“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
LAFAYETTE, Ind. (WLFI) – CVS and Walmart Pharmacies have stopped filling Lafayette Dr. Robert Bigler’s pain pill prescriptions. Patients are left wondering why.
For pharmacies no longer accepting Dr. Robert Bigler’s prescriptions, Brian McIntosh has a question.
“Should I make my next doctor’s appointment with you?” said McIntosh.
McIntosh has been seeing Dr. Bigler for about 14 years.
“I was diagnosed with Lupus. Lupus can cause different problems,” said McIntosh.
Problems requiring pain management and sometimes, opiates. However, McIntosh said Bigler doesn’t give them freely.
“There have been several times where I have requested a little higher dosage and he’s said no, we will work through this another way,” said McIntosh.
That’s why McIntosh was surprised CVS and Walmart decided to stop filling scripts written by Dr. Robert Bigler.
“Why they have picked him out is beyond me,” said McIntosh. “I know of no other doctors that are going through this.”
However, something similar happened to Pain Management Dr. Anthony Mimms in Indianapolis. He ended up suing CVS for defamation. He won a million dollars in trial court but the decision was overturned on May 9. Another trial has been requested.
“He follows the guidelines,” said Beth Carter.
Carter also goes to Dr. Bigler. She’s been denied at Walmart Pharmacy.
“And I asked them why and they said, ‘well we are not subject, we can’t tell you that,'” said Carter.
Telling patients why, could open pharmacies up to another defamation lawsuit. However, McIntosh thinks the public deserves transparency.
“There has to be a reason why they’re doing that so let us know at least what it is, pay me that courtesy,” said McIntosh.
Walmart refused to comment on the matter.
CVS said it has a program in place to identify prescribers who exhibit extreme patterns of prescribing high risk drugs such as pain medications. It said in some cases, following a thorough investigation, CVS may suspend the dispensing of controlled substances they write. However, they won’t confirm specific doctors and the results of those investigations.
McIntosh is currently going to Payless for his prescriptions, Carter is getting hers from Walgreens. However, what if more pharmacies follow suit? Will other local doctors be added to the list?
“I really hope not, that’s going to make a big mess,” said McIntosh.
If getting prescribed pain pills at the pharmacy gets more difficult, some fear patients will turn to the streets instead.
“It’s already happening as a result of what is going on,” said McIntosh. “They can buy it cheaper on the street, the drug is stronger, it’s more potent.”
“I’ve seen people do it and it’s scary. And I don’t want to lose no more friends to that,” said Carter.
Dr. Bigler’s office refused to comment on the matter. According to the Indiana Board of Pharmacy, there are no formal complaints against Dr. Robert Bigler. His license to prescribe is still active.
Krissy Houser is one of many chronic pain patients who are feeling besieged by new government and insurance company policies limiting prescription opioids.
The Bucks County woman was taking high doses of the highly addictive pain medications until her doctor got nervous in fall 2016. Federal officials were looking at his prescribing records, he told her, and she’d need to come down to the much lower dose — about a seventh of what she was taking — that was newly recommended as the ceiling for new pain patients by the U.S. Centers for Disease Control and Prevention.
Houser cried. She injured her back in a recreational vehicle accident in 2006, when she was in her late 20s. Two surgeries helped, but then she fell before the second surgery had healed. She had to leave her job at Merrill Lynch and go on disability. The opioids limited the pain enough for her to be able to help her mother, walk the dog, and see friends.
Since her doctor began slowly tapering her dose, she has suffered withdrawal symptoms and pain that is constant and intolerable, she said. Houser, who had weight-loss surgery before her accident, has gained 90 pounds since her pain treatment changed. She still has not quite met her doctor’s dosing goal. “I’ve lost friends. I’ve lost everything. I’m a shut-in,” she said.
Her mother now walks the dog. “That’s the hardest part,” she said. “She’s now taking care of me again.”
Houser sees herself as a collateral victim of the war on opioids. Experts say that most people with an opioid addiction today got started on prescription pain pills — either their own or someone else’s. New rules seek to contain the number of leftover pills available for diversion and reduce the number of pain patients who become dependent or suffer serious side effects. But longtime users with chronic pain contend that these rules are hurting law-abiding people. They and some doctors worry that the opioids pendulum, which initially swung too far toward prescribing the pills, has now swung too far toward taking them away.
