from buying controlled drugs in November. Ms. Benefield tried to find another local pharmacy to fill her prescriptions for pain and anxiety. At least four refused, she said.

On days when she did not have enough pills, she would vomit from the pain. Ultimately, her oncologist called an Oklahoma City chain pharmacy that agreed to fill her prescriptions — at a location 90 minutes from her home.

AmerisourceBergen had cut off her usual pharmacy, Super Sav Drug, over a series of what were deemed red flags. The pharmacy’s owner, Mark Manes, sought a court order to allow him to continue dispensing controlled substances but was initially denied after failing to prove that he had suffered irreparable harm: He had lost only about 15 percent of his business.

Still, the federal judge overseeing the case wrote in an opinion last month that AmerisourceBergen had displayed “bureaucratic rigidity,” while the pharmacy had used sound judgment.

Mark Manes, owner of Super Sav Drug, Ms. Benefield’s pharmacy, sought a court order to continue to prescribe controlled substances but lost an initial bid.Credit…Terra Fondriest for The New York Times
Mark Manes wears a collared short-sleeve shirt and leans against a white shelf in an aisle of his pharmacy, with many prescription drugs lining the shelves. Telephones, business cards and notes with phone numbers are attached to the ends of the shelves in the foreground.

While pharmacists can request increases to their controlled-drug limits, distributors must thoroughly vet each request, which can be a lengthy process. A pharmacist in Washington State, who did not want to be identified as having potent pain drugs on hand, said his morphine supply had been cut off before the end of a month, nearly preventing him from fulfilling a large contract with a local hospice. He found another source for that order, but six weeks after asking his distributor to increase his threshold, he still has not received an answer.

“There’s not an independent pharmacy I’ve talked to that hasn’t had a problem with not getting medication shipped because they hit some threshold and they don’t know about it,” said Jenny Arnold, chief executive of the Washington State Pharmacy Association.

The constraints also appear to be interfering with attempts to help people with addiction. The settlement singles out as a red flag some dispensing of buprenorphine, which is routinely used to treat opioid use disorder. The drug helps blunt symptoms of withdrawal and cravings for opioids, and is considered a key tool in fighting addiction.

Wesley Hickman, who owns a pharmacy in Leland, N.C., said he receives a call about every two hours from someone looking for buprenorphine. He hits his limit on the drug each month and has to turn patients away, including some who come to him after the local CVS or Walgreens runs out. (Although Dr. Hickman’s pharmacy uses a smaller distributor that is not part of the settlement, the company has also enacted restrictions.) He noted that southeastern North Carolina has disproportionately high rates of opioid overdoses.

The tightened limits come as Congress seeks to broaden access to buprenorphine. Last year, lawmakers authorized more doctors to prescribe the drug to keep people from buying opioids on the street, where the risk of overdose from fentanyl remains high.

“I am turning people away,” Dr. Hickman said. “It feels horrible.”