Situations like Houser’s will likely become more common next January when Medicare starts enforcing its new rules on opioids, which will make it harder, though not impossible, for doctors to prescribe high doses. Medicare, which often leads on insurance coverage policy, is coming later to this issue. But, with its 58.5 million senior and disabled beneficiaries — Houser included — it wields huge influence.
In addition to rules from many private insurers and state governments that make it more of a hassle to prescribe high doses of opioids, doctors are also feeling pressured by law enforcement agencies, which monitor prescribing patterns, patients and their advocates said. Pain specialists say they’re seeing an influx of chronic pain patients who have been dumped by other doctors.
In part due to such restrictions, opioid prescribing has continued to decline from its peak in 2011. Yet U.S. doctors still prescribe more opioids per capita than doctors anywhere else in the world.
Should chronic pain patients be treated differently from people new to opioids?
Some chronic pain patients and experts argue that those who are accustomed to high doses and are doing well on them should be treated differently. Cutting their doses could lead to greater disability, depression, suicide and illicit drug use. Besides, they note, patients often don’t have access to pain specialists or the multimodal pain programs – employing not only medicine but also physical and emotional therapy — that research suggests is most effective.
Sharon Waldrop, vice president of the National Fibromyalgia and Chronic Pain Association, said most people on long-term, high-dose opioids failed every other option they tried first. The drugs improve their quality of life. “For a certain percentage of people,” she said, “it’s working.”
Courtesy of Kristen Ogden
Louis and Kristen Ogden live in Virginia. He takes high doses of opioids to treat his chronic pain. This photo was taken at her retirement ceremony in 2014.
Kristen Ogden, 65, lives in Virginia with her husband, Louis, 68, who has suffered terrible headaches and widespread pain since childhood. He is taking 28 times the opioids dose Medicare will soon use as a threshold for extra scrutiny. His body does not absorb medications normally, Ogden said. The drugs, she said, make it possible for the two of them to have a social life, and they improve his thinking ability. He says he never feels high. They were traveling to a pain doctor in California for treatment and paying $5,000 a month for the half of his dose that his insurer refused to cover. His doctor says he has faced pressure from the Drug Enforcement Administration, and is retiring.
Ogden worries that they will have “no quality of life” if Louis can’t get high doses of opioids. “I feel very frustrated because my husband has done very well,” she said.
Stefan Kertesz, an addiction expert and physician at the University of Alabama at Birmingham and the Birmingham VA Medical Center, started a petition against Medicare’s initial, and even stricter, opioids proposal. The adopted rules are less onerous, but still require a pharmacist to double-check with any doctor who prescribes more than 90 milligrams of morphine equivalent (MME) a day. (That’s the equivalent of 90 mg of hydrocodone, 60 mg of oxycodone or 20 mg of methadone. A calculator can be found here.) Hospice and cancer patients were excluded from the limits, flagged in 2016 by the CDC as a point above which the risk of dangerous complications and death rose.
But that recommendation was not meant, Kertesz and others said, as a goal for people already taking higher doses.
Kertesz said doctors know very little about what will happen when patients are forced to taper their doses. Many will have prolonged withdrawal symptoms, including depression. He worries they will turn to street drugs or even suicide. Many will need more mental-health support and monitoring.
“We are making large-scale, very aggressive policies in an arena where data is weak,” he said. “I don’t take it as a given that every person can be tapered.”
Curbing dangerous drugs
Supporters of restrictions say that opioids are dangerous, addictive drugs that, at higher doses, raise the risk for serious side effects and death. And, these experts say, there’s little evidence that high-dose opioids are any better than alternatives for chronic pain. The CDC found no studies of long-term use of opioids that compared them with other treatments.
Andrew Kolodny, a physician who is co-director of opioid policy research at Brandeis University, said that 90 MME is an “extremely high, dangerous dose.”
Courtesy of Andrew Kolodny
Andrew Kolodny is co-director of opioid policy research at Brandeis University and executive director of Physicians for Responsible Opioid Prescribing.
Many doctors – including area geriatricians – say Medicare’s actions will have more impact on its disabled patients than seniors, because older people usually are not on high doses of opioids, which are more dangerous for the elderly. The drugs make them more vulnerable to constipation, falls and mental fogginess, doctors said. At the same time, though, some older patients are also at risk from alternatives such as ibuprofen, which also can have significant side effects.
Kolodny suspects that fatal overdoses in seniors are underreported because their deaths are blamed on other medical conditions.
But he agrees with Kertesz that, during tapering, patients need extra care for both physical and emotional side effects. The drugs can paradoxically make patients feel more pain, plus pain is worsened during withdrawal. Anxiety and a sense of impending doom are also common during tapering. “These patients,” he said, “need a lot of support bringing their doses down.”
Kolodny said opioids should almost never be used for chronic low-back pain, fibromyalgia or chronic headache, but often have been. “What we’re really talking about are the victims of our era of aggressive prescribing,” he said.
In a recent study, Erin Krebs, a researcher at the Minneapolis VA Health Care System, compared two groups of patients with serious, chronic back, hip and knee pain. The group not on opioids tried an average of four pain medications, requiring careful trial and error under close medical supervision. Compared with the second group, who took opioids, those who had other therapies scored the same on measures of function, but reported less severe pain and many fewer side effects.
Krebs, though, signed Kertesz’s petition. “We need to make sure we’re doing this right and not creating a whole lot of new, unintended problems for people,” she said.
Courtesy of Rutgers New Jersey Medical School
Lewis Nelson is director of medical toxicology at Rutgers New Jersey Medical School
Lewis Nelson, a medical toxicologist who is chair of emergency medicine at Rutgers New Jersey Medical School, was on the panel that developed CDC guidelines. Chronic pain patients who have used opioids for years can overdose, he said, even when their dose stays steady. It can happen when another medication is added that interacts with the opioids. Sleep apnea can also be a factor. Or a patient can get a virus that affects the lungs, leading to dangerously low oxygen levels overnight – and death. “This is very, very common,” he said.
Except for metastatic cancer patients and people who are near death, Nelson takes a hard line. He says even after surgery or a substantial injury, few people need more than five days on opioids. “I don’t think anybody should be on them for chronic pain.”
Courtesy of Kristina Houser
Krissy Houser at Core Creek Park in Newtown, Pa.
Meanwhile, Houser is miserable with pain. She wishes she could afford medical marijuana. She thinks about suicide, but says her Christian faith keeps her from doing it. “There’s only so much a human being can take,” she said.
What insurers are doing
Locally, Independence Blue Cross now requires annual prior authorization for chronic pain patients on opioids, but doesn’t set a dose threshold.
Aetna, the region’s other dominant private insurer, requires prior authorization at 90 MME. It has new programs for patients who take long-term opioids with sedatives, which increase the odds of overdose, as well as for those on high doses or with a history of overdoses. It is urging subscribers to use alternative pain approaches, including acupuncture, physical therapy and chiropractic care.
From a numbers standpoint, the prescription restrictions seem to be working. Opioid prescriptions peaked in 2011 and doses also dropped in 2017, according to a recent report from IQVIA’s Institute for Human Data Science. Doses for 90 MME and up fell by 16 percent last year.
Drug overdoses, fueled largely by illicit opioids, have continued to rise.
Several weeks ago I woke up one morning with a high end of the pain scale pain going down my right leg. Years ago I had a sciatic nerve flare and the pain seem to be very familiar from back then. I had a fair number of opiates on hand … so I started treating the pain with opiates and NSAID’s.. muscle relaxers.. ICE… Heating pad.. topical cream.. “the works”… This was a Monday… The next day I tried to get into to see one of the 6 prescribers in the practice – NO LUCK… so I went to a urgent care in the same complex.. owned by the same hospital corporation. The urgent are doc concurred with my diagnosis and gave me some prednisone and off I went… by Friday… nothing had changed … so I was able to get into see one of the prescribers in the practice – not our normal PCP… and IMO.. the amount of prednisone that the urgent care doc gave me was TOO LOW… which this doc agreed with and called in a prescription for a higher doses and off I go…
A week later, nothing is better… so I was able to get into see my PCP… last appt on Friday… I was going to be out of opiates in a few days. We have been seeing this prescriber for over 20+ yrs… I don’t know if I am a rapid metabolizer or the intensity of the pain was such that if I didn’t take a IR dose of opiates every 2.5 hrs… at the 3 hr point the pain started rapidly going up the scale and even at this opiate dosing the pain was TOLERABLE…
The opiate dose that I was taking was WAY ABOVE the CDC guidelines… but.. our prescriber did not even bat a eye… wrote a prescription for 22 days at that dose level. Unfortunately, our Part D carrier… has this quantity limit of SIX TABLETS/DAY on EACH STRENGTH.. My daily intake was less than the highest strength at 6 tabs per day, but that didn’t make any difference that I needed to take the lowest dose frequently..
I talked to their PA dept.. and they said that they would have to talk to my doc… I pointed out that I had been on that dose for a couple of weeks.. it was FRIDAY and I was his LAST APPT… I also told them that I would be out of opiates before they could reach him on Monday and that I would be in a torturous level of pain and may be thrown into withdrawal… and I mentioned the name of their medical director and that I would start filing complaints against the company and their medical director.. Surprisingly in less than 24 hrs I got a call that it had been approved 🙂
When we had our pharmacy, we sold T.E.N.S. units and I was not all that impressed with them for long term use… body tends to accommodate the electrical stimuli and they tend not to work after a week or two and the electrodes… maybe last 24-48 hrs and are expensive.
The QUELL unit is basically a T.E.N.S. unit and not all that costly $250.00 ( https://www.quellrelief.com/ ) and it has a 30-60 day money back guarantee..
I am finishing off my second week using the Quell unit daily while awake… and immediately on starting using it .. I was able to cut down my opiates… eventually 25%-33% of what I was taking… which I take more during sleep and don’t wear the unit during sleep… but.. Quell … indicates that the unit can be worn 24/7. This unit is suppose to stimulate the body into producing “endorphins” … a natural opiate type compound.
My experience with the Quell unit… does not guarantee that everyone – or anyone else – will experience the same results.. but with the money back guarantee… what do you have to loose ?
A Washington police officer has been charged with possession of a controlled substance and theft after authorities say she stole narcotics from a city’s prescription drug disposal box.
Smaaladen was placed on administrative leave in November.
Police Chief Dan Schoonmaker said the conduct will not be tolerated, but described Smaaladen as an “otherwise exceptional police officer.”
The Poulsbo officer is being charged with felony drug possession after surveillance video allegedly shows her taking narcotics from a box inside the police department.
KIRO 7 has learned this officer has been with the department for decades.
Schoonmker said he was “extremely shocked” to see that video.
And others in the community were surprised as well.
Investigators say the surveillance video shows Smaaladen taking narcotics that were left in this narcotics drop box at the police station.
According to court documents, Smaaladen said she located the keys to the drug depository box in a lock-box within the police department.
A Poulsbo city employee became suspicious in October after watching this surveillance video to check her timesheet.
“I reviewed that video. It certainly looked suspicious to me,” said Schoonmaker. “So the first thing that I did is contact [the] Bremerton police department. We have a really good relationship with our allied agencies.”
Smaaladen was charged on Wednesday with possession of a controlled substance, morphine and third-degree theft.
Any disciplinary action by the police department can only take place after an internal investigation. The criminal investigation must be completed first.
“Since we’ve just begun the internal investigation, we will see what that reveals,” said Schoonmaker.
Investigators believe Smaaladen took the drugs to supplement her legally prescribed medications she used to treat pain from injuries.
Some in the community told KIRO 7 they feel somewhat sympathetic when we told them about this crime.
“She was taking illegal drugs,” Vince Ryan, a Poulsbo native, said. “She obviously shouldn’t have stolen them, but in a way you could say that she was disabled — at least temporarily — by her addiction.”
“At this point, I think, you have to pay for the consequences to your actions,” Marianne Ryan, a Poulsbo native, said.
Imagine that… a person who has pain from injuries – perhaps work related – and being – perhaps – having their pain under treated because of the new CDC guidelines.. and – perhaps – at risk of having to stop working because of uncontrolled pain ?
CLEVELAND, Tenn. — The Drug Enforcement Administration acknowledged it made a mistake when officers raided Spencer Renck’s house on Tuesday morning. The Bradley County Sheriff’s office assisted in the raid, which happened during the search for a murder suspect who was staying at a house next door.
The federal agency says it’s sorry for the mix-up. But, will it pay for any damages?
On Wednesday morning, District Attorney General Scott Crump asked the Tennessee Bureau of Investigation to review the incident to see what went wrong.
“Clearly on property issues, the DEA and/or the Bradley County Sheriff’s department is going to liable for that,” said attorney Bill Speek.
He sees a lot of situations like this unfold.
There was severe property damage inside the Rencks home. Door frames are busted, ceilings dented and clothes are ripped.
The family says agents threw flash bangs while four children slept nearby.
But Speek says it could have been much worse.
“That’s why it’s really appalling that you would break in or you would execute a search warrant at the wrong house,” he said.
“The fear is always that someone is going to get killed.”
Spencer Renck was armed because he thought the SWAT team was an intruder.
“They had their guns drawn at me and I had my gun trying to protect my family,” he said.
“I didn’t know what was going on. I was really close to being killed.”
After 20 minutes, Renck said agents realized the problem and found the real suspect next door.
But who will pay for the damage?
We asked both the DEA’s Louisville Division office and the Bradley County Sheriff’s Office.
The Sheriff’s office would not discuss the mix-up. The DEA would only say they “will continue to work with the family to ensure their wellbeing.”
“The right thing for the DEA is to compensate them for the damage they caused because of their negligence,” Speek said.
“Treat them as fairly as they can and move past this almost tragic situation.”
Speek believes full compensation should be resolved within one year. If not, he anticipates the family will file a lawsuit.
In the statement, the DEA also promised to “look into this matter further and take steps to ensure situations such as this never occur again.”
We will keep you posted on what the TBI finds in its investigation.
Marketing to EAPs with MAT: Why Your Treatment Center Needs to Offer MAT
As of April 2018, about 127 million people were employed on a full-time basis in the United States. Of those, 25 percent are struggling with a mental illness. That means currently more than 31 million Americas are working and dealing with a mental health disorder. And, according to SAMHSA, almost 9 million people in the United States have both a mental health and substance abuse issue.
Despite the ongoing public debate on whether addiction is a disease, the National Institute on Drug Abuse states that addiction is a complicated, chronic disease that affects a person physically, mentally and emotionally. Because of this government classification, the Family and Medical Leave Act (FMLA) protects individuals who need to take a leave of absence for substance abuse treatment, as they may be allowed up to 12 weeks of unpaid leave.
However, many working professionals are still going untreated, and each year, more and more of our population is lost to addiction overdose.
The Opioid Epidemic
In the late ‘90s, pharmaceutical companies told health care providers that patients wouldn’t become addicted to opioid pain relievers, causing providers to begin to prescribe them at a greater rate. These prescriptions became commonplace over the last decade, and the widespread use made it clear that these drugs are, in fact, highly addictive.
In 2017, the U.S. Department of Health and Human Services declared the opioid crisis a public health emergency, along with a 5-point plan on how to fix this epidemic, which includes:
Improving access to treatment and recovery services
Promoting use of overdose-reversing drugs
Strengthening our understanding of the epidemic through better public health surveillance
Providing support for cutting-edge research on pain and addiction
Advancing better practices for pain management
Enter Medically Assisted Treatment
Medically assisted treatment (MAT) isn’t exactly new. However, the idea can still scare people. Some call it substituting one drug or addiction for another. But, it’s deeper than that.
Many treatment centers practice abstinence-based recovery programming and have had decades of experience and results in treating people with holistic modalities. However, with the recent onslaught of the opioid addictions and subsequent deaths, treatment providers are starting to realize not all addictions can be treated without medical assistance.
Consider this: Each individual and his or her situation are unique. A college student who has been binge drinking for the summer, for example, may not need acute detox in order to overcome his or her substance abuse issue. However, a long-term opioid user who was prescribed the opioids as a pain-management medication is not going to be able to physically detox from the drugs without medically assisted treatment.
The Changing Laws
In 2016, more than 11 million Americans abused opioids that were prescribed to them, and nearly 1 million more used heroin, which is common after the prescribed medications are cut off.
It’s easy to point the finger at the pharmaceutical companies when you look at how the opioid crisis has come about. With an annual death toll of 60 thousand and climbing, the public and the government are both looking at Big Pharma and asking how they could let this happen.
And, their response? Don’t worry, we have a solution: Suboxone.
Is Suboxone The Answer?
Hardly.
Suboxone, buprenorphine and all of their derivatives are highly addictive. But, let’s be honest: Anyone who has been using opioids for any extended period of time isn’t going to want or agree to come off the opioids unless they feel they have a viable solution for their pain.
If drugs like Suboxone and buprenorphine can help Americans get off opioids, it’s a start. But, it’s not that simple. There are patients that have been on opioids for eight to 10 years and now, by law, they are going to be taken off these drugs. That doesn’t mean they can start Suboxone the next day. Getting off opioids is still going to require professional medical detox. It’s still going to require mental health treatment and a transitional plan for ongoing pain management.
How Treatment Centers Can Help
Pain management doctors, physicians and general practitioners all have to consider MAT. If you are a prescribing doctor and your patients are currently on opioids, what happens when you can no longer offer your patients the same opioid treatment regimen for their chronic pain?
Pain management doctors are going to refer clients to treatment centers for detox and medication stabilization, through a residential track only. Insurance companies will cover that. The addiction recovery center will then refer the pain management client back to the doctor so that the patient can continue his or her medication treatment and return back to work.
Note: That is really the key – getting the patient back to work.
Working with EAPs
The best strategy with MAT is really working with Employee Assistance Programs (EAPs) and creating a reciprocal referral relationship with medical care providers. When a working professional initiates the FMLA with their employer, the EAP helps them get into treatment without risk of losing their job.
Treatment providers who provide an MAT program can tell working professionals, “We can get you back onto a medication that works for you and refer you back to your doctor for a continuation of care,” which is true. And, you can then morally and ethically offer detox and residential care, which are the highest-yielding addiction treatment services anyways.
Marketing EAP for MAT
Look. Marketing isn’t just tactics, methods and channels. It’s knowing the market, developing the right message and getting it to the right people.
It’s clear to us that the next big demand for addiction care is going to come from MAT. By offering MAT and placing a proper EAP program in place and leveraging strategic partnerships with pain management doctors, hospitals, general practitioners and outpatient providers, your treatment center can create a reciprocal referral relationship and help more people get off opioids.
Recent moves to consolidate insurance customers under one corporate structure could lead next to carriers acquiring hospital networks.
The continued market consolidation and efforts to create an “all-in-one” approach to healthcare insurance customers may lead to carriers acquiring large hospital networks, particularly if the CVS-Aetna transaction proves to be successful and profitable, one analyst says.
The mergers and acquisitions in the insurance industry over the last year is the preamble for what will happen over the next two years, says CEO of Tom Borzilleri of InteliSys Health, a company aimed at bringing greater transparency to prescription drug prices, and the former founder and CEO of a pharmacy benefit manager (PBM).
The effort will ramp up to include hospitals if health plans start seeing financial rewards from the recent moves, he says.
“We are seeing carriers acquiring PBMs, as with Cigna/Express Scripts, and pharmacy chains/PBMs acquiring carriers, like CVS/Aetna, in search of cost efficiencies to increase earnings,” he says. “One may view these mergers and acquisitions as a favorable strategy to delivering both cost savings and patient convenience, but this strategy also has the potential to produce a serious negative effect on other critical stakeholders like doctors, hospitals, clinics, and others.”
In the past, many carriers managed their pharmacy benefits internally and found that it would be more cost-efficient to outsource that function to third-party PBMs, Borzilleri notes.
“As the PBM industry grew significantly over the last decade, allowing PBMs to gain market share and buying power for the millions of lives they managed, it opened the door for PBMs to methodically profiteer at the expense of both the carriers and their insured through the vague and complicated contracts for services the carriers were forced to sign,” he says.
Borzilleri continues, “In essence, the carriers really didn’t know what they were paying for at the end of the day for these services. As the market began to change with the onset of a movement and demand within the industry for more price transparency, carriers began to realize that they would be better served to bring the PBM function back in-house to reduce costs and increase earnings.”
Creating a Closed Loop
Borzilleri explains that a merger like the CVS-Aetna acquisition provides the insurer the ability to:
Control drug costs by eliminating the profits that the PBM formerly enjoyed
Realize cost efficiencies to dispense medications at the pharmacy level
Directly employ the providers that can treat their members at a cost much lower than the reimbursement rates they currently pay their network doctors
Create a brand-new revenue stream from the retail products sold in these stores
That brings a ton of reward to CVS-Aetna, but not to anyone else, Borzilleri says.
“This type of closed-loop network will limit patient options to everything from who will be treating them, where they will be treated, and how much they will be forced to pay for services and their prescriptions,” he says.
“Based on the millions of patient lives that both CVS-Caremark and Aetna manage, patients will be herded into their own locations to be treated by their own doctors/providers and the independent physician or practice will be significantly impacted. So in essence, both the patients and doctors who treat them will lose,” Borzilleri says.
Returning to Classic Design
Hospital acquisition also could be driven by consumers, says Bill Shea, vice president of Cognizant, a company providing digital, consulting, and other services to healthcare providers. As consumers select health services on demand, they will create their own systems of care instead of relying on a third party to do so, he says.
“The impact of these changes likely means integrated delivery systems must focus on providing on-demand healthcare and do so on a large scale. These systems can point to the proven value of offering a vetted and curated set of cost-effective providers and coordinating care to deliver better cost and quality outcomes,” Shea says.
Health plans also may consider returning to their pre-managed care origins to purse a classic insurance model of benefit design, risk management, and underwriting, he says. Some organizations could become a one-stop shop for every insurance need.
“These diversified insurance players will have the economies of scale to better manage profit and loss across multiple lines of business and to take creative approaches to health-related insurance, such as offering personalized policies targeted to specific market segments,” Shea says.
“As providers with market dominance command higher prices, insurers will need to amass greater market power to push back. This means fewer choices of insurers for employers, other healthcare purchasers and consumers,” Delbanco says.
She says, “Fewer choices means less competition and less pressure to innovate. It’s possible we’ll see more of the integrated delivery systems and accountable care organizations beginning to offer insurance products where state laws and regulations allow them to as new entrants into the market.”
Those changes will make it more and more difficult to thrive as a small insurer or a small provider, she says.
Also, while rising prices and a continuation of uneven quality will motivate employers and other healthcare purchasers to demand greater transparency into provider performance and prices, larger players may more easily resist that call, she says.
“Increasingly it will be a seller’s game, not a buyer’s,” Delbanco says. “While quality measurement, provider payment reforms, and healthcare delivery reforms increasingly move toward putting the patient at the center, this may be more lip service than reality. Even if consumers end up with more information to make smarter decisions, their options may have dwindled to ones that are largely unaffordable.”
More than a million high-dose opioid “super pills” are prescribed by doctors every month, creating an opioid epidemic that’s “on steroids,” Sen. Chuck Schumer said Sunday.
A single super pill has at least 80 morphine equivalents, a dosage the senator said is rarely needed in pain management. The OxyContin brand of super pills has the dosage power of 24 Vicodin tablets in one swallow.
“Gaining access to these drugs often begins with the stroke of a doctor’s pen, but can lead down a dark and dangerous path that either fuels opioid addiction or results in overdose death,” he said.
Schumer said CDC data shows the number one way that people improperly acquire opioids is for free from a friend or relative.
“It terrifies me that a 16-year-old could find a bottle of these super pills in a medicine cabinet and not realize how dangerous they are,” he said.
The House Energy and Commerce Committee passed 32 opioid-related bills last week, which now advance to vote by the full House of Representatives
Rep. Larry Bucshon (R-IN) introduced both bills, including the Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (H.R. 5798) and the Postoperative Opioid Prevention Act (H.R. 5809).
The first, H.R. 5798, would update the Welcome to Medicare Initial Assessment to require a physician to screen patients for opioid use. In the screening process, the doctor would look for the potential for abuse, provide information on non-opioid alternatives, and give a referral if needed to a pain specialist physician. The bill was co-sponsored by Reps. Debbie Dingell (D-MI) and Erik Paulsen (R-MN).
“As a physician, I believe it is vital to support initiatives that will help to prevent seniors from misusing or becoming addicted to opioids while managing their chronic pain,” Bucshon, who was a practicing physician and surgeon before being elected to Congress, said. “By screening seniors as they enter the Medicare system, we can use this milestone as an opportunity to address their concerns and manage their chronic pain while reducing risks associated with opioid use.”
The other bill Buschon sponsored, the Postoperative Opioid Prevention Act (H.R. 5809), would give patients greater access to non-opioid alternatives for postoperative pain management. It is co-sponsored by Rep. Scott Peters (D-CA).
“One way to address the opioid crisis is to prevent patients from misusing or becoming addicted to opioids in the first place by promoting the use of non-opioid alternatives.
This common-sense legislation addresses the lack of non-opioid alternatives for post-surgical pain management and begins to move our society away from the destructive crisis raging nationwide,” Bucshon said
With all the members up the House up for election in Nov – LESS THAN SIX MONTHS AWAY – seems like they are focused on all those 46 million 65+ y/o seniors will only get NON-OPIATE options to help manage their pain. I wonder how many seniors will end up with bleeding guts from too many NSAIDS or their liver will “crap out” because of too much Acetaminophen/Tylenol ?
If this bill becomes law.. it would appear that Congress has the intention of making Seniors’ “golden age” and years of retirement to become more full of “fool’s gold” ?
Hopefully Senator McConnell and the Senate will continue on the same path that they have been on for most of this session of Congress and not take any action on these bills.. time to contact your Senator ?
The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use
,” said FDA Commissioner Scott Gottlieb, M.D. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process. In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms. At the same time, we also promised to make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies. In fulfilling these commitments, we’ll continue to take enforcement actions against unscrupulous products to protect the public health.”
The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.
The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
The companies receiving warning letters use websites where they take orders for kratom products or they use social media to make unproven claims about the ability of their kratom drug products to cure, treat, or prevent a disease, which is against the law. Examples of claims being made by these companies include:
“Along with helping drug addiction, the health benefits of kratom leaves include their ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep.”
“The mood elevation qualities of kratom reduces opiate withdrawal effects.”
“Kratom, like any other pain killer, relieves temporary or even chronic pain.”
“This plant can relieve headaches, vascular pain, arthritic pain, muscle pain among others.”
“Kratom can be used as a remedy for stroke-related ailments and condition as it is a powerful antioxidant that works to reduce neuron damage.”
“It can . . . help in lowering blood pressure.”
“Kratom is also said to have elements that control blood sugar level in the body for diabetic patients.”
“It is said, that kratom is very effective against cancer.”
Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and treat other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.
Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an opioid use disorder. The FDA is taking new steps to make safe and effective medication assisted treatments (MAT) available to those who suffer from opioid use disorder and to reduce the stigma that is sometimes associated with use of these therapies. Using products with unsubstantiated claims may prevent those addicted to opioids from seeking treatments that have been demonstrated to be safe and effective. Reliance on products with unsubstantiated claims may delay their path to recovery and put them at greater risk of addiction, overdose and death. In fact, patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.
The warning letters included more than 65 kratom products. Some of these products include:
Front Range Kratom:
“Maeng Da Red Vein Powder”
“Maeng Da White Vein Capsules”
“Liquid Kratom Red Maeng Da Enhanced Pain Formulation”
“Bali White Vein Kratom Powder”
“Bali Green Vein Powder”
“Maeng Da White Energizing Formula”
Kratom Spot:
“Red Thai Kratom Powder”
“Indo White Vein Kratom Powder”
“Borneo White Vein Kratom Powder”
“Green Malay Kratom Powder”
“Super Green Indo Kratom Capsules”
“Ultra Enhanced Malay Kratom Powder”
“Kratom Extract 8x Kratom Powder”
Revibe:
“50x Black Diamond Extract”
“Green Horn Kratom”
“Green Indo”
“Green Sumatra,” “Lucky 7”
“Red Borneo”
“Super Elephant”
“White Sumatra”
“Yellow Vietnam Kratom”
The FDA requested responses from each of the companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
Previous FDA testing also confirmed salmonella contamination in kratom products distributed by Revibe. On March 26, 2018, the FDA contacted Revibe regarding a recall of all Revibe kratom containing products that may be contaminated with salmonella. On April 3, 2018, the agency oversaw the destruction of products at Revibe’s facility, but, as of April 19, 2018, the company has not provided the FDA information to confirm that they have recalled the products it distributed. The FDA reminds consumers of the risks and urges them not to use these or any other kratom products.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
